Harvard Scientific Acquires Rights to Oral Treatment for Both Male & Female Sexual Dysfunction
BusinessWire, Friday, June 12, 1998 at 13:53
LAKE MARY, Fla.--(BW HealthWire)--June 12, 1998--Harvard
Scientific Corp., (OTC Bul Bd: HVSF) a Nevada corporation, announced
today that it has reached an agreement with its once parent company,
BioSphere Technologies, Inc., to acquire the rights for an oral
delivery treatment for male and female sexual dysfunction via the
lyophilized liposomal delivery of Apomorphine. BioSphere Technologies,
Inc., holds U.S. Patent applications and has been issued a parent
patent in Australia with appropriate PCT filings with broad coverage,
for this very unique oral delivery system, designed to permit
virtually any drug of choice to pass through the stomach and into the
small intestine without degradation or corruption of the active agent
or drug. Once inside the small intestine, the liposome attaches to the
intestinal wall thus enabling uptake of the therapeutic agent.
BioSphere Technologies is currently utilizing its proprietary
technology in animal trials to deliver oral vaccines for the treatment
of Hepatitis C and the AIDS virus and intends to petition the U.S.
Food and Drug Administration for approval to begin clinical trials on
humans in the near future. These trials are being conducted by Dr.
Darryl M. See, the Company's Medical Director of Clinical Affairs.
"Apomorphine is an excellent drug for use in the treatment of
male erectile dysfunction," stated Dr. See. "However, its use is
limited by nausea and vomiting caused in part by its current
sublingual (under-the-tongue) usage, passage of the drug into the
stomach and consequently release and uptake of some of the drug into
the stomach. By using the Company's patented lyophilized liposomal
delivery system, we can essentially bypass the stomach due to the
liposomes ability to protect the integrity of the drug through that
organ. Our scientists encapsulate the Apomorphine in liposomes for
oral delivery, scientifically manipulate the liposome through the
stomach and into the small intestine where it attaches to the
intestinal wall. The liposomes are designed to allow gradual uptake of
the Apomorphine into the body, thus greatly reducing the adverse
effects generally associated with this drug. Lack of liposomal
delivery technology has previously prevented the effective use of
Apomorphine by oral delivery. The Company is currently preparing to
seek FDA approval for trials of its oral delivered Apomorphine."
Dr. See, utilizes current immunology and molecular biology
techniques to design and conduct specific research applications which
primarily focus on the enhancement of the human immune system. In
1996, Dr. See studied, designed and conducted research at the Louis
Pasteur Institute in Paris, and at the World Health Organization Viral
Reference Laboratory for Western Europe in Lyon, France. In 1997, he
joined Harvard Scientific as a Consultant and Project Manager to
oversee the development of products which utilize the Company's
patented delivery of Lyophilized Liposomal Prostaglandin E-1. Just
recently, the Company named Dr. See as its Medical Director of
Clinical Affairs.
Company President and CEO, Thomas E. Waite stated, "the
scientific technology developed by the Company's highly skilled and
world renowned medical team has laid the essential groundwork for
Harvard Scientific Corp. to become a leader in the first and second
line treatment of male and female sexual dysfunction. The Company is
confident that this latest addition to its portfolio will become the
most effective oral therapy to compete with Viagra without the
potential life threatening adverse effects as recently reported in the
media. The market for sexual dysfunction is rapidly growing and
Harvard Scientific will become a major contributor of treatment
products for the millions that suffer from this ailment."
Apomorphine, developed in 1869, is not an opiate and therefore
not addictive and has been effective as a therapeutic agent for
Parkinson's disease and as a treatment for animal and human ingestion
of toxins. It has also shown to be an effective agent for inducing
male erections.
BioSphere Technologies, Inc., is a privately held Nevada
corporation, that specializes in the research and development of new
and innovative drugs to better the lives of mankind through
revolutionary medicines.
Prostaglandin E-1 is a naturally occurring vasodilator originally
approved by the U.S. Food and Drug Administration for intravenous
infusion in neonates. In 1995, PGE-1 was approved by the FDA for use
in Pharmacia & Upjohn Inc.'s (NYSE:PNU) Caverject(r), which is
administered by needle injection as a treatment for male erectile
dysfunction. In November 1996, Vivus, Inc.'s (NASDAQ:VVUS) MUSE(r)
solid pellet delivery system was approved by the FDA. Recently, the
FDA approved PGE-1 again by needle administration via Edex(r),
(Schwartz-Pharma). Viagra(r), Pfizer, Inc.'s (NYSE:PFE) oral
medication treatment was approved by the FDA in March, 1998. Zonagen
Inc. (NASDAQ:ZONA) has in development an oral treatment product as
well. The Company believes that its product represents a substantial
treatment advantage over other delivery systems currently being
utilized in the industry.
From time to time the Company may issue forward looking
statements which involve risks and uncertainties. This statement may
contain forward looking statements within the meaning of Section 27A
of the Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. Actual results could
differ and any forward looking statements should be considered
accordingly.
CONTACT: Ira Miller Elliott Jacobson
I.W. Miller & Co. Martin E. Janis & Co.
(714) 833-9001 (312) 943-1100
or
Michael Snell
Harvard Scientific Corp.
(407) 324-1606
www.harvardscientific.com
KEYWORD: FLORIDA NEVADA
INDUSTRY KEYWORD: BIOTECHNOLOGY MEDICINE
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Companies or Securities discussed in this article:
Symbol Name
NYSE:PFE Pfizer Inc
NASDAQ:ZONA Zonagen Inc
BB:HVSF Harvard Scientific Corp
NASDAQ:VVUS Vivus Inc
NYSE:PNU Pharmacia & Upjohn Inc
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