Big moves in pharma today: Repros tanks, Protalix jumps
Aug 17th 2009 5:00PM
Updated Dec 3rd 2009 4:36PM
Earlier today, BloggingStocks' Elizabeth Harrow reported that Repros said the amount of cash it has on hand is insufficient and it is "exploring potential new financing alternatives." The company went on to say that there is no guarantee such a measure would be successful.
Repros focuses on developing treatments for male and female reproductive disorders. Proellex is the company's experimental drug for uterine fibroids and Androxal is currently being tested in men with low testosterone levels.
But the company has been facing a hurdle that all pharmas face at some point or another: the safety of the drugs it makes. Two weeks ago, Repros had to suspend clinical trials for Proellex, which the FDA said could be contributing to increased liver enzymes in patients. While this makes Androxal the more attractive asset should a buyer comes in, it too is in tests and cash strapped Repros can't fund further clinical testing for the drug.
Adding fuel to the fire are legal matters, including a class-action lawsuit filed by Repros shareholders alleging that the company issued misleading statements, including press releases on the trial results, related to its Proellex drug.
Things are looking brighter, however, at Protalix, which last month submitted a treatment protocol to the FDA for its Gaucher disease drug, prGCD. Gaucher is a very rare disease where patients lack a certain enzyme needed to break down fats. As a result, patients with Gaucher end up with an enlarged spleen and liver, anemia, low blood platelets, painful skeletal disorders and bone lesions among other symptoms.
Protalix got lucky here. If it had not been for a plant shut down due to a virus at Genzyme (GENZ), which makes the leading blockbuster Gaucher treatment Cerezyme, it's doubtful the FDA would have acted so quickly.
Now, physicians will be able to treat patients of Gaucher disease with prGCD during the expected shortage of Cerezyme while studies of prGCD continue as part of the Protalix's ongoing Phase III clinical trial. Patients enrolled in the protocol could continue to be treated with prGCD until its anticipated marketing approval from the FDA. And given this vote of confidence, the approval is nearly certain.
But here's the catch: Protalix will provide the drug free of charge to patients enrolled in the protocol. What this means is that as Protalix seeks a marketing partner, it too may have to raise capital. It also means it has actually overcome one of the biggest hurdles -- introducing its drug to patients and getting them to switch to it from their current medication, usually Genzyme's Cerezyme.
Neither of these companies can rest, however. Another Gaucher drug is coming from Shire Plc, and it also has received a similar approval from the FDA.