Pipeline updates are highly awaited events in the
pharma/biotech sector as they play an important role in deciding
whether or not to invest in a particular company. These updates
provide information on experimental drugs and at times give an
insight into the commercial potential of the candidate once it is
successfully developed and commercialized.
With the commencement of 2014, several companies have been
providing an update on their pipelines as well as goals for the
BioDelivery Sciences International, Inc.
) has important catalysts coming up this year with the database
for a phase III study on its lead candidate, BEMA buprenorphine,
expected to be locked soon.
BEMA buprenorphine is being developed for the treatment of
moderate to severe chronic pain in opioid naive subjects and
topline data from the phase III study should be out later this
month/early next month.
BioDelivery Sciences has a licensing and development agreement
Endo Health Solutions, Inc.
) for BEMA buprenorphine. According to the agreement, BioDelivery
Sciences will receive a milestone payment of $10 million from
Endo once the database for the phase III study is locked.
Meanwhile, the database for a second phase III trial on BEMA
buprenorphine (for opioid experienced patients) is scheduled to
be locked by mid-2014. The company expects to file a New Drug
Application (NDA) for the candidate in late 2014.
BioDelivery Sciences continues to work on its
commercialization plans for Bunavail, which is currently under
FDA review for maintenance treatment of opioid dependence. A
response should be out by Jun 7, 2014. The re-launch of Onsolis
(management of breakthrough pain in opioid tolerant patients with
cancer) is slated for the second half of the year.
BioDelivery Sciences also said that it intends to commence a
phase III study on clonidine topical gel in the first quarter for
the treatment of painful diabetic neuropathy.
We expect investor focus to remain on the phase III BEMA
buprenorphine data that should be out in the coming weeks.
BioDelivery Sciences carries a Zacks Rank#3 (Hold). Some
better ranked stocks in the same sector include
Acceleron Pharma, Inc.
). While Actelion (ALIOF) is a Zacks Rank #1 (Strong Buy) stock,
Acceleron Pharma (XLRN) is a Zacks Rank #2 (Buy) stock.
ACTELION LTD (ALIOF): Get Free Report
BIODELIVERY SCI (BDSI): Free Stock Analysis
ENDO PHARMACEUT (ENDP): Free Stock Analysis
ACCELERON PHARM (XLRN): Free Stock Analysis
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