Endo Health Solutions (ENDP - Free Report) and partner BioDelivery Sciences International (BDSI - Free Report) recently provided an update on the development of their chronic pain candidate BEMA Buprenorphine which is undergoing phase III studies.
The interim analyses, conducted by an independent biostatistician, determined whether adjustments to the original sample size were needed for the maintenance of appropriate study power in order to find statistically significant differences between BEMA Buprenorphine and placebo.
The companies stated that they have completed the interim analyses of two phase III studies on the candidate. While one of the studies involved opioid naive patients, the other evaluated opioid experienced patients. The interim analysis of the study on opioid naïve patients revealed that no adjustments in the sample size were necessary and the original assumptions regarding sample size were appropriate. With the interim analysis not revealing the need for additional patients, the companies expect data from the study in early 2014.
The interim analysis of the phase III study on opioid experienced patients, however, revealed the need for additional patients to be enrolled. Consequently, the companies do not expect the study to be completed before mid-2014. However, U.S. approval for BEMA buprenorphine is still expected to be sought in the second half of 2014.
We remind investors that in Jan 2012, Endo Health inked a global license and development agreement with BioDelivery Sciences regarding BEMA buprenorphine. Per the terms of the deal, Endo Health is responsible for the manufacturing, distribution and commercialization of BEMA Buprenorphine on a worldwide basis.
While BioDelivery Sciences will be responsible for the development of the candidate leading to the submission of the new drug application to the FDA, Endo Health will submit the marketing application to the U.S. regulatory body.
The successful development and subsequent commercialization of BEMA Buprenorphine would be a big positive for Endo Health which is struggling with its pain franchise with two of its lead painkillers, Opana ER and Lidoderm facing/likely to face generic competition. While sales of Opana ER are already on the decline due to generic competition, Lidoderm will be facing the same from Actavis, Inc. shortly. We note that the pain market boasts of big players like Pfizer Inc. (PFE - Free Report) .
Endo Health currently carries a Zacks Rank #3 (Hold). Actavis appears to be more attractive with a Zacks Rank #2 (Buy).