CHF cohorts

CAMBRIDGE, Mass.—In the latest example of the company's"find a need and fill it" drug development strategy, Biogen Idec has signed anagreement with Cardiokine Inc. to develop the latter's lixivaptan, an oralcompound for the treatment of hyponatremia in patients with congestive heartfailure (CHF). The drug is expected to enter Phase III clinical trials laterthis year.

According to Biogen Idec's Dr. Barry Ticho, senior directorof medical research, CHF is responsible for more hospitalizations worldwidethan any other indication, with about one-third presenting with low sodium onadmission or developing it during their hospital stay. Dr. Ticho, who combineshis responsibilities at Biogen Idec with teaching positions as an assistant inpediatrics at Massachusetts General Hospital and as an instructor in theHarvard Medical School, points out that lixivaptan is a selective V2vasopressin receptor antagonist that, in clinical trials to date, hasdemonstrated promising activity in treating hyponatremia. Lixivaptan works bycausing water to be excreted from the kidney, without affecting sodium or otherelectrolytes. Particularly in heart failure patients, hyponatremia isassociated with volume overload, a key symptom leading to hospitalization ofthese patients. In addition, hyponatremia is an important feature of otherdisorders, including liver cirrhosis and syndrome of inappropriate antidiuretichormone (SIADH), and contributes to morbidity and negative outcomes.

Ticho says that lixivaptan is an excellent example of thecompany's overall development strategy to provide novel therapeutics thataddress unmet medical needs. Currently, he notes, patients with low sodiumlevels are associated with the worst outcomes—longer hospital stays,re-hospitalizations and death. Frequently, "Don't drink when you're thirsty" isthe best medical advice available, he adds.

Cadiokine is a privately-held specialty pharmaceuticalcompany focused on the development of drugs for the treatment of heart failureand related indications led by David Brand, a 30-year veteran who spent most ofhis career in various sales and marketing positions at GlaxoSmithKline and itspredecessor companies."Lixivaptan was a Wyeth development," he notes, "but theyhave essentially no cardiovascular franchise, so business development put it upfor out-licensing and we grabbed it.

"We are extremely pleased to be partnering lixivaptan withBiogen Idec. We share an appreciation of the adverse health consequencesassociated with hyponatremia and have a common vision for lixivaptan." Brandnotes that there are about one million hospitalized patients with hyponatremiain the U.S.annually, with double that number globally. The outpatient cohort is perhaps1.5 million here and three million worldwide. Company estimates put the cost for CHF drug treatment at three billiondollars and total CHF healthcare costs at $30 billion annually.

Under terms of the agreement with Biogen Idec, the companywill receive a $50 million upfront payment and up to $170 million in additionalmilestone payments for successful development and global commercialization oflixivaptan, as well as royalties on commercial sales. Biogen Idec will beresponsible for the global commercialization of lixivaptan and Cardiokine willhave 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 willrepresent the company's third entry in the cardiovascular category, Biogen Idechas no cardiovascular sales force as yet and doesn't contemplate embarking on asaturation marketing model like those of pharma giants. "We concentrate onfocused patient populations, identify specialty positions and go to hospitalswhere we can sell efficiently," Dr. Ticho states.