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Catalyst (CPRX) to Develop Generic Version of Sanofi's Sabril

Catalyst Pharmaceuticals, Inc.CPRX announced that it has launched a complex, high-barrier program to develop its generic version of Sabril (vigabatrin), which is marketed in the U.S. by Lundbeck Inc. and in the EU by Sanofi SNY .

Sabril (500 mg tablets and 500 mg packets of powder for reconstitution) is approved for the treatment of infantile spasms and complex partial seizures. Orphan drug exclusivity for the product is set to expire on Aug 21, 2016.

According to the Centers for Disease Control and Prevention, nearly 2.9 million patients in the U.S. suffer from epilepsy, while approximately 5.1 million people in the country having a history of the disease. The disease has become a social burden in the U.S. and inflicts an estimated total direct and indirect cost of $15.5 billion per year.

As per the press release issued by Catalyst, revenues earned by Lundbeck from Sabril sales in 2014 were approximately $120 million, up 35% year over year. Sabril's demand has accelerated over the past few years driven by acceptance in the medical community, and is likely to grow over the next few years.

Catalyst, which is working on developing CPP-109 (its own formulation of Sabril) for the treatment of Tourette's disorder, believes that its experience related to the development of CPP-109 should help in a speedy development and regulatory filing for its generic version of the drug. The program should leverage its proficiency in this field. Upon successful development and approval of the generic version of Sabril, the company will be able to capture a foothold in the market for rare neurological and neuromuscular diseases.

Additionally, Catalyst's pipeline consists of CPP-115, being developed for infantile spasms, epilepsy and other neurological conditions associated with reduced GABAergic signaling. CPP-115 enjoys orphan drug status in the U.S. for the treatment of infantile spasms and orphan medicinal product designation in the EU for the treatment of West Syndrome.

We note that Supernus Pharmaceuticals, Inc.'s SUPN Oxtellar XR is approved for use with other therapies for the treatment of partial seizures in patients aged six years and above.

Catalyst carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Valeant Pharmaceuticals International, Inc. VRX , sporting a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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