Biodelivery Sciences International (MM) (NASDAQ:BDSIW)
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From May 2019 to May 2024
BioDelivery Sciences International, Inc. (NASDAQ:BDSI)
(NASDAQ:BDSIW) announced today that it has entered into a clinical
development and license agreement with Clinical Development Capital,
LLC ("CDC") pursuant to which CDC will provide up to $7 million in
funding for Phase III clinical trials relating to BDSI's BEMA(TM)
Fentanyl product. BEMA(TM) Fentanyl is being targeted for use as a
treatment for "breakthrough" cancer pain, meaning episodes of severe
pain that "break through" the medication used to control persistent
pain associated with the disease. BDSI has previously disclosed that
it intends to initiate Phase III trials of BEMA(TM) Fentanyl in the
second half 2005.
BDSI believes that the market for treating breakthrough cancer
pain represents significant opportunity for the company. The leading
product in this area in the U.S. market is Cephalon's Actiq(TM), which
had reported sales of $345 million in 2004 and is projected to exceed
sales of $400 million in 2005.
BDSI's BEMA(TM) drug delivery technology consists of a
dissolvable, dime-sized polymer disc for application to mucosal (inner
lining of cheek) membranes. BEMA(TM) discs are designed to deliver a
rapid dose of drug across the mucous membranes for time-critical
conditions such as pain. BEMA(TM) Fentanyl represents the company's
lead BEMA(TM)-based product. BDSI licenses the BEMA(TM) technology
from a third party on an exclusive worldwide basis.
Under the agreement, CDC will receive a milestone payment as well
as royalty payments based on net sales of BEMA(TM) Fentanyl. CDC's
obligation to provide funding is subject to certain conditions set
forth in the transaction documents.
Dr. Mark A. Sirgo, President and COO of BDSI, stated: "This
transaction represents another important milestone for BDSI. Not only
will it provide the expected funding needs for the clinical
development of our lead BEMA(TM) product, but it also provides an
important third party validation of the BEMA(TM) technology and our
plans to develop, seek FDA approval of, and ultimately market and
sell, BEMA(TM) Fentanyl. In addition, BDSI will benefit from a close
association with the experienced group of pharmaceutical executives at
CDC, and we look forward to a productive working relationship."
Pat Nasshorn, Senior Vice President, Business Development and
Licensing of CDC, stated: "We believe that BEMA(TM) Fentanyl
represents an important drug delivery alternative for the treatment of
breakthrough cancer pain. The market for the treatment of breakthrough
cancer pain is growing, and we believe that BEMA(TM) Fentanyl has the
potential to capture a material share of this market."
Further details of BDSI's transaction with CDC (including copies
of the relevant agreements) will be available in the Current Report on
Form 8-K which BDSI will file with the Securities and Exchange
Commission.
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.
Clinical Development Capital, LLC, based in Princeton, New Jersey,
invests in Phase III and Phase IV development programs as well as
royalty interests.
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 (including, without limitation, with respect to
funding to be provided by CDC), 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 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.