Lundbeck to collaborate with Otsuka Pharmaceutical for Alzheimer's drug candidate

TOKYO—H. Lundbeck A/S and Otsuka PharmaceuticalCo., Ltd. have joined forces in a license and development agreement for LuAE58054, a selective 5HT6 receptor antagonist from Lundbeck that is currentlybeing developed as a treatment for Alzheimer's disease.

"The global collaboration between Otsuka and Lundbeckcontinues to grow stronger with the addition of Lu AE58054. Not only does theproduct further enhance the synergy between the companies as we work togetherto bring to the market solutions for better health, Lu AE58054 is a potentiallypromising development in a very difficult disease area," Taro Iwamoto,president and representative director of Otsuka, commented in a press releaseregarding the agreement.

Per the terms of the agreement, Otsuka will pay Lundbeckapproximately DKK 855 million ($150 million) upon signing, for which Otsukawill be granted co-development and co-commercialization rights to the compoundin the United States, Canada, east Asia (including Japan), major European countriesand Nordic countries. The agreement stipulates that both Lundbeck and Otsukawill share the development, sales and commercialization costs associated withLu AE58054. Lundbeck will also be eligible to receive up to approximately DKK3.9 billion ($675 million) in regulatory and sales milestone payments.

"There is a serious, global, unmet medical need regardingtreatments for Alzheimer's disease in aging populations," Ulf Wiinberg,president and CEO of Lundbeck, said in a statement. "Together, Otsuka andLundbeck, with their development capabilities, commercial experience andgeographical reach, will provide a solid foundation in the development of LuAE58054."

The 5-HT6-receptor is found primarily in areas of the brainthat play a role in cognition, and early trials have shown that an antagonistof the 5-HT6-receptor could offerpotential benefits in treating disorders like Alzheimer's disease.

Results from a previous trial of Lu AE58054 were announcedin May 2012, when Lundbeck reported that Lu AE58054 had met its primaryendpoint in a fixed-dose, randomized, placebo-controlled, 24-week clinicalstudy of the compound in 278 patients who had moderate Alzheimer's disease. LuAE58054 was administered as an add-on to donepezil.

The next clinical program for this compound is expected tobegin later this year. The global program will be made up of several studies,and will include more than 2,500 patients. in the first Phase III trial,patients with mild-to-moderate Alzheimer's disease will be enrolled, and LuAE58054 will be examined as an adjunct treatment to donepezil. Additionalstudies are also planned to begin towards the end of this year.

According to the Alzheimer's Association, Alzheimer'sdisease accounts for 50 to 70 percent of dementia cases, making it the mostcommon cause of dementia. Some 36 million people have dementia worldwide,according to Alzheimer's Disease International, with an expected 115 millionpeople to have the condition by 2050. The global cost of dementia came toroughly $604 billion in 2010.

SOURCE: Lundbeck press release