Valeant Pharmaceuticals International (NYSE: VRX) and Metabasis
Therapeutics, Inc. (Nasdaq: MBRX) today announced the signing of definitive
agreements for the assignment and license of development and commercial
rights to pradefovir to Schering-Plough Corporation (NYSE: SGP). The
transaction is expected to close in the first quarter of 2007 subject to
expiration or early termination of the waiting period under the
Hart-Scott-Rodino Antitrust Improvements Act of 1976 and the satisfaction
of other customary closing conditions. Valeant licensed pradefovir from
Metabasis in 2000 and has been conducting clinical trials to evaluate the
safety and efficacy of pradefovir for the treatment of compensated chronic
hepatitis B. Pradefovir is a pro-drug of PMEA, an antiviral compound that
uses Metabasis' HepDirect(R) technology to enable higher concentrations of
the drug in the liver, the primary site of replication for the hepatitis B
virus (HBV) and lower concentrations elsewhere.
Under the terms of the agreements, Schering-Plough will make an upfront
payment of $19.2 million to Valeant and $1.8 million to Metabasis and will
pay up to an additional $90 million in aggregate fees upon the achievement
of certain development and regulatory milestones to Valeant and Metabasis.
Approximately $65 million of the additional fees would be paid to Valeant
and $25 million to Metabasis. The amount to be paid to Metabasis includes
the remaining $16 million in milestone payments that could have been
realized under the previous agreement between Metabasis and Valeant.
Schering-Plough will also pay royalties to Valeant and Metabasis in the
event pradefovir is commercialized.
Timothy C. Tyson, Valeant's president and chief executive officer,
said, "We are very pleased to license pradefovir to Schering-Plough, a
partner with a global reach and commitment to developing medicines for
treating life-threatening diseases like hepatitis B. Our development
program for pradefovir has produced encouraging results. The compound's
Phase 2 results showed significant reductions in viral load, which if
confirmed in Phase 3 trials, could demonstrate a potential advantage over
current therapies."
Dr. Paul Laikind, Metabasis' president and chief executive officer,
said, "Based on the clinical results to date, we believe pradefovir's
profile could make it best-in-class should it be approved. The agreements
announced today with Schering-Plough, a company with a strong commitment to
providing innovative treatments for hepatitis, further validate this
product candidate's potential. Like our colleagues at Valeant, we are very
pleased with the fact that pradefovir is moving to a team that can complete
development and maximize the commercial potential of the product."
About Hepatitis B
Hepatitis B is a potentially fatal disease that can lead to
complications such as cirrhosis and primary liver cancer. Approximately 2
billion people worldwide are estimated to have hepatitis B, with 350-400
million people estimated to be chronically infected. According to a recent
study, the HBV market currently represents more than $1 billion in annual sales, and is expected to grow to over $2.8 billion by 2012.
Pradefovir is an investigational compound that has not been found by
the Food and Drug Administration (FDA) or any other regulatory agency to be
safe or effective in the diagnosis, mitigation, treatment or cure of any
disease or illness. It may not be sold or promoted in the United States
unless and until the FDA has approved its New Drug Application. Similar
restrictions apply in other countries.
About Valeant
Valeant Pharmaceuticals International (NYSE: VRX) is a global specialty
pharmaceutical company that develops, manufactures and markets a broad
range of pharmaceutical products primarily in the areas of neurology,
infectious disease and dermatology. More information about Valeant can be
found at valeant.
About Metabasis
Metabasis Therapeutics is a biopharmaceutical company focused on the
discovery, development and commercialization of novel drugs to address some
of the world's most widespread and costly chronic diseases. The Company has
established a pipeline that includes clinical stage and preclinical product
candidates targeting major diseases with significant unmet medical needs.
Targeted diseases include metabolic diseases such as diabetes,
hyperlipidemia and obesity as well as liver diseases such as hepatitis and
primary liver cancer. Metabasis has developed several proprietary
technologies for use in discovering and optimizing drugs, including the
NuMimetic(TM) and HepDirect(R) technologies. Metabasis is continuing to
identify and develop new product candidates using its proprietary
technologies and expertise.
Forward-looking Statement
This press release contains forward-looking statements, including, but
not limited to, statements regarding the expected closing of the assignment
and license to Schering-Plough as well and the anticipated benefits and
potentially successful development of pradefovir. These statements are
based upon the current expectations and beliefs of management and are
subject to certain risks and uncertainties that could cause actual results
to differ materially from those described in the forward-looking
statements. These risks and uncertainties include, but are not limited to,
the risk that the assignment and license will not close as currently
anticipated, as well as risks and uncertainties relating to the future
development of pradefovir, dependence on Schering-Plough relating to the
development and regulatory approval of pradefovir, approval of pradefovir
by the FDA and other similar governmental authorities outside the United
States, and the receipt of milestone and other payments under the
pradefovir license agreement, and other cautionary statements discussed in
the companies' filings with the U.S. Securities and Exchange Commission.
Valeant and Metabasis wish to caution the reader that these factors are
among the factors that could cause actual results to differ materially from
the expectations described in the forward- looking statements. Valeant and
Metabasis also caution the reader that undue reliance should not be placed
on any of the forward-looking statements, which speak only as of the date
of this release. The companies undertake no obligation to update any of
these forward-looking statements to reflect events or circumstances after
the date of this release or to reflect actual outcomes.
Metabasis Therapeutics, Inc
valeant