naproxen/esomeprazole / Generic mfg. - LARVOL DELTA

Severe DRESS with myocarditis secondary to naproxen/esomeprazole. (PubMed, BMJ Case Rep) - "DRESS is a rare drug-induced hypersensitivity reaction with a mortality rate of 10%. The objective of this case report is to highlight the significant but rare cardiac complications that can ensue from DRESS, which warrant prompt recognition and withdrawal of the causative drug."

Journal • Acute Coronary Syndrome • Acute Kidney Injury • Atrial Fibrillation • Cardiovascular • Eosinophilia • Immunology • Inflammation • Nephrology • Renal Disease

Severe Myocarditis in Setting of Drug Rash with Eosinophilia and Systemic Symptoms secondary to Naproxen / Esomeprazole (EADV 2023) - "The main offending medications are anticonvulsants, antibiotics (particularly beta-lactams), and allopurinol. However other medications that are known to be associated with DRESS include non-steroidal anti-inflammatory drugs, captopril, mood stabilisers, and antiretrovirals... DRESS is a rare drug induced hypersensitivity reaction that includes skin eruption, haematological abnormalities, lymphadenopathy, and internal organ involvement which has morality rate of up to 10%. The objective of this case report is to highlight the significant cardiac complications that can ensue. Although not a common offending medication, (esomeprazole/naproxen) was the culprit drug."

Acute Coronary Syndrome • Acute Kidney Injury • Atrial Fibrillation • Back Pain • Cardiovascular • Eosinophilia • Hepatology • Inflammation • Liver Failure • Musculoskeletal Pain • Nephrology • Pain • Renal Disease

When you wear your heart on your sleeve, DRESS secondary to Vimovo complicated by severe, acute myocarditis (WCD 2023) - "DRESS should always be considered with a new onset rash in the context of a new medication. In this case the patient developed a severe rash complicated by atrial fibrillation and myocarditis which resolved within 3 months based on loop recordings, MRI and clinical findings"

Acute Coronary Syndrome • Acute Kidney Injury • Atrial Fibrillation • Back Pain • Cardiovascular • Eosinophilia • Hematological Disorders • Hepatology • Immunology • Inflammation • Liver Failure • Musculoskeletal Pain • Nephrology • Pain • Renal Disease

Comparison tables: H2-receptor antagonists and PPIs. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder • Peptic Ulcer

Miravo Healthcare Announces Summary Judgment Ruling by the United States District Court for the District of New Jersey (Businesswire) - "U.S. Patent Nos. 8,858,996 and 9,161,920 (the '996 and '920 patents) covering Vimovo in the U.S. have been found to be invalid...Nuvo Pharmaceuticals Inc...d/b/a Miravo Healthcare...today announced that the United States District Court for the District of New Jersey has granted Dr. Reddy’s Laboratories Inc.’s (DRL) motion for Summary Judgment, finding the asserted claims of the ‘996 and ‘920 patents invalid. Miravo’s wholly owned subsidiary, Nuvo Pharmaceuticals (Ireland) DAC d/b/a Miravo Healthcare (Miravo Ireland) is evaluating the court’s decision and is assessing its option"

Patent • Ankylosing Spondylitis • CNS Disorders • Immunology • Osteoarthritis • Pain • Rheumatoid Arthritis

WDEIA manifestation only in combination with selected drugs (EAACI 2021) - "Thereafter, we tried triple combination on different occasions Bread feeding Paracetamol / Diclofenac / Naproxen / esomeprazole intake and ergometry over 15 minutes. We recommended the avoidance of this two triple-combinations. If necessary, she was allowed to take Diclofenac or Naproxen with bread feeding and be physically active."

Combination therapy • Late-breaking abstract • Allergy • Immunology

Depot-opioids for Pre- and Postoperative Pain Relief After Primary Knee Arthroplasty.Tapentadol vs Oxycodone vs Placebo (clinicaltrials.gov) - P3; N=134; Completed; Sponsor: St. Olavs Hospital; Recruiting ➔ Completed

Trial completion • Orthopedics • Pain • Rheumatology

"Quero uma dessas com Vimovo. @AstraZeneca, seria pedir demais?" (@mateusmormar)

Horizon Therapeutics plc Reports Record Third-Quarter 2020 Results; Increases TEPEZZA Full-Year Net Sales Guidance to Greater Than $800 Million; Increases Full-Year 2020 Net Sales and Adjusted EBITDA Guidance (Businesswire) - "Inflammation Segment (in millions ($) except for percentages): Q3 2020: PENNSAID 2%®: 0.3; DUEXIS®: 27.9; VIMOVO®: 5.3."

Sales • Back Pain • CNS Disorders • Osteoarthritis • Pain

HORIZON THERAPEUTICS PUBLIC LTD CO MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (form 10-Q) (Market Screener) - "PENNSAID 2%. Net sales decreased $16.4 million, or 32%, to $35.1 million during the three months ended June 30, 2020, from $51.5 million during the three months ended June 30, 2019....DUEXIS. Net sales decreased $2.3 million, or 8%, to $27.8 million during the three months ended June 30, 2020, from $30.1 million during the three months ended June 30, 2019....VIMOVO. Net sales decreased $8.4 million, or 57%, to $6.2 million during the three months ended June 30, 2020, from $14.6 million during the three months ended June 30, 2019."

Commercial • Sales • Osteoarthritis • Pain

Pozen reports fourth quarter & year end 2013 results (Businesswire) - "Q4 2013 global net sales of VIMOVO by AstraZeneca...were $25 million, up 36% vs. Q4 2012 and up 9% from Q3 2013. POZEN earned a royalty of $1.7 million in Q4 2013. Total 2013 net sales of VIMOVO were $91 million, up 42% from 2012, and POZEN earned a royalty of $6.3 million, up 30% year on year. We anticipate continued growth in VIMOVO sales and royalties this year."

Sales • Pain

Horizon Pharma reports 2013 financial results and provides business update (Marketwire) - "Full year 2013 DUEXIS gross and net sales were $85.5 million and $59.0 million, respectively; versus 2012 DUEXIS gross and net sales of $13.2 million and $10.3 million, increases of 548% and 473%, respectively....VIMOVO gross and net sales during the fourth quarter of 2013 were $1.0 million each..."

Sales • Pain

Pozen reports first quarter 2013 results (Businesswire) - "Q1 2013 global net sales of VIMOVO by AstraZeneca...were $19.7 million, up 7% from Q4 2012 and 24% vs. Q1 2012... By the end of third quarter of this year, AstraZeneca will continue to make available, but plans to cease promotion of VIMOVO in certain countries, including the U.S. and in Europe, with the exception of Spain and Portugal, due to existing contractual arrangements with third parties...Decisions to launch in new countries will be made by AstraZeneca on a case-by-case basis."

Anticipated launch • Commercial • Sales • Pain

Phase shift : Filed->Launched in EU (Corporate website) - Vimovo / AstraZeneca

Corporate Pipeline Update

The majority of surveyed PCPs and pain specialists indicate that they have experienced reimbursement restrictions when prescribing Janssen's Nucynta ER for chronic low back pain (Businesswire) - Surveyed MCO pharmacy (28% and 36%) reported reimbursement restrictions with respect to Nucynta ER prescription; Vimo reported as pharmacy benefit by 44%of MCO pharmacy directors; Surveyed pharmacy expects tanezumab price at $35 per treatment day or higher and may have cost controls and prior authorization requirement

Commercial • Pain

"#Horizon Pharma Announces District Court Decision to Uphold VIMOVO(R) Patents https://t.co/dFH1qosTIs @RareDiseases @raredisorders" (@CheckOrphan)

Biosimilar

Grünenthal buys certain rights to AZ’s Nexium and Vimovo for $922m (pharmaphorum) - "AstraZeneca has agreed to sell some of the rights to its drugs Nexium and Vimovo to Grünenthal for an upfront payment of $922 million....Grünenthal will also buy the worldwide rights – excluding the US and Japan – to pain-relief drug Vimovo for $115 million plus potential additional payments of up to $17 million."

Licensing / partnership • Ankylosing Spondylitis • Pain

A 6-month, multicenter, open-label study of fixed dose naproxen/esomeprazole in adolescent patients with juvenile idiopathic arthritis. (PubMed, Pediatr Rheumatol Online J) - P4; "NAP/ESO was well tolerated in JIA patients aged 12 to 16 years with high levels of response to ACR criteria. No new safety signals were identified for the well-characterized components of this fixed dosed JIA treatment, which was developed to reduce the risk of gastric ulcers."

Clinical • Journal • P1 data • P4 data • Biosimilar • Rheumatoid Arthritis

"AstraZeneca completes divestment of European rights to Nexium for $700m and global rights (excl. US and Japan) to Vimovo for $115m." (@Accendo_Mike)

Clinical

Horizon Therapeutics plc reports strong first-quarter 2020 financial results; increasing TEPEZZA full-year 2020 net sales guidance to greater than $200 million due to rapid uptake; increasing full-year 2020 net sales guidance (Businesswire) - "Inflammation Segment: (in millions...): Q1 20 - PENNSAID 2%®: 41.6...DUEXIS®: 31.3...VIMOVO®: 19.4."

Sales • CNS Disorders • Immunology • Inflammation • Osteoarthritis • Pain • Rheumatology

Lupin launches generic version of Vimovo tablets (Business Standard) - "Pharma major Lupin on Thursday announced the launch of the authorized generic for Horizon Therapeutics Plc's Vimovo (naproxen/esomeprazole magnesium) delayed-release tablets, 375 mg/20 mg and 500 mg/20 mg in the US."

Generic launch

Nuvo Pharmaceuticals announces ‘at risk’ launch of generic version of Vimovo in the United States (Canada Newswire) - "Nuvo Pharmaceuticals Inc....today announced Dr. Reddy's Laboratories Inc. (DRL) has launched its generic version of Vimovo in the United States. DRL's launch of its generic version of Vimovo is 'at risk' as Nuvo Pharmaceuticals (Ireland) DAC (Nuvo Ireland) continues to hold valid U.S. Patent Nos. 8,858,996 and 9,161,920 (the '996 and '920 patents) covering Vimovo in the U.S. The '996 and '920 patents are currently the subject of patent infringement litigation against DRL. The parties have mutually agreed on a pretrial litigation schedule with the court extending through to mid-2021. The term of the '996 and '920 patents extends to May 31, 2022."

Corporate lawsuit • Generic launch • Patent

Dr. Reddy's Laboratories announces the first generic launch of naproxen and esomeprazole magnesium delayed-release tablets in the U.S. market (Dr.Reddy's Press Release) - “Dr. Reddy’s Laboratories Ltd….announced the first-to-market launch of Naproxen and Esomeprazole Magnesium Delayed-Release Tablets, a therapeutic equivalent generic version of Vimovo® (Naproxen and Esomeprazole Magnesium) Delayed-Release Tablets approved by the U.S. Food and Drug Administration (USFDA).”

Generic launch

Horizon Therapeutics Plc (HZNP) Q4 2019 earnings call transcript - “Horizon Therapeutics Plc…as we look at the inflammation or primary care business side, our goal is to continue to manage the decline of this business while driving PENNSAID 2% and DUEXIS, we assume less than $5 million for the year for VIMOVO….Comment of the 2020 to 2023 timeframe, on the back end of that, we expect DUEXIS and RAYOS to become generic….In fact, we saw significant increase in the margin from the inflammation business in 2019 with roughly similar sales.”

Generic launch • Sales projection

Nuvo Pharmaceuticals announces repayment of bridge loan and entitlement to receive 2019 Vimovo U.S. annual minimum royalty (PRNewswire) - "Nuvo Pharmaceuticals...announced the Company will repay its Bridge Loan to Deerfield Management Company, L.P. (Deerfield) during the second week of January and will receive the full US$7.5 million annual minimum royalty payment due from the 2019 sales of Vimovo in the U.S. The Company has received US$5.6 million to-date."

Commercial