Actavis plc’s (ACT) antibiotic, Xydalba, received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The company is looking to get Xydalba approved in the EU for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults. With the CHMP issuing a positive opinion, chances of gaining EU approval look high and a decision should be out in the coming months.
Xydalba is already marketed in the U.S. under the trade name, Dalvance, for the treatment of adult patients with ABSSSI caused by susceptible Gram-positive bacteria, including methicillin resistant Staphylococcus aureus (MRSA).
Dalvance had gained FDA approval earlier this year as a Qualified Infectious Disease Product (QIDP) which means it will enjoy an additional five years of marketing exclusivity in the U.S. Meanwhile, a single-dose regimen of Dalvance is being studied with a supplemental New Drug Application (sNDA) expected to be filed by mid-2015. Dalvance also has the potential to be studied for additional indications like hospitalized community-acquired pneumonia and pediatric osteomyelitis.
Dalvance became a part of Actavis’ portfolio following the company’s Nov 2014 acquisition of Durata Therapeutics. Actavis has been actively looking to expand its branded product portfolio. The company, which also acquired Forest Labs this year, is currently looking to acquire Botox maker Allergan (AGN).
Once the $66 billion Allergan acquisition goes through, Actavis, which was previously known for its strong presence in the generics market, will find itself in the company of the top 10 pharmaceutical companies across the world based on sales.
Actavis is a Zacks Rank #2 (Buy) stock. Some better ranked stocks in the healthcare sector include Mylan (MYL) and Akorn, Inc. (AKRX) – both are Zacks Rank #1 (Strong Buy) stocks.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
To read this article on Zacks.com click here.
Get all Zacks Research Reports and be alerted to fast-breaking buy and sell opportunities every trading day.
Be the first to comment