Paladin Labs has entered an agreement with GSK and Glaxo Group Ltd. under which Paladin will be the exclusive distributor of Dexedrine (dextroamphetamine sulfate) in Canada for three years, after which Paladin has the option to purchase all remaining rights to the product in Canada. GSK will provide certain distribution support services for an interim period. The two companies have also entered a strategic relationship whereby Paladin will have the first right to partner with GSK on a number of products that GSK may choose to license or divest in Canada. Financial terms were not disclosed.
   
Dexedrine is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) and in the adjunctive treatment of narcolepsy. According to IMS Canada, the ADHD market in Canada was valued at about $120 million in 2007. Dexedrine sales in 2007 were $14 million.
   
"This agreement will allow us to add to our portfolio of specialty pharmaceutical products and to build significant critical mass for our organization. Not only will we be adding close to $14 million to our top line next year, but just as importantly, we are establishing a strategic relationship with GSK for potential future transactions like this one," said Jonathan Ross Goodman, president and chief executive officer of Paladin Labs.
   
"We are very pleased to establish this preferred partner relationship with Paladin owing to their clear history of success in commercializing products like Dexedrine and their record of building win-win relationships with partners," said Paul Lucas, president and chief executive officer of GSK. "Dexedrine has a long history of efficacy and safety in improving the lives of Canadians suffering from ADHD and narcolepsy. In the very capable hands of Paladin, we are confident that it will continue to meet the needs of Canadian patients and their healthcare providers."

Lilly has withdrawn its sNDA from FDA for Cymbalta for the management of chronic pain. Lilly plans to resubmit the application in 1H09, adding recent positive data from a study in chronic osteoarthritis pain of the knee.
   
Lilly submitted the application in 2Q08 based on three clinical trials: one positive study in chronic osteoarthritis pain of the knee and two studies in chronic low back pain, one positive and one that didn't meet its primary endpoint. In discussions between Lilly and the FDA, agency reviewers raised questions about efficacy and dosing that revolved primarily around statistical methodology and study design.
   
"This was a difficult decision, but we believe the updated data package will give the FDA a broader basis for reviewing our application," said John Hayes, M.D., a vice president at Lilly Research Laboratories.
   
The drug is currently FDA-approved for major depressive disorder, generalized anxiety disorder, management of diabetic peripheral neuropathic pain and management of fibromyalgia.

Vical, Inc. received a $1.0 million milestone payment from Merck based on Merck's planned initiation of a Phase I trial of an investigational plasmid DNA (pDNA) cancer vaccine. The vaccine is based on Vical's DNA gene delivery technology and encodes human telomerase reverse transcriptase (hTERT), which is the subject of a separate license agreement.
   
"The breadth of applications for Vical's gene delivery technology continues to grow, and now encompasses vaccine candidates against infectious diseases and cancer, cancer immunotherapies, and gene-based angiogenesis for cardiovascular diseases," said Vijay B. Samant, Vical's president and chief executive officer. "We are pleased that our long-standing partner Merck is expanding to a second clinical-stage evaluation of our technology in the cancer area."

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