OPKO Health Enters into Exclusive Agreement with Japan Tobacco to Develop and Commercialize RAYALDEE® in Japan
12 October 2017 - 11:00PM
OPKO Health, Inc. (NASDAQ:OPK) announced that its subsidiary EirGen
Pharma has entered into an exclusive agreement with Japan Tobacco
Inc. (JT) for the development and commercialization in Japan of
RAYALDEE® for the treatment of secondary hyperparathyroidism (SHPT)
in non-dialysis and dialysis patients with chronic kidney disease
(CKD).
Under the terms of the agreement, JT will make an upfront
payment to OPKO of $6 million with another $6 million payment to be
made upon initiation of OPKO’s planned phase 2 study of RAYALDEE in
U.S. dialysis patients. In addition, OPKO will be eligible to
receive up to an additional $31 million in development and
regulatory milestones and $75 million in sales based milestones. JT
will also pay OPKO tiered, double digit royalties on net product
sales. JT will be responsible for all regulatory approvals and
commercial activities pertaining to RAYALDEE in Japan.
According to JT, an estimated 13.3 million people in Japan have CKD
and more than 300,000 are undergoing dialysis, with both patient
populations increasing due to the aging population.
“JT, together with its subsidiary Torii Pharmaceuticals, has a
strong and growing franchise in hemodialysis and renal diseases,
which makes JT an ideal partner to bring RAYALDEE to physicians and
patients in Japan,” said Phillip Frost, M.D., Chairman and Chief
Executive Officer of OPKO. “We believe JT and Torii’s
innovative marketing activities and their established network with
Japanese nephrologists will accelerate adoption of RAYALDEE in this
key market. We are confident this collaboration will substantially
expand access to the important clinical benefits of RAYALDEE for
Japanese patients with CKD.”
RAYALDEE is an extended-release prohormone of calcitriol, the
active form of vitamin D3 that is the first and only such therapy
approved by the U.S. Food and Drug Administration (FDA) that both
raises serum 25-hydroxyvitamin D and lowers blood levels of intact
parathyroid hormone. RAYALDEE is indicated for the treatment of
SHPT in adults with stage 3 or 4 CKD and vitamin D insufficiency.
It is not indicated in patients with stage 5 CKD or end stage renal
disease on dialysis.
OPKO Health launched RAYALDEE in the U.S. in November
2016.
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
RAYALDEE and the success of the collaboration and licensing
agreement with Japan Tobacco, whether Japan Tobacco will
successfully develop, obtain regulatory approval for, launch or
commercialize RAYALDEE in Japan, whether the parties will
successfully develop RAYALDEE for the treatment of SHPT in dialysis
patients, whether we will be successful in accelerating adoption of
RAYALDEE in Japan, whether payment milestones and royalty
obligations will ever be triggered, and the expected market for
RAYALDEE. 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 RAYALDEE, and that RAYALDEE may not have
advantages or prove to be superior over presently marketed
products, including the currently used high monthly doses of
prescription vitamin D2, activated vitamin D hormone and
over-the-counter vitamin D supplements. 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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