PENMIX LTD Product Information No . 1
Indication(적응증)
New drug(신약) (Ingredients)
IMD(개량신약) (Ingredients)
Candida infection
Biomedicine (Ingredients)
Etc. Anidulafungin
Item description - Anidulafungin Lyophilized for Inj. 100 mg (Antifungal agents) Development status - Formulation Setting: 2Q 2017 - Pilot manufacturing: 1Q 2018 - 6 month stability: 3Q 2018 - Dossier ready: 1Q 2019 Plans for Out-Licensing or joint R&D or investment - Not applicable Patent - Patent No.: KR10-0613136 - Patent: Composition - Expiration Date: 01. 20. 2021 2
Candida infection Item description - Caspofungin Lyophilized for Inj. 50, 70 mg (Antifungal agents) Development status - Formulation Setting: 1Q 2017 - Pilot manufacturing: 3Q 2017 - 6 month stability: 2Q 2018 - Dossier ready: 4Q 2018
Plans for Out-Licensing or joint R&D or investment - Not applicable
Caspofungin
Patent - Patent No.: US6136783 - Patent: Composition - Expiration Date: 09. 28. 2017
3
MSSA, MRSA infection Item description - Daptomycin Lyophilized for Inj. 500 mg (Mainly Gram-Positive infection, Antibacterial) Development status - Formulation Setting: 3Q 2017 - Pilot manufacturing: 3Q 2018 - 6 month stability: 2Q 2018 - Dossier ready: 3Q 2019
Daptomycin
Plans for Out-Licensing or joint R&D or investment - Not applicable Patent - Patent No.: US6468967, US6852689 - Patent: Use - Expiration Date: 09. 24. 2019
4
Sedation (Nonopioid) Item description - Dexmedetomidine Inj. 200 mcg/2 mL (Sedative) Development status - Formulation Setting: Completed - Pilot manufacturing: Completed - 6 month stability: Completed - Launch: 2Q 2017
Dexmedetomidin e
Plans for Out-Licensing or joint R&D or investment - Not applicable Patent - Patent No.: Expiration - Patent: Expiration - Expiration Date: Expiration
5
Multiple sclerosis Item description - Glatiramer PFS 20, 40 mg
Glatiramer acetate
(Neuromuscular disorder related drugs) Development status - Formulation Setting: 4Q 2017 - Pilot manufacturing: 2Q 2018 - 6 month stability: 1Q 2019 - Dossier ready: 2Q 2019 Plans for Out-Licensing or joint R&D or investment - Not applicable Patent - Patent No.: Completed - Patent: Completed - Expiration Date: Completed
6
Acute attacks of hereditary angioedema Item description - Icatibant PFS 30 mg/3 mL (Circulatory system drug) Development status - Formulation Setting: 3Q 2017 - Pilot manufacturing: 1Q 2018 - 6 month stability: 4Q 2018 - Dossier ready: 2Q 2019
Icatibant
Plans for Out-Licensing or joint R&D or investment - Not applicable Patent - Patent No.: US5648333 - Patent: Material - Expiration Date: 06. 30. 2019
7
Candida Infection Item description - Micafungin Lyophilized for Inj. 50 mg (Antifungal agents) Development status - Formulation Setting: 2Q 2017 - Pilot manufacturing: 3Q 2017 - 6 month stability: 2Q 2018 - Dossier ready: 3Q 2018 Plans for Out-Licensing or joint R&D or investment - Not applicable Patent - Patent No.: JP2897427
Micafungin
- Patent: Material - Expiration Date: 09. 29. 2020
8
Acromegaly, Etc. Item description - Octreotide LAR Powder in Vial kit 10, 20 mg (Other hormones) Development status - Formulation Setting: Completed - Pilot manufacturing: 4Q 2017 - 6 month stability: 3Q 2018 - Dossier ready: 1Q 2019 Plans for Out-Licensing or joint R&D or investment - Not applicable
Octreotide LAR
Patent - Patent No.: US5922338, 5922682 - Patent: Composition - Expiration Date: 01. 13. 2017
9
Schizophrenia Item description - Paliperidone PFS 25, 50, 75, 100, 150 mg (Psychotropic agent) Development status - Formulation Setting: 4Q 2017 - Pilot manufacturing: 4Q 2018 - 6 month stability: 3Q 2019 - Dossier ready: 1Q 2020 Plans for Out-Licensing or joint R&D or investment - Not applicable Patent - Patent No.: KR10-0365077 - Patent: Composition - Expiration Date: 05. 12. 2023 (Plan to Circumvent invention)
Paliperidone
10
Emetogenic cancer chemotherapy Item description - Palonosetron Inj. & PFS 0.084 mg/1.5 mL, 0.28 mg/5 mL (Antiemetics)
Palonosetron
Development status - Formulation Setting: 3Q 2017 - Pilot manufacturing: 1Q 2018 - 6 month stability: 4Q 2018 - Dossier ready: 1Q 2019 Plans for Out-Licensing or joint R&D or investment - Not applicable Patent - Patent No.: JP5690461, 5893950 - Patent: Use - Expiration Date: 03. 16. 2026
11
Narcotic analgesics Item description - Remifentanil Lyophilized for Inj. 1, 2, 5 mg (Designer drug) Development status - Formulation Setting: 3Q 2017 - Pilot manufacturing: 4Q 2018 - 6 month stability 3Q 2019: - Dossier ready: 1Q 2020 Plans for Out-Licensing or joint R&D or investment - Not applicable
Remifentanil
Patent - Patent No.: US5866591 - Patent: Composition - Expiration Date: 03. 10. 2018
12
Serious infections by MESA/MRSE Item description - Vancomycin Lyophilized for Inj. 500 mg, 1 g (Mainly Gram-Positive infection, Antibacterial) Development status - Formulation Setting: 3Q 2017 - Pilot manufacturing: 1Q 2018 - 6 month stability: 3Q 2018 - Dossier ready: 4Q 2018 Plans for Out-Licensing or joint R&D or investment - Not applicable Patent - Patent No.: Expiration - Patent: Expiration
Vancomycin
- Expiration Date: Expiration
13
Aspergillus infections Item description - Voriconazole Lyophilized for Inj. 200 mg (Antifungal agents) Development status - Formulation Setting: 3Q 2017 - Pilot manufacturing: 4Q 2017 - 6 month stability: 3Q 2018 - Dossier ready: 1Q 2019 Plans for Out-Licensing or joint R&D or investment - Not applicable Patent - Patent No.: US6632803 - Patent: Composition - Expiration Date: 06. 02. 2018
Voriconazole