The Medicines Co.’s New Minocin Formulation Approved

The Medicines Company MDCO gained FDA approval for its supplemental new drug application for a new formulation of Minocin.

In addition to this, the FDA granted Qualified Infectious Disease Product (QIDP) designation to the new formulation of Minocin under the Generating Antibiotic Incentives Now (GAIN) Act. The QIDP status makes Minocin eligible for certain benefits apart from priority review. These include five years of marketing exclusivity upon approval for additional potential indications.

The FDA has also granted QIDP designation to Minocin for new potential indications including hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia and certain gram-negative infections in cystic fibrosis patients.

This marks the third QIDP designation for the company’s anti-infective portfolio. We note that Orbactiv (marketed – gram-positive infections) and Carbavance (phase III – gram-negative infections) already enjoy QIDP status.

Minocin, an intravenous (IV) formulation of a tetracycline-class antibiotic, is approved in the U.S. for the treatment of infections due to susceptible strains of designated gram-positive and gram-negative pathogens, including acinetobacter species bacteria.

We remind investors that both Minocin IV and Carbavance were added to The Medicines Co.’s anti-infective portfolio following the 2013 Rempex Pharmaceuticals acquisition.

We are encouraged by the approval of the new formulation of Minocin. The new formulation will provide an easier administration option of using a lower fluid volume in patients with serious infections. Moreover, the approval should boost the product’s sales.

The Medicines Co. carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include AVEO Pharmaceuticals, Inc. AVEO, Osiris Therapeutics, Inc. OSIR and Horizon Pharma HZNP. All three are Zacks Rank #1 (Strong Buy) stocks.

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