Wow 899 wraps up would be competition and 628 lists just Crestor...hope your on to something.
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Crestor reps!
- Thread starter Anonymous
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Vascepa/statin sNDA would receive 3 yrs of exclusivity, then would coast on the patent when approved to 2030. Amarin recently changed statin from Atorvastatin to Rosuvastatin. AHA is recommending heart patients take combo pills to simplify regimen. Crestor is tier 2 now and Vascepa is tier 3 (some 2) after 7 weeks post launch. Vascepa's weekly sales have also surpassed Brilinta (the future best seller?
CRESTOR's game is NOT over.
"December 17, 2012
Amarin Announces Completion of Dosing in a Fixed-Dose Combination Study With Vascepa(R) and a Leading Statin
BEDMINSTER, N.J., and DUBLIN, Ireland, Dec. 17, 2012 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that it has completed dosing and pharmacokinetic sampling in a study to test a fixed-dose combination of Vascepa® (icosapent ethyl) capsules and a leading statin. The clinical name for this combination product is AMR102. Prior to commencement of the study, Amarin opened an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration which became effective after the standard 30-day review.
The purpose of this AMR102 study is to determine the bioavailability of the EPA (eicosapentaenoic acid) and statin components when taken as a fixed-dose combination product, relative to the individual reference agents taken concomitantly. Statin bioavailability from both the fixed-dose and concomitant regimens will also be compared with that from the reference statin taken alone in healthy subjects. Additionally, pharmacokinetic data from this study will be examined to explore relationships between in vitro dissolution data and in vivo pharmacokinetic data. The study is designed as a randomized, open-label, multiple dose, parallel-group study in 48 healthy subjects conducted at a single site in the United States.
"This study is aimed at expanding the potential commercial application of Vascepa by leveraging the clinical successes of the MARINE and ANCHOR trials, namely effective triglyceride lowering without increasing LDL-C," stated Joseph Zakrzewski, Amarin's Chairman and Chief Executive Officer. "Amarin's goal is to identify ways for patients to simplify their lipid management by developing a single therapy that offers the powerful triglyceride lowering effects of Vascepa combined with one of the most prescribed statin products."
Amarin looks forward to analyzing the results from this study and expects to communicate such results in the first half of 2013."
The only way these combo drugs ever work is if you get the patients switched to the new drug before the old one expires and goes generic and cheap. (see Vytorin) If this is the plan, and it may well be, they had better get moving on getting this combo on the market very quickly. I don't know if there is enough time to do the studies, get FDA approval, and then do the launch, all by mid 2016.
Relocating clinical research to another state and then cutting some more people too might speed up that process of filing? Not very likely.
They have two years to files sNDA for CRESTOR combo capsule. Two Phase three studies have already been done (MARINE & ANCHOR) with Icosapent, they both showed unexpected statistical significant reductions in LDL, hs-CRP, and triglycerides despite patients being on CRESTOR. The combo provides the safest and most effective cholesterol, lipid, and inflammation cardiovascular drug ever.
The combo would statistically increase the number of patients that could lower their hs-CRP under 2, thus potentially reducing CV events greater than just CRESTOR alone.
Let's hope AZ bolt's on before GSK makes a grab in an effort to save Lovaza.
Not seeing the connection with layoffs and filing a 505b2...
Priority is to save sales of Crestor and expand protection. Not sure if this will happen, but AZ at this point has nothing to lose.
Crestor R.I.P. Amarin has the patent for Epanova and Crestor combo and has no intension of giving AZN rights to market.
#13417899
https://dl.dropbox.com/u/57678878/13417899 Claims.pdf
#13124628
https://dl.dropbox.com/u/57678878/Co...2013124628.pdf
Epanova has ZERO IP.
Pfizer, Merck, GSK, TEVA to get combo market rights by 2014...by 2016 Crestor's done.