Bioventus Receives ANVISA Approval to Market DUROLANE® in Brazil and Selects Pfizer as Exclusive Distribution Partner
HOOFDDORP, Netherlands--(BUSINESS WIRE)--Oct 2, 2018--Bioventus, a global leader in orthobiologic solutions, has received approval from Agência Nacional de Vigilância Sanitária (ANVISA) to market , its single-injection joint-fluid osteoarthritis (OA) treatment, in Brazil. ANVISA has approved DUROLANE for the symptomatic treatment of mild to moderate knee and hip OA. In addition, Bioventus has selected Pfizer as its exclusive distribution partner for the market.
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DUROLANE is a single-injection, hyaluronic acid product used for joint lubrication in the treatment of pain associated with knee and hip osteoarthritis and is now available in Brazil. (Photo: Business Wire)
OA involves the breakdown, or degeneration, of cartilage and the synovial fluid that cushions and lubricates joint tissues . Hyaluronic acid (HA)-based products like DUROLANE, help manage pain in the knees and hips of patients with OA.
Pfizer has more than 100 sales representatives throughout Brazil and will offer DUROLANE as part of its arthritis pain management portfolio which also includes CELEBRA ®, a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID).
“Brazil is the largest market for patients seeking osteoarthritis pain solutions in Latin America and one of the larger markets worldwide,” said Tony Bihl, CEO of Bioventus. “Introducing DUROLANE here gives patients and physicians access to a proven pain reliever for knee OA, expands the footprint of Bioventus and underscores our continuing efforts to bring orthobiologic solutions to patients around the world.”
“We are very pleased Pfizer is adding DUROLANE to its pain management portfolio for OA patients in Brazil,” said John Nosenzo, Chief Commercial Officer, Bioventus. “The company’s sales representatives have tremendous knowledge regarding osteoarthritis pain solutions. In addition, they have deep relationships with physicians and hospitals, making this a natural fit for Bioventus.”
DUROLANE is based on a natural, safe and proven technology process called NASHA ®. This process yields stabilized (HA) which is a naturally occurring molecule that provides the lubrication and cushioning in a normal joint . It has been proven to provide greater reduction in OA knee pain versus Synvisc-One ®1 * and longer lasting pain relief versus a steroid injection 2. DUROLANE is also safe for repeated courses of therapy. Repeated use of DUROLANE does not increase the incidence of adverse events. 2,3
Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The orthobiologic products from Bioventus include offerings for osteoarthritis, surgical and non-surgical bone healing. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.BioventusGlobal.com and follow the company on Twitter @Bioventusglobal.
Bioventus, the Bioventus logo, and DUROLANE are registered trademarks of Bioventus LLC. NASHA is a registered trademark of Nestle Skin Health s.a. CELEBRA is a registered trademark of Pfizer. Synvisc-One and Synvisc are registered trademarks of Genzyme Corporation.
Summary of Indication for Use: Symptomatic treatment of mild to moderate knee or hip osteoarthritis. There are no known contraindications. You should not use DUROLANE if you have infections or skin disease at the injection site. DUROLANE has not been tested in pregnant or lactating women, or children. Risks can include transient pain, swelling and/or stiffness at the injection site.,Indications presented are those approved in Brazil; indications and product offerings vary by country. Consult with your local Bioventus representative for approved use within your region of interest. Full prescribing information can be found in product labeling, at www.DUROLANE.com.
References: 1. McGrath AF, McGrath AM, Jessop ZM, et al. A comparison of intra-articular hyaluronic acid competitors in the treatment of mild to moderate knee osteoarthritis. J Arthritis. 2013; 2(1):108. doi:10.4172/2167-7921.1000108. 2. Leighton R, Åkermark C, Therrien R, et. al. NASHA hyaluronic acid vs methylprednisolone for knee osteoarthritis: a prospective, multi-centre, randomized, non-inferiority trial. Osteoarthritis Cartilage. 2014; 22(1):17-25. 3. DUROLANE [package insert]. Durham, NC: Bioventus LLC; 2017.
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CONTACT: Bioventus LLC
Thomas Hill, 919-474-6715
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PUB: 10/02/2018 10:00 AM/DISC: 10/02/2018 10:01 AM