The Medicines Company's Orbactiv Approved on Solid SOLO Data

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Great news came in The Medicines Company’s (MDCO) way when the FDA approved the company’s antibiotic Orbactiv. Orbactiv was approved in the U.S. for the treatment of adults suffering from acute bacterial skin and skin structure infections (ABSSSIs) caused by susceptible designated gram-positive bacteria including methicillin-resistant staphylococcus aureus (:MRSA).

As per The Medicines Co., Orbactiv, expected to be launched in the U.S. by the end of this year, is the first and only drug approved in the U.S. for the treatment of ABSSSIs with a single and once-only administration.

Approval was gained on the basis of positive results from the SOLO I and SOLO II studies. Results from these studies revealed that Orbactiv demonstrated non-inferiority compared to 7-to-10 days of twice-daily vancomycin.

Last year, the company had announced that it has gained Qualified Infectious Disease Product (:QIDP) designation for Orbactiv. The QIDP designation enabled the NDA for Orbactiv to be reviewed on a priority basis. Orbactiv enjoys an additional five years of exclusivity.

We note that Orbactiv is also under review in the EU for the treatment of complicated skin and soft tissue infections. A final decision from the European Commission on the approval of Orbactiv is expected by the first half of 2015.

Our Take

We are encouraged by the U.S. approval of Orbactiv. With the company’s lead product Angiomax facing several patent challenges from companies like Hospira (HSP) and Mylan (MYL), Orbactiv’s approval comes as a sigh of relief. We believe that the company’s share price will rise on Orbactiv’s approval. We also expect investor focus to remain on the ongoing patent challenges on Angiomax and Orbactiv’s launch process.

The Medicines Co. is a Zacks Rank #3 (Hold) stock. A better-ranked stock in the healthcare sector is Actelion Ltd. (ALIOF), carrying a Zacks Rank #1 (Strong Buy).

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