BDSI Secures $7 Million Financing Commitment For Development of BEMA(TM) Fentanyl; Funding Targeted for Phase III Trials of Canc
19 7월 2005 - 12:03AM
Business Wire
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.
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