|By Brian Wilson|
|Tuesday, 13 March 2012 00:00|
As of now, investors are more eagerly anticipating the FDA’s decision to Peginesatide’s New Drug Application (NDA) which is due on March 27th 2012. Buyers have been increasingly excited since December 7, 2012 where the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted in favor of approval 15 to 1, with 1 abstention. Investors were ecstatic about the news given the price action of the stock. The benefit to risk ratio was also concluded to be positive (meaning that the benefits of the drug far outweigh the risk).
While this doesn’t completely guarantee an official FDA approval for Peginesatide, the likelihood has been increased dramatically. This explains much of the stock’s incredible rally from $6/share to a whopping $11/share. In addition, since anemia affects so many patients undergoing dialysis, John Orwin (CEO of Affymax) remarks that since it is a once-monthly treatment, the drug should have enormous potential in hospitals.
About 9% of traded shares are being shorted, which shows that certain traders remain skeptical about the worth of Peginesatide’s likely approval. This is despite a recent milestone payment from Takeda Pharmaceuticals for Peginesatide’s marketing approval in Europe worth $5 million, and the fact that the dialysis market is enormous (NIH statistics from recent years show as many 350,000 people on In-center hemodialysis). Nonetheless, an NDA approval seems virtually guaranteed at this point. Traders may still have the opportunity to make profits from the growing hype over Peginesatide.
Affymax has developed a discovery platform based on advanced recombinant peptide and peptide chemistry techniques that has been used to generate novel peptide alternatives to protein drugs. The approach has identified peptides with no amino acid sequence homology to other known naturally-occurring human sequences. The company has amassed significant expertise in peptide drug discovery and development, including capabilities in creating long acting versions of drugs using PEGylation technology.
Affymax's drug discovery process generates small peptides that bind to and activate or block protein targets such as receptors, ligands, antibodies, or toxins. This approach incorporates several advanced peptide chemistry techniques resulting in peptides with significantly greater potency and stability than those arising from more traditional approaches. The company's peptide drug discovery process generally begins with Recombinant Peptide Diversity (RPD) technique that generates billions of peptide molecules that are then selected and optimized for drug activity. The RPD approach identifies peptides that bind to specific molecular targets but have little to no sequence homology to native proteins. These peptides then serve as prototype compounds for further chemical optimization and eventually for the development of experimental therapeutics.
The BioMedReports FDA Calendar shows that in August of 2011, Affymax, Inc. announced that the FDA had assigned a Prescription Drug User Fee Act action date of March 27, 2012 for the review of the investigational agent peginesatide (formerly known as Hematide) New Drug Application. The company had announced on July 27, 2011 that the FDA accepted the peginesatide NDA submission for review.
If approved, peginesatide will be the first once-monthly erythropoiesis stimulating agent (ESA) available for the treatment of anemia associated with CKD patients on dialysis in the United States.
Peginesatide is a synthetic, PEGylated peptidic compound that binds to and activates the erythropoietin receptor and thus acts as an ESA. The NDA included data from two Phase III studies (EMERALD 1 and 2) that evaluated the efficacy and safety of peginesatide, dosed once every four weeks, compared to epoetin alfa or epoetin beta, dosed more frequently (according to the product labels) in maintaining hemoglobin (Hb) levels. In the studies, over 1,600 CKD patients on dialysis who were receiving stable doses of epoetin were randomized to receive once-monthly peginesatide or continue treatment with epoetin. The EMERALD findings suggested that once-monthly peginesatide was comparable to epoetin in maintaining Hb levels in CKD patients on dialysis with anemia with a similar adverse event rate. The most common adverse events reported in the clinical studies were diarrhea, cough, dyspnea, nausea, and muscle spasm. A similar frequency of serious adverse events was reported between the EMERALD treatment groups.
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