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EXHIBIT 99.1
Avigen Signs Hemophilia Gene Therapy Deal With Bayer
Leaders in Gene Therapy and Hemophilia Join Forces
ALAMEDA, Calif. and LEVERKUSEN, Germany, Nov. 17 /PRNewswire/ -- Bayer
Corporation, a worldwide health care and life sciences company and leader in the
development, manufacture, and distribution of hemophilia treatments, and Avigen,
Inc. (Nasdaq: AVGN - news), a biotechnology company at the forefront of new gene
transfer therapies, announced today that they have taken an important step in
the treatment of hemophilia B. The two companies signed an agreement that grants
exclusive worldwide marketing and distribution rights to Bayer for Avigen's
Coagulin-B(TM) gene therapy treatment for hemophilia B.
Under the terms of the agreement, Bayer, in collaboration with Avigen, will
conduct the planned Phase II/III clinical trials for Coagulin-B(TM). In
collaboration with Bayer, Avigen will file for regulatory approvals and will be
the holder of regulatory licenses worldwide, including the United States,
European Union, Canada, and Japan.
The partnership, valued up to $60 million, includes a $15 million up-front
purchase of Avigen stock, at a premium to market, milestone payments, and
payment of the clinical trial and AAV vector manufacturing costs by Bayer.
Additionally, Avigen will receive a royalty on net sales for its intellectual
property, as well as a substantial share of revenue from future Coagulin-B(TM)
sales. Avigen will manufacture the product for worldwide distribution at its new
manufacturing facility in Alameda, Calif. The product's label will bear the
names of both companies, Avigen as the manufacturer and Bayer as the
distributor.
Hemophilia B is a sex-linked bleeding disorder caused by the absence or
deficiency of the blood clotting protein factor IX. According to the World
Hemophilia Foundation, one in 10,000 males born worldwide has hemophilia. The
two major forms of the disease are hemophilia A and hemophilia B. The more
common, hemophilia A, is caused by a lack of blood clotting protein factor VIII.
Hemophilia B, the target of the current research, is about one-fifth as common
as hemophilia A. Worldwide, the estimate of people suffering from hemophilia is
400,000.
"We are pleased to partner with Avigen in this effort because it represents an
exciting leap forward for people with hemophilia," said Jan Turek, Senior Vice
President and General Manager of Bayer Corporation's Biological Products
Business Unit Worldwide. "We are confident that Coagulin-B(TM) will be the first
gene therapy application for the treatment of hemophilia. This is the kind of
significant discovery the hemophilia community has been anxiously awaiting."
"Avigen is pleased with the agreement on two levels," said John Monahan, Ph.D.,
Avigen President and CEO. "First, in Bayer we have found a prestigious worldwide
pharmaceutical company that is a leader in the hemophilia market, having worked
to treat this disease for decades. Second, Bayer has the resources to conduct
and finance worldwide clinical testing for
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Coagulin-B(TM) and has a strong worldwide marketing and distribution presence in
hemophilia treatment. The Bayer-Avigen combination of expertise and resources
will enhance our capability to deliver this product to market quickly so that
patients can benefit from it. At the same time, the partnership will enable
Avigen to focus its resources on other products in the development pipeline for
the treatment of hemophilia A and other genetic disorders."
"Gene transfer therapy shows promise in the treatment of hemophilia, and is an
important medical breakthrough offering the potential for a cure," continued
Turek. "Avigen is on the cutting edge of technology for gene therapy products
derived from adeno-associated virus (AAV), and we are excited about bringing our
expertise in clinical development to this partnership in order to move
Coagulin-B(TM) to market as quickly as possible. This alliance reinforces our
ongoing commitment to bleeding disorders, and serves as an example of how our
substantial investments in research and development are making pioneering
therapies a reality for the bleeding disorders community."
Coagulin-B(TM) is Avigen's proprietary AAV vector, which carries the gene for
factor IX, the missing or deficient protein that causes hemophilia B.
Coagulin-B(TM) is designed to deliver the factor IX gene into the patient's
muscle cells where it will continuously produce factor IX. Sustained levels of
factor IX in the bloodstream are expected to substantially reduce spontaneous
bleeding episodes and the need for factor IX protein infusion. Avigen officials
are optimistic that the continuing research will demonstrate promising results.
"The agreement advances our tradition of offering innovative, safe and effective
therapies to individuals with hemophilia. Bayer has more than two decades of
proven success in the hemophilia market including the recent launch of
Kogenate(R) FS/KOGENATE(R) Bayer for the treatment of hemophilia A," added
Turek. "At Bayer, it has been our mission, since the introduction of the first
factor IX replacement product in 1969, to quickly make available new, safer and
more technologically advanced products to patients with bleeding disorders.
Bayer will continue to explore new treatment options that can dramatically
improve the quality of life of patients with hemophilia including gene therapy
research in hemophilia A."
This AAV vector-based product builds on the foundation of pioneering research
conducted at the Children's Hospital of Philadelphia (CHOP) and Stanford
University by Dr. Katherine High and Dr. Mark Kay, respectively. Numerous
experiments in animals have shown the product to be extremely safe and capable
of producing therapeutic levels of the missing Factor IX in animals. Phase I
clinical studies are underway, being led by Dr. Catherine Manno at CHOP and Dr.
Bertil Glader at Stanford. If the results observed in the animal studies are
borne out in clinical trials, such levels in humans would result in significant
reduction in bleeding episodes.
Based in the San Francisco Bay area, Avigen, Inc., is a biotechnology company
involved in the development of gene therapy products derived from AAV for the
treatment of inherited and acquired diseases. Avigen's proposed gene therapy
products are designed for direct administration to patients in order to achieve
production of therapeutic proteins within the body. Additional information on
Avigen's proprietary gene therapies can be found at www.avigen.com.
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Bayer Corporation is a research-based company with major businesses in health
care, life sciences, and chemicals, with 1999 sales of $8.9 billion. The Bayer
Biological Products Business Unit, headquartered in Research Triangle Park,
N.C., is responsible for the global development and marketing of Bayer's
recombinant antihemophilic factor replacement products. Bayer currently provides
nearly 50 percent of the world's supply of recombinant factor VIII for
hemophilia A patients. Bayer recently made a significant advancement in the
treatment of the hemophilia A with the launch of Kogenate(R)FS/KOGENATE(R)
Bayer, a next generation formulation recombinant factor VIII, which is
formulated without human proteins. Recent and planned investments in research
and development and manufacturing technology are expected to result in
additional new products, enhanced safety profiles, and increased production
capacity for products in chronically short supply.
This news release contains forward-looking statements regarding Bayer's and
Avigen's beliefs as to the future of gene therapy for the treatment of
hemophilia, and benefits that will result to Avigen from its agreement with
Bayer, which involve risks and uncertainties that may cause actual results to
differ materially. In particular: the agreement is subject to regulatory
approval before it comes into effect, which approval may not be obtained;
Coagulin-B(TM) is in the early stages of clinical trials, and only a small
sample of patients have been treated, in which case the results obtained to date
could be a statistical anomaly and not indicative of future results; further
studies may return different results, which could delay or prevent
Coagulin-B(TM) from progressing to later stage clinical trials or being approved
for commercial sale; other companies may develop products that compete favorably
against Coagulin-B(TM) at the time, if ever, that Coagulin-B(TM) receives
regulatory approval; and other risks detailed from time to time in documents
filed by Avigen with the SEC, including the report on Form 10-K for the year
ended June 30, 2000.
SOURCE: Avigen, Inc.
