PHARMACY

Addex, Merck ink potential $700 million licensing deal

BY Drew Buono

ZURICH, Switzerland Addex Pharmaceuticals is stating that it may receive more than $700 million from a licensing deal it made with Merck regarding its drug ADX63365, which is used to treat schizophrenia, Reuters reported.

The company will receive $22 million upfront from Merck for the drug, which also covers undisclosed indications for the drug and will then be eligible for up to $680 million in milestone payments.

Addex also announced that its lead compound, ADX10059 failed to meet its main target in a mid-stage Phase IIa clinical trial for acute anxiety. Development of ADX10059 for two other indications, gastroesophageal reflux disease and migraines, will continue as planned, according to the company.

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Orion, Sun in patent fight over Stalevo

BY Drew Buono

HELSINKI, Finland Orion has extended a patent suit against Sun Pharmaceuticals, which is challenging the company on its Parkinson’s disease treatment drug Stalevo, according to published reports.

Orion is already suing Sun to prevent it from making a generic version of the drug, which is generically called carbidopa/levodopa. Sun has now amended its application to contain Paragraph IV challenges against three of Orion’s patents covering Stalevo.

The challenges mean Sun is either claiming Orion’s patents are invalid or that it would not be infringing on Orion’s patent rights by making a generic version.

Orion, which is evaluating its legal options together with Novartis, the company which exclusively markets Stalevo in the, said the application review process has only just begun and that generic competition is ‘neither certain nor imminent’.

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Forest, Cypress submit application to FDA for fibromyalgia treatment

BY Drew Buono

NEW YORK and SAN DIEGO Forest Laboratories and Cypress Bioscience have recently submitted a drug application to the Food and Drug Administration for milnacipran, a drug for treatment of fibromyalgia syndrome, according to published reports.

The submission includes efficacy data from two Phase III trials involving 2,084 patients, which showed that milnacipran demonstrated improvement compared to a placebo in treating fibromyalgia, the companies said.

Currently, only Pfizer’s Lyrica is approved in the U.S. to treat fibromyalgia, which affects up to 6 million Americans.

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