The European Commission (Brussels, Belgium) has awarded a $1.5 million contract to investigate controlled drug delivery from implants including vascular stents. The European Union (EU) multinational contract has been won by a group of companies including Jomed (Unterschleissheim, Germany), PolyBioMed (Nottingham, England) and Global Medical Systems (Beerse, Belgium). The intention of the project is to produce stent surface coatings which can precisely control drug release from the stent surface, using the surface modification technology developed by PolyBioMed.
B. Braun (Melsungen, Germany) also is planning to use coated stents for controlled drug release. Braun intends to use the Medi-Coat polymer matrix technology developed by STS Biopolymers (Henrietta, New York) to deliver an undisclosed anti-restenosis drug direct to the vascular wall. STS said it is currently in discussions with several stent suppliers interested in using the Medi-Coat technology.
Yet another stent coating developed by German researchers was announced at the recent European Society of Cardiology meeting in Stockholm, Sweden. Dr. Iris Haehnel and her group at the Klinikum Rechts der Isar (Munich, Germany) have successfully shown positive in vitro and in vivo animal trial results using a water-soluble thermosensitive gel to deliver genes to the vascular wall. Haehnel used a non-liposomic transfection enhancer to deliver plasmid-DNA.
Protein C concentrate cleared
Baxter International (Deerfield, Illinois) said that the European Medicines Evaluation Agency (London) has issued market authorization for Ceprotin protein C concentrate for use as a replacement therapy for treatment of life-threatening blood clotting complications related to severe congenital protein C deficiency.This initial market authorization is for severe hereditary protein C deficiency only, but Baxter plans to start clinical trials for Ceprotin use in acquired protein C deficiency in the near future. Protein C is a human plasma component which regulates the coagulation cascade and prevents thrombosis and currently there is no ideal alternative to specific protein C replacement therapy. Ceprotin has now been launched in most European countries, according to Baxter.
AF cryoablation launch eyed
CryoCath Technologies (Kirkland, Quebec), which already markets its Freezor cryoablator for tachyarrhythmia treatment in Europe, has signed a five-year marketing agreement with Endocare (Irvine, California) for a line of cryosurgical probe systems to be developed for the treatment especially of atrial fibrillation.Endocare will produce the systems, based on its proprietary cryoablation technology that already is CE-marked. CryoCath will market the systems under the Surgifrost label, with European launch scheduled for the first half of 2002.
Tissuemed gets CE mark for sealant patches
Tissuepatch V is a contact-adhesive pliable film developed by Tissuemed (Leeds, England) for use in vascular or cardiac surgery. The product, made from porcine albumin, polymers and elastomers, is absorbed in about 30 days after application and is intended to be wrapped round stitches joining blood vessels and grafts to seal the wound and to staunch blood flow.Tissuemed has gained the CE mark for this product and also for Tissuepatch T, a highly elastic sheet laid over lung tissue incisions to seal air leaks. The company is reviewing its commercialization and marketing options for these products, said CEO David Fortune.
Actelion starts dosage studies for Veletri
Actelion (Allschwil, Switzerland) has begun new clinical trials to establish optimal dosage levels for its Veletri (tezosentan) drug for treatment of patients with acute cardiac insufficiency. Tezosentan is an intravenous dual Endothelin receptor antagonist. In the trial, dosage levels of less than 50 mg/hour will be studied and results should be available around 3Q02. In February 2000, Actelion negotiated a co-promotion agreement for tezosentan with Genentech (South San Francisco, California)
Contrast agent doesn't infringe patent
The Imavist cardiac ultrasound imaging contrast agent, jointly developed by Alliance Pharmaceutical (San Diego, California) and Schering (Berlin, Germany), uses perfluorohexane (PHF) microbubbles to improve the quality of cardiac imaging.There had been concerns that Imavist might infringe upon a patent concerning PHF microbubbles in U/S imaging that was acquired by Nycomed Imaging (Oslo, Norway) from Sonus Pharmaceuticals (Bothell, Washington) in July. However, Alliance has gained a favorable final decision from the U.S. Patent and Trademark Office board of appeal, which ruled that the claims of the Nycomed patent were invalid and as a result unpatentable.