By Ed Silverman//January 27, 2011//5: 23 pm
Shaken by the setbacks in getting approval for his Lorqess diet pill, Arena pharmaceuticals is layoffs 66-about 25 percent of its workforce-and continues to maintain that a resubmission can be filed with the FDA by the end of the year. However, the drugmaker couldn’t guarantee the deadline can be met and offered a list of problems to be solved before with FDA staff.
The list includes what the drugmaker deemed as “non-clinical issues” involving links between Lorqess and tumours in rats, a notion that has plagued executives Arena for months, especially after it was criticized for failing to vet the topic more thoroughly with investors first refusal by the FDA last Advisory Group September Arena ceo Jack Lief (see this).
In a statement, Arena says five independent pathologists were retained to refer to review “the diagnostic uncertainty” for the classification of breast masses in female rats. The next involves demonstrating that a mechanism for mammary adenocarcinoma in female rats that “is fairly irrelevant to human risk,” requiring “further experiments to test that theory” Lorqess causes breast cancer in rats by increasing prolactin. The FDA has suggested Arena consider a study of 12 months.
The third issue concerns the method identified action and clear margin of safety for Astrocytoma brain in male rats. To satisfy the FDA, Arena plans what defines a small clinical study and experiments of “non-clincal”. Interestingly, the drugmaker will expand even further study to assess the risk of valvulopathy, which is the heart valve disease.
You may remember that the mechanism of Lorqess is similar to the mechanism in fenfluramine. Both are designed to block appetite signals in the brain. And this was half of the fen-phen cocktail weight loss of Pfizer and Wyeth recalled that in 1997, together with a pill called Redux-chemically similar due to a fatal lung disease and heart valve problems (read more here).
The Arena has a lot of work to do and, now, fewer people to help meet its deadlines. The layoffs should save $ 13 million in annual costs, but Lief is under pressure to salvage its agreement with Eisai, who paid $ 50 million for the rights to sell Lorqess in the United States; another 160 million dollars on the basis of development and approval milestones and a 1. 16 billion, one-time payment that will follow based on annual sales. Can pull out or Arena is just another fat chance?
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