MRx Pipeline - April 2020

April 2020

MRx PIPELINE A VIEW INTO UPCOMING SPECIALTY & TRADITIONAL DRUGS

TABLE OF CONTENTS Introduction Pipeline Deep Dive

EDITORIAL STAFF Maryam Tabatabai, PharmD Editor in Chief Senior Director, Drug Information Carole Kerzic, RPh Executive Editor Drug Information Pharmacist

Keep on Your Radar

Consultant Panel

Pipeline Drug List

Lara Frick, PharmD, BCPS, BCPP Drug Information Pharmacist

Becky Borgert, PharmD, BCOP Director, Clinical Oncology Product Development

Robert Greer, RPh, BCOP Senior Director, Clinical Strategy and Programs

Glossary

Sam Leo, PharmD Director, Clinical Strategy and Innovation, Specialty Troy Phelps Senior Director, COAR - Analytics

Nothing herein is or shall be construed as a promise or representation regarding past or future events and Magellan Rx Management expressly disclaims any and all liability relating to the use of or reliance on the information contained in this presentation. The information contained in this publication is intended for educational purposes only and should not be considered clinical, financial, or legal advice. By receipt of this publication, each recipient agrees that the information contained herein will be kept confidential and that the information will not be photocopied, reproduced, distributed to, or disclosed to others at any time without the prior written consent of Magellan Rx Management.

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INTRODUCTION Welcome to the MRx Pipeline. In its fourth year of publication, this quarterly report offers clinical insights and competitive intelligence on anticipated drugs in development. Our universal forecast addresses trends applicable across market segments.

Traditional and specialty drugs, agents under the pharmacy and medical benefits, new molecular entities, pertinent new and expanded indications for existing medications, and biosimilars are profiled in the report.

Clinical analyses, financial outlook, and pre-regulatory status are considered as part of the evaluation process.

The products housed in the MRx Pipeline have been researched in detail and developed in collaboration and in consultation with our internal team of clinical and analytics experts.

Emerging therapeutics continue to grow and influence the clinical and financial landscape. Therefore, Magellan Rx Management has developed a systematic approach to determine the products with significant clinical impact. For the in-depth clinical evaluations, the products’ potential to meet an underserved need in the market by becoming the new standard of care and the ability to replace existing therapies were investigated. The extent to which the pipeline drugs could shift market share on a formulary and their impact on disease prevalence were also important considerations.

In order to assist payers with assessing the potential impact of these pipeline drugs, where available, a financial forecast has been included for select products. Primarily complemented by data from EvaluateTM, this pipeline report looks ahead at the 5-year projected annual US sales through the year 2024. These figures are not specific to a particular commercial or government line of business; rather, they look at forecasted total US sales. Depending on a variety of factors, such as the therapeutic category, eventual FDA-approved indications, population within the plan, and other indices, the financial impact could vary by different lines of business.

In the past few years, game changers, such as chimeric antigen receptor (CAR) T therapies and antibody drug conjugates (ADCs), deliver drug therapy directly to the site of action in the body. In 2020, first-time drugs for peanut allergies were approved by the FDA. The agency also continues to approve select therapies under new programs.

Examples include the real-time oncology review (RTOR) pilot, in which the FDA reviews clinical data prior to the formal submission of the drug application, leading to an approval well in advance of the FDA goal date; and Project Orbis, a framework for concurrent submission and review of oncology drugs among international regulatory counterparts.

Moreover, in response to the COVID-19 pandemic, the FDA has established a special emergency program, the Coronavirus Treatment Acceleration Program (CTAP), as well as a public-private partnership (Accelerating COVID-19 Therapeutic Interventions and Vaccines [ACTIV]) with the National Institutes of Health (NIH) and other partners, to speed the development of treatments and vaccines for COVID-19.

As we look ahead, a continued trend toward the approval of specialty medications, drugs for rare diseases, growth of biosimilars, new treatment modalities using gene therapy, and additional CAR T therapies are expected. Noteworthy pipeline trends to watch in 2020 include therapies for COVID-19, the first gene therapy for hemophilia A, and the first treatment for NASH. In the upcoming quarters, development of complex therapies, therapeutic options for rare hereditary diseases, oncology, immunology, neurology, cardiology, and investigational agents will be monitored on the MRx radar. Moreover, sprouting products for ophthalmology, hematology, and women’s health await on the horizon.

The drug pipeline ecosphere will continue to evolve as it faces challenges and successes. Novel agents that apply innovation to show positive results without compromising patient safety and access offer true therapeutic advances and hold the promise to alter the treatment paradigm.

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PIPELINE DEEP DIVE Objective evidence-based methodology was used to identify the Deep Dive drugs in the upcoming quarters. This section features a clinical overview and explores the potential place in therapy for these agents. Moreover, it addresses their FDA approval timeline and 5-year financial forecast.

SPECIALTY

PRIORITY REVIEW

89%

BREAKTHROUGH THERAPY

44%

39% BIOSIMILAR

ORPHAN DRUG

44%

28%

pecialty drug names appear in ï‚« S magenta throughout the publication.

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ONCOLOGY

belantamab mafodotin IV GlaxoSmithKline PROPOSED INDICATIONS

Relapsed or refractory multiple myeloma (R/R MM) after prior therapy with an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody

CLINICAL OVERVIEW

B cell maturation antigen (BCMA) is expressed by mature B lymphocytes. BMCA is overexpressed in multiple myeloma (MM). Belantamab mafodotin is an antibody drug conjugate (ADC) that contains a humanized antiBCMA monoclonal antibody linked to the cytotoxic agent auristatin F. ADCs are designed to deliver potent cytotoxic therapy directly to tumor cells using the selectivity of the monoclonal antibody.

The phase 2, open-label DREAMM2 trial enrolled adults with R/R MM with disease progression after ≥ 3 lines of therapy who were refractory to an immunomodulatory drug and proteasome inhibitor and refractory and/ or intolerant to an anti-CD38 antibody. Patients had undergone or were ineligible for autologous SCT. Among 97 patients who received belantamab mafodotin 2.5 mg/kg, the ORR was 31%, including 18.6% of patients who achieved a very good partial response or better. At 6 months, overall survival (OS) was not reached among those who achieved a response. Although DREAMM2 included a 3.4 mg/kg dose, the 2.5 mg/kg dose demonstrated a similar efficacy and more favorable safety profile and was the only dose submitted to the FDA. The most common serious (grade 3 or 4) adverse events reported were keratopathy (e.g., corneal epithelium changes, 27%), thrombocytopenia (20%), and anemia (20%). One death due to sepsis and 1 death due to hemophagocytic lymphohistiocytosis occurred in the 2.5 mg/kg and 3.4 mg/kg groups, respectively. Both were considered potentially related to the study drug.

PLACE IN THERAPY

Over 32,270 new cases of MM are predicted in the US in 2020, and approximately 12,830 deaths could occur due to the condition. Median age at diagnosis is 69 years. Newly diagnosed MM responds to initial cytotoxic chemotherapy; however, eventual treatment-resistant relapse usually occurs. During the past decade, the introduction of more effective, less toxic treatments, including immunomodulatory drugs, proteasome inhibitors, monoclonal antibodies, histone deacetylase (HDAC) inhibitors, and a nuclear export inhibitor, has brought significant improvements in survival. Nonetheless, an unmet medical need still exists.

If approved, belantamab mafodotin will be the first anti-BCMA treatment for heavily pretreated patients with R/R MM. The BCMA-targeting chimeric antigen receptor (CAR) T cell therapy idecabtagene vicleucel, by Bristol-Myers Squibb and Bluebird Bio, has also been submitted to the FDA for heavily pretreated R/R MM. The ORR for idecabtagene vicleucel was 73.4% across all doses studied. The FDA decision for idecabtagene vicleucel is expected in the first quarter of 2021. Several other BCMA-directed therapies are on the horizon, including CAR T therapies by Janssen, Poseida, and Cartesian, and bispecific antibodies targeting BCMA and CD38 by Amgen and Regeneron (phase 2 development for all).

FDA APPROVAL TIMELINE August 14, 2020

 Breakthrough Therapy

 Orphan Drug

 Priority Review

FINANCIAL FORECAST (reported in millions) 2020

2021

2022

2023

2024

$46

$148

$231

$318

$397

The forecast is a projection of total US sales per year.

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IMMUNOLOGY

filgotinib oral Gilead PROPOSED INDICATIONS Rheumatoid arthritis (RA)

CLINICAL OVERVIEW

Filgotinib is a selective Janus kinase 1 (JAK1) inhibitor.

Safety and efficacy of filgotinib were evaluated in the phase 3, randomized FINCH trial program in adults (n=3,452 total) with moderate to severe active RA. The 3 studies enrolled patients who had an inadequate response to methotrexate (MTX) (FINCH 1), an inadequate response to biologic DMARDs (FINCH 2), or who were MTX-naïve (FINCH 3). Oral daily doses of filgotinib 100 mg and 200 mg were studied in each trial, either as monotherapy (FINCH 3), in combination with MTX (FINCH 1 and 3), or added to a stable background conventional synthetic DMARD (csDMARD) (FINCH 2). In the study program, filgotinib was compared to placebo (FINCH 1 and 2), adalimumab (FINCH 1), and MTX (FINCH 3). Across the trials, both doses of filgotinib demonstrated a significantly greater clinical response rate compared to placebo at week 12 (FINCH 1 and 2) and week 24 (FINCH 3). This was reported using ACR20 and DAS28-CRP, among other measures. FINCH 1 also demonstrated non-inferiority of both doses of filgotinib to adalimumab based on DAS28-CRP. Clinical remission (DAS28-CRP ≤ 2.6) was achieved in 23.8% and 33.9% of patients on filgotinib 100 mg and 200 mg, respectively, compared to 23.7% on adalimumab, while low disease activity (DAS28-CRP ≤ 3.4) was reported in 38.8%, 49.7% and 43.4% of patients in each group, respectively. In FINCH 3, both doses of filgotinib plus MTX demonstrated significantly higher ACR20, ACR50, ACR70, and clinical remission at 24 weeks compared to MTX alone. Incidences of serious adverse events were similar among the groups. Few cases of VTE and MACE were reported across the groups.

PLACE IN THERAPY

An estimated 1.3 million adults in the US suffer from RA. DMARDs (MTX preferred) are considered first-line treatment for RA. If disease activity remains moderate or severe, a combination of DMARDs or a TNF inhibitor or a non-TNF biologic, with or without MTX is recommended.

Oral JAK inhibitors are available and include baricitinib (Olumiant®; JAK1 and JAK2 inhibitor), tofacitinib (Xeljanz®/Xeljanz XR®; JAK1 and JAK3 inhibitor), and upadacitinib (Rinvoq™; selective JAK1 inhibitor).

Tofacitinib and upadacitinib are indicated after inadequate response or intolerance to MTX. Baricitinib is indicated in patients with an inadequate response to ≥ 1 TNF inhibitor. These agents are taken once daily and may be used as monotherapy or in combination with MTX or a nonbiologic DMARD. If approved, filgotinib may compete with the other selective JAK1 inhibitor, upadacitinib, for moderate to severe RA. Both agents may provide more desirable efficacy and safety profiles compared to baricitinib and tofacitinib. Moreover, baricitinib and tofacitinib are associated with an increased risk of thromboembolic events and dose-limiting anemia, which have not been reported with filgotinib or upadacitinib in clinical trials; however, labeling of all approved JAK inhibitors for RA carries a boxed warning for thromboembolic events. Market uptake of filgotinib may be limited by its late entry to the market among JAK inhibitors and by increasing availability and uptake of anti-TNF biosimilars. Tofacitinib is also approved for PsA and UC, indications for which filgotinib is in late-stage development, along with CD.

FDA APPROVAL TIMELINE August 19, 2020

 Priority Review

FINANCIAL FORECAST 2020

2021

2022

$19

$138

$278

2023

2024

$445 The forecast is a projection of total US sales per year.

$628

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INFECTIOUS DISEASE

fostemsavir oral Viiv PROPOSED INDICATIONS

Multidrug-resistant (MDR) human immunodeficiency virus-1 (HIV-1) infection in adults

CLINICAL OVERVIEW

Fostemsavir inhibits HIV attachment to the cellular CD4 receptor by binding to the viral envelope glycoprotein gp120.

The phase 3 BRIGHTE trial studied fostemsavir in 2 cohorts of heavily pretreated adults with MDR HIV-1 infection. In Cohort 1 (n=272; randomized 3:1), fostemsavir or placebo was added to optimized background therapy in a double-blind manner. Viralogic suppression (HIV-1 RNA < 40 copies/mL) was reported in 53%, 54%, and 60% of patients at the 24-, 48-, and 96-week timepoints, respectively, in the fostemsavir-treated patients. The mean increase in CD4 at 96 weeks was 205 cells/µL. After 1 week of treatment, the study demonstrated a statistical superiority of fostemsavir over placebo (0.79 log10 c/mL versus 0.17 log10 c/ mL; p<0.0001). In Cohort 2 (n=99), all patients were without any fully active ARV option and all received fostemsavir. Virologic suppression in the group was reported in 37%, 38%, and 37% of patients at the 24-, 48-, and 96-week timepoints, respectively. Higher rates of serious TEAEs, including death, were reported among Cohort 2 compared to Cohort 1 (serious adverse events, 48% versus 34%; death, 16% versus 4%).

Most deaths were due to complication of the disease and acute infection.

Fostemsavir 600 mg was administered orally twice daily.

PLACE IN THERAPY

It is estimated that approximately 1.2 million people in the US are HIV-positive and about 10,000 of those people have MDR HIV. While several antiviral agents are available to treat HIV-1 infection, treatment failure may occur due to the virus’s ability to mutate and become resistant to available ARV drugs. Patient choices among ARVs may also be limited based on tolerability and the potential for drug-drug interactions. Resistance testing, viral load monitoring, and access to care and ARV therapy may decrease acquired drug resistance and stabilize rates of transmitted drug resistance. The use of regimens with greater potency and genetic barriers, such as integrase strand transfer inhibitors (INSTIs), provide additional options for second- and third-line regimens. Despite these strategies, there continues to be an unmet need in patients with drug-resistant HIV due to the nature of viral mutation.

If approved, fostemsavir will be a first-in-class attachment inhibitor. It will also be the first oral agent approved for the treatment of HIV-1 infection for use in combination with other ARVs in heavily treatment-experienced adults with MDR HIV-1 infection. This follows the 2018 approval of the CD4-directed post attachment HIV-1 inhibitor ibalizumab-uiyk (Trogarzo®) that is administered IV every 2 weeks. Also on the horizon for treatmentresistant HIV-1 is leronlimab, a weekly SC injected monoclonal antibody viral-entry inhibitor that targets chemokine receptor 5 (CCR5). Final data submission for leronlimab is expected in 2Q 2020.

FDA APPROVAL TIMELINE October–December 2020  Breakthrough Therapy

 Fast Track

FINANCIAL FORECAST (reported in millions) 2020

2021

2022

2023

2024

$25

$55

$94

$134

$156

The forecast is a projection of total US sales per year.

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ONCOLOGY

lisocabtagene maraleucel IV Bristol-Myers Squibb PROPOSED INDICATIONS

Relapsed or refractory (R/R) diffuse large B cell lymphoma (DLBCL) after ≥ 2 prior therapies

CLINICAL OVERVIEW

Lisocabtagene maraleucel (liso-cel) is an CAR T cell immunotherapy. T cells taken from the patient are reengineered to express a CD19 CAR and a truncated form of human EGFR (EGFRt). The cells are expanded and infused back into the patient. In the body, the CAR T cells are directed to the CD19 antigen on the surface of tumor B cells where they exert their toxic effect. The EGFRt domain and administration of the EGFR inhibitor cetuximab stimulate elimination of the CAR T cells to mitigate severe toxicities.

The open-label, phase 1 TRANSCEND NHL trial enrolled patients with aggressive R/R B cell NHL, including DLBCL, who had received a median of 3 prior therapies. Among 256 evaluable patients who received liso-cel, ORR and completed response (CR) rates were 73% and 53%, respectively. The median time to first response was 1 month, and the DOR was 54.7% at 12 months. Liso-cel was associated with a 79% rate of adverse events of grade ≥ 3 severity, including cytopenias. Cytokine release syndrome (CRS) of any grade was reported in 42% of patients, 2% of which were grade ≥ 3. Neurologic events (NE) were reported in 30% of patients, 10% of which were grade ≥ 3. A total of four grade 5 TEAEs were reported, which included diffuse alveolar damage, pulmonary hemorrhage, multi-organ dysfunction, and cardiomyopathy.

Liso-cel was infused as a single IV dose of 50 x 106 (n=51), 100 x 106 (n=177), or 150 x 106 (n=41).

PLACE IN THERAPY

Over 25,000 new cases of DLBCL are diagnosed annually in the US. While some aggressive forms are often curable with intensive chemotherapy, others are less responsive. For patients who are refractory to or relapse after chemotherapy and SCT, there remain few options. In recent years, therapies that target tumor biomarkers or stimulate the body's immune response against tumor cells have been approved.

If approved, lisocabtagene maraleucel will be the third CD19-directed CAR T therapy approved for DLBCL salvage therapy, following the 2017 FDA approvals of axicabtagene ciloleucel (Yescarta®) and tisagenlecleucel-T (Kymriah®). In clinical trials, liso-cel demonstrated a CR rate (53%) in adults comparable to or higher than axicabtagene ciloleucel (CR, 51%) and tisagenlecleucel-T (CR, 32%). Moreover, lido-cel incorporates an EGFRt domain that diminishes toxic effects when used with cetuximab. Clinical studies with liso-cel demonstrated lower rates of serious (grade ≥ 3) CRS and NE than studies with axicabtagene ciloleucel or tisagenlecleucel-T (CRS: 2%, 13%, and 23%, respectively; NE: 10%, 31%, and 18%, respectively).

Notably, across 3 liso-cel clinical studies, a total of 43 patients received the dose in an outpatient setting at the discretion of the investigator. This approach required patient education, a caregiver, and proximity to the treatment facility. A total of 24 (55%) required hospitalization. The CR rate in outpatients was consistent with the overall TRANSCEND NHL trial.

While approximately 10% of liso-cel doses administered in TRANSCEND NHL were nonconforming (out of quality standard specification necessary to achieve desired clinical response), efficacy produced was similar to conforming doses. Concern may remain regarding manufacturing of liso-cel.

FDA APPROVAL TIMELINE August 17, 2020

 Breakthrough Therapy

 Orphan Drug

 Priority Review

FINANCIAL FORECAST (reported in millions) 2020

2021

2022

2023

2024

$36

$161

$304

$450

$638

The forecast is a projection of total US sales per year.

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 RMAT

ONCOLOGY

nadofaragene firadenovec Intravesical Fergene PROPOSED INDICATIONS

High-grade, Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC)

CLINICAL OVERVIEW

Nadofaragene firadenovec is a non-replicating adenoviral (Ad5) vector-based gene therapy. It contains the interferon alfa-2b transgene and an excipient, called Syn3, to improve its delivery into the bladder wall cells.

Once in the cells, the interferon alfa-2b transgene is incorporated into the cellular DNA causing large amounts of interferon protein to be made intracellularly and enhancing the body’s immune defense.

A phase 3, open-label study enrolled 157 patients in the US who were diagnosed with carcinoma in situ (CIS) bladder cancer confined to the superficial layer, with or without concomitant high-grade Ta or T1 papillary disease (CIS ± Ta/T1). At 3 months, a complete response (CR) was achieved in 53% of patients, of which 24% had continued CR at 12 months. Notably, the rate of high-grade recurrence-free (HGRF) survival in patients with papillary disease was 73% and 44% at 3 and 12 months, respectively. TEAEs were typically localized and lasted a median of 2 days, with the exception of fatigue and urinary frequency which lasted a median of 11 and 41 days, respectively.

Nadofaragene firadenovec is administered via a catheter directly into the bladder every 3 months.

PLACE IN THERAPY

Bladder cancer is the sixth most common cancer in the US. In 2019, an estimated 80,470 individuals were diagnosed with bladder cancer and an estimated 17,670 deaths occurred due to the condition. The median age at diagnosis is 73 years. Approximately 75% of new cases are NMIBC. Treatment for NMIBC (Ta, T1, and Tis) focuses on reducing recurrences and preventing disease progression to an advanced stage. Current therapy includes intravesical chemotherapy (e.g., gemcitabine, mitomycin), BCG after transurethral resection, and intravesical BCG maintenance therapy. Up to 75% of cases will develop tumor recurrence after BCG therapy, and 20% will experience disease progression within 5 years. Notably, Merck is the sole supplier of TICE BCG strain in the US and in a number of other countries, and supply constraints have impacted availability of BCG live.

In patients who do not respond to BCG therapy, radical cystectomy is recommended. In patients who wish to preserve their bladders or who are ineligible for cystectomy, nonsurgical options are limited to IV pembrolizumab (Keytruda®; administered every 3 weeks) and intravesical valrubicin (Valstar®; administered weekly for 6 weeks) which are FDA-approved for BCG-unresponsive CIS bladder cancer. In non-comparative trials, response rates with intravesical nadofaragene firadenovec were similar to pembrolizumab (also produced by Merck) and higher compared to investigational intravesical antibody-drug conjugate (ADC) oportuzumab monatox.

FDA APPROVAL TIMELINE May–June 2020

 Breakthrough Therapy

 Fast Track

 Priority Review

FINANCIAL FORECAST (reported in millions) The financial forecast for nadofaragene firadenovec is not currently available.

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ONCOLOGY – RET-DIRECTED THERAPY

ofatumumab (Arzerra®) SC Novartis PROPOSED INDICATIONS

Relapsing forms of multiple sclerosis (RMS) in adults Current indications for ofatumumab for IV administration are for the treatment of CLL.

CLINICAL OVERVIEW

Ofatumumab is a human, high-affinity antibody targeted at the cluster of differentiation 20 (CD20) molecule in the cell membrane of B cells. Research has demonstrated that anti-CD20 treatment leads to lysis and depletion of B cells, ultimately reducing formation of new inflammatory CNS lesions.

The replicate phase 3, double-blind, double-dummy, parallel-group ASCLEPIOS I and II trials compared ofatumumab with teriflunomide in adults with RMS. A total of 1,882 patients with EDSS 0 to 5.5 were treated for up to 30 months. Both studies reported a significantly lower annualized relapse rate (ARR) with ofatumumab than with teriflunomide (ARR, 0.11 versus 0.22 and 0.1 versus 0.25 for ASCLEPIOS I and II, respectively; RRR, 50.5% and 58.5%, respectively; p<0.001 for both studies). In ASCLEPIOS I and II, a significantly lower number of gadolinium-enhancing (Gd+) T1 lesions per scan and new or enlarging T2 lesions per year were also seen with ofatumumab compared to teriflunomide (T1 lesions: RRR, 97.5% and 93.8% for ASCLEPIOS I and II, respectively; p<0.001 for both studies; T2 lesions: RRR, 82% and 84.5% for ASCLEPIOS I and II, respectively; p<0.001 for both studies). Across both studies, the confirmed disability worsening (CDW) was significantly lower with ofatumumab than teriflunomide at 3 months (RRR, 34.4%; p=0.002) and 6 months (RRR, 32.5%; p=0.012). The safety profile of ofatumumab in the ASCLEPIOS trials was consistent with that reported in phase 2 trials. In the earlier phase 2 MIRROR study, the most common adverse event was injection-related reactions (52%), which were typically of mild to moderate severity and diminished with subsequent administrations.

Ofatumumab was administered as 20 mg SC every 4 weeks, and teriflunomide was administered as 14 mg orally once daily. Corresponding matching placebo was used.

PLACE IN THERAPY

Nearly 1 million people in the US are living with MS, and the majority have relapsing forms of the condition.

Disease-modifying therapies (DMT) indicated to treat RMS aim to decrease relapse rate and slow the accumulation of MRI-detected brain lesions. Once-monthly doses of ofatumumab, which may be selfadministered, demonstrated improved efficacy compared to daily oral teriflunomide (Aubagio®).

If approved, ofatumumab will compete with Genentech’s CD20-directed cytolytic monoclonal antibody ocrelizumab (Ocrevus®) in the RMS space. Ofatumumab’s monthly self-administered SC dosing may be considered more convenient compared to ocrelizumab’s every 6-month IV maintenance regimen.

Ocrelizumab is also FDA-approved for treatment of primary progressive MS (PPMS), an indication that ofatumumab is not currently seeking. Other agents used to treat relapsing forms of MS also carry risks.

Natalizumab, dimethyl fumarate, fingolimod, alemtuzumab, and cladribine (oncology setting) have been associated with progressive multifocal leukoencephalopathy (PML), which can be fatal.

FDA APPROVAL TIMELINE June 2020

 Priority Review

FINANCIAL FORECAST (reported in millions) 2020

2021

2022

2023

2024

$175

$546

$961

$1,387

$1,652

The forecast is a projection of total US sales per year.

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ONCOLOGY – RET-DIRECTED THERAPY BACKGROUND

Abnormalities in the rearranged during transfection (RET) kinase, including activating mutations and fusions, result in the upregulation and/or overactivation of RET tyrosine kinase activity leading to uncontrolled cell proliferation in various cancer cell type, including NSCLC and thyroid cancer.

Selpercatinib and pralsetinib selectively block RET, inhibiting the activity of abnormal RET proteins.

selpercatinib oral Eli Lilly PROPOSED INDICATIONS

RET fusion-positive non-small cell lung cancer (NSCLC), RET-mutant medullary thyroid cancer (MTC), and RET fusion-positive thyroid cancer

CLINICAL OVERVIEW

The ongoing, open-label LIBRETTO-001 trial is evaluating oral selpercatinib monotherapy for the treatment of RET fusion-positive NSCLC. The phase 2 analysis for efficacy included patients (n=105) with prior platinumbased chemotherapy. Selpercatinib treatment resulted in a 68% ORR (95% CI, 58 to 76) regardless of prior therapy (e.g., anti-PD-1/PD-L1, multikinase inhibitor [MKI]). Notably, in patients with brain metastases (n=11), the CNS ORR was 91% (95% CI, 59 to 100), including 2 complete responses. At the data cut-off, the majority of patients were still responding to treatment, with a median DOR of 20.3 months (considered nonsignificant) and median PFS of 18.4 months. Selpercatinib was also studied in a subset of treatment-naïve patients (n=34) with RET fusion-positive NSCLC. In this population, selpercatinib resulted in an 85% ORR (95% CI, 69 to 95) and median DOR and PFS were not reached at data cut-off.

The LIBRETTO-001 trial also included patients with RET fusion-positive thyroid cancer. Among those with RET-mutant MTC (n=55), selpercatinib led to an ORR of 56% (95% CI, 42 to 70) in patients who received prior cabozantinib and/or vandetanib and an ORR of 59% (95% CI, 47 to 70) in patients who were naïve to both agents (n=76). Calcitonin and carcinoembryonic antigen response, defined as a ≥ 50% decrease that lasted for ≥ 4 weeks, were observed in most patients. In addition, in heavily pretreated RET fusion-positive thyroid cancer patients (n=26), selpercatinib resulted in a 62% ORR (95% CI, 41 to 80). The DOR and PFS were not reached at data cut-off among any thyroid cancer patient group. In LIBRETTO-001, selpercatinib was generally well-tolerated, with an overall treatment discontinuation rate of 1.7%.

An oral selpercatinib dose of 160 mg twice daily was determined as the phase 2 dose.

FDA APPROVAL TIMELINE July–August 2020

 Breakthrough Therapy

 Orphan Drug

 Priority Review

FINANCIAL FORECAST (reported in millions) 2020

2021

2022

2023

2024

$17

$117

$319

$506

$658

The forecast is a projection of total US sales per year.

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pralsetinib oral Blueprint Medicines PROPOSED INDICATIONS

RET fusion-positive non-small cell lung cancer (NSCLC)

CLINICAL OVERVIEW

In the phase 2 portion of the ARROW trial, pralsetinib demonstrated a 61% ORR (95% CI, 50 to 72) in RET fusion-positive NSCLC patients (n=80) previously treated with platinum-based chemotherapy. At data cut-off, CR rate was 14%, and DOR was not reached. In treatment-naïve RET fusion-positive NSCLC patients (n=26), ORR was 73% (95% CI, 52 to 88) and CR was 12%. Pralsetinib was generally well tolerated with 4% of patients among the safety population (n=354) discontinuing treatment due to TEAEs. The study dosage of pralsetinib was 400 mg administered orally once daily.

FDA APPROVAL TIMELINE January–March 2021

 Breakthrough Therapy

 Orphan Drug

FINANCIAL FORECAST (reported in millions) 2020

2021

2022

2023

2024

$0

$43

$82

$119

$152

The forecast is a projection of total US sales per year.

PLACE IN THERAPY

It is estimated that 228,820 Americans will be diagnosed with lung cancer in 2020, of which 84% of cases will be NSCLC. In 2018, an estimated 53,900 cases of thyroid carcinoma (TC) were diagnosed in the US. It is estimated that 89.8% of TC cases are papillary carcinoma and 1.6% are MTC. Moreover, activating RET mutations or RET fusions are detected in up to 2% of all NSCLC cases, 10% to 20% of papillary thyroid cancers, and 60% of MTCs. Furthermore, RET mutations are predictive of aggressive tumor progression.

Papillary carcinoma is usually caused by radiation therapy to the head and neck particularly when received during childhood. It is often asymptomatic, which leads to delayed diagnosis. Standard therapy is thyroidectomy followed by thyroxine supplementation in most patients and radioactive iodine ablation or external beam radiotherapy in select patients. Systemic therapies, such as lenvatinib or sorafenib, are used when tumors are not resectable, do not respond to radioactive iodine, are not amenable to localized beam radiation therapy, and have significant clinical disease progression.

MTC is a neuroendocrine tumor of the thyroid gland and is characterized by the production of calcitonin.

Most MTC cases (80%) are sporadic, but some are inheritable with germline RET mutations. The primary treatment for MTC is total thyroidectomy. For patients with progressive or symptomatic metastatic disease who are ineligible for surgery, systemic therapy may be considered. Chemotherapy shows little benefit in this setting; however, MKIs have provided longer-term response.

Available systemic treatments for NSCLC and thyroid carcinomas discussed here include MKIs, such as cabozantinib and vandetanib. Currently there are no systemic therapies that selectively target RET, and MKIs are associated with toxicities, including a boxed warning for vandetanib regarding QT prolongation, torsades de pointes, and sudden death leading to its availability only through a REMS program. As selective RET agents, selpercatinib and pralsetinib demonstrate greater efficacy and more favorable safety profiles compared to the MKIs and could provide important options in the armamentarium for patients with RET fusions and mutations. While the application for pralsetinib covers only treatment for NSCLC, the ARROW study is also evaluating the drug for RET-mutant MTC in previously treated and treatment-naïve patients, as well as for RET fusion-positive thyroid cancer (ORR, 60%, 74%, and 89%, respectively, reported to date).

Blueprint plans to submit a thyroid cancer application in 2Q 2020.

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ONCOLOGY

valoctocogene roxaparvovec IV Biomarin PROPOSED INDICATIONS

Hemophilia A treatment and prevention in adults

CLINICAL OVERVIEW

Individuals with hemophilia A lack or have low levels of clotting factor VIII (FVIII). Valoctocogene roxaparvovec (valrox) is an adeno-associated virus 5 (AAV5)-mediated gene therapy that delivers human B domain-deleted coagulation factor VIII (FVIII), resulting in an active variant of FVIII. A phase 1/2 study demonstrated efficacy and safety among 7 adult males with severe hemophilia A (FVIII ≤ 1 IU/dL) who received valrox 6x1013 vg/kg. A 96% reduction in mean annualized bleeding rate (ABR) from baseline was seen 3 years after the dose was administered. The mean FVIII expression declined by 43% during year 2 and by 10% during year 3 (mean FVIII levels of 64, 36, and 33 IU/dL at 1, 2, and 3 years, respectively). At year 3, complete or near complete elimination of prophylactic FVIII use was observed (mean, zero infusions). In addition, all patients experienced full resolution of bleeding in target joints at year 2. A transient elevation in ALT levels with no signs of ongoing liver damage was the most common adverse event reported. No development of FVIII inhibitors or other FVIII antibodies was identified. No patients withdrew from the study.

Valrox is administered as a single IV infusion.

PLACE IN THERAPY

Hemophilia A is a congenital X-linked bleeding disorder that affects 1 in 5,000 male births. It is characterized by coagulation FVIII deficiency leading to chronic spontaneous bleeding into muscles and joints that can progress to debilitating arthropathy. For decades, the standard of care has been routine infusion of FVIII replacement products that are dosed 2 to 4 times per week. However, replacement therapy is complicated by the development of inhibitors (antibodies), which can reduce therapeutic efficacy. In November 2017, the monoclonal antibody emicizumab-kxwh (Hemlibra®) was approved for routine prophylaxis of bleeding events in hemophilia A in patients with or without inhibitors. It demonstrates substantially reduced incidence of bleeding with a dosing regimen as little as every 4 weeks.

Valrox is poised to be the first gene therapy for hemophilia. If approved, a single IV infusion may provide a long-term option to dramatically reduce ABR and eliminate the need for prophylactic FVIII therapy.

While FVIII expression plateaued at approximately 20% three years after valrox administration, data demonstrating long-tern efficacy beyond 3 years are not yet available. Several viral gene therapies are in clinical trials for hemophilia A. Phase 3 trials are ongoing by Pfizer/Sangamo and Spark, while therapies by Takeda and Ultragenyx are in phase 1/2 trials. The small interfering RNA (siRNA) product fitusiran by Sanofi/ Alnylam is also in late stage development. A number of agents are also being studied for hemophilia B. The FDA is also reviewing a valrox total antibody assay by ARUP as a companion diagnostic to identify patients most likely to respond to valrox. Biomarin estimates that about 80% of patients with hemophilia A in the US do not have preexisting immunity to AAV5 that would make them ineligible for valrox.

FDA APPROVAL TIMELINE August 21, 2020

 Breakthrough Therapy

 Orphan Drug

 Priority Review

FINANCIAL FORECAST (reported in millions) 2020

2021

2022

2023

2024

$27

$126

$237

$427

$711

The forecast is a projection of total US sales per year.

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IMMUNOLOGY

viaskin peanut transdermal DBV Technologies PROPOSED INDICATIONS

Peanut allergy in children 4 to 11 years of age

CLINICAL OVERVIEW

Viaskin Peanut is an epicutaneous immunotherapy (EPIT) technology that delivers 250 mcg of peanut extract.

The phase 3, randomized (2:1), double-blind, placebo-controlled PEPITES trial enrolled 356 peanut-allergic children 4 to 11 years of age. After 12 months, 35.3% of patients treated with viaskin peanut were able to consume ≥ 300 mg of peanut protein (equivalent to ~1 peanut) compared to 13.6% with placebo (p=0.00001).

Although the difference was significant, the primary outcome of the trial was not met because a lower bound of the 95% CI of < 15% was not reached. The most common TEAE was local application site reaction (57.6% versus 27.1% with placebo), which was generally mild to moderate in severity and occurred during the first month of treatment. A total of 10 anaphylactic episodes (8 patients) were considered to be related to viaskin peanut. Epinephrine was used to treat 6 of the episodes.

In the PEPITES study, the first viaskin peanut transdermal patch was applied for 3 hours under medical supervision. Subsequent patches were applied at home where the daily application duration time was increased gradually to 6 hours during week 1, 12 hours during week 2, and 24 (±4) hours thereafter.

PLACE IN THERAPY

Peanut allergy is a public health concern, placing a significant burden on patients and caregivers. Approximately 2.5% of children in the US suffer from peanut allergy, and this figure is rising. Reaction to peanut exposure varies from mild skin and/or GI symptoms to severe angioedema and anaphylaxis. The main approach to managing food allergy is avoidance of the precipitating allergen. When accidental peanut exposure occurs, antihistamines can manage mild to moderate reactions, but patients often carry an epinephrine auto-injector to treat severe reactions.

If approved, viaskin peanut will be the first transdermal formulation to mitigate allergic reactions to accidental peanut exposure in individuals with confirmed peanut allergy. It follows the January 2020 approval of oral peanut allergen powder-dnfp (Palforzia™) that is mixed with food and consumed daily. Initial doses and dose escalations of Palforzia must be administered in a certified medical facility. While both products demonstrate desensitization compared to placebo, the Palforzia clinical trial enrolled patients who were sensitive to lower doses of peanut allergen. In addition, a higher response rate was reported with Palforzia (67% of patients tolerated ≥ 600 mg of peanut protein) compared to viaskin peanut (35% of patients tolerated ≥ 300 mg of peanut protein eliciting dose). The Palforzia indication also allows for start of therapy in the broader age range of 4 to 17 years compared to the study population for viaskin peanut of 4 to 11 years.

Viaskin peanut and Palforzia provide consistent peanut allergen doses to increase a patient’s tolerance to accidental peanut exposure and reduce the risk of serious allergic reactions. Neither is a curative therapy, and both must be combined with a peanut avoidance diet. Therapy adherence will be key to continued desensitization. In clinical trials, proportionately fewer patients on viaskin peanut compared to those on Palforzia withdrew from the study (10.5% versus 21%). Ongoing trials are evaluating safety and efficacy of each product in patients 1 to 3 years of age in addition to their long-term (3 years) safety and tolerability.

FDA APPROVAL TIMELINE October 2, 2020

 Breakthrough Therapy

 Fast Track

FINANCIAL FORECAST (reported in millions) 2020

2021

2022

2023

2024

$13

$69

$160

$254

$335

The forecast is a projection of total US sales per year.

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Biosimilar Overview CLINICAL OVERVIEW

Biosimilars are very different from generic drugs in that they are not exact duplicates of their reference biologic product. The FDA approval process for biosimilars is designed to ensure that the biosimilar product is highly similar to the reference product without having any meaningful clinical differences.

Many controversies surround biosimilars, and regulatory and litigation hurdles remain. The FDA has issued final and draft guidances. Select FDA biosimilar guidances are noted here. In January 2017, the agency issued final guidance on the nonproprietary naming of biologic products, which also applies to biosimilars. The biological products must bear a core name followed by a distinguishing 4-letter, lowercase, hyphenated suffix that is devoid of meaning. The FDA is still considering how to implement the nomenclature for previously approved biosimilar products. The international nonproprietary name (INN) impacts interchangeability as it affects pharmacists’ ability to substitute an interchangeable biosimilar for the reference product. The FDA withdrew the September 2017 draft industry guidance on determining similarity of a proposed biosimilar product to its reference product to allow for further consideration of the most current and relevant scientific methods in evaluating analytical data. The agency will focus on providing flexibility for efficient development of biosimilars while maintaining high scientific standards.

In July 2018, the FDA finalized its guidance on labeling biosimilars. The guidance pertains to prescribing information (PI) but does not contain specific recommendations on interchangeability in the labeling. The labeling guidance provides recommendations on how to include, identify, and differentiate the biosimilar and the reference product in various sections of the PI. The basic premise remains that the originator product’s safety and effectiveness can be relied upon for HCPs to make prescribing decisions; therefore, a biosimilar should include relevant data from the originator in its PI. In May 2019, the agency released its final guidance on interchangeability. Several states had already enacted biosimilar substitution legislation.

Biosimilars are expected to receive full extrapolation for the eligible indications of the reference products without requiring additional trials. Nevertheless, as each biosimilar comes to market, it will likely need to be considered individually.

Insulins were historically regulated by the FDA as small molecules. However, effective March 23, 2020, drugs such as insulin and growth hormone are deemed biologics and transitioned from the drug pathway to the biologics pathway. Their licensure as biologics allows these agents to be considered in the biosimilar space and promotes competition and access.

PLACE IN THERAPY

The patents of several biologic drugs are set to expire in the next few years, opening the US market for biosimilar entry; however, patent litigation has resulted in significant launch delays of FDA-approved biosimilars. In June 2017, the US Supreme Court issued 2 landmark rulings: (1) allowing a biosimilar manufacturer to provide launch notice of commercial marketing to the originator manufacturer before or after FDA approval of the biosimilar product; and (2) eliminating any federal requirement for disclosure, also known as the “patent dance.” Some states, however, mandate disclosure. These decisions may bring biosimilars to the market sooner and potentially create price competition in the marketplace.

In July 2018, the FDA unveiled its Biosimilar Action Plan (BAP), a series of 11 steps to encourage biosimilar market competition, some of which were previously announced or underway. The BAP contains 4 key strategies: (1) improving the biosimilar development and approval process; (2) maximizing scientific and regulatory clarity for sponsors; (3) effective communications for patients, clinicians, and payers; and (4) reducing unfair tactics that may delay market approval and entry. The BAP strives to promote access to biosimilar products and reduce healthcare costs.

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To date, a total of 26 biosimilars have received FDA approval. Of these, only 17 have entered the market.

APPROVED BIOSIMILARS Brand Name (Nonproprietary name)

Manufacturer

Approval Date

Zarxio® (filgrastim-sndz)

Sandoz

March 2015

Inflectra® (infliximab-dyyb)

Pfizer/Celltrion

April 2016

Erelzi™ (etanercept-szzs)

Sandoz

August 2016

Amjevita™ (adalimumab-atto)

Amgen

September 2016

Renflexis® (infliximab-abda)

Samsung Bioepis/ Merck

May 2017

Cyltezo® (adalimumab-adbm)

Boehringer Ingelheim

August 2017

Mvasi™ (bevacizumab-awwb)

Amgen

September 2017

Ixifi™ (infliximab-qbtx)*

Pfizer

December 2017

Ogivri™ (trastuzumab-dkst)

Mylan

December 2017

Retacrit (epoetin alfa-epbx)

Pfizer/Hospira

May 2018

Fulphila® (pegfilgrastim-jmdb)

Mylan

June 2018

Nivestym® (filgrastim-aafi)

Pfizer

July 2018

Hyrimoz™ (adalimumab-adaz)

Sandoz

October 2018

Udenyca® (pegfilgrastim-cbqv)

Coherus

November 2018

Truxima® (rituximab-abbs)

Celltrion/Teva

November 2018

Herzuma® (trastuzumab-pkrb)

Celltrion/Teva

December 2018

Ontruzant® (trastuzumab-dttb)

Samsung Bioepis/ Merck

January 2019

Trazimera™ (trastuzumab-qyyp)

Pfizer

March 2019

Eticovo™ (etanercept-ykro)

Samsung Bioepis/ Merck

April 2019

Kanjinti™ (trastuzumab-anns)

Amgen

June 2019

Zirabev™ (bevacizumab-bvzr)

Pfizer

June 2019

Hadlima™ (adalimumab-bwwd)

Samsung Bioepis/ Merck

July 2019

Ruxience™ (rituximab-pvvr)

Pfizer

July 2019

Abrilada™ (adalimumab-afzb)

Pfizer

November 2019

Ziextenzo® (pegfilgrastim-bmez)

Novartis/Sandoz

November 2019

®

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Commercially Available

  -

 -

 -

    -

     -

  -

 -



Originator Product (Manufacturer) Neupogen® (Amgen) Remicade® (Janssen) Enbrel® (Amgen) Humira® (Abbvie) Remicade (Janssen) Humira (Abbvie) Avastin® (Genentech) Remicade (Janssen) Herceptin® (Genentech) Epogen® (Amgen) Procrit® (Janssen) Neulasta® (Amgen) Neupogen (Amgen) Humira (Abbvie) Neulasta (Amgen) Rituxan® (Genentech) Herceptin (Genentech) Herceptin (Genentech) Herceptin (Genentech) Enbrel (Amgen) Herceptin (Genentech) Avastin (Genentech) Humira (Abbvie) Rituxan (Genentech) Humira (Abbvie) Neulasta (Amgen)

APPROVED BIOSIMILARS continued APPROVED BIOSIMILARS Brand Name (Nonproprietary name) Avsola™ (infliximab-axxq)

Manufacturer Amgen

Approval Date

Commercially Available

December 2019

-

Originator Product (Manufacturer) Remicade (Janssen)

* Pfizer already has Inflectra on the market and has not announced plans to launch Ixifi.

Also available are Eli Lilly’s Basaglar® insulin glargine, a biosimilar agent to Sanofi’s Lantus®, and Sanofi’s Admelog® insulin lispro, approved as a biosimilar product to Eli Lilly’s Humalog®.

A host of factors will contribute to market acceptability and the potential success of biosimilars. Payers, pharmacies, prescribers, and patients each play a role in market adoption of biosimilars.

While < 2% of Americans use biologics, they account for almost 40% of all prescription drug spending. Moreover, they comprised 70% of growth in drug spending from 2010 to 2015. Not surprisingly, there is a growing body of evidence on predicted biologic spend and potential biosimilar savings. The global biologic market is projected to exceed $390 billion by 2020. The global biosimilar market is expected to grow from $5.95 billion in 2018 to $23.63 billion in 2023. An IMS Health analysis expects biosimilars to save the US and Europe’s top 5 markets up to $110 billion by 2020. In the US, it is estimated that biosimilars will cost 15% to 35% less than the originator product.

The potential cost savings, however, can vary based on the market segment where brand contracts can play a role.

A 2017 report by the RAND Corporation estimates a $54 billion cost savings from biosimilars between 2017 and 2026. In July 2018, an FDA analysis reported that if Americans had access to FDA-approved biosimilars in 2017, it would have resulted in a $4.5 billion savings. A 2017 analysis by the Moran Company projects biosimilars could save the government an estimated $11.4 billion by 2027, but it would require the Centers for Medicare and Medicaid Services (CMS) to revise its reimbursement policy for biosimilars. Subsequently, in November 2017, the CMS revised its reimbursement policy. The CMS now issues a unique Healthcare Common Procedure Coding System (HCPCS) code to each individual biosimilar. Under this rule, Medicare Part B separately codes and pays for biosimilars and no longer groups them into a common payment code with originator agents. A June 2018 infliximab case study by the Pacific Research Institute forecasts annual savings of up to $465 million from increased use of biosimilars to replace a single biologic for commercial payers and Medicare.

Biosimilars are paving the way for increased access to important biologic therapies that may increase survival and/ or QOL for many patients with difficult-to-treat diseases while also reducing costs.

ONCOLOGY

bevacizumab IV MYL-1402O and SB8 are biosimilars to Genentech’s Avastin, a vascular endothelial growth (VEGF)-specific angiogenesis inhibitor indicated for the treatment of metastatic colorectal cancer, non-squamous non-small cell lung cancer (nsNSCLC), glioblastoma, metastatic renal cell carcinoma (RCC), and recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

FDA APPROVAL TIMELINE Merck/Samsung Bioepis (SB8) July–September 2020 Mylan/Biocon (MYL-1402O) December 25, 2020

FINANCIAL FORECAST (reported in millions) 2020

2021

2022

2023

2024

$2,078

$1,412

$1,143

$961

$808

The forecast is a projection of total US sales per year for the branded originator product.

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BIOSIMILAR OVERVIEW continued

BLOOD MODIFIER

filgrastim IV, SC Apotex and Kashiv are seeking biosimilars to Amgen’s Neupogen, a leukocyte growth factor indicated for use in patients with nonmyeloid malignancies who are receiving myelosuppressive anti-cancer drugs; following induction or consolidation chemotherapy for acute myeloid leukemia (AML); with nonmyeloid malignancies in patients who are undergoing myeloablative chemotherapy followed by bone marrow transplantation; to mobilize autologous hematopoietic progenitor cells for collection by leukapheresis; with symptomatic congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia; and in patients who are acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome [HSARS]).

FDA APPROVAL TIMELINE Apotex (Grastofil) Pending Kashiv Pending

FINANCIAL FORECAST (reported in millions) 2020

2021

2022

2023

2024

$134

$113

$98

$89

$82

The forecast is a projection of total US sales per year for the branded originator product.

DIABETES

insulin glargine (Semglee) SC Mylan/Biocon Semglee is a biosimilar insulin to Sanofi’s Lantus, a long-acting insulin indicated for the treatment of type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM).

FDA APPROVAL TIMELINE June 2020

FINANCIAL FORECAST (reported in millions) 2020

2021

2022

2023

2024

$948

$719

$538

$417

$344

The forecast is a projection of total US sales per year for the branded originator product.

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BIOSIMILAR OVERVIEW continued

BLOOD MODIFIER

pegfilgrastim SC Lapelga and PF-06881894 are biosimilars to Amgen’s Neulasta, a leukocyte growth factor indicated for use in patients with nonmyeloid malignancies who are receiving myelosuppressive anti-cancer drugs and in patients acutely exposed to myelosuppressive doses of radiation.

FDA APPROVAL TIMELINE Apotex (Lapelga) Pending

Pfizer/Hospira (PF-06881894) June 2020

FINANCIAL FORECAST (reported in millions) 2020

2021

2022

2023

2024

$1,889

$1,507

$1,237

$1,036

$895

The forecast is a projection of total US sales per year for the branded originator product.

ONCOLOGY

rituximab (ABP-798) Amgen/Allergan ABP-798 is an investigational biosimilar to Genentech’s Rituxan, a CD20-directed cytolytic antibody indicated for the treatment of non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), and antineutrophil cytoplasmic antibodies-associated vasculitis.

FDA APPROVAL TIMELINE October 19, 2020

FINANCIAL FORECAST (reported in millions) 2020

2021

2022

2023

2024

$3,332

$2,225

$1,749

$1,464

$1,235

The forecast is a projection of total US sales per year for the branded originator product.

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KEEP ON YOUR RADAR Notable agents that are further from approval have been identified in this unique watch list. These are products with the potential for significant clinical and financial impact. Their development status is being tracked on the MRx Pipeline radar. These pipeline products, their respective class or proposed indication, as well as an estimated financial forecast for the year 2024, are displayed. The financials are projected total annual US sales, reported in millions. transcon pegylated growth hormone

aducanumab Neurology

$1,024

Endocrine

tafasitamab

$888

berotralstat Immunology

$193

Oncology

$492

betibeglogene autotemcel (Zynteglo)

roxadustat

Hematology/Gene therapy

Hematology

$343

$569

casimersen

risdiplam

Neurology/Gene therapy

Neurology

$293

$709 ripretinib

elivaldogene tavalentivec (Lenti-D)

$596

$35

Neurology/Gene therapy

Oncology

idecabtagene vicleucel

remestemcel-L Immunology

Oncology

$241

$1,040 inclisiran

relugolix

Women's health/ Oncology

$597

Cardiovascular

lenadogene nolparvovec (GS010)

$693

Ophthalmology/ Gene therapy

$15 pecialty drug names appear in ď&#x201A;Ť S magenta throughout the publication.

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PIPELINE DRUG LIST The pipeline drug list is an aerial outline of drugs with anticipated FDA approval through 2021. It is not intended to be a comprehensive inventory of all drugs in the pipeline; emphasis is placed on drugs in high-impact categories. Investigational drugs with a Complete Response Letter (CRL) and those that have been withdrawn from development are also noted.

APPLICATION APPLICATION SUBMITTED SUBMITTED TO THE FDA

IN PHASE PHASE 33 TRIALS TRIALS

66% 34% 35% 27% 25% 6%

Specialty

65% 35% 35 % 13% 9%

Traditional

Priority Review

Orphan Drug

Breakthrough Therapy

Biosimilar

Specialty drug names appear in ï&#x201A;« magenta throughout the publication.

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PIPELINE DRUG LIST  Specialty drug names appear in magenta throughout the publication.

NAME

MANUFACTURER

DOSAGE FORM

CLINICAL USE

APPROVAL STATUS

FDA APPROVAL

dapagliflozin (Farxiga®)

AstraZeneca

T2DM-related CV risk reduction in patients with heart failure

Oral

Submitted – sNDA; Fast Track; Priority Review

May 2020

ramucirumab (Cyramza®)

Eli Lilly

NSCLC (1st-line, metastatic, EGFR+, in combination with erlotinib)

IV

Submitted – sBLA

May 2020

ixekizumab (Taltz®)

Eli Lilly

Axial spondyloarthritis (non-radiographic)

SC

Submitted – sBLA

May–Jun 2020

mannitol (dry powder)

Pharmaxis

CF (adults)

Inhaled

Submitted – NDA; Fast Track; Orphan Drug

May–Jun 2020

nadofaragene firadenovec

Fergene

Bladder cancer (highgrade, BCG-unresponsive, non-muscle invasive)

Intravesical

Submitted – BLA; Breakthrough Therapy; Fast Track; Priority Review

May–Jun 2020

olaparib (Lynparza®)

AstraZeneca

Ovarian cancer (maintenance, post 1st-line platinumbased chemotherapy & bevacizumab); Prostate cancer

Oral

Submitted – sNDA; Breakthrough Therapy; Orphan Drug; Priority Review

May–Jun 2020

ticagrelor (Brilinta®)

AstraZeneca

Coronary artery disease in patients with T2DM

Oral

Submitted – sNDA

May–Aug 2020

padeliporfin di-potassium

Steba Biotech

Prostate cancer

IV

Submitted – NDA

05/01/2020

avapritinib (Ayvakit )

Blueprint Medicines

GIST (4th-line)

Oral

Submitted – sNDA; Breakthrough Therapy; Fast Track; Orphan Drug

05/14/2020

dasotraline

Sumitomo Dainippon

Binge eating disorder

Oral

Submitted – NDA

05/14/2020

nivolumab (Opdivo®)

Bristol-Myers Squibb

NSCLC (metastatic, recurrent, EGFR-negative, ALK-negative)

IV

Submitted – sBLA; Fast Track; Priority Review

05/15/2020

rucaparib (Rubraca®)

Clovis Oncology

Prostate cancer

Oral

Submitted – sNDA; Breakthrough Therapy; Priority Review

05/15/2020

apomorphine

Sumitomo Dainippon

Parkinson’s disease (off episodes)

Oral transmucosal

Submitted – 505(b)(2) NDA; Fast Track

05/21/2020

artesunate

La Jolla

Malaria (severe)

Not specified

Submitted – NDA; Breakthrough Therapy; Orphan Drug

05/25/2020

dupilumab (Dupixent®)

Sanofi

Atopic dermatitis (ages 6 to 11 years)

SC

Submitted – sBLA; Breakthrough Therapy; Priority Review

05/26/2020

L-lactic acid/citric acid/ potassium bitartrate

Evofem

Contraception

Intravaginal

Submitted – NDA

05/26/2020

insulin glargine (biosimilar to Sanofi’s Lantus)

Mylan/Biocon

T1DM; T2DM

SC

Submitted – BLA

June 2020

®

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PIPELINE DRUG LIST continued NAME

MANUFACTURER

DOSAGE FORM

CLINICAL USE

APPROVAL STATUS

FDA APPROVAL

ofatumumab (Arzerra)

Novartis

MS (relapsing)

SC

Submitted – sBLA; Priority Review

June 2020

pegfilgrastim (biosimilar to Amgen’s Neulasta)

Pfizer/Hospira

Neutropenia/leukopenia

SC

Submitted – BLA

June 2020

abicipar pegol

Allergan

Wet AMD

Intraocular

Submitted – BLA

Jun–Jul 2020

celecoxib oral solution

Dr. Reddy’s

Migraine treatment

Oral

Submitted – NDA

Jun–Jul 2020

inebilizumab

Viela Bio

Neuromyelitis optica (Devic’s syndrome)

IV

Submitted – BLA; Breakthrough Therapy; Orphan Drug

Jun–Jul 2020

minocycline 1.5% foam

Foamix

Rosacea

Topical

Submitted – 505(b)(2) NDA

06/02/2020

relebactam/imipenem/ cilastatin

Merck

HAP

IV

Submitted – NDA; Fast Track; Priority Review; QIDP

06/04/2020

elagolix (Orilissa®)

Abbvie

Uterine fibroids

Oral

Submitted – sNDA

06/05/2020

avelumab (Bavencio )

Merck

Bladder cancer (1st-line, maintenance, locally advanced or metastatic)

IV

Submitted – sBLA; Breakthrough Therapy; RTOR

06/09/2020

ketotifen

Bausch Health

Allergic conjunctivitis

Ophthalmic

Submitted – NDA

06/11/2020

pembrolizumab (Keytruda)

Merck

Solid tumors (monotherapy, unresectable or metastatic, tumor mutational burden-high ≥ 10 mutations/megabase, treatment-experienced)

IV

Submitted – sBLA; Priority Review

06/16/2020

burosumab-twza (Crysvita®)

Ultrenyx

Tumor-induced osteomalacia

SC

Submitted – sBLA; Priority Review

06/18/2020

tazemetostat (Tazverik™)

Epizyme

Follicular lymphoma (relapsed/refractory, 2+ prior therapies)

Oral

Submitted – sNDA; Accelerated Approval; Fast Track; Orphan Drug; Priority Review

06/18/2020

atezolizumab (Tecentriq®)

Genentech

NSCLC (1st-line, monotherapy, without EGFR or ALK mutations, high PD-L1 expression)

IV

Submitted – sBLA; Priority Review

06/19/2020

fosfomycin

Nabriva

UTI (complicated)

IV

Submitted – 505(b)(2) NDA; Fast Track; QIDP

06/19/2020

metoclopramide

Evoke

Diabetic gastroparesis (in women)

Intranasal

Submitted – 505(b)(2) NDA

06/19/2020

brigatinib (Alunbrig®)

Takeda

NSCLC (1st-line, ALK+, metastatic)

Oral

Submitted – sNDA; Breakthrough Therapy; Orphan Drug; Priority Review

06/23/2020

selinexor (Xpovio®)

Karyopharm

DLBCL (relapsed/ Oral refractory, post ≥ 2 multi-drug therapies, SCTineligible)

Submitted – sNDA; Accelerated Approval; Fast Track; Orphan Drug; Priority Review

06/23/2020

®

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PIPELINE DRUG LIST continued NAME

MANUFACTURER

DOSAGE FORM

CLINICAL USE

APPROVAL STATUS

FDA APPROVAL

fenfluramine (low dose)

Zogenix

Dravet syndrome

Oral

Submitted – NDA; Fast Track; Orphan Drug; Priority Review

06/25/2020

bupivacaine/meloxicam ER

Heron

Postsurgical pain

Instillation

Submitted – NDA; Breakthrough Therapy; Fast Track

06/26/2020

obeticholic acid (Ocaliva®)

Intercept

NASH

Oral

Submitted – sNDA; Breakthrough Therapy; Priority Review

06/26/2020

octreotide

Chiasma

Acromegaly

Oral

Submitted – 505(b)(2) NDA; Orphan Drug

06/26/2020

pembrolizumab (Keytruda)

Merck

Cutaneous squamous cell carcinoma (recurrent/ metastatic, not curable with surgery/radiation)

IV

Submitted – sBLA

06/29/2020

cedazuridine/decitabine

Otsuka

Chronic myelomonocytic leukemia; Myelodysplastic syndrome

Oral

Submitted – NDA; Orphan Drug; Priority Review

Jul–Aug 2020

selpercatinib

Eli Lilly

NSCLC (RET-altered); Thyroid cancer (RETaltered)

Oral

Submitted – NDA; Breakthrough Therapy; Orphan Drug; Priority Review

Jul–Aug 2020

bevacizumab (biosimilar to Genentech’s Avastin)

Merck/Samsung Bioepis

CRC; Glioblastoma; NSCLC; Ovarian cancer; RCC

IV

Submitted – BLA

Jul–Sep 2020

omalizumab (Xolair®)

Genentech

Nasal polyposis

SC

Submitted – sBLA

Jul–Sep 2020

insulin lispro, ultra rapid

Eli Lilly

T1DM; T2DM

SC

Submitted – BLA

Jul–Oct 2020

remimazolam

Cosmo

Anesthesia

IV

Submitted – NDA

07/05/2020

dantrolene

Eagle

Heat stroke (exertional)

IV

Submitted – sNDA; Fast Track; Orphan Drug

07/08/2020

daratumumab (Darzalex®)

Janssen

Multiple myeloma

SC

Submitted – sBLA

07/10/2020

cantharidin 0.7% solution

Verrica

Molluscum contagiosum

Topical

Submitted – NDA

07/13/2020

guselkumab (Tremfya )

Janssen

PsA

SC

Submitted – sBLA

07/16/2020

oxymetazoline 0.1% solution

Osmotica

Acquired blepharoptosis

Topical

Submitted – NDA

07/16/2020

capsaicin (Qutenza®)

Grünenthal

Diabetic peripheral neuropathy

Topical

Submitted – sNDA

07/19/2020

calcipotriene/ betamethasone dipropionate

MC2

PSO

Topical

Submitted – 505(b)(2) NDA

07/20/2020

sodium oxybate (low dose)

Jazz

Narcolepsy

Oral

Submitted – NDA; Priority Review

07/21/2020

cortrophin (purified gel)

ANI

MS

IV

Submitted – sNDA

07/24/2020

atezolizumab (Tecentriq)

Genentech

HCC (1st-line, unresectable, in combination with bevacizumab)

IV

Submitted – sBLA; Breakthrough Therapy; RTOR

07/27/2020

®

23 | magellanrx.com

PIPELINE DRUG LIST continued NAME

MANUFACTURER

DOSAGE FORM

CLINICAL USE

APPROVAL STATUS

FDA APPROVAL

bevacizumab (Avastin)

Genentech

HCC (1st-line, unresectable, in combination with atezolizumab)

IV

Submitted – sBLA; RTOR

07/27/2020

secukinumab (Cosentyx®)

Novartis

Axial spondyloarthritis (non-radiographic)

SC

Submitted – sBLA; Priority Review

07/29/2020

donepezil transdermal system

Corium

Alzheimer’s disease

Transdermal

Submitted – NDA

07/30/2020

cannabidiol (Epidiolex®)

GW

Tuberous sclerosis complex

Oral

Submitted – sNDA; Orphan Drug; Priority Review

07/31/2020

fluticasone furoate/ umeclidinium bromide/ vilanterol (Trelegy® Ellipta®)

GlaxoSmithKline

Asthma (adults)

Inhaled

Submitted – sNDA

07/31/2020

triheptanoin

Ultrenyx

Fatty acid oxidation disorders

Oral

Submitted – NDA; Fast Track; Orphan Drug

07/31/2020

esketamine (Spravato®)

Janssen

MDD (with suicidal ideation with intent)

Intranasal

Submitted – sNDA; Breakthrough Therapy; Fast Track

08/02/2020

viaskin peanut

DBV

Peanut allergy (ages 4 to 11 years)

Transdermal

Submitted – BLA; Breakthrough Therapy; Fast Track

08/05/2020

ipilimumab (Yervoy®)

Bristol-Myers Squibb

NSCLC (1st-line, metastatic or recurrent, EGFR- and ALK-negative, in combination with nivolumab and limited chemotherapy)

IV

Submitted – sBLA; Fast Track; Priority Review

08/06/2020

nivolumab (Opdivo)

Bristol-Myers Squibb

NSCLC (1st-line, metastatic or recurrent, EGFR- and ALK-negative, in combination with ipilimumab and limited chemotherapy)

IV

Submitted – sBLA; Fast Track; Priority Review

08/06/2020

oliceridine

Trevena

Acute pain

IV

Submitted – NDA; Fast Track

08/07/2020

ustekinumab (Stelara®)

Janssen

PSO (ages 6 to 11 years)

IV, SC

Submitted – sBLA

08/07/2020

KTE-X19

Gilead

Mantle cell lymphoma (relapsed/refractory)

IV

Submitted – BLA; Breakthrough Therapy; Orphan Drug; Priority Review

08/10/2020

capmatinib

Novartis

NSCLC

Oral

Submitted – NDA; Breakthrough Therapy; Orphan Drug; Priority Review

08/11/2020

sodium thiosulfate

Fennec

Chemotherapy-induced ototoxicity prevention

IV

Submitted – NDA; Breakthrough Therapy; Fast Track; Orphan Drug

08/11/2020

ripretinib

Deciphera

GIST (prior treatment with Oral imatinib, sunitinib, and regorafenib)

Submitted – NDA; Breakthrough Therapy; Fast Track; Orphan Drug; Priority Review; RTOR

08/13/2020

24 | magellanrx.com

PIPELINE DRUG LIST continued NAME

MANUFACTURER

DOSAGE FORM

CLINICAL USE

APPROVAL STATUS

FDA APPROVAL

belantamab mafodotin

GlaxoSmithKline

Multiple myeloma (relapsed/refractory)

SC

Submitted – BLA; Breakthrough Therapy; Orphan Drug; Priority Review

08/14/2020

satralizumab

Genentech

Neuromyelitis optica (Devic’s syndrome)

SC

Submitted – BLA; Breakthrough Therapy; Orphan Drug

08/14/2020

dolutegravir/lamivudine (Dovato®)

Viiv

HIV-1 treatment (switch therapy)

Oral

Submitted – sNDA

08/16/2020

lurbinectidin

Mar

SCLC (relapsed)

IV

Submitted – NDA; Accelerated Approval; Orphan Drug; Priority Review

08/16/2020

lisocabtagene maraleucel

Bristol-Myers Squibb

DLBCL (relapsed/ refractory)

IV

Submitted – BLA; 08/17/2020 Breakthrough Therapy; Orphan Drug; Priority Review; RMAT

filgotinib

Gilead

RA

Oral

Submitted – NDA; Priority Review

margetuximab

Macrogenics

Breast cancer (HER2+, in combination with chemotherapy)

IV

Submitted – BLA; Fast 08/19/2020 Track

tucatinib

Seattle Genetics

Breast cancer (locally advanced unresectable, metastatic [including brain], HER2+, in combination with trastuzumab and capecitabine)

Oral

Submitted – NDA; Breakthrough Therapy; Fast Track; Orphan Drug; Priority Review

08/20/2020

valoctocogene roxaparvovec

Biomarin

Hemophilia A

IV

Submitted – BLA; Breakthrough Therapy; Orphan Drug; Priority Review

08/21/2020

veverimer

Tricida

CKD-related metabolic acidosis

Oral

Submitted – NDA

08/22/2020

risdiplam

Genentech

Spinal muscular atrophy (types 1, 2, 3)

Oral

Submitted – NDA; Breakthrough Therapy; Fast Track; Orphan Drug; Priority Review

08/24/2020

bupivacaine

Innocoll

Postsurgical pain

Surgical implantation

Submitted – NDA

08/26/2020

clascoterone

Cassiopea

Acne

Topical

Submitted – NDA

08/27/2020

tafasitamab

Morphosys

DLBCL (relapsed/ refractory, post lenalidomide monotherapy)

IV

Submitted – BLA; Breakthrough Therapy; Fast Track; Orphan Drug; Priority Review

08/28/2020

testosterone undecanoate

Lipocine

Hypogonadism

Oral

Submitted – 505(b)(2) NDA

08/28/2020

HIV vaccine (Remune)

Immune Response Bio

HIV-1 infection treatment (pediatrics)

IM

Submitted – BLA; Orphan Drug

Sep–Dec 2020

25 | magellanrx.com

08/19/2020

PIPELINE DRUG LIST continued NAME

MANUFACTURER

DOSAGE FORM

CLINICAL USE

APPROVAL STATUS

FDA APPROVAL

ibrutinib (Imbruvica®)

Abbvie

CLL/SLL (1st-line, ages < 70 years, in combination with rituximab)

Oral

Submitted – sNDA; Orphan Drug; RTOR

09/08/2020

terlipressin

Mallinckrodt

Hepatorenal syndrome type 1

IV

Submitted – NDA; Fast Track; Orphan Drug

09/12/2020

somapacitan

Novo Nordisk

Growth hormone deficiency (adults)

SC

Submitted – BLA

09/21/2020

diazepam film

Aquestive

Seizure clusters

Oral transmucosal

Submitted – 505(b)(2) NDA; Fast Track; Orphan Drug

09/27/2020

remestemcel-L

Mesoblast

GVHD (steroid-refractory, pediatric)

IV

Submitted – BLA; Fast 09/30/2020 Track; Orphan Drug; Priority Review

linaclotide acetate (Linzess®)

Ironwood

IBS (treatment of abdominal symptoms)

Oral

Submitted – sNDA

October 2020

fostemsavir

Viiv

HIV-1 infection (multidrug-resistant)

Oral

Submitted – NDA; Breakthrough Therapy; Fast Track

Oct–Dec 2020

viltolarsen

Nippon Shinyaku

DMD (exon 53 skipping)

IV

Submitted – NDA; Fast Track; Orphan Drug; Rare Pediatric Disease

Oct–Dec 2020

hydrocortisone granules

Diurnal

Adrenal insufficiency (ages birth to < 17 years)

Oral

Submitted – 505(b)(2) NDA; Orphan Drug

10/02/2020

tramadol

Fortress

Pain (moderate to severe, medically supervised setting)

IV

Submitted – 505(b)(2) NDA

10/09/2020

dolutegravir (Tivicay®) dispersible tablet

Viiv

HIV-1 treatment (pediatrics)

Oral

Submitted – sNDA

10/13/2020

trastuzumab/pertuzumab

Genentech

Breast cancer (HER2+, in combination with chemotherapy)

SC

Submitted – BLA

10/16/2020

rituximab (biosimilar to Genentech’s Rituxan)

Amgen/Allergan

RA; CLL/ SLL; NHL (indolent); Antineutrophil cytoplasmic antibodies associated vasculitis

IV

Submitted – BLA

10/19/2020

zolmitriptan (micro-needle patch)

Zosano

Migraine treatment

Transdermal

Submitted – 505(b)(2) NDA

10/20/2020

eflapegrastim

Spectrum

Neutropenia/leukopenia

SC

Submitted – BLA

10/23/2020

pembrolizumab (Keytruda) - 6-week dosing regimen

Merck

Melanoma; Classical NHL; DLBCL; Gastric cancer; HCC; Merkel cell carcinoma

IV

Submitted – sBLA; Breakthrough Therapy; Orphan Drug

10/23/2020

REGN-EB3

Regeneron

Ebola virus infection treatment

IV

Submitted – BLA; Breakthrough Therapy; Orphan Drug; Priority Review

10/23/2020

estradiol/progesterone

TherapeuticsMD

Menopause (including hormone replacement therapy [HRT])

Oral

Submitted – NDA

November 2020

26 | magellanrx.com

PIPELINE DRUG LIST continued NAME

MANUFACTURER

DOSAGE FORM

CLINICAL USE

APPROVAL STATUS

FDA APPROVAL

niraparib (Zejula®)

GlaxoSmithKline

Ovarian cancer (1stline maintenance, post response to platinumbased chemotherapy)

Oral

Submitted – sNDA; Orphan Drug; RTOR

Nov–Dec 2020

viloxazine

Supernus

ADHD

Oral

Submitted – NDA

11/06/2020

samidorphan/olanzapine

Alkermes

Bipolar disorder; Schizophrenia

Oral

Submitted – NDA

11/13/2020

treprostinil dry powder

Liquidia

PAH

Inhaled

Submitted – 505(b)(2) NDA

11/24/2020

idecabtagene vicleucel

Bristol-Myers Squibb

Multiple myeloma (≥ 3 prior therapies)

IV

Submitted – BLA; Breakthrough Therapy; Orphan Drug

11/30/2020

naxitamab

Y-mAbs

Neuroblastoma (relapsed/ IV refractory, high-risk)

Submitted – BLA; Breakthrough Therapy; Orphan Drug; Priority Review

11/30/2020

nifurtimox

Bayer

Chagas disease

Oral

Submitted – NDA; Orphan Drug

11/30/2020

inclisiran

The Medicines Company

Dyslipidemia (in secondary prevention patients with ASCVD and familial hypercholesterolemia)

SC

Submitted – NDA; Orphan Drug

December 2020

ocrelizumab (Ocrevus®) 2-hour infusion

Genentech

MS (relapsing and primary IV progressive)

Submitted – sBLA

December 2020

tanezumab

Pfizer

Osteoarthritis pain

IV

Submitted – BLA; Fast December Track 2020

berotralstat

Biocryst

Hereditary angioedema

Oral

Submitted – NDA; Fast Track; Orphan Drug

12/03/2020

carfilzomib (Kyprolis®)

Amgen

Multiple myeloma (relapsed/refractory, in combination with daratumumab)

IV

Submitted – sBLA; Orphan Drug

12/10/2020

daratumumab (Darzalex)

Janssen

Multiple myeloma (relapsed/refractory, in combination with carfilzomib)

IV

Submitted – sBLA; Orphan Drug

12/10/2020

roxadustat

AstraZeneca

Anemia due to CKD (dialysis-independent; dialysis-dependent)

Oral

Submitted – NDA

12/20/2020

ansofaxine

Luye

MDD

Oral

Submitted – NDA

12/25/2020

bevacizumab (biosimilar to Genentech’s Avastin)

Mylan/Biocon

CRC; Glioblastoma; NSCLC; Ovarian cancer; RCC

IV

Submitted – BLA

12/25/2020

vibegron

Urovant

Overactive bladder

Oral

Submitted – NDA

12/25/2020

tirbanibulin

Almirall

Actinic keratoses

Topical

Submitted – NDA

12/30/2020

lonafarnib

Eiger Bio

Hutchinson – Gilford Progeria syndrome

Oral

Submitted – NDA; Breakthrough Therapy; Orphan Drug; Rare Pediatric Disease

Jan–Mar 2021

27 | magellanrx.com

PIPELINE DRUG LIST continued NAME

MANUFACTURER

DOSAGE FORM

CLINICAL USE

APPROVAL STATUS

FDA APPROVAL

pralsetinib

Blueprint Medicines

NSCLC (RET-fusion+)

Oral

Submitted – NDA; Breakthrough Therapy; Orphan Drug

Jan–Mar 2021

setmelanotide

Rhythm

Obesity (proopiomelanocortin and leptin receptor deficiency)

SC

Submitted – NDA; Breakthrough Therapy; Orphan Drug

Jan–Mar 2021

peginterferon β-1a (Plegridy®)

Biogen

MS (relasping/remitting, active secondary progressive)

IM

Submitted – sBLA

February 2021

serdexmethylphenidate

Kempharm

ADHD

Oral

Submitted – 505(b)(2) NDA

March 2021

ponesimod

Janssen

MS (relapsing)

Oral

Submitted – NDA

03/18/2021

dasiglucagon

Zealand

Hyperinsulinemia/ hypoglycemia

SC

Submitted – NDA; Orphan Drug

03/31/2021

tivozanib hydrochloride monohydrate

AVEO

RCC (relapsed/refractory)

Oral

Submitted – NDA

03/31/2021

lumasiran

Alnylam

Hyperoxaluria

SC

Submitted – NDA; Breakthrough Therapy; Orphan Drug

Apr–Jun 2021

estetrol/drospirenone

Mayne

Contraception

Oral

Submitted – NDA

04/16/2021

relugolix

Myovant

Prostate cancer (advanced)

Oral

Submitted – NDA

04/21/2021

filgrastim (biosimilar to Amgen’s Neupogen)

Apotex

Neutropenia/leukopenia

IV, SC

Submitted – BLA

Pending

filgrastim (biosimilar to Amgen’s Neupogen)

Kashiv

Neutropenia/leukopenia

IV, SC

Submitted – BLA

Pending

oxycodone ER

Intellipharmaceutics

Chronic pain

Oral

Submitted – 505(b)(2) NDA; Fast Track

Pending

pegfilgrastim (biosimilar to Amgen’s Neulasta)

Apotex

Neutropenia/leukopenia

SC

Submitted – BLA

Pending

5-aminolevulinic acid (Ameluz®)

Biofrontera

Actinic keratoses (with conventional photodynamic therapy)

Topical

Phase 3 – sNDA

TBD

abaloparatide-TD

Radius

Osteoporosis/osteopenia

Transdermal

Phase 3 – NDA

TBD

abametapir

Dr. Reddy’s

Head lice (ages ≥ 6 months)

Topical

Phase 3 – NDA

TBD

abrocitinib

Pfizer

Atopic dermatitis

Oral

Phase 3 – NDA; Breakthrough Therapy

TBD

adalimumab (biosimilar to Abbvie’s Humira)

Coherus

RA; AS; PSO; PsA; JIA; CD; UC

SC

Phase 3 – BLA

TBD

adalimumab (biosimilar to Abbvie’s Humira)

Fresenius

RA; AS; PSO; PsA; JIA; CD; UC

SC

Phase 3 – BLA

TBD

adalimumab (biosimilar to Abbvie’s Humira)

Momenta

RA; AS; PSO; PsA; JIA; CD; UC

SC

Phase 3 – BLA

TBD

adalimumab (biosimilar to Abbvie’s Humira)

Mylan

RA; AS; PSO; PsA; JIA; CD; UC

SC

Phase 3 – BLA

TBD

28 | magellanrx.com

PIPELINE DRUG LIST continued NAME

MANUFACTURER

DOSAGE FORM

CLINICAL USE

APPROVAL STATUS

FDA APPROVAL

ado-trastuzumab emtansine (Kadcyla®)

Genentech

Breast cancer (HER2+, adjuvant, with pertuzumab)

IV

Phase 3 – sBLA; Breakthrough Therapy

TBD

aducanumab

Biogen

Alzheimer’s disease

IV

Phase 3 – BLA; Fast Track

TBD

aflibercept (biosimilar to Regeneron’s Eylea®)

Mylan

Diabetic macular edema

Intraocular

Phase 3 – BLA

TBD

albuterol (ProAir® RespiClick®)

Teva

COPD

Inhaled

Phase 3 – sNDA

TBD

albutrepenonacog alfa (Idelvion®)

CSL

Hemophilia B (21-day dosing schedule)

IV

Phase 3 – sBLA; Orphan Drug

TBD

alicaforsen

Atlantic Healthcare

UC (pouchitis)

Rectal

Phase 3 – NDA; Fast Track; Orphan Drug

TBD

alpha 1 proteinase inhibitor

Kamada

Emphysema

Inhaled

Phase 3 – BLA; Orphan Drug

TBD

andolast

Mylan

Asthma

Inhaled

Phase 3 – NDA

TBD

anifrolumab

AstraZeneca

SLE

IV

Phase 3 – BLA; Fast Track

TBD

antolimab

Allakos

Gastroenteritis (eosinophilic esophagitis)

IV

Phase 3 – BLA; Orphan Drug

TBD

apalutamide (Erleada®)

Janssen

Prostate cancer (metastatic, castrationresistant); Prostate cancer (localized)

Oral

Phase 3 – sNDA

TBD

APR-246

Aprea

Myelodysplastic IV syndrome (with susceptible TP5 mutation)

Phase 3 – NDA; Breakthrough Therapy; Fast Track; Orphan Drug

TBD

arimoclomol

Orphazyme

Niemann-Pick disease

Oral

Phase 3 – NDA; Breakthrough Therapy; Fast Track; Orphan Drug

TBD

asciminib

Novartis

Chronic myelogenous leukemia (CML)

Oral

Phase 3 – NDA; Orphan Drug

TBD

ataluren

PTC

DMD

Oral

Phase 3 – NDA; Fast Track; Orphan Drug

TBD

atezolizumab (Tecentriq)

Genentech

CRC; RCC; Melanoma; Ovarian cancer; NSCLC (adjuvant); NSCLC (neoadjuvant); Bladder cancer (1st-line metastatic); Bladder cancer (adjuvant muscle-invasive); Breast cancer (TNBC, neoadjuvant, with nabpaclitaxel); Breast cancer (1st-line, TNBC, with paclitaxel)

IV

Phase 3 – sBLA; Breakthrough Therapy; Orphan Drug

TBD

autologous genetically modified human dermal fibroblasts

Castle Creek

Epidermolysis bullosa

Intradermal

Phase 3 – BLA; Fast Track; Orphan Drug; RMAT

TBD

avacopan

Chemocentryx

ANCA-associated vasculitis

Oral

Phase 3 – NDA; Orphan Drug

TBD

29 | magellanrx.com

PIPELINE DRUG LIST continued NAME

MANUFACTURER

DOSAGE FORM

CLINICAL USE

APPROVAL STATUS

FDA APPROVAL

avalglucosidase alfa

Sanofi

Pompe disease

IV

Phase 3 – BLA

TBD

avatrombopag (Doptelet®)

Ararx

Thrombocytopenia (chemotherapy-induced)

Oral

Phase 3 – sNDA; Orphan Drug

TBD

azacitidine

Bristol-Myers Squibb

AML

Oral

Phase 3 – NDA

TBD

baclofen/naltrexone/ sorbitol

Pharnext

Charcot-Marie-Tooth disease

Oral

Phase 3 – NDA; Fast Track; Orphan Drug

TBD

baricitinib (Olumiant®)

Eli Lilly

Atopic dermatitis; SLE; Alopecia; JIA; Uveitis

Oral

Phase 3 – sNDA; Breakthrough Therapy; Fast Track

TBD

bedaquiline (Sirturo®)

Janssen

Tuberculosis (ages 5 to 11 years, multidrugresistant)

Oral

Phase 3 – sNDA; Fast Track; Orphan Drug

TBD

belimumab (Benlysta®)

GlaxoSmithKline

Lupus nephritis

IV

Phase 3 – sBLA

TBD

benralizumab (Fasenra®)

AstraZeneca

Nasal polyposis

SC

Phase 3 – sBLA

TBD

betibeglogene autotemcel (Zynteglo)

Bluebird Bio

Thalassemia

IV

Phase 3 – BLA; Breakthrough Therapy; Fast Track; Orphan Drug

TBD

bevacizumab

Outlook

Wet AMD

Intraocular

Phase 3 – BLA

TBD

bevacizumab (biosimilar to Genentech’s Avastin)

Bio-Thera Solutions

CRC; Glioblastoma; NSCLC; Ovarian cancer; RCC

IV

Phase 3 – BLA

TBD

bevacizumab (biosimilar to Genentech’s Avastin)

Boehringer Ingelheim

CRC; Glioblastoma; NSCLC; Ovarian cancer; RCC

IV

Phase 3 – BLA

TBD

bevacizumab (biosimilar to Genentech’s Avastin)

Kyowa Kirin

CRC; Glioblastoma; NSCLC; Ovarian cancer; RCC

IV

Phase 3 – BLA

TBD

bexagliflozin

Theracos

T2DM

Oral

Phase 3 – NDA

TBD

bimekizumab

UCB

Axial spondyloarthritis; PsA; PSO

IV

Phase 3 – BLA

TBD

biotin (high dose)

Medday

MS

Oral

Phase 3 – NDA

TBD

brexpiprazole (Rexulti®)

Otsuka

Alzheimer’s diseaserelated agitation

Oral

Phase 3 – sNDA; Fast Track

TBD

budenoside

Calliditas

Immunoglobulin A (IgA) nephropathy (Berger’s disease)

Oral

Phase 3 – NDA; Orphan Drug

TBD

cabotegravir (long-acting)

Viiv

HIV-1 infection preexposure prevention (PrEP)

IM

Phase 3 – NDA

TBD

cabozantinib (Cabometyx®)

Exelixis

RCC (1st-line, with nivolumab)

Oral

Phase 3 – sNDA

TBD

calmangafodipir

Pledpharma

Chemotherapy-induced peripheral neuropathy

IV

Phase 3 – NDA

TBD

cannabidiol (Epidiolex)

GW

Rett syndrome

Oral

Phase 3 – sNDA

TBD

cannabidiol gel

Zynerba

Fragile X syndrome

Topical

Phase 3 – NDA; Fast Track; Orphan Drug

TBD

capsaicin

Centrexion

Osteoarthritis

Intraarticular

Phase 3 – NDA; Fast Track

TBD

carglumic acid

Recordati

Hyperammonemia (genetic autosomal disorder-related)

Oral

Phase 3 – NDA; Orphan Drug

TBD

30 | magellanrx.com

PIPELINE DRUG LIST continued NAME

MANUFACTURER

DOSAGE FORM

CLINICAL USE

APPROVAL STATUS

FDA APPROVAL

casimersen

Sarepta

DMD

IV

Phase 3 – NDA

TBD

CD24Fc

Oncoimmune

COVID-19

IV

Phase 3 – BLA

TBD

cedazuridine/decitabine

Otsuka

AML

Oral

Phase 3 – NDA

TBD

cediranib

AstraZeneca

Ovarian cancer

Oral

Phase 3 – NDA; Orphan Drug

TBD

cefiderocol (Fetroja®)

Shionogi

HAP

IV

Phase 3 – sNDA

TBD

ceftobiprole medocaril

Basilea

ABSSSI

IV

Phase 3 – NDA; Fast Track; QIDP

TBD

cenicriviroc mesylate

Allergan

NASH

Oral

Phase 3 – NDA; Fast Track

TBD

CM-AT

Curemark

Autism spectrum disorders

Oral

Phase 3 – BLA; Fast Track

TBD

conbercept

Chengdu Kanghong

Wet AMD

Intraocular

Phase 3 – BLA

TBD

crisantaspase (recombinant)

Jazz

ALL

IM, IV

Phase 3 – BLA; Fast Track

TBD

cyclic pyranopterin monophosphate

Bridgebio

Molybdenum cofactor deficiency (MoCD)

IV

Phase 3 – NDA; Breakthrough Therapy; Orphan Drug

TBD

dalcetrapib

Dalcor

Dyslipidemia/ hypercholesterolemia

Oral

Phase 3 – NDA

TBD

daprodustat

GlaxoSmithKline

Anemia due to CKD (dialysis-independent)

Oral

Phase 3 – NDA

TBD

daratumumab rHuPH20

Janssen

Amyloidosis

SC

Phase 3 – BLA

TBD

dehydrated human Mimedx amnion-chorion membrane

Achilles tendonitis; Plantar fasciitis

IV

Phase 3 – BLA

TBD

denosumab (biosimilar to Amgen’s Prolia®)

Novartis

Osteoporosis/osteopenia

SC

Phase 3 – BLA

TBD

deramanido

Otsuka

Tuberculosis

Oral

Phase 3 – NDA

TBD

dexmedetomidine

Bioxcel

Schizophrenia

SL/Oral transmucosal

Phase 3 – NDA; Fast Track

TBD

dianhydrogalactitol

Delmar

Brain cancer

IV

Phase 3 – NDA; Fast Track; Orphan Drug

TBD

difelikefalin

Enteris

Pruritus (hemodialysisrelated)

IV

Phase 3 – NDA; Breakthrough Therapy

TBD

digoxin immune Fab

AMAG

Eclampsia/pre-eclampsia

IV

Phase 3 – BLA; Fast Track; Orphan Drug

TBD

docosahexaenoic acid

Micelle

Sickle cell disease

Oral

Phase 3 – NDA; Orphan Drug

TBD

donaperminogene seltoplasmid

Helixmith

Diabetic foot ulcers

IM

Phase 3 – BLA; RMAT

TBD

dovitinib lactate

Oncology Venture

RCC

Oral

Phase 3 – NDA

TBD

dupilumab (Dupixent)

Sanofi

COPD; Esophagitis

SC

Phase 3 – sBLA; Orphan Drug

TBD

durvalumab (Imfinzi®)

AstraZeneca

Bladder cancer (in combination with tremelimumab); NSCLC (1st-line, in combination with tremelimumab)

IV

Phase 3 – sBLA

TBD

31 | magellanrx.com

PIPELINE DRUG LIST continued NAME

MANUFACTURER

DOSAGE FORM

CLINICAL USE

APPROVAL STATUS

FDA APPROVAL

dusquetide

Soligenix

Mucositis

IV

Phase 3 – NDA; Fast Track

TBD

dust mite immunotherapy

Stallergenes

Allergic rhinitis

SL/Oral transmucosal

Phase 3 – BLA

TBD

edasalonexent

Catabasis

DMD

Oral

Phase 3 – NDA; Fast Track; Orphan Drug

TBD

efgartigimod

Argenx

Myasthenia gravis; Immune thrombocytopenic purpura

IV, SC

Phase 3 – BLA; Fast Track; Orphan Drug

TBD

efpeglenatide

Hanmi

T2DM

SC

Phase 3 – NDA

TBD

elafibranor

Genfit

NASH

Oral

Phase 3 – NDA; Fast Track

TBD

elivaldogene tavalentivec (Lenti-D)

Bluebird Bio

Adrenomyeloneuropathy (adrenoleukodystrophy)

IV

Phase 3 – BLA; Breakthrough Therapy; Orphan Drug

TBD

empagliflozin (Jardiance®)

Boehringer Ingelheim

Diabetic nephropathy

Oral

Phase 3 – sNDA

TBD

enmetazobactam

Allecra

UTI (complicated)

IV

Phase 3 – NDA; Fast Track; QIDP

TBD

entinostat

Syndax

Breast cancer

Oral

Phase 3 – NDA; Breakthrough Therapy

TBD

EP-2101 vaccine

OSE Immunotherapeutics

NSCLC

SC

Phase 3 – NDA; Orphan Drug

TBD

erdosteine

Alitair

COPD

Oral

Phase 3 – NDA

TBD

estetrol

Mithra

Menopausal vasomotor symptoms

Oral

Phase 3 – NDA

TBD

etanercept (biosimilar to Amgen’s Enbrel)

Coherus

RA; JIA; AS; PSO; PsA

SC

Phase 3 – BLA

TBD

etranacogene dezaparvovec

Uniqure

Hemophilia B

IV

Phase 3 – BLA; Breakthrough Therapy

TBD

etrasimod

Arena

UC

Oral

Phase 3 – NDA

TBD

etrolizumab

Genentech

CD; UC

SC

Phase 3 – BLA; Orphan Drug

TBD

evinacumab

Regeneron

Dyslipidemia/ hypercholesterolemia

SC

Phase 3 – BLA; Breakthrough Therapy

TBD

fasinumab

Regeneron

Osteoarthritis

SC

Phase 3 – BLA

TBD

fenfluramine (low dose)

Zogenix

Lennox-Gastaut syndrome

Oral

Phase 3 – NDA; Orphan Drug

TBD

fexapotide triflutate

Nymox

Benign prostatic hyperplasia

Intratumoral

Phase 3 – NDA

TBD

fezolinetant

Astellas

Menopause vasomotor symptoms

Oral

Phase 3 – NDA

TBD

filgotinib

Gilead

PsA; CD; UC

Oral

Phase 3 – NDA

TBD

fitusiran

Sanofi

Hemophilia A and B (with and without inhibitors)

SC

Phase 3 – NDA; Orphan Drug

TBD

fluocinolone (Iluvien®)

Alimera

Uveitis (chronic noninfectious)

Intraocular

Phase 3 – sNDA; Orphan Drug

TBD

32 | magellanrx.com

PIPELINE DRUG LIST continued NAME

MANUFACTURER

DOSAGE FORM

CLINICAL USE

APPROVAL STATUS

FDA APPROVAL

follitropin alfa (biosimilar to EMD Serono’s Gonal-F®)

Allergan

Reproductive disorder

SC

Phase 3 – BLA

TBD

follitropin alfa (biosimilar to EMD Serono’s Gonal-F)

Finox

Reproductive disorder

SC

Phase 3 – BLA

TBD

follitropin delta

Ferring

Female infertility

IV

Phase 3 – BLA

TBD

fusidic acid

Arrevus

ABSSSI

Oral

Phase 3 – NDA; Orphan Drug; QIDP

TBD

gefapixant

Merck

Chronic cough

Oral

Phase 3 – NDA

TBD

gepotidacin

GlaxoSmithKline

UTI (uncomplicated)

Oral

Phase 3 – NDA; QIDP

TBD

givinostat

Italfarmaco

DMD

Oral

Phase 3 – NDA

TBD

glatiramer acetate depot

Mylan

MS

IM

Phase 3 – 505(b)(2) NDA

TBD

GLPG1690

Galapos

Idiopathic pulmonary fibrosis

Oral

Phase 3 – NDA; Orphan Drug

TBD

glycopyrronium bromide (Seebri Neohaler®)

Sumitomo Dainippon

Asthma

Inhaled

Phase 3 – sNDA

TBD

HLCM051

Athersys

COVID-19

IV

Phase 3 – BLA

TBD

hydrogen peroxide (Eskata®)

Aclaris

Warts

Topical

Phase 3 – sNDA

TBD

hydroxychloroquine

National Institutes of Health

COVID-19

Oral

Phase 3 – NDA

TBD

ibrexafungerp

Scynexis

Fungal infections (systemic and nonsystemic)

Oral

Phase 3 – NDA; Fast Track; Orphan Drug; QIDP

TBD

iclaprim

Motif Bio

ABSSSI; HAP

IV

Phase 3 – NDA; Fast Track; QIDP

TBD

idasanutlin

Genentech

AML

Oral

Phase 3 – NDA

TBD

idebenone

Santhera

DMD

Oral

Phase 3 – NDA; Fast Track; Orphan Drug

TBD

idursulfase

Takeda

Mucopolysaccharidosis II (Hunter syndrome)

Intrathecal

Phase 3 – BLA; Fast Track; Orphan Drug

TBD

immunoglobulin IV 10%

Prometic Life Sciences

Primary immunodeficiencies

IV

Phase 3 – BLA

TBD

infliximab (biosimilar to Janssen’s Remicade)

Nichi-Iko

RA; AS; PSO; PsA; CD; UC

IV

Phase 3 – BLA

TBD

insulin aspart (biosimilar to Novo Nordisk’s Novolog®)

Mylan

T1DM; T2DM

SC

Phase 3 – BLA

TBD

insulin aspart (biosimilar to Novo Nordisk’s Novolog)

Sanofi

T1DM; T2DM

SC

Phase 3 – BLA

TBD

insulin glargine (biosimilar to Sanofi’s Lantus)

Gan & Lee

T1DM; T2DM

SC

Phase 3 – BLA

TBD

iodine I-131 monoclonal antibody

Actinium

Myeloablation (prior to allogeneic HSCT to treat AML)

IV

Phase 3 – BLA; Orphan Drug

TBD

ipatasertib

Genentech

Breast cancer; Prostate cancer

Oral

Phase 3 – NDA

TBD

lacosamide (Vimpat®)

UCB

Partial seizures

IV, Oral

Phase 3 – sNDA

TBD

L-citrulline

Asklepion

Acute lung injury

IV

Phase 3 – NDA; Orphan Drug

TBD

lebrikizumab

Dermira

Atopic dermatitis

SC

Phase 3 – BLA; Fast Track

TBD

33 | magellanrx.com

PIPELINE DRUG LIST continued NAME

MANUFACTURER

DOSAGE FORM

CLINICAL USE

APPROVAL STATUS

FDA APPROVAL

lenadogene nolparvovec (GS010)

Gensight

Leber’s hereditary optic neuropathy

Intraocular

Phase 3 – BLA; Orphan Drug

TBD

leriglitazone

Minoryx

Adrenomyeloneuropathy (adrenoleukodystrophy)

Oral

Phase 3 – NDA; Fast Track; Orphan Drug

TBD

leronlimab

Cytodyn

HIV-1 infection treatment; SC COVID-19

Phase 3 – BLA; Fast Track

TBD

levodopa/carbidopa (patch pump)

Mitsubishi Tanabe

Parkinson’s disease

SC

Phase 3 – 505(b)(2) NDA

TBD

levoketoconazole

Strongbridge

Cushing’s syndrome

Oral

Phase 3 – 505(b)(2) NDA; Orphan Drug

TBD

ligelizumab

Novartis

Urticaria

SC

Phase 3 – BLA

TBD

linzagolix

Obseva

Endometriosis; Uterine fibroids

Oral

Phase 3 – NDA

TBD

L-lactic acid/citric acid/ potassium bitartrate

Evofem

Urogenital chlamydia and gonorrhea prevention in women

Intravaginal

Phase 3 – NDA; Fast Track; QIDP

TBD

lonafarnib

Eiger

Hepatitis D infection

Oral

Phase 3 – NDA; Breakthrough Therapy; Fast Track; Orphan Drug

TBD

Samumed

Osteoarthritis (knee)

Intraarticular

Phase 3 – NDA

TBD

lumateperone (Caplyta )

Intra-Cellular Therapies

Bipolar disorder

Oral

Phase 3 – sNDA

TBD

lutetium 177Lu-PSMA-617

Novartis

Prostate cancer

IV

Phase 3 – NDA

TBD

LYS-SAF302

Sarepta

Mucopolysaccharidosis IIIA (Sanfilippo A syndrome)

Intracerebral

Phase 3 – BLA; Fast Track; Orphan Drug

TBD

maribavir

Takeda

Cytomegalovirus infection treatment

Oral

Phase 3 – NDA; Breakthrough Therapy; Fast Track; Orphan Drug

TBD

marstacimab

Pfizer

Hemophilia A and B

SC

Phase 3 – BLA; Orphan Drug

TBD

masitinib

AB Science

Asthma (eosinophilic); Alzheimer’s disease; MS (primary progressive, non-active secondary); Pancreatic cancer; Prostate cancer

Oral

Phase 3 – NDA; Orphan Drug

TBD

mavacamten

Myokardia

Obstructive hypertrophic cardiomyopathy

Oral

Phase 3 – NDA; Orphan Drug

TBD

melflufen

Oncopeptides

Multiple myeloma

IV

Phase 3 – NDA; Orphan Drug

TBD

meloxicam/rizatriptan

Axsome

Migraine treatment

Oral

Phase 3 – 505(b)(2) NDA

TBD

mepolizumab (Nucala®)

GlaxoSmithKline

COPD

SC

Phase 3 – sBLA

TBD

meropenem/vaborbactam (Vabomere®)

Melinta

HAP; Bacteremia

IV

Phase 3 – sNDA; QIDP TBD

metachromatic leukodystrophy gene therapy

Orchard

Metachromatic leukodystrophy

IV

Phase 3 – BLA; Orphan Drug

lorecivivint ®

34 | magellanrx.com

TBD

PIPELINE DRUG LIST continued NAME

MANUFACTURER

DOSAGE FORM

CLINICAL USE

APPROVAL STATUS

FDA APPROVAL

microbiota suspension

Ferring

Clostridium difficile infection (recurrent)

Rectal

Phase 3 – BLA; Breakthrough Therapy; Fast Track; Orphan Drug

TBD

mirikizumab

Eli Lilly

PSO; CD; UC

IV, SC

Phase 3 – BLA

TBD

mirvetuximab soravtansine

Immunogen

Ovarian cancer

IV

Phase 3 – BLA; Fast Track; Orphan Drug

TBD

molgramostim

Savara

Pulmonary alveolar proteinosis

Inhaled

Phase 3 – BLA; Breakthrough Therapy; Fast Track; Orphan Drug

TBD

nadofaragene firadenovec

Trizell

Mesothelioma

Percutaneous catheter/ Injection

Phase 3 – BLA

TBD

nalbuphine ER

Trevi

Pruritus

Oral

Phase 3 – NDA

TBD

napabucasin

Sumitomo Dainippon

CRC

Oral

Phase 3 – NDA

TBD

narsoplimab

Omeros

HSCT-associated thrombotic microangiopathy

SC

Phase 3 – BLA; Breakthrough Therapy; Orphan Drug

TBD

natalizumab (biosimilar to Biogen’s Tysabri®)

Novartis

MS

IV

Phase 3 – BLA

TBD

niraparib (Zejula®)

GlaxoSmithKline

Ovarian cancer (in combination with dostarlimab)

Oral

Phase 3 – sNDA

TBD

nirsevimab

AstraZeneca

RSV infection prevention

IM, IV

Phase 3 – BLA; Breakthrough Therapy; Fast Track

TBD

nitric oxide

Mallinckrodt

Bronchopulmonary dysplasia

Inhaled

Phase 3 – NDA

TBD

nitric oxide

Novan

Molluscum contagiosum

Topical

Phase 3 – NDA

TBD

olaparib (Lynparza)

AstraZeneca

Ovarian cancer (adjuvant); Oral Ovarian cancer (BRCA mutated)

Phase 3 – sNDA; Orphan Drug

TBD

olipudase alfa

Sanofi

Niemann-Pick disease

IV

Phase 3 – BLA; Breakthrough Therapy; Orphan Drug

TBD

omalizumab (Xolair)

Genentech

Peanut allergy

SC

Phase 3 – sBLA; Breakthrough Therapy

TBD

omidubicel

Gamida Cell

Hematologic cancer

IV

Phase 3 – BLA; Breakthrough Therapy; Orphan Drug

TBD

onasemnogene abeparvovac-xioi (Zolgensma®)

Novartis

Spinal muscular atrophy (type 2, 3)

IV, Intrathecal

Phase 3 – sBLA; Breakthrough Therapy; Fast Track; Orphan Drug

TBD

ondansetron ER (oncedaily)

Redhill

Gastroenteritis

Oral

Phase 3 – 505(b)(2) NDA

TBD

oportuzumab monatox

Sesen Bio

Bladder cancer (BCGunresponsive, nonmuscle invasive)

Intravesical

Phase 3 – BLA; Fast Track

TBD

35 | magellanrx.com

PIPELINE DRUG LIST continued NAME

MANUFACTURER

DOSAGE FORM

CLINICAL USE

APPROVAL STATUS

FDA APPROVAL

OTL-103

Orchard

Thrombocytopenia

IV

Phase 3 – BLA; Orphan Drug; RMAT

TBD

oxalobacter formigenes

Oxthera

Hyperoxaluria

Oral

Phase 3 – BLA; Orphan Drug

TBD

ozanimod

Celgene

CD; UC

Oral

Phase 3 – NDA

TBD

paliperidone (6-month injectable)

Janssen

Schizophrenia

IM

Phase 3 – NDA

TBD

palovarotene

Ipsen

Fibrodysplasia ossificans progressive

Oral

Phase 3 – NDA; Breakthrough Therapy; Fast Track; Orphan Drug

TBD

pamrevlumab

Fibrogen

Idiopathic pulmonary fibrosis

IV

Phase 3 – BLA; Fast Track; Orphan Drug

TBD

pegcetacoplan

Apellis

Paroxysmal nocturnal hemoglobinuria

SC

Phase 3 – NDA; Fast Track; Orphan Drug

TBD

pegunigalsidase alfa

Chiesi

Fabry’s disease

IV

Phase 3 – BLA; Fast Track

TBD

pegzilarginase

Aeglea

Arginase 1 deficiency

IV

Phase 3 – BLA; Breakthrough Therapy

TBD

pertuzumab (Perjeta®)

Genentech

Breast cancer (HER2+, adjuvant, with adotrastuzumab)

IV

Phase 3 – sBLA

TBD

PF-06651600

Pfizer

Alopecia areata

Oral

Phase 3 – NDA; Breakthrough Therapy

TBD

pimecrolimus lotion

Bausch

Atopic dermatitis

Topical

Phase 3 – NDA

TBD

pimodivir

Janssen

Influenza treatment

Oral

Phase 3 – NDA; Fast Track

TBD

pineapple proteolytic enzymes extract

Mediwound

Burn injury

Topical

Phase 3 – BLA; Orphan Drug

TBD

pirfenidone (Esbriet®)

Genentech

Idiopathic pulmonary fibrosis (adults with unclassifiable interstitial lung disease [uILD])

Oral

Phase 3 – sNDA; Breakthrough Therapy; Fast Track; Orphan Drug

TBD

plinabulin

Beyondspring

Neutropenia/leukopenia; NSCLC

IV

Phase 3 – NDA

TBD

pneumococcal 15-valent conjugate vaccine

Merck

Invasive pneumococcal disease prevention

IM

Phase 3 – BLA; Breakthrough Therapy

TBD

polatuzumab vedotin-piiq (Polivy®)

Genentech

DLBLC (1st-line)

IV

Phase 3 – sBLA; Orphan Drug

TBD

pollinex quattro grass

Allergy Therapeutics

Allergic rhinitis

SC

Phase 3 – BLA

TBD

prasterone (Intrarosa )

AMAG

Female sexual arousal disorder

Intravaginal

Phase 3 – sNDA

TBD

ranibizumab (biosimilar to Genentech’s Lucentis®)

Samsung Bioepis

Wet AMD

Intraocular

Phase 3 – BLA

TBD

ranibizumab (biosimilar to Genentech’s Lucentis)

Santo

Wet AMD

Intraocular

Phase 3 – BLA

TBD

ranibizumab (biosimilar to Genentech’s Lucentis)

STADA Arzneimittel

Wet AMD

Intraocular

Phase 3 – BLA

TBD

®

36 | magellanrx.com

PIPELINE DRUG LIST continued NAME

MANUFACTURER

DOSAGE FORM

CLINICAL USE

APPROVAL STATUS

FDA APPROVAL

ravulizumab-cwvz (athome, weekly dose) (Ultomiris®)

Alexion

Paroxysmal nocturnal hemoglobinuria

SC

Phase 3 – sBLA; Orphan Drug

TBD

reltecimod

Atox

Necrotizing soft tissue infection

IV

Phase 3 – NDA; Fast Track; Orphan Drug

TBD

relugolix

Myovant

Endometriosis; Uterine fibroids

Oral

Phase 3 – NDA

TBD

remdesivir

Gilead

COVID-19

IV

Phase 3 – NDA

TBD

remestemcel-L

Mesoblast

CD; COVID-19

IV

Phase 3 – BLA; Fast Track

TBD

reproxalap

Aldeyra

Congenital ichthyosis

Topical

Phase 3 – NDA; Orphan Drug

TBD

resmetirom

Madrigal

NASH

Oral

Phase 3 – NDA; Fast Track

TBD

ridinilazole

Summit

C. difficile-associated diarrhea

Oral

Phase 3 – NDA; Fast Track; QIDP

TBD

risankizumab-rzaa (Skyrizi®)

Abbvie

PsA; CD; UC

SC

Phase 3 – sBLA; Orphan Drug

TBD

rituximab (biosimilar to Genentech’s Rituxan)

Archigen

RA; CLL/SLL; NHL (indolent); Antineutrophil cytoplasmic antibodies associated vasculitis

IV

Phase 3 – BLA

TBD

rituximab (biosimilar to Genentech’s Rituxan)

Teva

RA; CLL/SLL; NHL (indolent); Antineutrophil cytoplasmic antibodies associated vasculitis

IV

Phase 3 – BLA

TBD

rivoceranib

LSK Biopartners

Gastric cancer

Oral

Phase 3 – NDA; Orphan Drug

TBD

ropeginterferon alfa-2b

Essentia

Polycythemia vera

SC

Phase 3 – BLA; Orphan Drug

TBD

roxadustat

AstraZeneca

Anemia due to oncology treatment

Oral

Phase 3 – NDA

TBD

rozanolixizumab

UCB

Myasthenia gravis

SC

Phase 3 – BLA

TBD

RSV nanoparticle vaccine

Novavax

RSV infection prevention

IM

Phase 3 – BLA; Fast Track

TBD

ruxolitinib (Jakafi®)

Incyte

COVID-19

Oral

Phase 3 – sNDA

TBD

ruxolitinib cream

Incyte

Atopic dermatitis; Vitiligo

Topical

Phase 3 – NDA

TBD

sacubitril/valsartan (Entresto®)

Novartis

Heart failure with preserved ejection fraction (HFpEF); Postacute myocardial infarction

Oral

Phase 3 – sNDA; Fast Track

TBD

sarilumab (Kevzara®)

Sanofi

COVID-19

SC

Phase 3 – sBLA

TBD

seladelpar

Cymabay

Primary biliary cholangitis/hepatic fibrosis

Oral

Phase 3 – NDA; Breakthrough Therapy; Orphan Drug

TBD

selinexor (Xpovio®)

Karyopharm

Multiple myeloma (with bortezomib and dexamethasone)

Oral

Phase 3 – sNDA; Orphan Drug

TBD

semaglutide (Ozempic®)

Novo Nordisk

Obesity

SC

Phase 3 – sNDA

TBD

37 | magellanrx.com

PIPELINE DRUG LIST continued NAME

MANUFACTURER

DOSAGE FORM

CLINICAL USE

APPROVAL STATUS

FDA APPROVAL

sepofarsen

Proqr

Leber’s congenital amaurosis

Intraocular

Phase 3 – NDA; Fast Track; Orphan Drug

TBD

sodium hyaluronate/ triamcinolone hexacetonide

Anika

Osteoarthritis (knee)

Intraarticular

Phase 3 – NDA

TBD

sodium oxybate (oncenightly dosing)

Avadel

Narcolepsy

Oral

Phase 3 – 505(b)(2) NDA; Orphan Drug

TBD

sofpironium bromide

Brickell

Axillary hyperhidrosis

Topical

Phase 3 – NDA

TBD

somatrogon

Opko

Growth hormone deficiency (pediatric)

SC

Phase 3 – BLA; Orphan Drug

TBD

sotagliflozin

Lexicon

T2DM

Oral

Phase 3 – NDA

TBD

sparsentan

Retrophin

Focal segmental glomerulosclerosis

Oral

Phase 3 – NDA; Orphan Drug

TBD

spartalizumab

Novartis

Melanoma

IV

Phase 3 – BLA

TBD

sulopenem

Iterum

UTI (uncomplicated)

IV, Oral

Phase 3 – NDA; Fast Track; QIDP

TBD

sutimlimab

Sanofi

Cold agglutinin disease

IV

Phase 3 – BLA; Breakthrough Therapy; Orphan Drug

TBD

suvodirsen

Wave Life Sciences

DMD

IV

Phase 3 – NDA; Fast Track; Orphan Drug

TBD

tabelecleucel

Atara

Epstein-Barr virus-associated post-transplant lymphoproliferative disease

IV

Phase 3 – BLA; Breakthrough Therapy; Orphan Drug

TBD

tanezumab

Pfizer

Cancer pain; Chronic low back pain

SC

Phase 3 – BLA; Fast Track

TBD

Roivant

PSO

Topical

Phase 3 – NDA

TBD

tasimelteon (Hetlioz )

Vanda

Smith-Magenis syndrome

Oral

Phase 3 – sNDA; Orphan Drug

TBD

taurolidine

Cormedix

Prevention of catheterrelated bloodstream infection in hemodialysis patients

IV

Phase 3 – NDA; Fast Track; QIDP

TBD

Espero

Anticoagulation

Oral

Phase 3 – NDA

TBD

tecovirimat (Tpoxx )

SIGA

Smallpox

IV

Phase 3 – sNDA; Fast Track; Orphan Drug

TBD

tenapanor (Ibsrela®)

Ardelyx

Hyperphosphatemia (in CKD patients on dialysis)

Oral

Phase 3 – sNDA

TBD

teplizumab

Provention Bio

T1DM (prevention or delay)

IV

Phase 3 – BLA; Breakthrough Therapy

TBD

teprasiran

Quark

Delayed graft function; Kidney injury prevention following cardiac surgery

IV

Phase 3 – NDA; Orphan Drug

TBD

teriflunomide

Sanofi

MS (pediatrics)

Oral

Phase 3 – NDA

TBD

tezepelumab

AstraZeneca

Asthma

SC

Phase 3 – BLA; Breakthrough Therapy

TBD

ticagrelor (Brilinta)

AstraZeneca

Sickle cell disease

Oral

Phase 3 – sNDA

TBD

tapinarof ®

tecarfarin ®

38 | magellanrx.com

PIPELINE DRUG LIST continued NAME

MANUFACTURER

DOSAGE FORM

CLINICAL USE

APPROVAL STATUS

FDA APPROVAL

timbetasin

Regenerx

Dry eye syndrome

Ophthalmic

Phase 3 – NDA

TBD

timrepigene emparvovec

Biogen

Choroideremia

Intraocular

Phase 3 – BLA; Orphan Drug; RMAT

TBD

tirzepatide

Eli Lilly

T1DM

SC

Phase 3 – NDA

TBD

tisagenlecleucel-t (Kymriah™)

Novartis

DLBCL (relapsed/ refractory in 1st relapse)

IV

Phase 3 – sBLA; Breakthrough Therapy; Orphan Drug

TBD

tofersen

Biogen

Amyotrophic lateral sclerosis

Intrathecal

Phase 3 – NDA; Orphan Drug

TBD

tonogenchoncel-L

Kolon Tissuegene

Osteoarthritis

Intraarticular

Phase 3 – BLA

TBD

tradipitant

Vanda

Atopic dermatitis; Gastroparesis; Pruritus; COVID-19

Oral

Phase 3 – NDA

TBD

tralokinumab

AstraZeneca

Atopic dermatitis

SC

Phase 3 – BLA

TBD

transcon PEG growth hormone

Ascendis

Growth hormone deficiency

SC

Phase 3 – BLA

TBD

trastuzumab (biosimilar to Genentech’s Herceptin)

Novartis

Breast cancer; Gastric/ gastroesophageal cancer

IV

Phase 3 – BLA

TBD

trastuzumab (biosimilar to Genentech’s Herceptin)

Tanvex

Breast cancer; Gastric/ gastroesophageal cancer

IV

Phase 3 – BLA

TBD

tripotassium citrate monohydrate/potassium hydrogen carbonate microtablet

Advicenne

Renal tubular acidosis

Oral

Phase 3 – NDA

TBD

trivalent hepatitis B vaccine

VBI Vaccines

Hepatitis B prevention

IM

Phase 3 – BLA

TBD

trofinetide

Acadia

Rett syndrome

Oral

Phase 3 – NDA; Fast Track; Orphan Drug

TBD

ublituximab

TG

CLL/SLL; MS

IV

Phase 3 – BLA; Orphan Drug

TBD

udenafil

Allergan

Congenital single ventricle heart disease (adolescents)

Oral

Phase 3 – NDA; Orphan Drug

TBD

umbralisib

TG

CLL/SLL; DLBCL; Indolent NHL; Marginal zone lymphoma

Oral

Phase 3 – NDA; Breakthrough Therapy; Orphan Drug

TBD

upadacitinib (Rinvoq™)

Abbvie

Atopic dermatitis; Axial spondyloarthritis; PsA; CD; UC; Giant cell arteritis

Oral

Phase 3 – sNDA; Breakthrough Therapy

TBD

ustekinumab (Stelara)

Janssen

SLE

IV, SC

Phase 3 – sBLA

TBD

vadadustat

Akebia

Anemia due to CKD (dialysis-independent)

Oral

Phase 3 – NDA

TBD

vazegepant

Biohaven

Migraine treatment; COVID-19

Intranasal

Phase 3 – NDA

TBD

veliparib

Abbvie

Breast cancer

Oral

Phase 3 – NDA

TBD

vilanterol trifenatate

GlaxoSmithKline

Asthma; COPD

Inhaled

Phase 3 – NDA

TBD

visomitin

Mitotech

Dry eye syndrome

Ophthalmic

Phase 3 – NDA

TBD

vocimagene amiretrorepvec

Tocen

Brain cancer (malignant glioma; glioblastoma)

Intratumoral

Phase 3 – BLA; Breakthrough Therapy; Fast Track; Orphan Drug

TBD

39 | magellanrx.com

PIPELINE DRUG LIST continued NAME

MANUFACTURER

DOSAGE FORM

CLINICAL USE

APPROVAL STATUS

FDA APPROVAL

voclosporin

Aurinia

Lupus nephritis

Oral

Phase 3 – NDA; Fast Track

TBD

volanesorsen

Akcea

Familial chylomicronemia syndrome

SC

Phase 3 – NDA; Orphan Drug

TBD

vonoprazan

Phathom

Helicobacter pylori infection

Oral

Phase 3 – NDA; QIDP

TBD

vosoritide

Biomarin

Achondroplasia

SC

Phase 3 – NDA; Orphan Drug

TBD

vutrisiran

Alnylam

Transthyretin amyloid cardiomyopathy (ATTR-CM, wild-type or hereditary)

SC

Phase 3 – NDA; Orphan Drug

TBD

zanubrutinib (Brukinsa®)

Beigene

Waldenstrom macroglobulinemia

Oral

Phase 3 – sNDA; Fast Track; Orphan Drug

TBD

zilucoplan

Ra

Myasthenia gravis

SC

Phase 3 – NDA; Orphan Drug

TBD

zoliflodacin

Entasis

Gonorrhea

Oral

Phase 3 – NDA; Fast Track; QIDP

TBD

Complete Response Letter (CRL)/Withdrawn Drugs NAME

MANUFACTURER

DOSAGE FORM

CLINICAL USE

APPROVAL STATUS

FDA APPROVAL

empagliflozin (Jardiance)

Boehringer Ingelheim

T1DM

Oral

CRL

TBD

exenatide SC pump

Intarcia

T2DM

SC

CRL

TBD

lamotrigine oral liquid

Eton

Partial seizures; Primary generalized tonic-clonic seizures; Lennox-Gastaut syndrome

Oral

CRL

TBD

paclitaxel injection concentrate for suspension

Sun Advanced Research

Breast cancer

IV

CRL

TBD

ranibizumab (biosimilar to Genentech’s Lucentis)

Santo

Wet AMD

Intraocular

Withdrawn

N/A

rizatriptan film

Gensco

Migraine treatment

Oral transmucosal

CRL

TBD

40 | magellanrx.com

GLOSSARY ABSSSI Acute Bacterial Skin and Skin Structure Infection ACR20 American College of Rheumatology 20% Improvement ACR50 American College of Rheumatology 50% Improvement ACR70 American College of Rheumatology 70% Improvement ADHD Attention Deficit Hyperactivity Disorder ADL Activities of Daily Living AED Anti-Epileptic Drug ALK Anaplastic Lymphoma Kinase ALL Acute Lymphoblastic Leukemia ALT Alanine Transaminase AMD Age-Related Macular Degeneration AML Acute Myeloid Leukemia ANCA Antineutrophil Cytoplasmic Antibodies ANDA Abbreviated New Drug Application ART Antiretroviral Therapy ARV Antiretroviral AS Ankylosing Spondylitis ASCVD Atherosclerotic Cardiovascular Disease AST Aspartate Aminotransferase BLA Biologics License Application BsUFA Biosimilar User Fee Act BCVA Best Corrected Visual Acuity CABP Community Acquired Bacterial Pneumonia CAP Community Acquired Pneumonia CD Crohn's Disease CDC Centers for Disease Control and Prevention CF Cystic Fibrosis CHF Congestive Heart Failure CI Confidence Interval

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CKD Chronic Kidney Disease CLL Chronic Lymphocytic Leukemia CNS Central Nervous System COPD Chronic Obstructive Pulmonary Disease COVID-19 Coronavirus Disease 2019 CRC Colorectal Cancer CRL Complete Response Letter CV Cardiovascular CVD Cardiovascular Disease DAS28-CRP Disease Activity Score-28 with C Reactive Protein DEA Drug Enforcement Administration DLBCL Diffuse Large B Cell Lymphoma DMD Duchenne Muscular Dystrophy DMARD Disease Modifying Antirheumatic Drug DNA Deoxyribonucleic Acid DOR Duration of Response DPP-4 Dipeptidyl Peptidase 4 DR Delayed-Release EDSS Expanded Disability Status Scale EGFR Epidermal Growth Factor Receptor ER Extended-Release FDA Food and Drug Administration FLT3 FMS-Like Tyrosine Kinase-3 GI Gastrointestinal GIST Gastrointestinal Stromal Tumor GLP-1RA Glucagon-Like Peptide-1 Receptor Agonist GVHD Graft Versus Host Disease H Half HAM-D Hamilton Depression Rating Scale HAP Healthcare-Associated Pneumonia HbA1c Hemoglobin A1c

GLOSSARY continued HCC Hepatocellular Carcinoma

NSCLC Non-Small Cell Lung Cancer

HCP Healthcare Professional

ODT Orally Disintegrating Tablet

HCV Hepatitis C Virus

ORR Overall/Objective Response Rate

HER Human Epidermal Growth Factor Receptor

OS Overall Survival

HER2 Human Epidermal Growth Factor Receptor 2

PAH Pulmonary Arterial Hypertension

HFA Hydrofluoroalkane

PARP Poly(ADP-ribose) polymerase

HIT Heparin Induced Thrombocytopenia

PASI 50 Psoriasis Area and Severity Index ≥ 50%

HIV Human Immunodeficiency Virus

PASI 70 Psoriasis Area and Severity Index ≥ 70%

HIV-1 Human Immunodeficiency Virus-1

PASI 90 Psoriasis Area and Severity Index ≥ 90%

HR Hazard Ratio

PCI Percutaneous Coronary Intervention

HSCT Hematopoietic Stem Cell Transplant

PD-1 Programmed Death Protein 1

HTN Hypertension

PD-L1 Programmed Death-Ligand 1

IBS Irritable Bowel Syndrome

PDUFA Prescription Drug User Fee Application

IBS-C Irritable Bowel Syndrome, Constipation Predominant

PFS Progression-Free Survival

IM Intramuscular IV Intravenous JIA Juvenile Idiopathic Arthritis LDL-C Low-Density Lipoprotein Cholesterol MACE Major Adverse Cardiovascular Events MADRS Montgomery – Åsberg Depression Rating Scale MAOI Monoamine Oxidase Inhibitor MDD Major Depressive Disorder MDI Metered Dose Inhaler MRI Magnetic Resonance Imaging MRSA Methicillin-Resistant Staphylococcus Aureus MS Multiple Sclerosis N/A Not Applicable NASH Non-Alcoholic Steatohepatitis NDA New Drug Application NHL Non-Hodgkin Lymphoma NSAID Non-Steroidal Anti-Inflammatory Drug

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PGA Physician Global Assessment PsA Psoriatic Arthritis PSO Plaque Psoriasis PTCA Percutaneous Transluminal Coronary Angioplasty PTSD Post-Traumatic Stress Disorder Q Quarter QIDP Qualified Infectious Diseases Product QOL Quality of Life RA Rheumatoid Arthritis RBC Red Blood Cell RCC Renal Cell Carcinoma REMS Risk Evaluation and Mitigation Strategy RMAT Regenerative Medicine Advanced Therapy RNA Ribonucleic Acid RRR Relative Risk Reduction RSV Respiratory Syncytial Virus RTOR Real-Time Oncology Review

GLOSSARY continued sBLA supplemental Biologics License Application

WBC White Blood Cell

SC Subcutaneous

WHO World Health Organization

SCCHN Squamous Cell Cancer of the Head and Neck

XR Extended-Release

SCLC Small Cell Lung Cancer SCT Stem Cell Transplant SGLT Sodium-Glucose Co-Transporter SL Sublingual SLE Systemic Lupus Erythematosus SLL Small Lymphocytic Lymphoma sNDA supplemental New Drug Application SOC Standard of Care sPGA Static Physician Global Assessment SR Sustained-Release SNRI Serotonin and Norepinephrine Reuptake Inhibitor SSRI Selective Serotonin Reuptake Inhibitor SSSI Skin and Skin Structure Infection T1DM Type 1 Diabetes Mellitus T2DM Type 2 Diabetes Mellitus TBD To Be Determined TEAE Treatment-Emergent Adverse Events TNBC Triple Negative Breast Cancer TNF Tumor Necrosis Factor TNFα Tumor Necrosis Factor-alpha UA Unstable Angina UC Ulcerative Colitis US United States UTI Urinary Tract Infection VAS Visual Analog Scale VEGF Vascular Endothelial Growth Factor VTE Venous Thromboembolism

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