As the 2011-12 patent drop-off for a majority of solid selling pharma products approaches, and phase III trial products are watched even more closely by the larger pharma companies, a solid report here or there can only boost value in a company. As the FDA vary rarely telegraphs its likelihood of acceptance for a new drug product, placing an investment on a pharma research company is still a risk. But if the investment pans out, it could provide a very large return.
Avanir Pharmaceuticals Inc., a biopharmaceutical company, focuses on acquiring, developing and commercializing drug candidates directed primarily at the central nervous system. Currently it has several products in late stage development. It also offers an over the counter product (Abreva) for cold sores now available at most pharmacy outlets and has completed Phase III trials for a diabetic neuropathy pain product.
The biggest news for the company is that it has completed three phase III safety and efficacy double blind studies for its Zenvia product. The product, which addresses Pseudobulbar affect, an affliction that causes uncontrolled laughter or crying past the norm, has implications to ALS, MS and might be considered an underline symptom in some unknown way. What is important in this regard is that the company has been accepted for presentation of three “data posters” at the American Academy of Neurology. In this respect, the “posters” are being classified as Late Breaking Science, which means they must show significant scientific importance. In investors parlance, progress is being made toward marketing the product for the directed affliction and possibly others in the future.
• Poster number P02.295: PERSISTENT EFFICACY OF DEXTROMETHORPHAN (DM)/QUINIDINE (Q) FOR PSEUDOBULBAR AFFECT (PBA): RESULTS FROM A 12-WEEK, OPEN-LABEL EXTENSION (OLE) STUDY
• Poster number P06.119: SUMMARY OF CARDIAC SAFETY FROM A RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF DEXTROMETHORPHAN/QUINIDINE (STAR) FOR TREATMENT OF PSEUDOBULBAR AFFECT
• Poster number P06.128: SAFETY AND TOLERABILITY OF DEXTROMETHORPHAN/QUINIDINE FOR PSEUDOBULBAR AFFECT IN A 12-WEEK OPEN-LABEL EXTENSION STUDY
As one might expect, the company is currently going through a period of transition. It has completed trials for its primary product and is awaiting its acceptance letter from the FDA (expected Q2.) As a result, research and development costs have decreased while administrative costs have increased. In an overall sense this makes way for increased revenue unless the company decides to go the rout of licensing. It does have current revenues from this rout with regards to its other products and may well follow this rout for its diabetic neuropathy product, where there is a history of several larger companies dominating the product class. In any event, as the 2011-12 patent drop-off approaches, Avanir Pharmaceuticals is shaping up to be a very popular player in the marketplace.