BioDelivery Sciences International, Inc.
) is working hard to develop its pipeline. We believe the
pipeline at BioDelivery Sciences must deliver to facilitate the
company's long-term growth. Currently, the company has only one
marketed product, Onsolis, for the management of breakthrough
pain in opioid tolerant, adult patients with cancer.
BioDelivery Sciences focuses on developing products for pain
management and addiction using its proprietary patented drug
delivery technologies. The U.S. Food and Drug Administration
accepted BioDelvery Sciences' New Drug Application (NDA) for
Bunavail for the maintenance therapy of opioid dependence. A
response from the U.S. regulatory body is expected by Jun
Bunavail (buprenorphine naloxone buccal film), like Onsolis,
is based on the company's patented BioErodible MucoAdhesive
(BEMA) drug delivery technology. BEMA is based on application of
a thin film to the inner lining of the cheek.
The NDA for Bunvail was based on the results of an open-label
safety study comprising 249 opioid dependent patients who
switched from Suboxone tablets or films to Bunavail. In the
study, it was observed that Bunavail was easier to use and tasted
better than Suboxone.
Bunavail is a combined high dose formulation of buprenorphine
and naloxone. Management believes that following approval,
Bunavail would be the first treatment for opioid dependence
administered in a dosage form instead of other treatments which
require tongue (sublingual) administration.
We note that last month BioDelivery Sciences and partner
Endo Health Solutions Inc.
) provided update on development of another candidate, BEMA
Buprenorphine, based on BEMA technology. BEMA Buprenorphine is
undergoing phase III studies for chronic pain
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.
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 manufacturing, distribution and
commercialization of BEMA Buprenorphine on a worldwide basis.
BioDelivery Sciences carries a Zacks Rank #2 (Buy). Companies
that currently look well-positioned include
) with a Zacks Rank #1 (Strong Buy) and
Alexion Pharmaceuticals, Inc.
) with a Zacks Rank #2 (Buy).
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