Amgen and UCB Team Up With NASA on Final Space Shuttle Mission to Conduct Preclinical Test of Sclerostin Antibody on Bone Loss

News provided by

Jul 05, 2011, 04:31 ET

Thousand Oaks, Calif. and BRUSSELS, July 5, 2011 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and UCB (Euronext Brussels: UCB) announced today that they are collaborating with the National Aeronautics and Space Administration (NASA) Ames Research Center to conduct a preclinical test of a sclerostin antibody in an experiment that will take place aboard space shuttle Atlantis, on the final NASA shuttle mission, Space Shuttle Flight STS-135, scheduled to launch July 8, 2011.

UCB Logo. (PRNewsFoto/Amgen) (PRNewsFoto/)

The loss of bone mass during space flight remains a significant problem for human space missions, especially long-term flights. This experiment will assess the effect of a sclerostin antibody on the loss of bone associated with space flight in mice. In this experiment of 30 space-flown mice, half of the mice are given the sclerostin antibody and the remaining mice receive a placebo. After the flight, various aspects of the structure, composition, strength, and cell and molecular nature of the bones from the flight and ground-based control mice will be analyzed.

The sclerostin antibody is designed to inhibit the action of "sclerostin," a protein that is a key negative regulator of bone formation, bone mass, and bone strength. The findings may also provide insight into potential further research in the prevention and treatment of the skeletal fragility that can result from "skeletal disuse" in such conditions as immobilization, stroke, cerebral palsy, muscular dystrophy, spinal cord injury, and reduced physical activity.

"It is an honor to work with NASA on this historic final mission," said Chris Paszty, Ph.D., scientific executive director at Amgen. "This proof of principle study will enhance our understanding of the science behind the sclerostin antibody and arm us with important research to support potential future therapeutic applications in both astronauts and patients suffering from bone loss."

"We are very excited to be working on this momentous experiment. It will help us to better understand the sclerostin antibody," said Prof. Iris Loew-Friedrich, chief medical officer and executive vice president of Global Projects and Development at UCB. "The origin of UCB's sclerostin program was the discovery of the genetic cause of a rare inherited high bone mass condition. This fascinating approach of turning genetic discovery into novel and innovative drug development seems fitting to the collaboration with NASA whose mission is exploration and discovery."

AMG 785/CDP7851, a different sclerostin antibody than the one being used for this STS-135 mouse study, is currently in Phase 2 clinical trials for bone-related conditions, including postmenopausal osteoporosis and fracture healing, as a collaboration between Amgen Inc. and UCB.

About Amgen

Amgen discovers, develops, manufactures, and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab to manufacturing plant to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and vital medicines, visit www.amgen.com.

About UCB

UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 8,000 people in about 40 countries, the company generated revenue of EUR 3.2 billion in 2010. UCB is listed on Euronext Brussels (symbol: UCB).

UCB Forward-Looking Statement

This press release contains forward-looking statements based on current plans, estimates and beliefs of management. Such statements are subject to risks and uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, effects of future judicial decisions, changes in regulation, exchange rate fluctuations and hiring and retention of its employees.

Amgen Forward-Looking Statements

This statement contains forward-looking statements that are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen's most recent annual report on Form 10-K and most recent periodic reports on Form 10- Q and Form 8-K. Please refer to Amgen's most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of July 5, 2011 and expressly disclaims any duty to update information contained in this news release.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and products liability claims. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development.

In addition, sales of our products are affected by the reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others' regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors and there can be no guarantee of our ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee that we will be able to produce commercially successful products or maintain the commercial success of our existing products. Our stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of our products or product candidates. Further, the discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations.

The scientific information discussed in this statement related to our product candidates is preliminary and investigative and is not part of the labeling approved by the U.S. FDA or the European Medicines Agency (EMA) for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. Only the FDA, EMA or other applicable regulatory bodies can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the approved labeling for the products, and not the information discussed in this statement.

CONTACT: Amgen, Thousand Oaks
Mary Klem: (805) 341-0687 (Media)
Arvind Sood: (805) 447-1060 (Investors)

CONTACT: UCB, Brussels
Antje Witte, Investor Relations UCB
T +32.2.559.9414, [email protected]
Michael Tuck-Sherman, Investor Relations, UCB
T +32.2.559.9712, [email protected]
Scott Fleming, Global Communications Manager UCB– Immunology
T +44.770.277.7378, [email protected]

(Logo: http://photos.prnewswire.com/prnh/20081015/AMGENLOGO)

(Logo: http://photos.prnewswire.com/prnh/20110421/LA87263LOGO)

SOURCE Amgen