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Salk Institute Inks Regenerative Medicine Research Pact with Sanofi-Aventis

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The Salk Institute for Biological Studies last week announced it has inked a drug-discovery alliance with Sanofi-Aventis in the area of regenerative diseases, marking the second broad-based research pact the institute has penned in as many years with a pharma company.

Under the agreement, which is for up to five years, Sanofi-Aventis' regenerative medicine program will sponsor "discovery grants" throughout the institute that will pair Sanofi and Salk scientists on mutually interesting research projects.

The pact also calls for Sanofi-Aventis to provide undisclosed and unrestricted funding for Salk's stem-cell core facility each year over the course of the agreement.

The alliance, which was formalized by a memorandum of understanding signed in February, follows in the footsteps of a similar deal Salk inked in early 2008 with French specialty pharma Ipsen.

Under that agreement, which was Salk's first broad-based corporate research pact, Ipsen agreed to pay Salk as much as $12.5 million over five years to create the Ipsen Life Science program at the institute and fund applied and basic biological research in disease areas of interest to Ipsen, particularly inflammation (see BTW, 1/16/08).

It is unclear how the size and scope of that agreement will compare with Salk's deal with Sanofi-Aventis because the latter's financial details have not been disclosed. A Sanofi spokesperson referred questions about the deal to a statement released by Salk.

However, as an industrial partner Sanofi represents a step up from Ipsen in terms of size: One of the top-10 largest pharmaceutical companies in the world, Sanofi said it spent €4.6 billion ($6.1 billion) on worldwide R&D in 2008. By comparison, Ipsen spent about €183 million during that period.

Both collaborations stem from a recent effort by San Diego-based Salk to change its reputation as an insular, basic-research only institution, Michael White, senior director of the Salk Office of Technology Management and Development, told BTW this week.

"In order for Salk's research to benefit mankind, and to satisfy the needs of our investigators to see their work carried further, we began to realize that we need to have access to, and collaborate with, companies that can actually take things to the next step," White said.

"We do very basic research here," he added. "We're target-rich. We don't have a chemistry department. We're not making thousands of compounds. So the question is, 'How do we further what we're doing in terms of getting the science out?'"

One way is through research partnerships with the breadth of the Sanofi and Ipsen deals, White said. Such academic-industrial partnerships have been common in the engineering field for decades, he added, and have only in recent years gained popularity in the life sciences industry. In particular, over the past five years, pharmaceutical companies have been dipping into academic waters to replenish their dwindling R&D pipelines as they gradually lose patent protection for their drugs.

"I think it's something new for us, because the thinking here was, up until about three or four years ago, that we don’t need the outside world," White said. "We collaborated with other [academic] scientists and were doing just fine. But I think the realization is that a lot of these things need resources and capabilities that are beyond what a basic biological research institute can give."

The second major driver for Salk was a need to maintain research funding levels in the face of a flat budget resulting from cuts to the National Institutes of Health and the broader financial downturn, White added.

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"NIH funding has been level — actually negative, if you count inflation — over the last three or four years," he said. "So the question that also arose was, 'How do we maintain our labs and our people with this downward trend in funding?'"

French Connection?

That Sanofi-Aventis and Ipsen are both headquartered in Paris is a coincidence, White told BTW, as the partnerships came about quite differently.

The Ipsen partnership was facilitated primarily by a personal relationship between Salk researcher Inder Verma and Ipsen executives. Meantime, Salk and Sanofi got their talks started at last year's Biotechnology Industry Organization annual meeting in San Diego when Salk officials met Remi Brouard, a vice president for external innovation at Sanofi who is responsible for sniffing out potential collaborations at US West coast institutions.

According to White, once talks started heating up late last year, Salk stem-cell researcher Juan Carlos Belmonte traveled back to his home country of Spain and was asked to give a presentation on his work at Sanofi's Paris headquarters.

"Sanofi said that they really wanted to get into regenerative medicine," White said. "So their initial focus when they came back was to do something around this area, and we explored whether we could do some kind of broad-based agreement."

Using the Ipsen agreement as a guideline, Salk and Sanofi hammered out their own deal. One aspect includes Sanofi-sponsored collaborations through so-called "discovery innovation grants." Under this program a joint committee of Sanofi and Salk representatives twice yearly will decide new areas of research in which to solicit proposals, and determine which projects should be initiated.

"The idea is that there will be scientists from Sanofi and Salk working on the project together," White said. "Let's say we have a diabetes target, and our scientists want to look up- and downstream of that target. They may be able to supply compounds, screening technology, or animal models that we don't have."

As part of the agreement, Sanofi does not have automatic rights to intellectual property generated from such projects, and cannot hold up scientific publication, but has the benefit of being "in the know" when the research is of interest to therapeutic programs at the company. If desired, Sanofi can negotiate an official sponsored research agreement at any time, including the usual IP rights included therein.

In a statement, Marc Cluzel, senior vice president of research and development at Sanofi, said that the company's goal "is to advance scientific knowledge, mostly in stem cell research, and apply major discoveries made under this strategic alliance toward diagnostics or therapies for human disease.

"We believe one way this can be expedited is through a collaborative research agreement in which the talents and expertise from Salk and Sanofi-Aventis are joined in an environment that favors creativity and early access to sciences," Cluzel added.

"If these things are set up properly, there is no way they can influence publications or research direction," White said. "Our scientists design the projects, and are not being told what to do. Nobody here has to do this. If they want to they can. If they do a sponsored collaboration, they get the same rights as any company. There is nothing unique there."

Sanofi will also contribute an undisclosed amount of money annually, with no restrictions, to Salk's stem-cell core facility, which the institute set up through alternative funding sources to support the burgeoning amount of stem-cell research there.

"We had to set up a separate facility, buy separate equipment, and hire separate people," White said. "They're going to make a gift of a certain amount of money annually. It's not the total support, but it will help."

And though the initial research focus will be in the area of regenerative medicine, "as our scientists get to know each other, there could be interest in many other research areas," White said.