Ferring Pharmaceuticals presented the results of two studies on the effectiveness of EUFLEXXA(TM), an intra-articular hyaluronic acid (IA-HA) for the relief of pain in knee osteoarthritis (OA), at the Osteoarthritis Research Society International's World Congress on Osteoarthritis 2007 in Ft. Lauderdale, December 6-9.

One study showed that EUFLEXXA(TM) is equally effective in different radiographic stages of knee OA severity. The other demonstrated that, based on patients' perceptions, EUFLEXXA(TM) is effective in reducing the amount that knee OA pain interferes with patients' activities of daily living (ADLs) and social/leisure activities, for up to six months.

OA is one of the most common types of arthritis, affecting an estimated 21 million American adults.(1)

Equal Effectiveness in Different Disease Stages

As a subset analysis of a larger double-blind trial, the study comparing EUFLEXXA and Synvisc(R) demonstrated that an IA-HA treatment for knee OA is equally effective whether the disease severity is two or three on the Kellgren-Lawrence (K-L) radiographic scale. The study also showed a trend toward greater pain relief and patient satisfaction with EUFLEXXA. The K-L three patients treated with EUFLEXXA had numerically more improvement than those given Synvisc(R) (33.6 vs. 27.2, p=0.05), and reported greater satisfaction (3.24 vs. 3.05 on a 4-point scale, p=0.08).

"There are different schools of thought among physicians about when IA-HA should be administered, based on how effective it might be at different radiographic stages of OA," said Erol Onel, M.D., Director of Medical Affairs at Ferring. "This study shows that the treatment is equally effective at stages two and three, so that patients can benefit earlier in their course of treatment."

The original study was a prospective, multicenter, randomized, double-blind trial evaluating patients with confirmed knee OA and a K-L score of two or three, using the WOMAC pain subscale as the primary effectiveness measure. Both products were administered in three weekly injections. This subset analysis, comparing Synvisc(R) with EUFLEXXA, uses the K-L radiographic scale to define disease severity and treatment groups to see if the pain caused by OA is more resistant or responsive to IA-HA treatment at different stages of OA.

The 167 patients with a K-L score of two had a mean change on the pain subscale of the WOMAC of 29.1; the 147 patients with a K-L score of three had a change of 30.2. The K-L two patients in both groups had comparable improvements (28.4 vs. 29.9, p=0.66). EUFLEXXA patients also reported greater satisfaction (3.24 vs. 3.04 on a 4 point scale (p=.08)).

Patient Perception Study

The results of the second study revealed that patients perceive EUFLEXXA(TM) as being effective in reducing the amount that knee OA pain interferes with activities of daily living, as well as social and leisure activities, and maintains its effectiveness out to six months.

"It is very important that patient satisfaction is taken into account when evaluating different options for treating the pain caused by knee OA," said Dr. Onel. "OA is a disease that can seriously affect quality of life. The goal of this treatment is to provide effective pain relief that leads to a better quality of life for patients."

The results showed that EUFLEXXA is effective for reducing the amount that knee pain interferes not only with regular daily activities, but also with social and leisure activities, allowing patients greater social interactions, which can potentially reduce the risk of depression.

In this ongoing prospective study, 1,261 physicians gave survey materials to their patients eligible for EUFLEXXA. Patients voluntarily participated in a voice-response telephone survey about their condition at baseline, after three months, and after six months. A total of 161 patients (mean age 65) completed all three surveys. Patients receiving EUFLEXXA reported a decrease in the amount that their knee pain interfered with their ADLs, with a mean baseline score of 5.8 (range of 0 - 10=interferes very much), decreasing to 3.7 at three months and maintaining at 3.9 at six months. Patients receiving EUFLEXXA also reported a decrease in the amount that their knee pain interfered with their social and leisure activities, with a mean baseline score of 5.6, decreasing to 3.6 at three months and maintaining at 3.7 at six months.

About EUFLEXXA(TM)

EUFLEXXA(TM) (1% sodium hyaluronate) is the first and only non-avian derived hyaluronic acid approved in the U.S. for the treatment of pain caused by knee osteoarthritis and is indicated for a three-injection treatment regimen for patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (e.g., acetaminophen). In a prospective, randomized, double-blind, head-to-head study versus the market leading HA therapy, significantly more patients were "pain-free" and "symptom-free" with EUFLEXXA(TM).(2)

The process used to manufacture EUFLEXXA(TM) produces the HA that most closely resembles the HA in healthy human synovial fluid and the most highly purified HA product available today. In addition, since it is not derived from an avian source (chicken or rooster combs), the risk of reactions related to avian proteins is eliminated.(3-8)

EUFLEXXA(TM) received PMA approval from the U.S. Food and Drug Administration (FDA) on December 3, 2004, and became available to the public on November 8, 2005. For more information, visit http://www.EUFLEXXA.com.

About Ferring Pharmaceuticals Inc.

Ferring Pharmaceuticals Inc., part of the Ferring Group, is a privately owned, international pharmaceutical company. Ferring's line of orthopaedic products includes EUFLEXXA(TM), hyaluronic acid for pain from osteoarthritis in the knee. Urology products include degarelix for prostate cancer (Phase III) and Minirin Melt for bladder dysfunction (Phase III).

Ferring also markets BRAVELLE(R) (urofollitropin for injection, purified), MENOPUR(R) and REPRONEX(R) (menotropins for injection, USP), Novarel(R) (chorionic gonadotropin for injection, USP) and ENDOMETRIN (progesterone) Vaginal Insert, 100 mg in the U.S. to infertility specialists and their patients. Ferring also offers the Q-CAP(TM), the first and only needle-free reconstitution device, for use with its fertility treatments.

Other products include ACTHREL(R) (corticorelin ovine triflutate for injection) for the differential diagnosis of Cushing's syndrome and DESMOPRESSIN ACETATE in injectable and rhinal tube forms for the treatment of diabetes insipidus and primary nocturnal enuresis.

The Ferring Group specializes in the research, development and commercialization of compounds in general and pediatric endocrinology, urology, gastroenterology, obstetrics/gynecology and infertility.

Synvisc is a registered trademark of Genzyme Corporation.

References

(1) Arthritis Rheum 1999; 41(5): 778-799

(2) Kirchner M, Marshall D. A double-blind randomized controlled trial comparing alternate forms of high molecular weight hyaluronan for the treatment of osteoarthritis of the knee. Osteoarthritis Cartilage. 2006; 14: 154-162.

(3) Schiavinato A, Finesso M, Cortivo R, & Abatangelo G (2002). Comparison of the effects of intra-articular injections of Hyaluronan and its chemically cross-linked derivative (Hylan G-F20) in normal rabbit knee joints. Clin Exp Rheumatol 20, 445-454.

(4) Goomer RS, Leslie K, Maris T, & Amiel D (2005). Native hyaluronan produces less hypersensitivity than cross-linked hyaluronan. Clin Orthop Relat Res 239-245.

(5) Leopold SS, Warme WJ, Pettis PD, & Shott S (2002). Increased frequency of acute local reaction to intra-articular hylan GF-20 (synvisc) in patients receiving more than one course of treatment. J Bone Joint Surg Am 84-A, 1619-1623.

(6) Puttick MP, Wade JP, Chalmers A, Connell DG, & Rangno KK (1995). Acute local reactions after intraarticular hylan for osteoarthritis of the knee. J Rheumatol 22, 1311-1314.

(7) Pullman-Mooar S, Mooar P, Sieck M, Clayburne G, & Schumacher HR (2002). Are there distinctive inflammatory flares after hylan g-f 20 intraarticular injections? J Rheumatol 29, 2611-2614.

(8) Chen AL, Desai P, Adler EM, & Di Cesare PE (2002). Granulomatous inflammation after Hylan G-F 20 viscosupplementation of the knee: a report of six cases. J Bone Joint Surg Am 84-A, 1142-1147.

Ferring Pharmaceuticals Inc.
http://www.FerringUSA.com