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DATA COMPILATION #PharmaFlow

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Novartis, GSK, Sanofi, BMS shell out over US$ 10 bn in dealmaking, as mid-size deals take centerstage in 2024
The world of pharmaceuticals and biotechnology continued to evolve this year with strategic alliances reshaping industry contours. With mid-size deals taking centerstage, the growth trajectory appears to be marked by a balance of both caution and calculated ambition.The deal-making environment was robust in 2023, with over 2,000 unique pharma and biotech deals totaling more than US$ 410 billion, according to the PharmaCompass database. Last year, there were over 200 mergers and acquisitions (M&As) with transactions exceeding US$ 160 billion in total value. Oncology, infections and infectious diseases, and neurology had emerged as the top three therapeutic areas for deals.PharmaCompass’ analysis indicates that the momentum has been maintained in 2024. As of August 6, the industry had seen over 1,200 unique deals valued at more than US$ 230 billion, including over 120 M&A transactions surpassing US$ 60 billion in aggregate value. While oncology maintains its lead position, neurology and immunology have gained notable traction.The one big difference is that 2024 is yet to witness a mega-deal, comparable to Pfizer’s US$ 43 billion acquisition of Seagen in 2023 or Amgen’s US$ 27.8 billion Horizon buyout announced in 2022. The largest transaction thus far has been Novo Nordisk Foundation’s US$ 16.5 billion acquisition of Catalent, a contract development and manufacturing organization (CDMO).This compilation does not include deals related to acquisition of facilities, divestment, medical devices, diagnostics and animal health. We have considered deals announced, irrespective of when these transactions were completed. For a comprehensive overview of CDMO deals and developments in 2024, please refer to our dedicated roundup.View Pharma & Biotech Acquisitions, Deals & Agreements in 2024 as of Aug. 6 (Free Excel Available) Vertex buys Alpine Immune for US$ 4.9 bn; Gilead’s CymaBay buyout pays off via FDA nodAmongst the biggest acquisitions of 2024 was Vertex Pharmaceuticals’ buyout of Alpine Immune Sciences for US$ 4.9 billion. It granted Vertex access to protein-based immunotherapies, including the promising povetacicept for IgA nephropathy, a serious kidney disease.Gilead Sciences’ acquisition of CymaBay Therapeutics for US$ 4.3 billion in February secured it access to seladelpar (Livdelzi), an experimental drug that received FDA’s accelerated approval this month for primary biliary cholangitis, a liver disease that affects the bile ducts. Eli Lilly bolstered its presence in the US$ 26.65 billion inflammatory bowel disease (IBD) market by purchasing Morphic Holding for approximately US$ 3.2 billion in July. Through this deal, Lilly gained the oral IBD therapy candidate MORF-057, which will offer a more convenient dosing option compared to injectable drugs currently available in the market. Lilly sees the IBD space as a way to diversify beyond obesity.Merck expanded its ophthalmology portfolio by acquiring Eyebiotech Limited for US$ 1.3 billion (plus US$ 1.7 billion in milestone payments), obtaining Restoret for diabetic macular edema and neovascular age-related macular degeneration.Japanese drugmaker Ono Pharmaceutical acquired Deciphera Pharmaceuticals for US$ 2.4 billion, gaining Qinlock for gastrointestinal stromal tumors and vimseltinib for tenosynovial giant cell tumors. Sanofi targeted rare diseases by purchasing Inhibrx for up to US$ 2.2 billion. The acquisition gave the French drugmaker access to INBRX-101 for Alpha-1 antitrypsin deficiency, a genetic condition that can cause lung and liver damage.View Pharma & Biotech Acquisitions, Deals & Agreements in 2024 as of Aug. 6 (Free Excel Available)  Novartis buys two oncology firms for their assets; J&J, Genmab join ADC bandwagonNovartis has been on a shopping spree, and has made two significant purchases this year. First, it acquired MorphoSys for € 2.7 billion (US$ 2.9 billion), thereby adding the promising bone-marrow cancer treatment pelabresib to its pipeline. Second, it announced the acquisition of Mariana Oncology for US$ 1 billion upfront (plus US$ 750 million in milestone payments), thereby expanding into radioligand therapies (RLTs) to treat cancers with high unmet need. RLTs take a targeted approach, delivering radiation to the tumor, while limiting damage to the surrounding cells.AstraZeneca entered the field of radioconjugates, which is a promising modality in the treatment of cancer, by acquiring Fusion Pharmaceuticals for US$ 2.4 billion.In January this year, Johnson & Johnson had announced the acquisition of antibody-drug-conjugate (ADC) developer Ambrx Biopharma for about US$ 2 billion. With this buyout, J&J has joined the likes of Bristol Myers Squibb, AbbVie and GSK who had entered this promising field through acquisitions last year.Similarly, Denmark’s Genmab bought ProfoundBio for US$ 1.8 billion in cash, boosting its oncology portfolio with three next-generation ADC candidates. This includes Rina-S, which recently received FDA’s fast track designation for the treatment of ovarian cancer.View Pharma & Biotech Acquisitions, Deals & Agreements in 2024 as of Aug. 6 (Free Excel Available)  Novartis signs multiple collaborations; GSK, Takeda, AbbVie sign billion-dollar dealsNovartis was not just busy signing M&A deals, it also signed a bevy of collaboration agreements. For instance, Shanghai-based Argo partnered Novartis on two early-stage RNA interference candidates for cardiovascular diseases, potentially earning the former up to US$ 4.2 billion plus tiered royalties.Novartis also agreed to pay up to US$ 3 billion (including US$ 150 million upfront) to Dren Bio to use the latter’s Targeted Myeloid Engager and Phagocytosis platform to develop bispecific antibodies to treat cancer.Moreover, the Swiss drugmaker expanded its peptide discovery collaboration with Japan-based PeptiDream in a deal worth over US$ 2.71 billion in milestone payments, plus an upfront payment of US$ 180 million. Peptide-drug conjugates (PDCs) are the next generation of targeted therapeutic drugs after ADCs and Novartis is, thus far, the only big pharma with FDA-approved radioligand PDCs. GSK entered a groundbreaking partnership with Flagship Pioneering, potentially worth over US$ 7 billion, to identify and develop 10 novel drugs and vaccines. The deal, starting with respiratory and immunology drugs, involves US$ 720 million in upfront and milestone payments for each candidate. This collaboration leverages Flagship’s extensive portfolio of over 40 biopharma companies with drug development capabilities.There were two significant deals in the field of neuroscience. First, Takeda said it is paying Swiss biotech AC Immune US$ 100 million upfront with potential further payments of US$ 2.1 billion for an exclusive option to license global rights to an Alzheimer’s vaccine and related immunotherapies.Second, AbbVie and clinical stage biotech Gilgamesh Pharmaceuticals joined forces in a deal potentially worth over US$ 2 billion to develop a new class of psychedelic compounds for psychiatric conditions, combining AbbVie’s psychiatric expertise with Gilgamesh’s innovative neuroplastogen research platform.View Pharma & Biotech Acquisitions, Deals & Agreements in 2024 as of Aug. 6 (Free Excel Available)  Our viewDuring this year, companies like Novartis (with US$ 16.8 billion), GSK (US$ 14.5 billion), Sanofi (US$ 11.9 billion), Bristol Myers Squibb (US$ 11.6 billion), and AbbVie (US$ 9.1 billion) have made substantial investments in acquisitions, collaborations and other forms of dealmaking.Though the deal-making environment is robust, we notice a shift towards mid-size transactions. Alongside, we notice a growing interest in areas such as ADCs, radiopharmaceuticals, and protein-based immunotherapies, underscoring their growing importance in drug development. There has also been significant interest in silencing RNA (siRNA) therapeutics, highlighting the industry's focus on novel approaches to disease treatment. With the industry focusing on cutting-edge technologies that address unmet medical needs, we feel there is little reason to fret over the size of the deals.  

Impressions: 2505

https://www.pharmacompass.com/radio-compass-blog/novartis-gsk-sanofi-bms-shell-out-over-us-10-bn-in-dealmaking-as-mid-size-deals-take-centerstage-in-2024

#PharmaFlow by PHARMACOMPASS
22 Aug 2024

STOCK RECAP #PipelineProspector

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Pipeline Prospector Feb 2024: Novo’s parent buys Catalent for US$ 16.5 bn, FDA okays Iovance’s cell therapy
February was a good month for the pharma sector, complete with some important deals, successes from clinical trials and healthy fourth quarter (Q4) results announced by some drugmakers. The market cheered the good news — the Nasdaq Biotechnology index gained 1 percent from 4,385.06 to 4,428.56, the SPDR S&P Biotech ETF index spiked 12 percent to 98.42 after ending January at 87.43. The S&P Biotechnology Select Industry Index (SPSIBI) soared 16 percent from 6,815.3 to 7,896.47 in February.The month saw some big acquisitions. Novo Holdings, the parent company of Novo Nordisk, acquired contract development and manufacturing organization (CDMO) Catalent for US$ 16.5 billion. Novo Holdings plans to sell three of Catalent’s “fill-finish” sites to Novo Nordisk for US$ 11 billion. Novo’s game plan hasn’t gone down well with its arch rival in the diabetes and obesity segment Eli Lilly. The Indianapolis-headquartered drugmaker has called for a scrutiny of the deal as it relies on Catalent for some of its diabetes and obesity drugs that compete with Novo’s meds.Both Novo and Lilly have been struggling to meet the demand for their weight loss meds. With the acquisition of this key CDMO, Novo has scored an edge over competition.Meanwhile, Gilead boosted its liver portfolio with the US$ 4.3 billion acquisition of CymaBay Therapeutics. And Novartis announced the acquisition of cancer treatment developer MorphoSys for € 2.7 billion (US$ 2.9 billion). With this buyout, Novartis gets a late-stage, rare bone-marrow cancer treatment — pelabresib — that holds plenty of promise.Several drugmakers announced their Q4 results last month. Notable amongst them was Eli Lilly, as it posted a 28 percent increase in revenues — from US$ 7.3 billion in Q4 2022 to US$ 9.4 billion led by its new products Mounjaro and Zepbound. GSK touted the “exceptional launch of Arexvy”, the world's first RSV vaccine, as it brought in sales of £ 1.2 billion (US$ 1.52 billion) in 2023. And Merck’s Keytruda saw a 19 percent increase in its sales in 2023 — at US$ 25 billion.Access the Pipeline Prospector Dashboard for February 2024 Newsmakers (Free Excel)FDA okays Iovance’s T-cell therapy; Roche’s asthma med okayed for food allergiesThe US Food and Drug Administration (FDA) granted accelerated approval to Iovance Biotherapeutics’ cell therapy — Amtagvi (lifileucel) — for treating the deadliest form of skin cancer. Amtagvi is the first and only one-time, individualized T cell therapy to receive FDA approval for a solid tumor cancer. Iovance hopes to start reporting noteworthy revenue in the second quarter of 2024, despite the fact that Amtagvi comes with a boxed warning (the highest safety warning) for treatment-related mortality. FDA also approved Takeda’s Eohilia as the first oral treatment for an allergic inflammation of the esophagus. Eohilia (budesonide oral suspension) was on course to becoming the first treatment for eosinophilic esophagitis (EoE) until it was rejected by the FDA in December 2021.In January, Sanofi and Regeneron’s jab Dupixent had pipped Eohilia to become the first FDA drug approved for EoE. The chronic condition can make it very hard for patients to consume food. Dupixent (dupilumab) is injected weekly or biweekly and two pens cost US$ 3,803.20. In contrast, Takeda’s drug is taken twice daily and costs US$ 1,875 per month.Roche and Novartis’ asthma drug Xolair (omalizumab) became the first FDA-approved med to help people with food allergies avoid severe reactions following accidental exposure. This opens the drug to around 17 million people in the US whose allergies can potentially be deadly.Access the Pipeline Prospector Dashboard for February 2024 Newsmakers (Free Excel) Boehringer’s obesity candidate, Lilly’s tirzepatide show promise in trials for MASHBoehringer Ingelheim announced promising phase 2 trial data for its experimental obesity drug survodutide in treating metabolic dysfunction-associated steatohepatitis (MASH), a liver disease. The drug is being developed in collaboration with Zealand Pharma. It had received a fast-track designation from the FDA in June 2021. MASH causes histologic liver damage and occurs in patients who are not alcoholics and who are often obese or have type 2 diabetes.The trial met its primary endpoint with survodutide reaching a biopsy-proven improvement in MASH after 48 weeks. Survodutide also met all secondary endpoints, including a statistically significant improvement in liver fibrosis. The companies said this potentially positions it as a “best-in-class” treatment. The drug belongs to the glucagon-like peptide 1 (GLP-1) class of drugs.In another trial, Eli Lilly announced positive results from a phase 2 study of tirzepatide in adults with MASH — 74 percent of participants were cured of MASH and their fibrosis also did not worsen at 52 weeks (as compared to nearly 13 percent for participants in the placebo group).Access the Pipeline Prospector Dashboard for February 2024 Newsmakers (Free Excel) J&J’s autoimmune drug posts trial gains; Sanofi’s frexalimab shows benefit in MSOne of Johnson & Johnson’s most watched experimental drugs — nipocalimab — posted positive results in trials for the treatment of two autoimmune disorders. In a phase 3 study, nipocalimab significantly reduced symptoms of generalized myasthenia gravis (GMG). And, in a phase 2 study, it helped reduce the severity of Sjögren’s disease (SjD). GMG weakens the skeletal muscles and particularly affects control of the limbs, throat, mouth, and eyes. SjD is an immune disorder that is identified by symptoms like dry eyes and dry mouth. J&J expects over US$ 5 billion from this drug. In a phase 2 trial, Sanofi’s frexalimab significantly slowed disease activity in people with relapsing multiple sclerosis (MS). In December last year, the French multinational had named frexalimab as one of three “pipeline-in-a-product” assets with the potential of generating annual peak sales in excess of €5 billion (US$ 5.4 billion). The phase 2 results give credence to those expectations.In trial failures, Gilead (stock down 8 percent) said the FDA has paused all trials of its drug magrolimab in the treatment of two blood cancers – acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) – because of increased risk of patient death (when used in combination with azacitidine plus venetoclax). Magrolimab was the lead candidate of Gilead’s US$ 4.9 billion acquisition of Forty Seven in 2020.Access the Pipeline Prospector Dashboard for February 2024 Newsmakers (Free Excel) Our viewThe year has gotten off to a good start with drugmakers posting healthy Q4 results and the indices showing some positive growth month-on-month. Several drugmakers have entered 2024 with a simplified business model and an increased strategic focus on R&D. Given the favorable demand, we are hopeful of a better year for the industry, as opposed to the volatility of the last two years.Access the Pipeline Prospector Dashboard for February 2024 Newsmakers (Free Excel) 

Impressions: 2631

https://www.pharmacompass.com/pipeline-prospector-blog/pipeline-prospector-feb-2024-novo-s-parent-buys-catalent-for-us-16-5-bn-fda-okays-iovance-s-cell-therapy

#PharmaFlow by PHARMACOMPASS
07 Mar 2024

NEWS #PharmaBuzz

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https://www.prnewswire.com/news-releases/ryvu-therapeutics-presents-clinical-and-preclinical-data-on-rvu120-at-the-2024-european-hematology-association-congress-302173184.html

PR NEWSWIRE
14 Jun 2024

https://www.accesswire.com/856134/morphosys-to-present-new-phase-3-manifest-2-data-on-pelabresib-in-myelofibrosis-in-oral-presentation-at-2024-asco-annual-meeting

ACCESSWIRE
24 Apr 2024

https://www.novartis.com/news/media-releases/novartis-strengthen-oncology-pipeline-agreement-acquire-morphosys-ag-eur-68-share-or-aggregate-eur-27bn-cash

PRESS RELEASE
06 Feb 2024

https://www.businesswire.com/news/home/20231210152441/en

BUSINESSWIRE
10 Dec 2023

https://www.businesswire.com/news/home/20231120962550/en

BUSINESSWIRE
20 Nov 2023