{"id":12695,"date":"2018-10-02T08:44:15","date_gmt":"2018-10-02T12:44:15","guid":{"rendered":"http:\/\/bioventuspub.wpengine.com\/bioventus-receives-anvisa-approval-to-market-durolanein-brazil\/"},"modified":"2018-10-02T08:44:15","modified_gmt":"2018-10-02T12:44:15","slug":"bioventus-receives-anvisa-approval-to-market-durolanein-brazil","status":"publish","type":"post","link":"https:\/\/www.bioventus.com\/de\/bioventus-receives-anvisa-approval-to-market-durolanein-brazil\/","title":{"rendered":"Bioventus Receives ANVISA Approval to Market DUROLANE in Brazil and Selects Pfizer as Exclusive Distribution Partner"},"content":{"rendered":"<p><strong>HOOFDDORP, THE NETHERLANDS \u2013 October 2, 2018 \u2013 <\/strong><a href=\"https:\/\/new.bioventusglobal.com\">Bioventus<\/a>, a global leader in orthobiologic solutions, has received approval from Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (ANVISA) to market <a href=\"http:\/\/www.durolane.com\"><strong>DUROLANE<\/strong><\/a>, its single-injection joint-fluid osteoarthritis (OA) treatment, in Brazil. ANVISA has approved <strong>DUROLANE<\/strong> 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.<\/p>\n<p>OA involves the breakdown, or degeneration, of cartilage and the synovial fluid that cushions and lubricates joint tissues<strong>. <\/strong>Hyaluronic acid (HA)-based products like<strong> DUROLANE, <\/strong>help manage pain in the knees and hips of patients with OA.<\/p>\n<p>Pfizer has more than 100 sales representatives throughout Brazil and will offer <strong>DUROLANE\u00a0<\/strong>as part of its arthritis pain management portfolio which also includes CELEBRA<sup>\u00ae<\/sup>, a COX-2 selective\u00a0nonsteroidal anti-inflammatory drug\u00a0(NSAID).<\/p>\n<p>\u201cBrazil is the largest market for patients seeking osteoarthritis pain solutions in Latin America and one of the larger markets worldwide,\u201d said Tony Bihl, CEO of Bioventus. \u201cIntroducing <strong>DUROLANE<\/strong> 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.\u201d<\/p>\n<p>\u201cWe are very pleased Pfizer is adding <strong>DUROLANE <\/strong>to its pain management portfolio for OA patients in Brazil,\u201d said John Nosenzo, Chief Commercial Officer, Bioventus. \u201cThe company\u2019s 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.\u201d<\/p>\n<p><strong>DUROLANE<\/strong> is based on a natural, safe and proven technology process called NASHA<strong><sup>\u00ae<\/sup><\/strong>. This process yields stabilized (HA) which is a naturally occurring molecule that provides the lubrication and cushioning in a normal joint<em>.<\/em> It has been proven to provide greater reduction in OA knee pain versus Synvisc-One<sup>\u00ae1<\/sup>* and longer lasting pain relief versus a steroid injection<sup>2<\/sup>. <strong>DUROLANE <\/strong>is also safe for repeated courses of therapy. Repeated use of<strong> DUROLANE<\/strong> does not increase the incidence of adverse events.<sup>2, 3<\/sup><\/p>\n<p><strong>About Bioventus<\/strong><\/p>\n<p>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 <a href=\"https:\/\/new.bioventusglobal.com\">www.BioventusGlobal.com<\/a> and follow the company on Twitter <a href=\"https:\/\/twitter.com\/BioventusGlobal\">@Bioventusglobal.<\/a><\/p>\n<p>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.<\/p>\n<p><strong>Media\u00a0Contact:<\/strong> Thomas Hill, &nbsp;, <a href=\"mailto:thomashill@bioventusglobal.com\">thomas.hill@bioventusglobal.com<\/a><\/p>\n<p><strong>Summary of Indication for Use: <\/strong>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 <a href=\"http:\/\/www.DUROLANE.com\">www.DUROLANE.com<\/a>.<\/p>\n<p><strong>References: 1. <\/strong>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. <em>J Arthritis<\/em>. 2013; 2(1):108. doi:10.4172\/2167-7921.1000108. <strong>2. <\/strong>Leighton R, \u00c5kermark C, Therrien R, et. al. NASHA hyaluronic acid vs methylprednisolone for knee osteoarthritis: a prospective, multi-centre, randomized, non-inferiority trial. <em>Osteoarthritis Cartilage<\/em>. 2014; 22(1):17-25. <strong>3. <\/strong>DUROLANE [package insert]. Durham, NC: Bioventus LLC; 2017.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>HOOFDDORP, THE NETHERLANDS \u2013 October 2, 2018 \u2013 Bioventus, a global leader in orthobiologic solutions, has received approval from Ag\u00eancia [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-12695","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Bioventus Receives ANVISA Approval to Market DUROLANE in Brazil and Selects Pfizer as Exclusive Distribution Partner - Bioventus<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.bioventus.com\/de\/bioventus-receives-anvisa-approval-to-market-durolanein-brazil\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Bioventus Receives ANVISA Approval to Market DUROLANE in Brazil and Selects Pfizer as Exclusive Distribution Partner - 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