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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: 55398

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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Pipeline Prospector Oct 2023: Disappointing Q3 results, attacks on Israel, Gaza drag pharma indices down further
October was a gloomy month that saw Palestinian militant group Hamas attack Israel in the first week, resulting in the killing of hundreds of innocent people. Israel retaliated, formally declaring a war on Hamas. Another raging war, after the ongoing Russia-Ukraine conflict, doesn’t augur well for the planet, let alone humanity, economies and industries.The pharma indices reacted to the bloodshed, as also to the disappointing third quarter (Q3) results posted by some drugmakers. The Nasdaq Biotechnology Index (NBI) was down 8 percent, at US$ 3,637.05 while the SPDR S&P Biotech ETF (XBI) was down 12 percent, at US$ 64.12, and the S&P Biotechnology Select Industry Index (SPSIBI) was down by 9 percent, at US$ 4,991.31.On the upside, the month saw several large deals. The biggest deal of the month was Roche’s acquisition of Telavant from Roivant for US$ 7.1 billion. BMS announced the acquisition of Mirati Therapeutics for US$ 4.8 billion. Through this acquisition, BMS will gain access to the US Food and Drug Administration (FDA) approved lung cancer drug Krazati (adagrasib). And Eli Lilly expanded its oncology capabilities by acquiring Point Biopharma for US$ 1.4 billion.Access the Pipeline Prospector Dashboard for October 2023 Newsmakers (Free Excel)Sanofi, Takeda cut 2023 profit forecasts; AbbVie, BMS post drop in Q3 salesSeveral drugmakers announced their Q3 2023 results last month. Sanofi (stock down by 15 percent in October) reported a 4.1 percent drop in Q3 sales, at €11.9 billion (US$ 12.5 billion). What was worse, the French drugmaker lost €20 billion (US$ 21 billion) in market capitalization soon after announcing these results as it had abandoned its 2025 profit target of 32 percent. Instead of chasing the lofty target, Sanofi has decided to focus on “long-term profitability”, and increase spending on immunology and inflammation drug development. Sales of Sanofi’s multiple sclerosis drug Aubagio dropped by a whopping 60.5 percent to €199 million (US$ 210.2 million) primarily due to competition from generics in the US market. Takeda (down by 7 percent) slashed its full-year profit forecast by 36 percent to 225 billion yen (US$ 1.5 billion) as it contends with disappointments in its development pipeline and the loss of patent protection in key products.BMS (down by 10 percent) reported Q3 revenue of US$ 11 billion, a 2 percent decrease from the same quarter last year, mainly due to 41 percent decline in sales of its cancer drug Revlimid.AbbVie (down by 5 percent) reported Q3 net revenues of US$ 13.92 billion, marking a 6 percent decrease over Q3 2022. This drop is attributed in part to the launch of Humira biosimilars, which have caused a 36.2 percent reduction in the immunology drug’s net revenues. Additionally, AbbVie’s blood cancer drug Imbruvica’s net revenues have dropped by 20 percent.Access the Pipeline Prospector Dashboard for October 2023 Newsmakers (Free Excel) Low Covid sales hit Pfizer, BioNTech, Roche stocks; Pfizer’s Q3 sales dip by 42%Pfizer (down by 9 percent) saw a 42 percent decline in its Q3 revenues — at US$ 13.23 billion — primarily due to lower sales of its Covid products. While sales of its mRNA vaccine Comirnaty fell by 70 percent (at US$ 1.3 billion), its Covid drug Paxlovid saw a 97 percent drop in sales over Q3 2022.Pfizer has significantly reduced its full-year revenue forecast and also plans to save US$ 3.5 billion through job cuts and cost reductions. Its partner for Comirnaty, BioNTech, is yet to announce its Q3 results, but its stock fell by 13 percent during October.Roche’s Q3 sales also slipped by 3 percent to CHF 14.3 billion (US$ 15.9 billion) owing to a slump in Covid sales. The Swiss drugmaker has predicted a decline in 2023 sales of Covid products at about CHF 4.5 billion (US$ 4.99 billion). Its previous estimate was CHF 5 billion (US$ 5.5 billion). Roche’s stock was down by 6 percent last month.Access the Pipeline Prospector Dashboard for October 2023 Newsmakers (Free Excel) Merck, Novo raise 2023 guidance; Ozempic, Wegovy boost Novo salesAmong the gainers were mega-cap drugmakers Merck (stock up by 1 percent in October) and Novo Nordisk (up by 4 percent). Merck has reported higher-than-expected third-quarter results on strong demand for its Covid-19 treatment, Lagevrio (molnupiravir), cancer med Keytruda and HPV vaccine Gardasil. As a result, Merck has revised its 2023 sales upwards, in the range of US$ 59.7 billion to US$ 60.2 billion (from US$ 58.6 billion to US$ 59.6 billion).Novo Nordisk’s popular diabetes med Ozempic and weight loss med Wegovy are boosting the company’s sales. Ergo, the company expects full-year sales to grow between 32 and 38 percent at constant exchange rates. Moreover, Novo has acquired ocedurenone, a drug in late-stage trial, from KBP Biosciences for up to US$ 1.3 billion. Ocedurenone is an oral treatment for uncontrolled hypertension with potential applications in cardiovascular and kidney disease.Access the Pipeline Prospector Dashboard for October 2023 Newsmakers (Free Excel) Astra, Ventyx stocks hit by disappointing trial data; Lilly, Vertex post gainsAstraZeneca’s stock was hit by disappointing results from a late-stage trial of its experimental lung cancer drug — datopotamab deruxtecan. Astra’s stock was down by 6 percent in October and its partner in developing the drug, Daiichi Sankyo’s stock fell by 4 percent.Similarly, Ventyx Biosciences (down by 56 percent) announced positive results from a phase 2 trial  in patients with moderate-to-severely active ulcerative colitis, but investors were unimpressed due to doubts about whether the candidate has an edge over rival Pfizer’s etrasimod and BMS’ Zeposia. Akero Therapeutics’ (down by 76 percent) nonalcoholic steatohepatitis (NASH) candidate, efruxifermin, failed mid-stage trial as it didn’t show any significant benefit for patients with cirrhosis caused by NASH, the most advanced and life-threatening stage of the fatty liver disease. Similarly, Sarepta Therapeutics’ treatment for Duchenne muscular dystrophy (a muscle-wasting disease) — Elevidys — failed a phase 3 study, taking its stock down by 44 percent in October.In a positive clinical trial news, Lilly’s Crohn’s disease experimental drug mirikizumab met the main goals of a phase 3 study. Similarly, Vertex (up by 4 percent) posted encouraging positive clinical trial results of VX-880 to treat type 1 diabetes.Meanwhile, FDA issued a complete response letter (CRL) to Alnylam Pharmaceuticals’ siRNA therapy Onpattro (patisiran) for the treatment of cardiomyopathy of transthyretin-mediated amyloidosis. It stated that Alnylam (down by 15 percent) has not provided enough evidence of the therapy’s benefit in the proposed indication.Access the Pipeline Prospector Dashboard for October 2023 Newsmakers (Free Excel) Our viewThe biopharma industry is eagerly awaiting the approval of several experimental drugs in Q4 2023, including Italfarmaco’s givinostat for Duchenne muscular dystrophy (DMD), and Valneva’s single-shot chikungunya vaccine VLA1553.We are already seeing the market inch upwards. Let’s hope the exciting pipeline and new drug approvals are able to pull pharma indices out of the doldrums.Access the Pipeline Prospector Dashboard for October 2023 Newsmakers (Free Excel) 

Impressions: 2355

https://www.pharmacompass.com/pipeline-prospector-blog/disappointing-q3-results-attacks-on-israel-gaza-drag-pharma-indices-down-further

#PharmaFlow by PHARMACOMPASS
02 Nov 2023

NEWS #PharmaBuzz

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https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209697

FDA
04 Apr 2024

https://www.reuters.com/business/healthcare-pharmaceuticals/merck-kgaa-says-ms-drug-fails-late-stage-trials-2023-12-05/

Ludwig Burger REUTERS
06 Dec 2023

https://tiefenbacher-pharmaceuticals.com/2023/09/27/launch-tiefenbacher-pharmaceuticals-generic-version-teriflunomide/

PRESS RELEASE
27 Sep 2023

https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/glenmark-reports-rs-403-crore-loss-in-q4fy23/articleshow/100363533.cms

ECONOMIC TIMES
19 May 2023
Alembic intros generic Aubagio
Alembic intros generic Aubagio

22 Mar 2023

// DRUGSTORENEWS

https://drugstorenews.com/alembic-intros-generic-aubagio

DRUGSTORENEWS
22 Mar 2023
Stem cell transplants may slow disability progression in MS
Stem cell transplants may slow disability progression in MS

22 Dec 2022

// Caroline Peachey EUROPEANPHARMACEUTICALREVIEW

https://www.europeanpharmaceuticalreview.com/news/177879/stem-cell-transplants-may-slow-disability-progression-in-ms/

Caroline Peachey EUROPEANPHARMACEUTICALREVIEW
22 Dec 2022