FDA Approves Docetaxel Injection, Non-Alcohol Formula

Teikoku Pharma USA, Inc. Announces FDA Approval of Docetaxel Injection, Non-Alcohol Formula

San Jose, Calif. - December 28, 2015 - Teikoku Pharma USA (TPU) announced today that the U.S. Food and Drug Administration ("FDA") has approved Docetaxel Injection, Non-Alcohol Formula ("Docetaxel Injection") for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer. Teikoku entered into an exclusive licensing agreement with Eagle Pharmaceuticals Inc. ("Eagle Pharmaceuticals") in October 2015 to market, sell and distribute Docetaxel Injection in the U.S.

The main difference, compared to other docetaxel formulations, is that Docetaxel Injection is the first non-alcohol formulation approved in the U.S. Further differentiating it from some of the currently marketed docetaxel formulations is that Teikoku's Docetaxel Injection:

Requires no prior dilution with a diluent and is ready to add to the infusion solution; and

Is available in three presentations: 20mg/ml in single-dose vials, and 80 mg/4 mL or 160 mg/8 mL in multiple-dose vials.

The need for non-alcohol docetaxel gained visibility in June 2014 when the FDA issued a Drug Safety Communication warning patients that docetaxel may cause symptoms of alcohol intoxication after treatment. Manufacturers of docetaxel formulations for domestic use were subsequently required to revise their product labels to warn about this risk. Some U.S. hospitals and clinics require patients to wait two or more hours after treatment with docetaxel before they can be released. The Company's formulation of docetaxel was specifically developed to address these concerns.

"Docetaxel Injection addresses a compelling need in the docetaxel market. As the first alcohol-free formulation approved in the U.S., we believe the benefits of this novel formulation will provide an option for patients with alcohol sensitivity or a preference for an alcohol-free treatment. We are excited to add alcohol-free docetaxel to our growing portfolio of differentiated injectable products and believe it has the potential to improve the lives of patients, resolve concerns among health care professionals at hospitals and infusion centers, and ultimately drive value for Eagle stakeholders," said Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.

"The approval of Docetaxel Injection, our first oncology product, is a significant milestone in Teikoku's history, and Docetaxel Injection marks our second FDA approved product as New Drug Application (NDA). In addition, Eagle Pharmaceuticals' strong presence in the oncology space makes Eagle an excellent partner for our product," said Paul Mori, President and CEO of Teikoku.

About Docetaxel

Docetaxel is a taxane product indicated for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer. Taxotere® (docetaxel) is marketed by sanofi-aventis U.S. LLC. Since its patent expiration in 2011, several generics have entered into the market. The alcohol content of these docetaxel formulations, including Taxotere, ranges from 2.0 to 6.4 grams in a 200 mg dose.

About Teikoku Pharma USA, Inc.

Teikoku Pharma USA Inc., located in San Jose, California, 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 post-herpetic neuralgia developed by Teikoku and distributed by Endo Pharmaceuticals in the U.S and Grunenthal GmbH in Europe and Latin America as Versatis® and by Mundipharma in Asia. Teikoku's 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.

Source: Teikoku Pharma USA, Inc.

Posted: December 2015

Docetaxel Non-Alcohol Formula FDA Approval History