AstraZeneca and POZEN Inc. today announced that VIMOVO (naproxen/ esomeprazole magnesium) 500/20 mg modified-release tablets has cleared an important regulatory milestone by receiving positive agreement for approval in 23 countries across the European Union (EU). This follows all 22 Concerned Member States agreeing with the assessment of the Netherlands Health Authority (MEB), acting as the Reference Member State for the Decentralised Procedure (DCP). It also results in a harmonised Summary of Product Characteristics (SmPC). The Member States will now pursue pricing and reimbursement and national approvals.
VIMOVO is indicated for the symptomatic treatment of osteoarthritis (OA), rheumatoid arthritis (RA), and ankylosing spondylitis (AS) in patients who are at risk for developing non-steroidal anti-inflammatory drug (NSAID)-associated gastric and/or duodenal ulcers and where treatment with lower doses of naproxen or of other NSAIDs is not considered sufficient.
VIMOVO, co-developed by AstraZeneca and POZEN Inc., is a fixed-dose combination of enteric-coated naproxen, a pain-relieving NSAID, and immediate-release esomeprazole, a proton pump inhibitor (PPI). The positive agreement is based on a submission package including data from the pivotal trials PN400-301 and PN400-302, which demonstrated that patients taking VIMOVO experienced significantly fewer endoscopic gastric ulcers, compared to patients receiving enteric-coated naproxen.
"This support for the approval of VIMOVO in Europe is a significant milestone, which we believe will provide a new treatment option for the millions of arthritis patients in the EU at risk for NSAID-associated ulcers," said Lori Kreamer, Global Products Vice President, AstraZeneca. "In one tablet, VIMOVO offers the proven pain relief of naproxen with built-in ulcer risk reduction."
Nearly 151 million people worldwide and approximately 28 million people in Europe suffer from OA, which is the most common form of arthritis. While many patients with OA treat their symptoms with NSAIDs, 50% of chronic NSAID users are at risk of gastrointestinal ulcers.
About VIMOVO
VIMOVO (naproxen/esomeprazole magnesium) 500/20 mg modified-release tablets is a fixed-dose combination of enteric-coated naproxen, an NSAID, and immediate-release esomeprazole, a stomach acid-reducing PPI, indicated for the symptomatic treatment of OA, RA, and AS in patients who are at risk for developing NSAID-associated gastric and/or duodenal ulcers and where treatment with lower doses of naproxen or of other NSAIDs is not considered sufficient.
AstraZeneca submitted a Marketing Authorisation Application (MAA) in Europe via the DCP in the EU for VIMOVO on 15 October 2009. The EU Concerned Member States that formed the DCP include: Austria, Belgium, Bulgaria, Czech Republic, Estonia, Finland, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom. Following this positive agreement, the Member States will now work to pursue pricing/reimbursement and national approvals.
On 30 April 2010, the US Food and Drug Administration (FDA) approved VIMOVO for the relief of signs and symptoms of OA, RA, and AS, and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.
About OA
OA is the most common form of arthritis. Known as the “wear-and-tear” kind of arthritis, OA is a chronic condition characterised by the breakdown of the joint’s cartilage. Cartilage is the part of the joint that cushions the ends of the bones and allows easy movement of joints. The breakdown of cartilage causes the bones to rub against each other, causing stiffness, pain and loss of movement in the joint.
About RA
RA is a chronic disease, mainly characterised by inflammation of the lining, or synovium, of the joints. It can lead to long-term joint damage, resulting in chronic pain, loss of function and disability.
About AS
AS is a chronic inflammatory disease that primarily causes pain and inflammation of the joints between the vertebrae of the spine and the joints between the spine and pelvis (sacroiliac joints). AS may also cause inflammation and pain in other parts of the body as well.
About POZEN
POZEN Inc., headquartered in Chapel Hill, NC, is a pharmaceutical company committed to transforming medicine that transforms lives. Since its founding in 1996, POZEN has successfully created novel pharmacologic agents primarily for pain and pain-related conditions by combining existing drug therapies that result in superior patient outcomes. Moving forward, POZEN is poised to become a model 21st century pharmaceutical company dedicated to ensuring that they produce cost-effective, evidence-based medicines; take a fresh approach to sales, marketing and medical education; and deliver high-quality, affordable pharmaceuticals to their customers. The Company's common stock is traded on The NASDAQ Stock Market under the symbol "POZN". For more detailed company information, including copies of this and other press releases, please visit: www.pozen.com.
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines. As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease medicines, AstraZeneca generated global revenues of US $32.8 billion in 2009. For more information please visit: www.astrazeneca.com.