OSAKA, Japan and HAMILTON, Bermuda, June 6, 2016 /PRNewswire/ -- Takeda Pharmaceutical Company Limited (TSE: 4502) and Roivant Sciences Ltd.
today announced the formation of Myovant Sciences Ltd. ("Myovant"), a biopharmaceutical company focused on delivering innovative
women's health and prostate cancer solutions by efficiently advancing new medicines to market that have the potential to improve
the lives of millions of patients. In addition, Lynn Seely, MD, an endocrinologist who led the
development of XTANDI® (enzalutamide) for the treatment of prostate cancer as the Chief Medical Officer of Medivation from 2005
to 2015, was named the President & Chief Executive Officer of Myovant Sciences, Inc.
Myovant Partnership Summary
Takeda has granted Myovant an exclusive, worldwide license (excluding Japan and certain other
Asian countries) to relugolix (TAK-385), a phase 3 drug candidate that has been evaluated in over 1,300 patients to date.
Relugolix has successfully demonstrated significant clinical benefit and was generally well-tolerated across multiple, large,
randomized phase 2 clinical trials in three different indications. Relugolix is being developed as an oral, once-daily, potential
best-in-class gonadotropin-releasing hormone (GnRH) receptor antagonist for uterine fibroids, endometriosis and prostate cancer.
Takeda will retain commercial rights for relugolix in Asian countries, including Japan, where
Takeda is actively conducting two phase 3 registration studies for the treatment of uterine fibroids. Takeda has also granted
Myovant an exclusive, worldwide license to RVT-602 (TAK-448), a novel, oligopeptide kisspeptin receptor agonist as a product
candidate for the treatment of infertility in females. Financial terms of the partnership were not disclosed.
"With Takeda strengthening its focus around the core therapeutic areas of oncology, gastroenterology and central nervous
system diseases, as well as establishing a strategy that embraces innovative partnerships, it is important that we seek
alternatives to further develop and create value around promising assets that are either outside these areas of focus or where
strategic partnership makes more sense for our business," said Andrew Plump, M.D., Ph.D., Chief
Medical and Scientific Officer of Takeda. "The formation of Myovant Sciences represents such an innovative partnership
arrangement to further advance relugolix by relying on Roivant's and Myovant's in-house development capabilities in the major
markets where they are building deep expertise, while leveraging Takeda's commercial presence in certain Asian territories."
"We are very pleased to partner with Takeda to meet the needs of patients suffering from hormone-driven diseases and
disorders," said Vivek Ramaswamy, CEO of Roivant Sciences, Inc. "The creation of Myovant
enables a 'win-win' outcome for both our partner and for patients by launching a company to address major unmet medical needs in
women's health, prostate cancer and beyond."
Appointment of Dr. Lynn Seely as President & Chief Executive Officer
Lynn Seely, MD, brings over 20 years of drug development and biopharmaceutical company
leadership to her role as the President & Chief Executive Officer of Myovant Sciences, Inc. Most recently, Dr. Seely served
as Chief Medical Officer of Medivation, Inc. from its early stages in March 2005 through
October 2015. She served on the Executive Committee and led the development of XTANDI for the
treatment of metastatic castration-resistant prostate cancer from IND-enabling studies through to NDA approval and post-approval
clinical studies. Dr. Seely was responsible for building the clinical organization at Medivation, as well as the regulatory,
quality, project management, medical affairs and biologics manufacturing functions. Dr. Seely currently serves on the board of
directors of Blueprint Medicines Corporation, and she previously served as Vice President of Clinical Development at Anesiva,
Inc. (formerly Corgentech) and at Cytyc Health Corporation. Dr. Seely received a medical degree from the University of Oklahoma College of Medicine and completed her residency in internal medicine at Yale-New Haven
Hospital. After serving as Chief Resident in Internal Medicine at Yale University School of Medicine,
she completed her basic science and clinical fellowship in endocrinology and metabolism at the University of
California, San Diego.
"I look forward to delivering on Myovant's mission to bring innovative new treatments to women suffering from diseases such as
uterine fibroids and endometriosis and to men with prostate cancer," stated Dr. Lynn Seely,
President & CEO of Myovant Sciences, Inc. "Relugolix and our partnership with Takeda represent an exceptional foundation on
which to build this exciting new company."
About Relugolix
Relugolix is a once-daily, orally administered, potential best-in-class gonadotropin-releasing hormone (GnRH) receptor
antagonist for the treatment of uterine fibroids and endometriosis, and a potential best- and first-in-class treatment for
hormone-sensitive prostate cancer (HSPC). Relugolix has been evaluated in over 1,300 patients to date, and has successfully
demonstrated significant clinical benefit and was generally well-tolerated across multiple, large, randomized phase 2 clinical
trials in three different indications. Takeda is currently enrolling two phase 3 clinical trials of relugolix for registration in
Japan for the treatment of uterine fibroids.
By inhibiting GnRH receptors in the pituitary gland, relugolix rapidly reduces circulating sex hormone levels leading to
suppression of estrogen and testosterone. Suppression of these sex hormones improves the symptoms of women with uterine fibroids
and endometriosis, and decreases prostate-specific antigen (PSA) levels in men with HSPC.
In a 216-patient phase 2 study for the treatment of uterine fibroids, women who received relugolix had a significant reduction
in menorrhagia, or abnormally heavy bleeding during menstruation. In a 487-patient phase 2 study for the treatment of
endometriosis, women who received relugolix had a significant reduction in both non-menstrual and menstrual pelvic pain. Based on
these results, two phase 3 registration studies in women with uterine fibroids are underway in Japan (NCT02655237, NCT02655224). In two phase 2 studies in approximately 225 men with HSPC, which included
control arms of either an injectable GnRH agonist (leuprolide acetate) or a GnRH antagonist (degarelix), respectively, oral
once-daily relugolix suppressed serum testosterone to castrate levels and decreased PSA. The safety of relugolix across all phase
2 studies was generally well-tolerated, consistent with the mechanism of action.
The clinical experience to date, supported by an extensive preclinical development program, suggests that oral relugolix,
administered once-daily, could be an important advancement in the treatment options available for women suffering from
endometriosis and uterine fibroids. In addition, relugolix could provide men with HSPC an important new treatment option as the
first oral GnRH receptor antagonist that offers an alternative to injectable therapies.
About RVT-602
RVT-602 (TAK-448) is a kisspeptin analog that acts to stimulate the physiologic release of GnRH and downstream hormones
important in fertility such as luteinizing hormone. Recent evidence from trials performed in women undergoing In-vitro
Fertilization (IVF) revealed that the native kisspeptin peptide has the potential to act as an alternative to human chorionic
gonadotropin (hCG) or GnRH agonists in triggering egg maturation, an essential step in every IVF cycle.
About Myovant Sciences
Myovant Sciences is focused on innovative treatments for women's health conditions and prostate cancer. The company's lead
program is relugolix, a phase 3 drug candidate for multiple indications, including uterine fibroids, endometriosis and prostate
cancer. Myovant was formed through a strategic partnership between Roivant Sciences and Takeda. Additional information about
Myovant Sciences is available through its website, www.myovant.com
About Roivant Sciences
Roivant Sciences delivers R&D solutions to its partners in the biopharmaceutical industry, helping them unlock value
from their pipelines by completing the clinical development of promising drug candidates. Roivant is an integrated
biopharmaceutical company with world-class drug development experts working across multiple clinical and functional
areas. The company allows pharmaceutical companies to realize the full potential of their research while improving the lives
of patients and their families. Additional information about Roivant Sciences is available through its website, www.roivant.com.
About Takeda
Takeda Pharmaceutical Company Limited (TSE: 4502) is a global, R&D-driven pharmaceutical company committed to bringing better
health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its research efforts
on oncology, gastroenterology and central nervous system therapeutic areas. It also has specific development programs in
specialty cardiovascular diseases as well as late-stage candidates for vaccines. Takeda conducts R&D both internally and with
partners to stay at the leading edge of innovation. New innovative products, especially in oncology, central nervous system and
gastroenterology, as well as its presence in emerging markets, fuel the growth of Takeda. More than 30,000 Takeda employees are
committed to improving quality of life for patients, working with our partners in health care in more than 70 countries. For more
information, visit http://www.takeda.com/news.
Takeda's Forward-Looking Statements
This press release contains "forward-looking statements." Forward-looking statements include all statements other than
statements of historical fact, including plans, strategies and expectations for the future, future revenues and profitability
from or growth or any assumptions underlying any of the foregoing. Statements made in the future tense, and words such as
"anticipate," "expect," "project," "continue," "believe," "plan," "estimate," "pro forma," "intend," "potential," "target,"
"forecast," "guidance," "outlook," "seek," "assume," "will," "may," "should," and similar expressions are intended to qualify as
forward-looking statements. Forward-looking statements are based on estimates and assumptions made by management that are
believed to be reasonable, though they are inherently uncertain and difficult to predict. Investors and security holders are
cautioned not to place undue reliance on these forward-looking statements.
Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially
from that expressed or implied by the forward-looking statements. Some of these risks and uncertainties include, but are not
limited to: required regulatory approvals for the transaction may not be obtained in a timely manner, if at all; the conditions
to closing of the transaction may not be satisfied; competitive pressures and developments; applicable laws and regulations; the
success or failure of product development programs; actions of regulatory authorities and the timing thereof; changes in exchange
rates; and claims or concerns regarding the safety or efficacy of marketed products or product candidates in development.
The forward-looking statements contained in this press release speak only as of the date of this press release, and neither
Roivant Sciences Ltd., Roivant Sciences, Inc., Myovant Sciences Ltd., Myovant Sciences, Inc., nor Takeda undertakes any
obligation to revise or update any forward-looking statements to reflect new information, future events or circumstances after
the date of the forward-looking statement. If one or more of these statements is updated or corrected, investors and others
should not conclude that additional updates or corrections will be made.
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SOURCE Roivant Sciences Ltd.