Two Biotechs Struggle With Problems
1 CommentBy Ed Silverman // August 9th, 2007 // 9:17 am
Genzyme faces an unwanted paradox - a biotech that has strong demand for a new product. The problem, however, is Genzyme can’t deliver the goods. Rising use of Myozyme, its treatment for Pompe disease, a rare and sometimes fatal enzyme disorder, is creating unexpected problems that is making some investors skittish, The Wall Street Journal reports (subscription required).
The biotech can’t meet demand, because the FDA is refusing to approve a Boston factory where most of the med is to be produced. And this means Genzyme can’t sell Myozyme from the factory to US patients. FDA approval, initially expected later this year, likely won’t come until the first half of next year at the earliest, the company says. And so Genzyme says some new patients will have to delay the start of their treatment while existing patients may be forced to skip some infusions.
Then, there’s Cytogen, a veteran player that struggles for recognition. Over 27 years, the Princeton biotech has racked up more than $433 million in accumulated losses and, as a result, has been forced to reinvent itself several times, reports The Star-Ledger of New Jersey (full disclosure: The Ledger owns Pharmalot).
Cytogan began life as a leader in cancer diagnostics keyed to protein signals, but suffered a crippling blow in 2005 when its Combidex technology, which used magnetic resonance imaging to detect the spread of cancer in lymph nodes, was rejected by the FDA. Now, Cytogen is almost a completely different company. Says Mike Becker, the ceo: “I think there are a lot of dated, historical perceptions of Cytogen.”
Sarah Millerick, Genzyme
In light of recent news coverage of Genzyme’s efforts to gain FDA approval of a larger-scale manufacturing process for Myozyme, I wanted to call your attention to our letter published today in the Wall Street Journal. The letter offers some clarification around this topic.