Alnylam And Silence Settle Over RNAi Patents
Executive Summary
Silence will receive a small royalty on future sales of Alnylam’s Onpattro in Europe, and Alnylam is free to use Silence IP in other products.
The UK’s Silence Therapeutics PLC and Alnylam Pharmaceuticals Inc. have agreed to settle litigation in which the former accused the latter of infringing its European patents.
Alnylam has agreed to pay a “low royalty” on annual net sales of its RNA interference therapeutic Onpattro (patisiran) in the EU. Silence has granted Alnylam a non-exclusive, global license to all relevant patents for all current and future Alnylam products, with no further payments to be required. The settlement resolves all legal proceedings in all jurisdictions between the two companies.
The royalty payable on Onpattro’s EU sales will be tiered from 0.33-1.0% through 2023.
In a Dec. 7 analyst note, Leerink forecast that sales of Onpattro in 2019 would reach $114m globally, while Morgan Stanley predicts 2019 revenues of $87m. With European sales only representing a proportion of the total figure, and assuming early royalties payable will be at the lower end of the disclosed range, Silence will be unlikely to receive much more than $100,000-200,000 next year under the agreement. However, with analysts expecting annual Onpattro sales to ramp up towards $1bn over the next few years, Silence could start to bring in a few million dollars per year.
Onpattro was approved for the rare condition hereditary transthyretin-mediated amyloidosis (hATTR) in adults in both the EU and US in August 2018. In the US it has an annual list price of $450,000, while it was launched in its first European market, Germany, at €362,500 per patient per year. In a recent interview with Scrip, Alnylam president Barry Greene said he thought there were around 2,000 hATTR patients in Europe for whom treatment with Onpattro would be appropriate. (Also see "Alnylam Offering Value-Based Deals In EU For Breakthrough RNAi Drug Onpattro" - Scrip, 14 Nov, 2018.)
By the end of September, Cambridge, Massachusetts-based Alnylam had booked total Onpattro revenues of $0.5m. The company has five additional late-stage RNAi candidates in late-stage development and more at an earlier stage in its pipeline.
Silence’s patent litigation was launched in July 2017 by former CEO Ali Mortazavi, who stepped down in June 2018 and was replaced by David Horn Solomon in July 2018. It claimed that its intellectual property around chemical modification, without which small interfering (siRNA) molecules would degrade in the body and become inactive, were infringed by products being developed by Alnylam and others. (Also see "Silence Seeks Share Of Alnylam RNAi Success In Legal Action" - Scrip, 18 Oct, 2017.)
AIM-listed Silence received a notice of intention to grant a new European patent on its chemical modification technology in October 2018, whereupon it filed a cross-border interim injunction application against Alnylam in the Netherlands (where Alnylam holds its Onpattro marketing authorization), requesting it be prohibited from commercializing the product.
In an interview earlier this year, Silence’s then executive chair Annalisa Jenkins, who joined the company in October 2017 and assumed interim leadership upon Mortazavi’s departure before leaving the firm in August 2018, told Scrip she hoped to turn around the widespread perception of Silence as “the company that was suing Alnylam” to one of it as “a drug development company with a platform and a long legacy.” She added that as industry becomes more interested in RNAi technology, larger companies would be looking for collaboration partners like Silence. “We fully intend to be front and center of the next phase of evolution and innovation in the space,” she said. (Also see "Interview: Silence Therapeutics’ Chair On Why Keeping Quiet Has Done The Biotech No Favors" - Scrip, 24 Jul, 2018.)
Silence is hoping to take its first product into clinical development in humans in the second half of 2019. Its preclinical pipeline includes candidates for beta thalassemia, myelodysplastic syndrome and alcohol use disorder. It has also licensed IP to Quark Pharmaceuticals Inc., whose acute kidney injury candidate QPI-1002 is in a Phase III trial and partnered with Novartis AG.