Swiss giant Novartis is planning big on multiple sclerosis (MS) drugs. It has already received FDA nod for selling Extavia, a copy of Bayer's own MS drug Betaseron.
Novartis got the rights to launch a copy of Betaseron through a complicated deal stemming from its 2006 acquisition of Chiron. Novartis has already started selling Extavia in Europe, and is paying Bayer royalties on the sales.
Novartis is getting a feel of the market place in regard to MS drug demand, it is said.
The US Food and Drug Administration (FDA) has approved Extavia® (interferon beta-1b), the first in a new planned portfolio of multiple sclerosis (MS) medicines from Novartis to help patients manage this devastating disease, the company said in a press release.
Extavia is approved by the FDA for the treatment of relapsing forms of MS to reduce the frequency of clinical exacerbations. The therapy is also indicated for patients who have experienced a first clinical episode of MS and have features consistent with the disease as shown by magnetic resonance imaging (MRI).
"Novartis has been a leader in neuroscience for more than 50 years, having pioneered a number of breakthrough therapies which remain important treatments to this day," said Joe Jimenez, CEO of the Novartis Pharmaceuticals Division. "We are committed to providing new approaches to MS care, and the FDA approval of Extavia marks the beginning of our long-term commitment to the MS community in the US."
Extavia will be available to patients in the US this fall. Along with their prescription for Extavia, patients will be given access to a support program including a nurse helpline, one-on-one injection training and reimbursement support services. Extavia patients will have an autoinjector available to them from Novartis
In the European Union Extavia is available in 12 countries and is approved for relapsing-remitting MS as well as early MS (defined as a single demyelinating event with an active inflammatory process) and a steadily worsening form of the disease known as secondary progressive MS with relapses.
"It's a way to build a strong commercial organization and a strong medical organization ahead of FTY," Novartis pharmaceuticals chief Joe Jimemez told the Wall Street Journal. Health Blog recently.
Novartis plans to submit FTY720, an oral drug, for U.S. and European regulatory approval by the end of this year. The company is in a race with a few rivals to bring the first oral MS drug to market. Such a drug is expected to have big sales, since taking a pill is a whole lot easier than getting an injection or infusion.