Merck Serono and Ambrx collaborate on growth hormone products

Merck Serono has revealed a collaboration with US biopharmaceutical company Ambrx to develop and commercialise Ambrx's long-acting biogeneric growth hormone products.

The collaboration will focus initially on the development of ARX201, the most advanced product candidate, currently in phase I/II clinical trials. ARX201 has improved pharmacological properties, which should allow less frequent administration than the daily dosing regimen of currently available growth hormones.

Per the agreement, Merck Serono will receive worldwide commercialisation rights for ARX201 and will make an initial payment to Ambrx, which is eligible to receive undisclosed clinical, regulatory and commercial milestone payments based on the successful development and commercialisation of products, as well as undisclosed royalties on net sales of such products.

Ambrx retains an option to co-promote products in the US market. If the option is exercised, Ambrx and Merck Serono will share US commercialisation expenses as well as profits. If Ambrx declines to exercise its option, it will receive undisclosed royalties on net sales of products worldwide.

Francois Feig, head of Merck Serono's Endocrinology and Cardio-Metabolic Care unit, said: "Merck Serono has a long-term commitment to children and adults with disorders requiring growth hormone treatment. We believe that ARX201 has the potential to establish a new standard of care in growth hormone therapy. Less frequent administration would represent a significant advance for patients in terms of improved convenience and quality of life. This may lead to improved treatment outcome for the patients."

Dr James W Young, who is interim CEO of Ambrx, added: "This alliance is consistent with our strategy to work with industry leaders in their respective fields and is a validation of Ambrx's ability to deliver differentiated, high-value drug candidates."

A Visiongain estimate valued the total global endocrine market at USD 43.2bn in 2005, a growth of 13.5 per cent from 2004. The endocrine diseases market is expected to produce revenues in 2010 of just under USD 70bn. Major changes of the market are expected over the forecast period, such as the arrival of insulin delivery technologies and massive losses of the hypothyroidism market due to increasing generic competition.

Epoetin, colony stimulating factors and human growth hormone are expected to account for the majority of the USD 2.2bn in biogeneric sales by 2010, according to a Bioportfolio report.