USA — Alnylam is expanding its partnership with Medison Pharma to strengthen its commercial operations in Europe and achieve former CEO John Maraganore’s goal of becoming a top-five biotech by mid-decade.

Initially launched in 2019 to commercialize Alnylam’s RNA interference portfolio in Israel, the expanded partnership will now include Poland, the Czech Republic, Hungary, Slovakia, Lithuania, Estonia, and Latvia.

According to Norton Oliveira, Alnylam’s Senior VP and Head of Partner and Emerging Markets, the expanded agreement with Medison builds on an existing model established in 2022, which aims to sustainably and compliantly broaden the reach of their commercial medicines by collaborating closely with partners.

However, the financial terms of the partnership remain undisclosed.

According to Norton Oliveira, Senior VP and Head of Partner and Emerging Markets at Alnylam, the company’s decision to expand its partnership with Medison aligns with its “P5x25 strategy.”

Established by former CEO John Maraganore in 2021, the strategy aims to make Alnylam a top-five biotech by 2025.

Although Maraganore announced his retirement later that year, Yvonne Greenstreet, his successor, is continuing to pursue this goal.

In a news release, Alnylam and Medison announced that Givlaari and Oxlumo are already approved for reimbursement in Poland, and the teams plan to “work together to obtain additional reimbursements in the territories.”

Gil Gurfinkel, VP of Corporate Development at Medison, said in an email that the successful collaboration led to the natural choice of Medison as Alnylam’s partner in additional Central Eastern European markets.

Going forward, Alnylam will benefit from Medison’s full suite of services in the region by leveraging their extensive existing capabilities on the ground.

The Business Research Company reports that the global market for antisense & RNAi therapeutics grew at a CAGR of 8.0%, from US$1.42 billion in 2022 to US$1.54 billion in 2023.

Major players in the market include Alnylam Pharmaceuticals, Ionis Pharmaceuticals, and GlaxoSmithKline PLC.

Alnylam has several RNAi products, including Onpattro, Givlaari, Oxlumo, and Amvuttra. In October, the company abandoned plans for a Phase III trial of Amvuttra in Stargardt disease, a rare genetic eye condition, citing the Inflation Reduction Act.

However, the drug is already FDA-approved for treating hereditary transthyretin-mediated (hATTR) amyloidosis, and Phase III results in transthyretin amyloidosis (ATTR) with cardiomyopathy are expected next year.

On the other hand, Onpattro is awaiting an FDA advisory committee meeting to expand its label to treat patients with Transthyretin Amyloidosis (ATTR-CM), with a decision expected by October 8th.

The high cost of RNA interference drugs, such as Onpattro at US$450,000 per year, is expected to impede growth in the antisense & RNAi therapeutics market due to factors like stringent regulations and a long product approval process.

To remain competitive, companies are collaborating and partnering for product innovation, as seen with Blackstone Life Sciences and Alnylam Pharmaceuticals’ US$2 billion strategic financing collaboration, and Aro Biotherapeutics Company’s licensing and collaboration agreement with Ionis Pharmaceuticals.

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