A key component of the deal includes a $1 billion purchase of 50% of royalties owed to Alnylam on sales of inclisiran, a drug for hypercholesterolemia that works by gene silencing. The company's CEO said uncertainty and volatility due to Covid-19 meant the timing was right for the deal.
The deal will make the Phase III drug inclisiran - which Novartis acquired when it bought The Medicines Company in November - available to patients in the U.K. and include manufacturing and clinical development efforts.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
The deal was originally announced in November. The Medicines Co.'s lead product candidate is inclisiran, an RNAi drug for reducing cholesterol, for which it submitted an FDA approval application in December.
The deal will give the Swiss drugmaker control of inclisiran, a drug for which The Medicines Company plans to file for approval in lipid disorders starting this quarter.
Although it hasn't yet released details, the company announced positive data from two Phase III studies of inclisiran, which it is developing with Alnylam. The drug prevents production of PCSK9, the target of drugs made by Amgen and Sanofi/Regeneron.
Inclisiran, which The Medicines Co. is developing with Alnylam, prevents production of PCSK9, the same protein targeted by two drugs that were the subject of a major patent lawsuit ruling last week. The company plans regulatory filings starting later this year.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Equity research analysts wrote in a note Thursday that the move could have a beneficial read-across to another drug that has the same target as Repatha.