BioDelivery Sciences International, Inc. Announces Licensing of Its Topical BioNasal (TM) Amphotericin B for Chronic Sinusitis
14 4월 2004 - 1:00AM
PR Newswire (US)
BioDelivery Sciences International, Inc. Announces Licensing of Its
Topical BioNasal (TM) Amphotericin B for Chronic Sinusitis NEWARK,
N.J., April 13 /PRNewswire-FirstCall/ -- BioDelivery Sciences
International, Inc. (Nasdaq: BDSI; BDSIW) today announced it has
licensed a topical formulation of its lead product, encochleated
amphotericin B to Accentia, Inc. Accentia, Inc., a Hopkins Capital
Group company, is a privately-held, vertically-integrated specialty
biopharmaceutical company that provides comprehensive
biopharmaceutical services, including product commercialization,
clinical manufacturing, contract sales and product distribution.
Accentia is commercializing technology licensed from Mayo
Foundation for Medical Education and Research for the treatment of
chronic sinusitis (rhinosinusitis) in the US and European Union
(EU). Chronic rhinosinusitis (CRS) is the largest market
opportunities lacking an approved pharmaceutical in the US. CRS
affects an estimated 37 million patients in the US and a comparable
number in the EU. For purposes of market-size comparison, the
hypercholesterolemic market in the US accounts for the top-selling
pharmaceuticals in the industry and the market is estimated to be
approximately 36 million patients. The technology consists of using
low-dose topical antifungals to control the debilitating symptoms
of chronic rhinosinusitis. According to the terms of the license,
Accentia will pay BDSI a running royalty of 12-14% on net sales in
the US. Accentia estimates that annual prescription cost will be
approximately $1000/patient. Accentia is responsible for all
expenses related to the development of an encochleated BioNasal
(TM) amphotericin B for the indication of CRS in the US and EU
including the filing of an IND and clinical trials. BDSI retains
world-wide rights to the oral and intravenous formulations of
encochleated amphotericin B and non-US and non-EU rights to a
topical formulation of BioNasal (TM) encochleated amphotericin B.
"We are delighted to be able to commercialize the unique, patented
BDSI nanocochleate delivery technology using amphotericin B for the
indication of chronic rhinosinusitis. We believe that amphotericin
B is the most promising topical antifungal for this indication
because it is an extremely powerful fungicidal and its use in CRS
is very unlikely to lead to acquired resistance. Because
amphotericin B in solution has a limited shelf life of just a few
weeks, and because it normally requires refrigeration, we believe
that the encochleated formulation is the only practical way to
develop a commercially viable topical amphotericin B with extended
stability at room temperature", said Martin Baum, President of New
Business Development for Accentia. "CRS is a very important chronic
disease based on a frustrating inability to identify its causation.
Investigators at the Mayo Clinic have published clinical studies
reporting a new disease paradigm wherein ubiquitous saprophytic
mold elicits an immune-mediated response in affected patients, but
not in unaffected patients. By using low-dose topical amphotericin
B, it was possible to target the origin of this disease in these
clinical studies, which provides many patients with symptomatic
improvement." Accentia is in the business of commercializing
targeted therapeutics in patent-protected drug delivery
technologies in the respiratory, oncology and critical care areas.
A rapidly growing market, targeted therapeutics focus their action
to specific cellular targets, reducing undesirable collateral
damage while boosting efficacy. Accentia, through its
majority-owned subsidiary Biovest International, Inc. (see
http://www.biovest.com/) is working to accelerate the development
of an autologous vaccine for non-Hodgkins lymphoma produced from a
hybridoma using the Biovest proprietary bioreactor. Accentia and
its subsidiaries collectively provide vertically integrated
capabilities that include pre-market research and outcomes
analyses; marketing and selling branded pharmaceuticals by
licensing or acquiring under-promoted products and late stage
development compounds; and a proprietary bioreactor technology to
perform contract production of custom-designed biologics, including
vaccines. For more information about Accentia, go to
http://www.accentia.net/. BioDelivery Sciences International, Inc.
is a biotechnology company that is developing and seeking to
commercialize a patented delivery technology designed for a
potentially broad base of pharmaceuticals, vaccines, over-the-
counter drugs, nutraceuticals and micronutrients in processed foods
and beverages. The Hopkins Capital Group owns approximately 40% of
the issued common stock of BDSI. Additional details relating to
BDSI's financial and operational results for 2003 may be found in
its Annual Report on Form 10-K for 2003, filed with the Securities
and Exchange Commission on March 30, 2004. Such Report is available
free of charge via EDGAR at the SEC's website, http://www.sec.gov/.
and at BDSI's website, http://www.bdsinternational.com/. Note:
Except for the historical information contained herein, this press
release contains forward-looking statements that involve risks and
uncertainties. Such statements are subject to certain factors,
which may cause the Company's results to differ. Factors that may
cause such differences include, but are not limited to, the
Company's ability to accurately forecast the demand for each of its
licensed technology and products associated therewith, the gross
margins achieved from the sale of those products and the expenses
and other cash needs for the upcoming periods, the Company's
ability to obtain raw materials from its contract manufacturers on
a timely basis if at all, the Company's need for additional
funding, uncertainties regarding the Company's intellectual
property and other research, development, marketing and regulatory
risks and certain other factors that may affect future operating
results and are detailed in the company's filings with the
Securities and Exchange Commission. 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. DATASOURCE: BioDelivery Sciences
International, Inc. CONTACT: Raphael Mannino, PhD, Executive VP,
+1-973-972-0015; Dawn Moore, L.G. Zangani LLC, +1-908-788-9660, Web
site: http://www.bdsinternational.com/ http://www.accentia.net/
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