Pharmaceutical Technology Editors

Pfizer and BioNTech announced on Jan. 22, 2021 that they have entered into an advance purchase agreement with COVAX, a global initiative focused on providing lower-middle-income countries with access to COVID-19 vaccines, for up to 40 million doses of the Pfizer-BioNTech COVID-19 vaccine, BNT162b2.

Under the terms of the agreement, the first doses of the vaccine will be delivered during the first quarter of 2021 and will be provided to COVAX at a not-for-profit, undisclosed price, Pfizer said in a company press release.

"At Pfizer, we believe that every person deserves to be seen, heard, and cared for. That's why from the very beginning of our vaccine development program, Pfizer and BioNTech have been firmly committed to working toward equitable and affordable access of COVID-19 vaccines for people around the world," said Pfizer Chairman and CEO Albert Bourla, in the press release. "We share the mission of COVAX and are proud to work together so that developing countries have the same access as the rest of the world, which will bring us another step closer to ending this global pandemic and proving that science will win for everyone, everywhere."

“SARS-CoV-2 does not differentiate between borders—a global pandemic requires comprehensive solutions and worldwide collaboration. COVAX is a truly global initiative and we are happy to support by making BNT162b2 available in many low- and lower-middle-income countries to help protect vulnerable people worldwide,” added Ugur Sahin, MD, CEO and co-founder of BioNTech, in the press release.

Articles

The companies have entered into an advance purchase agreement with COVAX to provide up to 40 million doses of the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, to lower-middle-income countries.

Pfizer and BioNTech Enter into Agreement with COVAX for COVID-19 Vaccine Delivery 

On Jan. 20, 2021, Janet Woodcock, MD announced in a 

 to FDA staff members that she will serve as acting commissioner of FDA, taking over for Stephen Hahn, FDA’s previous acting commissioner.

Woodcock joined FDA in 1986 and has held several positions, including deputy commissioner and chief medical officer, deputy commissioner for operations, chief operating officer for the commissioner’s office, and director of the Center for Drug Evaluation and Research (CDER).

“I know you all have endured hardships while carrying out our public health mission, balancing work and family, and trying to stay safe. It has not gone unnoticed,” she wrote in her note. “I believe life will improve in 2021, but I don’t know how quickly that will happen. The hope keeps me going. I look forward to working with you to achieve our vital public health mission, and with our HHS [Department of Health and Human Services] partners and The White House during this transitional period.”

Woodcock will serve as acting commissioner of FDA, taking over for Stephen Hahn, FDA’s previous acting commissioner. 

Janet Woodcock to Serve as Acting Commissioner of FDA

Merck, known as MSD outside the United States and Canada, announced on Jan. 25, 2021 that it is discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates, V590 and V591, to focus on advancing its two SARS-CoV-2/COVID-19 therapeutic candidates, MK-4482 (molnupiravir) and MK-7110. MK-4482 (molnupiravir) is being developed in collaboration with Ridgeback Bio, a US-based biotechnology company. 

According to a company press release, the decision came about after it was concluded that while the vaccines were well tolerated in Phase I clinical studies, the immune responses from participants were lesser to those seen following natural infection and those reported for other COVID-19 vaccines. Currently, the company is advancing clinical programs and scaling up manufacturing for its therapeutic candidates.

“We are grateful to our collaborators who worked with us on these vaccine candidates and to the volunteers in the trials,” said Dr. Dean Y. Li, president, Merck Research Laboratories, in the press release. “We are resolute in our commitment to contribute to the global effort to relieve the burden of this pandemic on patients, health care systems, and communities.”

The company is discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates, V590 and V591, to focus on advancing its two SARS-CoV-2/COVID-19 therapeutic candidates, MK-4482 and MK-7110. 

Merck Halts Development of its COVID-19 Vaccine Candidates

Eli Lilly and Company announced on Jan. 22, 2021 that it has completed its $1.5 billion acquisition of Prevail Therapeutics, a US-based gene therapy company.

Through the acquisition, Lilly will have access to Prevail’s portfolio of clinical-stage and preclinical neuroscience assets that include PR001 for patients with Parkinson's disease with GBA1 mutations and neuronopathic Gaucher disease, PR006 for patients with frontotemporal dementia with GRN mutations, PR004 for patients with specific synucleinopathies, and possible gene therapies targeted at Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis, and other neurodegenerative disorders, Lilly said in a Dec. 15, 2020 company press release. With Prevail’s pipeline, Lilly will work to create a new gene therapy program.

"We are pleased to complete the acquisition of Prevail and establish a gene therapy program at Lilly that has the potential to deliver transformative treatments for patients with neurodegenerative diseases such as Parkinson's, Gaucher, and dementia," said Mark Mintun, MD, vice president of pain and neurodegeneration research at Lilly, in a Jan. 22, 2021 company press release.

https://investor.lilly.com/news-releases/news-release-details/lilly-announces-agreement-acquire-prevail-therapeutics

https://investor.lilly.com/news-releases/news-release-details/lilly-completes-acquisition-prevail-therapeutics

Through the acquisition, Lilly will have access to Prevail’s portfolio of clinical-stage and preclinical neuroscience assets.

Eli Lilly Completes $1.5 Billion Acquisition of Prevail Therapeutics

Grifols, a Spanish pharmaceutical and chemical manufacturer, announced on Jan. 18, 2021 that it has initiated a clinical trial in Spain to evaluate a new COVID-19 drug based on its immunoglobulin, Gamunex-C, and antibodies from plasma donors who have recovered from the disease.

According to a company press release, the drug offers immediate post-exposure protection against the virus and will serve as a counterpart to the vaccine during its early phases. Additionally, the new drug has the potential to contain COVID-19 outbreaks in areas where vaccination measures haven’t started or are still underway.

“[The drug] is easy to refrigerate while its subcutaneous administration facilitates its distribution and use in any doctor’s office, avoiding hospitalization,” said Dr. Antonio Páez, medical director at Grifols, in the press release. “If the new therapy’s efficacy is confirmed, it could be administered to people who test positive for the virus through PCR and antigen tests in hospitals and primary care offices.”

The drug offers immediate post-exposure protection against the virus and will serve as a counterpart to the vaccine during its early phases.

Grifols Initiates Trial for New COVID-19 Drug

Merck, known as MSD outside the United States and Canada, announced on Jan. 20, 2021 that FDA has approved Verquvo, its soluble guanylate cyclase stimulator for the reduction of the risk of cardiovascular death and heart failure hospitalization in adults with symptomatic chronic heart failure.

The approval was based on positive data from a randomized, parallel-group, placebo-controlled, double-blind, event-driven, multi-center trial that compared the drug to a placebo in more than 5000 participants with symptomatic chronic heart failure, Merck said in a company press release. Verquvo proved to be more effective than the placebo in reducing the risk of cardiovascular death or heart failure hospitalization based on a time-to-event analysis.

“Verquvo has been shown to reduce the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient IV [intravenous] diuretics. We are pleased to offer a meaningful new treatment option for appropriate patients with symptomatic chronic heart failure,” said Dr. Roy Baynes, senior vice-president and head of global clinical development, chief medical officer, Merck Research Laboratories, in the press release. “This approval builds upon Merck’s proud history of developing therapies for the treatment of patients with cardiovascular disease.”

Verquvo is a soluble guanylate cyclase stimulator for the reduction of the risk of cardiovascular death and heart failure hospitalization in adults with symptomatic chronic heart failure. 