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Ferring Pharmaceuticals A/S Announces Launch Of EUFLEXXA(TM) For Osteoarthritis Knee Pain


11/14/2005 11:21:26 AM

SUFFERN, N.Y., Nov. 14 /PRNewswire/ -- Ferring Pharmaceuticals Inc. announced today the launch of EUFLEXXA(TM) (highly purified hyaluronan) for the treatment of pain caused by knee osteoarthritis (OA). It is the first and only non-avian* derived hyaluronic acid (HA) indicated for a three-injection treatment regimen for patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics. At the end of a 12-week study, significantly more patients treated with EUFLEXXA(TM) were symptom-free (p=0.038) than those treated with Synvisc**, the leading HA product in its class.(1)

(Photo: http://www.newscom.com/cgi-bin/prnh/20051114/NYM049 )

"EUFLEXXA(TM) is a new treatment option that can help millions of people who live with painful knees," said Wayne C. Anderson, president, Ferring Pharmaceuticals. "It is proven to offer better drug-free symptom relief over a 12-week period than the current leading HA therapy. Additionally, it offers proven safety and efficacy with significantly fewer joint effusions and less use of simple analgesics than Synvisc. Not surprisingly, patients reported higher satisfaction with EUFLEXXA(TM)."

Clinical Advantages

In a prospective, multicenter, randomized, double-blind controlled trial, 321 patients with confirmed knee osteoarthritis were randomized to treatment with either EUFLEXXA(TM) (n=160) or Synvisc (n=161). The Western Ontario McMaster Universities Osteoarthritis (WOMAC) Index pain subscale was the primary efficacy measure. Both products were administered as a course of three weekly injections, with follow-up evaluations at weeks 3, 6 and 12. Both treatment groups experienced statistically significant improvements from baseline (p=0.0001). EUFLEXXA(TM) (WOMAC pain score = 29.8 mm (-61.6%)) was shown to be comparable in efficacy to Synvisc (WOMAC pain score = 28.8 mm (-54.9%)).(1) At the study endpoint, 63% of patients treated with EUFLEXXA(TM) were symptom-free compared with 52% of those treated with Synvisc (p=0.038), as determined by a VAS (100-mm visual analog scale) score of <20 for the average of the five WOMAC pain questions.(1)

EUFLEXXA(TM) also showed a significant advantage over Synvisc in the number of patients requiring supplemental simple analgesics (p=0.013), joint effusion (p=0.0015) and patient satisfaction (p=0.03). For patient satisfaction, 50% of EUFLEXXA(TM) patients were 'very satisfied' with treatment results compared to 37% for the Synvisc group. A subanalysis performed on patients with unilateral OA found that only 49% of patients treated with EUFLEXXA(TM) used supplemental simple analgesics compared to 82% of those treated with Synvisc (p=0.001).(1)

About EUFLEXXA(TM)

EUFLEXXA(TM) is the first and only non-avian derived hyaluronic acid approved in the U.S. for the treatment of pain caused by knee osteoarthritis. Since it is not derived from an avian source (chicken or rooster combs), the risk of related reactions is eliminated.(2,3) In addition, the process used to manufacture EUFLEXXA(TM) results in ultra-high-purity HA with properties similar to the HA in human synovial fluid. EUFLEXXA(TM) is also free of chemical cross-linking which minimizes the risk of related reactions.(2-7)

EUFLEXXA(TM) received approval from the U.S. Food and Drug Administration (FDA) on December 3, 2004, and is also approved in Israel and the European Union. Ferring acquired the product in July 2005 as part of its acquisition of the global biologics manufacturing business of Savient Pharmaceuticals, Inc.

About Hyaluronic Acid

HA is a viscous, elastic liquid that is naturally found in many tissues of the body and in high concentrations in joint cartilage and synovial fluid. Within a joint, HA is essential to water balance, viscosity, lubrication and the structure of cartilage.(8) In cartilage, HA binds to other molecules, helping it withstand weight-bearing force and movement of the joint. Inside the knee joint, HA provides a cushion to protect the joint from mechanical damage and acts as both a shock-absorbing fluid and regulator of water and metabolites.

Osteoarthritis and the General Population

The Arthritis Foundation estimates that 66 million Americans are affected by arthritis, half of whom are unaware of available treatments, and that the disease costs the U.S. economy more than $86.2 billion annually. The Foundation also estimates that 21 million American adults suffer from osteoarthritis.(9) Osteoarthritis, a form of arthritis, affects certain parts of the body, most commonly the knee. Over time, articular cartilage in the knee loses elasticity and becomes worn. As a result, the bony surfaces of the joint can grind together and eventually wear the cartilage away entirely. This leads to symptoms of pain, stiffness and impaired joint movement. There are a wide range of treatment options for knee OA, including behavior modification, drug therapy, injections within the joint and knee replacement surgery.

Non-steroidal anti-inflammatory drugs (NSAIDs) are common first-line pharmacologic treatments for knee pain relief. Serious side effects and risks (i.e. potentially life-threatening stomach bleeding and kidney disease) have been associated with such treatments.

The effectiveness of different treatments varies from person-to-person and with the severity of the condition. Treatment options are generally a shared decision between the patient and his/her physician with total knee replacement surgery usually sought as the last option.

About Ferring Pharmaceuticals Inc.

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

Ferring also markets MENOPUR(R) (menotropins for injection, USP), BRAVELLE(R) (urofollitropin for injection, purified), REPRONEX(R) (menotropins for injection, USP) and NOVAREL(R) (chorionic gonadotropin for injection, USP) in the U.S. to infertility specialists and their patients. Ferring 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 generic 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, visit http://www.FerringUSA.com.

* Derived through bacterial fermentation **Synvisc is a registered trademark of Genzyme Corporation. (1) Data on file, Ferring Pharmaceuticals. (2) 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. (3) Goomer RS, Leslie K, Maris T, & Amiel D (2005). Native hyaluronan produces less hypersensitivity than cross-linked hyaluronan. Clin Orthop Relat Res 239-245. (4) 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. (5) 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. (6) 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. (7) 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. (8) Abatangelo, G., O'Regan. Hyaluronan: Biological Role and Function in Articular Joints. European Journal of Rheumatology and Inflammation; Vol15(1) 1995. (9) Arthritis Rheum 1999; 41(5):778-799

Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20051114/NYM049AP Archive: http://photoarchive.ap.orgAP PhotoExpress Network: PRN7PRN Photo Desk, photodesk@prnewswire.comFerring Pharmaceuticals Inc.

CONTACT: Kelly Laban of Kovak-Likly Communications for FerringPharmaceuticals Inc., +1-203-762-8833 ext 15 or KLaban@KLCpr.com


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