Deal Flow

Show me the vial

As work on recombinant vaccines speeds up at the global level as part of efforts to develop a Zika vaccine, Flublok, the FDA-approved flu vaccine that has been shown clinically to be more than 40 percent more effective in protecting you from cell culture confirmed flu than a traditional flu vaccine, is struggling to compete against market consolidation by big pharmacy chains

Photo courtesy of Protein Sciences

Manon Cox, the president and CEO of Protein Sciences, which is launching a social media campaign, #showmethevial, to encourage customers to demand their drug stores to offer Flublok, an FDA-approved recombinant flu vaccine for adults 18 years and older.

By Richard Asinof
Posted 9/19/16
To increase the market share for its FDA-approved recombinant flu vaccine, Flublok, Protein Sciences is launching a social media campaign, #showmethevial, to encourage customers to demand that their pharmacies provide them with the flu shot that has been clinically proven to be more than 40 percent more effective in preventing cell culture confirmed flu than a traditional flu shot for people 50 years or older. It is recommended for anyone 18 years or older.
Will the potential for increased demand by customers for Flublok create more transparency around the costs and pricing for flu vaccines as well as for measurements that compare effectiveness? How will the big chain pharmacies respond to such consumer challenges such as #showmethevial? Will the push to develop a Zika vaccine become a tipping point in the adoption of recombinant technology to produce vaccines? Will the governors of Connecticut, Rhode Island and Massachusetts be willing to get Flublok as their flu shots this year?
The continued threat of climate change and the way that it is reshaping the virulence of health threats, seen in the emergence of Zika and Chikungunya, raise questions about the continued vehemence of deniers in the face of incontrovertible scientific evidence. Some of it no doubt emanates from fear, some of it from deliberate misinformation. There is a similar kind of denial community building around vaccines, driven in part by fear and some deliberate information – but also in part by the limitations of flu vaccines produced by what some say are antiquated technologies and manufacturing processes.
There are many who still may believe that President Barack Obama was not born in America and that the Earth is flat, regardless of the evidence. But the willingness of big pharmacy box stores to deliver to its customers a recombinant flu shot that has been proven more effective clinically would be an important step in rebuilding a consensus around the value of getting a flu shot.

MERIDEN, Conn. – A customer in Dallas, Texas, raved about the results after receiving Flublok last year as her annual flu shot, having read about the FDA approved recombinant flu vaccine manufactured by Protein Sciences in a ConvergenceRI story. She then enthusiastically shared the story with all her friends, family and colleagues.

This year, she went back to the Target pharmacy where she had received last year’s flu shot, only to discover that it no longer supplied Flublok, because the Target pharmacy chain had been taken over by CVS Health as part of the continuing consolidation of the pharmacy market within big box stores.

Thanks to a new locator program, Flublok Finder, on the Flublok website, the satisfied Flublok customer was able to find a pharmacy near her home that offered the clinically proven more effective flu shot, particularly for customers over the age of 50.

Underside of the business
The story had a happy ending for one customer, but it illustrates a not-so-pretty underside of the big chain drug store business: big chains may be marketing less effective flu vaccines to the public and in turn preventing access to more effective flu vaccines by customers, allegedly maximizing profits over better health outcomes.

At a time when drug companies are in the news for their egregious efforts to jack up prices for drugs in order to increase profits at the expense of customers, resulting in a huge public outcry, the same kind of scrutiny may soon await the practices of big drug store chains around flu shots.

Because flu shots are considered preventive, most health insurers cover the costs, including Medicare Part B. In turn, big box stores and pharmacy chains often use the promotion of flu shots as a lure to encourage more traffic into the store, where customers can be enticed to buy other products, according to some market research reports.

At CVS Pharmacy and MinuteClinic, for instance, patients can get a flu shot any day of the week, including evenings and weekends, with no appointment needed, according to public relations officials at the firm.

In turn, one-third of all U.S. adults who have ever received a flu shot determine where to get vaccinated based on convenience, according to an annual flu survey by CVS.

[The lowest cost for a patient who does not have health insurance is $39.99 for what's known as the Quadrivalent flu vaccine, which protects against four strains of the influenza virus that are circulating most seasons, including A H1N1, A H3N2 and two B viruses, according to a CVS public relations spokeswoman. A higher dose of the flu vaccine costs $64.99.]

The problem is that in both the 2013-2014 and again in 2015-16 flu seasons, the flu shots offered had low effectiveness in combating the flu strains that were circulating the globe, in part because of the antiquated way flu vaccines are manufactured, using a 70-year-old, egg-based technology, and in part because of the way that flu viruses rapidly morph, change and evolve, creating strains that exhibit low immunogenic properties, limiting a vaccine’s effectiveness.

For the 2016-2017 flu season, similar questions have been raised about the effectiveness and limitations of the current flu vaccine to combat the H3N2 influenza virus by Nancy Cox, Ph.D., the former director of the Influenza Division at the Centers for Disease Control and Prevention, in her keynote address at the Options IX for the Control of Influenza conference, held in Chicago, from Aug. 24-26.

“Walgreens and CVS, they are very much stuck [in their commitment] to using the cheaper vaccines,” explained Dr. Manon Cox, the president and CEO of Protein Sciences, in an interview with ConvergenceRI last year.

The reason, she continued, is that “flu vaccines are a way to get people into their stores, not necessarily to keep them healthy.”

Marketing more effective flu vaccines in the age of consolidation
For Cox, the marketing of Flublok in the age of pharmacy chain consolidation has proven to be a major hurdle.

For the 2015-2016 flu season, Protein Sciences was licensed to bring some 1.2 million doses of Flublok to market. Demand for the more effective flu vaccine, however, fell short of expectations. Only some 250,000 doses of Flublok were sold, causing a major loss for the company.

This year, for the 2016-2017 flu season, Protein Sciences has lowered the number of the doses of Flublok to about 1 million, according to Cox.

The news so far this year has been encouraging, Cox continued, in an interview with ConvergenceRI last week. “We have already shipped as many doses this year as we shipped for all of last year,” she said.

But Cox expressed exasperation at the current market situation: “It’s crazy,” she said. “You have a better product, clinically proven to be more effective, the end users may want it, but if you don’t have access to the [big chain] outlets,”  Flublok becomes more difficult to bring to the consumer.

In response, Protein Sciences has developed a new social media marketing campaign, with the slogan, “Show me the vial,” asking customers to demand that pharmacists show them the actual vial to confirm that it is Flublok. [This year, Flublok is only available in single dose vials; next year it will also be available in prefilled syringes.]

If customers demand Flublok for their flu shot, it can be shipped overnight to the pharmacy, at no charge to the customer, according to Cox.

Protein Sciences is also partnering in fundraising efforts with Go Red for Women, targeting women’s health efforts. The data from large population studies show that patients who receive flu shots are 50 percent less likely to suffer a heart attack during the flu season, because flu viruses can often inflame arterial plaque, according to Cox.

Flublok, with its clinically proven effectiveness of more than 40 percent above a traditional vaccine, could offer women with heart health concerns a better choice, according to Cox.

Another piece of good news is that insurance administrators at Cigna and Humana will now offer $55 for reimbursement for Flublok, according to Cox.

Customer loyalty
One of the big pharmacy chains offered to buy up all of the available doses of Flublok for next year’s flu season, when the quadrivalent version of Flublok will be available in prefilled syringes. but Cox plans to honor loyalty to her existing customers.

“There are a lot of independent pharmacies in severe competition with very big multinationals, such as CVS and Walgreens, competing for the business,” she said. “We are loyal to the people who have bought from us before.”

The word about Flublok is spreading, Cox continued. “Customers want our product and don’t want something else,” she said, in parallel with the story told by the customer in Dallas.

To help accelerate an uptick in the market, Cox said that Protein Sciences was in conversations with some Big Pharma companies and expected to be able to announce a marketing partnership by the end of the year.

“Flublok is a life-saving product that performs much better than other flu vaccines,” Cox said, adding that she did not understand how pharmacy chains could offer incentives “to provide the cheapest flu shot possible” and not care about the performance of the vaccine.

Just the facts
ConvergenceRI reached out to CVS Health, the Woonsocket-based firm with annual revenues of some $153 billion in 2015, to ask: if customers requested Flublok, would CVS provide the recombinant flu vaccine?

Amy Lanctot, senior manager, Public Relations at CVS Health, responded by saying: “The Flublok vaccine is available at CVS Pharmacy and MinuteClinic upon request.”

However, that policy from corporate headquarters may not yet have reached some pharmacists. When ConvergenceRI went into several CVS stores in Rhode Island and requested the Flublok vaccine, the pharmacists asked said that CVS did not offer it, it was not available, and it could not be ordered.

Work on a Zika virus
Protein Sciences is also involved with work to develop a recombinant antigen vaccine for the Zika virus, working in collaboration as part of international consortium, in which five partners have each invested $500,000 for a total of $2.5 million in seed money to develop a vaccine candidate, according to Cox.

The work is taking the Flublok approach, creating proteins that can help a person’s immune system neutralize the virus, according to Cox.

By making specific changes to what’s known as the envelope protein of the virus, Cox continued, it becomes a very simple, straightforward process to get that product and make a Zika vaccine.

The capability to manufacture such a vaccine is not the issue, Cox explained. “What we’re trying to do is to convince the government partners that you want to deploy vaccines based on a technology that will be fast, safe and effective in combating the Zika virus,” she said.

With the $2.5 million in seed money, there are enough resources to generate the preliminary data and entice a public-private partnership with the government in order to fast track the work, Cox believes.

The reality is that the National Institutes of Health, Health and Human Services and the World Health Organization are usually going to look at products that come from big companies, Cox told ConvergenceRI.

“You have to have someone behind you with deep pockets and a lot of money,” Cox said, explaining the advantages of the international consortium, which includes companies from Japan, Mexico, and Argentina as well as the government of Brazil.

Shifting the paradigm
Has the paradigm shifted toward the use of recombinant technology to manufacture vaccines?

Cox believes that the jury is still out but “we are getting there; it has taken a long time,” she said, adding that it was encouraging to hear former CDC health officials such as Nancy Cox talking about the limitations of traditional vaccines.

“You can have data in mice as much as you want, with beautiful scientific rationales, but unless you have proven that it works in humans, no one is going to believe you,” Cox said, explaining why the clinical tests in Australia to develop an optimized recombinant vaccine to the H7N9 avian flu, working in collaboration with EpiVax, recenlty funded with a $600,000 SBIR award, is so important. [The new money will look at further improving a version that is currently being tested in Australia.]

“Until you have the human data, you’re always going to have naysayers,” Cox said.


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