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As Promised, Alnylam Forms Another Big Pharma Alliance, This Time With Takeda

Less than two weeks after Alnylam Pharmaceutical CEO John Maraganore tried to reassure the investment community that his company can still strike large-scale alliances with pharmaceutical companies, Alnylam announced that it has forged a partnership with Japanese drug maker Takeda Pharmaceutical that could be worth more than $1 billion.
The arrangement gives Takeda worldwide, non-exclusive access to Alnylam’s RNAi intellectual property and technology to help develop drugs for cancer and metabolic diseases. In exchange, Alnylam will receive $150 million upfront, $50 million in near-term technology-transfer payments, and up to $171 million in development and commercial milestones, as well as royalties.
Takeda also has the right to expand the number of therapeutic fields covered under the deal for a payment of $50 million per field.
The deal, Alnylam’s first with an Asian drug maker, makes Takeda Alnylam’s sole strategic partner for RNAi therapeutics on that continent for five years, thus “expand[ing] the advancement of RNAi therapeutics to patients on a global basis," Maraganore said in a statement this week.
“If you had to list a single company in the whole Asian territory that has got the commitment to innovation and the success track record, it would be Takeda,” Maraganore said during a conference call to discuss the deal. “Working with the best is something we like to do, [and] working with the strongest and the best is even smarter.”
The alliance gives Takeda the right of first negotiation to develop and commercialize in Asia any Alnylam drug candidate the RNAi shop chooses to partner out in that territory. The deal excludes Alnylam’s respiratory syncytial virus drug ALN-RSV01, currently in phase II testing.
This aspect of the partnership leaves Alnylam free to pursue other options if Takeda is not interested in a particular drug program.

“This new, non-exclusive alliance is structured to provide even greater value to Alnylam than any previous deal done to date.”

“If, for whatever reason, there is a program that Takeda is not interested in … we, of course, have the freedom to work with other Japanese companies,” Maraganore noted. “It’s certainly not that product opportunities will lie fallow if they are not pursued by Takeda.”
This part of the deal remains subject to Alnylam’s obligations to other partners, including Novartis, which has the right of first offer on targets that Alnylam may want to partner with third parties.
Additionally, the alliance “is structured to provide even greater value to Alnylam than any previous deal done to date,” Maraganore said. In particular, Takeda’s $150 million upfront payment to use Alnylam’s technology and IP in two therapeutic fields compares “very favorably” with a deal Alnylam made with Roche last July in which the Swiss life-science giant forked over a $278 million upfront fee in exchange for a platform alliance for four fields, including oncology and respiratory, metabolic, and certain liver diseases (see RNAi News, 7/12/2007).
Other terms of the Takeda deal give Alnylam the option to jointly develop and commercialize in the US any of Takeda’s RNAi drug programs in cancer and metabolic disease on a 50/50 basis. Jason Rhodes, Alnylam’s vice president of business development, noted during the call that for each therapeutic field Takeda wishes to add to the deal, Alnylam will receive two additional opt-in rights.
“This opt-in right may be exercised by Alnylam as late as the start of phase III trials and we have simply no limitations on the products we choose,” Maraganore said during the call. “The decision, flexibility, and ability to exercise the opt-in late in clinical trials provide us with a major strategic advantage.”
He added that Alnylam will pay a “modest” fee for each Takeda program it opts into, and will reimburse half of the Japanese company’s drug-development expenses incurred up until that point.
In response to a financial analyst’s comment during the call that exercise of Alnylam’s opt-in rights could make the company responsible for hundreds of millions of dollars in drug-development expenses, Maraganore said that “we would obviously choose products that are consistent with the expense profile that we would want to invest in.
“If it’s a product that has clear phase II efficacy … that’s going to address a multi-billion [dollar] market, maybe half a billion [in reimbursement costs] is not a bad idea,” he added. “But we have the flexibility to decide if we want to go into that product or not.”
Maraganore said that the deal with Takeda is expected to “positively impact our remaining goals and … financial guidance for the year,” but said that specific updates won’t be provided until Alnylam reports its second-quarter financial results.