GlaxoSmithKline ($GSK) and Japan's number three pharma company Daiichi Sankyo have created a joint venture to bring new treatments to the Japanese market, according to a report in the Nikkei.
First, the JV plans to sell approved products contributed by each company, with GSK offering up its cervical cancer vaccine, according to a report in Reuters. Then the two plan to work on new products that aren't already available in Japan.
The key focus of the new JV is on vaccines. GSK sold ¥60 billion worth of vaccines in Japan last year, and Daiichi is looking to build up its work in a field that contributed $1.73 billion in revenue back in 2010.
As the hurdles to successful commercialization of new medicines continue to mount, the ability to find and exploit cost efficiencies in the development process has become a critical source of competitive advantage. This is true not only for biologic drugs but also increasingly for vaccines, now a high growth segment of the medicines business, with a more diverse range of therapeutic targets in addition to traditional prophylactics. This intensifies the pressure in designing vaccines trials to address complex conditions and to provide evidence of safety, immunological superiority and clear clinical differentiation. Creating the internal capabilities to advance the process and hedge these risk factors can be more important to achieving a timely market entry than the clinical merits of the compound itself.
Who leads in the race to throw a blanket of predictability over that costly, high thread-count passage from bench to bedside? Sanofi Pasteur, the company’s vaccine division, has made a strong start against its rivals with a novel imitative, in vitro test and assay technology that can predict the immune response of a human individual or group to a vaccine candidate.
Sanofi acquired the technology in 2010 with the purchase of VaxDesign, a Florida-based company which invented a predictive modeling tool, Modular IMmune In vitro Construct [MIMIC], that simulates a clinical trial artificially, using human immune cells. This “virtual” approach lowers the cost and risks associated with relying on live patients or animals, and provides an early indication of how to structure a real trial in a way most likely to produce the tangible results expected by regulators. The outcome is – hopefully – fewer abandoned late stage trials and a better batting average in bringing promising vaccines forward to market approval.
Dr. Michel DeWilde (SVP R&D, Sanofi Pasteur), Dr. Elias Zerhouni (President Global R&D, Sanofi) and Olivier Charmeil (President and CEO, Sanofi Pasteur) at the new Orlando-based R&D facility.
Next for VaxDesign: Diseases of Age
On Monday, Sanofi’s President of Global R&D, Dr. Elias Zerhouni, and the Sanofi Pasteur leadership team dedicated a new R&D facility at VaxDesign’s HQ in Orlando, Fla. In a discussion with Pharm Exec following the ceremony, Zerhouni and colleagues said that the new facility and the 65 scientists hired to staff it was an expression of confidence in the VaxDesign approach, which will now be leveraged by the entire company to support R&D work in areas in addition to vaccines, such as age-related diseases and conditions. Following the demographic path of US baby boomers, the new facility will look for ways to apply the VaxDesign work to Sanofi’s portfolio on preventive treatments for the old—which may also fill a well of need among tens of millions of aging Chinese.
“This is a practical application of translational research, with the potential to guide development for any compound that triggers an immunological response, Zerhouni said. “We’ve come very far in science but it is still a complex mystery what the impact a new medicine has when taken by a human being. VaxDesign helps make sense of that mystery by facilitating a more targeted drug design, at an earlier stage of the development process.” Olivier Charmeil, President of Sanofi Pasteur, noted the MIMIC in vitro approach would not only improve prospects for successful trial design but also provide better guidance toward making those “early kills” that avoid huge costs further down the development line, in Phase II (b) and beyond. He also sees an opportunity for a steep reduction in the use of animals in testing—a sensitive reputational spot.
All in all, another step signifying the value of innovations in process as well as product. And the era of the virtual clinical trial? It’s real, not a misnomer—it’s coming.
A guest writer in a recent article in the Wall Street Journal repeated the oft quoted Jonas Salk statement about his Polio vaccine: “There is no patent. Could you patent the sun?” Many use this statement as the moral impetus for refusing patents on medically important innovations (see Michael Moore’s Capitalism: A Love Story). Unfortunately, Jonas Salk created a myth that day by leaving out several crucial details.
As pointed out by Robert Cook-Deegan at Duke University, “When Jonas Salk asked rhetorically “Would you patent the sun?” during his famous television interview with Edward R. Murrow, he did not mention that the lawyers from the National Foundation for Infantile Paralysis had looked into patenting the Salk Vaccine and concluded that it could not be patented because of prior art – that it would not be considered a patentable invention by standards of the day. Salk implied that the decision was a moral one, but Jane Smith, in her history of the Salk Vaccine, Patenting the Sun, notes that whether or not Salk himself believed what he said to Murrow, the idea of patenting the vaccine had been directly analyzed and the decision was made not to apply for a patent mainly because it would not result in one. We will never know whether the National Foundation on Infantile Paralysis or the University of Pittsburgh would have patented the vaccine if they could, but the simple moral interpretation often applied to this case is simply wrong.”
While the debate on whether patents are the best way to incentivize medical innovation and commercialization continues, that debate should proceed without reliance on this myth regarding the history of the Polio vaccine.
By David Welch, President/Senior Producer at M2 MultiMedia
When the HIV/AIDS epidemic became widely known in the early 1980s I lived in San Francisco. I lost many dear friends during those years. That made working on “HIV/AIDS and Biotechnology” very personal to me.
Thirty years later and despite an all-too-common public perception that this terrible disease has been solved, the research to find a vaccine is actually more important than ever. The sad truth is that the cost in both human lives and economic treasure remains astronomical.
Producing this short film for BIO about the role of biotechnology in the on-going fight to save lives and dollars brought me face-to-face with three awesome individuals: a researcher, a patient, and an advocate. The researcher is Dr. David Asmuth, one of the world’s leading HIV experts. The patient, Brian Brown, received VACC-4X, a biotech vaccine produced by Bionor Pharma, in a clinical trial and went a full 18 months without anti-retroviral treatments. The advocate is Stephen Bailous, executive vice president of the National Association of People with AIDS (NAPWA) — he’s also an HIV survivor.
Together, these three men send a compelling message to all of us: If we are to conquer HIV/AIDS the necessity to fund sustained biotechnology research has never been more vital and more hopeful.
I wish to thank our entire team, especially our director Emily Deckelman, for their commitment to producing this important video.
David Welch is President/Senior Producer at M2 MultiMedia, a science oriented video production company in Rockville, MD. His email is dwelch@m2inspired.com
