Endocyte Granted Orphan Drug Status for Folic Acid by European Commission
Orphan Designation in Place for all Components of Planned EU Marketing
WEST LAFAYETTE, Ind., Sept. 27, 2012 (GLOBE NEWSWIRE) -- Endocyte, Inc.
(Nasdaq:ECYT), a biopharmaceutical company developing targeted small molecule
drug conjugates (SMDCs) and companion imaging diagnostics for personalized
therapy, today announced that the Company was granted orphan drug status for
folic acid solution for injection by the European Commission for the condition
of ovarian cancer. Folic acid solution for injection is used as a
pre-injection for the radiodiagnostic imaging agent, etarfolatide, to select
patients for whom treatment with folate receptor targeted therapy, such as
vintafolide, is being considered. Vintafolide is the therapeutic designed to
target a potent drug to the folate receptors found on diseased cells.
The company plans to submit marketing authorization applications to EU health
authorities in the fourth quarter of 2012 for vintafolide, etarfolatide and
folic acid for the selection and treatment of women with folate receptor
positive platinum-resistant ovarian cancer. All three agents have now been
granted orphan drug status.
About Vintafolide (EC145)
Vintafolide is a conjugate of the vitamin folate and a potent vinca alkaloid.
Folate is required for cell division and rapidly dividing cancer cells often
over-express folate receptors in order to capture enough folate to support
cell division. By attaching a chemotherapy drug to folate through proprietary
chemistry, vintafolide targets cancer cells while avoiding most normal cells.
This targeted approach is designed to provide treatment with potent drugs
while lowering toxicity compared to standard chemotherapy. Endocyte and Merck,
known as MSD outside the United States and Canada, (NYSE:MRK) entered into an
agreement to develop and commercialize vintafolide. Vintafolide is currently
being evaluated in a Phase 3 clinical trial for platinum-resistant ovarian
cancer, (PROCEED trial) and a Phase 2 trial for non-small cell lung cancer;
both studies are also using Endocyte's investigational radiodiagnostic imaging
About Etarfolatide (EC20)
Etarfolatide is a folate-targeted molecular radiodiagnostic 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. Folic
acid is used with etarfolatide to enhance image quality. To date, etarfolatide
and folic acid have been administered safely to over 590 patients.
About Orphan Drug Designation
European Medicines Agency's Orphan Medicinal Product Designation is designed
to promote the development of drugs that may provide significant benefit to
patients suffering from rare, life-threatening diseases. This designation will
provide ten years of marketing exclusivity if the product candidate is
approved for marketing for the designated orphan indication in the European
Union. It also provides special incentives for sponsors, including eligibility
for protocol assistance and possible exemptions or reductions in certain
regulatory fees during development or at the time of application for marketing
Endocyte is a biopharmaceutical company developing targeted therapies for the
treatment of cancer and inflammatory diseases.Endocyte uses its proprietary
technology to create novel 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.
Forward Looking Statements
Certain of the statements in this press release are forward looking, such as
those, among others, relating to the planned submission of EU marketing
authorization applications and the expected availability of data from the
PROCEED trial. Actual results or developments may differ materially from those
projected or implied in these forward-looking statements. Factors that could
cause such a difference include the prolonged unavailability of Doxil, adverse
regulatory developments, and the fact that clinical data from one trial may
not be replicated in a subsequent trial. 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
CONTACT: Stephanie Ascher
Stern Investor Relations, Inc.
Martina Schwarzkopf, Ph.D.
Tony Russo, Ph.D.
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