Source : 'Generics Bulletin'
Dr. Reddy's Laboratories Ltd. expects to progress plans for the single-dose COVID-19 vaccine, Sputnik Light, in India, with regulatory submissions expected soon backed by “updated” data from its Russian partner.
“The Russia Phase III trials are going to be leveraged for the India filing as per the recommendations of the SEC [Subject Expert Committee] in India. We expect the submission of this data to be made soon,” Dr Reddy’s CEO (Active Pharmaceutical Ingredients and Services) Deepak Sapra said at a media briefing on the results for the fiscal first quarter ended 30 June.
The Indian firm expects to receive “full and final clinical data” on Sputnik Light within a week’s time. SECs advise the Indian regulator on trial-related permissions and approvals.
Sputnik Light is essentially the first dose component of Sputnik V, which uses two different vectors for the two shots in a course of vaccination. India had in April this year approved Sputnik V for restricted use in an emergency situation. ("Strides Considers Sputnik Light Production" "Scrip" ) ("UNICEF Strikes Deal To Buy Russias Sputnik V Vaccine" "Pink Sheet" )
Dr Reddy’s has partnered with the Russian Direct Investment Fund (RDIF) for clinical trials and supply of Sputnik V in India; the soft launch of the vaccine, as part of a limited pilot, had been initiated earlier this year and the first dose was administered in Hyderabad on 14 May. The vaccine has since been launched across 80 Indian cities and over 250,000 people have been vaccinated with it so far.
Dr Reddy’s is also closely monitoring the progress of Sputnik V trials in the adolescent segment of the population (12-18 years of age). “We expect to build on the trial that is being conducted in Russia for doing something similar in India,” Sapra added. The Russian trial on adolescents is expected to be completed by October. ("Coronavirus Update Moderna Shows 100 Efficacy In Teens" "Scrip" )
Earlier this year, Moderna, Inc. indicated that its mRNA-1273 vaccine prevented significant illness after two doses in all patients in the TeenCOVE trial, ages 12-18. On 23 July, the US biotech said that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization for the COVID-19 vaccine (Spikevax) to include adolescents (12-17 years of age). ("Rare Or Common Events COVID Vaccine Trials In Children Boost Safety Databases Triggering Fears Of Heart Events" "Pink Sheet" )
On 28 July, news agency reports said that the Italian regulator had cleared the use of Moderna's COVID-19 vaccine for children 12-17 years old, making it the second jab endorsed for adolescents, alongside that of Pfizer Inc.. In May this year, Pfizer/BioNTech SE said the Conditional Marketing Authorization for their COVID-19 vaccine Comirnaty in the EU had been expanded to include kids 12 to 15 years of age.
Plans to progress Sputnik Light also come against the backdrop of delays in securing adequate supplies of the second dose of Sputnik V from Russia, which has itself recently seen a surge in COVID-19 cases.
Dr Reddy’s has already received 150,000 of both dose one and two of Sputnik V; subsequently it received three million of the first dose and 300,000 of the second dose. It is now waiting for more of the second dose to come through to ensure that the remaining 2.7 million first doses can then be distributed.
“We are in touch with RDIF and we have seen last week that vaccination demand has gone down by 20% compared to what it was in the past. We are in discussions with RDIF to try and get the imported vaccines as soon as possible,” M V Ramana, Dr Reddy’s CEO, branded markets (India and Emerging Markets), said at the briefing.
The Indian firm expects to hear from RDIF by the end of July and start seeing a “better flow” of the imported Sputnik V in August.
Alongside, Dr Reddy’s is also working closely with six contract manufacturers in India for the vaccine.
“Each of them are at different stages of readiness and we are confident that in a couple of months they will have the product being manufactured and made available from India,” Sapra added.
To a question from Generics Bulletin sister publication Scrip on whether the company will market Sputnik V in India even once RDIF partner Serum Institute of India Pvt. Ltd. kicks off manufacturing, Sapra maintained that the vaccine will be marketed and distributed through Dr Reddy’s.
He clarified that the company has rights for 125 million people doses or 250 million Sputnik V vaccines, after which there will be a possibility of “discussing the contract” again. “So, till the time 250 million doses are administered in India, Dr Reddy’s continues to hold the marketing and distribution rights.”
RDIF had earlier struck deals with several leading Indian firms including Gland Pharma Ltd., Hetero Drugs Ltd., Panacea Biotec Ltd., Stelis Biopharma and Virchow Biotech, aimed at the production of more than 850 million doses of Sputnik V per year. Dr Reddy’s is also working with RDIF to take Sputnik V to some other emerging markets.
Earlier this month, RDIF and Serum Institute, the world’s largest vaccine manufacturer by volume, firmed up a deal to produce the Sputnik vaccine. The first batch of Sputnik vaccine is expected to be produced at Serum’s facilities in September and the partners expect to manufacture over 300 million doses of the jab in India per year.
Sputnik V was also the among the key talking points at the Dr Reddy’s earnings call to discuss the Q1 FY22 results, with CEO Erez Israeli indicting that the opportunity around the product is “big” but hinges on factors such as the way things may play out in terms of supplies from Russia, the ramp up/overall vaccination program in India and the COVID-19 waves. Fiscal year 2022 is the 12-month period ending 31 March 2022.
“Plus, we need to remember that the antibodies even for the people that took vaccine eventually are going down and we do see the impact in countries that have got vaccinations six months ago and now there is a pickup of cases again in certain areas,” Israeli noted on the earnings call, perhaps hinting at opportunities for booster shots.
He also went to explain how the company was moving on “multiple dimensions” to address emerging scenarios, including plans for Sputnik Light and other products in the firm’s portfolio.
“I don't know exactly, how the future will unfold but we are arranging for vaccine. We are kind of ramping up our infrastructure, registrations. So, it can be a significant opportunity, but it can be also less than that. It is a kind of unpredictable situation, especially when it is related to supply and these kind of things.”
The company also has several partnerships ongoing for COVID-19 therapies including with Gilead Sciences, Inc. (for remdesivir), Fujifilm Toyama Chemical Co. Ltd. (favipiravir), Merck & Co., Inc. (molnupiravir), Eli Lilly and Company (baricitinib) and India's Defence Research and Development Organization (2-deoxy-D-glucose). ("Can Avigan Bite Into Buzzing Indian Favipiravir Market" "Scrip" )
Launch planning is also on-going for liposomal amphotericin B, repurposed for COVID-19 associated mucormycosis.
The management also fielded a string of questions around a subpoena received from the US Securities and Exchange Commission calling for the production of documents pertaining to certain CIS geographies against the backdrop of a complaint alleging improper payments to healthcare professionals.
CEO Israeli indicated that the matter that was reported previously is still under investigation, which normally takes time. “I don't envision an immediate action in this respect. Once the investigation will come, we will share it with the authorities and address the relevant processes,” he added.
The anonymous complaint alleges that healthcare professionals in Ukraine and potentially in other countries were provided with improper payments by or on behalf of the company in violation of US anti-corruption laws, specifically the US Foreign Corrupt Practices Act. A US law firm is conducting the investigation at the instruction of a committee of the company's board of directors.
“While the matter may result in government enforcement actions against the company in the US and/or foreign jurisdictions, which could lead to civil and criminal sanctions under relevant laws, the probability of such action and the outcome are not reasonably ascertainable at this time,” the company said in its earnings filings.
Dr Reddy’s reported revenues of INR 49.19bn ($662m; +11%) for Q1FY22, with profit after tax at INR5.71bn (-1%).
By Anju Ghangurde