Contents
Analysis of import-export of MSN Pharma
In our firm, we analyse import-export of various pharmaceutical companies. We derive very interesting information. This month we analysed import-export of MSN Pharma and tried to find out in which molecules MSN is investing development recourses. At what stage that development would be at present? Whether there are any activities going on with innovators. We gather wealth of information. Due to space constraint, we are providing here glimpses of our findings.
Intermediate | Qty in Kg | API | SIDVIM Comments |
6 BROMO-3-HYDROXYPYRAZINE-2-CARBOXAMIDE | - | Favipiravir | MSN had filed DMF. This could be the second source activity to secure supply? Multiple shipments in two months. Favipiravir API price must be very competitive with increasing numbers of suppliers. Export prices are already settled in the range of $ 800-900/Kg |
DIETHYL 2-AMINOMALONATE HYDROCHLORIDE | 2 | Rebamipide, Ulodesine, SU-6668 (Orantinib) | Rebamipide is not approved in US. But approved in many other parts of the world. Ulodesine is in P-III trials and this RM is used for Ulodesine too. But it is still in early stage. MSN must be developing Rebamipide. |
(3AR 4R 6R 6AR)-4-(4-AMINOPYRROLO[2 1-F][1 2 4]TRAZIN-7-YL)-6-(HYDROXYMETHYL)-2 2-DIMETHYLTETRAHYDROFURO[3 4-D][1 3]DIOX | - | Remdesivir | Multiple shipments in higher quantities, a lot has been spoken about remdesivir and MSN must be developing it for various markets. |
1-CHLOROMETHYL-4-FLUORO-1 4-DIAZONIABICYCLO[2 2 2]OCTANE BIS(TETRAFLUOROBORATE) | 1 | H3B-6545 Eisai | This intermediate is used for Phase trial molecule of Eisai H3B-6545. It is highly likely that MSN might be working with Eisai for API supply. |
(4S 5R)-3-(TERT-BUTOXYCARBONYL)-2 2-DIMETHYL-4-PHENYLOXAZOLIDINE-5-CARBOXYLIC ACID | 1.5 | Cabazitaxel, Docetaxel | MSN filed DMFs for both these APIs long ago. Could be trying for intermediate source change? |
(2R-4S)-1-TERT-BUTYL-2-METHYL4-HYDROXY PIPERIDINE-1 2 DICARBOXYLATE | 0.5 | Glasdegib | 2018 approval. MSN is developing API for NCE-1 date filing in 2022! |
(3R 4S)-BENZYL 3-(2-BROMOACETYL)-4-ETHYLPYRROLIDINE-1-CARBOXYLATE | 1 | Upadacitinib | 2019 approval, though NCE-1 date is in 2023, generic launch looks difficult till 2031! |
(((2 2-DIMETHYLBUT-3-YN-1-Y) OXY)METHYL)BENZENE | 1 | Tezacaftor | Approved as combi products in 2018 and 2019. One can expect NCE-1 filings soon. |
ETHYL 5-ACETYLOXY-1 2-DIMETHYLINDOLE-3-CARBOXYLATE | 2 | Umifenovir | No USFDA approval for this antiretroviral drug, Russian innovator has not applied for US approval. The drug is available in RU, CN and many other countries. |
7 8-DIFLUORO-6 11-DIHYDRODIBENZO[B E]THIEPIN-11-OL | 1.5 | Baloxavir marboxil | 2018 approval in US and JP, and MSN seems to be at kilo lab stages, noticing ordered quantities |
(1R 3S)-3-AMINOCYCLOPENTANOL HYDROCHLORIDE | 3 | Bictegravir | Hetero already filed DMF. 2018 approval. MSN is ordering higher quantities of intermediate indicates that MSN is also at advance stages of development and would be able to file DMF soon. |
(4R 12AS)-7-METHOXY-4-METHYL-6 8-DIOXO-3 4 6 8 12 12A-HEXAHYDRO-2H-PYRIDO[1.2.5]PYRAZINO[2 1-B][1 3]OXAZINE-9-CARBOXYLIC--- | 1 | Dolutegravir | Seven companies are litigating in US (not MSN!) . MSN had filed DMF in 2016. This could be the source change activity. |
(6aS,7R,13S,14R,16R)-16-(((tert-butyldimethylsilyl)oxy)methyl)-5-hydroxy-9-methoxy-8-(methoxymethoxy)-4,10,17-trimethyl-6,6a,7,13,14,16-hexahydro-12H-7,13-epiminobenzo[4,5]azocino[1,2-b][1,3]dioxolo[4,5-h]isoquinoline-14-carbonitrile | 0.4 | Trabectedin | 2015 approval, already 2 DMFs, MSN was first IN DMF filed in December 2019. Small 150 mio product. Biosynthesis. There will not be too much competition. Generic launch will be (most probably) in 2028 though. |
(2R 3R)-3-(2 5-DIFLUOROPHENYL)-3-HYDROXY-2-METHYL-4-(1H-1 2 4-TRIAZOL-1-YL)THIOBLITY HAMIDE | 2 | Isavuconazole | Nobody has filed DMF yet for this 2015 approved product. MSN could be first to file! |
(2R)-2-(2 5-DIFLUOROPHENYL)PYRROLIDINE HCI | 0.1 | Larotrectinib | 2018 approval. MSN would be filing DMF soon. |
(6-BROMOPYRIMIDIN-2-YL)(1-METHYLPIPERIDIN-4-YL)METHANONE HYDROCHLORIDE | 1 | Lasmiditan | October 2019 approval. Very soon MSN to file DMF? |
(2-(1-ISOPROPYL-1H-PYRAZOL-5-YL)PYRIDIN-3-YL)METHANOL | 0.1 | Voxelotor | November 2019 approval. MSN is ordering still small quantities of intermediates! Early stage of development? Sources finalization stage? Drug has block buster potential and many Gx filers could be expected. |
(2R 4S)-1-TERT-BUTYL 2-METHYL4-HYDROXYPIPERIDINE-1 2-DICARBOXYLATE | 1 | Glasdegib | November 2018 approval. MSN will file DMF soon. |
(R)-1-[4-CHLORO-2-(3-METHYLPYRAZOL-1-YL)PHENYL]-2 2 2-TRIFLUOROETHANOL | 1 | Telotristat | 2017 approval, no DMF filed yet. MSN will file DMF soon. |
General information
Royalty Pharma Acquires Royalty Interest in Cabozantinib From GSK
Royalty Pharma plc today announced that it has acquired a royalty interest in the cabozantinib products Cabometyx and Cometriq from GlaxoSmithKline (GSK) for an upfront payment of $342 million and up to $50 million in additional payments contingent on the achievement of regulatory approvals of cabozantinib for prostate cancer and lung cancer in the U.S. and Europe. (here)
Ascentage Pharma Announces 2020 Annual Results and Reports Launch Readiness for Its Core Drug Candidate
As of December 31, 2020, Ascentage Pharma has built a robust pipeline of eight clinical-stage and four preclinical-stage small-molecule drug candidates. (here)
Intellectual Property
Mylan filed IPR for US 9,439,906 patent.
IPR (Inter Partes Review ) in USPTO, is like oppositions in Europe and in India, in patent offices. It is a trial proceeding conducted at the Board (in USPTO) to review the patentability of one or more claims in a patent. The grounds could be only novelty and obviousness and only on the basis of prior art consisting of patents or printed publications.
US `906 claims treatment regimen, long acting injectable paliperidone esters. This is the only OB listed patent.
Product No | Patent No | Patent Expiration | Patent Use Code | Submission Date |
004 | 9439906 | 01/26/2031 | U-543 U-1901 U-2757 U-2758 | 10/11/2016 |
Independent claim:
Independent claim:
A dosing regimen for administering paliperidone palmitate to a psychiatric patient in need of treatment for schizophrenia, schizoaffective disorder, or schizophreniform disorder comprising….
Janssen claimed IPR would be an inefficient use of Board resources because of two co-pending district court actions. One suit against Mylan and another suit against Teva.
PTAB agreed with Janssen.
Mylan appealed, but not succeeded.
The Federal Circuit granted Janssen's motion to dismiss Mylan's appeal. The matter is being litigated in court. Generic launch will be driven by the Court’s decision.
Disclaimer
Sidvim LifeSciences Private Ltd has taken due care and caution in developing this document. Since the data used for analysis in this document is based on the information available in the public domain, its adequacy or accuracy or completeness cannot be guaranteed. This document is for information only and Sidvim is not responsible for losses that may or may not arise due to any decisions made based on the same. No part of the document shall constitute or be represented as a legal opinion of any kind or nature. No warranties or guarantees, expressed or implied, are included in or intended by the document, except that it has been prepared in accordance with the current generally accepted practices and standards consistent with the level of care and skill exercised under similar circumstances by professional consultants or firms that perform the same or similar services.
