PARIS ¿ Meristem Therapeutics, a French biotechnology company specialized in the production of therapeutic proteins and active substances from plants, has granted the Belgian company Solvay Pharmaceuticals an exclusive license for the use of its recombinant gastric lipase in the treatment of digestive troubles linked with cystic fibrosis.
Meristem, of Clermont-Ferrand, will not only provide Brussels-based Solvay with gastric lipase for clinical trials, but will also be its exclusive supplier of the substance during the entire commercial life of the drug. Solvay is to carry out and fund Phase IIb and Phase III clinical trials of the product and will market the drug worldwide. In exchange, Meristem is receiving an up-front payment, followed by milestone payments and royalties.
The French company also has announced that it is to launch an IPO on the Nouveau Marchi in Paris. This move comes in the wake both of the deal with Solvay, which Meristem CEO Bertrand Merot said was ¿the first agreement of this type it has concluded with a major pharmaceutical company,¿ and of the partnership agreement signed with Goodwin Biotechnology Inc., of Plantation, Fla., in early April for the promotion of its corn- and tobacco-based plant cultivation systems in North America.
Solvay Pharmaceuticals, which is the world¿s largest producer of pancreatic enzymes for the treatment of cystic fibrosis, could become the first company in the world to bring a drug derived from plant engineering onto the market. Commenting on the deal, its international marketing and licensing manager, Coos de Graaf, described Meristem¿s ¿capacity to produce very high-quality gastric lipase from plants¿ as ¿truly remarkable,¿ and added that Solvay was ¿impatient to test this new gastric lipase on different types of patients presenting an insufficiency in digestive enzymes.¿
Gastric lipase is a protein used to correct the exocrine pancreatic insufficiency that characterizes cystic fibrosis sufferers, which results in their digestive systems being unable to produce the enzymes needed to assimilate lipids. Until now Solvay has used a lipase derived from the pancreas of pigs, whereas Meristem has developed a proprietary technology for expressing gastric lipase in genetically modified corn seeds. The lipase it produces generates maximum pH activity in the intestine and is particularly active in hydrolyzing long-chain fatty acids, which represent 95 percent of the lipids that humans absorb in their food.
Meristem already has produced several kilos of recombinant gastric lipase at its extraction/purification plant, which is equipped to GMP standards for manufacturing large quantities of pharmaceutical-grade recombinant proteins. The lipase already has been tested in preclinical studies and in a Phase I clinical trial in the UK completed last September, which confirmed the therapeutic potential of gastric lipase for the treatment of cystic fibrosis. Phase IIa trials are currently under way in France and Germany, but all further development of the compound, described by Merot as Meristem¿s ¿flagship product,¿ will be carried out by Solvay.
Meristem has two other products in its pipeline that could be taken into clinical development within a year or two. One is human collagen, a protein used in skin repair and reparative surgery, and the other is human lactoferrin, a protein secreted in mother¿s milk that protects against infections. Both have been successfully produced in maize and tobacco.