Medicines Co scores FDA OK for new antibiotic, now up on the auction block
The Medicines Company’s infectious disease business just got more valuable.
The FDA has come through with an accelerated approval of Vabomere — the combo of vaborbactam, a new beta-lactamase inhibitor, and meropenem, the leading carbapenem — which should help its deals team as the company hunts up a buyer for all or part of that business group.
Technically, the OK went to Rempex, which The Medicines Company bought in 2013 for up to $474 million.
The biotech $MDCO largely won the OK based on the data from TANGO-1, hitting the primary endpoint by demonstrating superiority over piperacillin-tazobactam for complicated urinary tract infections and acute pyelonephritis. And just a few weeks ago researchers say the antibiotic also scored in a separate Phase III, TANGO-2, for carbapenem-resistant Enterobacteriaceae infections, wrapping the study early.
During the recent Q2 call with analysts, The Medicines Company CEO Clive Meanwell told analysts:
While we’re not at this time going to disclose specific details regarding transaction structures, we believe we’re on track to complete well before the end of the year a transaction that will result in a monetization of the ID (infectious disease) business.
That deal is due to arrive before the end of the year as the biotech remains squarely focused on developing inclisiran, its LDL-lowering RNA drug from Alnylam.
Just yesterday The Medicines Company reported that their drug successfully slashed bad levels of LDL for up to a year with just two injections — a key feature of its plan to supplant leading PCSK9 drugs when it’s pivotal studies are up in 2019. In the meantime, the biotech has been restructuring its business, selling off or shelving drugs and going all in all LDL, which would appear more valuable as more studies — like Merck’s anacetrapib trial — highlight the importance of cutting LDL over boosting HDL in delivering longterm cardio benefits.
That leaves their new antibiotic on the market for anyone in the business. Big Pharma largely bowed out of antibiotic development over the past decade, unhappy with the margins. That may change, though, as rates of drug resistance grow and a demand for new products rises in coming years.
Big Pharma may be largely sidelined, but there’s been plenty of activity on that front in biotech. Paratek $PRTK just reportedly put itself on the sales block as it nears a regulatory pitch for a new antibiotic. Melinta beefed up its pipeline with the acquisition of a troubled Cempra. And Tetraphase $TTPH has been working on a comeback after regulators frowned on their application for the antibiotic eravacycline.