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METABASIS THERAPEUTICS, INC. AND SANKYO CO., LTD. SIGN OPTION
AGREEMENT FOR DISCOVERY AND DEVELOPMENT OF SECOND-GENERATION GLUCONEOGENESIS
INHIBITOR FOR THE TREATMENT OF DIABETES
SAN DIEGO, CA - October 29, 2002 -- Metabasis Therapeutics,
Inc. announced today that it has granted an exclusive option to
Sankyo Co., Ltd to enter into an agreement with Metabasis for the
discovery and development of a second-generation gluconeogenesis
inhibitor for the treatment of type II diabetes. As a result of
signing the option agreement, Sankyo will make a non-refundable
payment to Metabasis totaling over 8 million dollars. Sankyo is
currently working with Metabasis to develop CS-917 (formerly MB6322),
a first-generation gluconeogenesis inhibitor that Sankyo licensed
under a previous agreement with Metabasis. The exclusive option
agreement also gives Sankyo access to a potential backup compound
for CS-917 should one be required.
CS-917, which is currently being tested in Europe and the US, is
the first specific gluconeogenesis inhibitor to reach the clinic.
Metabasis discovered CS-917 as part of a research, development and
license agreement between Metabasis and Sankyo that was executed
in 1997. The drug entered human clinical development in August 2001
and Phase II testing in patients is currently proceeding in the
US. While Metabasis and Sankyo continue to collaborate on the ongoing
development of CS-917, the discovery portion of the 1997 agreement
concluded in May of this year.
Under the option agreement announced today, Sankyo was granted an
exclusive right to enter into a new research, development and license
agreement with Metabasis focused on the discovery of a second-generation
gluconeogenesis inhibitor for the treatment of diabetes. The timing
for exercise of this option is tied to a clinical study on CS-917
that is currently underway. Should Sankyo exercise the right to
enter the new agreement, it would be structured similarly to the
previous agreement including a substantial initiation fee, research
funding, milestone payments, payment of all development costs and
a royalty based on net-sales. However, the total potential value
of the various payments and royalties would be higher than similar
payments required by the 1997 agreement. In addition, as before,
Metabasis would retain the right to co-promote any resulting product
in North America. Finally, the option agreement gives Sankyo the
right to license a new compound - discovered by Metabasis since
May or during the option term - for use as a backup to CS-917 should
one be required.
Dr. Paul Laikind, Chairman, President and CEO of Metabasis stated,
"We are pleased to take this next step in our business relationship
with Sankyo. We look forward to continuing what has been an excellent
and fruitful collaboration with them. Over the past five years,
with Sankyo's help, we have taken a promising idea for a new approach
to treating diabetes, proved its value in preclinical testing, selected
the first drug of this new class and moved it rapidly into clinical
trials. To date we have made excellent progress on CS-917 and Sankyo's
decision to obtain certain rights to the second-generation product
certainly suggests a vote of confidence in the project."
"This is a very exciting time for Metabasis. By early 2003
we expect to have three products at various stages of clinical development.
In addition to CS-917, Metabasis expects Hepavir B (formally MB6866),
which entered the clinic earlier this year, to begin testing in
patients in early 2003. Hepavir B is a HepDirectTM prodrug for the
treatment of hepatitis B. The third product, MB7133, is a HepDirect
prodrug targeting primary liver cancer that is scheduled to reach
the clinic in early 2003. In addition Metabasis has several earlier
stage projects that should allow us to continue to make good on
our goal of recommending one new drug for clinical development each
year."
Dr. Mark Erion, Executive Vice President of Research and Development
at Metabasis said, "CS-917 is the result of a great deal of
creative thinking, good science and hard work by the Metabasis team.
Over the past few years, we have worked closely with our colleagues
at Sankyo to select, evaluate and complete pre-clinical development
of CS-917. Sankyo is now leading the way on the clinical program.
The new agreement will give us an opportunity to build upon our
strong relationship with Sankyo and find a second-generation gluconeogenesis
inhibitor that expands on the expected success of CS-917."
Metabasis Therapeutics, Inc. (www.mbasis.com) is a privately held,
biopharmaceutical company that develops proprietary products for
the treatment of human disease with a current focus on liver and
liver-related diseases. The Company employs various resources for
discovering and perfecting new products, is a leader in the field
of nucleoside/nucleotide chemistry and metabolism, and has proprietary
expertise in liver biology and liver-specific drug delivery. Metabasis
has discovered and developed a new class of drugs for treating diabetes
that act to lower liver glucose production in diabetic patients.
The first drug from this program, CS-917, is being developed in
collaboration with Sankyo Co., Ltd. and is currently undergoing
clinical testing. The Company has also developed the HepDirect Prodrug
Technology that allows liver-specific delivery of new and existing
drugs. Two drugs derived from the HepDirect Technology are in development;
a drug for hepatitis B called Hepavir B and a drug for primary liver
cancer called MB7133. Hepavir B is the subject of a partnership
with Ribapharm, Inc. and is currently being evaluated in Phase I
clinical trials. The drug for primary liver cancer is expected to
enter the clinic during the first quarter of 2003. The Company has
approximately 80 employees and occupies state-of-the-art research
facilities in San Diego, California.

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