Amidst rumors that Novartis might be interested in an acquisition, The Medicines Company announced data from ORION-10, the second of three 19-month Phase III trials of inclisiran for lowering cholesterol.
Amidst rumors that Novartis might be interested in an acquisition, The Medicines Company announced data from ORION-10, the second of three 19-month Phase III trials of inclisiran for lowering cholesterol.
Inclisiran is an investigational twice-yearly drug to reduce low-density lipoprotein cholesterol (LDL-C). It is the first and only in the small-interfering RNA (siRNA) class.
The ORION-10 trial met all primary and secondary efficacy endpoints. The drug demonstrated placebo-adjusted LDL-C decreases of 58% at day 510, and showed time-averaged placebo-adjusted LDL-C decreases of 56% from day 90 through day 540.
The safety signals for inclisiran was similar to the placebo group. A small number of patients in both groups showed at least one serious treatment emergent adverse event, with incidences of deaths, 1.4% and 1.5%, and malignancies, 3.3% versus 3.3%, for placebo and inclisiran, respectively.
“Cumulative exposure to high LDL-C levels presents a significant risk of future heart attacks and strokes for millions of people, particularly those with ASCVD,” said study principal investigator R. Scott Wright, professor of Medicine, Consultant in Cardiology, Mayo Clinic, in Rochester, Minnesota. “The data from ORION-10 show that inclisiran lowers LDL-C significantly and sustains reductions over a six-month period with a safety profile similar to placebo.”
The company expects to use the data to submit for a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) before the end of the year and in Europe in the first quarter of 2020.
Shares in The Medicines Company were up 26% premarket today on the basis of the report. Shares have risen more than 200% in the year-to-date. The recent climb is related to the positive clinical trial data, but apparently also because of a Bloomberg report of possible acquisition interest from Novartis.
According to Bloomberg’s sources, Novartis has been conducting due diligence on The Medicines Company and is in discussions about a potential acquisition.
The report, among other things, notes that since Novartis’ chief executive officer Vas Narasimhan is focusing on acquisitions to bolster the company’s oncology and rare disease portfolio. Since Narasimhan took over in February 2018, Novartis has announced almost $16 billion in acquisitions. Novartis also spun off the Alcon eye-care division and unloaded its stake in a consumer-health venture.
“Novartis currently has a rapidly growing heart failure drug, so the addition of another cardiovascular medicine would fit,” said Sam Fazeli, an analyst with Bloomberg Intelligence. The drug he refers to is Entresto.
Today’s data strengthens The Medicines Company’s efforts to compete with older cholesterol-lowering drugs from Amgen and partners Regeneron Pharmaceuticals and Sanofi.
“The results from ORION-10 are outstanding and provide yet another confirmation of the highly differentiated clinical profile of inclisiran,” said Mark Timney, chief executive officer of The Medicines Company. “We believe that inclisiran is ideally suited to address the effects of cumulative exposure to LDL-C and has the potential to change the course of how healthcare professionals manage ASCVD risk for the millions of patients who struggle to reach their LDL-C goals.”
The Medicines Company picked up global rights to develop, manufacture and commercialize inclisiran under a license and collaboration deal with Alnylam Pharmaceuticals.
