PAION ANNOUNCES U.S. FDA APPROVAL OF REMIMAZOLAM (BYFAVOTM) FOR THE INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION
DGAP-News: PAION AG
/ Key word(s): Regulatory Approval
- PAION will receive a milestone payment of EUR 15 million from Cosmo and tiered royalties on net sales ranging from 20% to 25%
- Acacia, who will commercialize BYFAVOTM (remimazolam) in the U.S., is planning to launch in the second half of 2020
- Conference call hosted by Acacia scheduled for 9:00 am ET, Monday 6 July 2020
PAION has developed BYFAVOTM including the conduct of three Phase III clinical studies and granted Cosmo Pharmaceuticals NV (Cosmo) exclusive rights to develop and commercialize BYFAVOTM for the U.S. market in 2016. In January 2020, Acacia Pharma sub-licensed the commercial rights to BYFAVO in the U.S. from Cosmo.
Under the terms of the agreement with Cosmo, PAION will receive a milestone payment of EUR 15 million from Cosmo and is entitled to tiered royalties on net sales in the U.S. ranging from 20% to 25%, which may be adjusted under certain conditions but cannot fall below 15% of net sales.
Dr. Jim Phillips, CEO of PAION AG, commented: The U.S. marketing approval of BYFAVOTM marks the most significant milestone in PAION's history, and I congratulate everyone who has played a role in this important achievement. The U.S. is the world's largest pharmaceutical market, and we are excited to see the product PAION successfully developed being made available to doctors there. We wish Acacia a highly successful market launch in this important market, and we will be supporting their commercialisation efforts. We also look forward to remimazolam being rolled out in other countries around the globe as we and our partners work to gain additional marketing approvals."
Gerard A. Silvestri, MD, MS, Professor of Medicine at the Medical University of South Carolina, Charleston, SC, and past-president of the American College of Chest Physicians, commented: "The approval of remimazolam (BYFAVOTM) is very exciting for proceduralists as the field has not seen new sedation medications added to our armamentarium in decades. The drug performed very well in clinical trials, with an excellent sedation effect enabling 80-90% of procedures to be completed successfully. The cardio-respiratory safety profile looked very encouraging and there was a rapid return of patients to consciousness enabling them to be discharged in a timely manner."
"It is gratifying to see how successfully our new strategy is unfolding. We entered into new partnerships with RedHill Biopharma and Acacia before their own main products were approved by taking substantial equity stakes in these companies and integrating our products Aemcolo(R) and BYFAVOTM into each so that they could potentially have a more stable and efficient marketing organization. The approval of BYFAVOTM follows the approval of RedHill's Talicia(R) and Acacia's BARHEMSYS(R) and is the third FDA approval in nine months for products in companies in which we hold an equity stake. We are now looking forward to Acacia Pharma's transforming BYFAVO into a resounding success," said Alessandro Della Chà, CEO of Cosmo Pharmaceuticals.
"BYFAVOTM is an important addition to the limited selection of drugs available for procedural sedation," said Acacia Pharma's Chief Medical Officer, Dr. Gabriel Fox. "BYFAVOTM demonstrated clear patient benefits in its extensive clinical trial program, offering very rapid onset and offset of action coupled with an incidence of cardio-respiratory and other adverse reactions similar to that seen in patients in the placebo group. We are grateful to all the clinical investigators and patients who made this approval possible through their participation in the development program."
The safety of BYFAVOTM was evaluated in three pivotal studies in 669 patients undergoing colonoscopy (two studies) or bronchoscopy (one study), of whom 630 received BYFAVOTM. In these studies, the most common adverse reactions (incidence greater than 10%) following BYFAVOTM administration were hypotension, hypertension, diastolic hypertension, systolic hypertension, hypoxia, and diastolic hypotension. The labeling for BYFAVOTM includes a Boxed Warning regarding appropriate training of personnel and equipment that must be available when administering BYFAVOTM, during sedation and during the recovery period of the procedure. The Boxed Warning also addresses risks from concomitant use of BYFAVOTM with opioid analgesics and other sedative hypnotics.
Acacia Pharma's first product, BARHEMSYS(R) (amisulpride injection), was approved by the FDA on 26 February 2020 for the treatment and prevention of postoperative nausea and vomiting (PONV) in adult patients and the company intends to launch both BARHEMSYS(R) and BYFAVOTM in the U.S. during the second half of 2020.
Conference Call hosted by Acacia Pharma
The Acacia Pharma management team will host a conference call Monday, 6 July 2020, at 9:00 ET.
For further information, please see:
- Press release Acacia Pharma (02 July 2020)
In Japan, licensee Mundipharma received market approval in general anesthesia in January 2020. In the U.S., licensee Cosmo Pharmaceuticals received market approval in procedural sedation in July 2020. In China, licensee Yichang Humanwell filed for market approval in procedural sedation in November 2018. In South Korea, licensee Hana Pharm filed for market approval in general anesthesia in December 2019. In Europe, PAION submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in procedural sedation in November 2019 and results of an EU Phase III trial in general anesthesia are expected in the second half of 2020.
In addition to procedural sedation and general anesthesia, based on positive Phase II study results, ICU sedation is another possible indication for remimazolam.
Remimazolam is partnered in the U.S. (brand name BYFAVOTM) with Cosmo Pharmaceuticals, sublicensed to Acacia Pharma, in Japan (brand name Anerem(R)) with Mundipharma, in China with Yichang Humanwell, in Canada with Pharmascience, in Russia/CIS, Turkey and the MENA region with R-Pharm, and in South Korea and Southeast Asia with Hana Pharm. For all other markets including parts of the EU, remimazolam is available for licensing.
In Europe, PAION is seeking approval of remimazolam for general anesthesia and for procedural sedation. PAION submitted a Marketing Authorization Application (MAA) for procedural sedation in November 2019. Results of a Phase III trial in general anesthesia are expected in the second half of 2020.
PAION's mission is to be a leading specialty pharmaceutical company in the fields of anesthesia and critical care by bringing novel products to market to benefit patients, doctors & other stakeholders in healthcare.
PAION is headquartered in Aachen (Germany) with an additional site in Cambridge (United Kingdom).
02.07.2020 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
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