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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Shadow Pharma Venture Private Limited, Mumbai and Gplife Healthcare Private Limited, Surat have announced that the next generation Phytochemistry technology-based Nutraceutical formulations ACT- 12 and ACT - 13 have successfully cleared Phase II clinical trials for the treatment of COVID 19 positive hospitalized patients.

The formulations were compared for its safety and clinical efficacy against standard of care in COVID 19 patients.

60.0% of cases from Test Group showed PCR negativity compared to 40.0% in standard Group at Day 4. No Patient continued to remain Covid positive after the 10th day in the Test group and 7 Patients remained Covid positive after 10 days in the standard group. The IgG and IgM immunoglobulin levels were noticed to be higher demonstrating improved antibody functionality and thereby the immunomodulatory activity offered.

Anti-inflammatory effect by Lowering LDH, CRP with improvement in SpO2 & Thrombocytopenia can reduces risk of lung fibrosis.

Kiran Narasimha Pai (MBA IIM Calcutta), Advisor to Gplife Healthcare, said that “These results are among the best results for any Nutraceutical or Phytochemistry based formulation in the world for the treatment of COVID-19. If the same results with No mortality and 40% faster recovery rates can be replicated in a much larger Phase III trial, then we could be looking at the end of, at least, the severity of the COVID-19 pandemic."

He further said, "Since these products have essentially very low side effects and are FSSAI approved, they can be started as an adjuvant treatment globally, almost immediately”.

Prasad Kanitkar, Chief Technical Officer (CTO), Shadow Pharma added “These products and technologies are the outcome of putting Science and Nature together for the betterment of human beings and hope of life in ongoing pandemic.” He congratulated Dr. Shridhar Pandya Scientist and Director Gplife on making this research a reality at the exact time when the whole world needed it. Shadow Pharma Venture Pvt. Ltd. Mumbai has tied up with Gplife Health Care Pvt. Ltd. to commercialize its COVID 19 ACT 12 & ACT 13 Treatment Therapy and remaining Nutraceutical portfolio.

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