Connecticut Business E-News

flublokBy Mitchell Young

 MERIDEN: Sanofi, [NYSE: SYN] the $111 billion  Paris, France based pharmaceutical giant announced it will purchase Protein Sciences Corp. [PSC] for up to $750 million including an up-front payment of $650 million and another $100 million if the company reaches [unannounced] benchmarks].

Protein Sciences was recognized by Business New Haven in 2011 as a greater New Haven Healthcare Hero for Innovation.

PSC developed an innovative vaccine development technology and its non-egg based Flu vaccine, Flu-blok is the only non-egg based flu vaccine approved by the US Federal Drug Administration. The business information website estimates revenues of $34 million and 120 employees for the private company.

Sanofi does more than $40 billion in annual revenues and is one of a handful of major pharmaceutical companies with a significant vaccines’ business, approximately $5 billion annually.

In a world of pharma giants. marketing Flu-blok has been a challenge for PSC, a relatively tiny bio-tech, but that could change under Sanofi’s control

The company claims it is the world’s leading flu vaccine company with more than $1.5 billion in flu vaccine revenues.

"The acquisition of Protein Sciences will allow us to broaden our flu portfolio with the addition of a non-egg based vaccine," said David Loew, Sanofi executive vice president and head of Sanofi Pasteur, the company's vaccines' arm.

Manon M.J. Cox, President and CEO of PSC, said, “as part of Sanofi Pasteur, we expect our Flublok influenza vaccine to benefit from Sanofi Pasteur’s expertise in the field of influenza vaccines.”

Protein Sciences was founded in 1983 with the hopes of creating a vaccine for HIV/AIDS. The company struggled for more than a decade and short of funds recruited Daniel Adams, [current executive chairman of the board] to be its new CEO in 1995 and attract new capital to the company.

Adams had been a biotech executive at several companies and a co-founder [1976] and CEO of Biogen of Cambridge Mass. [now a $58 billion company].

Adams quickly jettisoned the HIV vaccine effort and turned the company toward what was hoped would be a somewhat easier target, a new non-egg based Flu vaccine.

Egg based vaccines take many months to grow and can take up to a year to produce supply once the appropriate viral target is identified.

And while with PSC technology a vaccine could be developed in days and scaled up in production in weeks, the industry’s respect for the technology and the company and its ability to attract capital was still proving difficult.

Things started to change with the September 11, 2001 terrorist attacks however, when Protein Sciences found itself on the front lines of the war against bioterrorism.

In an interview with Business New Haven, published in October 2001, then-CEO Adams revealed that the federal Centers for Disease Control (CDC) told the company that “we were the only ones who could make a vaccine to protect people against the pandemic flu in time to make a difference.”

At the time Adams suggested to the CDC that the deadliest threat might be not from bio-terrorism, but rather a reprise of the “Spanish” flu pandemic that killed 50 million people worldwide immediately following World War I.

Two years later that fear hit home across the globe, when the World Health Organization identified SARS as a new disease in 2003.

SARS spread rapidly and infected thousands of people around the world, including people in Asia, Australia, Europe, Africa as well as the Western Hemisphere.

By 2005 fear that another flu, Avian Flu virus (H5N1), would find its way to the U.S. and promising results by Protein Sciences in treating chickens against the flu convinced the FDA to put a PSC vaccine on the fast track.

By 2007 the U.S. Department of Health & Human Services committed $8.5 billion to address concerns of a pandemic flu through expanding existing vaccine facilities and funding new technologies. However, much of that money continued to be directed to large pharmaceutical companies and much of that to traditional vaccine methods.

Development costs were sinking the company just as the technology effort was turning the corner, cost for a clinical trial was $20 million.

In 2008, Protein Sciences announced the sale of the company for $78 million as word of a major U.S. government contract surfaced.

The development would be funded and finished by the acquirer, Emergent BioSolutions of Rockville Md. Emergent provided immediate funding to shore up Protein Sciences, but the deal soon fell apart with acrimony and lawsuits a plenty.

In early 2009 H1N1 surfaced as a potential pandemic virus. Like many flu strains, H1N1 started in birds and was transferred to pigs, which is why it was initially called swine flu. With pigs as hosts the flu became more suitable for transmission to humans. Eventually more than 17,000 people worldwide would die, in part due to lack of supply of vaccines.

In 2009 PSC won a contract from the Biomedical Advanced Research and Development Authority of the U.S. Department of Health & Human Services for up to $150 million for the development of its vaccine technology, clinical testing and eventual manufacturing of the FluBlok vaccine.

Development was able to continue and FluBlok received its initial FDA approval in 2013 at the time only for adults 18-49, subsequent approvals included adults 18 and over.