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OFFON
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Press Release: ONO Receives a Manufacturing and Marketing Approval of Adlumiz(R) (Anamorelin), a Ghrelin Receptor Agonist for the Treatment of Cancer Cachexia in Japan

01/22/2021 | 01:39am EDT
 
 
 
   ONO Receives a Manufacturing and Marketing Approval of Adlumiz(R) 
(Anamorelin), a Ghrelin Receptor Agonist for the Treatment of Cancer 
Cachexia in Japan 
 
   Not intended for US media 
 
   Lugano, Switzerland, and Osaka, Japan, January 22, 2021 - Helsinn Group 
(Lugano, Switzerland; CEO: Riccardo Braglia, "Helsinn") and Ono 
Pharmaceutical Co., Ltd. (Osaka, Japan; President and Representative 
Director: Gyo Sagara; "ONO") announced today that ONO received the 
manufacturing and marketing approval of Adlumiz(R) (generic name: 
anamorelin hydrochloride) Tablet 50mg ("Adlumiz"), a ghrelin receptor 
agonist, for the treatment of cancer cachexia in malignant tumors of 
non-small cell lung cancer, gastric cancer, pancreatic cancer or 
colorectal cancer in Japan. 
 
   This approval is mainly based on the results from the following two 
clinical studies conducted in Japan in patients with cancer cachexia: 
 
 
   1. Phase II multi-center, randomized, double-blind, placebo-controlled, 
      parallel group study in cancer cachexia patients with non-small cell lung 
      cancer (ONO-7643-04) 
 
   2. Phase III multi-center, open-label, uncontrolled study in cancer cachexia 
      patients with gastric, pancreatic or colorectal cancer (ONO-7643-05) 
 
 
   Cancer cachexia is a complex metabolic disorder syndrome, characterized 
by decreased body weight (especially decreased muscle mass) and anorexia 
associated with cancer. It has been well documented that cancer cachexia 
causes a significant impact on patients' quality of life and prognosis. 
To date, an effective treatment method for cancer cachexia has not yet 
been established. 
 
   Anamorelin is a selective, novel, orally active ghrelin receptor 
agonist. Ghrelin is an endogenous peptide primarily secreted by the 
stomach. Upon binding to its receptor, ghrelin stimulates multiple 
pathways in the positive regulation of body weight, muscle mass, 
appetite and metabolism. Anamorelin has shown effects in increasing body 
weight and muscle mass, as well as appetite in patients with cancer 
cachexia. 
 
   Riccardo Braglia, Helsinn Group Vice Chairman and CEO commented: "We are 
delighted that Ono's application has been successful for the treatment 
of cancer cachexia in Japan. This is an important milestone towards the 
improvement of the quality of life for all cancer cachexia patients, a 
condition that is still largely untreatable." 
 
   Kiyoaki Idemitsu, Corporate Executive Officer and Executive Director, 
Clinical Development of ONO commented: "We are extremely pleased that 
Adlumiz has been approved for the indication of cancer cachexia in 
Japan. We believe that today's approval can provide a promising new 
treatment option for the patients suffering from cancer cachexia for 
which there previously were no other approved treatment methods". 
 
   Overview of Adlumiz(R) Tablet 50 mg 
 
 
 
 
Product Name              Adlumiz(R) Tablet 50mg 
------------------------  ---------------------------------------------------------- 
Generic name (JAN)        Anamorelin hydrochloride 
------------------------  ---------------------------------------------------------- 
Indication                Cancer cachexia in the following malignant tumors: 
                           Non-small cell lung cancer, gastric cancer, pancreatic 
                           cancer and colorectal cancer 
------------------------  ---------------------------------------------------------- 
Dosage and                Usually, for adults, administer 100 mg of anamorelin 
administration             hydrochloride at fasting state orally once a day 
------------------------  ---------------------------------------------------------- 
Manufacturer/distributor  Ono Pharmaceutical Co., Ltd. 
------------------------  ---------------------------------------------------------- 
Approval date             January 22, 2021 
------------------------  ---------------------------------------------------------- 
Conditions for approval   1.    Risk Management Plan should be designed and 
                                appropriately implemented. 
                          2.    A post-marketing use-results survey covering all 
                                cases should be performed until data on a certain 
                                number of patients have been accumulated after the 
                                launch of the product in order to collect safety and 
                                efficacy data as early as possible and take measures 
                                necessary for the proper use of the product. 
------------------------  ---------------------------------------------------------- 
 
   About the ONO and Helsinn Collaboration 
 
   In accordance with a license agreement in force with Helsinn Healthcare 
SA (a company of the Helsinn Group), ONO has exclusive rights to develop 
and commercialize Anamorelin in Japan, South Korea and Taiwan. Helsinn 
retains full rights in the rest of the world. 
 
   About Ono Pharmaceutical Co., Ltd. 
 
   Ono Pharmaceutical Co., Ltd., headquartered in Osaka, is an R&D-oriented 
pharmaceutical company committed to creating innovative medicines in 
specific areas. ONO focuses on the oncology, immunology, neurology and 
specialty research with high medical needs as priority areas toward 
discovery and development of innovative new drugs. For further 
information, please visit the company's website at www.ono.co.jp/eng. 
 
   About the Helsinn Group 
 
   Helsinn is a privately-owned Swiss Pharma Company which, since 1976, has 
been improving the lives of patients, guided by core family values of 
respect, integrity and quality. The Group has an extensive portfolio of 
marketed innovative cancer and rare disease therapies, a robust drug 
development pipeline and ambitions to further accelerate its growth 
through in-licensing and acquisition to address unmet medical needs. 
Helsinn operates a unique integrated licensing business model, achieving 
success with over 80 long-standing partners in 190 countries, who share 
our values. The Group's pharmaceutical business (Helsinn Healthcare) is 
headquartered in Lugano, Switzerland with operating subsidiaries in the 
U.S. (Helsinn Therapeutics US) and China (Helsinn Pharmaceuticals China) 
which market the Group's products directly in these countries. The Group 
has additional operating subsidiaries in Switzerland (Helsinn Advanced 
Synthesis, an active pharmaceutical ingredient manufacturer) and Ireland 
(Helsinn Birex Pharmaceuticals, a drug product manufacturer). Helsinn 
Investment Fund was created to enhance the future of healthcare by 
providing funding and strategic support to innovative companies. 
 
   Helsinn Group plays an active and central role in promoting social 
transformation in favor of people and the environment. Corporate social 
responsibility is at the heart of everything we do which is reinforced 
in the company's strategic plan by a commitment to sustainable growth. 
 
   To learn more about Helsinn Group please visit 
https://www.globenewswire.com/Tracker?data=-1GDxDKH_wp9sCSqlTebWNFsrGG7RSRa24WE5RG7FMhicpyxqgTdfQPW05Z0mqx9d9_PjFyaFV_91odNWVVvpA== 
www.helsinn.com 
 
   The press release has been prepared in compliance with the Japanese 
regulations. 
 
   Contacts: 
 
   Helsinn Group Media Contact 
 
   Paola Bonvicini 
 
   Group Head of Communication 
 
   Lugano, Switzerland 
 
   Tel: +41 (0) 91 985 21 21 
 
   https://www.globenewswire.com/Tracker?data=EYI3Xs4QAexahppyt9IREm9ibkWbMnw3gnxPRthUKzJPmlWIlqb8GS6mfsKRBTEt7OTFCL6jcCA0M4KjORQmHNBtMeJMqG__mxJO_RQwbZY= 
Info-hhc@helsinn.com 
 
   For more information, please visit 
https://www.globenewswire.com/Tracker?data=-1GDxDKH_wp9sCSqlTebWCZ-XbOkIIVF4dtDSlrRdjkD1OGUXIB-wnppqEVb_EUMKUkVKdDCoj6ERWAymkLz-A== 
www.helsinn.com and follow us on 
https://www.globenewswire.com/Tracker?data=i9mYXxvNsu2fkvhtEStxETn33-tdvXYMrYdkkpbbp5ifCuAT1Q15BjCHvq3ks6oNMSsfqsSDU-G13JL8d9mEtA== 
Twitter, 
https://www.globenewswire.com/Tracker?data=iPviGdw2HAhWIAmIOiXtqeVyiCrFaNie-cF9j-rF9mQm6NSfLuwaUqscC9yPw1h_KdbKfYc8JownZQnlaIfWUXjRQSTUi7ZyRwP0C5d4_6Y= 
LinkedIn and 
https://www.globenewswire.com/Tracker?data=__paUeptAJu08REol9rdhL_KWfBwcDbIeIC6DUONBysGcLp-Ww4Oc4dc0aQR5F4I_-iLCTomwdKNXCNtwo3qqw== 
Vimeo. 
 
   Ono Pharmaceutical Co., Ltd. 
 
   Corporate Communications 
 
   https://www.globenewswire.com/Tracker?data=QQL4fucnrZcary-JzwcLsPsNox5Onj8_val_k964UfCSXqXlUoykyuynHDvx2l___oPB8ysflZwkNubk4Hi5zj3X9blTTdE6gmGr4KMnwlC_GvX4HE6MMwPwEQSVRwaC 
public_relations@ono.co.jp 
 
 
 
 
 
 

(END) Dow Jones Newswires

January 22, 2021 01:38 ET (06:38 GMT)

Stocks mentioned in the article
ChangeLast1st jan.
MSCI TAIWAN (STRD) -0.74% 690.203 Real-time Quote.15.72%
ONO PHARMACEUTICAL CO., LTD. -1.70% 2485.5 End-of-day quote.-20.03%
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