January 8, 2015 / 7:36 PM / 4 years ago

UPDATE 2-Impax's Parkinson's drug gets FDA approval

* Co expects drug to be available in Feb

* Taiwan facility free to commercially manufacture - analyst

* Stock rises 16 pct to record high (Adds analyst comment, updates share movement)

By Anjali Rao Koppala

Jan 8 (Reuters) - Impax Laboratories Inc said the U.S. Food and Drug Administration had approved its drug for treating Parkinson’s disease, two years after rejecting it.

The drug, Rytary, is a long-acting oral capsule formulation of carbidopa-levodopa, the standard of care for Parkinson’s, which is characterized by reduced dopamine levels in the brain.

Existing forms of oral levodopa are effective for only up to four hours following a single dose. Steady levodopa administration can only be achieved through permanent implantation of a tube in the small intestine.

Impax, whose shares rose as much as 16 percent to a record of $36.09, said it expected Rytary to be available for commercial distribution in February.

Impax is looking to gain a foothold in the market for Parkinson’s therapies, which is expected to grow as the U.S. population ages.

About 1 million Americans live with the disease, more than the number of people diagnosed with multiple sclerosis, muscular dystrophy and Lou Gehrig’s disease combined, according to the Parkinson’s Disease Foundation.

Cowen & Co analyst Ken Cacciatore said last month that Rytary looked promising compared with carbidopa/levodopa and Novartis AG’s Stalevo in mild to moderate cases.

Cacciatore, noting the drug could achieve the same benefits as existing treatments with less-frequent dosing, estimated it could achieve annual U.S. sales of at least $300 million.

Leerink analyst Jason Gerberry said Impax could price Rytary at $12 a day, comparable to Stalevo’s price of $9-$15.

In its initial rejection of the drug in 2013, the FDA cited issues with Impax’s manufacturing plant in Hayward, California.

Impax then shifted production to Taiwan, but the FDA also raised concerns about this factory.

Impax is free to manufacture Rytary commercially in its Taiwan facility as the FDA has accepted the company’s response to last July’s objections, without any follow-up inspection, Wells Fargo analyst Michael Faerm wrote in a note.

Impax has submitted marketing application for Rytary with the European Medicines Agency and is looking for a partner to sell the drug outside the United States.

Other Parkinson’s drugs in development include Neuroderm Ltd’s injectable liquid formulation of levodopa/carbidopa and Acorda Therapeutics Inc’s CVT-301.

AbbVie Inc has said it expects the FDA to decide in April on its drug, Duodopa, which is available in Canada.

Shares of Impax were up about 12 percent at $34.76 in Thursday afternoon trading on the Nasdaq. (Reporting by Anjali Rao Koppala and Shailesh Kuber in Bengaluru; Editing by Ted Kerr and Don Sebastian)

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below