Merck and Endocyte Announce Withdrawal of Conditional Marketing Authorization Applications for Vintafolide and Companion Imaging Components, Etarfolatide and Intravenous (IV) Folic Acid in Europe


May 19, 2014 4:00 pm ET

WHITEHOUSE STATION, N.J. & WEST LAFAYETTE, Ind.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, and
Endocyte, Inc. (NASDAQ:ECYT), today announced the withdrawal of
conditional marketing authorization applications (CMA) from the European
Medicines Agency (EMA) for vintafolide and companion imaging components,
imaging agent etarfolatide and intravenous (IV) folic acid, for the
treatment of adult patients with folate receptor-positive,
platinum-resistant ovarian cancer, in combination with pegylated
liposomal doxorubicin (PLD).

The Companies’ decision was based on further review of interim data from
the PROCEED trial. Study enrollment was suspended earlier this month
based on the Data Safety Monitoring Board’s (DSMB) recommendation that
the study be stopped because vintafolide in combination with PLD versus
PLD alone did not meet the pre-specified criteria for progression-free
survival to allow continuation of the study. The DSMB did not identify
any safety concerns for the patients enrolled in the PROCEED trial. The
Companies will take steps to terminate the PROCEED trial and will
provide investigators with instructions to conclude the trial. The study
results will be presented in a future scientific congress.

“Advanced stage ovarian cancer is a difficult-to-treat disease with few
options available, and we are disappointed by the outcome of this
confirmatory study. We would like to thank our clinical investigators
and especially the patients with platinum-resistant ovarian cancer who
participated in the clinical studies for these investigational
candidates,” the Companies said.

The randomized Phase 2b TARGET trial in non-small cell lung cancer
(NSCLC) is ongoing. The Companies are awaiting maturation of the overall
survival data later this year to help inform potential further
development of the vintafolide and docetaxel combination in NSCLC.

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
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About Endocyte

Endocyte is a biopharmaceutical company and leader in developing
targeted small molecule drug conjugates (SMDCs) and companion imaging
agents for personalized therapy in cancer and other serious diseases.
Endocyte uses its proprietary technology to create novel SMDCs and
companion imaging agents for personalized targeted therapies. The
company’s SMDCs actively target receptors that are expressed or
over-expressed on diseased cells, relative to healthy cells. This
targeted approach is designed to enable the treatment of patients with
highly potent drugs into these cells. The companion imaging agents are
designed to identify patients whose disease expresses the molecular
target of the therapy and who therefore may be more likely to benefit
from treatment. 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. These statements are based
upon the current beliefs and expectations of Merck’s management and are
subject to significant risks and uncertainties. There can be no
guarantees with respect to pipeline products that the products will
receive the necessary regulatory approvals or that they will prove to be
commercially successful. If underlying assumptions prove inaccurate or
risks or uncertainties materialize, actual results may differ materially
from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry
conditions and competition; general economic factors, including interest
rate and currency exchange rate fluctuations; the impact of
pharmaceutical industry regulation and health care legislation in the
United States and internationally; global trends toward health care cost
containment; technological advances, new products and patents attained
by competitors; challenges inherent in new product development,
including obtaining regulatory approval; Merck’s ability to accurately
predict future market conditions; manufacturing difficulties or delays;
financial instability of international economies and sovereign risk;
dependence on the effectiveness of Merck’s patents and other protections
for innovative products; and the exposure to litigation, including
patent 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 2013 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 company’s
partnership with Merck. 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 clinical trial materials, 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.

Ian McConnell, +1 908-423-3046
Claire Mulhearn, +1 908-423-7425
Carol Ferguson, +1 908-423-4465
Justin Holko, +1 908-423-5088
Martina Schwarzkopf, +1 212-845-4292
Tony Russo, +1 212-845-4251
Stephanie Ascher, +1 212-362-1200

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