September 02, 2015 10:54am EDT
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VARUBI™ to Address a Potential U.S. Market Opportunity That Exceeds
$1 Billion
U.S. Commercial Launch Planned for Q4 2015; OPKO to Receive up to
$110 million of Milestone Payments and Double Digit tiered Royalties
MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE:OPK), today announced that the U.S. Food and
Drug Administration (FDA) has approved VARUBI™ (rolapitant) 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.
“We are extremely happy that our partners at TESARO were able to
successfully develop and obtain FDA approval for VARUBI. TESARO’s
excellent management team is the ideal partner to successfully
commercialize and reach VARUBI’s full commercial potential,” commented
Phillip Frost, MD, OPKO’s Chairman and Chief Executive Officer.
About Chemotherapy-Induced Nausea and Vomiting (CINV)
Chemotherapy-induced nausea and vomiting is a debilitating, yet often
preventable, side effect of chemotherapy.
Up to 50% of patients undergoing highly or moderately emetogenic
chemotherapy experience delayed CINV (25 to 120 hours post
chemotherapy)—even when prescribed a 5-HT 3 receptor
antagonist and corticosteroid.
Blocking both 5-HT 3 and NK-1 receptors has been shown to
offer better control of nausea and vomiting than inhibiting 5-HT 3
receptors alone. Adding a single dose of VARUBI to an antiemetic
regimen, including a 5-HT 3 receptor antagonist and
corticosteroid, further improves prevention of CINV in the delayed Phase
following chemotherapy.
About the VARUBI (Rolapitant) Clinical Program
The superior efficacy of VARUBI was established in multiple randomized,
well-controlled, blinded clinical trials that enrolled more than 2,500
patients. VARUBI, when administered in combination with a 5-HT 3
receptor antagonist and dexamethasone, was superior to a 5-HT 3
receptor antagonist and dexamethasone in preventing CINV in patients
receiving either moderately or highly emetogenic chemotherapy.
The clinical profile of VARUBI in cisplatin-based highly emetogenic
chemotherapy (HEC) was confirmed in two identical Phase 3 studies: HEC1
and HEC2. Both trials met their primary endpoint of complete response
(CR), and demonstrated statistical superiority of rolapitant 180 mg
compared to active control (5-HT 3 receptor antagonist +
dexamethasone) in the delayed Phase (25-120 hours) of CINV. In HEC1, 264
patients received rolapitant 180 mg and 262 received control. The
proportion of patients achieving a CR was 72.7% vs. 58.4% (p= < 0.001).
In HEC2, 271 patients received rolapitant and 273 received control. The
proportion of patients achieving a CR was 70.1% vs. 61.9% (p=0.043). The
most common adverse reactions (≥3%) among patients receiving
cisplatin-based chemotherapy were neutropenia (9% VARUBI vs. 8%
control), hiccups (5% vs. 4%), and abdominal pain (3% vs. 2%).
A Phase 3 trial was also conducted to evaluate rolapitant 180 mg
compared to active control in 1,332 patients receiving moderately
emetogenic chemotherapy regimens, including
anthracycline/cyclophosphamide combinations, carboplatin, irinotecan,
pemetrexed, oxaliplatin, and doxorubicin. This trial met its primary
endpoint of CR, and demonstrated statistical superiority of rolapitant
180 mg compared to active control (5-HT 3 receptor antagonist
+ dexamethasone) in the delayed Phase of CINV. The proportion of
patients achieving a CR was 71.3% vs 61.6% (p= < 0.001). The most common
adverse reactions (≥3%) among patients receiving these chemotherapies
were decreased appetite (9% VARUBI vs. 7% control), neutropenia (7% vs.
6%), dizziness (6% vs. 4%), dyspepsia (4% vs. 2%), urinary tract
infection (4% vs. 3%), stomatitis (4% vs. 2%), and anemia (3% vs. 2%).
Primary data from the three Phase 3 studies have recently been published
online ahead of print in Lancet Oncology, the analysis of the
non-AC MEC population was presented at the 2015 annual meeting for the
Multinational Association for Supportive Care in Cancer, and commentary
has been provided in Nature Reviews Clinical Oncology .
VARUBI Additional Safety Information
VARUBI is contraindicated in patients receiving thioridazine, a CYP2D6
substrate with a narrow therapeutic index.
Use of VARUBI should be avoided in patients who are receiving pimozide,
a CYP2D6 substrate with a narrow therapeutic index. Adverse reactions
should be monitored if concomitant use of VARUBI and other CYP2D6
substrates with a narrow therapeutic index cannot be avoided. The
inhibitory effect of VARUBI on CYP2D6 lasts for at least 7 days and may
last longer after administration of a single dose of VARUBI.
VARUBI is available by prescription only.
About VARUBI
VARUBI is a substance P/neurokinin-1 (NK-1) receptor antagonist
indicated 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. NK-1 receptors are highly
concentrated in the brain and bind neurokinin substance P. Activation of
NK-1 receptors plays a central role in nausea and vomiting induced by
emetogenic stimuli, including certain cancer chemotherapies. A Positron
Emission Tomography (PET) study with rolapitant in normal, healthy
volunteers demonstrated that rolapitant crosses the blood brain barrier
and occupies brain NK-1 receptors at high levels for up to 120 hours.
VARUBI has a half-life of approximately 7 days, which may contribute to
the ability of a single dose of VARUBI to cover the entire delayed CINV
Phase (25-120 hours).
An intravenous formulation of rolapitant is also being developed.
The full prescribing information for VARUBI will be available at www.VarubiRx.com .
About OPKO
OPKO is a multinational biopharmaceutical and diagnostics company that
seeks to establish industry-leading positions in large, rapidly growing
markets by leveraging its discovery, development and commercialization
expertise and novel and proprietary technologies. For more information,
visit http://www.opko.com .
Forward Looking Statements
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 VARUBI,
that it will address a U.S. market exceeding $1 billion, that TESARO
will launch VARUBI in the fourth quarter, expectations regarding
milestones, that it will be successfully commercialized, TESARO’s
ability to market and sell the product, 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 VARUBI 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150902006000/en/
OPKO Health, Inc.
Investor Relations, 305-575-4100
or
Media
Rooney & Associates
Terry
Rooney, 212-223-0689
or
Rooney
& Associates
Marion Janic, 212-223-4017
Source: OPKO Health, Inc.
Released September 2, 2015
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