In June this year, a drug candidate from Cubist Pharmaceuticals Inc (NASDAQ:CBST) received fast track status from the FDA. This product can potentially help around 2 million American patients who suffer from Gram negative bacteria infection every year. Just a small chunk of this market – gram negative bacteria infection in the urinary tract – is valued at nearly $2 billion. With the fast track status, Cubist Pharmaceuticals Inc (NASDAQ:CBST) can expect to own a major share of this market within two years.
In American hospitals, the most common bacterial infections occur in the urinary tract, abdominal region, surgical sites and the lungs. Most presently available drugs are not effective against gram negative bacteria. The new approach towards these infections is combination therapy, of which Cubist Pharmaceuticals Inc (NASDAQ:CBST)’s Phase III candidate CXA-201 is an example. Comprised of two molecules, Ceftolozane and tazobactam, the product has been categorized as a candidate for Qualified Infectious Disease Product (QIDP) indications.
The QIDP includes hospital acquired bacterial pneumonia (HABP), ventilator associated bacterial pneumonia (VABP), and complicated urinary tract infections (cUTI). In February 2013, the product was granted the same status for complicated Intra-Abdominal Infections (cIAI). All this helps CXA-201 get priority review and five years of exclusivity if approved by the FDA. The stock jumped up by 18% since the announcement.
Background to Cubist
Cubist Pharmaceuticals Inc (NASDAQ:CBST), a $3.6 billion biopharmaceutical company, has two wholly-owned products in the market, the drugs Cubicin and Entereg. Cubicin, approved in the US, EU and Japan, treats infection caused by Gram positive bacteria. Entereg is approved only in the U.S. for the treatment of upper and lower gastrointestinal infections. Another product Dificid is co-promoted by Cubist Pharmaceuticals Inc (NASDAQ:CBST) and Optimer Pharmaceuticals (NASDAQ:OPTR) and approved in the U.S to treat diarrhea-related infections.
In pipeline, Cubist Pharmaceuticals Inc (NASDAQ:CBST) has three late stage pipeline products which can be used for four different indications. Besides Ceftolozane/tazobactam, the other two Phase III candidates include Surotomycin or CB-315 for infection induced diarrhea and Bevenopran or CB-5945 for opioid induced constipation.
About the candidate CXA-201
Ceftolozane/tazobactam is a combination of two molecules Ceftolozane and Tazobactam. Ceftolozane prevents bacteria from growing, and Tazobactam inhibits an enzyme – that normally destroys antiobiotics – from doing so with ceftolozane. According to the company, the product has superior efficiency and safety profile compared to Cubicin. During Phase II study, the drug demonstrated better results than other antibacterial agents against Gram-negative bacteria.
Approximately 8 million people suffer from UTI infection in the US every year, which includes infection from both gram negative and gram positive bacteria. The prevalence rate is 40%-50% and estimated market size around $1.6 billion annually.