takeda pharmaceutic-sp adr (TKPYY) Key Developments
Takeda Pharmaceutical Company Limited Announces Availability of ADCETRI 50mg for Intravenous Drip Infusion in Japan
Apr 17 14
Takeda Pharmaceutical Company Limited announced that 'ADCETRIS® 50mg for intravenous drip infusion' (brentuximab vedotin) is now available for the treatment for patients with CD30 Positive Relapsed or Refractory Hodgkin Lymphoma (HL) or Relapsed or Refractory Anaplastic Large Cell Lymphoma (ALCL) in Japan. ADCETRIS received orphan drug designation from the Ministry of Health, Labour and Welfare (MHLW) in March 2012, and
Japanese manufacturing and marketing authorization on January 17th 2014. Additionally, ADCETRIS was placed on the country's National Health Insurance drug price list today, April 17th 2014. ADCETRIS is an antibody-drug conjugate (ADC) comprised of an anti-CD30 monoclonal antibody
attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics' proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.
Japanese Ministry of Health, Labour and Welfare Approves Takeda Pharmaceutical's NDA for Cell Cultured Influenza Vaccine
Apr 1 14
The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Takeda Pharmaceutical's new drug application (NDA) of Cell Cultured Influenza vaccine H5N1 'TAKEDA' 1mL (Cell Cultured Influenza vaccine (H5N1Strain)) and Cell Cultured Influenza vaccine (Prototype) 'TAKEDA' 1mL (Cell Cultured Influenza vaccine (Prototype)) for prevention of pandemic influenza. The new vaccine will be manufactured at a newly-established facility at the company's Hikari Plant in Hikari City, Yamaguchi Prefecture. The company has submitted the NDA to MHLW in March 2013 and the approval means that Takeda is now able to manufacture and supply pandemic influenza vaccines in Japan using new manufacturing technologies licensed from Baxter.
Trianni, Inc., and Takeda Pharmaceutical Company Limited Enter into a License Agreement
Apr 1 14
Trianni, Inc., and Takeda Pharmaceutical Company Limited, have entered into a license agreement for Takeda's use of the Trianni Mouse, a monoclonal antibody discovery platform. Trianni Mouse will provide Takeda with an access to a complete human antibody repertoire that has been optimized for the isolation of fully human therapeutics.
Dainippon Sumitomo Pharma Co., Ltd. and Takeda Pharmaceutical Company Limited Announce the European Marketing Authorization for Latuda®
Mar 31 14
Dainippon Sumitomo Pharma Co., Ltd. and Takeda Pharmaceutical Company Limited ('Takeda') jointly announced that the European Commission has granted Marketing Authorization for once-daily oral Latuda ® (lurasidone) for the treatment of schizophrenia in adults. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a Positive Opinion for Latuda on January 23, 2014. About 3.5 million people in Europe are currently living with schizophrenia which can have a huge impact on those affected, their families and caregivers. 1 Symptoms can be diverse and include hallucinations, distorted reality, depression and social withdrawal. Schizophrenia is also associated with shortened life expectancy of 10-22.5 years, 2.3 which can in part be due to the undesirable effects of antipsychotics such as weight gain, increased blood pressure and increased blood sugar. 4.5 The leading cause of mortality for people with schizophrenia is cardiovascular disease 5 – an estimated 75% die from this versus a general population mortality rate of 50%.
Otsuka Pharmaceutical Co., Ltd. and Takeda Pharmaceutical Company Limited Enter into a Co-Promotion Agreement in Japan for TAK-438
Mar 28 14
Otsuka Pharmaceutical Co., Ltd. and Takeda Pharmaceutical Company Limited announced that the two firms have entered into a co-promotion agreement in Japan for TAK-438 (generic name: Vonoprazan Fumarate), a drug discovered by Takeda for the treatment of acid-related diseases. Proton pump inhibitors (PPIs) are currently widely prescribed as first-line therapy for the treatment of acid-related diseases in Japan. However, PPIs do not always provide sufficient therapeutic efficacy, and the acid secretion inhibitory effects of PPIs may differ among individuals, because of the protein CYP2C19 which has gene polymorphisms that are involved in metabolism. TAK-438 inhibits proton pumps without the need for activation by acid, and the compound is distributed at high concentrations into the stomach, the target organ, thereby exerting a nearly maximum inhibitory effect from the first dose and remaining effective for 24 hours. Unlike PPIs, TAK-438 is not primarily metabolized by CYP2C19 (which has gene polymorphisms). Since TAK-438 is stable in acid and its immediate-release formulation is available without requiring an optimized formulation design (e.g., enteric-coating), the onset of efficacy does not significantly differ among treated patients. With these advantages, TAK-438 is expected to become a new therapeutic agent that resolves issues with current treatments for acid-related diseases.