PHARMACY

PPD, J&J subsidiary join forces to develop compound portfolio

BY Alaric DeArment

WILMINGTON, N.C. Drug maker PPD will work with Johnson & Johnson subsidiary Janssen to develop drugs to treat bowel, skin and respiratory illnesses, PPD announced.

Under an agreement between the two companies, PPD will develop drugs to treat diarrhea-predominant irritable bowel syndrome, and skin and respiratory infections through mid-stage clinical trials. After the phase 2 trials end, Janssen will have the option to resume development and commercialization of each compound.

In exchange, PPD will receive up to $330 million in milestone payments and royalties on sales of drugs that receive regulatory approval. If Janssen does not buy back a program, PPD will have the option of continuing to develop and commercialize the drug, paying Janssen $250 million in milestone payments and royalties.

“Our agreements with Janssen diversify and strengthen our compound partnering portfolio and may gain us entry into two large markets,” PPD executive chairman Fred Eshelman stated. “The [irritable bowel syndrome] market holds significant drug development potential because of the lack of approved products for this indication, and new antibiotics are needed to address increasing incidences of resistant-strain bacterial infections.”

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FDA approves Par’s chronic pain drug

BY Alaric DeArment

WOODCLIFF LAKE, N.J. The Food and Drug Administration has approved a generic version of a chronic pain drug.

Par Pharmaceuticals announced Monday the approval of tramadol extended-release tablets in the 100-mg and 200-mg strengths. The drug is a generic version of Johnson & Johnson’s Ultram ER, which has sales of $156 million per year, according to IMS Health. Ultram ER is used to treat chronic pain in adults who require around-the-clock treatment.

The U.S. District Court for the District of Delaware ruled in August that Par could market a generic version of the drug. Par plans to begin shipping the drug immediately.

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Addrenex acquired by Sciele Pharma

BY Alaric DeArment

DURHAM, N.C. The U.S. subsidiary of a Japanese drug maker has acquired a company that develops drugs for medical conditions related to the body’s adrenergic system.

Addrenex Pharmaceuticals announced Monday its acquisition by Sciele Pharma, the Atlanta-based subsidiary of Shionogi & Co., one of Japan’s largest drug companies, for $29 million. Sciele already held stock in Addrenex and licensed drugs from the Durham, N.C.-based company.

“Sciele has been a valuable partner and catalyst for the success of Addrenex,” Addrenex CEO Moise Khayrallah said in a statement. “Our initial business plan called for bringing innovative drugs to market and enabling our investors to achieve a positive return.”

Sciele had licensed Addrenex’s attention-deficit hyperactivity disorder drug Clonicel (clonidine) and the hypertention drug Jenloga XR (once-daily clonidine). Addrenex has four drugs in clinical trials and more than 400 possible drug candidates.

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