Join Free For Buyer|Sign In

Professional Online Trade Platform for API, Preparation and Pharmaceutical Machinery and Equipment_EN-CPhI.cn

You are here:  Home >>  News >>  Top Stories >>  The Medicines Co. nets $400M nod for UTI antibacterial treatment

The Medicines Co. nets $400M nod for UTI antibacterial treatment

August 31, 2017 By fiercepharma

Doctors treating patients with complicated urinary tract infections will soon have a new tool in their arsenal with the FDA’s Tuesday approval for Vabomere, a combination of the antibacterial meropenem and vaborbactam, a component to combat bacterial resistance.

The Medicines Company won approval for the new antibacterial, which is set for launch in the fourth quarter, the company said in a statement. The drug works by addressing bacteria that produce the KPC enzyme, which make up the majority of carbapenem-resistant Enterobacteriaceae that the CDC has called an “urgent antimicrobial resistance threat.”

“We look forward to a successful U.S. launch of Vabomere, leveraging our established, fully dedicated commercial infrastructure, and to expanding Vabomere into other global markets,” CEO Clive Meanwell said in a statement. The company will announce the med’s price at launch time, Leerink Partners analyst Joseph Schwartz wrote in a note to clients.

Medicines Company won a priority review with the med, and the antibacterial’s status as a Qualified Infectious Disease Product guarantees an additional 5 years of exclusivity, according to the pharma. Exclusivity on the antibacterial is expected to stretch into 2031. Schwartz, meanwhile, sees the product eventually racking up peak sales of about $400 million in 2028, but in the near term, he’s predicting $8 million in Q4 sales.

As Schwartz pointed out, Vabomere’s label is favorable for The Medicines Company; it includes specific pathogens  and microbiological data that “could facilitate product adoption by infectious disease physicians.” Among those pathogens: Klebsiella pneumoniae, Escherichia coli, and Enterobacter cloacae, which “collectively are believed to cause the majority of Carbapenem-resistant Enterobacteriaceae (CRE) infections,” he wrote, adding, “we expect revenues to increase in not only the cUTI market but also in CRE infections.”

It’s been a big week for the drugmaker, which over the weekend delivered new data on next-gen PCSK9 candidate inclisiran. Results showed “robust lowering” of LDL cholesterol levels at both the six-month and one-year marks, Jefferies analyst Biren Amin wrote to clients, adding that company management “continues to explore strategic options around partnering while moving forward” with both the phase 3 and cardiovascular outcomes studies it announced in April.

Readers'Comments
Add a comment
Click here to Login or to Register for free. You will be taken back to your selected item after Login/Registration.
More>> MarketNews
More>> Editors’Picks
More>> TopStories
More>> HotTags
Follow Us
CPhI Online Trade Platform: Worldwide|English|中国站
Customer Service:  86-400 610 1188 (9: 00-18: 00, Mon-Fri)
About Us| Contact Us| Terms of Services| Privacy Policy| Intellectual Property Statement| Links | Site Map
Copyright 2006-20 Shanghai UBM Sinoexpo International Exhibition Co Ltd (All Rights Reserved). ICP 05034851-53