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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: 55205

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 July 2024: Indices continue to climb; Lilly buys Morphic for US$ 3.2 bn, Kisunla bags FDA nod
The biotechnology sector ended in the green for the third month in a row in July, significantly outperforming the broader market. The Nasdaq Biotechnology Index (NBI) climbed by a robust 6.6 percent, closing at 4,843.6, up from a close of 4,545.28 in June. Similarly, the SPDR S&P Biotech ETF (XBI) index surged by 6.8 percent, reaching 99.06, up from June’s closing of 92.71. The S&P Biotechnology Select Industry Index (SPSIBI) followed suit, jumping 6.8 percent to 7,716.95 compared to a 4.25 percent rise in June, when it closed at 7,225.07.The month saw a few significant deals. Eli Lilly announced the acquisition of Massachusetts-based Morphic Holding for approximately US$ 3.2 billion in cash, bolstering its presence in the US$ 26.65 billion inflammatory bowel disease (IBD) market. Lilly also signed a strategic deal with radiopharmaceutical company Radionetics Oncology for US$ 140 million, with an option to purchase the entire company for US$ 1 billion. As the month drew to a close, Boehringer Ingelheim said it is acquiring Nerio Therapeutics for up to US$ 1.3 billion, in order to expand its immuno-oncology portfolio. Access the Pipeline Prospector Dashboard for July 2024 Newsmakers (Free Excel)Lilly’s donanemab finally gets approved; Dupixent okayed as add-on therapy for COPDWith the Alzheimer's Association International Conference (AAIC) taking place in Philadelphia (in the US), the spotlight was firmly on Alzheimer’s disease. In the last week of July, the US Food and Drug Administration (FDA) approved Alpha Cognition’s Zunveyl (benzgalantamine) to treat mild-to-moderate Alzheimer’s disease. In early July, and weeks prior to the conference, the FDA had granted a long-awaited approval to Eli Lilly’s donanemab, to be marketed as Kisunla, for the treatment of early symptomatic Alzheimer’s disease.In other approvals, European regulators became the first in the world to approve Sanofi and Regeneron’s Dupixent as an add-on therapy for chronic obstructive pulmonary disease (COPD) patients with high levels of certain white blood cells.In May, FDA had extended its target action date of its priority review of Dupixent as an add-on maintenance treatment for COPD by three months. The revised target action date is now September 27, 2024. Access the Pipeline Prospector Dashboard for July 2024 Newsmakers (Free Excel)Merck’s RSV jab shows efficacy in infants; GSK’s Dovato measures up to Gilead’s BiktarvyMerck said its monoclonal antibody jab to protect infants against RSV-related infections has met the main goals of a mid-to-late-stage trial. Clesrovimab reduced medically attended lower respiratory infections caused by RSV through day 150. Merck plans to submit the data to global regulators. Currently, Sanofi and Astra’s Beyfortus is approved by the FDA to prevent RSV in children up to 24 months.In the largest study of its kind, GSK’s HIV drug Dovato was found to be non-inferior to Gilead Sciences’ Biktarvy, which is seen as the benchmark for HIV treatment. Significantly, Dovato did so with lesser weight gain in a 48-week head-to-head study of virologically suppressed HIV-1 patients. Both Dovato and Biktarvy are single pill treatments for HIV given once a day. Biktarvy raked in US$ 11.9 billion in 2023.Pfizer’s gene therapy for hemophilia A, giroctocogene fitelparvovec, showed promising results in a late-stage trial by significantly reducing the number of annual bleeding episodes. This brings Pfizer closer to securing FDA approval, competing with BioMarin’s Roctavian. Pfizer also said it is moving ahead to mid-stage trials with a once-daily version of its glucagon-like peptide 1 (GLP-1) drug danuglipron for weight loss. In December, Pfizer had discontinued a twice-daily version of danuglipron on account of side effects. Pfizer’s stock also benefited from its healthy second quarter (Q2) results.Swiss drugmaker Roche is reintroducing Susvimo in the US after voluntarily recalling it in October 2022. The implant used to treat patients with neovascular age-related macular degeneration (wet AMD) requires a one-time surgery to be inserted into the eye.Roche also revealed that a second drug candidate from its up to US$ 3.1 billion buyout of Carmot Therapeutics — an obesity drug —  has delivered promising results in an early-stage trial. This once-daily weight-loss pill CT-996 reduced on average 6.1 percent of participants’ starting weight after four weeks. CT-996 works in a similar manner as other blockbuster weight loss drugs, such as Wegovy and Zepbound. Access the Pipeline Prospector Dashboard for July 2024 Newsmakers (Free Excel)Biogen-Sage’s essential tremor drug rejected; Novo’s weekly insulin hit with FDA’s CRL Several drugmakers faced setbacks last month. Novo Nordisk received a complete response letter (CRL) from the FDA, declining approval for its weekly insulin Awiqli. The agency requested additional information related to the manufacturing process, as well as on the type 1 diabetes indication. In May, an FDA panel had voted seven to four against the benefits of Awiqli outweighing its risks. Sage and Biogen’s partnership experienced another setback after the failure of their drug SAGE-324 in a phase 2 trial for essential tremor, a disorder that causes uncontrollable shaking of hands, arms and other parts of the body. This follows the previous failure of Zurzuvae to secure an FDA approval for clinical depression.Meanwhile, Eisai and Biogen’s Alzheimer’s drug Leqembi, faced a setback in Europe when the EU drugs regulator rejected its approval. The European Medicines Agency said the drug’s meager benefit on slowing cognitive decline in early Alzheimer’s did not outweigh the risk it brings of serious brain swelling. Leqembi is approved in the US market, where it has a new competitor — Lilly’s Kisunla.Also, BMS walked away from its rights to the ADC farletuzumab ecteribulin after having paid Japanese drugmaker Eisai US$ 650 million. As part of its portfolio reprioritization, BMS decided to end the co-development agreement. Access the Pipeline Prospector Dashboard for July 2024 Newsmakers (Free Excel) Our viewAs July drew to a close, several pharma majors announced their second quarter (Q2) earnings, including Pfizer, Merck, AbbVie and, AstraZeneca. Most of these drugmakers ended up beating Wall Street expectations. For instance, Pfizer saw revenue growth in Q2 after shrinking for five quarters. It posted revenues of US$ 13.3 billion in the second quarter of 2024, compared to US$ 13 billion in the corresponding quarter last year. It has subsequently raised its 2024 guidance by US$ 1 billion. This means it’s not just the indices and share prices, but even the brass tacks — the top line and the bottomline of drugmakers — are looking up. And that may bring more cheer to the markets in August. Access the Pipeline Prospector Dashboard for July 2024 Newsmakers (Free Excel) 

Impressions: 1939

https://www.pharmacompass.com/pipeline-prospector-blog/indices-continue-to-climb-lilly-buys-morphic-for-us-3-2-bn-its-alzheimer-s-drug-finally-bags-fda-nod

#PharmaFlow by PHARMACOMPASS
01 Aug 2024

NEWS #PharmaBuzz

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https://www.indianpharmapost.com/diagnostic-center/viiv-healthcare-to-announce-data-from-largest-head-to-head-randomised-clinical-trial-for-2-drug-regimen-dovato-against-3-drug-regimen-biktarvy-at-aids-2024-15882

INDIANPHARMAPOST
16 Jul 2024

https://www.businesswire.com/news/home/20240712714679/en

BUSINESSWIRE
15 Jul 2024

https://www.businesswire.com/news/home/20240319579558/en

BUSINESSWIRE
08 Apr 2024

https://www.businesswire.com/news/home/20240124470296/en

BUSINESSWIRE
05 Feb 2024
Colombia to seek compulsory license on ViiV's dolutegravir
Colombia to seek compulsory license on ViiV's dolutegravir

05 Oct 2023

// Fraiser Kansteiner FIERCE PHARMA

https://www.fiercepharma.com/pharma/seeking-cheaper-generics-colombia-plots-compulsory-license-viivs-hiv-med-dolutegravir

Fraiser Kansteiner FIERCE PHARMA
05 Oct 2023

https://endpts.com/gsks-viiv-to-lean-on-long-acting-hiv-portfolio-ahead-of-dolutegravir-patent-expiration/

Nicole DeFeudis ENDPTS
28 Sep 2023