SHAFAQNA – The US Food and Drug Administration (FDA) on Friday approved Cubist Pharmaceuticals, Inc.’s (NASDAQ:CBST) experimental antibiotic Zerbaxa for the treatment of complicated urinary tract infection (cUTI) and complicated intra-abdominal infection (cIAI), marking the second antibiotic approval for the company this year.
The FDA’s decision was based on the positive results from the two pivotal Phase III clinical studies conducted on 979 adults; one study evaluated the drug’s efficacy against cUTI and the other study tested the drug against cIAI. The two infections are said to be caused by gram-negative bacteria, which belong to a class of antibiotic-resistant pathogens commonly known as “superbugs.”
About two million diseases in the US are said to be caused by these superbugs, with almost 23,000 deaths resulting from such infections. Direct health-care costs of as much as $20 billion are linked to the gram-negative bacteria.
Zerbaxa succeeded in meeting the primary endpoints for the two clinical trials, which were pre-specified and agreed upon with the FDA and the European Medicines Agency. The company expects the EU approval during the second half of 2015. Common side-effects reported for the drug included nausea, diarrhea, and headache.
Zerbaxa is the fourth new anti-bacterial drug to be approved by the FDA this year. It has been designated the status of a qualified infectious disease product (QIDP) under the Generating Antibiotic Incentives Now Act, since it belongs in the category of drugs for the treatment of severe infections caused by the superbugs. It is the fourth drug to be granted the status of a QIDP.
The QIDP status grants certain incentives to the concerned company related to new antibiotics development, including an extended five years of marketing exclusivity. Zerbaxa’s approval is all the more crucial to Cubist since the court only recently invalidated four out of five patents on the company’s lead drug Cubicin. Cubicin generated over 80% of the company’s revenue in FY13.
Earlier this month, Merck & Co., Inc. (NYSE:MRK) agreed to acquire Cubist for $9.5 billion, including assuming the company’s debt. Merck, in an attempt to mitigate the risk associated with the Cubist deal, was inclined to make a portion of the payment contingent upon the court ruling regarding patents on Cubicin. However, Cubist, as reported by the Wall Street Journal, was not interested in that offer. Cubist was also reported to be in talks with other unnamed parties regarding an acquisition proposition. Merck, in its haste to not lose Cubist as an acquisition prospect, went on to accept the company’s demand to not have any of the payment amount contingent upon the court ruling. The acquisition deal was criticized as being over-priced and poorly timed, as Merck didn’t wait for the court ruling, which came in just a few hours after the acquisition deal was announced.
Zerbaxa is said to be the major driver behind Merck’s decision to buy Cubist at a premium. Roger Perlmutter, head of research and development at Merck, called antimicrobials like Zerbaxa “very rare assets.” Analysts expect Zerbaxa, which costs about $5,000-6,000 per patient, to bring in sales of $1.15 billion in 2023.
Zerbaxa’s rival drugs are currently being reviewed by the FDA, which is expected to announce its decision on the drugs in the first quarter of 2015. Actavis plc (NYSE:ACT), Tetraphase Pharmaceuticals Inc (NASDAQ:TTPH), and AstraZeneca plc (ADR) (NYSE:AZN) are some of the companies working on the development of drugs for antibiotic-resistant bacteria.
Source : http://www.bidnessetc.com/31274-fda-okays-cubist-pharmaceuticals-cbst-drug-for-antibioticresistant-bacteria/2/