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India in dialogue with Moderna, other biotech firms over progress in COVID vaccine development: Sources

NEW DELHI: India is in dialogue with the US-based biotech giant Moderna over the progress in the clinical trials of its coronavirus vaccine candidate, which the firm said has shown 94.5 percent efficacy, official sources said on Monday.

Moderna on Monday said the independent National Institutes of Health-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, found the vaccine to have an efficacy of 94.5 percent.

“We are in dialogue not only with Moderna, but also with Pfizer, Serum Institute, Bharat Biotech and Zydus Cadila over the progress of the clinical trials of each of the vaccine candidates and where their vaccines stand in terms safety, immunogenicity and efficacy, and regulatory approvals,” a source said.

According to the New Drugs and Cosmetics Rules 2019, any new drug or vaccine which has been tested and got regulatory approval outside India, will have to undergo bridging phase 2 and 3 clinical studies for its secure regulatory approval here.

“As per law, the CDSCO, under the New Drugs and Cosmetics Rule 2019, can omit, relax or abbreviate the regulatory requirement or conditions of submitting pharmaceutical and clinical data of a vaccine candidate in Indian population in case of any emergency or pandemic like situation,” the source said.

Cambridge, Massachusetts-based Moderna’s announcement comes just a week after Pfizer and Biontech said their COVID-19 vaccine candidate was found to be more than 90 percent effective in preventing COVID-19 in participants.

“This is a pivotal moment in the development of our COVID-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible,” said Stephane Bancel, Chief Executive Officer of Moderna.

“This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease,” he said.

Based on these interim safety and efficacy data, Moderna intends to submit for an Emergency Use Authorisation (EUA) with the US Food and Drug Administration (FDA) in the coming weeks and anticipates having the EUA informed by the final safety and efficacy data (with a median duration of at least 2 months).

Moderna also plans to submit applications for authorisations to global regulatory agencies.

( Originally published on Nov 16, 2020 )

In Video: Covid-19: Challenges of vaccinating a billion people

Over 158 applications for generic products pending with USFDA for approval: Lupin

NEW DELHI:Drug firm Lupin remains bullish over its US business with over 158 applications for generic products pending with the US drug regulator for approval, as per the company’s annual report for 2019-20.

Sharing information with company’s shareholders, Lupin MD Nilesh Gupta and CEO Vinita Gupta said the company’s US business stabilised last fiscal and saw an increase of 5 per cent on the back of products like Levothyroxine and Oseltamivir.

“We now have over 158 abbreviated new drug applications (ANDAs) pending approval with the US Food and Drug Administration (USFDA), a rich pipeline addressing a total market of over USD 71.7 billion comprising of inhalation, first-to-files and injectable products,” they said.

During the year, the company filed 21 ANDAs, two of which were confirmed exclusive first-to-files, Nilesh and Vinita Gupta said.

“We expect to continue our ramp-up of Levothyroxine and look forward to the launch of our first major inhalation product, Albuterol in the coming fiscal (pending FDA approval),” they added.

During 2019-20, the US business contributed 38 per cent to the company’s revenues, aggregating USD 800 million (about Rs 6,000 crore), a 3 per cent growth over 2018-19.

The Mumbai-based company’s domestic business continues to be the second largest vertical, contributing 34 per cent to the topline, which stood at Rs 15,142.8 crore in 2019.

“Our India business continues to outperform the Indian pharmaceutical market with 13 per cent year-on-year growth,” Nilesh and Vinita Gupta said.

Lupin’s top priority for 2019-20 was to get the company back on growth path from the decline witnessed in 2018-19 fiscal, the company leaders noted.

“We have made significant progress in this effort, as well as in optimising our costs on several fronts. We are confident that our performance will reflect the same over the next few quarters as the global situation normalises,” they added.

Lupin Executive Director, Global CFO and Head Corporate Affairs Ramesh Swaminathan said the company is conscious of the headwinds being faced by the industry.

“However, we see the emergence of an improved business environment, especially in the second half of 2020-21 and are confident that the measures taken by us in recent times would help us to come out stronger than ever,” he noted.

With the changing dynamics of the generic market, the company believes that cost optimisation and prudent capital allocation will continue to be a key business imperative, Swaminathan said.

“We aim to continue creating a leaner and more efficient organisation. In FY20, we made significant strides in our cost optimisation initiatives encompassing value engineering, procurement efficiencies and R&D productivity. However, input price rises on other molecules and sales mix changes eroded visibility of the same, to some measure,” he noted.

“These initiatives have however created a strong foundation and our cost optimization momentum will continue with increased rigor in FY21,” Swaminathan said.

Lupin said its net debt as on March 31, 2020 stood at Rs 1,511.8 crore as compared with Rs 5,243.8 crore as on March 31, 2019.

Lupin recalls around 5.61 lakh pouches of birth control pills in the US market

New Delhi: Drug major Lupin is recalling 5,60,922 pouches of a birth control product in the US, as per the US Food and Drug Administration (USFDA). Baltimore-based Lupin Pharmaceuticals Inc is recalling 5,60,922 pouches of Mibelas 24 Fe (norethindrone acetate and Ethinyl estradiol tablets and ferrous fumarate tablets) in the US, as per the latest enforcement report by the USFDA.

The product is used to prevent pregnancy. It is manufactured in India and then supplied in the US market by Lupin Pharmaceuticals Inc, the report said.

One pouch of Mibelas 24 Fe contains 28 chewable tablets.

The reason for the recall is “failed impurities/degradation specifications: Out of specification result observed in related substance test”, the USFDA said.

The nationwide (US) recall was initiated by the company on July 21 this year and the USFDA classified it as a Class II recall.

As per the US health regulator, a class II recall is initiated in a “situation in which the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

The company did not elaborate if the product is also sold in India. A mail sent to the company in this regard remained unanswered.

Usually, drug firms cater to the domestic market from separate manufacturing plants. The USFDA approved facilities are specifically utilised to cater to the US, the largest market for pharmaceutical products in the world.

Natco Pharma’s marketing partner gets USFDA nod for cancer treatment drug

New Delhi: Drug major

Natco Pharma

on Friday said its marketing partner Breckenridge Pharmaceutical has received final approval from the US health regulator for Pomalidomide Capsules, treatment of patients suffering from multiple myeloma cancer.

“Breckenridge Pharmaceutical Inc. has received final approval for its abbreviated new drug application (ANDA) for Pomalidomide Capsules from the US Food and Drug Administration (USFDA),” Natco Pharma said in a regulatory filing.

In addition, Natco and Breckenridge have settled the patent litigation with Celgene (now part of Bristol-Myers Squibb) in the US district court for this product, the company added.

The company, however, did not share details of the settlement.

Celgene sells Pomalidomide Capsules under Brand name Pomalyst in the USA market which is indicated for the treatment of patients suffering from multiple myeloma cancer.

Natco Pharma said as per industry sales data, Pomalyst had annual sales of USD 957 million during the twelve months ending September 2020.

Shares of Natco Pharma were trading 0.50 per cent higher at Rs 910.40 apiece on BSE.

Pfizer, Moderna testing their vaccines against UK coronavirus strain

Washington: Pfizer and Moderna are testing their coronavirus vaccines to see if they work against the new mutated version of the virus that’s recently been found in the United Kingdom and other countries, CNN reported.

“Based on the data to date, we expect that the Moderna vaccine-induced immunity would be protective against the variants recently described in the UK,” Moderna said in a statement adding, “We will be performing additional tests in the coming weeks to confirm this expectation.”

According to CNN, Pfizer said it is now “generating data” on how well blood samples from people immunized with its vaccine “may be able to neutralize the new strain from the UK.”

Pfizer and Moderna make the only two coronavirus vaccines that have been authorized by the US Food and Drug Administration.

The novel coronavirus has mutated before, and both companies say they’ve found that their vaccines worked against other variations of the virus.

Some researchers who are examining the genome of the UK variant told CNN they have concerns that this variant’s mutations might possibly “somewhat diminish” the effectiveness of the vaccine.

“You could imagine some modest hit in vaccine efficacy, which wouldn’t be good, but I don’t think it would break the vaccine,” said Trevor Bedford, an associate professor in the vaccine and infectious disease pision of the Fred Hutchinson Cancer Research Center.

Dr. Anthony Fauci, director of the National Institutes of Allergy and Infectious Diseases on Monday said that a new Covid-19 variant linked to surge of cases in the United Kingdom is probably already in the United States.

“You have to make that assumption,” Fauci told PBS Newshour’s Judy Woodruff as quoted by CNN.

“When you see something that is pretty prevalent in a place like the UK, there are also mutations that we’re seeing in South Africa, and given the travel throughout the world, I would not be surprised if it’s already here,” he added.

He added that “when we start to look for it we’re going to find it.”

“Certainly it’s not yet the prevalent one, the way it seems to have assumed that prevalent nature in the UK, but we’re going to be looking for it right now, and I’m sure sooner or later we’re going to run into it and find it,” Fauci said.

The new strain of Covid-19 is “out of control”, said UK Health Secretary Matt Hancock on Sunday.

“The only way you can do that is by restricting social contacts and essentially, especially in Tier 4 areas, everybody needs to behave as if they may well have the virus and that is the way that we can get it under control and keep people safe,” he added.

The new strain of Covid-19 is “out of control”, said UK Health Secretary Matt Hancock on Sunday.

“The only way you can do that is by restricting social contacts and essentially, especially in Tier 4 areas, everybody needs to behave as if they may well have the virus and that is the way that we can get it under control and keep people safe,” he added.

Chief of Asia’s largest pharmaceutical company urges transparency in virus vaccine rollout

TOKYO: Pharmaceutical firms must be “very transparent” about the risks and benefits of vaccines in efforts to end the coronavirus pandemic, the head of Asia‘s largest drugmaker has told AFP.

Takeda, one of the world’s biggest pharmaceutical companies, is not developing its own vaccine but has contracts with several firms to distribute their jabs in Japan and is also testing a virus treatment.

“We have to manage the situation well, be very transparent and extremely educative in the way we introduce products,” chief executive Christophe Weber told AFP in an interview.

“Medicines or vaccines are never perfect… there are always some side effects,” said Weber, who joined Takeda in 2014 and took the top job a year later after nearly two decades at Britain’s GlaxoSmithKline.

But he is optimistic the industry can explain the risks and benefits properly.

The Frenchman even sees a chance that the inoculation could help push back the growing tide of uncertainty and outright opposition to vaccination worldwide.

“It will be interesting to see. Vaccine hesitancy is strong, especially in some countries, but many vaccines are protecting against diseases that people never see,” he said.

“Here it’s different, everybody is seeing the impact of the coronavirus… so it could actually re-demonstrate the value of vaccines.”

Takeda inked a deal with the Japanese government and US firm Moderna Therapeutics in October to import and distribute 50 million doses of its vaccine in Japan from the first part of 2021.

The US Food and Drug Administration on Friday granted emergency authorisation for the Moderna jab — the same permission already granted to the Pfizer/BioNTech version.

Takeda has also signed a deal with US biotech firm Novavax to produce and deliver its vaccine in Japan, if ongoing clinical trials prove successful.

But the firm — which became one of the world’s largest pharma companies after its 2019 purchase of Ireland’s Shire — has decided not to develop its own coronavirus jab.

“When we assessed the situation and the technology that we have in-house, we felt we did not have the best technology to develop a vaccine,” Weber said.

– Covid-19 treatment – Japan’s pharmaceutical sector has moved comparatively slowly in the race to end the pandemic, and while companies including AnGes, Shionogi and Daiichi Sankyo are now developing vaccines, they are not expected to be available before 2022 at the earliest.

The country has however secured doses from players abroad, including Pfizer and AstraZeneca.

“There is no leading vaccine player in Japan,” said Weber, adding that Takeda hopes to develop in that direction, including with plans for a dengue vaccine.

He believes Japan’s biotech sector is less developed than that in the US because the country lacks the “vibrant spin-off mechanism” to help scientific research groups grow into successful start-ups.

“In Japan, scientific research and academia is strong, but there is much less in the way of spin-offs and venture capital,” he said.

“We need to make more efforts to generate this ecosystem in Japan,” he added, pointing to an open innovation research facility Takeda founded in 2018 that houses 70 companies, including young biotech firms.

And while it has shied away from coronavirus vaccines, Takeda has been working on a plasma therapy to treat the new respiratory disease in collaboration with an international alliance of drug manufacturers.

Called CoVIg-19, the treatment uses concentrated and purified antibodies taken from patients who have battled the coronavirus.

Weber expects clinical trial results for the treatment to be published early next year and says a timeframe for it to hit the market “will all depend on the data”.

He’s not concerned that the arrival of multiple vaccines renders the treatment irrelevant, warning “we shouldn’t drop the ball and assume vaccines will solve everything”.

“The vaccines don’t have 100 percent efficacy,” he said, adding that how long they protect for remains unclear and that some patients suffer conditions which prevent them from getting inoculated.

Vaccinating the entire world is also going to be a lengthy process, Weber stressed.

“There is still a great need for efficient treatments.”