The overall adverse event profiles of inclisiran-treated groups in ORION-11 were almost similar to the placebo side effects.
The data from ORION-11 will be submitted to a peer-reviewed journal. The sequential release of top-line Phase 3 data readout for the ORION-9 and ORION-10 studies is expected to continue later in the third quarter in advance of anticipated regulatory submissions in the United States in the fourth quarter of 2019 and in Europe in the first quarter of 2020.
The patients who have completed their respective Phase 3 trial Phase 3 studies are now enrolling into the ORION-8 into a long-term extension study where patients who completed 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 the drug.
Since highlighting The Medicines Company’s achievement, investors demonstrated enthusiasm for The Medicines Company. Today, in one of the most down stock market’s days, the stock is trading at $47 UP $5.58 (13.30%).
Cidara Therapeutics (CDTX) and Mundipharma entered into a strategic partnership to develop and market rezafungin for the prevention and treatment of invasive fungal infections. Rezafungin is a once-weekly echinocandin developed for the first line-line treatment of candidemia and invasive candidiasis as well as for the prophylaxis of invasive fungal infections in patients undergoing allogeneic blood and marrow transplantation for which no treatments have been approved in over 13 years.
The partnership agreement followed the announcement of successful completion of the Cidara’s announcement of the successful completion of the STRIVE B Phase 2 trial.
The Terms of the Agreement
In exchange for granting Mundipharma exclusive commercialization rights to rezafungin outside the U.S. and Japan. Cidara will receive the following from Mundipharma:
- $30 million upfront payment
- $9 million equity investment in Cidara.
- $42 million in long-term funding, which will support its global Phase 3 ReSTORE and ReSPECT trials.
- Development, regulatory and commercial milestones payments that could represent a total potential transaction value of $568 million, in addition to double-digit royalties.
Cidara will continue to lead the ongoing global Phase 3 development programs for rezafungin with the support of Mundipharma.
This is good news for both firms. We can feel investor’s enthusiasm for Cidara’s agreement as the stock has been trading at $2.70 UP $1.02 (61.01%). Cidara’s Market Cap. is $67.46 million only.
To read more about these firms please run a search from our website by clicking here.
Outperforming Biotechs In a Bad Market Day
On August 27, 2019 we posted “The Medicines Company Has Agreeable News” under Today’s Highlights.
The Medicines Company
We described The Medicines Company (MDCO) as a firm focused on cardiovascular diseases with a goal of halting the progression of atherosclerosis and lowering the cardiovascular risk caused by high levels of LDL Cholesterol (LDL-C). The Medicines Company’s good news emanated from the results of its first pivotal Phase 3 trial evaluating the safety, efficacy and tolerability of its inclisiran therapy designed to decrease LDL-C through twice yearly dosing. We witnessed the ORION-11 trial of inclisiran sodium 300 mg meeting all the primary and secondary endpoints with efficacy consistent with the findings from the Phase 1 and Phase 2 studies, and with safety almost equal to the placebo.
Yesterday, the full study results were presented during a late breaking science session at the European Society of Cardiology’s ESC Congress 2019 in Paris. For the primary endpoints of ORION-11 inclisiran delivered placebo-adjusted LDL-C reductions of 54% at day 510 and demonstrated time-averaged placebo-adjusted LDL-C reductions of 50% from days 90 through 540.