Shares in The Medicines Company have leapt on rumours that Novartis is eyeing a takeover of the company and its promising new cardiovascular drug inclisiran.
A report from Bloomberg also suggests that other buyers are interested in MedCo as it prepares to file for approval of inclisiran – a gene-silencing drug targeting PCSK9 that can reduce cholesterol with twice-yearly dosing, even in patients on maximum doses of statins.
MedCo has a market value of around $4.7bn, says the news agency, which cites people close to the matter as the source of the rumour but hasn’t indicated what Novartis – or indeed another party – may be prepared to pay for the company.
If approved, inclisiran could pose a major challenge to established antibody-based PCSK9 inhibitors, namely Repatha (evolocumab) from Amgen and Sanofi/Regeneron’s Praluent (alirocumab), which are dosed more frequently (either monthly or bimonthly).
Repatha and Praluent have struggled to make headway in the market mainly due to payer resistance, forcing their developers to slash prices from $14,000 per year at launch to around $6,000.
Analysts have suggested that inclisiran may also be priced at a discount to the antibody drugs on launch, and could quickly grow to blockbuster sales levels.
Novartis isn’t commenting on the speculation, but Bloomberg analyst Sam Fazeli says that inclisiran would slot neatly into the Swiss group’s cardiovascular portfolio alongside Entresto (sacubitril/valsartan), its heart failure medicine which after a slow start in the market has gathered pace and made $1.2bn in the first nine months of the year.
Novartis’ hopes of further growth for Entresto were dented earlier this year however when the drug failed to show an impact in a particular form of heart failure, characterised by normal or preserved ejection fraction from the heart, in a phase 3 trial.
At the American Heart Association (AHA) meeting last weekend MedCo reported additional data from the ORION-9 trial of inclisiran showing 50% reductions in LDL-cholesterol in patients with familial hypercholesterolaemia, an inherited condition characterised by very high cholesterol levels.
MedCo has said it intends to file the drug for approval in the US before the end of the year and in Europe in the first quarter of 2020.
While some analysts think it could be a blockbuster drug, others suggest it could be a slow-burner, gathering momentum after results from a cardiovascular outcomes study – ORION-4 – which is due to report in 2024.
Shares in the company rose almost 20% in the wake of the Bloomberg report.
The deal will enhance Merck’s expertise in developing and manufacturing mRNA for its customers for use in vaccines, treatments and diagnostics applicable in Covid-19 and various other diseases.
It’s the first significant visual redesign for Pfizer in 70 years since the company began using the blue oval background. The tagline outlining Pfizer’s purpose, “Breakthroughs that change patients’ lives,” remains the same.
The massive growth of gene therapy research and development over the last few years has boosted demand for viral vectors, the engineered viruses used to deliver therapeutic genes into patients’ bodies. Tokyo-based Fujifilm Diosynth Biotechnologies is stepping up to meet that demand.