September 08, 2014 12:20pm EDT
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MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE:OPK), reported that its licensee, TESARO, Inc.
(Nasdaq:TSRO), has submitted a New Drug Application (NDA) to the U.S.
Food and Drug Administration (FDA) for approval of oral rolapitant, an
investigational neurokinin-1 (NK-1) receptor antagonist in development
for the prevention of chemotherapy-induced nausea and vomiting (CINV).
This NDA is supported by data from four controlled studies covering a
spectrum of patients receiving chemotherapy that commonly causes nausea
and vomiting. The top-line results of three of the Phase 3 studies were
previously announced by TESARO and were presented in detail at the
American Society for Clinical Oncology (ASCO) annual meeting in June
2014.
Under the terms of OPKO’s agreement with TESARO, OPKO is eligible to
receive payments of up to $121 million, including up-front and
additional payments based on regulatory and commercialization
milestones, including acceptance by FDA of the NDA. OPKO will receive
double digit tiered-royalties on sales of rolapitant. In addition,
TESARO and OPKO will share future profits from the commercialization of
rolapitant in Japan, and OPKO will have an option to market the products
in Latin America.
“We are pleased by the very professional work of the TESARO team in
completing the studies required to file the NDA. OPKO's other internal
projects are progressing as planned and we are anxious to introduce
these important new products to the market as rapidly as possible,”
commented Phillip Frost, M.D., Chairman and Chief Executive Officer of
OPKO.
About Rolapitant
Rolapitant is a potent and selective neurokinin-1 (NK-1) receptor
antagonist with an extended plasma half-life that is being developed for
the prevention of chemotherapy-induced nausea and vomiting (CINV). NK-1
receptors are highly concentrated in the brain and bind the neurokinin
substance P. Activation of NK-1 receptors plays a central role in nausea
and vomiting induced by emetogenic stimuli, including certain cancer
chemotherapies. NK-1 receptor antagonists have been demonstrated to
improve the management of nausea and vomiting experienced by cancer
patients undergoing chemotherapy. The safety and tolerability of single
and repeat doses of rolapitant have been assessed in more than 2,500
healthy volunteers and patients. Rolapitant is being developed both in
oral and intravenous formulations. TESARO licensed exclusive rights for
the development, manufacture, commercialization and distribution of
rolapitant from OPKO.
About Chemotherapy-Induced Nausea and Vomiting (CINV)
CINV is estimated to afflict over 70% of cancer patients undergoing
chemotherapy and, if not prevented, may possibly result in a delay or
even discontinuation of chemotherapy treatment. Prolonged nausea and
vomiting may result in unwanted weight loss, dehydration and
malnutrition, as well as hospitalization.
About OPKO Health, Inc.
We are a multi-national biopharmaceutical and diagnostics company that
seeks to establish industry-leading positions in large and rapidly
growing medical markets by leveraging our discovery, development and
commercialization expertise and our novel and proprietary technologies.
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 expected benefits of rolapitant,
whether rolapitant will ever be successfully developed or
commercialized, the expected timing of approval of the product, Tesaro’s
ability to market and sell rolapitant, 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 could cause our actual activities or results to
differ materially from the activities and results anticipated in
forward-looking statements. These factors include those described in our
Annual Reports on Form 10-K filed and to be filed with the Securities
and Exchange Commission and in our other filings with the Securities and
Exchange Commission, as well as the risks inherent in funding,
developing and obtaining regulatory approvals of new,
commercially-viable and competitive products and treatments, that
earlier clinical results of effectiveness and safety may not be
reproducible or indicative of future results, that rolapitant and/or any
of our compounds or diagnostic products under development may fail, may
not achieve the expected results or effectiveness and may not generate
data that would support the approval or marketing of products for the
indications being studied or for other indications, that currently
available over-the-counter and prescription products, as well as
products under development by others, may prove to be as or more
effective than our products for the indications being studied. In
addition, forward-looking statements may also be adversely affected by
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.
OPKO Health, Inc.
FTI Consulting
Investor Relations
Barbara
Ryan, 212-850-5679
Managing Director
or
Media
Relations
Kimberly Ha, 212-850-5612
Senior Director
Source: OPKO Health, Inc.
Released September 8, 2014
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