Latest news with #FGF21
Yahoo
15-05-2025
- Business
- Yahoo
AbbVie expands siRNA push with $335m ADARx deal
AbbVie has signed a collaboration and licensing agreement with US-based ADARx Pharmaceuticals, committing $335m upfront to access its small interfering RNA (siRNA) platform. The partnership gives AbbVie exclusive options on multiple siRNA-based programmes across neuroscience, immunology, and oncology – therapeutic areas identified as strategic priorities for the company. Under the deal, ADARx will apply its proprietary siRNA discovery technology to identify and develop new molecular candidates. In addition, AbbVie will contribute expertise in antibody engineering, antibody-drug conjugates (ADCs), and targeted tissue delivery – capabilities intended to enhance the therapeutic potential and precision of the siRNA candidates. Along with the upfront payment, ADARx stands to receive 'several billion dollars' in potential option fees, development and commercial milestones, and tiered royalties on any resulting products, as per yesterday's (14 May) announcement. This is AbbVie's second major move into the siRNA space in less than a year. In October 2024, the company acquired Aliada Therapeutics for $1.4bn, primarily for its Alzheimer's disease candidate ALIA-1758 and blood-brain barrier shuttle technology, which also holds promise for RNA-based delivery. siRNA therapeutics work by selectively silencing the expression of disease-driving genes at the mRNA level, preventing the production of specific proteins. ADARx claims its approach can offer long-lasting effects without altering the genome, addressing some of the safety concerns associated with gene editing technologies. "siRNA is a promising genetic medicine approach for silencing disease-causing genes, but challenges still remain in targeting and delivering siRNA effectively," said Jonathon Sedgwick, senior vice-president and global head of discovery research at AbbVie. ADARx's internal pipeline includes ADX-324, a treatment for hereditary angioedema, which is nearing Phase III development. Other early-stage programmes target complement-mediated diseases, cardiovascular conditions, neurodegeneration, and obesity. The company raised $200m in a Series C round in August 2023 to advance these assets. Industry interest in siRNA continues to grow. In March 2025, Eli Lilly reported promising Phase II data for lepodisiran, its siRNA therapy targeting lipoprotein(a), a key cardiovascular risk factor. In January 2024, Boehringer Ingelheim entered a deal worth up to $2bn with Suzhou Ribe Life Science to develop siRNA therapies for liver disease. Just yesterday, GSK disclosed it was acquiring Boston Pharmaceuticals' FGF21 analogue efimosfermin for $2bn, with plans to combine it with its in-house siRNA candidate GSK'990 to address more advanced stages of steatotic liver disease. "AbbVie expands siRNA push with $335m ADARx deal" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Time of India
15-05-2025
- Health
- Time of India
Can a hormone reverse fatty liver disease? Here's what experts think
Researchers at Oklahoma University found that the hormone FGF21 can reverse fatty liver disease. The hormone signals the brain to improve liver function. It lowers liver fat and reverses fibrosis. The hormone also lowers cholesterol. This discovery could lead to new drugs for treating fatty liver disease. Clinical trials are showing good therapeutic benefits. Fatty liver disease is rising as a global health concern. Often considered a 'silent' disease as it shows few or no symptoms, fatty liver disease, however, can get serious, depending on its cause and progression. A new study has found that a certain hormone can reverse fatty liver disease . A groundbreaking study by the researchers at the University of Oklahoma found that a hormone can reverse the effects of fatty liver disease in mice. The study is published in Cell Metabolism . What is fatty liver disease? Fatty liver, medically known as hepatic steatosis, is a condition in which fat builds up in the liver. There are two major types of fatty liver disease: alcoholic fatty liver disease (AFLD) and nonalcoholic fatty liver disease (NAFLD). AFLD, as the name suggests, occurs in people who drink large amounts of alcohol. NAFLD, on the other hand, affects people who drink little or no alcohol. Though the cause of nonalcoholic fatty liver disease (NAFLD) is unknown, people who have type 2 diabetes, or prediabetes, obesity, are middle-aged or older, have high blood pressure, are prone to the disease. How does the hormone control fatty liver disease? The researchers found that the hormone FGF21 (fibroblast growth factor 21) can reverse fatty liver disease . The hormone works primarily by signaling the brain to improve liver function . Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Google Brain Co-Founder Andrew Ng, Recommends: Read These 5 Books And Turn Your Life Around Blinkist: Andrew Ng's Reading List Undo They delved into how FGF21 acts on the brain to influence liver metabolism. Understanding the mechanism of action of the hormone could become instrumental as a target for a new class of highly anticipated drugs that are in Phase 3 clinical trials. 'Fatty liver disease, or MASLD (metabolic dysfunction-associated steatotic liver disease), is a buildup of fat in the liver. It can progress to MASH (metabolic dysfunction-associated steatohepatitis) during which fibrosis and, ultimately, cirrhosis can occur. MASLD is becoming a very big problem in the United States, affecting 40% of people worldwide, and there is currently only one treatment approved by the Food and Drug Administration to treat MASH. A new class of drugs, based on FGF21 signaling, is showing good therapeutic benefits in clinical trials, but until now, the mechanism for how they work has been unclear,' Matthew Potthoff, Ph.D., the lead author and a professor of biochemistry and physiology at the University of Oklahoma College of Medicine and deputy director of OU Health Harold Hamm Diabetes Center said in a statement. Fatty liver diet: Best and worst foods for your liver The findings showed that FGF21 was effective at causing signaling in the model species that changed the liver's metabolism. The researchers found that this process lowered the liver's fat, and the fibrosis too was reversed. The hormone also sent a separate signal directly to the liver, specifically to lower cholesterol. 'It's a feedback loop where the hormone sends a signal to the brain, and the brain changes nerve activity to the liver to protect it. The majority of the effect comes from the signal to the brain as opposed to signaling the liver directly, but together, the two signals are powerful in their ability to regulate the different types of lipids in the liver,' Potthoff added. Similar to the GLP-1s (glucagon-like peptide 1) weightloss drugs that regulate blood sugar levels and appetite, FGF21 acts on the brain to regulate metabolism. Interestingly, both are hormones produced from peripheral tissues: GLP-1 from the intestine and FGF21 from the liver, and both work by sending a signal to the brain. 'It is interesting that this metabolic hormone/drug works primarily by signaling to the brain instead of to the liver directly, in this case. FGF21 is quite powerful because it not only led to a reduction of fat, but it also mediated the reversal of fibrosis, which is the pathological part of the disease, and it did so while the mice were still eating a diet that would cause the disease. Now, we not only understand how the hormone works, but it may guide us in creating even more targeted therapies in the future,' the lead author added. Future-Proof Your Child with AI Skills | Limited Early Bird Seats – 33% OFF! | WhatsApp: 9560500838
Yahoo
14-05-2025
- Business
- Yahoo
GSK to spend $2bn on Phase III liver disease drug acquisition
Just a day after dropping a $625m cancer asset, GSK has inked a deal worth a potential $2bn to acquire Boston Pharmaceuticals' efimosfermin, a drug ready to hit Phase III trials for the treatment of liver disease. The UK big pharma company will pay $1.2bn upfront for Boston's subsidiary BP Asset IX, which will give the company access to efimosfermin. GSK has also agreed to pay additional milestone payments totalling $800m, along with tiered royalties to Novartis, which originally owned the therapy. Shares in London-listed GSK opened relatively unchanged following the news, though climbed into the mid-morning to a share price high of £1,382.00 (correct at 11am GMT+1). The company has a market cap of £56.98bn. Efimosfermin is being developed to treat and prevent the progression of steatotic liver disease (SLD), a build-up of fat in liver cells. SLD is a broad disease term used to encompass various causes of fat accumulation in the liver. If untreated, fat build-up in cells can progress to more severe stages that include fibrosis and cirrhosis. GSK's new asset is taken once monthly via a subcutaneous injection. Efimosfermin is a long-acting variant of fibroblast growth factor 21 (FGF21) that is designed to regulate key metabolic pathways to decrease both liver fat and inflammation, and reverse liver fibrosis. The therapy has already performed well in a Phase II trial (NCT06920043) in patients with moderate-to-advanced (F2 or F3) metabolic dysfunction-associated steatohepatitis (MASH), a form of SLD. Data, posted by Boston in November 2024, demonstrated that efimosfermin has 'significant therapeutic potential' in liver disease. Of the 31 patients receiving the injection, 14 had a one-stage or greater improvement in fibrosis without MASH progression, compared to just seven out of 34 in the placebo group. Whilst there are other FGF21 drugs in development – such as Akero Therapeutics efruxifermin and 89bio's pegozafermin – Boston designed efimosfermin with an extended half-life to allow monthly dosing while Akero and 89bio's assets require weekly dosing, GSK's drug could be set for an early market advantage. GSK has also earmarked efimosfermin's potential to combine with its in-house siRNA therapeutic GSK'990 to address more advanced stages of SLD. According to GlobalData estimates, the MASH market is anticipated to reach sales of $25.7bn in 2032 across the seven major markets (7MM: US, France, Germany, Italy, Spain, the UK, and Japan). The market was revived in March 2024 when Madrigal Pharmaceuticals' Rezdiffra (resmetirom) won the first US Food and Drug Administration (FDA) approval for a MASH treatment. GlobalData noted an increase in drug partnership deal values in the MASH arena in 2024. Eli Lilly continued this trend into this year when it agreed to pay $630m for a Phase I RNA-based candidate from South Korea-based biotech OliX Pharmaceuticals in February 2025. GSK said the purchase of Boston's drug aligns with its R&D focus on 'science related to the immune system'. The deal agreement comes just a day after the drugmaker dropped an anti-TIGIT antibody it previously attained the rights for in a $625m upfront deal. GSK's chief scientific officer Tony Wood said: 'Efimosfermin will significantly expand our hepatology pipeline and provide us the opportunity to develop a new potential best-in-class medicine with its first launch expected in 2029. It complements GSK'990, also in development for alcohol-related liver disease and MASH, offering GSK options to develop both monotherapy and potential combinations to improve patient outcomes.' "GSK to spend $2bn on Phase III liver disease drug acquisition" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
14-05-2025
- Business
- Yahoo
GSK to acquire efimosfermin, a phase III-ready potential best-in-class specialty medicine to treat and prevent progression of steatotic liver disease (SLD)
Affecting up to 5% of the global population, SLD represents an area of significant unmet medical need with limited treatment options Phase II data show potential of efimosfermin to reverse liver fibrosis, demonstrated in metabolic dysfunction-associated steatohepatitis (a form of SLD) Unique properties offer potential for efimosfermin to be a new standard-of-care Significantly expands GSK's hepatology pipeline aimed at addressing steatotic and viral drivers of liver disease, offering multiple development options and potential first launch in 2029 CAMBRIDGE, Mass., May 14, 2025--(BUSINESS WIRE)--GSK plc (LSE/NYSE: GSK) and Boston Pharmaceuticals, a leading clinical stage biopharmaceutical company developing highly targeted therapies for patients with serious liver diseases, today announced that they have entered into an agreement under which GSK will acquire Boston Pharmaceuticals' lead asset, efimosfermin alfa. Efimosfermin is a phase III-ready, potential best-in-class, investigational specialty medicine to treat and prevent progression of steatotic liver disease (SLD). Under the agreement, GSK will pay $1.2 billion upfront, with potential for additional success-based milestone payments totalling $800 million. Efimosfermin is a novel, once-monthly fibroblast growth factor 21 (FGF21) analog therapeutic in clinical development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), including cirrhosis, and future development in alcohol-related liver disease (ALD), both forms of SLD. Given efimosfermin's direct antifibrotic mechanism of action and GSK's data-driven insights from work in human genetics and disease phenotyping, it has potential to address more advanced stages of SLD and opportunity in combination with GSK'990, a siRNA therapeutic in development for other subsets of patients with SLD. The acquisition of efimosfermin is highly aligned to GSK's R&D focus on science related to the immune system and is further evidence of the company's intent to build on its deep understanding of fibrosis and auto-inflammation to develop precision interventions that stop and reverse disease progression. SLD represents an area of significant unmet medical need affecting approximately 5% of the global population with limited therapeutic options for patients.1 SLD, including MASH and ALD, is characterised by the accumulation of fat in the liver (steatosis), with associated inflammation and fibrosis. ALD affects about 26 million patients globally, and together with MASH, is the leading cause of liver transplant in the US, representing a significant burden and cost on healthcare utilisation.1,3 Substantial and disproportionate costs are associated with end-stage liver disease. Interventions that reduce moderate-to-advanced fibrosis to prevent progression of cirrhosis, liver cancer, hospitalisations and transplant could save the US healthcare system between $40 - 100 billion over the next two decades.4 Recent data from a phase II trial of efimosfermin, designed to assess the efficacy and safety of a monthly subcutaneous dose in participants with biopsy-confirmed moderate-to-advanced (F2 or F3) MASH, showed that efimosfermin rapidly and significantly reversed liver fibrosis and stopped its progression, with a manageable tolerability profile. These data suggest potentially greater fibrosis improvement compared to that seen with other therapeutic approaches and with benefit expected independent of background glucagon-like peptide-1 (GLP-1) therapy. In addition, efimosfermin could offer triglyceride reduction and improved glycaemic control, important considerations for MASH patients who frequently face cardiometabolic co-morbidities. Efimosfermin's unique properties, including low immunogenicity and an extended half-life, also offer the potential for a monthly dosing regimen and improved patient convenience. Full data from the trial was presented at the American Association for the Study of Liver Diseases (AASLD) Meeting in November 2024.5 Tony Wood, Chief Scientific Officer, GSK said: "The FGF21 class has shown some of the most exciting data in MASH including first-in-disease evidence of cirrhosis reversal, and efimosfermin has the potential to define a new standard-of-care with its monthly dosing and tolerability profile. Efimosfermin will significantly expand our hepatology pipeline and provide us the opportunity to develop a new potential best-in-class medicine with first launch expected in 2029. It complements GSK'990, also in development for ALD and MASH, offering GSK options to develop both monotherapy and potential combinations to improve patient outcomes." Elias Zerhouni MD, Chair of the Board, Boston Pharmaceuticals, said: "I am very proud of today's agreement with GSK, a company I know and admire, and of the outstanding work of the Boston Pharmaceuticals team led by Sophie Kornowski. Notably, this would not have been possible without the impressive, sustained and long-term strategic commitment to leading edge science and biotechnology ventures of the Bertarelli family, which led to the development of our Efimosfermin alfa as a potential best-in-class therapy in its therapeutic field. We are delighted that GSK, a global leader, recognized Efimosfermin's potential to address a growing global public health concern and unmet medical need. Together, we look forward to Efimosfermin alfa's ongoing journey to become a best-in-class treatment for patients with SLD." Sophie Kornowski Pharm D, Chief Executive Officer, Boston Pharmaceuticals said: "Today marks a pivotal moment for Boston Pharmaceuticals and Efimosfermin alfa, as we begin a new chapter with GSK, a global organization with proven expertise in liver disease, and a shared commitment to patients. Our accomplishments were made possible thanks to the dedicated Boston Pharmaceuticals team, who focused on our mission to develop Efimosfermin with a great sense of urgency. I am especially grateful to Ernesto Bertarelli for his unflinching support and the commitment of his expertise over the last few years." The addition of efimosfermin further strengthens GSK's hepatology pipeline of specialty medicines aimed at addressing both viral (chronic hepatitis B) and steatotic (SLD) drivers of fibrotic liver diseases. Financial considerations Under the terms of the agreement, GSK will acquire BP Asset IX, Inc., a subsidiary of Boston Pharmaceuticals, to access efimosfermin. GSK will pay up to $2 billion of total cash consideration, comprising an upfront payment of $1.2 billion and up to $800 million in success-based milestone payments. GSK will also be responsible for success-based milestone payments as well as tiered royalties for efimosfermin owed to Novartis Pharma AG. GSK will account for the transaction as a business combination. This transaction is subject to customary conditions, including applicable regulatory agency clearances under the Hart-Scott-Rodino Act in the US. For GSK, Evercore Partners International LLP is acting as exclusive financial advisor and Cleary Gottlieb Steen & Hamilton LLP as legal counsel. For Boston Pharmaceuticals, Centerview Partners LLC is acting as exclusive financial advisor and Sullivan & Cromwell LLP as legal counsel. About efimosfermin alfa Efimosfermin is an investigational, once-monthly subcutaneous injection of a long-acting variant of FGF21 that is designed to regulate key metabolic pathways to decrease liver fat, ameliorate liver inflammation, and reverse liver fibrosis in patients with MASH. Efimosfermin is currently in trials for moderate to advanced fibrosis, including cirrhosis and is not available for prescription anywhere in the world. About Boston Pharmaceuticals Boston Pharmaceuticals is a clinical-stage biopharmaceutical company that leverages an experienced and committed drug development team to advance a portfolio of highly differentiated therapies that may address important unmet medical needs in serious liver diseases. Boston Pharmaceuticals is a portfolio company of B-Flexion, a private, entrepreneurial investment firm which manages the combined funds and investments associated with the Bertarelli family and also partners with sophisticated capital to meet the shared goal of delivering exceptional value over the generations, while also contributing positively to society. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the "Risk Factors" section in GSK's Annual Report on Form 20-F for 2024, and GSK's Q1 Results for 2025. Registered in England & Wales:No. 3888792 Registered Office:79 New Oxford StreetLondonWC1A 1DG References1 Global Burden of Disease Study 2017 Cirrhosis collaborators. 20202 Allen et al. Postgraduate Medicine. 2024, Vol 136, No. 3, 229–245.3 Younossi et al. Hepatol Commun. 2023 Dec 22;8(1):e03524 Wallace, Carolyn et al. Journal of Hepatology, Volume 0, Issue 05 Hepatology (2004) Late-Breaking Abstract Supplement p28-30 TLM2024LBA_20241115A.pdf View source version on Contacts GSK enquiries Media:Tim Foley +44 (0) 20 8047 5502 (London)Sarah Clements +44 (0) 20 8047 5502 (London)Kathleen Quinn +1 202 603 5003 (Washington DC)Lyndsay Meyer +1 202 302 4595 (Washington DC) Investor Relations:Constantin Fest +44 (0) 7831 826525 (London)James Dodwell +44 (0) 20 8047 2406 (London)Mick Readey +44 (0) 7990 339653 (London)Steph Mountifield +44 (0) 7796 707505 (London)Jeff McLaughlin +1 215 751 7002 (Philadelphia)Frannie DeFranco +1 215 751 4855 (Philadelphia) Boston Pharma enquiries Media: Sasha Damouni Ellis +1 (646) 240 2311; sasha@ (New York)David Patti +1 (908) 421 5971; dpatti@ (New York) B-Flexion enquiries Media: Blair Hennessy +1 (646) 757 0632; (New York)Emma Prenn-Vasilakis +1 (917) 763 6685; (Boston)
National Post
14-05-2025
- Business
- National Post
GSK to acquire efimosfermin, a phase III-ready potential best-in-class specialty medicine to treat and prevent progression of steatotic liver disease (SLD)
Article content Affecting up to 5% of the global population, SLD represents an area of significant unmet medical need with limited treatment options Phase II data show potential of efimosfermin to reverse liver fibrosis, demonstrated in metabolic dysfunction-associated steatohepatitis (a form of SLD) Unique properties offer potential for efimosfermin to be a new standard-of-care Significantly expands GSK's hepatology pipeline aimed at addressing steatotic and viral drivers of liver disease, offering multiple development options and potential first launch in 2029 Article content Article content CAMBRIDGE, Mass. — GSK plc (LSE/NYSE: GSK) and Boston Pharmaceuticals, a leading clinical stage biopharmaceutical company developing highly targeted therapies for patients with serious liver diseases, today announced that they have entered into an agreement under which GSK will acquire Boston Pharmaceuticals' lead asset, efimosfermin alfa. Efimosfermin is a phase III-ready, potential best-in-class, investigational specialty medicine to treat and prevent progression of steatotic liver disease (SLD). Under the agreement, GSK will pay $1.2 billion upfront, with potential for additional success-based milestone payments totalling $800 million. Article content Efimosfermin is a novel, once-monthly fibroblast growth factor 21 (FGF21) analog therapeutic in clinical development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), including cirrhosis, and future development in alcohol-related liver disease (ALD), both forms of SLD. Given efimosfermin's direct antifibrotic mechanism of action and GSK's data-driven insights from work in human genetics and disease phenotyping, it has potential to address more advanced stages of SLD and opportunity in combination with GSK'990, a siRNA therapeutic in development for other subsets of patients with SLD. Article content The acquisition of efimosfermin is highly aligned to GSK's R&D focus on science related to the immune system and is further evidence of the company's intent to build on its deep understanding of fibrosis and auto-inflammation to develop precision interventions that stop and reverse disease progression. Article content SLD represents an area of significant unmet medical need affecting approximately 5% of the global population with limited therapeutic options for patients. 1 SLD, including MASH and ALD, is characterised by the accumulation of fat in the liver (steatosis), with associated inflammation and fibrosis. ALD affects about 26 million patients globally, and together with MASH, is the leading cause of liver transplant in the US, representing a significant burden and cost on healthcare utilisation. 1,3 Substantial and disproportionate costs are associated with end-stage liver disease. Interventions that reduce moderate-to-advanced fibrosis to prevent progression of cirrhosis, liver cancer, hospitalisations and transplant could save the US healthcare system between $40 – 100 billion over the next two decades. 4 Article content Recent data from a phase II trial of efimosfermin, designed to assess the efficacy and safety of a monthly subcutaneous dose in participants with biopsy-confirmed moderate-to-advanced (F2 or F3) MASH, showed that efimosfermin rapidly and significantly reversed liver fibrosis and stopped its progression, with a manageable tolerability profile. These data suggest potentially greater fibrosis improvement compared to that seen with other therapeutic approaches and with benefit expected independent of background glucagon-like peptide-1 (GLP-1) therapy. In addition, efimosfermin could offer triglyceride reduction and improved glycaemic control, important considerations for MASH patients who frequently face cardiometabolic co-morbidities. Efimosfermin's unique properties, including low immunogenicity and an extended half-life, also offer the potential for a monthly dosing regimen and improved patient convenience. Full data from the trial was presented at the American Association for the Study of Liver Diseases (AASLD) Meeting in November 2024. 5 Article content Tony Wood, Chief Scientific Officer, GSK said: 'The FGF21 class has shown some of the most exciting data in MASH including first-in-disease evidence of cirrhosis reversal, and efimosfermin has the potential to define a new standard-of-care with its monthly dosing and tolerability profile. Efimosfermin will significantly expand our hepatology pipeline and provide us the opportunity to develop a new potential best-in-class medicine with first launch expected in 2029. It complements GSK'990, also in development for ALD and MASH, offering GSK options to develop both monotherapy and potential combinations to improve patient outcomes.' Article content Elias Zerhouni MD, Chair of the Board, Boston Pharmaceuticals, said: 'I am very proud of today's agreement with GSK, a company I know and admire, and of the outstanding work of the Boston Pharmaceuticals team led by Sophie Kornowski. Notably, this would not have been possible without the impressive, sustained and long-term strategic commitment to leading edge science and biotechnology ventures of the Bertarelli family, which led to the development of our Efimosfermin alfa as a potential best-in-class therapy in its therapeutic field. We are delighted that GSK, a global leader, recognized Efimosfermin's potential to address a growing global public health concern and unmet medical need. Together, we look forward to Efimosfermin alfa's ongoing journey to become a best-in-class treatment for patients with SLD.' Article content Sophie Kornowski Pharm D, Chief Executive Officer, Boston Pharmaceuticals said: 'Today marks a pivotal moment for Boston Pharmaceuticals and Efimosfermin alfa, as we begin a new chapter with GSK, a global organization with proven expertise in liver disease, and a shared commitment to patients. Our accomplishments were made possible thanks to the dedicated Boston Pharmaceuticals team, who focused on our mission to develop Efimosfermin with a great sense of urgency. I am especially grateful to Ernesto Bertarelli for his unflinching support and the commitment of his expertise over the last few years.' Article content The addition of efimosfermin further strengthens GSK's hepatology pipeline of specialty medicines aimed at addressing both viral (chronic hepatitis B) and steatotic (SLD) drivers of fibrotic liver diseases. Article content Under the terms of the agreement, GSK will acquire BP Asset IX, Inc., a subsidiary of Boston Pharmaceuticals, to access efimosfermin. GSK will pay up to $2 billion of total cash consideration, comprising an upfront payment of $1.2 billion and up to $800 million in success-based milestone payments. GSK will also be responsible for success-based milestone payments as well as tiered royalties for efimosfermin owed to Novartis Pharma AG. Article content GSK will account for the transaction as a business combination. This transaction is subject to customary conditions, including applicable regulatory agency clearances under the Hart-Scott-Rodino Act in the US. Article content For GSK, Evercore Partners International LLP is acting as exclusive financial advisor and Cleary Gottlieb Steen & Hamilton LLP as legal counsel. Article content For Boston Pharmaceuticals, Centerview Partners LLC is acting as exclusive financial advisor and Sullivan & Cromwell LLP as legal counsel. Article content Efimosfermin is an investigational, once-monthly subcutaneous injection of a long-acting variant of FGF21 that is designed to regulate key metabolic pathways to decrease liver fat, ameliorate liver inflammation, and reverse liver fibrosis in patients with MASH. Efimosfermin is currently in trials for moderate to advanced fibrosis, including cirrhosis and is not available for prescription anywhere in the world. Article content About Boston Pharmaceuticals Article content Boston Pharmaceuticals is a clinical-stage biopharmaceutical company that leverages an experienced and committed drug development team to advance a portfolio of highly differentiated therapies that may address important unmet medical needs in serious liver diseases. Boston Pharmaceuticals is a portfolio company of B-Flexion, a private, entrepreneurial investment firm which manages the combined funds and investments associated with the Bertarelli family and also partners with sophisticated capital to meet the shared goal of delivering exceptional value over the generations, while also contributing positively to society. Article content About GSK Article content GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at Article content GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the 'Risk Factors' section in GSK's Annual Report on Form 20-F for 2024, and GSK's Q1 Results for 2025. Article content References 1 Global Burden of Disease Study 2017 Cirrhosis collaborators. 2020 2 Allen et al. Postgraduate Medicine. 2024, Vol 136, No. 3, 229–245. 3 Younossi et al. Hepatol Commun. 2023 Dec 22;8(1):e0352 4 Wallace, Carolyn et al. Journal of Hepatology, Volume 0, Issue 0 5 Hepatology (2004) Late-Breaking Abstract Supplement p28-30 TLM2024LBA_20241115A.pdf Article content Article content Article content Article content Article content Contacts Article content GSK enquiries Article content Media: Tim Foley +44 (0) 20 8047 5502 (London) Sarah Clements +44 (0) 20 8047 5502 (London) Kathleen Quinn +1 202 603 5003 (Washington DC) Lyndsay Meyer +1 202 302 4595 (Washington DC) Article content Investor Relations: Constantin Fest +44 (0) 7831 826525 (London) James Dodwell +44 (0) 20 8047 2406 (London) Mick Readey +44 (0) 7990 339653 (London) Steph Mountifield +44 (0) 7796 707505 (London) Jeff McLaughlin +1 215 751 7002 (Philadelphia) Frannie DeFranco +1 215 751 4855 (Philadelphia) Article content Boston Pharma enquiries Article content Article content Article content
