Verastem Oncology to Receive an Upfront Payment of $15 Million USD;
Then Eligible to Receive Up To $30 Million USD in Development Milestone
Payments as well as Sales Milestone and Double-Digit Percentage Royalty
Payments
CSPC Pharmaceutical Group Obtains Rights to Develop the Oral
Inhibitor of Phosphoinositide 3-Kinase (PI3K), and the First Approved
Dual Inhibitor of PI3K-delta and PI3K-gamma (PI3K-δ,γ), COPIKTRA
(duvelisib) for All Oncology Indications in China
BOSTON & HONG KONG--(BUSINESS WIRE)--Sep. 25, 2018--
Verastem, Inc. (Nasdaq:VSTM) (Verastem Oncology or the Company), focused
on developing and commercializing medicines to improve the survival and
quality of life of cancer patients, and CSPC Pharmaceutical Group
Limited (HKEx: 1093) (CSPC), a leading pharmaceutical company in China,
today announced their entry into an exclusive licensing agreement for
CSPC 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 China. COPIKTRA received
approval from the U.S. Food and Drug Administration for the treatment of
adult patients with relapsed or refractory chronic lymphocytic
leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior
therapies.
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COPIKTRA also received accelerated approval for the treatment of adult
patients with relapsed or refractory follicular lymphoma (FL) after at
least two prior systemic therapies. The indication in FL is approved
under accelerated approval based on overall response rate. Continued
approval for this indication may be contingent upon verification and
description of clinical benefit in confirmatory trials.
Under the terms of the agreement, Verastem Oncology shall receive an
upfront payment of $15 Million USD. Verastem Oncology is also entitled
to receive additional development milestone payments of $30 Million USD,
plus potential sales milestone payments and double-digit percentage
royalties based on future net sales of COPIKTRA in China. CSPC will
receive exclusive rights to develop and commercialize COPIKTRA and hold
the marketing authorization and product license for COPIKTRA in China.
CSPC will have the right to collaborate with Verastem Oncology on
certain global development and clinical trial activities and will share
pro-rata in the cost.
“This agreement with Verastem Oncology brings to our pipeline an
overseas approved innovative oncology drug with the potential to help
Chinese patients battling cancer, including some high unmet need
hematologic malignancies,” said Cai Dongchen, Chairman of CSPC. “Our
long-standing development and commercial experience in the Chinese
pharmaceutical market, together with Verastem Oncology’s expertise with
COPIKTRA, will ensure the timely and efficient development of this
exciting therapy. At CSPC, we are dedicated to developing and
commercializing innovative medicines and we are honored to form this
strategic alliance with Verastem Oncology to advance COPIKTRA.”
“We are delighted to be working with CSPC, a respected leader in
developing, manufacturing and commercializing pharmaceuticals in China,”
said Robert Forrester, President and Chief Executive Officer of Verastem
Oncology. “CSPC successfully markets multiple oncology products,
including DUOMEISU (doxorubicin hydrochloride liposome injection),
JINYOULI (PEG-rhGCSF injection) and KEAILI (paclitaxel for injection
(albumin-bound)). CSPC is a constituent stock of the Hang Seng Index and
is recognized as one of the most valuable brands in China. We believe
this partnership underscores the global potential of COPIKTRA and
complements the growing list of strategic partners focused on bringing
COPIKTRA to patients worldwide. As we execute the launch of COPIKTRA in
the U.S., we will work collaboratively in parallel with CSPC to rapidly
advance COPIKTRA through the hospitals in China and ultimately to cancer
patients in need.”
About COPIKTRA™ (duvelisib)
COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and
the first approved dual inhibitor of PI3K-delta and PI3K-gamma, two
enzymes known to help support the growth and survival of malignant
B-cells. PI3K signaling may lead to the proliferation of malignant
B-cells and is thought to play a role in the formation and maintenance
of the supportive tumor microenvironment.1,2,3 COPIKTRA is
indicated for the treatment of adult patients with relapsed or
refractory chronic lymphocytic leukemia/small lymphocytic lymphoma
(CLL/SLL) after at least two prior therapies and relapsed or refractory
follicular lymphoma (FL) after at least two prior systemic therapies.
COPIKTRA is also being developed by Verastem Oncology for the treatment
of peripheral T-cell lymphoma (PTCL), for which it has received Fast
Track status, and is being investigated in combination with other agents
through investigator-sponsored studies.4 For more information
on COPIKTRA, please visit www.COPIKTRA.com.
Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.
About CSPC Pharmaceutical Group Limited
CSPC Pharmaceutical Group Limited is a leading pharmaceutical group in
China. The Company has been listed on the Main Board of the Hong Kong
Stock Exchange since 1994 and is currently a constituent stock of Hang
Sang Index. CSPC is a leading developer and manufacturer of innovative
and generic drugs in China. Blockbuster innovative products in CSPC
Pharmaceutical’s pipeline include NBP (butylphthalide), OULAINING
(oxiracetam), XUANNING (maleate levamlodipine), DUOMEISU, JINYOULI and
KEAILI. CSPC is also a major manufacturer of bulk drugs, including
vitamin C, antibiotics and caffeine. The production facilities of CSPC
are mainly located in Shijiazhuang City, Hebei Province, China. For more
information, please visit its website at http://www.cspc.com.hk.
About Verastem Oncology
Verastem, Inc. (Nasdaq:VSTM) (Verastem Oncology or the Company), is a
biopharmaceutical company focused on developing and commercializing
medicines to improve the survival and quality of life of cancer
patients. Verastem Oncology currently markets COPIKTRA™ (duvelisib), an
oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first
approved dual inhibitor of PI3K-delta and PI3K-gamma, which is indicated
for the treatment of adult patients with relapsed or refractory chronic
lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least
two prior therapies and relapsed or refractory follicular lymphoma (FL)
after at least two prior systemic therapies. The indication in FL is
approved under accelerated approval based on overall response rate.
Continued approval for this indication may be contingent upon
verification and description of clinical benefit in confirmatory trials.
In addition, Verastem Oncology is developing the focal adhesion kinase
(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.
Verastem Oncology 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 lead
product COPIKTRA, and Verastem Oncology’s PI3K and FAK programs
generally, its intent to commercialize 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,
among other things, uncertainties regarding the launch timing and
commercial success of COPIKTRA in the United States; uncertainties
regarding 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; Verastem
Oncology’s ability to obtain, maintain and enforce patent and other
intellectual property protection for COPIKTRA and its 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;
that regulatory authorities in the U.S. or other jurisdictions, if
approved, could withdraw approval; whether preclinical testing of
Verastem Oncology’s 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 Verastem Oncology’s product candidates is uncertain;
the risk that third party payors (including government agencies) will
not reimburse for COPIKTRA; that there may be competitive developments
affecting its product candidates; that data may not be available when
expected; that enrollment of clinical trials may take longer than
expected; that COPIKTRA or Verastem Oncology’s 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 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 FL in other jurisdictions; 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 Quarterly Report on Form 10-Q for the
quarterly period ended June 30, 2018 as filed with the Securities and
Exchange Commission (SEC) on August 8, 2018, its Annual Report on Form
10-K for the year ended December 31, 2017 as filed with the 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,
NCT03372057.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180925006174/en/
Source: Verastem, Inc.
Verastem Oncology:
Brian Sullivan, +1 781-469-1636
Senior
Director, Corporate Development
bsullivan@verastem.com
or
Media:
FleishmanHillard
Adam
Silverstein, +1 917-697-9313
media@verastem.com
or
Investors:
Argot
Partners
Joseph Rayne, +1 617-340-6075
joseph@argotpartners.com