Grifols announces positive topline phase 3 fibrinogen clinical trial results
Grifols announces positive results from Biotest's phase 3 clinical trial for fibrinogen concentrate BT524, showing efficacy in treating acquired fibrinogen deficiency. The regulatory approval process in Europe and the United States is set to begin in Q4 2024, potentially tapping into an USD 800 million market. Grifols' robust innovation strategy is highlighted, balancing internal and external investments to build a diversified portfolio.
Positive
Biotest's fibrinogen concentrate BT524 met the primary endpoint in the AdFIrst study, proving its effectiveness in treating acquired fibrinogen deficiency.
The regulatory approval process for BT524 is expected to start in Q4 2024 in Europe and the United States, aiming to become the first approved fibrinogen concentrate for AFD indication in the U.S. market with a potential value of USD 800 million.
Grifols emphasizes its innovation strategy, combining internal and external investments to create a comprehensive portfolio.
The acquisition of Biotest has strengthened Grifols' access to plasma, pipeline, and sales presence, enhancing revenue growth and margin expansion.
Biotest's other innovations, including Yimmugo® and trimodulin, further contribute to Grifols' growth and development.
Detailed results of the phase 3 clinical trial for BT524 will be presented later this year, showcasing further advancements in the treatment of acquired fibrinogen deficiency.
The positive outcome of the AdFIrst study for Biotest's fibrinogen concentrate, BT524, represents a significant development within the field of hemostasis management, particularly for patients with acquired fibrinogen deficiency (AFD). The successful meeting of the primary endpoint—equivalence in effectiveness to standard care with an excellent safety profile—underscores the potential for BT524 to become a key player in the management of intraoperative blood loss. This is noteworthy given that AFD can lead to significant morbidity and mortality during major surgical procedures.
From a medical research perspective, the introduction of a targeted therapy like FC is a step forward in precision medicine. It allows for a more direct and controlled administration of the essential protein, potentially reducing the risk associated with the transfusion of larger volumes of blood products like cryoprecipitate or fresh frozen plasma. Furthermore, the ease of use without the need for thawing could translate into critical time savings in emergency situations.
Grifols' announcement of the successful trial results for BT524 is poised to have a notable financial impact on the company and the market for AFD treatments. The global market potential of USD 800 million for AFD therapies indicates a substantial opportunity for revenue growth, especially considering BT524's potential to be the first approved FC for AFD in the U.S. market. The strategic acquisition of Biotest has evidently enhanced Grifols' product pipeline and market presence, which could lead to improved revenue streams and margin expansion.
Investors should closely monitor the upcoming regulatory approval process set to begin in Q4 2024, as it will be a critical milestone for the commercialization of BT524. The market's response to this news will depend on the detailed trial results expected later in the year, which will provide further insights into the drug's efficacy and safety profile relative to existing treatments.
The estimated market potential for AFD treatments, combined with the lack of approved FC therapies for AFD in the U.S., suggests that BT524 could capture a significant share of this niche market upon approval. The focus on a precision medicine approach aligns with current industry trends towards personalized healthcare solutions. Additionally, the ability of FC to address the specific needs of patients with AFD without the drawbacks associated with traditional treatments could drive preference among healthcare providers, potentially disrupting the current standard of care.
It's also important to consider the broader context of Grifols' innovation strategy. The company's diversified portfolio, including both plasma-derived and non-plasma products, positions it well to navigate the competitive landscape. The success of BT524 could further solidify Grifols' reputation as a leader in the plasma-derived medicine industry and enhance its overall market valuation.
02/14/2024 - 03:16 AM
In the AdFIrst study, Biotest's fibrinogen concentrate (FC), BT524, met the primary endpoint, demonstrating its effectiveness in treating acquired fibrinogen deficiency (AFD) as equivalent to standard of care, while maintaining an excellent safety profile Regulatory approval process in Europe and United States set to begin in Q4 2024. It would be the first FC approved for an AFD indication in the U.S. in a global market for AFD with an estimated potential of USD 800 million This milestone is part of Grifols’ robust innovation strategy, balancing internal and external investments to build a comprehensive and diversified portfolio BARCELONA, Spain, Feb. 14, 2024 (GLOBE NEWSWIRE) -- Grifols (MCE: GRF, MCE: GRF.P NASDAQ: GRFS), one of the world’s leading producers of plasma-derived medicines, today announced that Biotest’s positive topline results from AdFIrst, its phase 3 clinical trial of its fibrinogen concentrate (FC), BT524, advance this potential treatment for acquired fibrinogen deficiency (AFD), an underserved growth market.
The FC from Biotest, a Grifols Group company, met the primary endpoint. It is as effective as standard of care in reducing intraoperative blood loss in patients with AFD, while also maintaining an excellent safety profile.
“This successful clinical trial is a significant stride towards a potential therapy that could contribute to the care of patients who experience severe blood loss during major surgery,” said Jörg Schüttrumpf , Grifols Chief Scientific Innovation Officer.
AFD, which typically occurs during surgical procedures when there’s insufficient fibrinogen to arrest bleeding, is commonly treated with cryoprecipitate (a plasma extract) or fresh frozen plasma, both containing fibrinogen.
The drawback is that they also contain other proteins and elements that aren’t necessary, so large volumes are needed to ensure enough fibrinogen. Plus both need to be thawed in advance, time consuming when lives are at risk. FC, which is also used to treat AFD, is a precision medicine in which patients on the operating table immediately receive only what’s essential to curtail hemorrhaging.
BT524 will likely enter regulatory authorization processes in Q4 2024 starting in Europe and the United States. It would be the first FC approved for an AFD indication in the U.S. in a global market with an estimated potential of USD 800 million.
Fibrinogen, a plasma protein produced in the liver, plays a key role in stopping blood loss and in wound healing. Grifols’ experience with it to manage surgical bleeding includes the fibrinogen-based fibrin sealant the company launched five years ago.
“The positive results for Biotest’s fibrinogen are an important milestone and strengthen a Grifols innovation strategy that’s diversified across plasma and non-plasma, balanced between internal and external investments, and includes both shorter- and longer-term development cycles,” said Victor Grifols Deu , Grifols Chief Operating Officer.
Detailed results of the trial will be presented later this year.
Biotest, a Grifols innovation driver
The acquisition of Biotest has significantly reinforced Grifols’ access to plasma, as well as the company’s pipeline and sales presence. Furthermore, it has provided new scientific and industrial capabilities, enabling improved revenue growth and margin expansion through the introduction of innovative plasma proteins.
The step forward in BT524’s development comes in the middle of two other Biotest innovations that also highlight this company’s increasing contributions to Grifols’ profitable growth.
In late 2022, Biotest’s new immunoglobulin (Ig) Yimmugo® entered the European market and is awaiting authorization to become available in the U.S. Another Biotest protein, trimodulin – a polyvalent immunoglobulin with IgM, IgA and IgG – is in two phase 3 clinical trials evaluating its efficacy and safety in patients with either community-acquired pneumonia (CAP) or severe community-acquired pneumonia (sCAP).
About Biotest’s AdFIrst trial
The trial for Biotest’s fibrinogen concentrate (FC), BT524, is known as AdFIrst (Adjusted Fibrinogen Replacement Strategy) was a prospective, active-controlled, multicenter phase 3 trial investigating the efficacy and safety of BT524 in patients with acquired fibrinogen deficiency. Patients who had high blood loss during planned spinal or abdominal surgery were randomized 1:1 to treatment with BT524 or cryoprecipitate/fresh frozen plasma (FFP). To evaluate the efficacy of BT524, further blood loss was compared between both treatment options. Further information about the trial design can be found at www.clinicaltrialsregister.eu (EudraCT number: 2017-001163-20).
The trial met its primary endpoint, demonstrating that Fibrinogen concentrate (BT524) is non-inferior to standard of care (SOC), in reducing intraoperative blood loss in patients with acquired fibrinogen deficiency undergoing planned major spinal or abdominal surgery. Mean blood loss measured in the two treatment groups were 1,444 mL in the BT524 group versus 1,735 mL in the SOC group, resulting in a reduction of blood loss of 291 mL in patients treated with fibrinogen concentrate.
About fibrinogen and fibrinogen deficiency
Fibrinogen is a blood clotting factor that is produced in the liver. It plays a key role in primary haemostasis (stopping blood loss from bleeding wounds) and wound healing. In case of a lack or shortage of fibrinogen the blood's ability to clot is impaired, which leads to a much greater risk of bleeding and delayed haemostasis.
The fibrinogen concentrate alternatives fresh frozen plasma (FFP) and cryoprecipitate contain variable amounts of fibrinogen and must be thawed prior to treatment. The defined amount of fibrinogen in the fibrinogen concentrate will allow a tailor-made, patient specific and highly effective therapy.
About Grifols
Grifols is a global healthcare company founded in Barcelona in 1909 committed to improving the health and well-being of people around the world. A leader in essential plasma-derived medicines and transfusion medicine, the company develops, produces and provides innovative healthcare services and solutions in more than 110 countries.
Patient needs and Grifols’ ever-growing knowledge of many chronic, rare and prevalent conditions, at times life-threatening, drive the company’s innovation in both plasma and other biopharmaceuticals to enhance quality of life. Grifols is focused on treating conditions across a broad range of therapeutic areas: immunology, hepatology and intensive care, pulmonology, hematology, neurology and infectious diseases.
A pioneer in the plasma industry, Grifols continues to grow its network of donation centers, the world’s largest with over 390 across North America, Europe, Africa and the Middle East and China.
As a recognized leader in transfusion medicine, Grifols offers a comprehensive portfolio of solutions designed to enhance safety from donation to transfusion, in addition to clinical diagnostic technologies. It provides high-quality biological supplies for life-science research, clinical trials, and for manufacturing pharmaceutical and diagnostic products. The company also supplies tools, information and services that enable hospitals, pharmacies and healthcare professionals to efficiently deliver expert medical care.
Grifols, with more than 24,000 employees in more than 30 countries and regions, is committed to a sustainable business model that sets the standard for continuous innovation, quality, safety and ethical leadership.
In 2022, Grifols’ economic impact in its core countries of operation was EUR 9.6 billion. The company also generated 193,000 jobs, including indirect and induced.
The company’s class A shares are listed on the Spanish Stock Exchange, where they are part of the Ibex-35 (MCE:GRF). Grifols non-voting class B shares are listed on the Mercado Continuo (MCE:GRF.P) and on the U.S. NASDAQ through ADRs (NASDAQ:GRFS).
For more information, please visit www.grifols.com .
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LEGAL DISCLAIMER
The facts and figures contained in this report that do not refer to historical data are “future projections and assumptions”. Words and expressions such as “believe”, “hope”, “anticipate”, “predict”, “expect”, “intend”, “should”, “will seek to achieve”, “it is estimated”, “future” and similar expressions, insofar as they relate to the Grifols group, are used to identify future projections and assumptions. These expressions reflect the assumptions, hypotheses, expectations and predictions of the management team at the time of writing this report, and these are subject to a number of factors that mean that the actual results may be materially different. The future results of the Grifols group could be affected by events relating to its own activities, such as a shortage of supplies of raw materials for the manufacture of its products, the appearance of competitor products on the market, or changes to the regulatory framework of the markets in which it operates, among others. At the date of compiling this report, the Grifols group has adopted the necessary measures to mitigate the potential impact of these events. Grifols, S.A. does not accept any obligation to publicly report, revise or update future projections or assumptions to adapt them to events or circumstances subsequent to the date of writing this report, except where expressly required by the applicable legislation. This document does not constitute an offer or invitation to buy or subscribe shares in accordance with the provisions of the following Spanish legislation: Royal Legislative Decree 4/2015, of 23 October, approving recast text of Securities Market Law; Royal Decree Law 5/2005, of 11 March and/or Royal Decree 1310/2005, of 4 November, and any regulations developing this legislation. In addition, this document does not constitute an offer of purchase, sale or exchange, or a request for an offer of purchase, sale or exchange of securities, or a request for any vote or approval in any other jurisdiction. The information included in this document has not been verified nor reviewed by the external auditors of the Grifols group.
What is the primary endpoint that Biotest's fibrinogen concentrate BT524 met in the AdFIrst study?
BT524 demonstrated its effectiveness in treating acquired fibrinogen deficiency.
When is the regulatory approval process expected to begin for BT524 in Europe and the United States?
The regulatory approval process for BT524 is set to start in Q4 2024.
What market potential is estimated for the fibrinogen concentrate BT524 in the U.S.?
The U.S. market for AFD with BT524 is estimated at USD 800 million.
How does Grifols describe its innovation strategy in the PR?
Grifols highlights a robust innovation strategy balancing internal and external investments to build a diversified portfolio.
What impact did the acquisition of Biotest have on Grifols according to the PR?
The acquisition strengthened Grifols' access to plasma, pipeline, and sales presence, enhancing revenue growth and margin expansion.
What are the other innovations from Biotest mentioned in the PR?
Yimmugo® and trimodulin are highlighted as additional innovations from Biotest contributing to Grifols' growth.
