Biopharmaceuticals

 News Release - November 7, 2007

Cost-Effectiveness Study Supports Use of EUFLEXXA(TM) by Rheumatologists for Pain Relief in Patients with Knee Osteoarthritis

Ferring Pharmaceuticals Presents Study at the Annual Scientific Meeting of the American College of Rheumatology

BOSTON, Nov. 7 (HSMN NewsFeed) -- Ferring Pharmaceuticals presented the results of a cost-utility study supporting the adoption of EUFLEXXA(TM) (1% sodium hyaluronate) intra-articular hyaluronic acid (HA) for the relief of pain in patients with osteoarthritis (OA) of the knee at the American College of Rheumatology's Annual Scientific Meeting in Boston, MA, November 6-11.

Using data from a larger trial, the study demonstrated that an intra- articular treatment course of HA (EUFLEXXA(TM)) for knee OA, as compared with non-HA therapy, provides a cost-utility benefit that supports adopting this technology. The data also show that wider adoption of this technology would result in greater financial savings to the health care system. Osteoarthritis is one of the most common diseases seen in the rheumatologist's office, costing the health care system nearly $100 billion per year. (1)

"While the use of intra-articular HA is increasing, little has been published about its cost-effectiveness," said Erol Onel, MD, Director of Medical Affairs at Ferring. "This study is important because it not only presents rheumatologists with significant analysis regarding the cost-benefit of using this treatment, but it also demonstrates a potentially significant savings to our overall health care system." More information regarding the cost-effectiveness of various OA treatment therapies is available in the Ferring-sponsored OA Trends in Managed Care Report.

About the Study

The study of 160 patients with knee OA compared costs and the extension of quality-adjusted life years (QALY) in patients using hyaluronic acid (HA) with those using a non-HA treatment for this condition. Patients were randomized either to receive three 2 ml injections of EUFLEXXA(TM) or to be in a control group maintained on their prior non-HA therapy. Patients' utility scores were estimated and used to calculate QALYs. To determine costs, in addition to the costs of HA, patients who responded to HA treatment were assigned costs of health care utilization attributed to patients without OA, and non-responders were assigned costs of health care resources consumed by OA patients. Cost- effectiveness was expressed as average and incremental cost per QALY.

The responder rate for patients in the HA treatment arm was approximately 83 percent, and the mean QALY gained was 0.0877 for each patient responding to treatment with HA over baseline values. When the change of QALY of the non- responders was set as zero, the HA treatment yielded a cost-utility ratio of $38,964, while that of the control group ranged from $36,077 (assuming a 75 percent response rate) to $139,648 (25 percent response rate).

The study concluded that the cost-utility ratio for EUFLEXXA(TM) is within the range needed to adopt a new technology, and that the product's wider adoption would result in greater savings to the health care system.

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 (eg, 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 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® (urofollitropin for injection, purified), MENOPUR® and REPRONEX® (menotropins for injection, USP), Novarel® (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® (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. For more information, call 888-337-7464 or visit www.FerringUSA.com.

1 Centers for Disease Control and Prevention. MMWR. 2004;53:388-389,

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.

Source: Ferring Pharmaceuticals

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