Endocyte granted orphan drug status for folic acid by European Commission

Published: September 27, 2012

Orphan Designation in Place for all Components of Planned EU Marketing Authorization Applications

WEST LAFAYETTE, Ind., (GLOBE NEWSWIRE) - Endocyte Inc., 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, (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 agent, etarfolatide.

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 approval.

About Endocyte

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.
(212) 362-1200
stephanie@sternir.com
Martina Schwarzkopf, Ph.D.
Russo Partners
(212) 845-4292
martina.schwarzkopf@russopartnersllc.com
Tony Russo, Ph.D.
Russo Partners
(212) 845-4251
tony.russo@russopartnersllc.com