BDSI Prepares For Phase III with BEMA(TM) Fentanyl Following Positive Results of Comparative Pharmacokinetic Study
01 11์ 2005 - 9:30PM
Business Wire
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
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Zangani, LLC and/or its officers, agents and employees, receives
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