Cubist Pharmaceuticals Inc. recently announced that it has initiated a pivotal late-stage study (n~780) of its pipeline candidate ,CXA-201, in patients suffering from complicated intra-abdominal infections (cIAI). The study is the first of the two late-studies for evaluating the safety and effectiveness of CXA-201, as a combination therapy, versus AstraZeneca’s (AZN - Analyst Report) Merrem for the cIAI indication.
The multicenter, global, double-blind, randomized study intends to establish the non-inferiority of the candidate versus Merrem. The proportion of patients clinically cured after 26-30 days of treatment with CXA-201 is the standard of measure for the purpose.
The safety of the candidate, in addition to other pre-specified secondary endpoints, will also be assessed by the study. We note that Cubist Pharma is also evaluating CXA-201 for treating patients suffering from complicated urinary tract infections (cUTI).
Another promising pipeline candidate at Cubist Pharma is CB-183,315. The candidate is being developed to treat patients suffering from C. difficile acquired diarrhea (CDAD). We believe that CXA-201 and CB-183,315 are high-potential candidates and their successful development and commercialization would boost Cubist Pharma’s revenues.
Moreover, Cubist Pharma has three marketed products, Cubicin, Dificid and Entereg. The company’s primary growth driver is Cubicin, an antibiotic injection. Cubicin is marketed in the US and several other markets for the treatment of severe bacterial infections of the skin and bloodstream. Dificid is co-promoted in the US by Cubist Pharma and Optimer Pharmaceuticals Inc. for the CDAD indication. Dificid has been developed by Optimer.
Entereg has been added to Cubist Pharma’s portfolio through the recent acquisition of Adolor Corporation. The drug is marketed in the US to expedite the time needed for upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis. The acquisition of Adolor has added the chronic opioid induced constipation candidate ADL5945 to Cubist Pharma’s portfolio.
Currently we have a Neutral recommendation on Cubist Pharma which is in line with the Zacks #3 Rank (Hold rating) carried by the stock in the short-run.