Pharma Notes

SQI Diagnostics Inc.

(Toronto, ON) says it is being paid by an unidentifi ed pharmaceutical company to develop and validate two custom multiplex anti-drug-antibody (ADA) assays. According to SQI, the customer will evaluate these two products using an established drug from its portfolio in order to assess the capabilities and performance of SQI’s technologies.

Transition Therapeu-

tics Inc. (Toronto, ON) has dosed the fi rst patient in its Phase 2 clinical study of TT-401 (LY2944876), a drug candidate for the treatment of type 2 diabetes. The study is expected to enroll up to 375 subjects and will be performed by Transition’s development partner, Eli Lilly and Company (Lilly). The objectives of the study will be to evaluate the safety and effectiveness of TT-401 compared to once-weekly exenatide extended release and placebo. The study is randomized, double-blind and placebo-controlled. It will include six study arms, four doses of TT-401, a placebo arm and a once-weekly exenatide arm. It will also include a 12-week blinded treatment period, where neither the participant nor the investigator will know which treatment each individual is assigned.

Phase 3 results from

Bristol-Myers Squibb’s

(Mississauga, ON) global HALLMARK-Dual study were presented at the 49th annual meeting of the European Association for the Study of the Liver (EASL) in London, UK. The study focused on investigating the all-oral, interferon- and ribavirin-free regimen of daclatasvir (DCV), a NS5A inhibitor, and asunaprevir (ASV), a NS3 inhibitor, among genotype 1b hepatitis C virus (HCV) infected patients. The results showed that the 24-week regimen achieved an overall sustained virologic response (a functional cure) 12 weeks after the end of treatment (SVR12) among treatmentnaïve (90%), peginterferon/ ribavirin non-responder (82%), and peginterferon/ ribavirin ineligible/intolerant (82%) patients, including cirrhotic and non-cirrhotic patients (84% and 85%). In the study the DCV plus ASV regimen was generally well tolerated. The Phase 3 multinational clinical trial included 116 sites in 18 countries, including countries that have a high prevalence of GT1b such as Korea and Taiwan.

Helix BioPharma Corp.

(Aurora, ON) has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial with L-DOS47. L-DOS47 is Helix’s fi rst immunoconjugate-based drug candidate in development based upon the company’s DOS47 technology, which is designed to use an innovative approach to modify the microenvironmental conditions of cancer cells in a manner that leads to their destruction. L-DOS47 is currently being clinically evaluated as a treatment for certain patients with nonsmall cell lung cancer. The study is entitled: “A Phase 1, Open Label, Dose Escalation Study of Immunoconjugate L-DOS47 in Combination with Standard Doublet Therapy of Pemetrexed/ Carboplatin in Patients with Stage IV (TNM M1a and M1b) Recurrent or Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC).”

Specialty pharmaceutical company Medicure Inc. (Winnipeg, MB) has entered into an arrangement with

Knight Therapeutics Inc.

that will see Knight Therapeutics provide advisory services to help advance Medicure’s U.S. specialty pharmaceutical business and corporate development initiatives. Knight Therapeutics Inc., headquartered in Montréal, QC, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian and world markets.

BC-biotech company

Xenon Pharmaceuticals

Inc. is teaming up with Genentech to discover and validate new therapeutic targets and mechanisms for treating pain. The collaboration leverages Xenon’s Extreme Genetics discovery platform to focus on rare phenotypes where individuals have an inability to perceive pain or where individuals have non-precipitated spontaneous severe pain. It’s not the fi rst time that Xenon has teamed up with Genentech, a member company of the Roche Group. The two sides previously formed a strategic alliance in 2012 for the discovery and development of compounds and companion diagnostics for the potential treatment of pain. Pursuant to the terms of the new agreement, both Xenon and Genentech will own the intellectual property arising out of the collaboration. Xenon has also granted Genentech a time-limited exclusive right of negotiation on a target-by-target basis to form joint drug discovery collaborations. Financial terms of the agreement were not disclosed..

Amorfi x Life Sciences

(Mississauga, ON) has entered into a collaboration with Trellis Bioscience (San Fransisco, CA) to develop antibodies against misfolded CD38 protein as a treatment for haematological malignancies including leukemia and lymphoma. CD38 is a protein that is highly expressed on the surface of a variety of white blood cells and has been implicated in a number of hematologic malignancies including multiple myeloma, chronic lymphocytic leukemia, B-cell lymphoma, acute lymphoblastic leukemia, acute myeloid leukemia, follicular lymphoma and mantle cell lymphoma. Antibodies that bind to misfolded CD38 have the potential to only kill tumour cells and not normal cells through a variety of ways including the recruitment of the body’s immune system for complement-dependent cytotoxicity (CDC), antibodydependent cell-mediated cytotoxicity (ADCC), induced cell death (apoptosis) as well as by blocking or modulating CD38 enzymatic activity. The two sides hope that together, their technologies will enable the companies to isolate and develop fully human therapeutic antibodies that will target only cancer cells and not healthy ones. Under the terms of the collaboration, Amorfi x will have an exclusive option to develop any resulting antibodies.

An affi liate of Cardiome Pharma Corp. (Vancouver, BC) has entered into a distribution agreement with UDG Healthcare plc, headquartered in Dublin, to fulfi ll orders and distribute BRINAVESS™ (vernakalant intravenous) in Ireland. The initial term of the agreement is for three years effective as of April 1, 2014. Financial details have not been disclosed.

Warnex Inc. (Dorval, QC) has entered into a binding letter of agreement with DIAGNOS Inc. to merge with a wholly-owned subsidiary of Diagnos. As a condition to entering into a defi nitive agreement, Persistence Capital Partners, L.P., a healthcare private equity fi rm that holds approximately 52% of the issued and outstanding shares of Warnex, will enter into a lock-up agreement pursuant to which it will agree to vote its shares in favour of the transaction.

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