Biodelivery Sciences International (MM) (NASDAQ:BDSIW)
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Study Demonstrates BEMA(TM) Fentanyl Has Enhanced Absorption
Compared to Market Leader Actiq(R)
BioDelivery Sciences International, Inc. (NASDAQ: BDSI, BDSIW), a
specialty pharmaceutical company, today announced the results of a
crossover study comparing the pharmacokinetics between equal strengths
of BDSI's oral adhesive disc (known as BEMA(TM)) formulation of the
narcotic fentanyl and Actiq(R), a lozenge formulation of fentanyl
which is the current market leader in fast dissolving fentanyl
products in treating breakthrough cancer pain.
The study was conducted in 12 subjects who used both BEMA(TM)
Fentanyl and Actiq(R). The results showed that the BEMA(TM) Fentanyl
formulation showed greater bioavailability (absorption), higher
maximum plasma concentrations (Cmax) and faster concentrations of
fentanyl in the plasma (t-first and t-max) compared to Actiq(R).
Actiq(R), produced by Cephalon Inc. (NASDAQ:CEPH), had reported
2004 sales of $345 million and, according to Cephalon's public
statements, projected 2005 sales between $390 to $420 million. BDSI
has previously disclosed its belief that BEMA(TM) Fentanyl could
potentially achieve annual peak sales of approximately $250 million
for the company.
Dr. Andrew Finn, Executive Vice President of Clinical and
Regulatory Development for BDSI, stated "Simply put, the results of
this study demonstrate that fentanyl can potentially be delivered more
effectively and easily from BDSI's BEMA(TM) delivery system compared
to Actiq(R). Besides allowing greater absorption of fentanyl, this
study demonstrated that the BEMA(TM) disc was easier to use for the
subjects in the study as it only required seconds to apply while the
Actiq(R) lozenge required active sucking for up to 30 minutes."
BDSI reported in July 2005 that it had signed a $7 million dollar
licensing and development agreement with Princeton, New Jersey based
Clinical Development Capital, LLC (CDC) under which CDC, will provide
up to $7 million dollars in funding for BDSI's Phase III program for
BEMA(TM) Fentanyl provided certain conditions are met. BDSI has
previously reported that it plans to initiate its Phase III BEMA(TM)
Fentanyl program for the treatment of "breakthrough" cancer pain prior
to the end of 2005.
Dr. Francois Nader, Chief Medical Officer at Clinical Development
Capital, stated that "The results of this study continue to indicate a
profile of BEMA(TM) Fentanyl that will make it an effective and
valuable therapy for the treatment of breakthrough cancer pain and
demonstrates BDSI's ability to execute their development plan."
Dr. Mark A. Sirgo, President and CEO of BDSI stated "We believe
that the data from this trial represents another significant milestone
for BDSI. These results bolster our confidence that, if approved by
the FDA in the future, BEMA(TM) Fentanyl has the potential to be a
significant product for the management of breakthrough cancer pain.
Moreover, the results further demonstrate the potential viability of
the BEMA(TM) drug delivery platform as a whole. We look forward to now
commencing our Phase III program for BEMA Fentanyl."
BioDelivery Sciences International, Inc. is a specialty
biopharmaceutical company that is exploiting its licensed and patented
drug delivery technologies to develop and commercialize, either on its
own or in partnerships with third parties, clinically-significant new
formulations of proven therapeutics targeted at "acute" treatment
opportunities such as pain, anxiety, nausea and vomiting and
infections. The company's drug delivery technologies include: (i) the
patented Bioral(R) nanocochleate technology, designed for a
potentially broad base of applications, and (ii) the patented BEMA(TM)
(transmucosal or mouth) drug delivery technology. The company's
headquarters are located in Morrisville, North Carolina and its
principal laboratory is located in Newark, New Jersey.
Note: Except for the historical information contained herein, this
press release contains, among other things, certain forward-looking
statements, within the meaning of the Private Securities Litigation
Reform Act of 1995, that involve risks and uncertainties. Such
statement may include, without limitation, statements with respect to
the Company's plans, objectives, expectations and intentions and other
statements identified by words such as "may", "could", "would",
"should", "believes", "expects", "anticipates", "estimates",
"intends", "plans" or similar expressions. These statements are based
upon the current beliefs and expectations of the Company's management
and are subject to significant risks and uncertainties, including
those detailed in the Company's filings with the Securities and
Exchange Commission. Actual results, including, without limitation,
the results of additional clinical trials and FDA review of the
Company's formulations and products, may differ from those set forth
in the forward-looking statements. These forward-looking statements
involve certain risks and uncertainties that are subject to change
based on various factors (many of which are beyond the Company's
control).
L.G. Zangani, LLC provides financial public relations service to
the Company. As such L.G. Zangani, LLC and/or its officers, agents and
employees, receives remuneration for public relations and or other
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