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FDA approvals boost 2 Mass. biotech firms

A researcher at Cubist Pharmaceuticals in Lexington. Matthew Cavanaugh/New York Times

Federal regulators Friday approved a new antibiotic to fight intra-abdominal and urinary tract infections and a three-drug cocktail to treat the liver-ravaging hepatitis C virus, giving a holiday boost to patients and to a pair of Massachusetts biotech companies.

The antibiotic, developed by Lexington’s Cubist Pharmaceuticals Inc., has the brand name Zerbaxa. Given through infusions in hospitals, it is the first in a new generation of drugs aimed at a class of Gram-negative bacteria resisting today’s antibiotics. Such bacteria account for most “superbug” infections that cause an estimated 23,000 deaths in the United States annually.

Food and Drug Administration officials also approved an all-oral multidrug combo for hepatitis C, called Viekira Pak, that includes a key ingredient codeveloped by Watertown biotech Enanta Pharmaceuticals Inc. The drug application was filed by Illinois drug maker AbbVie Inc., which struck an alliance with Enanta in 2006 to work together on battling the virus.

While the drugs hold promise against serious diseases, they come at a price. The wholesale “sticker” price for Viekira Pak will be $83,319 per patient for a 12-week treatment regimen. That is slightly less than the best-selling hepatitis C medicine, Sovaldi.

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The price for Zerbaxa was not immediately disclosed by Cubist. Hospital antibiotics typically cost between $200 and $300 a day per patient. Cubist’s top-selling antibiotic, Cubicin, which treats a different family of bacteria, is priced at $250 to $320 a day depending on the kind of infection it treats, or a total of $3,500 to $4,480 for a 14-day treatment course.

Enanta, which went public last year, has about 50 employees. It developed a protease inhibitor drug that is coformulated with another drug into a single pill for the hepatitis C regimen. Patients prescribed the AbbVie cocktail will take two of those in the morning as well as another pill that is taken in the morning and at night.

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“You can put a lot of pressure on the virus that way,” said Enanta chief executive Jay R. Luly. “If the virus tries to escape one mechanism, the others pile up on it.”

Cubist, a global leader in the fight against superbugs, earlier this month accepted a $9.5 billion buyout offer from pharmaceutical goliath Merck & Co.

The current flagship Cubist drug, Cubicin, generates more than $1 billion a year in revenue worldwide targeting infections from Gram-positive bacteria. Zerbaxa has the potential to become as big a seller, according to projections from Cubist and independent analysts.

“We’re thrilled to be able to provide a new treatment option for patients with drug-resistant infections,” said Cubist chief scientific officer Steve Gilman. “With the rise of Gram-negative infections, there are few options out there today for these serious and life-threatening infections.”

It is the second Cubist drug approved this year under the GAIN Act, a US law that provides incentives for companies to fight superbugs. The company won FDA approval in June to sell an antibiotic called Sivextro that fights hard-to-treat skin infections caused by Gram-positive bacteria, including MRSA, a growing public health threat.

AbbVie’s new combination therapy will compete with another cocktail of pills developed by California’s Gilead Sciences Inc., which the FDA approved at the end of October.

To date, the most effective treatment for the disease has been Sovaldi, a drug made by Gilead, which costs $1,000 a pill, or $84,000 for a typical 12-week treatment.

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Enanta has previously received a total of $160 million in milestone payments from AbbVie as its therapy met clinical and regulatory targets. Friday’s approval by the FDA triggered another milestone payment of $75 million to Enanta, which is expecting to receive an additional $75 million if the drug combo is approved by European regulators next year.

Luly said Enanta will invest the funds in research and development of other medicines to treat hepatitis C and other as yet unspecified diseases.

“In the history of any company, the first drug approval is historic,” Luly said. “We’re so lucky we can work on something that ultimately leads to a cure. It’s a great thing for hepatitis C patients around the world.”


Robert Weisman can be reached at robert.weisman@globe.com. Follow him on Twitter @GlobeRobW.