Merck Gets FDA Approval For Investigational Drug Zinplava

Merck & Co., Inc. (NYSE:MRK) announced that the FDA has approved its pipeline candidate Zinplava (bezlotoxumab, injection 25 mg/mL) for the prevention of Clostridium difficile (C. difficile) infection recurrence. Merck expects to launch Zinplava in the first quarter of 2017.

Note that Zinplava can only be used in combination with an antibacterial drug treatment for the disease.

Zinplava was approved on the basis of two global, double-blind, phase III studies, MODIFY I and MODIFY II. These studies evaluated the use of bezlotoxumab alone or in combination with actoxumab, in comparison to placebo, for the prevention of recurrent CDI in patients receiving standard-of-care antibiotics.

We remind investors that earlier this year, an FDA advisory panel had voted (10 to 5 with one abstention) that the company has provided substantial evidence of the safety and effectiveness of Zinplava for the prevention of C. difficile infection recurrence in patients aged 18 years and older.

The FDA was initially expected to respond on Jul 23, 2016; however, the PDUFA date was extended by three months as the company was asked to submit new data and analyses MODIFY I and MODIFY II that were a part of the Biologics Licensing Application (BLA).

Both the studies met the primary efficacy endpoints. They showed that a single, one-time infusion of bezlotoxumab, along with the standard-of-care CDI antibiotic treatment, significantly reduced the recurrence of the infection compared to the standard of care alone. Bezlotoxumab showed this benefit for more than a 12-week period.

Zinplava was developed jointly by researchers at University of Massachusetts Medical School’s MassBiologics Laboratory and Medarex, a biopharmaceutical company which is now part of Bristol-Myers Squibb Company (NYSE:BMY) . The product was licensed to Merck in 2009.

Zacks Rank & Key Picks

Merck currently carries a Zacks Rank #2 (Buy). A couple of favorably placed stocks in the health care sector include BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) and Exelixis, Inc. (NASDAQ:EXEL) . Both these stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

BioMarin’s loss estimates have narrowed from 28 cents to 25 cents for 2016 and from $1.16 to $1.11 for 2017 over the last 60 days.

Exelixis’ loss estimates have narrowed from 71 cents to 63 cents for 2016 and from 19 cents to 3 cents for 2017 over the last 60 days. The company has posted a positive earnings surprise twice in the four trailing quarters with an average beat of 9.1%. Its share price skyrocketed 105% year to date.

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