Ahead of holding its first investor day, French drugmaker Ipsen has suffered a setback with the news that US health regulators is delaying a decision over approving Reloxin, a potential competitor to Allergan’s Botox.
The US Food and Drug Administration has told the company that the Prescription Drug User Fee Act action date for Reloxin (botulinum toxin of type A) Biologics License Application in aesthetic indications has been extended to April 13. The agency has not given any specific reason extension and has not requested additional information, Ipsen said, so it could be just another example of the growing workload at the FDA.
Ipsen also noted that the FDA has confirmed in an inspection report that the manufacturing process for Reloxin in its Wrexham, Wales facility is in compliance with current Good Manufacturing Practices. In March 2006, Ipsen granted Medicis rights to distribute and commercialise the product in the USA, Canada and Japan for aesthetic use by physicians.
Ipsen is confident it will get approval given that its botulinum toxin product is already approved in 23 countries.The company already sells it as a treatment for cervical dystonia, under the brandname Dysport.,
Later today, Ipsen is holding its first investor day at its headquarters in Boulogne Billancourt. Ahead of the meeting, the company said that it expects to meet its financial goals for 2009 (a revenue rise of 12%-14%) and generate sales in North America of around $300 million by 2012.
The company will provide an update on its R&D pipeline. Ipsen has five experimental drugs awaiting regulatory approval, plus three therapies at launch stage, and is planning “four Phase I/II initiations in key products and indications”. In 2009, the number of clinical studies led by Ipsen in almost 1,300 sites across the world will be tripled, the firm added.
