SINGAPORE, Dec. 18, 2017 /PRNewswire/ — Mundipharma has entered into an exclusive license agreement with Frankfurt-listed pharmaceuticals company, PAION AG ("PAION"), for the development and commercialisation of its lead medicine candidate, remimazolam, in Japan.
Under the terms of the agreement, Mundipharma takes over responsibility for market authorization and distribution, and has the rights to further develop remimazolam for all indications in Japan with PAION’s support. Mundipharma will collaborate with PAION on the further development for intensive care unit (ICU) sedation and procedural sedation after successful filing in general anesthesia.
Remimazolam is an ultra-short-acting intravenous benzodiazepine sedative/anesthetic that has already shown positive results in clinical Phase III trials in Japan. Remimazolam is rapidly metabolized to an inactive metabolite by tissue esterases and not metabolized by cytochrome-dependent hepatic pathways. Like other benzodiazepines, remimazolam can be reversed with flumazenil to rapidly terminate sedation and anesthesia if necessary. During clinical studies, remimazolam demonstrated efficacy and safety in over 1,700 volunteers and patients. Data so far indicates that remimazolam has a rapid onset and offset of action combined with a favorable cardio-respiratory safety profile.
"Strong collaborative partnerships continue to drive our growth and increase our ability to meet patient needs in Japan and across Asia" said Mundipharma CEO, Raman Singh. "We’re excited about the potential for remimazolam as a treatment for general anesthesia as well as other indications, as we continue to expand our medicine portfolio with synergistic treatments", he added.
"We are excited to have Mundipharma as our partner for remimazolam in Japan" said Dr. Wolfgang Sohngen, CEO of PAION. Mundipharma has an impressive track record in the global pharmaceutical market and a growing and successful presence in Asia. We look forward to intensive collaborative efforts towards a successful regulatory filing to advance remimazolam in this important territory as quickly as possible."
Mundipharma will now take over responsibility for filing with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), with PAION’s support. In an earlier pre-NDA meeting in January 2016, the PMDA stated that they considered the non-clinical and clinical data package for remimazolam to be complete for filing for the indication "induction and maintenance of general anesthesia". The PMDA previously had confirmed that both the raw materials produced by PAION in Europe as well as the finished formulation of remimazolam fulfilled the requirements for filing in Japan. Based on the positive pre-NDA meeting, PAION has begun to prepare filing for remimazolam in Japan.
Remimazolam is currently in the final stage of clinical development for procedural sedation in the U.S. After completion of the ongoing development, the implementation of a pediatric development plan already agreed with the FDA is planned. A full clinical development program for general anesthesia was completed in Japan, and a Phase II study in general anesthesia was completed in the EU. Based on the positive results of the Phase II study, development for ICU sedation beyond 24 hours is another potential indication.
PAION is a publicly listed specialty pharmaceutical company developing and aiming to commercialize innovative drugs to be used in out-patient and hospital-based sedation, anesthesia and critical care services. PAION’s lead compound is remimazolam, an intravenous, ultra-short-acting and controllable benzodiazepine sedative/anesthetic drug candidate which is in the final stage of clinical development for use in procedural sedation in the U.S. Currently, PAION is mainly focusing its business and financial resources on successfully completing its development program in procedural sedation in the U.S. Outside the U.S., PAION has so far focused on the development of remimazolam in the indication general anesthesia. A full clinical development program for general anesthesia was completed in Japan and PAION is preparing filing in Japan. In the EU, PAION is currently planning to continue the clinical development program. Development of remimazolam in the indication intensive care unit (ICU) sedation is also part of the longer term life-cycle plan for remimazolam. PAION is headquartered in Aachen (Germany) with a further site in Cambridge (United Kingdom). PAION’s vision is to become an acknowledged "PAIONeer" in sedation and anesthesia.
Mundipharma is a network of independent associated companies which are privately owned entities covering pharmaceutical markets in Asia-Pacific, Latin America, the Middle East and Africa. The headquarters for these territories is in Singapore. Mundipharma is a prime example of an organisation that consistently delivers high quality medicines while standing by the values it represents. Its mission is to alleviate the suffering of patients and to substantially improve their quality of life. Mundipharma is dedicated to bringing to patients the benefit of novel treatment options in fields such as pain, oncology, oncology supportive care, ophthalmology, respiratory disease and consumer healthcare.
For more information please visit: www.mundipharma.com.sg