New triptorelin formulation Phase III cancelled
formulation of triptorelin while it attempts to fine-tune the
manufacturing process of the hormone therapy drug.
The undisclosed investigational four-month formulation of triptorelin, a man-made version of the luteinising hormone releasing hormone (LHRH), was not meeting the expected trial results believed to be because of changes applied in the manufacturing process when the trial was up-scaled to Phase III.
The French pharmaceutical company decided against a second administration of the drug as planned when results showed that the levels of triptorelin in the blood were not sufficient for a therapeutic response.
However, Ipsen investor relations officer David Schilansky told in-PharmaTechnologist.com the unexpected results were not to do with the new formulation but rather the changes made in the manufacturing process, such as changing the temperature or the excipients.
The company experienced the same problems when it up-scaled its drug Somatuline Autogel to Phase III, he said.
The company had several ideas of what the issues were and would look at refining those to ensure a new Phase III trial was up and running by the end of this year.
"It will be more challenging.
We need to have something in the market by mid 2010 when the patent expires," Schilansky said.
The company currently markets triptorelin as Decapeptyl, a microspheric technology available as a one and three-month sustained-release formulation for the treatment of advanced metastatic hormone-dependent prostate cancer.
It is marketed in more than 80 countries.
The new formulation is a subcutaneous formulation, injected by a new retro (pen-like) injector where the molecule will control its own release over time.
The molecule itself has not been manipulated but the drug delivery formulation has been and should be an improvement on Decapeptyl, Schilansky said.
Considering the Phase I and II trials were so positive, the company would not be going back to the drawing board to develop a new formulation, he said.
No safety concerns had been observed throughout the trial, and patients would be switched to an appropriate approved treatment at the end of their respective monitoring period.
Ipsen executive vice president and chief scientific officer Jacques-Pierre Moreau said in a statement: "We are taking all appropriate actions to solve the scale-up issues seen during this Phase III, which are inherent to advanced formulations based on cutting edge technologies.
"From the outset, the introduction of an innovative subcutaneous presentation using a new retro-injection device was well received by patients and investigators.
Thus, the teams are now focusing their energy and expertise in order to resume Phase III as soon as possible.
Our advanced drug delivery platform has already been validated through the success of Somatuline Autogel, and we are confident in Ipsen's ability to have a differentiated formulation of triptorelin."
Decapeptyl brought in revenue of €222m in 2006 for Ipsen, while the worldwide market for LHRH agonists is worth more than $1,4bn (€1bn).
Earlier this month, Ipsen announced it was planning to invest €55m to upgrade its facilities in Dreux, France so as to focus on formulation, analytical development and manufacturing of drug batches intended for preclinical and clinical research.
