OPKO Health Licensee TESARO Announces FDA Approval of VARUBI® IV for Delayed Nausea and Vomiting Associated with Chemotherap...
October 26 2017 - 10:19AM
OPKO Health, Inc. (NASDAQ:OPK) announces that its licensee, TESARO,
Inc. (Nasdaq:TSRO), received U.S. Food and Drug
Administration (FDA) approval for VARUBI® (rolapitant) IV
in combination with other antiemetic agents in adults for the
prevention of delayed nausea and vomiting associated with initial
and repeat courses of emetogenic cancer chemotherapy, including,
but not limited to, highly emetogenic chemotherapy. Delayed nausea
and vomiting can occur anytime between 25 and 120 hours following
chemotherapy, and is often extremely debilitating.
TESARO licensed exclusive rights for the development,
manufacture, commercialization, and distribution of VARUBI
(rolapitant) from OPKO Health in December 2010. TESARO
previously launched an oral version of VARUBI in November 2015.
OPKO Health will receive tiered double-digit royalties on sales of
VARUBI IV. In addition, OPKO Health is eligible to receive
additional commercial milestone payments of up to $85 million upon
achievement of certain sales thresholds. TESARO is expected
to launch VARUBI IV in November 2017.
“We are especially pleased that our partner, TESARO, has
received FDA approval for VARUBI IV. This is particularly
important as IV treatments for chemotherapy induced nausea and
vomiting account for 90% of the market. We look forward to
TESARO’s continued success in commercializing the VARUBI product
line,” said Philip Frost, M.D., Chairman and Chief Executive
Officer of OPKO Health.
About VARUBI
VARUBI is a highly selective and competitive antagonist of human
substance P/neurokinin 1 (NK-1) receptors, which play an important
role in the delayed phase of chemotherapy induced nausea and
vomiting (CINV). With a long plasma half-life of approximately
seven days, a single dose of VARUBI, as part of an antiemetic
regimen, significantly improved complete response (CR) rates in the
delayed phase of CINV. Results from three Phase 3 trials of VARUBI
oral tablets demonstrated a significant reduction in episodes of
vomiting or use of rescue medication during the 25- to 120-hour
period following administration of highly emetogenic and moderately
emetogenic chemotherapy regimens. In addition, patients who
received VARUBI reported experiencing less nausea that
interfered with normal daily life and fewer episodes of vomiting or
retching over multiple cycles of chemotherapy. Results from a
bioequivalence trial demonstrated comparability of the IV and oral
formulations of VARUBI.
VARUBI is available by prescription only. Please see full
prescribing information, including additional important safety
information, available at www.varubirx.com.
About OPKO Health, Inc.
OPKO Health is a diversified healthcare company that seeks to
establish industry leading positions in large, rapidly growing
markets. Our diagnostics business includes BioReference
Laboratories, the nation's third largest clinical laboratory with a
core genetic testing business and a 400 person sales and marketing
team to drive growth and leverage new products, including the
4Kscore® prostate cancer test and the Claros® 1 in office
immunoassay platform. Our pharmaceutical business features
RAYALDEE, an FDA approved treatment for SHPT in stage 3-4 CKD
patients with vitamin D insufficiency (launched in November 2016),
VARUBI® for chemotherapy induced nausea and vomiting (oral
formulation launched by partner TESARO and IV formulation pending
FDA approval), OPK88003, a once weekly oxyntomodulin for type 2
diabetes and obesity that is a clinically advanced drug candidate
among the new class of GLP-1 glucagon receptor dual agonists, and
OPK88004, a selective androgen receptor modulator being developed
for benign prostatic hyperplasia and other urologic and metabolic
conditions. Our biologics business includes hGH-CTP, a once weekly
human growth hormone injection (in phase 3 and partnered with
Pfizer), and a long acting Factor VIIa drug for hemophilia in phase
2a. We also have production and distribution assets worldwide,
multiple strategic investments and an active business development
strategy. More information is available at www.opko.com.
Safe Harbor Statement This press release
contains "forward-looking statements," as that term is defined
under the Private Securities Litigation Reform Act of 1995 (PSLRA),
regarding product development efforts and other non-historical
facts about our expectations, beliefs or intentions regarding our
business, and products, financial condition, strategies or
prospects, including statements regarding expectations about VARUBI
and the success of the collaboration and licensing agreement with
TESARO, whether TESARO will successfully launch and
commercialize VARUBI IV, whether royalty or commercial milestone
obligations to OPKO will ever be triggered, and the expected market
for VARUBI IV. 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 OPKO's filings with the Securities and Exchange
Commission, as well as risks inherent in funding, developing and
obtaining regulatory approvals of new, commercially-viable products
and treatments, including the risks that others may develop
products which are superior to VARUBI IV, and that VARUBI IV may
not have advantages or prove to be superior over presently marketed
products. 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.
CONTACTS
CompanyOPKO Health, Inc.David Malina,
305-575-4137dmalina@opko.comDirector of Investor Relations
InvestorsLHA Investor RelationsAnne Marie
Fields, 212-838-3777afields@lhai.comorBruce Voss,
310-691-7100bvoss@lhai.com
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