Pfizer-BioNTech raises 2021 Covid-19 vaccine output target; Sanofi’s API business to be called EUROAPI

Pfizer-BioNTech raises 2021 Covid-19 vaccine output target; Sanofi’s API business to be called EUROAPI

By PharmaCompass

2021-01-14Impressions: 1625

Pfizer-BioNTech raises 2021 Covid-19 vaccine output target; Sanofi’s API business to be called EUROAPI

This week Phispers brings you more updates on Covid-19 vaccines. While Pfizer-BioNTech raised its expected output for 2021 by over 50 percent and said it will produce 2 billion doses of its Covid-19 vaccine, there was news that Johnson & Johnson maybe facing unexpected delays in manufacturing its jab. However, J&J will be submitting Phase 3 trial data of its one-dose vaccine to the USFDA on January 21. Meanwhile, the top brass of Novavax sold some of its stock holding in the company to capitalize on the nearly 3,000 percent rally in its shares.

In non-Covid news, Sanofi acquired Kymab for up to US$ 1.5 billion in order to expand its immunotherapy pipeline. The French drugmaker also revealed the name of the API business that is being carved out — the unit will be called EUROAPI. In a small, two year study on 272 patients, Eli Lilly’s investigational Alzheimer’s drug showed some positive results. And Boehringer Ingelheim announced a tie up with Google for quantum computing in drug R&D.


Pfizer-BioNTech raises 2021 Covid-19 vaccine output target to 2 billion doses

Pfizer Inc and its German partner BioNTech SE plan to produce 2 billion doses of their Covid-19 vaccine this year, raising its expected output by over 50 percent in response to surging global demand. Earlier Pfizer-BioNTech were expected to produce 1.3 billion doses in 2021. With this increased target, 1 billion people will get the designated two-dose regimen this year, BioNTech said in a presentation at the JP Morgan Healthcare Conference which started this week. This year, the annual conference is being held completely online.

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BioNTechs projections now far outpace those of Moderna, which said it will produce between 600 million and 1 billion doses of its messenger RNA vaccine in 2021.

Pfizer-BioNTech plan to ramp up output with the help of contract manufacturers. A new manufacturing site in Marburg (Germany), acquired from Novartis in September, will boost annual capacity by up to 750 million doses. The plant is likely to become operational by February-end.

The new target takes into account a label change — doctors are now allowed to extract six doses instead of five from each vaccine vial. This will be done using special syringes, known as low dead space syringes, which will also reduce the wastage of unused liquid left in a syringe.

Meanwhile, scientists have said Pfizer’s jab works against a coronavirus mutation that has led to some highly transmissible variants that were first discovered in the UK and South Africa.

Researchers from the University of Texas and Pfizer found that in lab dishes, the vaccine was able to neutralize an engineered version of a variant, which bears an N501Y mutation in its spike protein. The N501Y mutation increases the transmissibility of the variant in humans. The finding hasnt been peer-reviewed.

Death of US doctor, post getting Pfizer jab: A 56-year-old doctor, Gregory Michael, in South Florida (US) died recently, two weeks after getting the first dose of Pfizer’s vaccine.

Health officials from Florida and the Centers for Disease Control and Prevention are investigating if the vaccine played a role in the death of the obstetrician. Michael’s family says he was in good health. In a statement, Pfizer said while it was aware of the death, it didnt think there was any direct connection to the vaccine.


Sanofi buys Kymab for up to US$ 1.5 billion to grow its immunotherapy pipeline

After the Angelini Pharma-Arvelle Therapeutics merger news last week, there is news of another M&A deal — Sanofi has agreed to buy British immunotherapy firm Kymab for up to US$ 1.45 billion.

As per the terms of the deal, Sanofi will pay US$ 1.1 billion upfront to gain full rights to Kymabs KY1005, an antibody therapy viewed as having the potential to treat a wide range of inflammatory disorders and immune-related diseases. KY1005 passed a mid-stage Phase 2a clinical trial in August. Sanofi has agreed to an additional US$ 350 million in milestone payments. Kymabs pipeline also includes KY1044, a cancer treatment currently in Phase 1/2 clinical development.

Of late, the French drugmaker has made a string of acquisitions. In November, Sanofi spent US$ 376 million (€308 million) on Dutch biotechnology company Kiadis, which specializes in cell-based immunotherapy products to treat cancer. In August, it bought US autoimmune diseases specialist Principia Biopharma for US$ 3.7 billion, following a US$ 2.5 billion investment to acquire immuno-oncology treatments group Synthorx in December 2019.

Sanofi’s standalone API business: In February 2020, Sanofi had said it plans to create a major European drug company that will produce and market active pharmaceutical ingredients (APIs) to third parties. The standalone API company will be created by combining Sanofis API commercial and development activities with six of its European API production sites. This week, the French drugmaker revealed the name of its API carve out — it will be called EUROAPI. Karl Rotthier, a former chief executive at Dutch company Centrient Pharmaceuticals, will be CEO of EUROAPI from January 18 this year.


Boehringer Ingelheim ties up with Google for quantum computing in drug R&D

This week, Boehringer Ingelheim announced a collaborative agreement with Google Quantum AI to develop new drugs using quantum computing.

Boehringer Ingelheim is the first pharmaceutical company in the world to join forces with Google for quantum computing. The partnership is designed for three years and is co-led by Boehringer Ingelheim’s newly established Quantum Lab.

Through this collaboration, Boehringer Ingelheim and Google plan to focus on implementing quantum computing in drug research and development, including molecular dynamic simulations.

“The new partnership combines Boehringer Ingelheims leading expertise in the field of computer-aided drug design and in silico modeling with Googles outstanding resources as one of the leading developers of quantum computers and algorithms,” a press statement said.


Novavax’s top brass cashes out with US$ 46 million stock sale

The top brass of Novavax not willing to wait to see how their Covid-19 vaccine performs, is busy cashing out on its stock holdings in the company.

The American vaccine development company’s CEO, Stanley Erck, and three other top executives have sold around US$ 46 million worth of Novavax’s stock since the start of 2020, according to a Reuters review of securities filings. This way, they have capitalized on a 3,000 percent rally in Novavax’s shares, fueled by investors betting on the success of its investigational vaccine.

During 2020, Erck cashed out US$ 8.7 million. The stock sale amounts to more than 20 percent of his vested stake in Novavax.

The company received US$ 1.6 billion in taxpayer funding under the US governments Operation Warp Speed program. Though Novavax is a key contender in the global race to develop vaccines against the novel coronavirus, there is no guarantee that it will be successful.

Meanwhile, Fujifilm Diosynth Biotechnologies, and the Texas A&M University System Center for Innovation in Advanced Development & Manufacturing (CIADM) announced that production has begun in Texas on two different Covid-19 vaccine candidates with support from the US government to meet Operation Warp Speed's goals.

Fujifilm Diosynth will produce bulk drug substance NVX‑CoV2373, Novavax’s vaccine candidate, which began phase 3 clinical testing in the US and Mexico in December 2020.


J&J lags in production; to submit trial data of its single-dose Covid jab this month

So far, the three popular Covid-19 vaccines released by Pfizer-BioNTech, Moderna and AstraZeneca-Oxford require two separate shots to be given to each person. Given the complexities of the two-dose vaccine regimen, Johnson & Johnson’s one-dose jab is being keenly awaited.

This month, J&Js preliminary data from the South African arm of a phase 3 Covid-19 vaccine trial will be ready for submission to the US Food and Drug Administration (FDA). If the data, which should be available by January 21, shows the one-dose vaccine to be safe and effective, J&J will approach the FDA and other regulators around the world for an emergency use authorization (EUA) in February.

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Though Moncef Slaoui, the chief scientific adviser to the US Operation Warp Speed program, has said an EUA by US regulators could be granted by early February, there is news that J&J is facing unexpected delays in the manufacturing of its coronavirus vaccine. As a result, J&J may not be able to supply the doses it promised the US government by spring.

According to a New York Times report, J&J has fallen two months behind the original production schedule and will not catch up until the end of April.

J&J's vaccine was developed by the companys Belgian unit, Janssen Pharmaceutical, and is based on viral adenovirus vector technology. The company entered into an agreement with the US in August 2020 to deliver 100 million doses of the vaccine following approval or EUA by the FDA, and the option to purchase up to 200 million additional doses under a subsequent agreement. Similarly, the EU signed a deal with J&J in October for the supply of up to 400 million doses.


Eli Lilly’s Alzheimer's drug shows positive result in two-year study on 272 patients

Drugmakers have spent billions of dollars in conducting research on amyloid-targeting drugs in their bid to find a treatment for Alzheimer’s disease. In November, a panel of expert advisers to the US Food and Drug Administration (FDA) voted against the effectiveness of Biogen’s aducanumab for the treatment of Alzheimers disease.

Given this scenario, there seems to be some good news from Eli Lilly. The drugmaker moved a step closer to finding a treatment for Alzheimer’s. The company announced this week that in a small clinical trial, an experimental Alzheimers drug — donanemab — slowed the rate at which patients lost the ability to think and care for themselves.

Donanemab is an investigational antibody that targets a modified form of beta amyloid. The trial, known as Phase 2 Trailblazer ALZ study, was conducted on patients with early symptomatic Alzheimer’s disease. “Donanemab met the primary endpoint of change from baseline to 76 weeks in the Integrated Alzheimer's Disease Rating Scale (iADRS), slowing decline by 32 percent relative to placebo, which was statistically significant,” the company said in a statement. The iADRS is a clinical composite tool combining the cognitive measure ADAS-Cog13 and functional measure ADCS-iADL, two commonly used measures for Alzheimer's disease.

The findings have not been published in any form, and have not been peer-reviewed. The two-year study involved 272 patients with brain scans indicative of Alzheimers disease. Their symptoms ranged from mild to moderate.

While the trial was going on, Eli Lilly started a second Phase 2 trial, Trailblazer 2, with results expected in 2023.

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