Takeda Pharmaceutical Company Limited or ‘Takeda’ declared that it had broadened its cell therapy manufacturing efficiencies by opening a brand new 24,000 square-foot R&D cell therapy manufacturing facility at its Boston-based Research and Development headquarters. The new manufacturing facility will enhance end-to-end research and development abilities and speed up the development of next-generation cell therapies. This will initially be concentrated on oncology and, in the future, extend into other therapeutic areas. Moreover, the manufacturing facility, which follows the current Good Manufacturing Practices (CGMP) to meet all the regulatory requirements in the U.S., E.U. and Japan, would also produce cell therapies for clinical evaluation from discovery through pivotal Phase 2b trials.

The company is currently collaborating with the best scientists and innovators to develop a very diverse immuno-oncology pipeline evolving into new mechanisms with healing properties. According to Chris Arendt, Head of the Oncology Therapeutic Area Unit of Takeda, there are three oncology cell therapy programs in the clinic right now, and two more will join in the fiscal year 2021. Therefore, Takeda is working with urgency and purpose, and the new facility will help speed up and improve the manufacturing capabilities to carry out various diverse cell therapy programs simultaneously.

Due to its focus on redirected immunity, Takeda is currently involved in researching next-generation cell therapy. Takeda’s several immuno-oncology programs make use of innate immunity, including innovative cell therapies, innate immuno-modulation, immune engager platforms, novel-scaffold immune checkpoint platforms, as well as oncolytic viruses.

Takeda Pharmaceutical Company Limited is a biopharmaceutical company that has a presence in about 80 countries all over the world. Takeda specializes in pharmaceutical, oncology, therapeutics, vaccines, and gastroenterology. In its quarter 1 financial reports for the financial year 2020, its revenue from operations stood at JPY 801,850 million, which is 5.6% less than that of the previous year's corresponding period. However, the operating profit for Q1 stood at JPY 167,285 million, which is 270.4% more than that of Q1 FY2019.

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Dr. Reddy’s Laboratories Ltd announced the launch of over-the-counter (OTC) Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% and 0.1%, the storebrand equivalents of Pataday® Once Daily Relief and Pataday® Twice Daily Relief, in the U.S. market, as approved by the U.S. Food and Drug Administration (USFDA).

Dr. Reddy’s Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% and 0.1% are indicated for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair and dander. The Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1% is also indicated for the temporary relief of red eyes.

“This launch marks the entry of Dr. Reddy’s into the OTC eye care space, and is a testament to our deep capabilities in bringing store-brand equivalents of Rx-to-OTC switches to the U.S. market,” says Marc Kikuchi, CEO, North America Generics, Dr. Reddy’s Laboratories. “We are very excited to extend our strategic collaboration with Gland Pharma to bring these products to the market. We thank the teams at Gland and Dr. Reddy’s whose hard work and efforts have enabled the execution of this launch in such a short timeframe.”

The Pataday® brand had U.S. sales of approximately $31 million since the launch in March 2020 according to IRi*.

Dr. Reddy’s Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% is available in a 2.5 mL bottle and Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1% is available in a 5 mL bottle size.

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The Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, and Dr. Reddy’s Laboratories Ltd. (Dr. Reddy’s), a global pharmaceutical company headquartered out of India, have agreed to cooperate on clinical trials and distribution of Sputnik V vaccine in India. Upon regulatory approval in India, RDIF shall supply to Dr. Reddy’s 100 million doses of the vaccine. The Sputnik V vaccine, which is based on wellstudied human adenoviral vector platform with proven safety, is undergoing clinical trials for the coronavirus pandemic. Deliveries could potentially begin in late 2020 subject to completion of successful trials and registration of the vaccine by regulatory authorities in India.

The agreement between RDIF and Dr Reddy’s reflects the growing awareness of countries and organizations to have a diversified anti-COVID vaccine portfolio to protect their populations.

Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said, “We are very pleased to partner with Dr. Reddy’s in India. Dr. Reddy’s has had a very well established and respected presence in Russia for over 25 years and is one of the leading pharmaceutical companies in India. India is amongst most severely impacted countries from COVID 19 and we believe our human adenovirus dual vector platform will provide a safe and scientifically validated option to India in the battle against COVID 19. RDIF partners will receive an effective and safe drug to fight the coronavirus. The platform of human adenoviral vectors, which is the core of the Russian vaccine, has been tested in more than 250 clinical studies over decades, and it has been found safe with no potential negative long-term consequences.”

Prof. Sergey Tsarenko, Deputy Chief Physician for Anesthesiology and Reanimation at Hospital No. 52 in Moscow, said, “The main criteria for evaluating a vaccine are safety and efficacy. In Sputnik V, safety is ensured by the use of human adenoviral vectors, which we repeatedly encounter throughout our lives. Efficacy is achieved by using two different human adenoviruses sequentially, which differentiates this platform.”

On August 11, the Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world’s first registered vaccine against COVID-19 based on the human adenoviral vectors platform. Detailed information on the Sputnik V vaccine, the technological platform of human adenoviral vectors, and other details are available at sputnikvaccine.com

On September 4, a research paper on the results of Phase I and Phase II clinical trials of the Sputnik V vaccine was published in The Lancet, one of the leading international medical journals, demonstrating no serious adverse effects and a stable immune response in 100% of participants. Post-registration clinical trials of the Sputnik V vaccine involving 40,000 volunteers are currently ongoing. More than 55,000 volunteers have applied to take part in post-registration trials. The first results of these trials are expected to be published in October-November 2020.

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