The Medicines Company Announces Positive Topline Results from First Pivotal Phase 3 Trial of Inclisiran - Seite 2

“The Medicines Company thanks the many patients, investigators and their colleagues at the clinical trial sites for their participation in ORION-11,” said Peter Wijngaard, Ph.D., Chief Development Officer of The Medicines Company. “We look forward to presenting detailed study results during the ESC Congress 2019 and also submitting data for publication in a peer-reviewed journal.”

The sequential release of topline Phase 3 data readouts for the ORION-9 and ORION-10 studies are expected to continue later in the third quarter in advance of anticipated regulatory submissions in the U.S. in the fourth quarter of 2019 and in Europe in the first quarter of 2020. Patients who have completed their respective Phase 3 studies are now enrolling into ORION-8, an open-label, long-term extension study where patients completing ORION-9, ORION-10 and ORION-11 will receive inclisiran for three years to evaluate the efficacy, safety and tolerability of long-term dosing of inclisiran.

Background on Additional Events

In addition to presentation of ORION-11 data during the late-breaking science session at ESC Congress 2019, The Medicines Company will conduct two satellite symposia and will present data from the ORION-1 study during an oral abstract session.

• “The ORION Program: What to Look for in ORION-11” on Sunday, September 1, 1:00–2:00 PM CET, in Prague-Village 2, Hall 7, Level 3. Click here for more information about this satellite symposium.
• “Insights and Innovation: Can We Alter the Course of ASCVD?” on Monday, September 2, 6:15–7:45 PM CET, in Centre Stage, Hall 7, Level 2. Click here for more information about this satellite symposium.
• “Rapid Fire Abstracts” session – “Inclisiran-mediated reductions in Lp(a) in the ORION-1 trial” on Tuesday, September 3, 8:48 AM CET, in Agora 2-Poster Area, Hall 7, Level 3.

ORION-11 Investor Conference Call and Webcast Information

The Company will host a conference call and webcast on Monday, September 2, 2019 at 8:00 a.m. Eastern Daylight Time (2:00 p.m. Central European Time). During the call, the Company’s management and clinical trial investigators will discuss results of the ORION-11 study. The dial-in information to access the call is as follows:

U.S./Canada: [phone]
International: [phone]
Conference ID: 13692300

A taped replay of the conference call will be available after the call concludes, and may be accessed by telephone as follows:

U.S./Canada: [phone]
International: [phone]
Conference ID: 13692300

A live audio webcast of the conference call may be accessed in the “Investors” section of The Medicines Company website. An archived webcast will be available after the call concludes.