Amgen and UCB receive positive vote from FDA Advisory Committee in favor of approval for EVENITY™ (romosozumab)

AmgenAmgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) announced strong support from the U.S. Food and Drug Administration (FDA) Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) for the approval of EVENITY™* (romosozumab) for the treatment of postmenopausal women with osteoporosis at high risk for fracture after reviewing safety and efficacy data from the pivotal Phase 3 studies. Eighteen of 19 members voted yes for approval. In their discussion, the Committee emphasized the need for post-marketing follow-up.

"We are pleased with the Committee's recommendation to approve EVENITY for the treatment of postmenopausal women with osteoporosis at high risk for fracture," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "A fracture due to osteoporosis can be devastating to the lives of patients. After an osteoporotic fracture, a woman is five times more likely to suffer another fracture within the first year, and her risk remains elevated over time if untreated.(1) Despite available therapies, these women who are at high risk for fracture could benefit from an additional treatment option that has the potential to both build new bone and slow existing bone loss. We are committed to working with the FDA to help make EVENITY available to appropriate patients."

The EVENITY development program includes 19 clinical studies that enrolled approximately 14,000 patients.(2) Notable Phase 3 studies include FRAME,(3) a placebo-controlled study with 7,180 postmenopausal women with osteoporosis at risk for fracture; ARCH,4 an active comparator-controlled study with 4,093 postmenopausal women with osteoporosis and with prior history of fracture; and STRUCTURE,(5) an active comparator-controlled study with 436 postmenopausal women with osteoporosis. The BRUDAC evaluated the FRAME and ARCH studies in its review of the clinical benefit:risk profile of EVENITY, including the cardiovascular safety finding seen in the ARCH study, for the potential to reduce the risk of fractures and increase bone mineral density (BMD) in postmenopausal women with osteoporosis.

"Evidence suggests that many women who sustain a fragility fracture are not appropriately treated for osteoporosis. This is why new treatment options, like EVENITY, are so important," said Dr. Pascale Richetta, head of bone and executive vice president, UCB. "The Committee's recommendation represents a step forward for patients and we look forward to working with our partner, Amgen, in the coming months to bring EVENITY to the patients that need it most."

While the FDA is not bound by the Advisory Committee's recommendations, it takes the advice into consideration when making its decision.

In the U.S., one in two women over the age of 50 will experience an osteoporotic fracture.(6) Unfortunately, only 20 percent of women who have experienced a fracture receive any type of osteoporosis treatment during the first year post-fracture.(7)

EVENITY was granted marketing authorization - its first approval anywhere in the world - by the Japanese Ministry of Health, Labor and Welfare on Jan. 8, 2019, for the treatment of osteoporosis in patients at high risk of fracture.(8) The European Medicines Agency (EMA) is currently reviewing the marketing application for EVENITY and interactions between our partner and the agency are ongoing.

About EVENITY™* (romosozumab)

EVENITY is an investigational bone-forming monoclonal antibody. It is designed to work by inhibiting the activity of sclerostin, which enables EVENITY to rapidly increase bone formation and reduce bone resorption simultaneously. The EVENITY development program includes 19 clinical studies that enrolled approximately 14,000 patients. EVENITY has been studied for its potential to reduce the risk of fractures in an extensive global Phase 3 program. This program included two large fracture trials comparing EVENITY to either placebo or active comparator in more than 11,000 postmenopausal women with osteoporosis. Amgen and UCB are co-developing EVENITY.

About the Pivotal EVENITY Clinical Trials

FRAME (Fracture study in postmenopausal women with osteoporosis) is a randomized, double-blind, placebo-controlled study that evaluated 7,180 postmenopausal women with osteoporosis at risk for fracture. The study evaluated the effectiveness of EVENITY treatment (210 mg administered monthly), compared with placebo, in reducing the risk of new vertebral fractures through 12 months. The study also evaluated the effectiveness of treating with EVENITY for 12 months followed by denosumab for 12 months, compared with placebo followed by denosumab, in reducing the risk of new vertebral fractures through 24 months.

ARCH (Active-controlled fracture study in postmenopausal women with osteoporosis at high risk of fracture) is a randomized, double-blind, alendronate-controlled study of EVENITY in 4,093 postmenopausal women with osteoporosis at high risk for fracture based on previous fracture history. The study evaluated 12 months of EVENITY treatment (210 mg administered monthly) followed by at least 12 months of alendronate treatment (70 mg), compared with alendronate treatment alone, to assess its effectiveness in reducing the incidence of clinical fracture (non-vertebral fracture and clinical vertebral fracture) and new vertebral fracture.

About the STRUCTURE Clinical Trial

STRUCTURE (Study evaluating effect of romosozumab compared with teriparatide in postmenopausal women with osteoporosis at high risk for fracture previously treated with bisphosphonate therapy) is a Phase 3, multi-center, international, randomized, open-label, teriparatide-controlled study that evaluated safety, tolerability and efficacy of romosozumab in women with postmenopausal osteoporosis. The trial included 436 postmenopausal women averaging 72 years of age who had postmenopausal osteoporosis and a history of bone fracture; patients were treated with bisphosphonate therapy for a minimum of three years prior to screening, with treatment with alendronate (70 mg weekly or equivalent) during the year immediately prior to screening.

About Fragility Fractures

Worldwide, one in three women and one in five men, over the age of 50, will suffer a fragility fracture due to osteoporosis and with an aging population these numbers will rise.(9) Yet despite this, there is a large gap in the management and treatment of osteoporosis, especially in the post-fracture setting, with an estimated four out of five patients remaining undiagnosed and untreated after a fracture.(7) Without proper care or access to effective intervention options, they remain at risk of painful and disabling fractures in the future.

About the Amgen and UCB Collaboration

Since 2004, Amgen and UCB have been working together under a collaboration and license agreement to research, develop and market antibody products targeting the protein sclerostin. As part of this agreement, the two companies continue to collaborate on the development of romosozumab for the treatment of osteoporosis. This gene-to-drug project demonstrates how Amgen and UCB are joining forces to translate a genetic discovery into a new medicine, turning conceptual science into a reality.

About Amgen

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be the world's largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

About UCB

UCB, Brussels, Belgium 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 7,500 people in approximately 40 countries, the company generated revenue of € 4.5 billion in 2017. UCB is listed on Euronext Brussels (symbol: UCB).

* The trade name EVENITY™ is provisionally approved for use by the FDA and EMA.

1. Lindsay R, Silverman SL, Cooper C, et al. Risk of new vertebral fracture in the year following fracture. JAMA. 2001;285(3):320-323.
2. FDA Briefing Document. Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee. January 16, 2019. BLA 761062 Romosozumab Amgen, Inc. Available at: https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ReproductiveHealthDrugsAdvisoryCommittee/UCM629456.pdf. Accessed January 14, 2019.
3. Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis (FRAME). Available at: https://clinicaltrials.gov/ct2/show/NCT01575834?term=NCT01575834&rank=1. Accessed January 14, 2019.
4. Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis (ARCH). Available at: https://clinicaltrials.gov/ct2/show/NCT01631214?term=NCT01631214&rank=1. Accessed January 14, 2019.
5. An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women (STRUCTURE). Available at: https://clinicaltrials.gov/ct2/show/NCT01796301?term=STRUCTURE+ROMOSOZUMAB&rank=1. Accessed January 14, 2019.
6. National Osteoporosis Foundation. Osteoporosis Fast Facts. https://cdn.nof.org/wp-content/uploads/2015/12/Osteoporosis-Fast-Facts.pdf. Accessed January 14, 2019.
7. International Osteoporosis Foundation. Facts and Statistics. https://www.iofbonehealth.org/facts-statistics. Accessed January 14, 2019.
8. Amgen Astellas BioPharma (2018) Evenity subcutaneous injection 105mg syringe: 2 syringes. [package insert] Tokyo, Japan.
9. International Osteoporosis Foundation. Patient Brochure. http://share.iofbonehealth.org/WOD/2012/patient_brochure/WOD12-patient_brochure.pdf. Accessed January 14, 2019.

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