Endocyte, Inc.

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Press Release $ECYT Endocyte, Inc.

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Endocyte and Nihon Medi-Physics (NMP) Enter Into Exclusive License Agreement to Develop and Commercialize Companion Imaging Diagnostic Etarfolatide for Cancer in Japan

WEST LAFAYETTE, Ind. and TOKYO, Sept. 5, 2013 (GLOBE NEWSWIRE) -- Endocyte, Inc. (Nasdaq: ECYT), a biopharmaceutical company and leader in targeted small molecule drug conjugates (SMDCs) and companion imaging diagnostics for personalized therapy in cancer and other serious diseases, and Nihon Medi-Physics (NMP), a market leader in the development, production and distribution of radiopharmaceuticals for nuclear medicine procedures in Japan, today announced that they have entered into a license and commercialization agreement.

Under the terms of the agreement, Endocyte and NMP will develop and commercialize the companion imaging diagnostic etarfolatide (EC20) for cancer indications in Japan. Approval will be sought from the regulatory authorities to use etarfolatide to select patients who will most likely respond to vintafolide, Endocyte's folate receptor (FR)-targeting SMDC, by identifying tumors that express the FR. Endocyte has previously entered into a worldwide exclusive license agreement for vintafolide with Merck. Endocyte will receive an initial upfront fee and is eligible for development and regulatory milestones and royalties on sales of etarfolatide in Japan.  

"This collaboration further validates the benefits of Endocyte's unique approach to personalized medicine by using non-invasive companion imaging diagnostics to select patients likely to respond to our targeted SMDCs," said Ron Ellis, president and CEO of Endocyte. "As the leader in single-photon emission computed tomography (SPECT) imaging in Japan, NMP has extensive commercial expertise across medical imaging facilities such as hospitals and clinics, and we will continue to focus on advancing the global development and commercialization of our pipeline assets."

Yutaka Takeuchi, president of NMP, said, "NMP is committed to improving diagnosis of diseases with nuclear medicine procedures, and we are looking forward to collaborating with Endocyte, the leader in the small molecule drug conjugate and companion imaging diagnostic space. This relationship will benefit patients and further strengthen NMP's commercial leadership position in SPECT imaging in Japan."

Etarfolatide and the corresponding SMDC vintafolide are currently being evaluated in a Phase 3, randomized, double-blind clinical trial for platinum-resistant ovarian cancer (PROCEED trial; ClinicalTrials.gov Identifier NCT01170650) and a Phase 2b trial in patients with non-small cell lung cancer (TARGET trial; ClinicalTrials.gov Identifier NCT01577654). A Phase 2 randomized trial of vintafolide in FR-positive triple-negative breast cancer is expected to be initiated later this year. Endocyte recently announced that the European Medicines Agency (EMA) has accepted for review the marketing authorization application (MAA) filings for vintafolide and etarfolatide for the targeted treatment of patients with FR-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.

About Etarfolatide (EC20)

Etarfolatide is a folate receptor-targeted companion diagnostic imaging agent that is being developed as the first non-invasive method to identify tumors that express the folate receptor. These tumors are the molecular target of Endocyte's folate receptor-targeted therapeutic compounds such as vintafolide. Folic acid is used with etarfolatide for the enhancement of image quality.

About Vintafolide (MK-8109/EC145)

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, the first small molecule drug conjugate (SMDC), is designed to exploit this characteristic by selectively targeting the folate receptor to deliver the anti-cancer agent DAVLBH intracellular to the tumor.

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 SMDCs and companion imaging diagnostics for personalized targeted therapies. The company's SMDCs actively target receptors that are 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 expresses the molecular target of the therapy and who are therefore more likely to benefit from treatment. Targeted SMDCs for cancer, inflammatory disorders and kidney disease are in preclinical development. For additional information, please visit Endocyte's website at www.endocyte.com.

Endocyte Forward-Looking Statement

Certain of the statements in this press release are forward looking, such as those, among others, relating to the potential effectiveness of folate receptor-targeted therapies, the ability to determine the folate receptor expression status of patients, and the timing of clinical trial enrollment. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. 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.

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
Source: Endocyte, Inc.
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