San Diego-based Phenomix isn’t one to shy away from a fight. This privately held biotech company with just 50 employees is forging ahead with a new drug for diabetes, one of the most competitive, and crowded marketplaces in the entire pharmaceutical industry.
As long as the diabetes epidemic rages on like a “runaway train” in the words of the Centers for Disease Control, affecting more than 20 million people in the U.S., Phenomix figures it can carve out a lucrative niche by being just one of several contenders in the market. I learned about the company’s game plan for the year ahead from CEO Laura Shawver a couple weeks ago at an investor conference in San Francisco.
Phenomix (pronounced Fuh-NO-mix) has been developing an experimental drug for treating diabetes that blocks an enzyme called DPP4. Pharmaceutical giant Merck led the way in October 2006 with sitagliptin (Januvia), the first drug of this class approved in the U.S. Scientifically, the drugs in this class aim to achieve the same goal as San Diego-based Amylin Pharmaceuticals, through a different method. By blocking DPP4, these drugs raise the levels of a peptide called GLP-1, which signals that food is in the body and tells the pancreas to make more insulin to control blood sugar. The advantage with these drugs is they can be taken as an oral pill once a day, instead of having patients take twice-daily injections as required with Amylin’s exenatide. The market for these DPP4 blockers ought to be worth more than $10 billion a year, Shawver says. The Merck drug alone is expected to generate $2.4 billion to $2.7 billion in worldwide sales this year.
“These drugs are safe. They’re oral. They’re convenient,” Shawver says.
Many of the existing drugs on the market, like metformin or TZD drugs, have side effects that would make it difficult for them to pass muster with today’s FDA, Shawver says. The DPP4 blockers promise to be safer, and therefore draw in a broader group of patients looking to prevent disease, just as people now take statin drugs to prevent heart attack. “We’ll see a similar pattern when the right drug comes along for diabetes,” she says.
Phenomix doesn’t have much to say publicly about how its drug is really different from others in its class. Besides Januvia, there are competing drugs under FDA review from New York-based Bristol-Myers Squibb and Japan-based Takeda Pharmaceutical that are further along in development, Shawver says. Another drug from German pharmaceutical company, Boehringer Ingelheim is in the final stages of development. And, there’s the Phenomix candidate, called dutoglipton, which is now in the final stage of clinical trials under a partnership with New York-based Forest Laboratories.
Evidence to support the Phenomix drug looks promising. Shawver says a study of 422 patients showed the drug reached all of its goals, … Next Page »