Hemolink™ is a highly purified human haemoglobin-based oxygen carrier that has been developed by Hemosol.1It combines both polymerised and non-polymerised haemoglobin components of varying molecular weights. Hemolink™ is designed to facilitate delivery of oxygen to vital organs and tissues in patients undergoing cardiac, orthopaedic and other surgery, as well as in patients undergoing chemotherapy.Hemolink™ is under review in Canada for use in coronary artery bypass grafting (CABG) surgery to reduce or avoid the use of donor red cells. In August 2000, Hemosol announced that the Canadian New Drug Submission for Hemolink™ had received Priority Review status from Health Canada. In their Q2 2001 results, Hemosol stated that it has responded in full to requests for more information from Canada’s Biologics and Genetic Therapies Directorate. In March 2002, Health Canada advised Hemosol™ that Hemolink™ would not be approved at this time and that additional data would be required for a refiled New Drug Submission. Hemosol has been conducting continuing dialogue with the US Food and Drug Administration (FDA) over amendments of its phase III Hemolink™ programme in cardiac surgery. In November 2001, Hemosol announced that it has received approval from the US FDA to begin a key phase III clinical trial of Hemolink™ in primary CABG. This trial will be conducted in the USA and the UK. The modified clinical programme also includes a ‘re-do’ CABG trial. The ‘re-do’ trial, which was approved by the FDA in January 2002, will enrol approximately 140 patients in more than 40 centres in the USA. It is anticipated that results from these studies will be reported towards the end of 2002. Following analysis of the results, Hemosol will work with the FDA to design and initiate a third phase III study. Phase III trials in the UK have been completed, and a marketing authorisation application (MAA) has been submitted to European authorities. The UK will act as the reference member state for the Mutual Recognition Procedure. Hemosol has received a comprehensive set of questions from the UK Medicines Control Agency (MCA) regarding the MAA. Hemosol plans to strengthen its regulatory filing in the UK in mid-2002 with results from the CABG and ‘re-do’ trials so that the MCA can complete its review by the end of 2002. Several other clinical trials of Hemolink™ have also been conducted. Phase II clinical trials have been completed in Canada for use as a blood substitute in patients undergoing orthopaedic surgery and in patients with chronic anaemia associated with renal failure. Hemosol is to begin a phase I/II Canadian/US study of Hemolink™ in patients with non-small cell lung cancer experiencing chemotherapy-associated anaemia. Hemosol has also completed a phase II trial of Hemolink™ in elective orthopaedic surgery in the UK, and in patients with anaemia in the USA. An extended trial in orthopaedic surgery patients has been completed in the UK and the USA. A phase IIb trial in patients undergoing orthopaedic surgery was expected to start in Canada/USA in the first half of 2001. In March 2002, the US FDA approved the start of a phase II trial of Hemolink™ as a treatment for chemotherapy-induced anaemia. The single-blind study will enrol 50 patients with lung or ovarian cancer who are being treated with erythropoietin for chemotherapy-induced anaemia. The study will be conducted at Duke University and is due to begin enrolment in June 2002.Other potential indications for Hemolink™ include trauma, oxygen delivery for cancer patients, ischaemic rescue in patients with stroke or myocardial infarction, and tissue perfusion in angioplasty and organ transplants.On 31 October 2000, Hemosol announced that it intended to form a strategic alliance with Dompé Farmaceutici for marketing of Hemolink™ in Austria, Greece, Hungary, Italy, Poland, Portugal, Russia, Spain and Switzerland. Under the terms of this memorandum of understanding and depending on regulatory approval of the product, Dompé will purchase $Can5 million of Hemosol common shares at $Can15 per share. In addition, Dompé has a 16-month option to make a further $Can5 million equity investment at $Can22.50 per share. The formation of the strategic alliance is subject to negotiation and execution of definitive agreements, after which Dompé will hold exclusive marketing rights to Hemolink™ in the aforementioned Southern and Eastern European countries.In September 1999, Hemosol announced that it had regained all rights to Hemolink™ from Fresenius AG. Previously, in June 1995, Hemosol had formed an alliance with Fresenius that gave the latter company exclusive marketing rights for Hemolink™ in Europe, including countries of the former Soviet Union, the Middle East and Africa. In April 1999, Hemosol received a $Can2.12 million milestone payment from Fresenius. The payment was made on the basis of the regulatory approval for phase III trials to begin in the USA, UK and Canada. The reason given for the termination of the agreement between the two companies was strategic differences concerning marketing of Hemolink™. Hemosol intends to develop Hemolink™ as an oxygen therapeutic in elective surgery and other therapeutic applications, whereas Fresenius viewed it strictly as a blood replacement product. In April 2000, Hemosol signed a 5-year renewable agreement with Pennyslvania Plama, a division of Sera-tec Biologics Limited Partnership in the USA to source human red blood cells used in the production of Hemolink™. In June 1998, Hemosol received a US patent for Hemolink™.A reduced but more stable form of Hemolink™, Deoxy-Hemolink™, has also been prepared for investigation by Hemosol.