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Alnylam swaps Sanofi for Regeneron as R&D partner

Novel alliance between two biotechs

Alnylam

Regeneron has agreed to pay $800m to gene-silencing specialist Alnylam to buy into its pipeline of drugs for central nervous system, eye and liver diseases.

The new deal – announced just after Sanofi and Alnylam dissolved a rare disease R&D partnership set up in 2014 – will see Regeneron pay $400m upfront to the RNA interference specialist and spend another $400m on a 5% equity stake in the biotech. There’s also another $200m in milestones if the drugs hit certain early clinical development targets.

There are no specific programmes for CNS and eye diseases mentioned in the deal as the intention is to bring the two companies’ respective strengths in gene silencing and genetics together to build a joint pipeline.

Regeneron will however take the lead on eye disease candidates, a category in which it is already strong with blockbuster age-related macular degeneration (AMD) therapy Eylea (aflibercept), with Alnylam in line for milestones and royalties.

For the CNS programmes, the intention is to allocate a lead company for each asset so that Regeneron and Alnylam alternate when it comes to development and commercial rights. The other party will however have the option to split the development costs in return for a share of the profits for programmes they do not lead.

The liver disease alliance is a little different in approach, and will involve combining drugs already in the two companies’ development pipelines into multidrug regimens for diseases including non-alcoholic steatohepatitis (NASH) – a hot target for the biopharma industry with millions of patients worldwide.

That includes pairing Regeneron's phase 1 antibody pozelimab (REGN3918) with Alnylam’s phase 2 RNAi drug cemdisiran, both of which target the complement C5 pathway, including other antibody/RNAi combinations.

C5 is also targeted by Alexion’s Soliris (eculizumab) for paroxysmal nocturnal hemoglobinuria (PNH) and haemolytic uremic syndrome (HUS), which was a $2.56bn product last year.

Like Alnylam, Regeneron has recently reconfigured a long-standing R&D collaboration in the area of immuno-oncology, having previously decided to go their separate ways in a broader antibody alliance that resulted in commercial products including cholesterol therapy Praluent (alirocumab), Dupixent (dupilumab) for atopic dermatitis and rheumatoid arthritis therapy Kevzara (sarilumab).

The pairing of two biotech players is interesting, breaking away from the traditional biotech/big pharma model of collaborations, as is the way the assets will be split between the two parties. It also reinforces the emergence of RNAi as a new drug class after decades of development.

John Maraganore

Alnylam's John Maraganore

“The alliance structure enables Alnylam to continue to build its industry-leading pipeline of RNAi therapeutics while retaining significant product rights,” commented the company’s CEO John Maraganore.

Since last year, Alnylam like Regeneron has been making revenues from commercial product sales, having picked up approvals for Onpattro (patisiran) in late 2017 in the US and in 2018 in Europe. While still early days, Onpattro sales reached $12m last year, and Alnylam is also gearing up to file for approval of its second product – givosiran for acute hepatic porphyria – before the end of the year.

Article by
Phil Taylor

9th April 2019

From: Research

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