Teikoku Pharma USA and Eagle Pharmaceuticals Enter into License Agreement for Docetaxel, Non-Alcohol Formula

News provided by

15 Oct, 2015, 17:06 GMT

SAN JOSE, California, Oct. 15, 2015 /PRNewswire/ -- Teikoku Pharma USA Inc. ("TPU") today announced that it has entered into an exclusive license agreement with Eagle Pharmaceuticals, Inc. to market, sell, and distribute TPU's Docetaxel Injection, Non-Alcohol Formula in the United States. Once approved by the U.S. Food and Drug Administration ("FDA"), Docetaxel Injection has the potential to be the first docetaxel alcohol-free formulation approved in the US. Docetaxel Injection is an antineoplastic agent intended for the treatment of breast cancer, non-small cell lung cancer ("NSCLC"), prostate cancer, gastric adenocarcinoma, and head and neck cancer. The New Drug Application ("NDA") for Docetaxel Injection for these indications is currently under review with the FDA; the Prescription Drug User Fee Act ("PDUFA") action date is December 26, 2015.

Under the terms of the agreement, Eagle will pay Teikoku near-term milestones, including an upfront cash payment, an additional payment based upon the timing of an FDA approval and double-digit royalties on gross profits.

"We are very excited to license our Docetaxel Injection to Eagle, an established leader in specialty injectables in the U.S. Eagle is an excellent partner for Teikoku and for this important product," said Paul Mori, Chief Executive Officer of Teikoku.

"Our mission is to improve the quality of life of patients around the world by providing new benefits for unmet patient needs," added Mori.

About Docetaxel Injection Docetaxel is a cytotoxic anticancer agent indicated for treating breast cancer, non-small cell lung cancer, hormone refractory prostate cancer, gastric adenocarcinoma, and squamous cell carcinoma of the head and neck cancer

Teikoku's Docetaxel Injection comes as one vial docetaxel injection in three presentations: 20mg/1ml, 80mg/4mL, and 160mg/8mL.

About Teikoku Pharma USA

Teikoku Pharma USA Inc., located in San Jose, California is a wholly-owned subsidiary of Teikoku Seiyaku Co.,LTD. of Japan, is an international specialty pharmaceutical company that develops and manufactures pharmaceutical products based on our delivery platform technologies.

Teikoku's main product is Lidoderm® (Lidocaine 5% Patch) for PHN, developed by Teikoku and distributed by Endo Pharmaceuticals in the U.S and Grunenthal GmbH in Europe and Latin America as Versatis®.

Teikoku's internal therapeutic focus is in Pain Management, CNS and Oncology.

About Eagle Pharmaceuticals, Inc.

Eagle is a specialty pharmaceutical company focused on developing and commercializing injectable products that address the shortcomings, as identified by physicians, pharmacists and other stakeholders, of existing commercially successful injectable products. Eagle's strategy is to utilize the FDA's 505(b)(2) regulatory pathway. Additional information is available on the company's website at www.eagleus.com.

For more information please contact: Francisco Bejar at fbejar@teikokuusa.com

Citations

1) Docetaxel Package Insert. Sanofi-Aventis U.S. LLC. Bridgewater, NJ.Revised: 11/2014. Available at:
http://products.sanofi.us/Taxotere/taxotere.html. Accessed: February 20, 2015.