Merck and Endocyte Announce Acceptance for Review of European Marketing Authorization Applications for Vintafolide and Companion Diagnostic Etarfolatide for Folate-Receptor Positive Platinum-Resistant Ovarian Cancer


November 27, 2012 8:30 am ET

Novel personalized treatment approach targets folate receptors on cancer cells

Merck, known as MSD outside the United States and Canada (NYSE: MRK),
and Endocyte Inc. (NASDAQ: ECYT), today announced that the European
Medicines Agency (EMA) has accepted for review the marketing
authorization application (MAA) filings for the novel investigational
cancer candidate vintafolide (MK-8109/EC145) and investigational
companion diagnostic imaging agent etarfolatide (EC20), for the targeted
treatment of patients with folate-receptor positive platinum-resistant
ovarian cancer in combination with pegylated liposomal doxorubicin
(PLD). Both vintafolide and etarfolatide have been granted orphan drug
status by the European Commission.

Vintafolide is a proprietary, injectable, conjugate consisting of folate
(vitamin B9) linked to a potent vinca alkaloid anti-cancer agent,
desacetylvinblastine hydrazide (DAVLBH). Folate is essential for cell
division, and cancer cells generally consume higher levels of folate
than normal cells to fuel their rapid rate of growth and division. In
order to satisfy the demand for folate, some cancer cell types –
including ovarian – express high concentrations of folate receptors on
their surface. Vintafolide is designed to exploit this characteristic by
selectively targeting the folate receptor to deliver the anti-cancer
agent DAVLBH intracellular to the tumor.

“The acceptance of the EMA filing for vintafolide is an important
milestone for Merck and Endocyte,” said Gary Gilliland, M.D., Ph.D.,
senior vice president and oncology franchise head, Merck Research
Laboratories. “Vintafolide is designed to preferentially target cancer
cells that actively take up folate via the folate receptor.”

The MAA filings are supported by four clinical studies: a Phase I study
in solid tumors, two single-agent, single-arm Phase II studies in
ovarian cancer and non-small cell lung cancer, and the PRECEDENT trial,
a randomized Phase IIb study in patients with platinum-resistant ovarian
cancer. The application is being submitted for conditional approval on
the basis that the results from the Phase II studies fulfill an unmet
medical need.

Vintafolide is currently being evaluated in a Phase III randomized,
double-blind clinical trial for platinum-resistant ovarian cancer
(PROCEED trial). The PROCEED trial is evaluating vintafolide in
combination with PLD compared to PLD plus placebo for the treatment of
folate-receptor positive platinum-resistant ovarian cancer. This trial
also employs the companion diagnostic imaging agent etarfolatide, which
is a molecular imaging agent that is being developed as a non-invasive
method to identify tumors that over-express folate receptors. The
primary endpoint of the trial is progression-free survival as measured
by RECIST v 1.1 (Response Evaluation Criteria In Solid Tumor) criteria
in patients with all target tumor lesions positive as assessed by
etarfolatide imaging. Overall survival is a secondary endpoint. The
trial anticipates recruiting patients at approximately 150 sites in the
United States, Canada, Europe and Asia. For further information
regarding these trials, please visit

“We are pleased with the acceptance of the applications in Europe as an
important milestone towards providing a new treatment option targeted
for folate-receptor positive platinum-resistant ovarian cancer
patients,” said Ron Ellis, Endocyte’s president and CEO. “The use of
etarfolatide as a companion diagnostic imaging agent to guide patient
selection for vintafolide is a key element in implementing a
personalized medicine approach to treating ovarian cancer.”

As part of an exclusive license agreement with Endocyte, Merck, through
an MSD affiliate, is responsible for the development and worldwide
commercialization of vintafolide in oncology. Endocyte intends to
co-promote vintafolide in the United States, and is responsible for the
development, manufacture and commercialization of etarfolatide
worldwide. Merck will pay Endocyte a $5 million milestone payment for
the EMA filing acceptance.

About Folate-Receptor Positive Platinum-Resistant Ovarian Cancer

In 2012, it is estimated that there will be 22,280 new cases of ovarian
cancer in the United States and over 40,000 new cases in the European
Union. Ovarian cancer causes more deaths than any other cancer of the
female reproductive system. Overall, approximately 80 percent of
patients relapse after first-line platinum-based chemotherapy.
Platinum-resistant ovarian cancer is a challenging disease with a high
unmet need. This type of cancer recurs within six months of completion
with a platinum-containing regimen, the standard of care for ovarian
cancer. An estimated 80 percent of platinum-resistant ovarian cancer
patients have been found to have folate-receptor positive disease, and
40 percent express the receptor in all of their target tumor lesions.
Compared to patients who do not express folate receptors on their
tumors, folate-receptor positive patients have been shown to have a
poorer overall prognosis.

About Merck

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

About Endocyte

Endocyte is a biopharmaceutical company developing targeted therapies
for the treatment of cancer and other serious 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, and
deliver highly potent drugs into these cells. Patients can be identified
prior to the treatment with the corresponding companion imaging
diagnostic. For more information, visit

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
forward-looking statements.

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 (

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 PLD, 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.

Media Contacts:
Pamela Eisele, 908-423-5042
Tony Russo, 212-845-4251
Monica May, 619-308-6542
Investor Contacts:
Alex Kelly, 908-423-4465
Paul Cox, 212-362-1200

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