Montreal-based Haemacure believes that the operational qualification of fibrin sealant production machinery at its plant in Sarasota, Florida triggers the payment. The approval is a step to towards full good manufacturing practice (GMP) accreditation under the US Food and Drug Administration’s rules.
A Haemacure spokesperson told in-PharmaTechnologist that: "Future required regulatory steps are the amendment of Haemacure's existing Investigational New Drug (IND) application with the US FDA to commence pivotal phase II-III clinical trials for the fibrin sealant" followed by FDA approval by the Biologics License Application (BLA).
Haemacure began the Heamaseel HMN project in 1996, signing a pilot manufacturing deal with ZLB, a division of the Swiss Red Cross in 1999, for the production of clinical trial supplies. CSL, which along with Baxter and Omrix Biopharmaceuticals is a major player in the fibrin sealant sector, became involved in 2000 when it acquired ZLB.
A year after the ZLB acquisition CSL decided not to pursue commercialisation of Hemaseel in the US market, where Omrix’ Evicel dominates, halting a pivotal trial a year early and agreeing to pay $4.5m to Haemacure on the achievement of certain milestones by way of settlement.
However, in August last year CSL told the Canadian firm that it believes it is no longer obliged to pay these sums, resulting in the current dispute. Neither Haemacure nor CSL Behring responded to in-PharmaTechnologist’s request for additional information.
In a press statement Joseph Galli, Haemacure’s CEO, said that the qualification of production equipment showed "clear progress in our transition from a development to a manufacturing company. This allows us to take steps towards the next milestone of producing clinical lots of our lead product candidate, human fibrin sealant, and advancing it to market.”
Loewen, Ondaatje, McCutcheon analyst Connie Chen said that “while there is no guarantee that Haemacure will successfully secure the payment, the company maintains it has a strong position” from which to pursue them.
Chen was fairly positive about Hemaseel’s prospects, arguing that Hemaseel may be attractive to physicians and patients as a result of its favourable safety profile compared with bovine derived competitor products.
She added that the ability to ship the product as a lyophilized powder for reconstitution, in contrast with other fibrin sealant agents that must be frozen, potentially offers significant cost advantages.
Haemacure said that plasma processing at the Sarasota facility is continuing as planned and the product and production process are meeting expectations. The firm hopes to achieve its first patient-in-the-clinic objective in early 2009 and commercial launch in the US in 2011.