October 13, 2009 9:04am EDT
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Lead Drug, Rolapitant, Completed Successful Phase II Trials for
Nausea and Vomiting
MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE Amex:OPK) today announced that it has entered
into a definitive agreement with Schering-Plough Corporation (NYSE: SGP)
("Schering-Plough") to acquire assets relating to Schering's
neurokinin-1 (NK-1) receptor antagonist program. Rolapitant, the lead
product, recently completed Phase II clinical testing for prevention of
nausea and vomiting related to cancer chemotherapy and surgery, and
other indications. Phase 1 clinical testing has also been initiated for
a second compound in the same class. It is anticipated that these
compounds may have advantages over presently marketed products.
"We are pleased to acquire these assets from Schering-Plough," said
Phillip Frost, M.D., OPKO's Chairman and Chief Executive Officer. "They
will fit in well with our strategy to create a portfolio of important
products that will bring significant value to patients and shareholders."
In connection with its pending merger with Merck & Co., Inc.,
Schering-Plough determined to divest its oral and intravenous
formulations of rolapitant and other assets in its NK-1 program. Closing
of the transaction between OPKO and Schering-Plough is subject to
completion of the merger.
NK-1 receptors are highly concentrated in the brain and are also found
in other tissues of the body. Activation of NK-1 receptors leads to the
release of neurotransmitters and other signaling molecules that play a
central role in controlling nausea and vomiting and other basic
functions. Jamie Freedman, M.D., Ph.D., Executive Vice President of
Research & Development at OPKO commented, "The profile of rolapitant and
the positive clinical data generated so far are very promising. We
believe rolapitant has the potential to be a best-in-class product for
preventing nausea and vomiting in the post-surgical setting or induced
by cancer chemotherapy drugs. We will also be exploring various other
uses of rolapitant."
The market for nausea and vomiting drugs is estimated to be in excess of
$2 billion in the U.S., alone. NK-1 receptor antagonists and 5-HT3
receptor antagonists are major classes of drugs used for prevention of
nausea and vomiting, and, while there are several approved 5HT-3
receptor antagonists, there is only one NK-1 receptor antagonist
approved for commercial use, aprepitant (Emend (R) ).
About OPKO Health, Inc.
Miami-based OPKO is a specialty healthcare company involved in the
discovery, development, and commercialization of proprietary
pharmaceutical products, medical devices, vaccines, diagnostic
technologies and imaging systems. Initially focused on the treatment and
management of ophthalmologic diseases, OPKO has since expanded into
other areas of major unmet medical need such as oncology, infectious
diseases and neurological disorders.
This press release contains "forward-looking statements," as that
term is defined under the Private Securities Litigation Reform Act of
1995 (PSLRA), which statements may be identified by words such as
"expects," "plans," "projects," "will," "may," "anticipates,"
"believes," "should," "intends," "estimates," and other words of similar
meaning, including statements regarding the market for nausea and
vomiting drugs and the ability of rolapitant to be a best-in-class
product, statements regarding our product development efforts, including
our ability to develop and commercialize rolapitant for post-operative
or chemotherapy-induced nausea and vomiting, as well as other
non-historical statements about our expectations, beliefs or intentions
regarding our business, technologies and products, financial condition,
strategies or prospects. Many factors, including those described in our
filings with the Securities and Exchange Commission, could cause our
actual activities or results to differ materially from the activities
and results anticipated in forward-looking statements. These
factors include, that the Merger may not occur, that the
acquisition of rolapitant and the NK-1 program assets may be delayed or
may not be consummated at all, that we will be unable to successfully
develop and commercialize rolapitant and the NK-1 program assets, that
rolapitant may not achieve the expected results or effectiveness and may
not generate data that would support the approval or marketing of this
product, that others may develop products, including other NK-1 receptor
antagonists, which are superior to rolapitant, and that the acquired
compounds may not have advantages over presently marketed products. In
addition, forward-looking statements may also be adversely affected by
risks inherent in funding, developing and obtaining regulatory approvals
of new, commercially-viable and competitive products and treatments,
general market factors, competitive product development, product
availability, federal and state regulations and legislation, the
regulatory process for new products and indications, manufacturing
issues that may arise, patent positions and litigation, among other
factors. The forward-looking statements contained in this press release
speak only as of the date the statements were made, and we do not
undertake any obligation to update forward-looking statements. We intend
that all forward-looking statements be subject to the safe-harbor
provisions of the PSLRA.
Source: OPKO Health, Inc.
Released October 13, 2009
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