Verastem to Receive Upfront Payment of $10 Million USD,Then Eligible
to Receive Up To $90 Million USD in Future Milestones, Plus Royalties
Yakult Obtains Rights to First-in-class Oral Dual Inhibitor of
Phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma (PI3K-δ,γ),
Duvelisib for Oncology Indications in Japan
BOSTON & TOKYO--(BUSINESS WIRE)--Jun. 5, 2018--
Verastem, Inc. (President and CEO: Robert Forrester)(NASDAQ:VSTM) and
Yakult Honsha Co., Ltd. (President: Takashige Negishi)(Tokyo:2267),
today announced their entry into an exclusive licensing agreement for
Yakult to develop and commercialize Verastem’s duvelisib, a
first-in-class oral dual inhibitor of phosphoinositide 3-kinase
(PI3K)-delta and PI3K-gamma, for the treatment, prevention or diagnosis
of all oncology indications in Japan. Verastem’s New Drug Application
(NDA) for duvelisib is currently under review with the U.S. Food and
Drug Administration (FDA) and is seeking full approval for the treatment
of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic
lymphoma (CLL/SLL) and accelerated approval for the treatment of
relapsed or refractory follicular lymphoma (FL). On April 9, 2018,
Verastem announced that the FDA had accepted the NDA for filing with
Priority Review.
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Under the terms of the agreement, Verastem will receive a one-time
upfront payment of $10 million from Yakult. Verastem is eligible to
receive up to an additional $90 million if certain future pre-specified
development and commercialization milestones are successfully achieved
by Yakult, plus double-digit royalties based on future net sales of
duvelisib in Japan. In exchange, Yakult will receive exclusive rights to
develop and commercialize duvelisib in Japan, at its own cost and
expense. Yakult will also fund certain global development costs on a
pro-rata basis. Verastem will retain all rights to duvelisib outside of
Japan.
“In Japan, current therapies to treat CLL/SLL and FL are extremely
limited and duvelisib has robust clinical data supporting its efficacy
and safety in both indications, which we can build upon,” said Masanori
Ito, Head of Pharmaceutical Business Division/Managing Executive
Officer, Member of the Board of Yakult. “We are eager to collaborate
with Verastem to develop duvelisib in these initial hematologic
malignancies, and then plan to later expand development to include the
additional indications of PTCL and DLBCL. We believe this collaboration
underscores our commitment to innovation, growing our oncology
franchise, and commercializing medicines that positively impact the
lives of patients in Japan.”
“This agreement is an important, validating achievement for both
duvelisib and Verastem Oncology and speaks to the significant global
potential of this novel therapeutic for a broad range of hematologic
malignancies,” said Robert Forrester, President and Chief Executive
Officer of Verastem. “Yakult is an established oncology leader in Japan
that successfully markets several branded anti-cancer therapies,
including Elplat® and Campto®. We look forward to working with the
world-class development, regulatory and commercial teams at Yakult as
they advance oral duvelisib toward commercialization in Japan.”
About Duvelisib
Duvelisib is a first-in-class investigational oral, dual inhibitor of
phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, two enzymes known
to help support the growth and survival of malignant B-cells and
T-cells. PI3K signaling may lead to the proliferation of malignant B-
and T-cells and is thought to play a role in the formation and
maintenance of the supportive tumor microenvironment.1,2,3
Duvelisib was evaluated in late- and mid-stage extension trials,
including DUO™, a randomized, Phase 3 monotherapy study in patients with
relapsed or refractory chronic lymphocytic leukemia/small lymphocytic
lymphoma (CLL/SLL),4 and DYNAMO™, a single-arm, Phase 2
monotherapy study in patients with refractory indolent non-Hodgkin
lymphoma (iNHL).5 Both DUO and DYNAMO achieved their primary
endpoints. Verastem Oncology’s New Drug Application (NDA) requesting the
full approval of duvelisib for the treatment of patients with relapsed
or refractory CLL/SLL, and accelerated approval for the treatment of
patients with relapsed or refractory follicular lymphoma (FL) was
accepted for filing by the U.S. Food and Drug Administration (FDA),
granted Priority Review and assigned a target action date of October 5,
2018. Duvelisib is also being developed by Verastem Oncology for the
treatment of peripheral T-cell lymphoma (PTCL), and is being
investigated in combination with other agents through
investigator-sponsored studies.6 Information about duvelisib
clinical trials can be found on www.clinicaltrials.gov.
About Verastem Oncology
Verastem, Inc. (Nasdaq:VSTM), operating as Verastem Oncology, is a
biopharmaceutical company focused on developing and commercializing
medicines to improve the survival and quality of life of cancer
patients. Verastem Oncology is currently developing duvelisib, a dual
inhibitor of PI3K-delta and PI3K-gamma, which has successfully met its
primary endpoint in a Phase 2 study in indolent Non-Hodgkin Lymphoma
(iNHL) and a Phase 3 clinical trial in patients with chronic lymphocytic
leukemia/small lymphocytic lymphoma (CLL/SLL). Verastem Oncology’s New
Drug Application (NDA) requesting the full approval of duvelisib for the
treatment of patients with relapsed or refractory CLL/SLL, and
accelerated approval for the treatment of patients with relapsed or
refractory follicular lymphoma (FL) was accepted for filing by the U.S.
Food and Drug Administration (FDA), granted Priority Review and assigned
a target action date of October 5, 2018. In addition, Verastem Oncology
is developing the FAK inhibitor defactinib, which is currently being
evaluated in three separate clinical collaborations in combination with
immunotherapeutic agents for the treatment of several different cancer
types, including pancreatic cancer, ovarian cancer, non-small-cell lung
cancer (NSCLC), and mesothelioma. Verastem Oncology’s product candidates
seek to treat cancer by modulating the local tumor microenvironment and
enhancing anti-tumor immunity. For more information, please visit www.verastem.com.
About Yakult Honsha Co., Ltd.
Yakult is a leading Japanese company focused on the development and
marketing of pharmaceuticals, foods, beverages, and cosmetics. With
respect to its pharmaceutical business, Yakult has a strong presence in
development and commercialization of the therapeutic products in the
field of oncology. The company, led by Takashige Negishi, in 2017
recorded ¥378.3 Billion Revenues.
For more information on Yakult, visit: http://www.yakult.co.jp/english/index.html
or view the following company profile: http://www.yakult.co.jp/english/pdf/profile2017-2018_en.pdf
Verastem, Inc. forward-looking statements notice:
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
investigational product candidates, including duvelisib and defactinib,
and Verastem Oncology’s PI3K and FAK programs generally, the potential
to receive milestone and royalty payments under the agreement with
Yakult, the structure of our planned and pending clinical trials,
Verastem Oncology’s financial guidance and the timeline and indications
for clinical development and regulatory submissions. 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 that approval of
Verastem Oncology’s New Drug Application for duvelisib in any
jurisdiction will not occur on the expected timeframe or at all,
including by the U.S. Food and Drug Administration’s target action date;
that a filing of a European Marketing Application may not be achieved in
fiscal year 2019 or at all; that partnerships or collaborations for the
development of duvelisib outside of the United States may not be
successful; that even if data from clinical trials is positive,
regulatory authorities may require additional studies for approval or
may approve for indications or patient populations that are not as broad
as intended and the product may not prove to be safe and effective or
may require labeling with use or distribution restrictions; that the
preclinical testing of Verastem Oncology’s product candidates and
preliminary or interim data from clinical trials may not be predictive
of the results or success of ongoing or later clinical trials; that the
full data from the DUO study will not be consistent with the previously
presented results of the study; that data may not be available when
expected, including for the Phase 3 DUO study; that the degree of market
acceptance of product candidates, if approved, may be lower than
expected; that the timing, scope and rate of reimbursement for our
product candidates is uncertain; 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 our product candidates will cause unexpected
safety events or result in an unmanageable safety profile as compared to
their level of efficacy; that duvelisib will be ineffective at treating
patients with lymphoid malignancies; that Verastem Oncology will be
unable to successfully initiate or complete the clinical development and
eventual commercialization of its product candidates; that the
development and commercialization of Verastem Oncology’s product
candidates will take longer or cost more than planned; that Verastem
Oncology may not have sufficient cash to fund its contemplated
operations; that Verastem Oncology or Infinity Pharmaceuticals, Inc.
will fail to fully perform under the duvelisib license agreement; that
Verastem Oncology may be unable to make additional draws under its debt
facility or obtain adequate financing in the future through product
licensing, co-promotional arrangements, public or private equity, debt
financing or otherwise; that Verastem Oncology will not pursue or submit
regulatory filings for its product candidates, including for duvelisib
in patients with CLL/SLL or iNHL; and that Verastem Oncology’s 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 Annual Report on Form 10-K
for the year ended December 31, 2017 as filed with the Securities and
Exchange Commission (SEC) on March 13, 2018 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.
References
1 Winkler D.G., Faia K.L., DiNitto
J.P. et al. PI3K-delta and PI3K-gamma inhibition by IPI-145 abrogates
immune responses and suppresses activity in autoimmune and inflammatory
disease models. Chem Biol 2013; 20:1-11.
2 Reif K et al.
Cutting Edge: Differential Roles for Phosphoinositide 3 kinases,
p110-gamma and p110-delta, in lymphocyte chemotaxis and homing. J
Immunol 2004:173:2236-2240.
3 Schmid M et al. Receptor
Tyrosine Kinases and TLR/IL1Rs Unexpectedly activate myeloid cell PI3K,
a single convergent point promoting tumor inflammation and progression.
Cancer Cell 2011;19:715-727.
4www.clinicaltrials.gov,
NCT02004522
5www.clinicaltrials.gov,
NCT01882803
6www.clinicaltrials.gov,
NCT02783625, NCT02158091
View source version on businesswire.com: https://www.businesswire.com/news/home/20180605005267/en/
Source: Verastem, Inc.
Verastem Oncology, Inc.
Marianne M. Lambertson,
+1-781-292-4273
Vice President, Corporate Communications
Investor
Relations/Public Relations
mlambertson@verastem.com