Merck and Endocyte Announce European CHMP Positive Opinions for VYNFINIT® (vintafolide) and Companion Imaging Agents FOLCEPRI® (etarfolatide) and NEOCEPRI® (Intravenous (IV) folic acid) in Patients with Platinum-Resistant …


March 21, 2014 8:05 am ET

Merck and Endocyte Announce European CHMP Positive Opinions for
® (vintafolide) and Companion Imaging
® (etarfolatide) and NEOCEPRI®
(Intravenous (IV) folic acid)
in Patients with Platinum-Resistant
Ovarian Cancer

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 that the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines Agency
(EMA) has issued positive opinions for the Conditional Marketing
Authorisations of VYNFINIT® (vintafolide) and companion
imaging components, imaging agent FOLCEPRI® (etarfolatide),
and NEOCEPRI® (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).

“These positive CHMP opinions bring Merck and Endocyte one step closer
to providing a personalized approach to address a significant unmet
medical need in platinum-resistant ovarian cancer,” said Dr. Eric Rubin,
vice president, Clinical Development for Oncology, Merck Research
Laboratories. “We want to acknowledge our colleagues at Endocyte for
their pioneering work in this field, and look forward to the European
Commission completing their review of the applications.”

“Vintafolide is a folate receptor targeted agent, and if approved, would
be the first oncology therapeutic to employ an imaging agent as a
companion diagnostic for patient selection,” said Ron Ellis, Endocyte’s
president and CEO. “Today’s positive CHMP opinions are an important step
toward personalizing ovarian cancer management for appropriate patients,
and validate our Company’s focus on the development of targeted
medicines and companion imaging agents designed to improve patient

Vintafolide is proposed for use in combination with PLD for the
treatment of adult patients with platinum-resistant ovarian cancer who
express the folate receptor on all target lesions. Folate receptor
status should be assessed by a diagnostic medicinal product approved for
the selection of adult patients for treatment with vintafolide, using
Single Photon Emission Computed Tomography (SPECT) imaging, in
combination with Computed Tomography (CT) or Magnetic Resonance Imaging

Etarfolatide and IV folic acid are medicinal products proposed for
diagnostic use only. Etarfolatide, following radiolabelling with sodium
pertechnetate (99mTc) solution, is proposed for SPECT imaging
in combination with CT or MRI, for the selection of adult patients for
treatment with vintafolide. Intravenous folic acid would be
administrated prior to 99mTc-etarfolatide for the enhancement
of SPECT image quality.

The applications for Conditional Marketing Authorisation for
vintafolide, etarfolatide and IV folic acid were submitted based on
results in platinum-resistant ovarian cancer patients who express the
folate receptor on all target lesions as evaluated in the PRECEDENT
Phase 2 study ( Identifier: NCT00722592).

The CHMP positive opinions will be reviewed by the European Commission
(EC). If approved, the EC grants a centralized marketing authorization
with unified labeling that is valid in the 28 countries that are members
of the European Union, as well as European Economic Area members
Iceland, Liechtenstein and Norway. The EC usually issues a final legally
binding decision within three months of a CHMP opinion.

About vintafolide, etarfolatide and IV folic acid

Vintafolide is an investigational conjugate of folic acid (vitamin B9)
linked to an anti-cancer agent, the potent vinca alkaloid
desacetylvinblastine hydrazide (DAVLBH). Since cancer cells generally
consume higher levels of folate than normal cells to fuel their growth,
some cancer cell types – including ovarian – have high concentrations of
the folate receptor on their surface. Vintafolide is designed to
selectively target the folate receptor to deliver the anti-cancer agent
to the cancerous tissue. Tumors that have high concentrations of the
folate receptor are identified by etarfolatide, a non-invasive imaging
diagnostic agent. Intravenous folic acid is used with 99mTc-etarfolatide
for the enhancement of image quality.

Vintafolide, etarfolatide and IV folic acid have been granted orphan
drug status by the EMA. The U.S. Food and Drug Administration has
also granted orphan drug status to vintafolide and etarfolatide. Further
evaluation is ongoing in the global PROCEED Phase 3 clinical trial in
folate receptor-positive (FR 100%), platinum-resistant ovarian cancer (
Identifier: NCT01170650
). The randomized TARGET Phase 2b study of
vintafolide in non-small cell lung cancer has completed enrollment
( Identifier: NCT01577654),
and a Phase 2 study in triple-negative breast cancer is expected to be
initiated in Q2 ( Identifier: NCT01953536).

About Folate Receptor-Positive Platinum-Resistant Ovarian Cancer

In 2012, it was estimated that there would be over 40,000 new cases of
ovarian cancer in the European Union. Ovarian cancer is one of the most
lethal cancers of the female reproductive system. Overall, approximately
80 percent of patients relapse after first-line, platinum-based,
chemotherapy. Platinum-resistant ovarian cancer, also known as PROC, is
a challenging disease with a high unmet need for new treatments. This
type of cancer recurs within six months of completion of 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 approximately
40 percent express the receptor, as detected by etarfolatide, in all of
their target tumor lesions (FR 100%). 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
and connect with us on Twitter, Facebook
and YouTube.

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.

VYNFINIT® is a registered trademark of Merck & Co., Inc.,
Whitehouse Station, N.J., USA.

FOLCEPRI® and NEOCEPRI® are registered trademarks
of Endocyte, Inc.

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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