Irvine-based drug makers, Spectrum Pharmaceuticals Inc. and Allergan Inc. announced Tuesday that they received ‘Fast Track’ designation from the Food and Drug Administration (FDA) for their bladder cancer drug candidate. The fast track designation is designed to speed up the development and review of drugs that intended to treat serious illness or demonstrate the potential to address unmet medical needs.

The FDA granted a faster review of the companies’ drug, EOquin or apaziquone which is intended to treat bladder cancer that has not spread deep into a patient’s muscle layer. According to Spectrum and Allergan, the non-muscle invasive bladder cancer accounts for an estimated 70 percent of new bladder cancer diagnoses and it affects more than a million patients in the U.S. and Europe.

“We are pleased that the FDA has accepted apaziquone for bladder cancer under its Fast Track program,” said Rajesh C. Shrotriya, M.D., chairman, president and chief executive officer of Spectrum. “In a marker lesion study, where patients had previously failed multiple therapies, apaziquone produced a 67% complete response and was well-tolerated. We look forward to continuing with Phase III studies evaluating the efficacy and safety of apaziquone, while working with the FDA to expedite the drug’s development, review and approval process so we can help address the substantial unmet needs of patients suffering from non-muscle invasive bladder cancer.”
Last October, Allergan paid Spectrum $41.5 million in order to get the rights to market EOquin as a bladder cancer treatment in the U.S., Europe and Canada. Spectrum would get an additional amount up to $304 million if the drug advances through development and is approved by the regulators and reaches certain sales milestones. Besides, Spectrum is also likely to receive royalties on sales of EOquin outside the U.S. Both companies plan to co-promote the drug in the U.S., with Allergan covering most of the development costs. Spectrum owns rights to EOquin in Asia.

Spectrum shares closed up 12 percent with a market value of $220 million, while Allergan’s shares were flat with a market value of $15 billion.

This entry was posted on Wednesday, July 22nd, 2009 at 12:48 pm and is filed under Venture Capital Events, Venture Capital News. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.