Sep 10 Pharma News

Daiichi Sankyo fuels commercialization of DS-8201 in Japan; Roivant Sciences transfers its biotech stake for USD 3 Billion; FDA, EMA accepts marketing of Allergan’s abicipar

Daiichi Sankyo announced the submission of a New Drug Application (NDA) of DS-8201 to Japan's Ministry of Health, Labour and Welfare (MHLW).

DS-8201 [fam-] trastuzumab deruxtecan), is an investigational antibody-drug conjugate (ADC) designed to deliver cytotoxic chemotherapy to cancer cells via a human epidermal receptor 2 (HER2) antibody attached to a novel topoisomerase I inhibitor payload and a tetrapeptide-based linker.

Japan’s NDA is based on the results of DESTINY-Breast01, a global pivotal phase II study.

Daiichi Sankyo, a pharmaceutical company developing novel treatment regimens for cancer, entered into a collaboration with Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize [fam-] trastuzumab deruxtecan as a medicine worldwide

Metastatic HER2-Positive Breast Cancer is a type of breast cancer in which breast cancer cells test shows positive status for a protein receptor called human epidermal growth factor receptor 2. According to DelveInsight’s estimates, the total incident population of breast cancer in the 7MM was found to be 626,867 in 2017, which is expected to grow during the study period [2017–2028].

According to the American Cancer Society, about 17% of breast cancers overproduce the growth-promoting protein HER2.

Key players such as MacroGenics, Puma Biotechnology, Seattle Genetics, Jiangsu HengRui Medicine, Prestige Biopharma Pte Ltd, EirGenix, Inc., and others are involved in developing therapies for Metastatic HER-2 Positive Breast Cancer.

Allergan’s DARPin- a drug discovery platform- has received the recommendations of US FDA and EMA Marketing Authorisation for Abicipar pegol in Patients with Neovascular (Wet) Age-related Macular Degeneration.

Abicipar pegol is a novel, investigational DARPin therapy used to treat patients with neovascular (wet) age-related macular degeneration (nAMD). The FDA is expected to take action on the BLA mid-2020. A decision from the European Commission is expected in the second half of 2020.

The Biologics License Application (BLA) and Marketing Authorization Application (MAA) filings depend on the results of Phase III clinical trials, CEDAR and SEQUOIA. The trials supported the non-inferior efficacy of the Abicipar quarterly dosing regimen to maintain vision gains with more than 50 per cent fewer injections versus ranibizumab (13 vs. 6) dosed monthly in the first year.

Abicipar, is the most advanced DARPin therapeutic candidate, as claimed by Molecular partners. It is designed to inhibit VEGF and is currently under investigation for the treatment of wet age-related macular degeneration, or wet AMD, and diabetic macular edema, or DME.

Designed offers the potential for less frequent dosing as it is designed to remain in the eye for a longer period of time, it was licensed to Allergan in May 2011.

Sumitomo Dainippon Pharma has entered into a strategic partnership with Roivant Sciences to obtain the stake in the Roivant’s subsidiaries for USD 3 Billion.

The collaboration will give the Sumitomo Dainippon ownership of Roivant’s companies, technology platforms and an equity stake of over 10% of Roivant’s shares. The companies set to be overtaken include Myovant, Urovant, Enzyvant, Altavant and another undisclosed spinout company.

The companies acquired are focused on advancing the therapy areas significantly in women’s health, urinary diseases and paediatric rare diseases. With the acquisition, Sumitomo will also have dominance over 25 clinical programmes, with potential product launches expected from 2020 to 2022.

Sumitomo Dainippon is planning to prepare beforehand for the loss it may incur after the patent of its major selling schizophrenia drug Latuda antipsychotic expires in the US in the year 2023.

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