EU committee recommends that the Commission give EU marketing authorisation for a promising new osteoporosis drug from Nycomed. Preotact(R) strengthens and rebuilds bones enabling osteoporosis suffers a better chance of avoiding debilitating bone fractures.
Today, the treatment of osteoporosis took an important step forward when The European Committee for Medicinal Products for Human Use, CHMP, recommended the Commission to give Nycomed an EU marketing authorization for a promising new drug against "the silent disease", osteoporosis.
The new medicine, Preotact(R), which the Commission is expected to approve for treatment of osteoporosis in post-menopausal women, is a more thermostable, parathyroid hormone variant that both rebuilds and strengthens the bones thus reducing the risk of patients with osteoporosis suffering debilitating and painful bone fractures.
Preotact(R), which is taken as a daily injection, has shown good effect in a number of studies. Furthermore the drug represents a vast improvement in the treatment of osteoporosis, because it is easy to inject and practical to use. Current therapies for treating osteoporosis, despite significant effects, still have some limitations.
Preotact(R) is injected with the specially designed and patient focused
Preotact(R) Pen, which is easy to use, even for elderly patients. Preotact(R) and the Preotact(R) Pen, does not require permanent cold storage. Consequently the patients are not limited by access to cold storage and despite the disease have the opportunity to continue their active life style, get out and go away on trips and visit friends and family.
"Today, people live very active and busy lives, and when a disease, such as osteoporosis, and the medicines they take, impact on their normal daily routines this can drastically affect their overall quality of life. Preotact(R) offers an effective treatment for patients with osteoporosis while helping them maintain an active life," says Dr Richard Keen, Consultant Rheumatologist at the Royal National Orthopaedic Hospital, London.
Osteoporosis is a debilitating disease with impact on mobility and independence thus diminishing the patients' quality of life considerably. According to the International Osteoporosis Foundation (IOF), 30% of women over 50 will experience osteoporotic fractures, and in Europe alone 20 million woman suffer from osteoporosis. The number of patients is estimated to rise significantly.
Nycomed expects the Commission to follow the recommendation from CHMP and ratify the approval of Preotact(R) within the first half of 2006 and reckon a product launch after the summer.
About Preotact(R)
Preotact(R) is the more thermostable full-length parathyroid hormone variant.
Preotact(R) has been studied in a number of clinical settings to assess its safety and its effect on bone. The pivotal Phase 3 study, known as TOP (Treatment of Osteoporosis with PTH), was a multi-centre, randomized, double-blind and placebo-controlled clinical trial designed to evaluate the potential of Preotact(R) to reduce the risk of fractures in post-menopausal women.
In the TOP study, Preotact(R) demonstrated a statistically significant reduction in the risk of new vertebral fractures in women with and without osteoporosis-related fractures prior to entering the study. In addition Preotact continued to improve bone mineral density (BMD) for up to 18 months.
In another study, the PaTH trial, Preotact(R) followed by bisphosphonate showed more rapid benefit than treatment with bisphosphonate alone.
Results from the TOP study are the foundation of the EU marketing authorisation applications.
About Nycomed
Nycomed is a pharmaceutical company dedicated to meeting medical needs in Europe. Nycomed has been working in the field of osteoporosis for the past 20 years and is the leading manufacturer of Calcium/Vitamin D3 chewable tablets in Europe. The company provides hospital products throughout the region and general practitioner and pharmacy medicines in selected markets.
New products are sourced through licensing agreements with research companies. Here Nycomed provides late-stage clinical development, registration and marketing.
Headquartered in Roskilde, Denmark, the company employs about 3,000 people throughout Europe and Russia/CIS. Nycomed is privately owned and had a 2004 revenue of E 644.6 million.
For more information visit nycomed
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