Teva Pharmaceutical Industries Ltd and Active Biotech AB have signed an agreement to develop and commercialize laquinimod, Active Biotech's novel immunomodulatory compound, which has the potential to be an orally available disease modifying treatment of multiple sclerosis (MS), according to a release from Active Biotech.
Under the terms of the agreement, which is subject to Hart-Scott-Rodino review and the applicable waiting period, Teva will acquire the exclusive rights to develop, register, manufacture and commercialize laquinimod worldwide, with the exception of the Nordic and Baltic countries, where Active Biotech will retain all commercial rights.
Active Biotech has successfully completed a phase II trial and presented its results at the 2004 American Academy of Neurology (AAN) Annual Meeting held in San Francisco this past April.
These results showed that oral laquinimod, in a dosage of 0.3 mg daily, is well tolerated and effective in suppressing the development of active lesions in relapsing MS. Teva intends to complete the clinical development program and will conduct phase III studies.
"As a leader in the global MS Market, the addition of laquinimod to Teva's innovative pipeline further demonstrates our commitment to developing new classes of therapies for MS patients to treat their disease and improve their quality of life, while expanding our company's presence in the field of neurology," said Israel Makov, President & CEO of Teva Pharmaceutical Industries. "We are pleased to collaborate with a growing biotechnology company such as Active Biotech, who shares our dedication to sound science and innovation."
"Teva is our partner of choice as they are a market leader in the MS field and have a proven experience in clinical development in neurology. If laquinimod reaches the market, it will contribute to a better life for MS patients. A success of the laquinimod project would mean significant royalty streams to Active Biotech," said Sven Andréasson, president & CEO of Active Biotech.
Teva has agreed to make an upfront payment of 5 million USD to Active Biotech and to conduct and fund the further clinical development of laquinimod. The contract between the two companies also calls for Teva to make payments to Active Biotech upon the achievement of various milestones, which include sales targets. If such milestones were all to be met, payments to Active Biotech would aggregate to 92 million USD. Active Biotech will also receive tiered double digit royalties on sales of the product, once marketed.
Laquinimod is a novel immunomodulatory substance developed as an orally available disease modifying treatment of MS. The conclusion from a recently concluded phase II study is that oral laquinimod in a dosage of 0.3 mg daily is well tolerated and effective in suppressing development of active brain MRI lesions in relapsing MS. Treatment over six months with 0.3 mg of laquinimod daily resulted in a 30-per cent decrease in MRI disease activity. Patients with disease activity at the start of the study showed a decrease of more than 40 per cent. The study also confirmed laquinimod's advantageous safety profile.
Multiple sclerosis (MS) is a chronic, progressive disease of the central nervous system. It is the most common neurological disease causing disability in young adults. It has been described as an autoimmune disease because it is one of many diseases in which the immune system attacks healthy areas of the body as if they were foreign. In MS, these attacks are aimed at the central nervous system. The central nervous system is made up of nerves covered by a substance called myelin, which is similar to insulation protecting electrical wires because it surrounds and protects nerve fibers. When myelin or the nerve fiber is destroyed or damaged, the nerves cannot send electrical impulses to and from the brain, causing the onset of MS symptoms.