(NIH Director Francis Collins drew drug companies into an unusual pact)
Ten big drug companies that have spent billions racing one another to find breakthroughs on diseases like Alzheimer’s have formed an unusual pact to cooperate on a government-backed effort to accelerate the discovery of new medicines.
Under a five-year collaboration to be announced on Tuesday, the companies and the National Institutes of Health have agreed to share scientists, tissue and blood samples, and data. They aim to decipher the biology behind Alzheimer’s, Type 2 diabetes, rheumatoid arthritis and lupus, and to thereby identify targets for new drugs.
The price tag, roughly $230 million, is relatively small: The global drug industry spends about $135 billion a year on research and development. But the collaborators seek something money can’t buy.
By pooling their brightest minds and best lab discoveries they hope to put together a research system that can decipher the diseases in ways each hasn’t been able to on its own.
Diseases like Alzheimer’s and diabetes “are looming tsunamis,” says Elias Zerhouni, research-and-development chief of Sanofi SA, SAN.FR +0.22% a participant. Deciphering them “could not be done by any single organization. Even the NIH, with all of its might, doesn’t have all of the solutions inside it. And no one company can do it.”
The pact is unusual because drug companies are traditionally secretive about their science, rushing to acquire patents to protect rights to potential future drugs. The new agreement bars participants from using any discovery for their own drug research until the project makes data public on that discovery.
“The moment the project results are out,” says David Wholley, director of research partnerships of the Foundation for the NIH, “all-out competition resumes to develop the winning drug. And that’s what the patients want.”
Taking a page from the “open-source” movement that has swept the software world, the group will share all findings with the public, for anyone to use freely to conduct their own experiments.
The alliance involves rivals such as Bristol-Myers Squibb Co. BMY +0.62% , Johnson & Johnson JNJ -0.18% and GlaxoSmithKline GSK.LN +0.54% PLC. A number of foundations, including the American Diabetes Association and the Alzheimer’s Association, have agreed to back the project and to help recruit patients for trials.
Most of today’s drug-development programs fail, often in the expensive clinical-trial phases in which a company tests a drug on patients. Frequently, the failure happens because the company has an imperfect understanding of the disease at an early research stage before it begins looking for a potential drug.
The new pact involves that early stage. Under the plan, dubbed the Accelerating Medicines Partnership, the collaborators hope to gain a better understanding of how each disease works, and then use that knowledge to find molecules, or “targets,” that play important roles in the courses that each disease can take and could be attacked with potential drugs.
The plan also seeks to create methods to better measure how a disease is progressing and is responding to treatment. Getting more targets right early on should reduce costly failures later.
“A drug company really wants to know where it should put its next billion-dollar bet in a new area of therapeutics,” says NIH Director Francis Collins, who spearheaded the effort and is well known for having led the federal human-genome project.
The payoffs could be better medicines for lucrative markets. The market in 2018 could be about $60 billion for diabetes treatments and $4.6 billion for Alzheimer’s drugs, says EvaluatePharma, an industry-analysis firm. Analysts say a more-effective Alzheimer’s drug could more than double the market.
There are already approved drugs for the four ailments, but Alzheimer’s lacks one that can slow its memory-robbing march, and all of the diseases lack cures.
The collaborators don’t expect quick cures. Though some researchers have started using new technology to decipher the biology behind certain diseases, the efforts are relatively unproven. And it can take over a decade to develop a drug and get federal approval after finding a target.
Critics are likely to debate the group’s choice of diseases and to ask whether the companies are exploiting federal money to support their commercial agendas, says Sanofi’s Dr. Zerhouni, a former NIH director.
Participants, including Takeda Pharmaceutical Co. 4502.TO +0.75% , say the four diseases are among the largest public-health threats and that the project, if successful, could expand to other diseases.
Then there is the question of whether the rivals can really get along and hold off on competing.
Distrust and dissent marked the path to the pact. Prospective participants pointedly disagreed at times over which diseases to focus on, how to share management of the project and when to bail out if results didn’t bear fruit, says Dr. Collins, the NIH director.
“We had moments of sharp elbows,” he says, particularly as the rivals hashed out research plans last summer.
Some companies have declined to join. Amgen Inc. AMGN -0.83% says it didn’t join because the project overlaps with its own effort to use human genetics to help discover new medicines. Amgen in 2012 bought an Iceland company that sequences genes, and it aims to use that information to find drug targets in ways similar to the NIH pact. Still, Amgen says it is “strongly supportive” of the NIH collaboration.
Roche Holding AG RO.EB -0.04% didn’t join because the group dropped the disease Roche was most interested in—schizophrenia—but is “very open” to joining in the future, a spokesman says. AstraZeneca AZN.LN +0.57% PLC didn’t join, but a spokeswoman says it “will continue to see how it develops.”
The theory behind the project is that many of the clues and tools already exist that science needs in order to unlock the biology of diseases—but that the pieces are scattered among federal and academic labs, and behind corporate walls. By putting the pieces together, the theory goes, scientists can much more quickly decipher the biological puzzles.
Here is how the project will work: The companies and the NIH have agreed to contribute scientists who are experts on each disease, along with relevant data and samples from clinical trials, and to share costs.
Companies must share their current research that is within the project design, says an NIH spokesman, but needn’t share “other downstream and competitive activities on these same diseases” that aren’t within the pact’s scope.
“The disease-specific project teams will be watching for any reticence to share,” says the NIH’s Dr. Collins.
The NIH and companies—as well as academic research centers with grants from the project—will do lab tests and other studies. Companies will assist in recruiting patients and provide the “deep computing” for analyses. NIH scientists will review progress and provide help with scientific decisions.
The project aims to map molecular paths that each disease follows and to identify key points that could be targets for treatment. In Type 2 diabetes, for instance, researchers hope to catalog the genetic changes that raise or lower a person’s risk for developing the disease.
It also will seek novel methods to measure each disease’s course while assessing if a potential drug is working. Being able to measure a disease’s progress in that way could speed drug development by raising a company’s confidence that an experimental drug is working, or let it more quickly end a project if a drug isn’t working.
The pact sets mileposts for each disease to assess whether researchers are making progress. After discoveries are made public—or a project is abandoned—the companies may compete using the findings.
The NIH pact isn’t the first public-private drug collaboration, but it is one of the most ambitious in scale in the number of diseases, in the number of companies and in its goals.
The pact also marks a new stage in the industry’s evolution toward openness. In recent years, companies have become more willing to share resources in research pacts with government and academic labs—and with one another—on specific diseases. Most pacts, however, give the participants any rights to findings, rather than making them open to anyone as the new NIH project does.
“I kind of look at it as a Google Maps of human disease,” says Mikael Dolsten, Pfizer Inc. PFE +2.75% ‘s research-and-development chief.
The project shouldn’t face any antitrust concerns, the NIH says, because it involves early, “pre-competitive” research and will make all results freely available.
The project harks to a 2011 pharmaceutical conference. Drug-industry research heads groused to the NIH’s Dr. Collins that developing a drug through federal approval takes over a decade, has a failure rate of 99% and costs $1 billion for each success, says Dr. Collins.
Dr. Collins invited industry scientists to a November 2011 meeting with academic and NIH researchers. He pitched them a bold idea: to combine their scientific and financial power with the NIH’s to map the biology of all diseases. There was serious skepticism among executives, he says, who “were choking on the magnitude” of the idea.
He tried a second meeting in May 2012. “Another failure,” he says. He phoned Pfizer’s Dr. Dolsten, asking, “Do we have a project or not?”
Dr. Dolsten said companies needed projects that fed their drug pipelines. A consulting-firm report concluded that companies would collaborate if the focus narrowed to specific diseases: Alzheimer’s, diabetes, schizophrenia, rheumatoid arthritis and lupus.
Dr. Collins set up research teams for each disease, but industry executives remained unconvinced. They insisted on timetables and benchmarks to ensure their funding and work wouldn’t disappear into the “federal bureaucracy,” one participant says.
“The concern I had was that the money not go to a purely academic exercise” but have goals and direction, says Tadataka Yamada, Takeda’s chief medical and scientific officer.
Then there was the human element. Kathy Hudson, an NIH deputy director, says that participants would approach her after meetings to complain about others. At other times, some weren’t even talking with one another.
Figuring out how to cooperate despite being rivals, says Jan Lundberg, who leads Eli Lilly LLY +0.84% & Co.’s research laboratories, had a “bonding role: Do we respect each other as scientists and human beings?”
In the fall of 2013, Dr. Collins sent plans on the five diseases to the drug companies. For schizophrenia, too few wanted in. The decision “was more business than science,” says Dr. Collins, who dropped schizophrenia.
For the past three months, he held weekly conference calls with drug-company R&D heads to make sure they were committed, as lawyers ironed out details. By last month, the 10 firms had agreed to participate. Dr. Collins plans to announce the collaboration at the National Press Club on Tuesday.
Συνεργασία φαρμακευτικών εταιρειών και αμερικανικής κυβέρνησης για νέες θεραπείες
Σύμφωνο συνεργασία συνήψαν δέκα κορυφαίες εταιρείες φαρμάκων στο πλαίσιο μιας προσπάθειας να επιταχυνθεί η ανακάλυψη νέων φαρμάκων, που υποστηρίζεται από την υποστηριζόμενης από την αμερικανική κυβέρνηση.
Όπως αναφέρεται σε σχετικό δημοσίευμα της εφημερίδας Wall Street Journal, οι φαρμακευτικές εταιρείες σε συνεργασία με τα Εθνικά Ινστιτούτα Υγείας των ΗΠΑ θα μοιραστούν δεδομένα, δείγματα ιστών και αίματος, καθώς και ανθρώπινο δυναμικό προκειμένου να αναπτυχθούν νέα φάρμακα για ασθένειες όπως η νόσος Αλτσχάιμερ, ο διαβήτης τύπου ΙΙ, η ρευματοειδής αρθρίτιδα και ο συστηματικός ερυθηματώδης λύκος.
Η «Σύμπραξη για την Επιτάχυνση της Παρασκευής Φαρμάκων», όπως ονομάστηκε η συμφωνία, θα κοστίσει περίπου 230 εκατομμύρια δολάρια και θα συμμετάσχουν σ’ αυτήν, μεταξύ άλλων οι φαρμακευτικοί κολοσσοί Bristol-Myers Squibb Co, Johnson & Johnson, GlaxoSmithKline, Takeda Pharmaceuticals και Sanofi.
Η συμφωνία απαγορεύει στους συμμετέχοντες να χρησιμοποιήσουν οποιαδήποτε ανακάλυψη για να αναπτύξουν δικό τους φάρμακο έως ότου το πρόγραμμα δημοσιοποιήσει τα δεδομένα της ανακάλυψης αυτής.