MedCo gets FDA OK on antibacterial, boosting sale potential
- The Food and Drug Administration announced early this morning that it has approved an antibacterial drug from The Medicines Company.
- The injection, dubbed Vabomere, will be available to treat complicated urinary tract infections (cUTI), and a type of kidney infection, including pyelonephritis caused by a specific bacteria.
- The company said earlier this year that it is looking into strategic options to monetize its infectious disease business, including a sale of the entire unit.
MedCo’s infectious disease business just got a little more valuable. The approval of Vabomere (meropenem/vaborbactam) is the lynchpin of the unit. CEO Clive Meanwell said during a second quarter earnings call that the company plans to announce a "transaction that will result in a monetization of the ID business" before the end of the year.
“Unlike many companies developing new antibacterial products, we have an established organization already commercializing antibiotics in the U.S. and capabilities which span anti-infective drug discovery through development and commercialization,” said Meanwell.
“Our R&D for antibiotics is offset by public-private partnership contracts including a BARDA transaction for $132 million in place and an IMI contract for another $10 million in place. We believe that the regulatory and pricing environment for innovation in antibiotics supports attractive growth and margins. And as a whole, the business is a valuable element of our firm and an attractive asset,” he added during the call in early August.
Vabomere, which treats gram-negative bacterial infections, makes that business more attractive. Antibacterial infections are becoming increasingly prevalent and both the World Health Organization and the Centers for Disease Control and Prevention agree that the development of new antibiotics that can treat these resistant forms of bacteria are in urgent need.
In studies that supported the approval, Vabomere has bested Zosyn (piperacillin/tazobactam), the best treatment currently available.
Vabomere was approved under the FDA’s Qualified Infectious Disease Product (QIDP) program, which provides incentives for companies developing antibiotics. This also guarantees five years of market exclusivity for the drug, and MedCo noted in a statement that the drug is covered by patents until 2031.
The anti-infective will be available in the fourth quarter. Its approval triggered a $40 million milestone payment to the security holders of Rempex Pharmaceuticals, Inc., which MedCo acquired in 2013.
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