Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Amgen submits denosumab BLA

Executive Summary

Amgen has submitted a BLA for its novel RANK ligand inhibitor denosumab for two indications: treatment and prevention of postmenopausal osteoporosis in women and bone loss in patients undergoing hormone ablation for either prostate or breast cancer. The filing, announced Dec. 18, is supported by two Phase III pivotal studies with fracture endpoints. Analysts have projected the twice-yearly injectable fully human monoclonal antibody could be worth as much as $2.4 billion worldwide by 2016, just in the PMO indication (1"The Pink Sheet" DAILY, July 29, 2008)
Advertisement

Related Content

Amgen’s Positive Denosumab Pivotal Trial Reduces Overhangs For Firm
Amgen’s Positive Denosumab Pivotal Trial Reduces Overhangs For Firm
Advertisement
UsernamePublicRestriction

Register

PS050458

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel