The biotechs have experienced a nice run since March, a run fueled by anticipated positive news out of the recent ASCO meeting. Well, the meeting did not disappoint the medical profession and the “big four” Genentech (DNA | Quote | Chart | News | PowerRating), Imclone (IMCLE | Quote | Chart | News | PowerRating), OSI Pharmaceuticals (OSIP | Quote | Chart | News | PowerRating), and Millennium Pharmaceuticals (MLNM | Quote | Chart | News | PowerRating) certainly did not disappoint investors. In addition, much of the momentum gained from the ASCO meeting was rolled into several companies that presented at the American Society of Gene Therapy, Targeted Genetics (TGEN | Quote | Chart | News | PowerRating) and Introgen (INGN | Quote | Chart | News | PowerRating).
Now that the wake of the recent cancer meetings has subsided, my attention turns to another big market disease, diabetes. Starting Friday, the American Association of Diabetes will hold its annual meeting, bringing together diabetes specialists from all over the world. The meeting will run through the weekend and many companies will be making presentations on developing new drugs. Diabetes affects over 15 million people in this country and diabetic complications lead to billions of healthcare costs. Both the medical profession and investors will closely watch the presentations coming out of this large meeting.
Companies making presentations at this upcoming meeting include Amylin Pharmaceuticals (AMLN | Quote | Chart | News | PowerRating), Generex Biotechnology (GNBT | Quote | Chart | News | PowerRating), Emisphere Technologies (EMIS | Quote | Chart | News | PowerRating), Nektar Therapeutics (NKTR | Quote | Chart | News | PowerRating), and Alteon (ALT | Quote | Chart | News | PowerRating). Amylin Pharmaceuticals probably has the strongest presence at the meeting. The company has several new drugs to treat diabetes in late-stage clinical development. Amylin plans to present the latest clinical data on the use of its developing drug Exantide (and an extended-release form) to treat diabetics failing other oral therapy.
In addition to Exantide, the company is also ready to file a supplemental New Drug Application with the FDA regarding its other late-stage diabetic drug, Symlin. Symlin has already been reviewed by an FDA advisory panel and deemed approvable if Amylin generated more data regarding the drug’s safety profile. The company now appears poised to submit this additional data and take the drug one step closer to unconditional approval. It would not surprise me if news regarding this supplemental filing surfaces during this meeting. If so, this would only add to the momentum this stock may have going into the meeting. Amylin also has a new drug in phase II trials to treat congestive heart failure. No data on this trial has been made public yet.
Generex and Emisphere are two companies developing their own unique form of oral insulin. Insulin is usually administered by subcutaneous injection and a company that can develop an effective oral form of the drug will generate a lot of excitement in the medical community. Over the life of a diabetic, injections are a chronic pain. An alternative to insulin injections will be welcome, especially in the diabetic pediatric population. Both these companies will present clinical data on their perspective oral insulin technologies at the upcoming meeting.
Alteon (ALT | Quote | Chart | News | PowerRating) is an interesting company for reasons not related to diabetes. However, the company will present an abstract on its flagship drug (ALT-711) that shows efficacy against diabetic nephropathy in mice. This abstract may get some attention at the meeting but the real investor attention is focused on the ongoing clinical trials of this drug testing it against hypertension. ALT-711 acts by affecting the rigidity of blood vessels, a rigidity that is implicated in the etiology of hypertension as we age. The company plans to release much-anticipated data from the ongoing phase II anti-hypertension trials in late July or early August. Take advantage of price dips in this stock, because positive news from this trial will send this stock price to new highs.
The abstracts to be presented at the American Diabetic Association meeting have already been made public and can be accessed on the meeting’s website. However, I suspect the companies mentioned will still get some favorable attention once the data from the abstracts are formally announced. Thanks to ASCO, the climate for good biotech news is very investor friendly.
Good Luck,
Paul Ruggieri, MD, FACS