Exhibit 99.1
Contact:
William A. Hockett
Vice President of Corporate Communications
(801) 584-3600
Email: bhockett@myriad.com www.myriad.com
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FOR IMMEDIATE RELEASE
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MYRIAD GENETICS SUBMITS CLINICAL TRIAL ON ITS LEAD
PROSTATE CANCER DRUG, FLURIZAN(TM), TO THE FDA
Salt Lake City, December 20, 2001 - Myriad Genetics, Inc. (Nasdaq: MYGN),
announced today that it has submitted a large, multi-center, double-blind,
placebo-controlled human clinical trial of its prostate cancer drug, Flurizan
(MPC-7869), to the Food and Drug Administration. This new clinical trial is
designed to demonstrate the efficacy of Flurizan in prostate cancer patients and
will be conducted at approximately 65 sites in the United States.
The Company plans to enroll approximately 400 early-stage prostate cancer
patients in the study, which is designed to evaluate systemic disease
progression of prostate cancer. In the study, patients will be assigned to one
of three regimes (either one of two different doses of Flurizan or placebo). The
primary clinical endpoints for the trial include time to metastases and effect
on Prostate Specific Antigen (PSA) levels. To date, two Phase I trials and one
Phase IIa trial have been completed with Flurizan in healthy volunteers and
late-stage cancer patients to date, respectively. These earlier trials with the
drug demonstrated encouraging results in safety, bioavailability and
pharmacokinetics.
"This clinical trial represents a milestone in the development of Myriad as an
integrated biopharmaceutical company," said Peter Meldrum, President of Myriad
Genetics, Inc. "We believe that we have the resources and expertise in place to
take
therapeutic products all the way through clinical trials and deliver them to our
existing 90 person oncology sales force."
Flurizan affects a key drug target in a novel pathway that appears to be
involved in the regulation of NFkB, a transcriptional activator implicated in
cancer and inflammatory diseases. Myriad is further elucidating the complete
biological pathway around the drug target, upon which Flurizan acts, using its
proprietary pathway technologies, including ProNet(R) and ProSpec(TM). Four
issued U.S. and foreign patents cover Flurizan and an additional nine patents
are pending worldwide.
Marc C. Gittelman, M.D., F.A.C.S., Director, South Florida Medical Research and
Medical Director, Uro-Care P.A. said, "There is an enormous unmet medical need
in the treatment of prostate cancer. There are more Americans living today with
prostate cancer than any other single cancer and there is an urgent need for
new, more effective, non-cytotoxic drugs for the treatment of prostate cancer.
We look forward to participating in this trial with Flurizan, which showed
promise in pre-clinical and clinical studies for the treatment of this
potentially life-threatening disease. "
Myriad successfully conducted a Phase IIa clinical trial of Flurizan in
late-state prostate cancer patients. That trial was designed to test Flurizan's
safety in patients and provide initial information about dosing and
effectiveness. Some of the data from this trial was reported at the American
Association for Cancer Research conference in New Orleans in March 2001.
MYRIAD'S COMMITMENT TO ONCOLOGY
Myriad has built an integrated organization for therapeutic and predictive
medicine product discovery, development and marketing. The Company is committed
to the oncology field with standard-of-care cancer predisposition
products addressing breast cancer, ovarian cancer, colon cancer, uterine cancer
and melanoma skin cancer on the market today. A complete customer assistance
infrastructure is in place at Myriad to support product marketing, which
includes medical billing, insurance reimbursement assistance, medical education
and clinical assistance for physicians and counselors by Myriad physicians and
counselors. To market its oncology therapeutic and predictive medicine products,
Myriad has an 90-person specialty sales force calling on medical and surgical
oncologists and other members of cancer care teams in cancer centers, hospitals
and physician practices throughout the United States.
PROSTATE CANCER
Prostate cancer is the most frequently diagnosed type of cancer in American men,
other than skin cancer. The American Cancer Society estimates that there will be
approximately 200,000 new cases of prostate cancer in the United States this
year, and that over 30,000 men will die of the disease. Approximately one of
every six men will be diagnosed with prostate cancer during his lifetime. There
are an estimated 8 million adult males living with prostate cancer in the United
States.
ABOUT MYRIAD GENETICS
Myriad Genetics, Inc. is a leading biopharmaceutical company focused on the
development of novel healthcare products. The Company has established wholly
owned subsidiaries, including Myriad Pharmaceuticals, Inc., which develops and
intends to market therapeutic products, and Myriad Genetic Laboratories, Inc.
which develops and markets proprietary predictive medicine and personalized
medicine products. The Company has established strategic alliances with Bayer,
Eli Lilly, Hitachi, Hoffman-LaRoche, Novartis, Pharmacia, Schering AG,
Schering-Plough and Torrey Mesa Research Institute.
The discussion in this news release includes forward-looking statements that are
subject to certain risks and uncertainties, including statements relating to
Myriad's ability to take therapeutic products through clinical trials and
deliver them to its sales force. Such statements are based on management's
current expectations that are subject to risks and uncertainties that could
cause actual results to differ materially from those set forth or implied by
forward-looking statements, including, but not limited to uncertainties as to
the extent of future government regulation of Myriad Genetics' business,
uncertainties as to whether Myriad Genetics and its
collaborators will be successful in developing, and obtaining regulatory
approval for, and commercial acceptance of, therapeutics; the risk that markets
will not exist for therapeutic compounds that Myriad Genetics develops or if
such markets exist, that Myriad Genetics will not be able to sell compounds,
which it develops, at acceptable prices. These and other risks identified in the
Company's filings with the Securities and Exchange Commission, including the
Company's Annual Report on Form 10-K for the fiscal year ended June 30, 2001.
All information in this press release is as of December 20, 2001, and Myriad
undertakes no duty to update this information unless required by law.