firstwordpharmaAugust 23, 2018
Tag: gilead , experimental myelofibrosis
Gilead Sciences sold its experimental drug momelotinib to Sierra Oncology for an upfront fee of $3 million, as well as potential milestone payments of up to $195 million, the latter company announced Wednesday. Gilead gained the oral JAK 1/2 and ACVR1 inhibitor via its 2013 purchase of YM BioSciences for around $510 million.
In 2016, Gilead reported mixed late-stage results for momelotinib in patients with myelofibrosis. Specifically, while the SIMPLIFY-1 study achieved its primary endpoint of non-inferiority to Incyte's Jakafi (ruxolitinib) for splenic response rate after 24 weeks, the SIMPLIFY-2 trial failed to achieve its main goal of superiority of momelotinib compared to best alternative therapy in patients previously treated with Jakafi.
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"Opportunistically adding this compelling Phase III asset to our existing pipeline…helps establish Sierra as a diversified late-stage drug development company with a commercial orientation," remarked Nick Glover, chief executive of Sierra. Glover said "the company is uniquely positioned to advance momelotinib towards potential registration," adding that "we believe an additional clinical study likely will be required to consolidate [previous] clinical data."
Sierra noted that current members of its management team have prior experience developing momelotinib whilst at Cytopia, which discovered the drug, YM and Gilead. Sierra explained that momelotinib has a "differentiated therapeutic profile" with a number of potential benefits on anaemia, including eliminating or reducing the need for blood transfusions, in addition to controlling symptoms. The drugmaker noted that the therapy is covered by patents that would allow it to maintain market exclusivity in the US until 2035 and in Europe until 2033.
Under the terms of the agreement with Gilead, Sierra will take over all ongoing clinical studies with momelotinib following a transition period. Sierra, whose shares climbed as much as 24 percent on the news, has also agreed to pay Gilead tiered-based sales royalties ranging from the mid-teens to high-twenties.
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