Verastem Oncology to Receive an Upfront Payment
of $5 Million USD; Then Eligible to Receive Up To $42 Million USD
in Development and Sales Milestones and Double-Digit Percentage
Royalties
Sanofi Obtains Rights to Develop and
Commercialize COPIKTRA in the Licensed Territories
Verastem, Inc. (NASDAQ: VSTM) operating as Verastem Oncology,
(or “the Company”), today announced their entry into an exclusive
licensing agreement with Sanofi to develop and commercialize
Verastem Oncology’s COPIKTRA® (duvelisib), an oral inhibitor
of phosphoinositide 3-kinase (PI3K), and the first approved dual
inhibitor of PI3K-delta and PI3K-gamma, for the treatment of all
oncology indications in Russia and CIS, Turkey, the Middle East and
Africa.
Under the terms of the agreement, Verastem Oncology shall
receive an upfront payment of $5 million USD. Verastem Oncology is
also eligible to receive up to an additional $42 million USD in
development and sales milestone payments, plus double-digit
percentage royalties based on future net sales of COPIKTRA in the
licensed territories. Sanofi will receive exclusive rights to
develop and commercialize COPIKTRA, and hold the marketing
authorization and product license for COPIKTRA, in the licensed
territories. Sanofi will also have the right to collaborate with
Verastem Oncology on certain global development and clinical trial
activities.
“Sanofi brings world-class capabilities in developing and
commercializing products, making them an ideal partner to bring
COPIKTRA to patients in these territories,” said Dan Paterson,
President and Chief Operating Officer of Verastem Oncology.
“Establishing this third partnership outside the U.S. validates the
global potential of COPIKTRA and underscores our commitment to
bring COPIKTRA to patients worldwide.”
David Khougazian, Head of Sanofi Genzyme, China & Emerging
Markets, commented, “As a specialty care leader, we welcome
partnerships that have the potential to bring value for patients
and caregivers. This agreement adds to our pipeline an oncology
medicine with an innovative mechanism of action and a significant
potential of new hope for the patients suffering from those types
of blood malignancies with high unmet medical need. Partnering with
Verastem Oncology for the development and commercialization of
COPIKTRA is consistent with our goals to deliver enhanced patient
care and to expand our presence in oncology in Emerging
Markets.”
COPIKTRA was approved in September 2018 by the U.S. Food and
Drug Administration (FDA) for the treatment of adult patients with
relapsed or refractory chronic lymphocytic leukemia/small
lymphocytic lymphoma (CLL/SLL) after at least two prior therapies.
In addition, COPIKTRA has been granted accelerated approval by the
FDA for the treatment of adult patients with relapsed or refractory
follicular lymphoma (FL) after at least two prior systemic
therapies. Accelerated approval in FL was based on overall response
rate and continued approval may be contingent upon verification and
description of clinical benefit in confirmatory trials. COPIKTRA
includes a Boxed Warning for fatal and serious toxicities including
infections, diarrhea or colitis, cutaneous reactions and
pneumonitis. See full Prescribing Information for complete Boxed
Warning and other important safety information.
About Verastem Oncology
Verastem Oncology (Nasdaq: VSTM) is a commercial
biopharmaceutical company committed to the development and
commercialization of medicines to improve the lives of patients
diagnosed with cancer. We are driven by the strength, tenacity and
courage of those battling cancer – single-minded in our resolve to
deliver new therapies that not only keep cancer at bay, but improve
the lives of patients diagnosed with cancer. Because for us, it’s
personal.
Our first FDA approved product is now available for the
treatment of patients with certain types of indolent non-Hodgkin’s
lymphoma (iNHL). Our pipeline comprises product candidates that
seek to treat cancer by modulating the local tumor
microenvironment. For more information, please visit
www.verastem.com.
Verastem Oncology Forward Looking Statements
This press release includes forward-looking statements about
Verastem Oncology’s strategy, future plans and prospects, including
statements regarding the development and activity of Verastem
Oncology’s lead product COPIKTRA, and Verastem Oncology’s PI3K
program generally, its commercialization of COPIKTRA, the potential
commercial success of COPIKTRA, the anticipated adoption of
COPIKTRA by patients and physicians, the structure of its planned
and pending clinical trials and the timeline and indications for
clinical development, regulatory submissions and commercialization
activities. The words "anticipate," "believe," "estimate,"
"expect," "intend," "may," "plan," "predict," "project," "target,"
"potential," "will," "would," "could," "should," "continue," and
similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words. Each forward-looking statement is subject
to risks and uncertainties that could cause actual results to
differ materially from those expressed or implied in such
statement.
Applicable risks and uncertainties include the risks and
uncertainties, among other things, regarding: the commercial
success of COPIKTRA in the United States; physician and patient
adoption of COPIKTRA, including those related to the safety and
efficacy of COPIKTRA; the uncertainties inherent in research and
development of COPIKTRA, such as negative or unexpected results of
clinical trials; whether and when any applications for COPIKTRA may
be filed with regulatory authorities in any other jurisdictions;
whether and when regulatory authorities in any other jurisdictions
may approve any such other applications that may be filed for
COPIKTRA, which will depend on the assessment by such regulatory
authorities of the benefit-risk profile suggested by the totality
of the efficacy and safety information submitted and, if approved,
whether COPIKTRA will be commercially successful in such
jurisdictions; our ability to obtain, maintain and enforce patent
and other intellectual property protection for COPIKTRA and our
other product candidates; the scope, timing, and outcome of any
legal proceedings; decisions by regulatory authorities regarding
labeling and other matters that could affect the availability or
commercial potential of COPIKTRA; the fact that regulatory
authorities in the U.S. or other jurisdictions, if approved, could
withdraw approval; whether preclinical testing of our product
candidates and preliminary or interim data from clinical trials
will be predictive of the results or success of ongoing or later
clinical trials; that the timing, scope and rate of reimbursement
for our product candidates is uncertain; that third-party payors
(including government agencies) may not reimburse for COPIKTRA;
that there may be competitive developments affecting our product
candidates; that data may not be available when expected; that
enrollment of clinical trials may take longer than expected; that
COPIKTRA or our other product candidates will cause unexpected
safety events, experience manufacturing or supply interruptions or
failures, or result in unmanageable safety profiles as compared to
their levels of efficacy; that COPIKTRA will be ineffective at
treating patients with lymphoid malignancies; that we will be
unable to successfully initiate or complete the clinical
development and eventual commercialization of our product
candidates; that the development and commercialization of our
product candidates will take longer or cost more than planned; that
we may not have sufficient cash to fund our contemplated
operations; that we, Sanofi, CSPC Pharmaceutical Group, Yakult
Honsha Co., Ltd. or Infinity Pharmaceuticals, Inc. will fail to
fully perform under the duvelisib license agreements; that we may
be unable to make additional draws under our debt facility or
obtain adequate financing in the future through product licensing,
co-promotional arrangements, public or private equity, debt
financing or otherwise; that we will not pursue or submit
regulatory filings for our product candidates, including for
duvelisib in patients with chronic lymphocytic leukemia/small
lymphocytic lymphoma (CLL/SLL) or indolent non-Hodgkin lymphoma
(iNHL) in other jurisdictions; and that our product candidates will
not receive regulatory approval, become commercially successful
products, or result in new treatment options being offered to
patients.
Other risks and uncertainties include those identified under the
heading "Risk Factors" in the Company’s Quarterly Report on Form
10-Q for the quarterly period ended March 31, 2019, as filed with
the Securities and Exchange Commission (SEC) on May 9, 2019, its
Annual Report on Form 10-K for the year ended December 31, 2018 as
filed with the SEC on March 12, 2019 and in any subsequent filings
with the SEC. The forward-looking statements contained in this
press release reflect Verastem Oncology’s views as of the date
hereof, and the Company does not assume and specifically disclaims
any obligation to update any forward-looking statements whether as
a result of new information, future events or otherwise, except as
required by law.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190725005671/en/
Investors: John Doyle Vice President, Investor Relations &
Finance +1 781-292-4279 jdoyle@verastem.com Media: Lisa Buffington
Corporate Communications +1 781-292-4205
lbuffington@verastem.com
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