Merck and Endocyte Announce Acceptance for Review of European Marketing Authorization Applications for Vintafolide and Companion

  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

Novel personalized treatment approach targets folate receptors on cancer cells

Business Wire

WHITEHOUSE STATION, N.J. & WEST LAFAYETTE, Ind. -- November 27, 2012

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

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

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

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
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 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; the risk
that the businesses will not be integrated successfully; disruption from the
merger making it more difficult to maintain business and operational
relationships; Merck’s ability to accurately predict future market conditions;
dependence on the effectiveness of Merck’s patents and other protections for
innovative products; the risk of new and changing regulation and health
policies in the United States and internationally 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 2010
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.

Photos/Multimedia Gallery Available:



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
Press spacebar to pause and continue. Press esc to stop.