News story out on Bloomberg
LIDAK SETTLES LIDAKOL OWNERSHIP DISPUTE AND RETAINS RIGHTS TO LE
8/10/98 8:49
Therapeutic and Other Technologies
SAN DIEGO, Aug. 10 /PRNewswire/ -- LIDAK Pharmaceuticals
(Nasdaq: LDAKA) announced today that it has agreed on terms for the settlement
of its dispute with the Medical Biology Institute. The Company retains all
rights to its lead therapeutic product, LIDAKOL(R) (n-docosanol) Cream and all
rights to certain technologies for the development of asthma and allergy drugs
and an innovative drug discovery technology. The terms of the settlement
provide LIDAK with undisputed rights to n-docosanol cream, a topical treatment
for recurrent oral facial herpes infections that is currently awaiting FDA
marketing approval, according to Gerald J. Yakatan, Ph.D., President and CEO
of LIDAK.
"Bringing these advanced technologies under our control is critical as we
begin efforts for a potential product launch and for further development of
our next wave of therapeutic compounds," Dr. Yakatan said. "Obtaining closure
to this ownership dispute enables us to move forward as we build the new
LIDAK.
"In addition to developing drugs based on our own technologies, we are in
discussions with several pharmaceutical companies to in-license therapeutic
compounds in the later stages of clinical development. In-licensing is part
of LIDAK's overall strategy to transform itself into a biopharmaceutical
company with a full pipeline of therapeutics targeted to profitable niche
markets, such as the treatment of viral disease, allergies and asthma."
LIDAK filed a New Drug Application (NDA) with the U.S. Food and Drug
Administration (FDA) for n-docosanol in December 1997. Phase III clinical
trial results reported in August 1997 showed that n-docosanol cream provided a
statistically significant reduction in healing times in oral facial herpes and
in herpes-associated symptoms such as pain and/or burning, itching or
tingling.
In addition to undisputed rights to n-docosanol, LIDAK retains rights to
three key technologies in its development pipeline: IgE regulation; a drug
discovery technology termed Cross-Combinatorial Method; and the hu-PBL-SCID
mouse model. The IgE regulation technology has already been used by Company
scientists to identify several highly active candidate compounds that appear
to be specific in their inhibition of IgE antibody responses. The Cross-
Combinatorial Method is a technique for identifying protein-protein
interactive sites and is being used to generate small peptides against a
variety of major therapeutic targets. The hu-PBL-SCID mouse model has been
used extensively for testing of anti-HIV compounds and is potentially useful
in creating human monoclonal antibodies.
In return for obtaining full control of the LIDAK technologies and
avoidance of potential future royalty payments, LIDAK will loan $500,000 to
the Medical Biology Institute and return other technologies that no longer fit
the Company's long-term strategic plans. The loan will be forgiven by LIDAK,
subject to certain loan covenants to be maintained by the Medical Biology
Institute over a 180-day period. The terms of the settlement, which includes
termination of the technology license agreement between the two parties, is
subject to the parties entering into a definitive agreement and approval by
the court. The Medical Biology Institute is a non-profit biomedical research
company based in La Jolla, California.
LIDAK Pharmaceuticals is developing therapeutic products designed to treat
virally caused diseases, allergies and asthma. The Company completed clinical
trials in August 1997 and filed an NDA for n-docosanol, its topical drug for
the treatment of oral facial herpes, in December 1997. LIDAK is currently
pursuing co-promotion agreements to assist in the marketing of this product
should it receive FDA approval. The Company is also seeking in-licensing
agreements with pharmaceutical companies for late-stage compounds that
complete its product pipeline.
SOURCE LIDAK Pharmaceuticals
-0- 08/10/98
/NOTE TO EDITORS: The information contained in this press release,
including any forward looking statements contained herein, should be reviewed
in conjunction with the Company's Annual Report on Form 10-K and other
publicly available information regarding the Company, copies of which are
available from the Company upon request. Such publicly available information
sets forth many risks and uncertainties related to the Company's business and
such statements, including risks and uncertainties related to drug
development, clinical trials and litigation. Final decisions made by the FDA,
other regulatory agencies and the courts are unpredictable and outside of the
influence and/or control of the Company./
/CONTACT: Gerald J. Yakatan, Ph.D., President and CEO of LIDAK
Pharmaceuticals, 619-558-0364, gyakatan@lidak.com; or Media: Linda Seaton,
ext. 133, lcs@mentusonline.com or Kathy Witz, ext. 140, kwitz@mentusonline.com
of Mentus, Inc., 619-455-5500/ |
