Merck and Endocyte Enter Exclusive Worldwide Agreement to Develop and Commercialize Phase III Cancer Candidate Vintafolide (EC145)
WHITEHOUSE STATION N.J. & WEST LAFAYETTE, Ind.--(BUSINESS WIRE)--
Merck, known as MSD outside the United States and Canada, (NYSE: MRK)
and Endocyte Inc. (NASDAQ: ECYT), today announced that they have entered
into an agreement to develop and commercialize Endocyte's novel
investigational therapeutic candidate vintafolide (EC145). Vintafolide
is currently being evaluated in a Phase III clinical trial for
platinum-resistant ovarian cancer, (PROCEED trial) and a Phase II trial
for non-small cell lung cancer (NSCLC); both studies are also using
Endocyte's investigational companion diagnostic agent, etarfolatide
"Vintafolide is a promising and innovative late-stage cancer drug
candidate. In addition to pursuing the lead indication of
platinum-resistant ovarian cancer, Merck plans to further evaluate its
potential for treatment of multiple other cancer types," said Peter S.
Kim, executive vice president and president Merck Research Laboratories.
"This agreement underscores our strategy of building a portfolio of
oncology therapeutics that employ a companion diagnostic to facilitate
selection of those patients most likely to respond to treatment."
Under the agreement, Merck, through a subsidiary, will gain worldwide
rights to develop and commercialize vintafolide. Endocyte will receive a
$120 million upfront payment and is eligible for milestone payments of
up to $880 million based on the successful achievement of development,
regulatory and commercialization goals for vintafolide for a total of
six cancer indications. In addition, if vintafolide receives regulatory
approval, Endocyte will receive an equal share of the profit in the
United States (U.S.) as well as a double digit percentage royalty on
sales of the product in the rest of the world. Endocyte has retained the
right to co-promote vintafolide with Merck in the U.S. and Merck has the
exclusive right to promote vintafolide in the rest of world. Endocyte
will be responsible for the majority of funding and completion of the
PROCEED trial. Merck will be responsible for all other development
activities and costs and have all decision rights for vintafolide.
Endocyte remains responsible for the development, manufacture and
commercialization worldwide of etarfolatide, a non-invasive companion
diagnostic imaging agent that is used to identify folate receptor
positive tumor cells.
"Following a rigorous selection process we believe Merck represents the
ideal strategic partner to achieve the full potential of vintafolide,
accelerating our development in numerous cancers," said Ron Ellis,
Endocyte's president and chief executive officer. "The agreement also
positions us well to build our own commercial infrastructure for
vintafolide in the U.S. and for etarfolatide worldwide."
Endocyte has completed three single arm studies of vintafolide in
patients with advanced platinum resistant ovarian cancer, non-small cell
lung cancer and solid tumors. In a randomized Phase II clinical trial
(PRECEDENT) comparing vintafolide plus pegylated liposomal doxorubicin
(PLD) versus PLD alone in women with platinum-resistant ovarian cancer,
vintafolide demonstrated a statistically significant delay in disease
progression or death in the overall population, with the largest
improvement observed in patients with all tumors imaged as positive for
folate receptor expression utilizing etarfolatide. Vintafolide in
combination showed limited additional toxicity versus standard therapy
with PLD alone. Common adverse events observed with this combination
were neutropenia, fatigue, mouth sores, and redness/swelling/pain on the
hands and feet.
In March 2012, Endocyte announced that the European Union had granted
orphan drug status to vintafolide, and that the company planned to file
a marketing authorization application in the third quarter of 2012.
Closing of the transaction is contingent upon obtaining Hart-Scott
Rodino clearance from the Federal Trade Commission.
Endocyte will host a conference call and webcast at 8:30am ET today to
discuss the agreement. To listen to the conference call, please dial
877-845-0711 or 760-298-5081. A replay of the call will be available
beginning at 11:30am ET today. To access the replay, please dial
855-859-2056 or 404-537-3406 and reference the conference ID 72307636.
The webcast can be accessed through Endocyte's website at www.endocyte.com.
About Vintafolide (EC145)
Vintafolide is a proprietary, injectable, conjugate consisting of folate
(vitamin B9) linked to a potent vinca alkaloid chemotherapy agent,
desacetylvinblastine monohydrazide (DAVLBH). Vintafolide is designed to
preferentially target the chemotherapy agent to fast growing cancer
cells that actively take up folate via the folate receptor. The folate
receptor is expressed in a wide variety of cancers including ovarian,
NSCLC, breast, colon and kidney.
About Etarfolatide (EC20)
Etarfolatide is a folate-targeted molecular imaging agent that is being
developed as a non-invasive method to identify tumors that over-express
folate receptors. These tumors are the molecular target of Endocyte's
folate-targeted therapeutic compounds such as vintafolide. To date,
etarfolatide has been administered to over 550 patients.
About the PROCEED Trial
The PROCEED trial is a Phase III randomized, double-blind clinical trial
evaluating vintalofide in combination with PLD compared to PLD plus
placebo for the treatment of folate-receptor positive platinum-resistant
ovarian cancer. The primary endpoint of the trial is progression-free
survival as measured by RECIST (Response Evaluation Criteria In Solid
Tumor) criteria in patients with folate-receptor positive tumors
assessed by etarfolatide imaging. Overall survival is a secondary
endpoint. The trial anticipates recruiting more than 400 patients at
approximately 150 sites in the U.S., Canada, Europe, and Asia. For
further information regarding the PROCEED trial please visit http://www.clinicaltrials.gov.
Today's Merck is a global healthcare leader working to help the world be
well. Merck is known as MSD outside the United States and Canada.
Through our prescription medicines, vaccines, biologic therapies, and
consumer care and animal health products, we work with customers and
operate in more than 140 countries to deliver innovative health
solutions. We also demonstrate our commitment to increasing access to
healthcare through far-reaching policies, programs and partnerships. For
more information, visit www.merck.com
and connect with us on Twitter, Facebook and YouTube.
Endocyte is a biopharmaceutical company developing targeted therapies
for the treatment of cancer and inflammatory diseases. Endocyte uses its
proprietary technology to create novel Small Molecule Drug Conjugates
(SMDCs) and companion imaging diagnostics for personalized targeted
therapies. The company's SMDCs actively target receptors that are
over-expressed on diseased cells, relative to healthy cells. This
targeted approach is designed to enable the treatment of patients with
highly active drugs at greater doses, delivered more frequently, and
over longer periods of time than would be possible with the untargeted
drug alone. The companion imaging diagnostics are designed to identify
patients whose disease over-expresses the target of the therapy and who
are therefore more likely to benefit from treatment.
Merck Forward-Looking Statement
This news release includes "forward-looking statements" within the
meaning of the safe harbor provisions of the United States Private
Securities Litigation Reform Act of 1995. Such statements may include,
but are not limited to, statements about the benefits of the merger
between Merck and Schering-Plough, including future financial and
operating results, the combined company's plans, objectives,
expectations and intentions and other statements that are not historical
facts. Such statements are based upon the current beliefs and
expectations of Merck's management and are subject to significant risks
and uncertainties. Actual results may differ from those set forth in the
The following factors, among others, could cause actual results to
differ from those set forth in the forward-looking statements: the
possibility that all of the expected synergies from the merger of Merck
and Schering-Plough will not be realized, or will not be realized within
the expected time period; the impact of pharmaceutical industry
regulation and health care legislation in the United States and
internationally; Merck's ability to accurately predict future market
conditions; dependence on the effectiveness of Merck's patents and other
protections for innovative products; and the exposure to litigation
and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events or
otherwise. Additional factors that could cause results to differ
materially from those described in the forward-looking statements can be
found in Merck's 2011 Annual Report on Form 10-K and the company's other
filings with the Securities and Exchange Commission (SEC) available at
the SEC's Internet site (www.sec.gov).
Endocyte Forward-Looking Statement
Certain of the statements made in this press release are forward
looking, such as those, among others, relating to the company's
expectations for seeking regulatory approval and commercial launch of
its products, including any conditional marketing authorization from the
EMA, initiation of future clinical trials, and expectations for the
receipt of milestones, royalties or other profits from the partnership.
Actual results or developments may differ materially from those
projected or implied in these forward-looking statements. Factors that
may cause such a difference include risks that the company may
experience delays in the completion of its clinical trials (whether
caused by competition, adverse events, patient enrollment rates,
unavailability of Doxil, regulatory issues or other factors); risks that
data from its clinical trials may not be indicative of subsequent
clinical trial results; risks related to the safety and efficacy of the
company's product candidates, the goals of its development activities,
estimates of the potential markets for its product candidates, estimates
of the capacity of manufacturing and other facilities required to
support its product candidates, projected cash needs, and expected
financial results. More information about the risks and uncertainties
faced by Endocyte, Inc. is contained in the company's periodic reports
filed with the Securities and Exchange Commission. Endocyte, Inc.
disclaims any intention or obligation to update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise.
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