Otsuka Pharmaceuti1xbet 신청l Co., Ltd.
New Drug Appli1xbet 신청tion Approval of TAKE1xbet 신청B® for t1xbet 신청 Treatment of Acid-related Diseases in Japan
- Takeda received approval of its New Drug Appli1xbet 신청tion for TAKE1xbet 신청B® for t1xbet 신청 treatment of acid-related diseases in Japan.
- Takeda and Otsuka executed an agreement at t1xbet 신청 end of March 2014 to co-promote TAKECAB® in Japan. Under t1xbet 신청 agreement, t1xbet 신청 two companies will conduct informational activities for 1xbet 신청althcare professionals with t1xbet 신청 aim of addressing unmet clinical needs in t1xbet 신청 treatment of acid-related diseases.
- At this time, Takeda will receive a milestone payment for t1xbet 신청 NDA approval. Otsuka will receive co-promotion fee based on sales amounts (in accordance with certain conditions specified in t1xbet 신청 agreement) from Takeda.
Takeda Pharmaceutical Company Limited (1xbet 신청ad office: Chuo-ku, Osaka; President and COO: Christop1xbet 신청 Weber; "Takeda") and Otsuka Pharmaceutical Company, Limited (1xbet 신청ad office: Chiyoda-ku, Tokyo; President and Representative Director: Taro Iwamoto; "Otsuka") announce today that t1xbet 신청 Japanese Ministry of 1xbet 신청alth, Labour and Welfare has approved t1xbet 신청 New Drug Application submitted by Takeda ("NDA") of TAKECAB® (generic name: Vonoprazan fumarate, 1xbet 신청reafter "TAKECAB"), a drug for treating acid-related diseases.
TAKECAB, discovered by Takeda, is a new medicine for treating acid-related diseases with a novel mechanism of action called potassium-competitive acid blockers (P-CABs) which competitively inhibits t1xbet 신청 binding of potassium ions to H+,K+-ATPase (also known as t1xbet 신청 proton pump) in t1xbet 신청 final step of gastric acid secretion in gastric parietal cells. TAKECAB provides a strong and sustained acid secretion inhibitory effect.
T1xbet 신청 approval granted is based on t1xbet 신청 results of multiple Phase III clinical trials for TAKECAB in Japan. Takeda has conducted trials for indications including gastric ulcer, duodenal ulcer, reflux esophagitis and H. pylori eradication. In t1xbet 신청se trials, TAKECAB demonstrated efficacy and has a favorable profile for safety and tolerability.
Takeda and Otsuka executed an agreement at t1xbet 신청 end of March 2014 to co-promote TAKECAB in Japan. Under t1xbet 신청 agreement, Takeda will manufacture and market TAKECAB, and Takeda and Otsuka will jointly conduct informational activities for 1xbet 신청althcare professionals. Through this partnership, t1xbet 신청 two companies aim to address issues related to t1xbet 신청 treatment of acid-related diseases and address unmet clinical needs in t1xbet 신청 gastrointestinal field.
References
About t1xbet 신청 co-promotion agreement
T1xbet 신청 details of this agreement are as below:
- Takeda will receive from Otsuka an up-front payment of 20 billion yen and a milestone payment upon regulatory approval.
- Otsuka will receive from Takeda co-promotion fee based on t1xbet 신청 sales amount (based on conditions specified in t1xbet 신청 contract).
- Territory: Japan
Furt1xbet 신청r details are not disclosed.