BioTech Sage Report - small-capped biotechs in Phase II/III clinical trials, chemotherapy-induced nausea and vomiting (CINV)
November 25 2002. In the December's BioTech Sage Report we evaluated new therapeutics addressing a variety of indications. These therapeutic agents are developed by small-capped biotechs and are in Phase II/III clinical trials. In our opinion, these new therapeutic agents have a good chance of success. Most address incurable and/or chronic diseases. The biotechs developing the therapeutic agents are companies that are going to have an impact on the market and whose current share price is reasonable. And, if all pans out, these biotechs will have the advantage of being the leader of the pack to tap into a lucrative market, which in some cases could be a billion dollar market.  At the same time, Big Pharma companies have been going through consolidation for a number of years now, and they are at the point where if they don't have a billion-dollar product, they can't move forward. That leaves a big opening, an unmet need for companies that can create those $100 million to $500 million products and make them successful. Niche drugs can fulfill a smaller market and these biotech companies are aiming to fill that demand. Here are some examples of companies that are mentioned in our report.  Chemotherapy is one of the primary methods of treating cancer and one of the most successful. However, chemotherapy is often associated with severe side effects that limit the use of certain agents. Thus, for the oncologist, managing these unwanted effects is crucial to the goal of eradicating the cancer. To aid oncologists’ efforts, several biotech companies are evaluating novel treatments for managing some of these side effects, and we think they will do well once they receive FDA (Food Drug Administration) approval. One side effect routinely observed in patients receiving chemotherapy is chemotherapy-induced nausea and vomiting (CINV). If not prevented, CINV is estimated to afflict 85% of cancer patients undergoing chemotherapy and can result in a delay or even discontinuation of chemotherapy treatment. One biotech targeting CINV is MGI Pharma (NASDAQ: MOGN). MGI and their Swiss partner, Helsinn Healthcare SA, have submitted an NDA (new drug application) to the FDA for palonosetron, their agent for the prevention of CINV. Another is Adolor Corporation (NASDAQ: ADLR). In collaboration with GlaxoSmithKline (NYSE: GSK), Adolor is evaluating Alvimopan, an orally administered mu opioid antagonist, which is intended to reverse the effects of opioid-induced bowel dysfunction, or constipation, without affecting the central nervous system analgesic properties of the opioid.  Then there is Regeneron (NASDAQ: REGN). The next six months will be a critical period for Regeneron. The release of interim Phase III clinical data in the first quarter of 2003 will provide a peek at whether the broader patient experience amassed can support Axokine in the treatment of patients with obesity; the drug needs to provide at least 5% or more weight loss. If all goes well for Regeneron, Axokine could be approved to treat severe obesity, which is a becoming a significant problem here in the United States.  Not all biotechs and pharmaceuticals will be successful, so investors wanting to capitalize on the potential financial rewards associated with a marketed compound need to choose carefully and time their actions.
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