Primex Nears Market With Oral Pediatric Sedation Solution. Switzerland’s fast growing critical-care company has submitted for approval what it believes is the first oral solution for the mild to moderate sedation of anxious children undergoing surgical and diagnostic procedures, with a launch in Europe pencilled in for a year’s time.
Anesthesiology is often overlooked by pharma, and many believe there has been little innovation in the area since propofol was developed 30 years ago, but the fast-growing Swiss company Primex Pharmaceuticals AG wants to change that perception.
Primex has submitted a marketing authorisation in Europe for ADV6209, a new 0.2% oral solution of midazolam as a pediatric sedative, and expects the product to be launched in around a year’s time. It will market the product through its network of agents and distributors.
The indication being sought is use as premedication in anesthesia, although Primex is also aiming to seek approval for use in procedural sedation. The oral solution of the rapidly acting benzodiazepine has been formulated to mask its bitter taste, and global rights licensed from the French company Advicenne SA, that developed ADV6209 in collaboration with researchers at Amiens University Hospital, France, one of the leading pediatric hospitals in Europe. Nearly 10,000 patients have used the drug in the hospital.
In many pre-surgery situations, and before diagnostic procedures like incredibly noisy MRI scans, there are few if any agents that can be used to reduce anxiety in children. “Children are being scared and traumatized every day, and this could lead to them avoiding hospitals when they become adults,” commented Primex’s president Kari Sarvanto, who co-founded the company in Finland eight years ago.
There are a number of sedatives available to clinicians, but mostly they have not been approved for use in children, do not have children-appropriate formulations, or have other drawbacks to their use in children, Sarvanto told Scrip in a recent interview. Propofol, for example, is widely used in young children, but its administration usually has to be monitored by an anesthetist, a time consuming and costly process when only mild sedation is required to reduce anxiety.
Primex considers the market for reducing anxiety in children via oral pediatric sedation to be worth Euro 100-350m annually. “There are no competitors in sight, and we are happy to be first to the market with the product,” Sarvanto added. The company is not using the EU’s pediatric-use marketing authorisation (PUMA) process because of that procedure’s complexities.
A review of Informa Pharma Intelligence’s Biomedtracker data base reveals there are only a handful of anesthesia-related agents in development worldwide; one of the most advanced is Cosmo Pharmaceuticals/Paion’s ultra-short acting intravenous benzodiazepine remimazolam that is in Phase III trials in the US for anesthesia during procedures.
An Open Phase II Study
At the 16th World Congress of Anesthesiologists, held in Hong Kong from Aug. 28 to Sept. 2, Hervé Dupont, head of anesthesiology at Amiens University Hospital, France, reported a Phase II open study in 37 children in which 78.4% of patients achieved satisfactory sedation within 30 minutes. There was no significant difference between response rates achieved with ADV6209 and historical studies in the literature involving other oral midazolam formulations.
Primex was established in 2008, and quickly acquired several products from Bayer, including the anesthetic Recofol (propofol) and the acute heart failure therapy Dobuject (dobutamine). After the early years the company has been profitable, Sarvanto said. Investors in the company include two private investment funds as well as family and friends, and it has an aggressive growth strategy. “We want to be the leader in anesthesia, and we are keen to acquire new products,” Sarvanto said.
The company has also brought in several new executives. Ernesto Alegria joined last month as chief financial officer, having been CFO of the Acino Group and before that worked at Takeda Pharmaceutical International GmbH and Nycomed. Alan Knox became head of marketing in June, 2016, having previously been vice-president of global marketing at MSD International AG.