BDSI Announces Supply Agreement Relating to BEMA(TM) Fentanyl; Agreement with Aveva Drug Delivery Systems a Key Milestone as BDS
November 08 2005 - 9:44AM
Business Wire
BioDelivery Sciences International, Inc. (NASDAQ: BDSI, BDSIW), a
specialty pharmaceutical company, today announced that it has
entered into a supply agreement with Aveva Drug Delivery Systems,
Inc. (Aveva) under which Aveva will prepare clinical supplies for
BDSI's Phase III trials and provide commercial manufacturing for
BEMA(TM) Fentanyl. BDSI's BEMA(TM) Fentanyl is an oral adhesive
disc formulation of the narcotic fentanyl. BDSI has been and
expects to continue its production ramp-up of the clinical trial
materials for Phase III BEMA(TM) Fentanyl trials during the fourth
quarter of 2005. BDSI plans on completing its Phase III program
during the second half of 2006 for the treatment of "breakthrough"
cancer pain (i.e., episodes of severe pain which "breakthrough" the
medication used to control the persistent pain). In related
BEMA(TM) Fentanyl news, BDSI recently reported positive results in
a pharmacokinetic study comparing BEMA(TM) 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. In this trial, BEMA(TM) Fentanyl enabled 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), made by Cephalon Inc.
(NASDAQ:CEPH), is considered the market leader in breakthrough
cancer pain treatment with projected 2005 sales, based on
Cephalon's public statements, between $410 and $420 million. Dr.
Mark Sirgo, President and CEO of BDSI, stated "We are very pleased
to be able to work with Aveva toward the production of the BEMA(TM)
Fentanyl product. The entry into this agreement represents the
fulfillment of a key component of our BEMA(TM) Fentanyl strategy.
With this agreement in place, we are well positioned for
manufacturing of the Phase III program supplies and, if FDA
approval is obtained, the ultimate commercial launch of BEMA(TM)
Fentanyl." Dr Andrew Finn, BDSI's Executive Vice President of
Clinical and Regulatory Affairs, added "In our recent
pharmacokinetic study, we experienced excellent results with large
production batches of BEMA(TM) Fentanyl manufactured at Aveva. We
believe Aveva's capabilities will, at the appropriate time, allow
us to move into commercial scale very quickly." Wallace K. Reams,
President and Chief Operating Officer of Aveva, stated "We are
pleased to bring Aveva's depth of experience in transdermal and
transmucosal drug delivery systems to the BEMA(TM) Fentanyl
program. Our arrangement with BDSI further demonstrates our
commitment to add value to our partners." Under the terms of the
supply agreement, Aveva, of Miramar, Florida, will have the
exclusive right to manufacture and supply the BEMA(TM) Fentanyl
discs to BDSI, which will, either alone or in partnerships with
other third parties, market, sell and distribute the product within
North America. Aveva Drug Delivery Systems, Inc. is a Nitto Denko
company, which is one of the world's largest manufacturers of and a
pioneer in transdermal drug delivery systems. Nitto Denko has a
20-year history of providing pharmaceutical partners with fully
integrated, controlled-release transdermal products that fulfill
unmet market needs or are high-quality, low-cost brand equivalents.
Leveraging this experience, Aveva offers a full range of research,
development and manufacturing capabilities using a number of
sophisticated technologies to produce proprietary and generic
transdermal drug delivery systems that fortify research and
development pipelines and maximize the life cycles of products.
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 services in the form of monies,
capital stock in the Company, warrants or options to purchase
capital in the Company.
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