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DATA COMPILATION #PharmaFlow

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Top drugs and pharmaceutical companies of 2019 by revenues
Acquisitions and spin-offs dominated headlines in 2019 and the tone was set very early with Bristol-Myers Squibb acquiring New Jersey-based cancer drug company Celgene in a US$ 74 billion deal announced on January 3, 2019. After factoring in debt, the deal value ballooned to about US$ 95 billion, which according to data compiled by Refinitiv, made it the largest healthcare deal on record. In the summer, AbbVie Inc, which sells the world’s best-selling drug Humira, announced its acquisition of Allergan Plc, known for Botox and other cosmetic treatments, for US$ 63 billion. While the companies are still awaiting regulatory approval for their deal, with US$ 49 billion in combined 2019 revenues, the merged entity would rank amongst the biggest in the industry. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) The big five by pharmaceutical sales — Pfizer, Roche, J&J, Novartis and Merck Pfizer continued to lead companies by pharmaceutical sales by reporting annual 2019 revenues of US$ 51.8 billion, a decrease of US$ 1.9 billion, or 4 percent, compared to 2018. The decline was primarily attributed to the loss of exclusivity of Lyrica in 2019, which witnessed its sales drop from US$ 5 billion in 2018 to US$ 3.3 billion in 2019. In 2018, Pfizer’s then incoming CEO Albert Bourla had mentioned that the company did not see the need for any large-scale M&A activity as Pfizer had “the best pipeline” in its history, which needed the company to focus on deploying its capital to keep its pipeline flowing and execute on its drug launches. Bourla stayed true to his word and barring the acquisition of Array Biopharma for US$ 11.4 billion and a spin-off to merge Upjohn, Pfizer’s off-patent branded and generic established medicines business with Mylan, there weren’t any other big ticket deals which were announced. The Upjohn-Mylan merged entity will be called Viatris and is expected to have 2020 revenues between US$ 19 and US$ 20 billion and could outpace Teva to become the largest generic company in the world, in term of revenues.  Novartis, which had followed Pfizer with the second largest revenues in the pharmaceutical industry in 2018, reported its first full year earnings after spinning off its Alcon eye care devices business division that had US$ 7.15 billion in 2018 sales. In 2019, Novartis slipped two spots in the ranking after reporting total sales of US$ 47.4 billion and its CEO Vas Narasimhan continued his deal-making spree by buying New Jersey-headquartered The Medicines Company (MedCo) for US$ 9.7 billion to acquire a late-stage cholesterol-lowering therapy named inclisiran. As Takeda Pharmaceutical Co was busy in 2019 on working to reduce its debt burden incurred due to its US$ 62 billion purchase of Shire Plc, which was announced in 2018, Novartis also purchased the eye-disease medicine, Xiidra, from the Japanese drugmaker for US$ 5.3 billion. Novartis’ management also spent a considerable part of 2019 dealing with data-integrity concerns which emerged from its 2018 buyout of AveXis, the gene-therapy maker Novartis had acquired for US$ 8.7 billion. The deal gave Novartis rights to Zolgensma, a novel treatment intended for children less than two years of age with the most severe form of spinal muscular atrophy (SMA). Priced at US$ 2.1 million, Zolgensma is currently the world’s most expensive drug. However, in a shocking announcement, a month after approving the drug, the US Food and Drug Administration (FDA) issued a press release on data accuracy issues as the agency was informed by AveXis that its personnel had manipulated data which the FDA used to evaluate product comparability and nonclinical (animal) pharmacology as part of the biologics license application (BLA), which was submitted and reviewed by the FDA. With US$ 50.0 billion (CHF 48.5 billion) in annual pharmaceutical sales, Swiss drugmaker Roche came in at number two position in 2019 as its sales grew 11 percent driven by its multiple sclerosis medicine Ocrevus, haemophilia drug Hemlibra and cancer medicines Tecentriq and Perjeta. Roche’s newly introduced medicines generated US$ 5.53 billion (CHF 5.4 billion) in growth, helping offset the impact of the competition from biosimilars for its three best-selling drugs MabThera/Rituxan, Herceptin and Avastin. In late 2019, after months of increased antitrust scrutiny, Roche completed its US$ 5.1 billion acquisition of Spark Therapeutics to strengthen its presence in gene therapy. Last year, J&J reported almost flat worldwide sales of US$ 82.1 billion. J&J’s pharmaceutical division generated US$ 42.20 billion and its medical devices and consumer health divisions brought in US$ 25.96 billion and US$ 13.89 billion respectively.  Since J&J’s consumer health division sells analgesics, digestive health along with beauty and oral care products, the US$ 5.43 billion in consumer health sales from over-the-counter drugs and women’s health products was only used in our assessment of J&J’s total pharmaceutical revenues. With combined pharmaceutical sales of US$ 47.63 billion, J&J made it to number three on our list. While the sales of products like Stelara, Darzalex, Imbruvica, Invega Sustenna drove J&J’s pharmaceutical business to grow by 4 percent over 2018, the firm had to contend with generic competition against key revenue contributors Remicade and Zytiga. US-headquartered Merck, which is known as MSD (short for Merck Sharp & Dohme) outside the United States and Canada, is set to significantly move up the rankings next year fueled by its cancer drug Keytruda, which witnessed a 55 percent increase in sales to US$ 11.1 billion. Merck reported total revenues of US$ 41.75 billion and also announced it will spin off its women’s health drugs, biosimilar drugs and older products to create a new pharmaceutical company with US$ 6.5 billion in annual revenues. The firm had anticipated 2020 sales between US$ 48.8 billion and US$  50.3 billion however this week it announced that the coronavirus  pandemic will reduce 2020 sales by more than $2 billion. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)  Humira holds on to remain world’s best-selling drug AbbVie’s acquisition of Allergan comes as the firm faces the expiration of patent protection for Humira, which brought in a staggering US$ 19.2 billion in sales last year for the company. AbbVie has failed to successfully acquire or develop a major new product to replace the sales generated by its flagship drug. In 2019, Humira’s US revenues increased 8.6 percent to US$ 14.86 billion while internationally, due to biosimilar competition, the sales dropped 31.1 percent to US$ 4.30 billion. Bristol Myers Squibb’s Eliquis, which is also marketed by Pfizer, maintained its number two position and posted total sales of US$ 12.1 billion, a 23 percent increase over 2018. While Bristol Myers Squibb’s immunotherapy treatment Opdivo, sold in partnership with Ono in Japan, saw sales increase from US$ 7.57 billion to US$ 8.0 billion, the growth paled in comparison to the US$ 3.9 billion revenue increase of Opdivo’s key immunotherapy competitor Merck’s Keytruda. Keytruda took the number three spot in drug sales that previously belonged to Celgene’s Revlimid, which witnessed a sales decline from US$ 9.69 billion to US$ 9.4 billion. Cancer treatment Imbruvica, which is marketed by J&J and AbbVie, witnessed a 30 percent increase in sales. With US$ 8.1 billion in 2019 revenues, it took the number five position. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available) Vaccines – Covid-19 turns competitors into partners This year has been dominated by the single biggest health emergency in years — the novel coronavirus (Covid-19) pandemic. As drugs continue to fail to meet expectations, vaccine development has received a lot of attention.  GSK reported the highest vaccine sales of all drugmakers with total sales of US$ 8.4 billion (GBP 7.16 billion), a significant portion of its total sales of US$ 41.8 billion (GBP 33.754 billion).   US-based Merck’s vaccine division also reported a significant increase in sales to US$ 8.0 billion and in 2019 received FDA and EU approval to market its Ebola vaccine Ervebo. This is the first FDA-authorized vaccine against the deadly virus which causes hemorrhagic fever and spreads from person to person through direct contact with body fluids. Pfizer and Sanofi also reported an increase in their vaccine sales to US$ 6.4 billion and US$ 6.2 billion respectively and the Covid-19 pandemic has recently pushed drugmakers to move faster than ever before and has also converted competitors into partners. In a rare move, drug behemoths  — Sanofi and GlaxoSmithKline (GSK) —joined hands to develop a vaccine for the novel coronavirus. The two companies plan to start human trials in the second half of this year, and if things go right, they will file for potential approvals by the second half of 2021.  View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)  Our view Covid-19 has brought the world economy to a grinding halt and shifted the global attention to the pharmaceutical industry’s capability to deliver solutions to address this pandemic.  Our compilation shows that vaccines and drugs for infectious diseases currently form a tiny fraction of the total sales of pharmaceutical companies and few drugs against infectious diseases rank high on the sales list. This could well explain the limited range of options currently available to fight Covid-19. With the pandemic currently infecting over 3 million people spread across more than 200 countries, we can safely conclude that the scenario in 2020 will change substantially. And so should our compilation of top drugs for the year. View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)   

Impressions: 55329

https://www.pharmacompass.com/radio-compass-blog/top-drugs-and-pharmaceutical-companies-of-2019-by-revenues

#PharmaFlow by PHARMACOMPASS
29 Apr 2020

STOCK RECAP #PipelineProspector

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Biotech indices inch up post SVB bloodbath; Covid drugmakers report drop in Q1 sales
In March, the collapse of Silicon Valley Bank (SVB) had dragged the biotech indices down. SVB had made considerable investments in the biotech space, and its downfall had left many life sciences and healthcare companies vulnerable.Within a month of the SVB storm, biotech indices have bounced back. The Nasdaq Biotechnology Index (NBI) gained 1 percent to end April at US$ 4,187.32. It was down 1.3 percent in March. The S&P Biotechnology Select Industry Index (SPSIBI) was up 2 percent at US$ 6,094.82, and the SPDR S&P Biotech ETF (XBI) increased 4 percent to US$ 80.20. Both SPSIBI and XBI had dropped by 8.3 percent and 8.2 percent, respectively, in March.In April, several drugmakers announced their first quarter (Q1) results. The month also saw three major M&A deals — Merck’s US$ 10.8 billion buyout of Prometheus Biosciences, Astellas Pharma’s US$ 5.9 billion acquisition of Iveric Bio and GSK’s US$ 2 billion deal to buy Bellus Health.Access the Pipeline Prospector Dashboard for April 2023 Newsmakers (Free Excel)Pfizer reports 29% drop in Q1 revenues, falls behind GSK in RSV vaccine raceWe have seen this happening for many months now, with Pfizer’s stock consistently falling since January. The Q1 results only echoed that sentiment — Pfizer’s revenues fell 29 percent to US$ 18.3 billion due to a 77 percent drop in sales of its Covid-19 vaccine Comirnaty. This led to a further 5 percent drop in the drug behemoth’s stock in April. What was going right for Pfizer was its experimental respiratory syncytial virus (RSV) vaccine. But GSK raced ahead of Pfizer this month when the US Food and Drug Administration (FDA) approved its RSV vaccine — Arexvy — for adults aged 60 years and older. The Prescription Drug User Fee Act (PDUFA) date for the Pfizer jab for older adults is this month too. GSK also announced the acquisition of Canada-based drug developer Bellus Health (up 114 percent) for US$ 2 billion.Among other Covid drugmakers, Moderna’s stock also suffered a 17 percent loss last month. What was worse, its experimental messenger RNA-based influenza vaccine failed to demonstrate effectiveness against influenza B. Moderna is planning to go ahead with a phase 3 study of mRNA-4157 (its investigational individualized neo-antigen therapy) and Keytruda combo in patients with adjuvant melanoma this year.Access the Pipeline Prospector Dashboard for April 2023 Newsmakers (Free Excel) Wegovy helps boost Novo’s Q1 revenues; Vabysmo brings gains for RocheIn April, both Novo Nordisk and Eli Lilly posted gains in the bourses. Wegovy’s success in the US helped Novo’s obesity care segment notch up a 131 percent increase in Q1 sales. Novo’s diabetes and obesity drug sales rose 33 percent and were at DKK 48.8 billion (US$ 7.11 billion). Overall, the Danish drugmaker posted an impressive 27 percent growth in its Q1 sales — which were at DKK 53.4 billion (US$ 7.7 billion) — while its stock rose 5 percent in April.Lilly is seeking to compete with Wegovy’s dominance in the obesity market with its own drug, Mounjaro. It recently posted favorable data from a late-stage trial, where Mounjaro achieved 21 percent weight reduction in non-diabetic patients, compared to 15 percent for Wegovy. Lilly is now conducting another Phase 3b trial to test Mounjaro against Wegovy. And in a separate trial, Mounjaro led to a 16 percent weight loss in patients with type 2 diabetes. The drugmaker‘s stock rose by a handsome 15 percent.Roche Group’s pharmaceutical division posted 9 percent growth in Q1 sales — at CHF 11.7 billion (US$ 12.7 billion) — due to strong demand for newer medicines. Eye diseases drug Vabysmo, approved last year, turned out to be the strongest growth driver, generating CHF 432 million (US$ 486 million) in global sales. Roche expects the drug to generate US$ 2 billion in revenue this year. The Swiss drugmaker also shared post-hoc analyses from four additional phase 3 studies showing Vabysmo to be more effective at drying retinal fluid than Regeneron’s Eylea in Age-related macular degeneration (AMD) and Diabetic Macular Edema (DME). Roche’s stock gained 11 percent.In addition, FDA approved Roche’s Polivy as part of a five-drug combination for previously untreated diffuse large B-cell lymphoma (DLBCL), the first new treatment in nearly 20 years to significantly improve outcomes in first-line DLBCL. In Q1, Roche reported a decline of 3 percent in group sales due to lower demand for Covid tests.Access the Pipeline Prospector Dashboard for April 2023 Newsmakers (Free Excel)Higher sales of key drugs take Novartis’ Q1 sales up 8%; J&J lowers 2023 guidanceNovartis’ Q1 sales grew 8 percent to US$ 12.95 billion, driven by strong performance of its heart failure drug Entresto, cancer meds Pluvicto and Kisqali, and multiple sclerosis drug Kesimpta. Based on higher Q1 sales, the Swiss drugmaker has raised its outlook for 2023.Novartis and partner BeiGene’s experimental drug tislelizumab showed promising results in treating certain types of gastric cancer in a late-stage trial. The partners hope this data will help make tislelizumab the first-line therapy for patients with advanced forms of gastric cancer. While Novartis’ stock went up 11 percent, BeiGene’s stock gained 17 percent in April.Though J&J’s Q1 results exceeded analyst expectations, the drugmaker lowered the 2023 guidance for its pharmaceutical business. Leaked data from a phase 3 trial showed that J&J and Legend’s cancer drug Carvykti performed better-than-expected in patients with multiple myeloma. J&J’s stock went up 4 percent. Legend’s stock rose 46 percent.Among small cap companies, Madrigal’s stock rose 24 percent in April on news of a breakthrough therapy designation for its drug Resmetirom as a treatment for nonalcoholic steatohepatitis.Access the Pipeline Prospector Dashboard for April 2023 Newsmakers (Free Excel)Merck acquires Prometheus for US$ 10.8 bn; Astellas buys Iveric Bio for US$ 5.9 bnApril proved to be a good month for both Merck and AstraZeneca, even though the two drugmakers reported a drop in their Q1 revenues due to decreased sales of their Covid-19 products.While Merck reported a 9 percent drop in Q1 sales (at US$ 14.5 billion), with sales of its Covid-19 antiviral pill Lagevrio (molnupiravir) dropping 88 percent, Astra reported a 4 percent decrease in revenue (at US$ 10.88 billion) in Q1. Stocks of both drugmakers rose by 6 percent.In early April, FDA had granted accelerated approval to Merck’s Keytruda in combination with Seagen and Astellas Pharma’s Padcev as a first-line treatment for adults with locally advanced or metastatic urothelial carcinoma. Later in the month, Merck announced it is acquiring San Diego-based biotech Prometheus Biosciences for US$ 10.8 billion to strengthen its immunology pipeline. Prometheus’ stock skyrocketed 76 percent on the news.A combination of AstraZeneca's cancer drugs — Imfinzi and Lynparza — met its main goal in a late-stage trial for patients with advanced epithelial ovarian cancer. Additionally, Astra’s Ultomiris also received a positive recommendation from the European Medicines Agency (EMA) for adult patients with neuromyelitis optica spectrum disorder.Japanese drugmaker Astellas Pharma announced its biggest deal last month when it acquired New Jersey-based eye drug developer Iveric Bio for US$ 5.9 billion, taking its stock up 9 percent. The deal will give Astellas access to Iveric Bio’s ophthalmology treatments, including its lead drug candidate for geographic atrophy — Zimura. Iveric Bio’s stock gained 22 percent.Access the Pipeline Prospector Dashboard for April 2023 Newsmakers (Free Excel)Disappointing Q1 sales drag AbbVie, BMS stocks downBoth AbbVie and Bristol Myers Squibb reported a drop in Q1 sales. AbbVie was hit due to weaker-than-expected performance of its blockbuster drugs Skyrizi and Rinvoq and dwindling sales of Humira (which experienced a sales drop of 25.2 percent in the face of biosimilar competition in the US). Its Q1 sales fell by 9.7 percent to US$ 12.25 billion, and its stock was down 6 percent. In positive news, FDA expanded the approval of AbbVie’s Qulipta as a preventive treatment for chronic migraine in adults. Rinvoq also received an add-on authorization in the EU as a treatment for moderate-to-severe active Crohn’s disease.BMS’ Q1 sales dropped 3 percent to US$ 11.3 billion, primarily due to an erosion in Revlimid’s sales in the face of competition from generic drugs. Revlimid’s revenues fell by 37 percent in Q1 compared to the same period last year. BMS’ stock experienced a 4 percent drop.Access the Pipeline Prospector Dashboard for April 2023 Newsmakers (Free Excel)Our viewThe collapse of three US banks over the last three months has dealt a blow to the US economy. Globally, the business scenario hasn’t improved much, with inflation, high interest rates, ongoing Russia-Ukraine war, supply chain kinks and other uncertainties continuing to pose challenges.If the biotech indices are able to hold up in these difficult times, it is an indication of strength and resilience within the sector.Access the Pipeline Prospector Dashboard for April 2023 Newsmakers (Free Excel)

Impressions: 1961

https://www.pharmacompass.com/pipeline-prospector-blog/biotech-indices-inch-up-post-svb-bloodbath-covid-drugmakers-report-drop-in-q1-sales

#PharmaFlow by PHARMACOMPASS
11 May 2023

NEWS #PharmaBuzz

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https://www.globenewswire.com/news-release/2024/10/24/2968342/0/en/Novartis-ribociclib-Kisqali-recognized-as-Category-1-preferred-breast-cancer-adjuvant-treatment-by-NCCN-Clinical-Practice-Guidelines-in-Oncology-NCCN-Guidelines.html

GLOBENEWSWIRE
24 Oct 2024

https://www.globenewswire.com/news-release/2024/10/18/2965447/0/en/Novartis-receives-positive-CHMP-opinion-for-Kisqali-to-help-reduce-risk-of-recurrence-in-people-with-HR-HER2-early-breast-cancer.html

GLOBENEWSWIRE
18 Oct 2024

https://www.prnewswire.com/news-releases/fda-approves-novartis-kisqali-to-reduce-risk-of-recurrence-in-people-with-hrher2--early-breast-cancer-302250689.html

PR NEWSWIRE
18 Sep 2024

https://www.globenewswire.com/news-release/2024/09/09/2942654/0/en/Relay-Therapeutics-Announces-Positive-Interim-Data-for-RLY-2608-Demonstrating-Clinically-Meaningful-Progression-Free-Survival.html

GLOBENEWSWIRE
09 Sep 2024
Novartis gears up for key expansions of 3 cancer drugs
Novartis gears up for key expansions of 3 cancer drugs

24 Apr 2024

// Angus Liu FIERCE PHARMA

https://www.fiercepharma.com/pharma/novartis-dials-2024-sales-outlook-preps-key-expansions-3-cancer-drugs

Angus Liu FIERCE PHARMA
24 Apr 2024

https://www.novartis.com/news/novartis-implements-manufacturing-adjustments-ribociclib-ensure-alignment-latest-regulatory-standards-ebc-end-q2

PRESS RELEASE
11 Apr 2024