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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 Jan 2023: Mega cap drugmakers face rout at bourses even as biotech indices inch upwards
After facing the worst year since 2008, biotech indices opened 2023 on a positive note. All the three indices posted gains in January — while the Nasdaq Biotechnology Index (NBI) was up 4.4 percent (at US$ 4,360), the S&P Biotechnology Select Industry Index (SPSIBI) rose 8.7 percent to US$ 6,896 and SPDR S&P Biotech ETF (XBI) increased 9 percent to US$ 88.90. In December 2022, the NBI was down 3.4 percent to US$ 4,213, while XBI had risen only 0.1 percent and SPSIBI had witnessed no change.Several major drugmakers have shared their financial results for 2022 since last month. Pfizer posted an operational growth of 30 percent with 2022 revenues touching an all-time high of US$ 100.3 billion. Merck posted a 22 percent increase, with sales of Keytruda growing 22 percent to US$ 20.9 billion. GSK generated £29.3 billion (US$ 36.3 billion) in revenue in 2022, an increase of 13 percent over 2021 figures, and Amgen posted a gain of 1 percent.Drugmakers like Eli Lilly and Johnson & Johnson saw a huge drop in sales of their Covid-19 products. Lilly suffered a 9 percent drop and J&J saw a 4 percent decline in Q4 2022 revenue. More companies are expected to release their 2022 results this month.Access the Pipeline Prospector Dashboard for January 2023 Newsmakers (Free Excel)Lower 2023 forecast, vaccine’s safety concern hammer Pfizer’s stockDespite the indices showing signs of recovery, stocks of several mega cap companies ended the month in the red. Pfizer’s stock suffered the biggest loss, dropping 14 percent in January, due to an interplay of various factors even as the drug behemoth reported best-ever sales in 2022, owing to its Covid-19 vaccine Comirnaty and antiviral pill Paxlovid. First, the US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) launched an investigation into the possibility of a stroke in older adults who had received its updated Covid-19 booster shot. Second, despite the stellar results, Pfizer’s forecast for 2023 was lower by 33 percent, with an estimated revenue of US$ 67 to 71 billion. With the pandemic receding, there has been a considerable drop in demand for Covid products. Pfizer’s Covid vaccine partner BioNTech also saw its stock go down 6 percent. The other big loser was AbbVie (drop of 9 percent) – its blockbuster immunology drug Humira (adalimumab) saw its exclusive run come to an end in the US with Amgen launching a copycat — Amjevita. Seven other biosimilars are due to be launched later this year.A federal appeals court in Philadelphia blocked J&J’s plan to use the Texas two-step bankruptcy strategy to resolve around 40,000 lawsuits alleging that its talc products cause cancer. In another setback, its Janssen unit halted a late-stage global trial of its HIV vaccine after the drug was found to be ineffective at preventing infection. All these factors led to a 8 percent drop in J&J stocks.AstraZeneca’s stock tumbled 6 percent in January due to factors such as a second cancer lawsuit filed by Bristol Myers Squibb, wherein it claimed Astra’s cancer treatment Imjudo infringes on two patents related to its blockbuster drug Yervoy. FDA also revoked the emergency use authorization (EUA) for AstraZeneca’s Covid-19 treatment Evusheld, expecting it to fail against the currently dominant Omicron sub-variant.January wasn’t a great month for Merck either, whose stock plummeted 4 percent. The drugmaker halted a late-stage trial of its blockbuster immunotherapy drug Keytruda in prostate cancer after interim data showed that the drug failed to extend survival or help improve patients’ lives. Meanwhile, the drugmaker said it has identified the source of a potential cancer-causing agent – Nitroso-STG-19 – in its popular diabetes drugs Januvia and Janumet, and plans to resolve the issue by the end of the year.Access the Pipeline Prospector Dashboard for January 2023 Newsmakers (Free Excel) Bayer gains on sales forecast for Kerendia, Nubeqa; lawsuit settlements benefit TevaThree large cap companies — Bayer AG (14 percent), Teva (10 percent) and Vertex Pharmaceuticals (12 percent)  – posted double digit gains on the bourses last month. Bayer hiked sales targets for two of its meds – heart drug Kerendia and prostate cancer treatment Nubeqa – to US$ 3.2 billion each.Israeli drugmaker Teva said it has either already settled with or confirmed participation of 48 US states to move forward with its US$ 4.25 billion proposed national settlement agreement to resolve thousands of lawsuits over its alleged role in the US opioid crisis.Vertex Pharmaceuticals said it plans to file for the US approval of its CRISPR gene-editing therapy exa-cel as a treatment for beta-thalassemia and sickle cell disease in the first quarter. If approved, the drug is expected to generate peak annual sales of over US$ 2 billion. Vertex has already applied for the drug’s authorization in the EU and UK. Vertex is also testing a non-opioid drug, VX-548, for acute pain in a late-stage trial.Among small cap companies, Massachusetts-based Theseus Pharmaceuticals posted a 180 percent surge in its stock price in January. The drugmaker said it plans to release clinical data from a phase 1/2 trial of its lead candidate – THE-630 – for advanced gastrointestinal stromal tumor patients, later this year. Analysts expect THE-630 to compete against Pfizer’s Sutent (sunitinib), with projected sales of over US$ 1 billion by 2035. Theseus is also developing two other early-stage candidates.Access the Pipeline Prospector Dashboard for January 2023 Newsmakers (Free Excel) Accelerated nods bring gains for Biogen, Seagen; Lilly loses on Alzheimer’s setback Biogen’s second Alzheimer’s drug – Leqembi (lecanemab) — received FDA’s accelerated approval to treat patients who are in the earliest stages of the neurodegenerative disease. However, Eli Lilly’s bid for an accelerated approval pathway for its experimental Alzheimer’s disease drug donanemab suffered a setback. FDA rejected the drug as Lilly did not provide enough data from patients who were treated for at least a year. However, days later Lilly’s cancer drug Jaypirca (pirtobrutinib) won accelerated approval as a treatment for mantle cell lymphoma, a rare form of blood cancer. FDA also accepted Lilly-Boehringer Ingelheim’s application for cancer drug Jardiance (empagliflozin) as a treatment for chronic kidney disease (CKD) in adult patients. Overall, while Biogen’s stock was up 5 percent in January, Lilly’s was down 7 percent.In another cancer drug update, FDA granted accelerated approval to Seagen’s Tukysa (tucatinib) to treat HER2-positive unresectable or metastatic colorectal cancer. Seagen’s stock rose 8 percent last month. And BeiGene’s cancer drug Brukinsa (zanubrutinib) received an approval in the US as a treatment for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), pushing its stock up 11 percent. The drug has also received authorization in the UK.Access the Pipeline Prospector Dashboard for January 2023 Newsmakers (Free Excel) Our viewAs always, the new year began with the JP Morgan Healthcare Conference (San Francisco, January 9 to 12). For  the last three years, the conference has been lackluster insofar as M&As were concerned. But this year, there were a number of buyouts – AstraZeneca said it will acquire US-based drug developer CinCor Pharma for up to US$ 1.8 billion. Italy’s privately-held Chiesi Farmaceutici announced it is buying Ireland-based rare diseases drugmaker Amryt Pharma for up to US$ 1.48 billion. And Ipsen picked up Albireo for US$ 952 million. Stocks of CinCor, Amryt and Albireo shot up by over 100 percent following the takeover news. While we do hope these buyouts signal an uptick in M&A activity, we also know that drugmakers who made billions from the pandemic are now facing a steep Covid cliff. Among these are Pfizer, BioNTech, Moderna, Gilead Sciences, AstraZeneca and Merck. The 2022 results announced so far confirm this trend. Insofar as biotech indices are concerned, we hope January has set the tone for the coming months.Access the Pipeline Prospector Dashboard for January 2023 Newsmakers (Free Excel) 

Impressions: 1923

https://www.pharmacompass.com/pipeline-prospector-blog/pipeline-prospector-jan-2023-mega-cap-drugmakers-face-rout-at-bourses-even-as-biotech-indices-inch-upwards

#PharmaFlow by PHARMACOMPASS
09 Feb 2023

NEWS #PharmaBuzz

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https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-december-11-2024-90405.pdf

FDA
11 Dec 2024

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218615

FDA
14 Mar 2024

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218012

FDA
21 Aug 2023

https://www.globenewswire.com/news-release/2023/06/03/2681533/0/en/Cogent-Biosciences-Announces-Positive-Lead-In-Data-from-Ongoing-Phase-3-PEAK-Trial-Evaluating-Bezuclastinib-in-Combination-with-Sunitinib-in-Patients-with-Gastrointestinal-Stromal-.html

GLOBENEWSWIRE
03 Jun 2023

https://www.businesswire.com/news/home/20220803005649/en

BUSINESSWIRE
03 Aug 2022