Four years ago Alnylam $ALNY jazzed the start of the JPMorgan conference with news that Sanofi had stepped up to pay $700 million for a chunk of its stock and the right to expand its commercial rights to the biotech’s lead drug, patisiran. But with patisiran on the verge of winning likely regulatory approval this year, the companies have once again restructured their deal in a way that gives Alnylam global control over its future.
Alnylam will now handle the global marketing for patisiran and ALN-TTRsc02, with the expected launch coming for ATTR amyloidosis. In return, Sanofi is landing global rights to fitusiran for hemophilia A and B.
The rest of the deal terms remain in place, with the two collaborators exchanging royalties on sales.
The move underscores Alnylam CEO John Maraganore’s confidence that the biotech can score big on patisiran, which is headed into a commercial rival with Ionis $IONS, which has also racked up positive data for its hATTR amyloidosis drug. Most analysts, though, give Alnylam a distinct edge after reviewing the pivotal data being hustled to the FDA and EMA.
Alnylam says it expects to land an OK from the FDA in mid-2018, with a green light from the EMA following soon after.
The new deal comes just weeks after regulators lifted a clinical hold on fitusiran, which was put in place following the death of a patient due to a blood clot. Sanofi had paid $100 million to opt in on fitusiran 10 months before the hold was clamped down on the late-stage study.
Notes Leerink’s Paul Matteis:
Under the new agreement, ALNY gains ROW commercialization rights for patisiran while retaining their rights to the US, Canada, and western EU. SNY now stands to receive tiered royalties of up to 25% on ROW sales for patisiran, with the caveat that in Japan, SNY will receive a flat royalty rate (not tiered) of 25%. ALNY gaining ROW rights to patisiran in exchange for the royalty is likely to have a more modest impact on our model. More impactful, the new agreement gives ALNY full global development and commercial rights to their follow-on TTR product ALN-TTRsc02 and ALNY will pay SNY tiered royalties of 15%-30% on global net sales. Finally, SNY will obtain full global development and commercialization rights to fitusiran (hemophilia). Per the agreement, ALNY stands to receive tiered royalties of 15%-30% on global net sales of fitusiran.
“This strategic restructuring enables streamlined development and an optimized approach to bringing innovative medicines to patients with ATTR amyloidosis and hemophilia around the world, maximizing the commercial opportunities for these programs,” said Maraganore. “For Alnylam, this provides strategic clarity and operational alignment with regard to the development and commercialization of patisiran and ALN-TTRsc02. This will allow us to develop both products in a comprehensive manner, potentially addressing the full spectrum of transthyretin-mediated amyloidosis disease treatment and prevention. At the same time, we will continue to support and benefit – via royalties – from the fitusiran opportunity through Sanofi’s significant development and commercial leadership.”
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