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DATA COMPILATION #PharmaFlow

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Drop in Covid sales, trial failures, restructuring trigger steep rise in layoffs in Q1 2023
Since 2022, layoffs have become commonplace. The ongoing global banking crisis, coupled with pre-existing factors such as the Ukraine-Russia conflict, inflation, looming recession and rising interest rates have made the business environment even more volatile and daunting. The kinks in the supply chain got exacerbated by China’s Covid policy. And all these economic challenges compelled companies to retrench employees the world over. While the surge in layoffs has been more apparent in the technology sector, the pharma sector has also been facing the headwinds.Though the biopharma sector has experienced significant growth due to new technologies such as gene editing, cell therapy, messenger RNA and the Covid-19 vaccines and therapies, some drugmakers began to see revenues of their Covid products fall significantly with a drop in cases.However, job cuts in the pharma industry aren’t limited to companies that make Covid products. Several others have announced job cuts citing restructuring, trial failures and holds, termination of deals, facility shutdowns and reprioritization of projects.In the first quarter (Q1) of 2022, we saw around 30 pharma companies announce layoffs. In Q1 of 2023, the corresponding number went up to over 50. Overall, more than 100 biopharma companies had announced layoffs in 2022.View Biopharma Layoff Tracker: 2022–Mid April '23 (Free Excel Available)Pandemic-hit Grifols to cut 2,300 jobs; Catalent, Thermo Fisher lay off hundredsSpanish pharma Grifols has announced the biggest layoff of 2023 so far — it plans to axe 8.5 percent of its global workforce, or around 2,300 employees, to save €400 million (US$ 427 million) annually. The Covid-19 pandemic dealt a severe blow to its plasma-derived medicines as blood collection collapsed around the world in 2020 and 2021. The drugmaker is now working on a “more efficient” platform to obtain plasma and reduce its expenses.French vaccine maker Valneva said it will lay off 20 to 25 percent of its workforce in order to save US$ 12 million. Valneva cited clinical trial costs and expedited winding down of Covid vaccine-related activities as reasons behind the layoffs. Some CDMOs have been hit equally badly. For instance, Catalent, which has played a critical role in producing Covid-19 vaccines and therapies, has cut around 600 jobs across multiple facilities in the US, and Thermo Fisher Scientific, a producer of Covid testing kits, has laid off around 500 employees across various locations in California between January 2022 and the middle of April 2023.Meanwhile, US-based Axcella said it will lay off 85 percent of its staff as it ended work on its NASH program to focus on developing a long Covid therapy. Last July, another US company, Inovio, said it will cut 18 percent of its workforce due to its troubled Covid program. And this year, it plans to downsize again and focus on its human papillomavirus (HPV) program.View Biopharma Layoff Tracker: 2022–Mid April '23 (Free Excel Available)Novartis to cut up to 8,000 jobs, J&J to downsize as part of restructuringBig pharma companies such as Novartis and Johnson & Johnson (J&J) have announced plans to restructure their businesses, and job cuts are a part of that exercise. In April 2022, Novartis announced plans to save at least US$ 1 billion by 2024 by combining its pharmaceuticals and oncology business units to form a new Innovative Medicine unit with the goal of achieving sales growth of at least 4 percent through 2026. It also revealed plans to spin off Sandoz to focus on patented prescription medicines. As a result of these changes, the Swiss drugmaker announced plans to eliminate up to 8,000 jobs.Novartis is moving ahead with the job cuts and has announced plant closures in the US. In addition, Novartis slashed 400 jobs in India following a new sales and distribution agreement with Dr. Reddy’s Laboratories.Similarly, as J&J moves ahead with plans to spin off its consumer health, it is cutting jobs. J&J is also restructuring the infectious disease and vaccine groups of its Janssen division and has planned global layoffs. Fate Therapeutics, a former partner of J&J, laid off 315 staff after ending its agreement with the company. Gilead has also cut jobs at the former Immunomedics headquarters in New Jersey and relocated the site to a larger space with no manufacturing.View Biopharma Layoff Tracker: 2022–Mid April '23 (Free Excel Available)Merck, BMS cut staff at acquired companies; Biogen downsizes due to Aduhelm, TecfideraMany retrenchments in the biopharma sector have been a result of acquisitions. Merck laid off around 143 employees from its Acceleron division in Cambridge, Massachusetts, shortly after acquiring the Boston-based company for US$ 11.5 billion in March 2022.BMS has also laid off 261 employees across two San Diego sites following its acquisition of Turning Point Therapeutics for US$ 4.1 billion. Similarly, US biotech Flexion Therapeutics laid off 110 employees, after being acquired by Pacira BioSciences. Six months after acquiring Kadmon Holdings, Sanofi is closing its Kadmon New York facility and laying off 25 employees. Sanofi-Aventis Korea is reducing its workforce through a voluntary retirement scheme. And AbbVie laid off 99 staffers from a single facility in Irvine (California), which was once an Allergan facility (a company it acquired in 2019 for US$ 63 billion).In 2022, Amgen made some high-value acquisitions and agreements – it bought rare disease drugmaker, Horizon Therapeutics, for US$ 27.8 billion and ChemoCentryx for US$ 4 billion as part of its growth strategy. But this year, Amgen has announced layoffs on two occasions, retrenching a total of around 750 employees to realign its expenses in the face of intensifying pressure on drug prices and high inflation. And Roche’s Genentech unit has shut down operations at its production facility in South San Francisco, laying off 265.In December 2021, Biogen had announced plans to lay off up to 1,000 staffers in an effort to cut about US$ 500-750 million in costs following the lower-than-expected sales of its controversial Alzheimer’s disease drug, Aduhelm, This year, Biogen has trimmed its multiple sclerosis team due to generic competition to its blockbuster drug Tecfidera. The job cuts were necessitated after the company failed to defend the market exclusivity of the drug through several lawsuits in the US.Japanese drugmakers Daiichi Sankyo and Eisai have shut down their R&D units in the US. While Daiichi has closed its R&D unit in San Francisco that employed 60 people, Eisai has closed its oncology R&D wing in the US, H3 Biomedicine, a move that has resulted in the loss of 88 jobs.View Biopharma Layoff Tracker: 2022–Mid April '23 (Free Excel Available)Drug rejections, trial failures lead to job cuts at Akebia, Y-mabs, SpectrumSeveral companies, such as Akebia, Y-mabs, Spectrum, have laid off sizable portions of their workforce due to drug rejections by the US Food and Drug Administration (FDA). Akebia laid off 42 percent of its workforce after FDA rejected its anemia drug vadadustat. Similarly, Spectrum laid off most of its R&D team after FDA rejected its drug poziotinib in November 2022. In January 2022, it had terminated 30 percent of its workforce. The same was the case with Y-mabs — a substantial number of employees lost their jobs after FDA rejected its drug omburtamab. In April 2022, Bluebird bio reduced its workforce by 30 percent to cut costs. Its gamble paid off as the FDA approved two of its cell and gene therapies – Skysona and Zynteglo – a few months later.Meanwhile, Galapagos dropped its kidney and fibrosis programs to focus on oncology and immunology candidates, laying off around 200 staffers. And disappointing data from a late-stage trial of its drug for symptomatic transthyretin amyloid cardiomyopathy (ATTR-CM) — avramidis — forced BridgeBio to announce retrenchment of an undisclosed number of employees last year.View Biopharma Layoff Tracker: 2022–Mid April '23 (Free Excel Available)Our viewThe biopharma industry grew impressively in 2022. Our analysis of combined (global) revenues of 15 leading (randomly selected) drugmakers in 2021 and 2022 reveals an impressive growth in revenues of around 7 percent. However, in 2023, a third of these drugmakers expect a drop in revenues, with Pfizer expecting its turnover to drop by over 30 percent this year. The reduced guidance may result in more layoffs.As we move into Q2, the layoff trend continues unabated. Last month, Thermo Fisher announced it will lay off 218 employees at three of its locations in San Diego, California, due to reduced demand for its Covid-19 products. These facilities will close in June. Japanese drugmaker Sumitomo and its subsidiary Sunovion Pharmaceuticals have announced plans to lay off 223 workers.The current business environment is not likely to cheer the job market. We have to wait for the cycle to turn.

Impressions: 2335

https://www.pharmacompass.com/radio-compass-blog/drop-in-covid-sales-trial-failures-restructuring-trigger-steep-rise-in-layoffs-in-q1-2023

#PharmaFlow by PHARMACOMPASS
04 May 2023

STOCK RECAP #PipelineProspector

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Pipeline Prospector Dec 2022: Biotech indices fall on close of a volatile year
The year 2022 was a difficult one for the biotech sector. Marked with geopolitical unrest, rising interest rates, the Russian-Ukraine war, inflation, and most of all, a stricter regulatory environment, biotech companies had a tough going. Biotech stocks were on a roller coaster ride through the year, with the first few months witnessing bearish trends. The sector bounced back in the second half of 2022 due to M&A deals, strong earnings performance, new drug approvals and pipeline successes. But the joy was short-lived – the indices dipped once again in December.The Nasdaq Biotechnology Index (NBI) fell 3.4 percent to US$ 4,213. In November, it was up 5 percent. There was no change in the S&P Biotechnology Select Industry Index (SPSIBI) last month. It was up 1.1 percent in November. And the SPDR S&P Biotech ETF (XBI) rose 0.1 percent in December, as opposed to 1 percent rise in November.For the full year, NBI fell 11 percent, while both SPSIBI and XBI plummeted 28 percent. Overall though, biotech companies can take heart from the fact that 2022 was the worst year for S&P 500 and Nasdaq Composite since 2008.Access the Pipeline Prospector Dashboard for December 2022 Newsmakers (Free Excel)Novo gains post Wegovy launch in Denmark; Sanofi’s stock rises post legal winDecember was a big month for Novo Nordisk as the Danish drugmaker launched its diabetes drug Wegovy (semaglutide) in its home market, fulfilling its promise to launch the med outside of the US by 2022-end. Wegovy also received an add-on approval from the US Food and Drug Administration (FDA) to treat obesity in teens 12 years and above just before Christmas. All the good news resulted in an 8 percent rise in Novo’s stock. Another mega cap company that made gains on the bourses last month was French drugmaker Sanofi — its stock rose 7 percent. A big reason behind this was the dismissal of about 50,000 lawsuits by a US district judge. The lawsuits had claimed that the heartburn drug – Zantac – causes cancer. Shares of GSK and Sanofi also made gains due to the dismissal, adding more than US$ 20 billion in combined value soon after the court’s decision. Sanofi’s blockbuster dermatitis and asthma drug Dupixent (dupilumab) also received marketing authorization in Europe as the first and only targeted medicine for prurigo nodularis, a chronic and debilitating skin disease.In early 2022, Novo had faced supply bottlenecks for Wegovy. Last month, its chief rival Eli Lilly met the same fate as it failed to meet the demand for its newly approved diabetes injection Mounjaro (tirzepatide). FDA added Mounjaro to its list of drugs facing shortages, along with a second diabetes med, Trulicity (dulaglutide). Lilly’s stock was down 2 percent in December.Access the Pipeline Prospector Dashboard for December 2022 Newsmakers (Free Excel) FDA’s Aduhelm nod gets flayed post probe; Roche suspends Alzheimer’s drug trialIt wasn’t a good month for Biogen, whose stock dropped by 9 percent in December. Three patient deaths got linked with Eisai and Biogen’s second Alzheimer’s drug — Leqembi (lecanemab). And, towards the end of the month, there was news that an 18-month-long investigation conducted by two House of Representatives’ committees found FDA’s approval process of Biogen’s controversial Alzheimer’s disease drug — Aduhelm (aducanumab) — to be “rife with irregularities”.There was more bad news on drugs for Alzheimer’s. Roche (down 2 percent) decided to suspend most trials of its Alzheimer’s drug – gantenerumab – after it failed to slow advancement of the disease in late-stage studies. In another setback to the Swiss drugmaker, a combination of Tecentriq (atezolizumab) and Exelixis-Ipsen’s Cabometyx (cabozantinib) failed to meet the primary endpoint in a phase 3 lung cancer trial. Ipsen’s stock fell 6 percent.Access the Pipeline Prospector Dashboard for December 2022 Newsmakers (Free Excel) Madrigal zips past rivals in NASH race; Prometheus’ colitis drug posts trial winAmong mid-cap companies, Pennsylvania-based Madrigal Pharmaceuticals’ shares soared by over 300 percent in December after its experimental drug to treat nonalcoholic steatohepatitis (NASH) – resmetirom – met the main goal in a late-stage study. The trial’s success has propelled Madrigal to the forefront of a race to develop the first treatment for NASH, a form of non-alcoholic fatty liver disease. Madrigal plans to move FDA for an accelerated approval of resmetirom this year.Another mid-cap company Prometheus Biosciences saw its stock soar 171 percent after its lead drug candidate – PRA023 – met the endpoints in a phase 2 study in patients with moderate-to-severely active ulcerative colitis.A small cap company named Icosavax saw its stock soar 125 percent after it announced a positive outcome for its respiratory syncytial virus (RSV) vaccine from a phase 1/1b study. Icosavax is a US-based, clinical stage vaccine company. A single dose of the shot, IVX-121, demonstrated a response against RSV that lasted six months.Access the Pipeline Prospector Dashboard for December 2022 Newsmakers (Free Excel) Horizon’s stock rises after Amgen acquires it for US$ 27.8 billionThe biggest biopharma deal of 2022 was Amgen’s acquisition of Horizon Therapeutics for US$ 27.8 billion. News of Amgen and Sanofi’s buyout interest in Horizon had led to a 61 percent rise in the rare disease drugmaker’s stock in November. Last month, Horizon’s shares increased by 10 percent after Amgen finally announced the acquisition.Another significant deal inked in December was Japanese drugmaker Takeda’s (up 7 percent)  acquisition of  Nimbus Therapeutics’ experimental psoriasis drug for up to US$ 6 billion. This is Takeda’s biggest buyout since it purchased Shire for US$ 62 billion in 2019. The deal is also among the pharma industry’s largest single-asset purchases since Amgen bought Otezla from Celgene in 2019 for US$ 13.4 billion.Access the Pipeline Prospector Dashboard for December 2022 Newsmakers (Free Excel) Moderna’s mRNA vaccine-Keytruda combo succeeds in mid-stage skin-cancer trialA combination of Moderna’s experimental messenger RNA cancer vaccine and Merck’s blockbuster immunotherapy Keytruda (pembrolizumab) was successful in a mid-stage skin cancer trial. Moderna’s stock grew 19 percent following the news, but it nosedived soon after. Merck is also carrying out clinical trials of Keytruda that can be injected under the skin. The drugmaker is testing at least two versions of the drug in the hope that a new formulation will allow it to retain the drug’s patent edge and protect it from competition.Novartis’ stock reported a 2 percent growth in December. Its drug Pluvicto showed survival benefits in a late-stage prostate cancer trial. Its rare blood disease drug iptacopan was also successful in treating paroxysmal nocturnal hemoglobinuria in a late-stage trial.Access the Pipeline Prospector Dashboard for December 2022 Newsmakers (Free Excel) Our viewSoothsayers do not have positive things to say about 2023. The Ukraine-Russia war has played havoc with food and energy costs, causing the highest rates of inflation. And a global recession seems inevitable in 2023.Even as the world grapples with these challenges, innovation is likely to save the day for the biotech sector. In 2023, Eisai and Biogen’s Leqembi became the first drug to receive an accelerated approval from the FDA. Several other pathbreaking drugs will come up for approval this year, including vaccines and therapies for RSV, new treatments for Alzheimer’s disease, a gene therapy for Duchenne muscular dystrophy and several treatments for obesity. The heady mix of recession and innovation may also trigger more M&A activity. And we hope these innovations result in a better year for the sector.Access the Pipeline Prospector Dashboard for December 2022 Newsmakers (Free Excel) 

Impressions: 1662

https://www.pharmacompass.com/pipeline-prospector-blog/pipeline-prospector-dec-2022-biotech-indices-fall-on-close-of-a-volatile-year

#PharmaFlow by PHARMACOMPASS
12 Jan 2023

NEWS #PharmaBuzz

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https://www.reuters.com/markets/deals/biogen-buy-human-immunology-biosciences-up-18-bln-deal-2024-05-22/

REUTERS
23 May 2024
FDA revises guidance on predicting Alzheimer's drug benefits
FDA revises guidance on predicting Alzheimer's drug benefits

12 Mar 2024

// Gabrielle Masson FIERCE BIOTECH

https://www.fiercebiotech.com/biotech/new-fda-guidelines-consider-amyloid-reduction-reasonably-likely-predict-clinical-benefit

Gabrielle Masson FIERCE BIOTECH
12 Mar 2024

https://www.reuters.com/business/healthcare-pharmaceuticals/biogen-discontinue-development-older-alzheimers-drug-aduhelm-2024-01-31/

REUTERS
01 Feb 2024
Biogen comes out ahead in Aduhelm-related investor lawsuit
Biogen comes out ahead in Aduhelm-related investor lawsuit

31 Mar 2023

// Zoey Becker FIERCE PHARMA

https://www.fiercepharma.com/pharma/biogen-scores-win-massachusetts-judge-dismisses-investor-lawsuit

Zoey Becker FIERCE PHARMA
31 Mar 2023

https://endpts.com/va-to-cover-eisais-new-alzheimers-drug-after-declining-to-cover-aduhelm/

Zachary Brennan ENDPTS
14 Mar 2023

https://www.fiercebiotech.com/biotech/dunn-fda-head-neuroscience-unit-depart

Max Bayer FIERCE BIOTECH
27 Feb 2023