Al­ny­lam is dou­bling down on a part­ner­ship to ex­pand its com­mer­cial pres­ence in Eu­rope, as it forges ahead on for­mer CEO John Maraganore’s mis­sion to be­come a top-five biotech by the mid­dle of the decade.

The com­pa­ny an­nounced on Thurs­day that it’s ex­pand­ing a five-year-run­ning com­mer­cial part­ner­ship with Medi­son Phar­ma. While the duo ini­tial­ly paired up in 2019 to com­mer­cial­ize Al­ny­lam’s RNA in­ter­fer­ence port­fo­lio in Is­rael, they’re now adding Poland, the Czech Re­pub­lic, Hun­gary, Slo­va­kia, Lithua­nia, Es­to­nia and Latvia to the list.

“The ex­pand­ed agree­ment with Medi­son is part of an ex­ist­ing mod­el im­ple­ment­ed in 2022 that fo­cus­es on how we sus­tain­ably and com­pli­ant­ly broad­en the reach of our com­mer­cial med­i­cines by work­ing close­ly along­side our Part­ners,” Nor­ton Oliveira, Al­ny­lam’s se­nior VP and head of part­ner and emerg­ing mar­kets, told End­points News via email.

The fi­nan­cial terms of the part­ner­ship were not dis­closed.

John Maraganore

Oliveira added that the move is in line with Al­ny­lam’s “P5x25 strat­e­gy,” which Maraganore es­tab­lished back in 2021 in the hopes of be­com­ing a top-five biotech by 2025. While Maraganore an­nounced his plans to re­tire lat­er that year, end­ing a 19-year ca­reer at the biotech he helped launch in 2002, his suc­ces­sor Yvonne Green­street con­tin­ues to push to­ward that goal.

Al­ny­lam boasts a hand­ful of RNAi prod­ucts, in­clud­ing On­pat­tro, Givlaari, Oxlu­mo and the close­ly watched Amvut­tra. Back in Oc­to­ber, the com­pa­ny point­ed to the In­fla­tion Re­duc­tion Act when it scrapped plans for a Phase III tri­al for Amvut­tra in Star­gardt dis­ease, a rare ge­net­ic eye con­di­tion. The drug is al­ready ap­proved by the FDA to treat hered­i­tary transthyretin-me­di­at­ed (hAT­TR) amy­loi­do­sis, and should pro­duce Phase III re­sults in transthyretin amy­loi­do­sis (AT­TR) with car­diomy­opa­thy next year.

Mean­while, On­pat­tro awaits an FDA ad­vi­so­ry com­mit­tee meet­ing to ex­pand its la­bel to treat pa­tients with AT­TR-CM, with a de­ci­sion ex­pect­ed by Oct. 8.

Al­ny­lam and Medi­son said in the news re­lease on Thurs­day that Givlaari and Oxlu­mo are ap­proved for re­im­burse­ment in Poland, and the teams will “work to­geth­er to ob­tain ad­di­tion­al re­im­burse­ments in the ter­ri­to­ries.”

“This suc­cess­ful col­lab­o­ra­tion led to a nat­ur­al choice of Medi­son as Al­ny­lam’s part­ner in ad­di­tion­al mar­kets in Cen­tral East­ern Eu­rope and go­ing for­ward Al­ny­lam will ben­e­fit from Medi­son’s full suite of ser­vices in this re­gion as well by lever­ag­ing Medi­son’s ex­ten­sive ex­ist­ing ca­pa­bil­i­ties on the ground,” Gil Gurfinkel, VP of cor­po­rate de­vel­op­ment at Medi­son, said in an email.

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.

Otonomy may be shutting down, but the lessons learned there will live on at another biotech working on new treatments for hearing loss.

San Francisco-based Spiral Therapeutics has bought certain assets related to three of Otonomy’s programs, ranging from data, patent rights, and know-how to inventory. That includes data around Otonomy’s twice-failed lead program, OTO-104 (Otividex), a sustained-exposure formulation of dexamethasone.