Pain- busting partnership

BMS and Allergan in $413 million deal to develop drug for neuropathic pain

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PRINCETON, N.J.— Global pharmaceutical giant Bristol-Myers Squibb Co. (BMS) and Irvine, Calif.-based Allergan Inc. have agreed to develop and commercialize a drug to treat chronic pain caused by tissue damage associated with diabetes, shingles and a weak immune system related to HIV, chemotherapy, radiation and stress. The drug, AGN-209323, is a Phase II-ready, orally administered small molecule in clinical development.

The deal, announced March 3, could potentially be worth $413 million, not counting royalty payments from sales if the drug is approved. BMS has paid $40 million upfront to Allergan and promised up to $373 million more in milestones to license the experimental therapy for neuropathic pain.

However, the oral version of the drug "still has a long way to go, with researchers preparing for a mid-stage study," according to a report by Fierce Biotech.

The agreement gives BMS worldwide rights to all but one indication—local delivery to the eye. Allergen is keeping the rights to develop AGN-209323 in eye-drop form.
The deal also allows Allergan partner Paris-based ExonHit Therapeutics to receive $4 million of the upfront and more than $32 million of the potential milestones. The oral small molecule was discovered by ExonHit using its profiling technology, according to Matthew Pando, ExonHit's executive vice president of therapeutics.

ExonHit and Allergan entered their collaboration in December 2002 to identify, develop and commercialize drugs to treat ophthalmology, pain and neurodegenerative diseases. In January 2009, the firms extended that partnership for the third time to December 2011, according to ExonHit spokeswoman Corinne Hoff.

Neither company would comment specifically on goals for future commercial expansion.

"We are fortunate to have a deep R&D pipeline, and believe that by partnering programs that extend into primary care, we can maximize the value of our science," said Dr. Scott Whitcup, executive vice president of research and development and chief scientific officer of Allergan, in a statement. "We are excited to have a partner interested in our technology and committed to developing AGN-209323 for neuropathic pain."

AGN-209323's novel mechanism of action and the unmet medical need in the neuropathic pain space first attracted BMS to forming a global agreement with Allergan, says BMS spokeswoman Jennifer Fron Mauer.

"Based on preclinical and Phase I data, it has the potential to be best in class, with limited side effects and a wide therapeutic window," Mauer says. "Neuropathic pain is a large, growing, underserved medical condition with significant patient and physician dissatisfaction with current treatments."

AGN-209323 is targeted to relieve the debilitating pain associated with diabetic peripheral neuropathic pain (DPNP)—neuropathic disorders associated with diabetes and post-herpetic neuralgia pain (PHNP)—a painful condition that affects nerve fibers and skin and diagnosed as a complication of shingles, a disease affecting mostly adults 60 and older who had contracted chicken pox as children. The difficult-to-treat pain and accompanying rash can also result from a weakened immune system caused by disease, mental and physical stress and different forms of treatment for cancer.

"There is significant unmet medical need for a more efficacious and tolerable therapy for neuropathic pain," says Francis Cuss, senior vice president of discovery and exploratory clinical research at BMS. "We are pleased to have the opportunity to develop this potential first-in-class compound that could help patients prevail over chronic pain and strengthen our neuroscience pipeline."

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