Today the International Atherosclerosis Society (IAS) and Pfizer Independent Grants for Learning & Change (IGLC) announce their collaboration on a new grant opportunity focused on improving care for patients around the world with medium or high levels of cardiovascular risk, with a particular focus on dyslipidemia.
Lipitor sales have started to slide in Europe, Pfizer offered a grant for a big idea...I think they might have an idea already. IAS had a presence at The 2013 Cardiometabolic Health Congress (CMHC), Vascepa's coming out party.
In addition many barriers will be placed for Lovaza. If AZN continues to pursue Epanova into the May PDUFA they likely have to contend with new Amarin patents and poor reimbursement.
October 7th, October 14th the last two Monday's before Amarin's indication is "opened" (Officially yes Dec 20th PDUFA date) to 1/3 US population. Supported be AMA, AHA, NIH, FDA, and ATP4 guidelines.
Reasons for Generics not enter the market, including AZN's Epanova:
1. Inferior product
2. Not approved for "Anchor" Trigs
3. Not approved for concomitant use with an inhibitor of HMG-CoA reductase (statin) to reduce non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (Apo B), low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC) and very-low-density lipoprotein cholesterol (VLDL-C) in adults with mixed dyslipidemia and coronary heart disease (CHD) or a CHD risk equivalent.(The rest of Anchor)
4. Amarin has all the IP for the above
5. Requirement the FDA will place on everything but Very High Trig treatment for a "REDUCE-IT" like outcomes study
6. Breaching Anchor IP and losing in court will cost Triple sales damage
#$%$ extremely unlikely mange care will provide Generics or Epanova with even Tier 4 coverage, remember Lovaza's warnings of A.fib ( costly complication to treat) and LDL tracking requirement ( costly labs)
8. Sourcing API will be EXTREMELY difficult
9. Amarin and Acquirer/ Partner will have 3 years of head start
10. Merck, AZN, GSK, PFE, and TEVA have patent fences to worry about, each are reducing costs through research reduction, selling of early pipeline candidates, selling real estate, and layoffs to tighten finances, fighting the most ever OB'd patent drug ever will to be cheap.
I'm feeling better than ever with Amarin's leverage. It's a greater than 50% chance Amarin receives a BO from one of or a combination of the above IMO. After my 1000's + hours of DD, I have never been as impressed with a companies long term plan and execution.
Amarin's IP advancement 10-3-2013
13/685,291, has Terminal Disclaimers approved 10-3-2013, "Generic" formulation covering up to 30% DHA with set ranges of EPA in escalating mg doses, combined with a statin to treat high Trigs and various lipid particle markers.
If Amarin get's this patent, they will have IP for any generic with greater than 30%DHA/70%EPA with or with out statin. Guessing within two Months they have NOA.
Will it be worth the risk to get sued for triple damages for Generics or Epanova? Not likely. This is a crushing blow to TEVA, GSK, AZN, and Par pharmaceuticals.
Ad Com around the corner to a multi billion dollar per year drug.
Merck announced it will layoff 8500 employees. AZ just bought rights to Merck phase 2 cancer drug, $50 million. AZ also changed Power of Autorney for one of the two Epanova patent ap to, Dechert LLP, who happen to be Merck clients and not AZN.
Guessing the two are teaming up for an Amarin bid.
You are 100% correct. Diabetes carries an exceptionally high burden of disease, including a higher mortality from CVD. Primary cardiovascular prevention is particularly important in this population because diabetic individuals suffering a first MI are much more likely to die than are their nondiabetic counterparts. Adherence to lipid guidelines is crucial to improving clinical outcomes in diabetic patients. A number of roadblocks to the successful implementation of lipid guidelines have been identified. Among the most common are failure to recognize that 1) the borderline LDL cholesterol elevations common in diabetic patients are associated with substantial cardiovascular risk because of their small, dense composition and the high CHD risk already present in this population; 2) seemingly mild abnormalities in LDL cholesterol interact with other lipid abnormalities to further heighten risk; and 3) intensive LDL cholesterol reduction in this setting results in significant reductions in cardiovascular morbidity and mortality. Indeed, the opportunity to substantially improve cardiovascular outcomes by assessing and treating the atherogenic diabetic dyslipidemia characteristic of this population should not be missed.
LDL Cholesterol Lowering in Type 2 Diabetes: What Is the Optimum Approach? (Search this title)
Big moneys not all in yet, massive manipulation until they have enough long shares. Just the way the games played.