Tuesday, April 09, 2013 6:58:29 PM
Apr 9, 2013 12:30 PM | about stocks: AMRN, GSK
A new guideline document for generic Vascepa issued by FDA (they opine by issuing these type of documents for all new and approved drugs) suggests two things:
1) They may be ready and willing to issue NCE, as the document specifies the active ingredient in a technically different way than on Lovaza's generic guideline document
2) Amarin's stated supplier/manufacturing barriers to entry may play a huge role in thwarting generics, as the FDA document includes specific API directives.
Stocks: AMRN, GSK
Back To Steve Rosenman's Instablog HomePage »
Instablogs are blogs which are instantly set up and networked within the Seeking Alpha community. Instablog posts are not selected, edited or screened by Seeking Alpha editors, in contrast to contributors' articles.
Share this Instablog
0
This post has 2 comments:
Track new comments on this article
bravo33Comments (42)
Steve,
Good comments on a document that has been discussed just recently on a limited number of other sites. One question I'm not clear on - is there any 'effective date' associated with this document or are its findings applicable, binding and enforceable now? Your second point regarding API directives sounds very significant. I take from your comments that you think this could translate into NCE yes very soon.
Thanks! 9 Apr, 01:49 PMReplyLike1
Steve RosenmanComments (472)
FDA issues the document as a general guideline when new drugs come to market, and can provide this type of document to would-be generic manufacturers - making no observation, determination or designation to any IP that the drug may have. In this case, the document is moot to generics, as AMRN's patents will not allow them to infringe (at least not without risk and liability).
Side note - I know of two generics (one top in the market and one a rather small player) that were looking to knock off Vascepa more than 1 year ago, they both have since abandoned their attempts and desire to go after Vascepa due to supply barriers causing the material to cost too much and due to AMRNs IP position. Forgetting the BS uncertainty talked about on Wall Street and in general, I am very confident AMRN will be the only Vascepa player for quite some time... The stock is only at this price b/c the big money is betting that there is more time to play with before the next leg up on AMRN begins again. This history has played out time and time again with AMRN and the big money supporters - just look at the charts relative to catalysts and news announcements. My take is we get a new multi-year high before Anchor approval.
http://m.seekingalpha.com/instablog/1282351-steve-rosenman/1737551-new-fda-document-could-mean-nce-for-amarin
Recent AMRN News
- Form 8-K - Current report • Edgar (US Regulatory) • 06/04/2024 11:30:10 AM
- Amarin Board of Directors Announces CEO Transition • GlobeNewswire Inc. • 06/04/2024 11:30:00 AM
- Amarin Receives National Reimbursement for VAZKEPA® (icosapent ethyl) in Greece and Announces Exclusive Marketing and Commercialization Agreement with Vianex S.A. • GlobeNewswire Inc. • 05/28/2024 12:15:23 PM
- Amarin to Present at H.C. Wainwright 2nd Annual BioConnect Investor Conference • GlobeNewswire Inc. • 05/06/2024 12:00:00 PM
- Amarin Reports First Quarter 2024 Business Update and Financial Results • GlobeNewswire Inc. • 05/01/2024 11:00:00 AM
- Amarin Applauds HealthyWomen’s Citizen’s Petition Urging FDA To Take Further Action On Fenofibrate Prescribing in Patients at Risk of Cardiovascular Event • GlobeNewswire Inc. • 04/24/2024 06:00:01 PM
- Amarin Announces Results of Annual General Meeting of Shareholders • GlobeNewswire Inc. • 04/22/2024 12:00:25 PM
- Amarin to Report First Quarter 2024 Financial Results and Host Conference Call on May 1, 2024 • GlobeNewswire Inc. • 04/15/2024 12:00:00 PM
- Amarin Highlights Key Data Providing Mechanistic Insights into Eicosapentaenoic Acid (EPA) at ACC.24 • GlobeNewswire Inc. • 04/08/2024 12:00:00 PM
- New REDUCE-IT® Analyses Show VASCEPA® (Icosapent Ethyl) Benefit in High-Risk Cardiovascular Disease Patient Subgroups • PR Newswire (Canada) • 04/08/2024 10:30:00 AM
- New REDUCE-IT® Analyses Show VASCEPA®/VAZKEPA® (Icosapent Ethyl) Benefit in High-Risk Cardiovascular Disease Patient Subgroups • GlobeNewswire Inc. • 04/06/2024 07:30:00 PM
- Amarin Provides Update on VAZKEPA® (Icosapent Ethyl) Intellectual Property Portfolio in Europe • GlobeNewswire Inc. • 04/03/2024 12:00:00 PM
- Research Evaluating Benefits of VASCEPA®/VAZKEPA® (icosapent ethyl) to be Presented at the American College of Cardiology’s (ACC) Annual Scientific Session & Expo • GlobeNewswire Inc. • 03/25/2024 12:00:00 PM
- Form ARS - Annual Report to Security Holders • Edgar (US Regulatory) • 03/04/2024 10:30:53 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 03/04/2024 01:00:24 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 02/29/2024 12:06:26 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/29/2024 12:05:56 PM
- Amarin Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update • GlobeNewswire Inc. • 02/29/2024 12:00:00 PM
- Amarin to Report Fourth Quarter and Full Year 2023 Financial Results and Host Conference on February 29, 2024 • GlobeNewswire Inc. • 02/15/2024 01:00:00 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 02/12/2024 01:00:24 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/09/2024 09:31:50 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/09/2024 09:30:28 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/09/2024 09:30:12 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/02/2024 09:30:24 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/02/2024 09:30:22 PM
VAYK Exited Caribbean Investments for $320,000 Profit • VAYK • Jun 27, 2024 9:00 AM
North Bay Resources Announces Successful Flotation Cell Test at Bishop Gold Mill, Inyo County, California • NBRI • Jun 27, 2024 9:00 AM
Branded Legacy, Inc. and Hemp Emu Announce Strategic Partnership to Enhance CBD Product Manufacturing • BLEG • Jun 27, 2024 8:30 AM
POET Wins "Best Optical AI Solution" in 2024 AI Breakthrough Awards Program • POET • Jun 26, 2024 10:09 AM
HealthLynked Promotes Bill Crupi to Chief Operating Officer • HLYK • Jun 26, 2024 8:00 AM
Bantec's Howco Short Term Department of Defense Contract Wins Will Exceed $1,100,000 for the current Quarter • BANT • Jun 25, 2024 10:00 AM