Partnering for Phase III

RALEIGH, N.C.—Amgen and PRA, a leading clinical researchorganization (CRO), have recently announced a new development agreement for aseries of Phase III studies to develop Amgen's biosimilar drugs on a worldwidebasis. No financial details regarding the agreement were disclosed.

"This agreement reflects and confirms PRA's commitment toproviding full-service support to our clients' development pipelines," KentThoelke, executive vice president of Scientific and Medical Affairs at PRA,said in a press release. "Our mission is to assist our clients across allphases of biotech drug development by combining therapeutic and operationalexpertise with local knowledge to help them meet their development goals. Assuch, this relationship represents a key milestone in PRA's commitment tosupporting our clients' biosimilar development programs. Amgen is a blue-chipcompany and a world leader with a global reputation for excellence in bringingbiologic therapies to patients with grievous illnesses. PRA has a strong trackrecord in executing our clients' global registration trials and helping to bringnew drugs to market. We are delighted to announce this strategic relationshipwith Amgen."

Under the terms of the agreement, PRA will be the soleprovider of CRO services for the Phase III studies. The Raleigh, N.C.-based CROoffers services in Phase I-IIa, bioanalytical laboratories, Phase II-III, latephase and minimal risk services, safety and risk management and therapeuticexpertise. The agreement will cover the full scope of Amgen's global biosimilarportfolio, and will focus specifically on the development of the portfolio.

Mary Klem, director of corporate communications at Amgen,says PRA will serve as a full-service provider for Phase III clinical trials,handling day-to-day activities related to planning and conducting the necessaryclinical trials for securing approval for biosimilar medicines. While she notesthat "Amgen expects that PRA will be the only CRO providing Phase III clinicaltrial services for the program," she adds that the company "is not obligated touse only PRA for these services."

PRA did not respond to requests for further commentsregarding the agreement.

"PRA has a strong track record in executing its clients'global registration trials and helping to bring new drugs to market positions,"says Klem. "This CRO has expertise across all phases of the development processand offers services in 80-plus countries. The company demonstrated a solidunderstanding of the emerging biosimilar landscape and exhibited a strongdesire to assist Amgen to compete successfully in this environment."

Biosimilars have been holding a place in the spotlightrecently as the pharmaceutical industry seeks out the benefits of this class ofdrugs, resulting in recent collaborations and increased regulatory focus.Biosimilars, follow-on biologic drugs that are characteristically similar toexisting drugs, offer a variety of advantages. Given that they sharepharmacokinetic profiles and mechanisms of action with existing drugs,biosimilars do not require the same stringency of testing as the originals,allowing companies to enjoy fewer trials and to get their drugs to marketsooner and less expensively.

Amgen considers biosimilars to represent "an excitinglong-term growth opportunity," Klem notes, adding that the company feels it is"well positioned to provide safe and effective biosimilars to patients."

The agreement with PRA is Amgen's second biosimilar-focusedpartnership of late. Amgen announced a collaboration in December of last yearwith Watson Pharmaceuticals Inc. for the development and commercialization ofseveral oncology antibody biosimilars on a worldwide basis. Amgen will assumeresponsibility for the development, manufacturing and initial commercializationof the oncology antibody drugs, and Watson will contribute up to $400 millionin co-development costs, as well as development support, and will share productdevelopment risks with Amgen. The collaboration will not include biosimilars ofAmgen's proprietary products, and products that result from the collaborationare expected to be sold under an Amgen/Watson label.