LEXINGTON — In its escalating battle against “superbugs” that resist today’s antibiotics, Cubist Pharmaceuticals Inc. is looking at 2014 as a pivotal year.
US regulators last month accepted for priority review Cubist’s application for tedizoid phosphate, an antibiotic for hard-to-treat infections, such as methicillin-resistant Staphylococcus aureus, or MRSA. Food and Drug Administration officials are set to rule in June on that drug, which Cubist acquired when it bought San Diego-based Trius Therapeutics Inc. last summer.
The company is also readying a European application for the first half of this year.
Cubist last fall reported positive late-stage clinical trial results for a second drug, ceftolozane/tazobactam, an antibiotic from its own labs that targets a potentially large market in urinary tract and intra-abdominal infections. That experimental treatment is expected to be submitted for review by US regulators in the next few months, and to European officials later this year.
And with fears of new superbugs growing worldwide, Cubist is expected to disclose next week that it will further accelerate its antibiotic research and development by moving another drug candidate into human clinical trials.
“We’ve established ourselves pretty firmly as the go-to company in the world of fighting resistant bacterial infections,” said Cubist chief executive Michael Bonney.
Cubist employs about 1,000 workers, including 600 at its Lexington headquarters and research campus; its market value more than doubled last year to $5 billion, and the company is expected to report next week that sales topped $1 billion in 2013, the first time in its history.
The revenue growth is largely due to worldwide demand for its lead antibiotic, Cubicin, which prevents bacterial skin infection and treats blood infections and heart disease caused by the bacterium MRSA.
“They are the premier hospital antibiotics company, and they have established themselves as the acquirer of choice,” said Jason Cantor, biotechnology analyst with financial firm Credit Suisse in San Francisco, who has placed a “buy” rating — his firm’s highest — on Cubist stock. “They’re at a very important moment in their history. They’ve been very successful with a single drug, Cubicin, and now they’re looking inside and outside the company to build a more diversified pipeline.”
Cubist has been working to build a pipeline of potent antibiotics at a critical time. It spent more than $300 million last year on antibacterial research, more than pharmaceutical giants active in the field, such as Merck & Co. and AstraZeneca PLC. In recent years, there have been a spate of new drug-resistant bugs, such as New Delhi Metallo-beta-lactamase-1, known as NDM-1, that spread rapidly across continents, underscoring the need for new treatments.
“Bacteria gets on the planes with us and flies around the world,” Bonney said.
Some other health care businesses, notably the Medicines Co. of Parsippany, N.J., and Tetraphase Pharmaceuticals Inc. of Watertown, have been lured into the hunt for novel antibiotics, seeking to capitalize on federal incentives to stay ahead of new bacterial infections.
The superbug threat is high on the agenda of the Centers for Disease Control and Prevention in Atlanta, which released a “threat report” on antibiotic resistance last September that detailed the emergence of drug-resistant bugs worldwide and called for the acceleration of new treatments.
“This threat is extensive and worrisome,” said Dr. Steve Solomon, director of the CDC’s Office of Antimicrobial Resistance. “We are already seeing infections that can’t be treated by any of the antibiotics currently at our disposal. The bacteria are constantly evolving and mutating. They develop resistance to the antibiotics, and the pharmaceutical companies have to come up with new antibiotics. But the output of antibiotics has slowed considerably.”
While researchers at Cubist are also working on other types of therapeutics, antibiotics will remain its chief focus, Bonney said. Toward that end, it has opened an office in Zurich, and has begun building a sales force to market antibacterial drugs in Europe.
“We’re becoming more than a Lexington project team,” Bonney said.
Cubist is also completing the integration of two smaller companies it acquired for a combined $1.2 billion last year: Trius and Jersey City, N.J.-based Optimer Pharmaceuticals Inc., which gave the Lexington buyer a US-approved drug to treat another hospital-related infection. The two buyouts are expected to add between 30 and 50 people to Cubist’s workforce.
“Our goal is to maintain a strong position in the antibacterial space, but also expand our activity in therapeutics in other areas,” Bonney said.
Cubist executives will be in San Francisco next week, site of the industry’s biggest gathering, the J.P. Morgan Healthcare Conference, where Bonney expects his team will be talking to other potential partners about collaborations or acquisitions.
“We’re always on the lookout,” Bonney said.