What's New

Nippon Kayaku Announces FDA Orphan Drug Designation to New Polymeric micelle Anti-Cancer Drug NK012 for Small Cell Lung Cancer

2016/04/27

Tokyo, Japan, April 22, 2016 - Nippon Kayaku Co., Ltd. (Head Office: Tokyo; President: Masanobu Suzuki; hereafter referred to as “Nippon Kayaku”) announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to 7-ethyl-10-hydroxycamptothecin, an active ingredient encapsulated in a new polymeric micelle anti-cancer drug NK012, for treatment of Small Cell Lung Cancer.

NK012 is a new polymeric micelle anti-cancer drug, which encapsulates 7-ethyl-10-hydroxycamptothecin (SN-38), an active metabolite of Irinotecan. The polymeric micelle is formed from aggregation of block copolymers. Since 2005, Nippon Kayaku has been conducting clinical trials in Japan and the US, with the goal of attaining approval as a novel anti-cancer drug.

Nippon Kayaku aims to move forward with the drug develop to provide patients, their families, and medical professionals with a wider array of new treatment options.


[Reference]
About Small Cell Lung Cancer
Small cell lung cancer accounts for around 15%-20% of all lung cancer cases. There is a high rate of recurrence or metastasis due to rapid growth of cancer cells. It tends to metastasize to the brain, lymph nodes, liver, bones, and other areas at relatively early phase. In comparison with non-small cell lung cancer, it is generally more responsive to treatment with anti-cancer drugs or radiation. Moreover, patients may present with symptoms from an overproduction of hormones as cancer cells produce various hormones.

About NK012
NK012 is a new polymeric micelle anti-cancer drug encapsulating 7-ethyl-10-hydroxycamptothecin (SN-38), an active metabolite of Irinotecan. The polymeric micelle is formed from aggregation of block copolymer. The polymeric micelle is a spherical structure that is several tens of nanometers in diameter. It has a feature to accumulate gradually in the tumor tissue due to its permeability. Hence, the polymeric micelle plays a role as a carrier which sends the active ingredient to the tumor effectively. NK012 is designed to release the active ingredient gradually under physiological conditions. In contrast with the existing Irinotecan drug therapy, NK012 is expected to offer improved efficacy and reduced side-effects.

About Orphan Drug Designation
The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.
Drugs that receive orphan-drug designation from FDA are entitled to seven years of marketing exclusivity if they are approved by the FDA for the same rare disease.

About Irinotecan
Irinotecan is a semisynthetic derivative of camptothecin. As a water-soluble analog that enhances the activity of camptothecin and reduces toxicity, it has demonstrated efficacy against tumors. In Japan, Irinotecan was launched in 1994.
Brand names: CAMPTO® for I.V. infusion; TOPOTECIN® INTRAVENOUS DRIP INFUSION

About Nippon Kayaku
Founded in 1916, Nippon Kayaku is a leading Japanese Pharmaceuticals, Functional chemicals, Safety systems and Agrochemicals company with over $1.34 billion in revenues.
Since BLEOMYCIN release of 1969, Pharmaceuticals Group has begun to develop its business with a focus on anti-cancer drugs and cancer-related agents. In recent years, we have been furthering our efforts into the areas of biosimilars, generic anti-cancer drugs, as well as interventional radiology (IVR) so that we can continue to provide highly necessary pharmaceuticals and medical devices for patients along with exceptionally reliable information to the medical institutions.

[Please direct inquiries regarding this matter to:]
Telephone: +81-3-6731-5237
Public Relations & Investor Relations Division
Nippon Kayaku Co., Ltd.


[Notice]
This is a translation of a document issued in Japanese and is made solely for the convenience of the foreign readers. In case of any discrepancy between the translation and the Japanese original, the latter shall prevail.









PageTop
我们的事业
研究开发
公司信息
全球网络
股东・投资者信息(English)
可持续发展(English)