- Facing pharmacy trends for the remainder of the year
- NACDS, NCPA, GPhA express support for Drug Quality and Security Act
- Senate passes Drug Quality and Security Act
- Reports: Bill to extend federal regulations for compounding pharmacies expected to pass House, Senate
- FDA approves Plan B One-Step OTC switch
PITTSBURGH Swiss drug maker Biogen Idec will develop and commercialize an investigational drug as a treatment for amyotrophic lateral sclerosis, also known as Lou Gehrig’s disease, under a partnership with Knopp Neurosciences, the two companies said Wednesday.
Biogen Idec said the drug, KNS-760704 (dexpramipexole), is expected to enter phase-3 clinical trials during the first half of next year. In a phase-2 study conducted by Knopp, the drug preserved motor function and extended survival in ALS patients. Sanofi-Aventis’ drug Rilutek (riluzole) was approved to treat ALS in 1995, and Impax Labs makes a generic version. The disease, which causes rapid muscular degeneration and wasting, affects 20,000 Americans.
The Food and Drug Administration has granted KNS-760704 orphan drug and fast-track designations. The FDA gives orphan-drug designation to drugs for treating diseases that affect fewer than 200,000 people in the United States, while fast track expedites review of applications for drugs that treat serious and life-threatening conditions while showing potential to address unmet medical needs.
Under the terms of the agreement, Biogen Idec will purchase $60 million of Knopp stock and pay the company $20 million upfront, as well as up to $265 million in milestone payments, in addition to royalties on potential sales.