Baxter International Inc. announced that it has entered into a definitive agreement to acquire all of the haemophilia-related assets of a privately-held biopharmaceutical company, Archemix, and entered into an exclusive license agreement for certain related intellectual property assets.
The lead product associated with the arrangement is ARC19499, a synthetic, subcutaneously-administered haemophilia therapy currently in a Phase I clinical trial in the UK. ARC19499 blocks Tissue Factor Pathway Inhibitor (TFPI) activity, thereby augmenting and improving blood clotting, potentially reducing replacement factor therapy for patients with haemophilia A and B.
“Baxter is committed to optimizing haemophilia care and improving the lives of people living with haemophilia around the world,” said Hartmut Ehrlich, MD, vice president, global research and development and medical affairs, for Baxter's Bio-Science business. “This anti-TFPI program is an important addition to other Baxter haemophilia development programs focusing on longer-acting rFVIII and rFIX and non-intravenous therapies” he added.
Baxter expects to record a special pre-tax in-process research and development charge of approximately $30 million in the fourth quarter of 2010 relating to an upfront payment associated with the transaction. In the future, Baxter may also make milestone-related payments to Archemix of up to $285 million. Subject to regulatory approvals and other conditions, the companies expect to complete the transaction by year-end.
ARC19499 is part of a new therapeutic class referred to as ‘aptamers.’ As an aptamer is smaller than a protein or biologic, these molecules have the potential to be developed for subcutaneous administration. The phase I clinical trial for ARC19499 was initiated by Archemix in the UK in August 2010 and continues to enrol patients. Currently there is one aptamer approved by the US FDA and available to patients: Macugen, for the treatment of age-related macular degeneration.
Haemophilia is a rare genetic blood clotting disorder that primarily affects males. People living with haemophilia do not have enough of, or are missing, one of the blood clotting proteins naturally found in blood. Two of the most common forms of haemophilia are A and B. In people with haemophilia A, clotting factor VIII is not present in sufficient amounts or is absent. Without enough FVIII, people with haemophilia can experience spontaneous, uncontrolled internal bleeding that is painful, debilitating, damaging to joints and potentially fatal. People with haemophilia B (also called Christmas disease) do not have sufficient amounts of clotting factor IX. In about 30 per cent of cases, there is no family history of haemophilia and the condition is the result of a spontaneous gene mutation. According to the World Federation of Haemophilia, more than 400,000 people in the world have haemophilia. All races and economic groups are affected equally.
Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with haemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions.