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CAMBRIDGE, Mass.—In the latest example of the company's "find a need and fill it" drug development strategy, Biogen Idec has signed an agreement with Cardiokine Inc. to develop the latter's lixivaptan, an oral compound for the treatment of hyponatremia in patients with congestive heart failure (CHF). The drug is expected to enter Phase III clinical trials later this year.
According to Biogen Idec's Dr. Barry Ticho, senior director of medical research, CHF is responsible for more hospitalizations worldwide than any other indication, with about one-third presenting with low sodium on admission or developing it during their hospital stay. Dr. Ticho, who combines his responsibilities at Biogen Idec with teaching positions as an assistant in pediatrics at Massachusetts General Hospital and as an instructor in the Harvard Medical School, points out that lixivaptan is a selective V2 vasopressin receptor antagonist that, in clinical trials to date, has demonstrated promising activity in treating hyponatremia. Lixivaptan works by causing water to be excreted from the kidney, without affecting sodium or other electrolytes. Particularly in heart failure patients, hyponatremia is associated with volume overload, a key symptom leading to hospitalization of these patients. In addition, hyponatremia is an important feature of other disorders, including liver cirrhosis and syndrome of inappropriate antidiuretic hormone (SIADH), and contributes to morbidity and negative outcomes.
Ticho says that lixivaptan is an excellent example of the company's overall development strategy to provide novel therapeutics that address unmet medical needs. Currently, he notes, patients with low sodium levels are associated with the worst outcomes—longer hospital stays, re-hospitalizations and death. Frequently, "Don't drink when you're thirsty" is the best medical advice available, he adds.
Cadiokine is a privately-held specialty pharmaceutical company focused on the development of drugs for the treatment of heart failure and related indications led by David Brand, a 30-year veteran who spent most of his career in various sales and marketing positions at GlaxoSmithKline and its predecessor companies."Lixivaptan was a Wyeth development," he notes, "but they have essentially no cardiovascular franchise, so business development put it up for out-licensing and we grabbed it.
"We are extremely pleased to be partnering lixivaptan with Biogen Idec. We share an appreciation of the adverse health consequences associated with hyponatremia and have a common vision for lixivaptan." Brand notes that there are about one million hospitalized patients with hyponatremia in the U.S. annually, with double that number globally. The outpatient cohort is perhaps 1.5 million here and three million worldwide. Company estimates put the cost for CHF drug treatment at three billion dollars and total CHF healthcare costs at $30 billion annually.
Under terms of the agreement with Biogen Idec, the company will receive a $50 million upfront payment and up to $170 million in additional milestone payments for successful development and global commercialization of lixivaptan, as well as royalties on commercial sales. Biogen Idec will be responsible for the global commercialization of lixivaptan and Cardiokine will have an option for limited co-promotion in the U.S. The agreement is expected to become effective in the third quarter of 2007.
Though lixivaptan will represent the company's third entry in the cardiovascular category, Biogen Idec has no cardiovascular sales force as yet and doesn't contemplate embarking on a saturation marketing model like those of pharma giants. "We concentrate on focused patient populations, identify specialty positions and go to hospitals where we can sell efficiently," Dr. Ticho states.