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Sanofi allegedly destroyed emails linked to Zantac recall; Moderna says IP waiver won’t increase mRNA jabs supply
This week’s Phispers brings you more updates on mRNA vaccines, as they witness a surge in demand from countries across the world. After the Biden Administration announced its support for a global waiver on patent protection for Covid-19 vaccines, Moderna CEO said the waiver is unlikely to help increase supply since very few companies across the world know how to make mRNA vaccines.
In the US, the emergency use authorization granted to Pfizer’s vaccine has now been extended to adolescents. Its partner, BioNTech, has announced it is setting up a manufacturing facility in Singapore to produce a wide range of mRNA vaccines and therapeutics beyond their Covid-19 collaboration with Pfizer.
As the pandemic continues to cause devastation across India, the WHO has designated B.1.617 as a variant of concern. Eli Lilly entered into a pact with three Indian drugmakers for baricitinib, a rheumatoid arthritis drug prescribed for use along with remdesivir for treatment of Covid in India.
The recall of heartburn drug Zantac in the US due to an impurity believed to cause cancer continues to haunt French drugmaker Sanofi. According to a court filing, Sanofi destroyed internal emails linked to 2019 recall of Zantac.
Meanwhile, AbbVie’s Allergen Aesthetics announced it is acquiring Soliton and its rapid acoustic pulse device Resonic. And Eli Lilly struck a deal with MiNA Therapeutics to develop small activating RNA candidates across key therapeutic focus areas.
Moderna CEO says US support for IP waiver unlikely to help increase supply of mRNA jabs
Last week, we had carried news on how the Biden administration had announced its support for a global waiver on patent protection for Covid-19 vaccines. A day after this announcement, Moderna held its first quarter earnings call where its CEO Stéphane Bancel dismissed any speculation that the US government’s support for IP waiver would impact the company’s bottomline.
“It doesn’t change anything for Moderna,” he said, adding that there is a lack of mRNA vaccine manufacturing capacity in the world. “People don’t know how to make it,” Bancel said. He said he didn’t think the waiver would increase supply of mRNA vaccines over the next two years.
“If someone wants to start from scratch, they would have to figure out how to make mRNA, which is not in our patents,” he added. “I really believe that the IP is not the issue. For mRNA, this is the wrong question.”
Morgan Stanley said in an investor note that it does not believe the WTO has any mechanism to force management to teach other manufacturers how to make their vaccine. The same view was held by others. On Twitter, an IP lawyer said Bancel’s statements only confirmed that Moderna’s statement issued in October last year, where it had said the company will not enforce its Covid-19 related patents against those making vaccines, “was just a PR stunt”.
“Drugmakers like Moderna will not do anything that comprises a dollar of their profits unless they are forced too,” the lawyer tweeted.
In a patent law weblog — Patent Docs — Kevin E. Noonan said the extent to which a private company’s patent or other IP rights are protected under the terms of GATT/TRIPs “depends on actions of these governments in enforcing them on the company's behalf.”
Meanwhile, Moderna announced US$ 19.2 billion in projected sales from its vaccine for this year. Last week, Pfizer had said it expects US$ 26 billion in revenues from the sale of its mRNA vaccine in 2021. Like Pfizer, Moderna also plans to file its vaccine for full approval this month with the US Food and Drug Administration.
Sanofi allegedly destroyed emails related to Zantac recall
In April last year, the US Food and Drug Administration had ordered a ban on heartburn drug Zantac and its generics over fears of an impurity that is believed to cause cancer. Though Zantac exited drug stores in the US, the problem is far from over for French drugmaker Sanofi.
According to a court filing, Sanofi destroyed internal emails tied to a 2019 recall of Zantac. This was revealed by lawyers for more than 70,000 former patients who have sued the company in the US. Sanofi and other drugmakers face lawsuits alleging they concealed cancer risks from the drug.
Lawyers for the former patients claim the emails could have been key evidence to show that Sanofi permitted Zantac to be tainted with a suspected carcinogen. “The mishandling of emails has resulted in the delay and/or postponement of many key Sanofi depositions,” lawyers for former patients said. They have asked for more time to prepare for their first trials, set to start next year.
Sanofi officials have begun an internal probe on the email destruction and are scheduled to deliver a report in August. Sanofi “did not intentionally destroy any emails related to the Zantac litigation,” a spokeswoman told Fierce Pharma via email. “Any suggestion to the contrary is false.”
Ashleigh Koss, a US-based spokeswoman for the French drugmaker, said “Sanofi is working to obtain as much of the data as possible from alternative sources.” According to her, the issue has no impact on the strong defenses Sanofi has in this litigation, “and the company remains fully confident in the safety of Zantac.”
WHO calls B.1.617 variant of concern; Lilly in pact with three Indian drugmakers for baricitinib
As India continues to reel under the devastation caused by the second wave of Covid-19, with over 348,000 cases and 4,205 deaths being reported on Tuesday, the focus has now shifted on the coronavirus variant — B.1.617 — first identified in India.
The World Health Organization (WHO) has designated B.1.617 as a 'variant of concern’.
Maria Van Kerkhove, Covid-19 Technical Lead at WHO, said: “In consultation with our virus evolution working group, and our Epi (Expanded Program on Immunizations) teams and our lab teams internally, there is some available information to suggest increased transmissibility of B-1617; as such we are classifying this as a variant of concern at the global level.”
This lineage consists of at least three sub-lineages — B.1.617.1, B.1.617.2 and B.1.617.3. Health authorities in England are believed to be especially concerned about one strain — B.1.617.2 — as it appears to spread more quickly than the two other identified subtypes of this variant.
There are also concerns regarding the efficacy of vaccines against B.1.617. While Chris Whitty, England’s chief medical officer said the variant appears less likely to be vaccine resistant than other variants, an article published in Biorxiv said vaccines are not totally effective on B.1.617.
The WHO has also said several factors potentially contributed to the “resurgence and acceleration” of Covid-19 transmission in India. In its Covid-19 weekly update, WHO said these factors include “several religious and political mass gathering events which increased social mixing”.
Lilly in pact with Indian drugmakers: In the face of India’s Covid emergency, the regulator has authorized rheumatoid arthritis drug baricitinib for emergency use when combined with Gilead’s antiviral remdesivir. The combo therapy is intended for hospitalized patients requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation.
Last week, Lilly said it would supply India with an initial 400,000 tablets of baricitinib to help the country battle its raging outbreak.
The Indianapolis-based drugmaker has signed licensing agreements with three Indian generic drugmakers—Cipla, Lupin and Sun Pharma—to expand baricitinib’s availability in the country.
Meanwhile, an India drugmaker — Natco Pharma — began rolling out its generic version of the baricitinib under the Barinat brand, ahead of the approval of patent waiver. Natco Pharma has filed for a compulsory license for baricitinib in India. According to a Times of India report, Natco launched its 4 mg tablets last week and stocks of the drug are already available in the market.
WHO advises against use of ivermectin: Research published recently in the American Journal of Therapeutics says regular use of the oral anti-parasitic drug ivermectin may significantly reduce the risk of contracting Covid-19. However, in February this year, Merck — the drugmaker that manufactures ivermectin — had issued a statement that said the company has not found any evidence to support the drug’s use in treating Covid-19. Now, several Indian states have started prescribing ivermectin as a prophylactic for Covid-19.
This week, WHO’s chief scientist Soumya Swaminathan tweeted that the UN agency recommends against the use of the drug to treat Covid-19 patients, except within clinical trials. Swaminathan included Merck’s press release from February in that tweet.
Swaminathan’s tweet came a day after the government of Goa announced it would give all people older than 18 years ivermectin – irrespective of whether they have Covid-19 or not — to “bring down mortality”. A case management protocol issued by the Tamil Nadu government also prescribes 12 mg of ivermectin for three days for people with all forms of Covid-19.
FDA expands EUA for Pfizer’s jab to include adolescents; BioNTech to make mRNA vaccines in Singapore
The US Food and Drug Administration (FDA) has expanded the emergency use authorization (EUA) for the Pfizer-BioNTech vaccine to include adolescents (12 to 15 years of age).
“Today’s action allows for a younger population to be protected from Covid-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic,” acting FDA commissioner Janet Woodcock said.
In the US, from March 1, 2020 through April 30, 2021, approximately 1.5 million Covid-19 cases in individuals 11 to 17 years of age have been reported to the Centers for Disease Control and Prevention (CDC).
“Having a vaccine authorized for a younger population is a critical step in continuing to lessen the immense public health burden caused by the Covid-19 pandemic,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said.
After reports of complications surrounding rare, but dangerous blood clots being linked to the AstraZeneca and Johnson & Johnson’s vaccines, the global demand for mRNA vaccines from Pfizer and Moderna has witnessed a sharp increase. Last week, there was news that Moderna plans to ramp up manufacturing and has pledged to supply 3 billion doses a year, starting in 2022.
This week, there is news that BioNTech is setting up a manufacturing facility in Singapore to produce a wide range of mRNA vaccines and therapeutics beyond their Covid-19 collaboration with Pfizer. The facility will produce mRNA vaccines and treatments for a plethora of illnesses ranging from cancer to infectious diseases. The plant will have fill-finish capability and annual capacity of several hundred millions of doses of mRNA-based vaccine.
Construction on the plant is set to start this year, while its office is set to open later in the year. The facility is expected to go online in 2023.
AbbVie’s Allergen Aesthetics buys Soliton; Lilly inks deal with MiNA Therapeutics
Allergan Aesthetics, an AbbVie company, and Soliton have announced an agreement under which Allergan Aesthetics will acquire Soliton and Resonic — its rapid acoustic pulse device which recently received US Food and Drug Administration’s clearance. This is a non-invasive treatment for the short-term improvement in the appearance of cellulite. The acquisition of Soliton expands and complements Allergan Aesthetics’ body contouring treatment portfolio.
Allergan Aesthetics unit will pay US$ 550 million in cash to acquire Soliton and Resonic. The novel platform technology uses non-invasive rapid, high-frequency sound waves to disrupt targeted cellular structures and connective tissue, physically impacting the fibrous septae beneath the skin that contribute to the dimpled appearance of cellulite.
Eli Lilly, MiNa Therapeutics deal: Eli Lilly has struck a deal with MiNA Therapeutics to develop small activating RNA (saRNA) candidates against up to five targets across its key therapeutic focus areas. Lilly is paying US$ 25 million upfront and committing to milestones of up to US$ 245 million per target to work with MiNA.
Under the terms of the agreement, MiNA will utilize its saRNA platform to research up to five targets selected by Lilly that aim to address diseases across Lilly’s key therapeutic focus areas. Lilly will be responsible for preclinical and clinical development of candidates and will retain exclusive commercialization rights for any products resulting from the collaboration.
“Small activating RNAs are a promising new technology, which will expand the breadth of Lilly's RNA therapeutics platform and the targets we can pursue,” said Andrew C. Adams, vice president for new therapeutic modalities at Lilly.
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