Sticking its feet into the pool

Alnylam joins GSK in donating intellectual property to patent pool for neglected tropical diseases

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CAMBRIDGE, Mass.—Since it established a patent pool to aid in the discovery and development of new medicines for the treatment of 16 neglected tropical diseases in March, U.K.-based GlaxoSmithKline PLC (GSK) has been a bit lonely, with no one else joining it there. But that all changed in early July, when Alnylam Pharmaceuticals Inc. became the first company to contribute intellectual property to the pool.

All told, Alnylam will contribute more than 1,500 issued or pending patents on its RNA interference (RNAi) technology patent estate to the patent pool—tripling the number of patents in the pool, which GSK jump-started with 800 patent filings of its own. Both companies hope that the combined intellectual property (IP) will lead to many new targets and treatments for neglected tropical diseases (NTDs), with or without contributions from anyone else.

"We are delighted that Alnylam will join GSK in this important program by adding their unique RNAi technology to the patent pool," says Andrew Witty, CEO of GSK. "The key objective of the pool is to make it easier for researchers across the world to access intellectual property that may be useful in the search for new medicines to treat neglected tropical diseases. The more companies, academic institutions and foundations that join the pool, the more effective it will be. Alnylam's announcement … is therefore a welcome and significant step forward."

As of late July, no other companies had come forward to join, but GSK Director of Product Communications Lisa Behrens says, "Our announcement about the patent pool and the subsequent posting of the patents and patent applications on attracted a lot of interest from a number of quarters. We've been in discussion with a number of groups about the patent pool but are not in a position to share more specific information at the moment. Over time, we hope there will be more announcements along the lines of the one we made with Alnylam."

"I strongly suspect that other companies and organizations will join and participate in this patent pool," says Dr. John Maraganore, CEO of Alnylam. "I think that we will not be the last one by any stretch of the imagination. I do think that because we are like-minded with GSK about our commitment to these types of diseases and patient-physician needs, we've been quicker to respond than others, but this is just the beginning."

The diseases targeted by the pool are the 16 diseases identified by the U.S. Food and Drug Administration (FDA) for its own NTD initiative: tuberculosis, malaria, blinding trachoma, buruli ulcer, cholera, dengue/dengue haemorrhagic fever, racunculiasis, fascioliasis, human African trypanosomiasis, leishmaniasis, leprosy, lymphatic filariasis, onchocerciasis, schistosomiasis, soil transmitted helminthiasis and yaws. The geographic focus of the pool will be the world's least developed countries as identified by the United Nations and includes much of western and central Africa as well as several countries in Southeast Asia.

By adopting a more flexible approach to intellectual property, the patent pool is intended to facilitate access to compounds and technologies for organizations that want to conduct research on treatments for these neglected diseases. What Alnylam brings to the table is an RNAi platform that provides an innovative approach to drug discovery and development through gene silencing, which targets the cause of diseases by potently silencing specific messenger RNAs, thereby preventing disease-causing proteins from being made.

Although he admits that parting with any kind of IP is a move that will make a company take pause, Maraganore says that being too conservative in protecting Alnylam's own interests would be hard to justify when his company touts itself as being committed to the innovation of medicines, including important new medicines for neglected diseases that afflict millions of people each year.

"We have built a strong IP base over the years and broadly enabling technology platform for RNAi, and it would be impossible to build the kind of company we aspire to be and ignore the health needs of so many people in some of the world's poorest nations," Maraganore notes. "There are leaders and turtles. Leaders stick their necks out and turtles pull them back into their shells. We want to be a leader, and that means finding your moral compass and being willing to perhaps take a little trade-off and face the potential goblins that come from putting your IP out there for free."

Alnylam will be providing RNAi intellectual property, technology and know-how on a royalty-free, non-profit basis in "least-developed countries" via licensing agreements with qualified third parties engaged in research efforts focused on discovery of new medicines for NTDs and their distribution to least developed countries.

In the near term, Alnylam's RNAi technology is expected to help validate novel drug targets for the discovery and development of treatments for the targeted NTDs. For example, the technology has already helped to identify new targets for malaria treatments. In the future, RNAi therapeutics may themselves be developed and used directly in the treatment of more neglected tropical diseases.

High five

Alnylam extends RNAi therapeutics collaboration with Novartis into a fifth year

CAMBRIDGE, Mass.—RNAi therapeutics company Alnylam Pharmaceuticals Inc. in mid-July elected to extend the company's RNAi therapeutics collaboration with Novartis for a fifth and final planned year, through October 2010.

Initiated in October 2005, the "landmark alliance," as Alnylam calls it, is focused on the discovery, development, and commercialization of RNAi therapeutics toward a defined number of Novartis-selected disease gene targets.

"This is the second extension that Novartis has elected to make, which we believe reflects the success of our collaborative efforts as well as the scientific progress we have made in advancing our innovative technology to patients," says Dr. John Maraganore, CEO of Alnylam. "Novartis has been an industry pioneer in recognizing the potential of RNAi therapeutics as a new class of medicines, and we look forward to continuing our work with them."

In the Novartis-Alnylam collaboration, both companies are jointly responsible for RNAi discovery activities and Novartis is generally responsible for development and commercialization of RNAi therapeutic products.

With the extension of the alliance term, Novartis will continue to fund collaboration research and development efforts conducted by Alnylam. Novartis retains its rights and conditions as per the original 2005 agreement. This includes a right to exercise a non-exclusive platform from Alnylam, in exchange for certain payments due upon platform license exercise, as well as an undisclosed payment and future milestones and royalties. Further, Novartis retains certain rights to purchase Alnylam equity up to its current ownership level, which is approximately 13.4 percent.

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