EFFICACY AND SAFETY OF MERIVA^® IN OSTEOARTHRITIS CONFIRMED BY A LONG TERM STUDY
Long-term efficacy study in 100 osteoarthritis patients shows that Meriva^® improves WOMAC score¹ and reduces markers of inflammation.

Milan, January 11^th, 2011 - In a new study from Italian researchers² published in Alternative Medicine Review Meriva^®, an Indena proprietary formulation of curcumin with soy phospholipids has been shown to relieve pain and increase mobility in patients with osteoarthritis as well as reduce a series of inflammatory markers.  

In this new registry study, 100 patients with X-ray confirmed osteoarthritis (OA), were divided in two groups. The first one was managed using the "best available treatment" and the second group used the best available treatment plus Meriva^®, at a dosage corresponding to 200 mg curcumin/day. 
 
The results showed that the Meriva^®-treated group had a statistically significant reduction in all primary clinical end-points, the Western Ontario and McMaster Universities (WOMAC) score, the Karnofsky Performance Scale, and the treadmill walking performance test. These results were complemented by the evaluation of a series of inflammatory markers (interleukin [IL]-1ß, , IL-6, soluble CD40 ligand [sCD40L], soluble vascular cell adhesion molecule (sVCAM)-1, and erythrocyte sedimentation rate [ESR]) that also showed a marked reduction in the Meriva^® treated group, while no significant variation was observed in the "best available treatment" group. 

Commenting on the results of the study Giovanni Appendino, Professor of Organic Chemistry at the University of Eastern Piedmont and Indena Scientific Advisor, said "this study represents the most ambitious attempt, to date, to evaluate the clinical efficacy and safety of curcumin as an anti-inflammatory agent. Although no direct comparison study of Meriva^® versus NSAIDs has been conducted, the decreased use of these drugs observed in the treatment group provides a rationale for evaluating whether the biochemical improvement in the inflammatory status associated with Meriva^® could eventually translate to a phase out of NSAIDs use, at least for mild-to-moderate OA."

These results follow a previous three months study on 50 osteoarthritis patients showing a reduction of the same clinical end points.

1. The WOMAC (Western Ontario and McMaster Universities Osteoarthritis) index is the golden standard to evaluate the conditions and the level of disability of patients with osteoarthritis of the knee and hip. It is a questionnaire completed by the patient and focusing on joint pain, stiffness and loss of function related to the disease.
2. Belcaro G., Cesarone M.R., Dugall M. et al., Efficacy and Safety of Meriva^®, al., Curcumin-phosphatidylcholine Complex, during Extended Administration in Osteoarthritis Patients Altern Med Rev. 2010 Dec;15(4):337-44.
3. Belcaro G, Cesarone MR, Dugall M, et al. Product evaluation registry of Meriva^®, a curcumin-phosphatidylcholine complex, for the complementary management of osteoarthritis. Panminerva Med 2010;52:55-62.
4. Nonsteroidal anti-inflammatory drugs.

About curcumin
Curcumin is the yellow pigment of turmeric (Curcuma longa L.), the most important spice of the Indian cuisine, and a major ingredient of curry powders. In Asian Medicine, turmeric is used for the treatment of inflammation and joint pain. In Western countries, it is mainly employed as a food additive to color dairy products (cheese and yogurts), margarine and canned food. With over 3,000 pre-clinical investigations, curcumin is one of the best investigated natural products of the whole biomedical literature; these studies have demonstrated its action as a master switch of inflammation. Nevertheless, just like most dietary phenolics, curcumin shows a very poor oral absorption. These problems have now been largely overcome by the patented formulation of curcumin with soy phospholipids that is capitalizing the basic tenets of the Phytosome^® strategy to improve the bioavailability by offering a higher stability and oral absorption in comparison with unformulated curcumin. 

About Meriva^®
Meriva^® is a patented formulation of curcumin, a dietary phenolic, with soy phospholipids. The two ingredients are combined in a 1:2 weight ratio, and two parts of microcrystalline cellulose are then added to improve the flowability, with an overall content of curcumin of 20%. Meriva^® is already included as an ingredient in food supplements marketed in USA, Canada and EU and available over the counter. 
Meriva^® has been elected "Best New Product" of the year by the judging panel of the European Outsourcing Awards. 

About Osteoarthritis (Reference: NIAMS, National Institute of Arthritis and Musculoskeletal and Skin Sideases - NIH, National Institutes of Health - Department of Health and Human Services)
Osteoarthritis (OA), also called osteoarthroses or degenerative joint disease, is the most common type of arthritis. OA is a chronic condition characterized by the degradation of the joint cartilage. Cartilage degradation causes the bones to rub against each others, producing stiffness, pain and loss of movement in the joint. Symptoms typically first begin after the age 40 and progress slowly. After age 50, women are more often affected by OA than men.
Osteoarthritis affects nearly 27 million Americans, and, as the population ages, the number of people with osteoarthritis will grow significantly. By 2030, 20 percent of Americans - about 72 million people - will have passed their 65th birthday and will be at high risk for the disease.


###
Indena is the world's leading company dedicated to the identification, development and production of active principles derived from plants, for use in the pharmaceutical, health food and cosmetics industries. Backed up by over 85 years of botanical experience, the key to Indena's success is its intense research activity. The company has more than 150 primary patents and has published more than 700 scientific studies. Indena employs more than 700 staff, including 10% dedicated to full-time research activities carried out at Settala Research Center, near Milan. Indena also co-operates with the world's most prestigious universities and private research institutions. Headquartered in Milan, Indena has 5 production sites and 4 international branches throughout the world and manages distribution operations in more than 40 countries. The Company's experts communicate and interact constantly with the major international regulatory authorities such as WHO, EMEA, and ESCOP, and work with all the main pharmacopoeias.

Further Information on Indena: www.indena.com  
Further Information on Indena's Phytosome^®: www.phytosomes.info 

Indena Press Contacts:
Cohn & Wolfe Milan
Laura Faravelli laura.faravelli@cohnwolfe.com 
Lorenzo Petracco lorenzo.petracco@cohnwolfe.com 
Tel.+39.02202391