To quote Tuesday’s Wall Street Journal, “Novavax is a winner.”
That certainly seems to be the consensus after the company released big news on Monday. According to the Maryland based company, Phase II clinical trials of its seasonal influenza virus-like particle vaccine showed the vaccine was well tolerated and worked well against three types of seasonal flu, including H1N1.
There are several reasons why this is an important development for the company, but there is a more daunting reason why this is big news for mankind.
Simply put, without faster processes for producing influenza vaccines that protect against new strains, pharmaceutical companies will be backed up and unable to help slow a pandemic.
Just last month, the World Health Organization reported that the swine flu viruses aren’t producing enough of a key vaccine ingredient, which has limited the amount of vaccine that is available. Its laboratory network went to work to produce a new set of viruses that it hoped would work better, and while some drugmakers have said they are running behind schedule others insist they will be able to start shipping the bigger batches of vaccine soon. Meanwhile, world governments with bigger pockets have placed huge orders with companies like Baxter International Inc. (NYSE: BAX), GlaxoSmithKline PLC (NYSE: GSK), NOVARTIS (NYSE: NVS) and Sanofi-Aventis SA (NYSE: SNY), moving them to the front of the line as other, less fortunate countries are being left to fend for themselves.
As Science Progress points out, for decades, most experts have agreed that the process of manufacturing influenza vaccine using hens’ eggs is archaic and needed to be improved. But because biotech funding seems to follow the trail of super drugs generated by big pharmaceutical companies, the standard has remained.
So what happens the moment a deadlier strain hits?
Would this process suffice? No
According to experts at the Department of Health and Human Services, producing a vaccine to protect the entire U.S. population against a pandemic would require an enormous supply of eggs: 900 million are necessary to produce 300 million doses. If strains hit that are too virulent and deadly, this process will fall way short.
Fortunately, Novavax appears to be blazing a path to faster production and better quality of flu vaccines.
The company circumvents the slow boat approach of taking the actual influenza virus, growing it, and then inactivating it. Instead, Novavax's recombinant, cell culture based VLP technology makes a genetic match to the flu strains of interest. It does not require live flu virus seed that has to be adapted to grow in eggs to create the egg-based vaccine.
This attribute of recombinant virus-like particle (VLP) will lead to a more efficacious vaccine against the flu strains that are circulating around the globe.
The results released as part of this study provided Novavax's first human data to support this hypothesis. Thus, this method could potentially meet the demands of “surge capacity” in the face of a pandemic.
That’s not all.
When VPLs are injected into a patient, the immune system reacts as if it were attacking a real virus, creating anti-bodies against it, and giving the patient immunity when the real strain attacks. Unlike traditional vaccines, these VLPs do not run the risk of becoming virulent again, making them safer to use.
The study showed that Novavax's VLP vaccine was not only well tolerated, but it also induced strong hemagglutination inhibition (HAI) antibody responses against three influenza strains: H1N1, H3N2, and B strains. That demonstrated the potential for VLP vaccines to be cross-protective against flu viruses from different seasons without the addition of an adjuvant.
Furthermore, the responses met the seroconversion criteria for licensure as outlined in the FDA guidance document for influenza vaccine development and if it’s good enough for the FDA, it’s not implausible to think that the door may have just been opened for other governments to fast-track the testing and licensing of Novavax’s VLP vaccine technology.
It’s not unheard of. Even the European Medicines Agency, the EU’s top drug regulatory body, has accelerated the approval process for the current swine flu vaccine, and countries such as Britain, Greece, France and Sweden say they’ll start using the vaccine the moment it’s greenlighted.
In an interview with The Associated Press, Dr. Keiji Fukuda, the World Health Organization’s flu chief, warned about the potential dangers of untested vaccines, although he stopped short of criticizing Europe’s approach outright.
“One of the things which cannot be compromised is the safety of vaccines,” Fukuda said. “There are certain areas where you can make economies, perhaps, but certain areas where you simply do not try to make any economies.”
NVAX’s reach across the pond has already begun. In June, the company announced an initial agreement to license its proprietary (VLP) vaccine technology to ROVI Pharmaceuticals of Spain. ROVI will use it to create a comprehensive influenza vaccine solution for the Spanish government under a new 60 million-euro program sponsored and led by the Spanish Ministry of Health and other government groups to develop pandemic and seasonal flu vaccines and establish its only in-border facility. This program, which was announced by Spanish health officials, is being launched to develop safe and effective flu vaccines to serve the entire population of Spain.
Under separate agreements, ROVI will receive exclusive licenses to Novavax's portable VLP vaccine technology to commercialize flu vaccines in Spain and Portugal, and non-exclusive licenses in Europe, Latin America and Africa. As part of the deal, Novavax is also set to receive royalties from ROVI's sales of their products, and will retain exclusive rights to the vaccine in North America, Asia and Australia.
In July, Cadila Pharmaceuticals announced the launch of a joint venture with Novavax in India. Under that agreement, the two will launch a joint venture, called CPL Biologicals Pvt. Ltd., which will develop and manufacture vaccines, biological therapeutics and diagnostics in India.
Novavax told The Associated Press that the deals would “bring the company development funding needed now and will be worth tens of millions of dollars in future royalty and milestone payments once the vaccines are approved and marketed.''
The safety of flu vaccines is a concern both here and abroad. Flu vaccines have been used for 40 years, and many experts say extensive testing is unnecessary, since the swine flu vaccine will simply contain a new ingredient: the swine flu virus, but European officials won’t know if the new vaccine causes any rare side effects until millions of people get the shots. Still, they say the benefit of saving lives is worth the gamble.
Novavax’s safety results strongly support moving forward with larger head-to-head trials of the VLP and egg-based vaccines, the first of which is scheduled to start this autum in elderly adults, according to the company.
"The safety and immunogenicity results from this study give us confidence to move our seasonal influenza VLP vaccine candidate forward into late phase development," said Dr. Penny Heaton, Chief Medical Officer and Vice President of Development of Novavax. "Given the immunogenicity results we saw with our VLP vaccine candidate as compared with the egg-based vaccine, we are now particularly excited to begin the larger head-to-head study in elderly adults this Fall," Dr. Heaton said.
Make no mistake, NVAX’s ability to produce more powerful vaccines in a little under two weeks and the study’s numerous other results have changed the game. Some on Wall Street now feel that the company has painted a clear "take-over bulls-eye" on their back, but that isn’t causing anyone to become distracted at Novovax headquarters. Everyone is more strongly committed and supportive of accelerated development of Novavax's pandemic influenza vaccines, including the novel H1N1 2009 influenza VLP vaccine.
"We are working tirelessly with partners and governments worldwide to potentially provide H1N1 vaccine to regions without an indigenous supply," said Dr. Rahul Singhvi, President and Chief Executive Officer of Novavax. "The current influenza pandemic underscores the potential for Novavax's advanced influenza vaccine technology to have significant public health impact by providing vaccine in time to those in need," said Dr. Singhvi.
Expect more news from the company as new milestones are reached and other study results are announced. I wouldn't be surprised to hear something positive as early as as next week.
Biotech investors interested in accessing the complete database of clinical trials and upcoming FDA decisions can access that information on at BioMedReports.
Disclosure: Long NVAX