Pfizer: How Pfizer’s partner BioNTech became a leader in the coronavirus vaccine race

By Bojan Pancevski and Jared S. Hopkins | Photo by Marzena Skubatz of The Wall Street Journal

Mainz, Germany-On Friday, late January, Uglu Shahin received an email containing bad news. A new study of the deadly new coronavirus in China has suggested that it is more infectious than previously believed. He believed that this outbreak could develop into a pandemic.

The following Monday, German scientist and CEO of a biotechnology company, BioNTech SE, will announce that the company, which was developing the next generation of cancer treatments, will begin developing the Covid-19 vaccine. I summoned a meeting. He added that human trials need to begin by April in case Europe and the United States had to be blocked.

Much of the world wasn’t aware of the danger yet, but BioNTech was scrambling, Dr. Sahin told The Wall Street Journal earlier this month that his lesser-known company was racing globally. He talked about a series of events that turned him into a front runner for the Covid-19 vaccine.

According to the CEO and a few employees, the directors and key employees, many of whom were trying to embark on ski vacations, initially opposed. However, he and his wife, BioNTech’s chief medical officer, Özlem Türeci, claimed to be the company’s co-founder and largest single shareholder.

“We had to do something convincing,” said Dr. Sahin. “Some people thought the situation in China was being hyped that it wouldn’t affect us.”

Nine months later, BioNTech has partnered with Pfizer Inc. and Tandem is nearing the end of clinical trials for vaccine candidates. Both companies may apply for urgent approval in late November and make shots available at that time or in December. BioNTech’s stock has nearly tripled in value since January.

The partnership between boutique German biotechnology and a major US pharmaceutical company began with a personal connection between Dr. Sahin and another German, Katrin Jansen, who is responsible for vaccine research and development at Pfizer.

The two had an early meeting in 2017 at Pfizer’s New York headquarters. At that time, Dr. Sahin was looking for a partner to work on a potential infectious disease treatment being developed by BioNtech. Dr. Janssen, a vaccine authority with a long list of academic and corporate qualifications, was initially skeptical of the BioNTech platform, but as they spoke, she became more acceptable.

“She was warned that she could be very tough, but I didn’t think she was. She asked a very good question and within 10 minutes we got a big understanding. I got it, “said Dr. Sahin.

In August 2018, the two companies agreed to develop an influenza vaccine. The injection is approved by Pfizer and is based on messenger RNA, also known as mRNA-a molecular courier that carries genetic instructions, when used in a vaccine, cells to create a protein that produces an immune response that protects against the virus. Instruct.

“Like other new technologies, mRNA needs to be scientifically proven, and at that time there was little evidence that RNA technology was effective in preventing infectious diseases,” Dr. Janssen said. .. “What was intriguing to this technology was the potential for RNA to develop better influenza vaccines that offer multiple potential benefits to the current approach.”

BioNTech does not yet have an approved treatment or vaccine. However, Dr. Sahin has been working with his wife on mRNA technology for over 25 years. In 2016, a couple of Turkish immigrant children who met while working at a cancer clinic sold their first company, Ganymed Pharmaceuticals AG, for € 1.4 billion ($ 1.66 billion).

BioNTech and Pfizer’s Influenza Jab were scheduled to enter human experimentation in 2020. However, Dr. Sahin’s pivot to Covid-19 in January confused the schedule. The epidemic has intensified in China, making it a good place to test vaccines. He is Shanghai Fosun Pharmaceutical Co., Ltd. I signed a contract with and tested the candidates there.

The BioNTech staff was divided into groups that worked for seven days, what Dr. Sahin called Project Lightspeed. The groups were separated to avoid infection if one member was infected. Dr. Sahin said he advised staff to stop flying and travel by car if possible.

By the end of February, BioNTech had identified 20 vaccine candidates, four of which were selected for the German trial. Techniques refined during the development of cancer treatments and flu vaccines have allowed the team to reduce the painstaking task of identifying candidates to months.

Dr. Sahin called Dr. Janssen on March 1 and a new partnership to test the Covid-19 vaccine in the United States as China became less attractive as a potential vaccine testing ground due to the authorities’ progress in virus containment. Proposed.

Dr. Janssen did not hesitate. “Of course I would be interested, which is probably the most important thing we have ever done,” she told Dr. Sahin.

Dr. Sahin proposed splitting the remaining development costs and benefits in between. Dr. Janssen accepted it, and he said the two companies began working on the project even before the deal was signed. Pfizer said Dr. Janssen had in principle agreed to work with BioNTech.

“It was all based on trust,” said Dr. Sahin.

“RNA technology has provided a faster path to clinical evaluation than traditional technology, and our cooperation on influenza has been very positive,” said Dr. Janssen. “Pfizer adds considerable development expertise and infrastructure to help BioNTech realize the potential of its technology. It took time to explore all the details, but We have reached an agreement to leverage the strengths of both in our pursuit of doing many things. It was unthinkable. ”

The video conference on March 14 brought together 60 executives and scientists from both companies to set out the legal and scientific terms of the partnership. Three days later, they announced the deal.

Under the agreement, BioNTech has agreed to open up mRNA research to Pfizer. Pfizer closed the infectious disease unit a few years ago. Scientists had to use Pfizer’s executive jets to reciprocate genetic material over the Atlantic Ocean because Europeans were banned from traveling in the United States, Dr. Sahin said.

According to Dr. Sahin, the collaboration between a 170-year-old pharmaceutical giant with nearly 100,000 employees and a 1,500 biotechnology company was surprisingly frictionless.

The agenda of the daily meeting and the mixed team have been established. Disagreements, such as which vaccine candidate to choose for the trial, were resolved among scientists within the team, regardless of company affiliation.

“There is no place for the ego. There is a lot of dialogue and that’s great,” said Dr. Sahin.

Initially, Dr. Sahin and Pfizer CEO Albert Bourla spoke several times a day. Then they embarked on a routine to connect every weekend to stock up on work for the week. Dr. Sahin said they made the most important decisions together, but did not meet in person until September when Bourla visited Europe.

Dr. Sahin has revealed that every vaccine will be a BioNTech product. Unlike influenza vaccination, Pfizer will seek a US license for the Covid-19 vaccine on behalf of BioNTech, not by itself, he said.

Pfizer said that BioNTech owns the intellectual property “mainly directed” to the vaccine, but new discoveries after the Covid-19 partnership began will ultimately be bio “depending on the nature” of the discovery. May be owned by either NTech or Pfizer.

Dr. Sahin’s claim to retain ownership of the vaccine came from his belief that it would support the company’s commitment to mRNA technology in other areas, such as cancer treatment, which is currently in clinical trials, he said. ..

As a result of BioNTech’s rise in stock prices this year, Dr. Sahin and Dr. Türeci are now one of the 100 wealthiest Germans. But this time, I’m not going to sell the company.

The first licensing of mRNA-based therapies will usher in a pharmacological revolution, he said, “and we will have the opportunity to shape this new industry.”

Please contact Bojan Pancevski ([email protected]) and Jared S. Hopkins ([email protected]).

(End) Dow Jones News Wire

10-22-20 0544ET