Tag Archives: Multiple Sclerosis

Dare to Compare: Genzyme Bets on MS

Riding positive data on a late-phase multiple sclerosis drug, Genzyme execs talked up the company’s willingness to go head-to-head against Rebif, EMD Serono and Pfizer’s blockbuster beta interferon. Genzyme execs didn’t go so far as to reiterate former CEO Henri Termeer’s 2010 prediction of $3 billion plus in potential sales for Lemtrada (alemtuzumab), but [...]
Posted in Biotech, Events, FDA, Global, IP, R&D, Regulatory, Safety, Sales, Strategy, Technology | Also tagged , , | 1 Comment

Is Sanofi Right to Bank on MS Drug?

Newswires have long been waiting for Sanofi-Aventis to officially announce its acquisition of US biotech company Genzyme, but what few analysts were expecting is just how much the transaction would hedge on one potentially controversial product. As the focus of Sanofi’s contingent value rights (CVR) approach, Genzyme’s multiple sclerosis treatment Lemtrada (also sold as Campath [...]
Posted in Safety, Strategy, pricing | Also tagged , , , , | 1 Comment

Merck KGaA MS Drug on the Fast Track

Merck KGaA received word July 25 that its application for the multiple sclerosis treatment Cladribine had received priority review status by FDA, decreasing the evaluation period from 10 months to six months, and closing the gap between Merck and the competition. “This is a critical milestone on the path to potential approval for short-course therapy with [...]
Posted in Strategy | Also tagged , , , , , , , | Leave a comment

Acorda Seeking NDA for MS Drug

Hawthorne, NY-based Acorda Therapeutics yesterday released Phase III clinical trial data of fampridine-SR, a novel treatment that improves walking ability in Multiple Sclerosis patients. Acorda filed a New Drug Application for fampridine on January 30, and FDA approval is expected in about 10 months. If green-lighted, fampridine will be the first drug approved with the indication [...]
Posted in Biotech | Also tagged , | Leave a comment