Agreement will supplement Urovant’s targeted
sales and market access efforts in the launch of vibegron by
expanding the outreach to Primary Care Physicians and their
patients
Urovant Sciences (Nasdaq: UROV) today announced it has entered
into a five-year U.S. co-promotion agreement with Sunovion
Pharmaceuticals Inc. to promote vibegron in the primary care
segment upon receiving U.S. Food and Drug Administration (FDA)
approval for the drug. In March 2020, the FDA accepted the New Drug
Application (NDA) for vibegron in overactive bladder (OAB) and
assigned a Prescription Drug User Fee Act (PDUFA) goal date of
December 26, 2020.
Under the terms of the agreement, Sunovion will deploy its
multi-specialty sales force to bring vibegron to primary care
physicians (PCP). In support of this effort, Sunovion will provide
sales and marketing activities targeting the PCP segment through
March 31, 2026. In compensation for its sales and marketing
activities during the period of this agreement, Sunovion will
receive a mid-single digit repayment fee based on the net sales of
vibegron beginning on April 1, 2023.
“The co-promotion agreement with Sunovion significantly expands
our planned commercial footprint for vibegron as we look forward to
the potential approval and launch of vibegron in the coming months.
While Urovant sales representatives will be focused on urologists,
long-term care, and high-prescribing PCPs, the Sunovion team will
significantly broaden our reach into the U.S. primary care
community,” said Walt Johnston, Urovant’s Senior Vice President of
Commercial. “This is a great example of the strategic benefit of
our affiliation with the Sumitomo Dainippon Pharma Group of
companies. This partnership allows us to reach the PCP community
without incurring any cash outlay through March 2023.”
“We are pleased to deepen our commercial relationship with
Urovant,” said Thomas Gibbs, SVP and Chief Commercial Officer of
Sunovion. “Together, we expect to accelerate Urovant’s path forward
by leveraging Sunovion’s sales expertise and infrastructure for
co-promotion activities within the primary care specialty.”
The co-promotion agreement is in addition to the exclusive
three-year agreement Urovant entered into with Sunovion in June
2020 for services related to wholesale trade and retail
distribution, contract operations, and select account management
activities for vibegron. Sunovion Pharmaceuticals Inc. is a
subsidiary of Sumitomo Dainippon Pharma Co., Ltd., which is the
majority shareholder of Urovant.
About Urovant Sciences
Urovant Sciences is a clinical-stage biopharmaceutical company
focused on developing and commercializing innovative therapies for
urologic conditions. The Company’s lead product candidate,
vibegron, is an oral, once-daily small molecule beta-3 agonist that
is being evaluated for overactive bladder (OAB). Urovant Sciences
reported positive data from the vibegron 12-week, phase 3 pivotal
EMPOWUR study and demonstrated favorable longer-term efficacy,
safety, and tolerability in a 40-week extension study. The Company
submitted a New Drug Application to the FDA seeking approval of
vibegron for the treatment of patients with OAB in December 2019.
Vibegron is also being evaluated for treatment of OAB in men with
benign prostatic hyperplasia (OAB+BPH) and for abdominal pain
associated with irritable bowel syndrome (IBS). Urovant’s second
product candidate, URO-902, is a novel gene therapy being developed
for patients with OAB who have failed oral pharmacologic therapy.
Urovant Sciences, a subsidiary of Sumitomo Dainippon Pharma Co.,
Ltd., intends to develop novel treatments for additional urologic
diseases. Learn more about us at www.urovant.com.
About Sunovion Pharmaceuticals Inc.
Sunovion is a global
biopharmaceutical company focused on the innovative application of
science and medicine to help people with serious medical
conditions. Sunovion’s vision is to lead the way to a healthier
world. The company’s spirit of innovation is driven by the
conviction that scientific excellence paired with meaningful
advocacy and relevant education can improve lives. With patients at
the center of everything it does, Sunovion has charted new paths to
life-transforming treatments that reflect ongoing investments in
research and development and an unwavering commitment to support
people with psychiatric, neurological and respiratory
conditions.
Headquartered in Marlborough,
Mass., Sunovion is an indirect, wholly-owned subsidiary of Sumitomo
Dainippon Pharma Co., Ltd. Sunovion Pharmaceuticals Europe Ltd.,
based in London, England, and Sunovion Pharmaceuticals Canada Inc.,
based in Mississauga, Ontario, are wholly-owned direct subsidiaries
of Sunovion Pharmaceuticals Inc. Additional information can be
found on the company’s web sites:
www.sunovion.com,
www.sunovion.eu and
www.sunovion.ca. Connect with
Sunovion on Twitter, LinkedIn, Facebook and YouTube.
About Sumitovant Biopharma Ltd.
Sumitovant is a global
biopharmaceutical company with offices in New York City and London.
Sumitovant is a wholly owned subsidiary of Sumitomo Dainippon
Pharma. Sumitovant is the majority shareholder of Urovant and
Myovant, and wholly owns Enzyvant, Spirovant, and Altavant.
Sumitovant's promising pipeline is comprised of early-through
late-stage investigational medicines across a range of disease
areas targeting high unmet need. For further information about
Sumitovant, please visit
https://www.sumitovant.com.
About Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma is among the top-ten listed
pharmaceutical companies in Japan, operating globally in major
pharmaceutical markets, including Japan, the U.S., China, and the
European Union. Sumitomo Dainippon Pharma is based on the 2005
merger between Dainippon Pharmaceutical Co., Ltd., and Sumitomo
Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more
than 6,000 employees worldwide. Additional information about
Sumitomo Dainippon Pharma is available through its corporate
website at https://www.ds-pharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements include all statements that are
not historical statements of fact and statements regarding the
Company’s intent, belief or expectations and can be identified by
words such as “anticipate,” “believe,” “can,” “continue,” “could,”
“estimate,” “expect,” “intend,” “likely,” “may,” “might,”
“objective,” “ongoing,” “plan,” “potential,” “predict,” “project,”
“should,” “strive,” “to be,” “will,” “would,” or the negative or
plural of these words or other similar expressions or variations,
although not all forward-looking statements contain these
identifying words. In this press release, forward-looking
statements include, but are not limited to, statements regarding
U.S. FDA approval of vibegron in patients with OAB, Urovant’s
planned commercial footprint for vibegron and Urovant’s
expectations regarding access to the PCP market. Forward-looking
statements are subject to risks and uncertainties that could cause
actual results to differ materially and reported results should not
be considered as an indication of future performance. These risks
and uncertainties include, but are not limited to, risks associated
with: the success and cost of Urovant’s efforts to commercialize
vibegron; Urovant’s ability to realize the anticipated benefits of
the co-promotion agreement with Sunovion in the manner or timeline
expected; Urovant’s reliance on Sunovion for the co-promotion and
distribution of vibegron and Urovant’s ability to secure
alternative access to commercial infrastructure or strategic
collaborations for the commercialization or distribution of
products if it is unable to continue the relationship with
Sunovion; the success, cost, and timing of Urovant’s development
activities, including the timing of the initiation and completion
of clinical trials and the timing of expected regulatory filings;
the clinical utility and potential attributes and benefits of
vibegron, including reliance on collaboration partners and the
ability to procure additional sources of financing; our
intellectual property position, including the ability to identify
and in-license or acquire third-party patents and licenses, and
associated costs; and other risks and uncertainties listed in the
Company’s filings with the United States Securities and Exchange
Commission (SEC), including under the heading “Risk Factors” in the
Company’s most recently filed Annual Report on Form 10-K and any
subsequent Quarterly Reports on Form 10-Q filed with the SEC, as
such risk factors may be amended, supplemented or superseded from
time to time by other filings with the SEC. Given these risks and
uncertainties, you should not place undue reliance on any
forward-looking statements. These forward-looking statements are
based on information available to Urovant as of the date of this
press release and speak only as of the date of this release.
Urovant disclaims any obligation to update these forward-looking
statements, except as may be required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20201007005313/en/
Investor and Media Inquiries: Ryan Kubota 949.769.2706
ryan.kubota@urovant.com
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