European patients gain future access to HAE drug navenibart in $300M deal
Biocryst partners with Neopharmed on marketing rights to preventive therapy
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Biocryst Pharmaceuticals is once again partnering with Neopharmed Gentili — now, with an Irish affiliate of the Italian pharmaceutical company — this time for marketing rights in Europe to navenibart, the still-experimental treatment Biocryst is developing to prevent attacks of hereditary angioedema (HAE)
Under the terms of a new agreement between the companies, the Irish affiliate of Neopharmed Gentili will have exclusive rights to market the injectable preventive therapy in all European nations. In exchange, the developer secures an upfront payment while it continues its work toward filing for regulatory approval in the U.S. by the end of 2027.
Last year, Biocryst licensed the European rights to market Orladeyo (berotralstat), its approved oral preventive treatment for patients ages 12 and older with HAE, to the Italian company while retaining responsibility for sales in the U.S. That deal was worth an estimated $250 million. The new one for navenibart could bring in more than $300 million altogether for Biocryst, according to a company press release announcing the deal.
“We are excited to partner with Neopharmed Gentili once again to help bring innovative medicines to patients living with HAE in Europe,” said Charlie Gayer, president and CEO of Biocryst. “This deal enables both companies to build upon the strong foundation of Orladeyo and leverages Neopharmed Gentili’s expertise in Europe.”
For its part, Neopharmed is “proud to further strengthen and expand our collaboration with Biocryst,” said Alessandro Del Bono, the company’s CEO, calling the deal a “strategic agreement for navenibart.”
Del Bono said the two pharmaceuticals are “reinforcing a partnership grounded in a shared commitment to delivering meaningful impact for people living with [HAE].”
In deal for navenibart, Biocryst to get upfront payment of $70M
In HAE, excess levels of a molecule called bradykinin cause sudden attacks of swelling that can occur anywhere in the body. Navenibart, formerly known as STAR-0215, is designed to block kallikrein, an enzyme overactive in HAE that increases bradykinin production. By blocking kallikrein, navenibart is expected to prevent those attacks.
Originally developed by Astria Therapeutics before being acquired by Biocryst, navenibart is now in Phase 3 clinical testing. That testing was launched after earlier data showed the treatment candidate was well-tolerated and prevented swelling in adults with HAE. Navenibart was found to offer sustained benefits when injected subcutaneously, or under the skin, once or twice over six months.
Under the new deal, Neopharmed will have exclusive rights to market and distribute navenibart in Europe, should the therapy be approved. In return, Biocryst will receive an upfront payment of $70 million. The company may also receive up to an additional $275 million if regulatory approval and other milestones are achieved, along with royalties on future sales, per Biocryst.
Del Bono said that, for Neopharmed Gentili, the agreement will aid in “consolidating our position as a leading European company in the field of rare diseases.”
“This agreement underscores our steadfast dedication to advancing therapeutic innovation in areas of significant unmet medical need, builds upon the strong expertise we have established in Europe in HAE, and further accelerates our long-term growth trajectory,” Del Bono said.
