Merck Serono seeks scripts in global MS effort
The announcement coincided with World MS Day (May 26), with the campaign—Real MS— slated to launch last month. Script submissions will be read by “an international judging panel of experts,” and visitors to the campaign website can also vote on the scripts, according to a company statement. Merck Serono is a division of Merck KGaA, a Germany-based pharmaceutical company.“The goal of Real MS is to change global perception of the disease, and we hope that its positive message will inspire and empower the MS community to find ways to live the lives they want,” said Roberto Gradnik, MD, head of the neurodegenerative diseases business unit at Merck Serono, in the statement.
Merck Serono—called EMD Serono in the US and Canada—co-markets the MS injection Rebif (interferon beta-la) with Pfizer, and is currently working on an oral formulation of Cladribine. Novartis is also developing an oral medication for MS, called Gilenia (fingolimod). Both Cladribine and Gilenia have faced setbacks in the FDA approval process. Novartis was granted a priority review for Gilenia last February, but FDA announced that it would extend the review period by three months, until September 2010. FDA told Merck KGaA last November that its New Drug Application for cladribine was incomplete in a Refuse to File letter.The MS market was worth close to $8 billion in 2009, according to a VisionGain study released in March. A recent Datamonitor analysis projected that the MS market will expand in the coming years, and an oral medication could generate significant sales. However, safety issues would likely prevent widespread use of Cladribine or Gilenia as a first-line treatment, according to the Datamonitor analysis.
Biogen Idec, makers of Tysabri and other drugs indicated for MS, is also hosting events for World MD Day, including yoga classes for MS patients with instructor Baron Baptiste. The company is also teaming up with O'Jays singer Walter Williams as he shares his experiences with MS, according to a release.Teva's Copaxone is currently the top-selling drug for MS, with sales of $796 million in 2009, according to Bloomberg and AP reports. Copaxone may face generic competition as early as next year, however; FDA has accepted ANDAs from Sandoz/Momenta and Mylan/Natco, according to a Teva annual report. Copaxone's patent is good until 2014, according to FDA's orange book listings.