Merck hasn’t exactly made a fortune on its $9.5 billion Cubist Pharmaceuticals buyout, but now, a next-generation antibiotic it acquired in that deal has a brand-new indication that could help jump-start sales.
Merck & Co. said Tuesday that a Phase III study of Zerbaxa (ceftolozane/tazobactam) for the treatment of adults with either ventilated hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) met its main goal, with an investigational dose of the drug demonstrating non-inferiority to meropenem. The company plans to submit filings in Europe and the US seeking to expand approval of the antibacterial combination product in this indication.
When Merck $MRK bought out Cubist close to 5 years ago for $9.5 billion, the sell-side crowd stoked considerable enthusiasm for Zerbaxa, a late-stage antibiotic that was tapped for peak sales in the lofty blockbuster range of $1.2 billion to $1.5 billion or so.
Bedford, Mass. – Kaleido Biosciences emerged from stealth mode with an additional capital raise, hitting a total of $65 million. In addition, the company appointed Mike Bonney as chief executive officer and chairman of the board.
Dickson Data has compiled a list of major drugs losing their IP protection this year, and standing at the top is Novartis’ Sandostatin LAR with $1.6 billion in annual sales. Used to treat acromegaly and severe diarrhea and flushing associated with carcinoid syndrome, the drug will quickly face generic erosion from a slew of companies, including Teva, Sun Pharma, Sagent Pharmaceuticals and Wockhardt.
Amplyx Pharmaceuticals, a company developing novel antifungal agents for life-threatening fungal infections, today announced the appointments of Ciara Kennedy, Ph.D., to president and chief executive officer (CEO) and Karen Joy Shaw, Ph.D., to chief scientific officer (CSO). In conjunction with this announcement, the company's former president and CEO, Mike Grey, has assumed the role of executive chairman of the Amplyx Board of Directors.
The company will be helmed by Jason Gardner, the former head of GSK’s Boston-area R&D department. Magenta launches with $48.5 million in Series A financing. The company plans to use the funding to “apply new stem cell science to reboot the immune and blood systems to treat patients with autoimmune diseases, genetic blood disorders and cancer.” The company said it wants to develop programs that will make stem cell transplants more effective for a broader range of diseases.
Merck ($MRK) is nearing FDA approval for its Clostridium difficile-fighting antibody, picking up the agency's priority review designation with the promise of a shortened vetting process.
Heptares Therapeutics, acquired by Japan's Sosei earlier this year, signed a deal with Teva Pharmaceutical ($TEVA) to co-develop novel migraine treatments, getting in line for as much as $410 million.