Join        Login             Stock Quote

Actavis (ACT) Confirms Generic Version Of Novartis' (NVS) Dementia Therapy

 March 08, 2013 10:20 AM

(By Balaseshan) Actavis Inc. (NYSE: ACT), a specialty pharmaceutical company, said it has confirmed the generic version of Novartis AG's (NYSE: NVS) Exelon Patch therapy to treat dementia associated with Alzheimer's or Parkinson's disease.

Actavis, formerly Watson Pharmaceuticals Inc., has confirmed that it has filed with the U.S. Food and Drug Administration (FDA) an amendment to its Abbreviated New Drug Application (ANDA) for Rivastigmine Transdermal System to include the 13.3 mg per 24 hours dosage strength.

[Related -Jobs Growth Tepid At Best]

Actavis' ANDA product is a generic version of Novartis' Exelon Patch, which is a prescription medicine used to treat people with mild to moderate dementia associated with Alzheimer's or Parkinson's disease.

Novartis filed suit against Watson on March 7, 2013 in the United States District Court for the District of Delaware seeking to prevent Actavis from commercializing its 13.3 mg/ 24 hr strength product prior to the expiration of certain U.S. patents.

The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's 13.3 mg/ 24 hr strength ANDA product for up to 30 months from the date that Novartis received notice of Actavis' ANDA amendment filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.

Actavis previously filed an ANDA with the FDA seeking approval to market Rivastigmine Transdermal System patch 4.6 mg/24 hr and 9.5 mg/24 hr, and was subsequently sued by Novartis in November 2011. That application is subject to a separate 30-month stay.

[Related -Mylan Inc (MYL): Patent Cliff Set To Fuel 200% Gain]

Watson believes it may be a "first applicant" to file an ANDA for the generic version of each strength of Exelon Patch and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.

For the twelve months ending January 31, 2013, Exelon had total U.S. sales of about $521 million according to IMS Health data.

Dementia is a serious loss of global cognitive ability in a previously unimpaired person, beyond what might be expected from normal ageing. It is a loss of brain function that occurs with certain diseases. It affects memory, thinking, language, judgment, and behavior.

ACT is trading up 0.78% at $87.32 on Friday. The stock has been trading between $57.45 and $91.47 for the past 52 weeks.

iOnTheMarket Premium


Post Comment -- Login is required to post message
Alert for new comments:
Your email:
Your Website:

rss feed

Latest Stories

article imageThe S&P 500’s Worrisome Downturn In Drawdown

Last Friday I reviewed some of the bearish signals that were casting dark shadows across the US stock read on...

article imageADP: Private-Sector Employment Rises A Solid 200k In September

The pace of growth for private-sector employment picked up in September, according to this morning’s ADP read on...

article imageTreasury Market’s Inflation Expectations Tumble

The odds for a Fed rate hike are falling like a stone, or so it appears based on the implied inflation read on...

article imageEmerging Market Stocks: Last Week’s Red-Ink Leader

Value investors on the lookout for bargains have recently been eyeing up the battered corner of emerging read on...

Popular Articles

Daily Sector Scan
Partner Center

Fundamental data is provided by Zacks Investment Research, and Commentary, news and Press Releases provided by YellowBrix and Quotemedia.
All information provided "as is" for informational purposes only, not intended for trading purposes or advice. iStockAnalyst.com is not an investment adviser and does not provide, endorse or review any information or data contained herein.
The blog articles are opinions by respective blogger. By using this site you are agreeing to terms and conditions posted on respective bloggers' website.
The postings/comments on the site may or may not be from reliable sources. Neither iStockAnalyst nor any of its independent providers is liable for any informational errors, incompleteness, or delays, or for any actions taken in reliance on information contained herein. You are solely responsible for the investment decisions made by you and the consequences resulting therefrom. By accessing the iStockAnalyst.com site, you agree not to redistribute the information found therein.
The sector scan is based on 15-30 minutes delayed data. The Pattern scan is based on EOD data.