FDA fast tracks Spectrum, Allergan cancer drug
Posted 07-22-2009 at 02:40 PM by admin
Associated Press, 07.21.09, 09:30 AM EDT
NEW YORK -- Spectrum Pharmaceuticals Inc. and Allergan Inc. said Tuesday the Food and Drug Administration will grant a faster review to their drug candidate EOquin, which is intended to treat non-muscle invasive bladder cancer.
The drug candidate received fast track status from the FDA. The fast track designation is intended to speed up the development and review of drugs that treat serious illnesses, including those for which no treatment exists, or that could be a significant improvement over drugs currently on the market.
The companies are enrolling patients in a late-stage clinical trial of the drug.
EOquin, or apaziquone, is intended to treat bladder cancer that has not that has not yet spread deep into the muscle layer. Spectrum and Allergan estimated that the non-muscle invasive type accounts for 70 percent of new bladder cancer diagnoses, and said it affects more than a million patients in the U.S. and Europe.
Spectrum shares rose 33 cents, or 5.6 percent, to $6.20 in premarket trading. Allergan shares rose 5 cents to $49.96.
In October, Allergan paid Spectrum $41.5 million to get the rights to market EOquin as a bladder cancer treatment in the U.S., Europe and Canada. If the drug advances through development and regulatory approval and reaches sales milestones, Allergan will pay Spectrum up to $304 million more. Spectrum is also eligible to receive royalties on sales of the drug outside the U.S.
The companies plan to co-promote EOquin in the U.S., with Allergan covering most of the development costs. Spectrum owns the rights to EOquin in Asia.
Spectrum and Allergan are located in Irvine, Calif.
Copyright 2009 Associated Press. All rights reserved. This material may not be published broadcast, rewritten, or redistributed
2009 Forbes.com LLC™ All Rights Reserved
NEW YORK -- Spectrum Pharmaceuticals Inc. and Allergan Inc. said Tuesday the Food and Drug Administration will grant a faster review to their drug candidate EOquin, which is intended to treat non-muscle invasive bladder cancer.
The drug candidate received fast track status from the FDA. The fast track designation is intended to speed up the development and review of drugs that treat serious illnesses, including those for which no treatment exists, or that could be a significant improvement over drugs currently on the market.
The companies are enrolling patients in a late-stage clinical trial of the drug.
EOquin, or apaziquone, is intended to treat bladder cancer that has not that has not yet spread deep into the muscle layer. Spectrum and Allergan estimated that the non-muscle invasive type accounts for 70 percent of new bladder cancer diagnoses, and said it affects more than a million patients in the U.S. and Europe.
Spectrum shares rose 33 cents, or 5.6 percent, to $6.20 in premarket trading. Allergan shares rose 5 cents to $49.96.
In October, Allergan paid Spectrum $41.5 million to get the rights to market EOquin as a bladder cancer treatment in the U.S., Europe and Canada. If the drug advances through development and regulatory approval and reaches sales milestones, Allergan will pay Spectrum up to $304 million more. Spectrum is also eligible to receive royalties on sales of the drug outside the U.S.
The companies plan to co-promote EOquin in the U.S., with Allergan covering most of the development costs. Spectrum owns the rights to EOquin in Asia.
Spectrum and Allergan are located in Irvine, Calif.
Copyright 2009 Associated Press. All rights reserved. This material may not be published broadcast, rewritten, or redistributed
2009 Forbes.com LLC™ All Rights Reserved
Total Comments 0
Comments
Recent Blog Entries by admin
- Research and Markets: Market of Paclitaxel Injection in China (08-20-2010)
- Relief for cancer patients may be 2,000 years old (08-20-2010)
- Melanoma Research Alliance Announces $5.2 Million in New Grants (08-20-2010)
- Melanoma Research Alliance Announces $5.2 Million in New Grants to Support Six Innova (08-20-2010)
- Breast cancer survivors don't need to be afraid of air travel: U of A study (08-20-2010)
