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Biotest successfully meets primary endpoint in phase III trial with Fibrinogen concentrate

• Positive results confirm excellent safety profile
• Top-line data demonstrate that Fibrinogen concentrate treatment is as effective as standard of care, either cryoprecipitate or fresh frozen plasma, in reducing intraoperative blood loss
• AdFIrst trial will be the basis for approval of Biotest’s Fibrinogen concentrate in patients with acquired fibrinogen deficiency in Europe and the United States
• Biotest’s fibrinogen concentrate aims to fulfil a high unmet medical need for additional fibrinogen concentrates to treat acquired fibrinogen deficiency, with a global market potential of USD 800 million

Dreieich, 14 February 2024. Biotest announced today that the AdFIrst (Adjusted FIbrinogen replacement strategy) phase III trial met its primary endpoint, demonstrating that Fibrinogen concentrate is non-inferior to standard of care 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 Fibrinogen concentrate group versus 1,735 mL in the standard of care group, resulting in a reduction of blood loss of 291 mL in patients treated with fibrinogen concentrate.

The AdFIrst trial was a prospective, randomised, active-controlled, multicentre phase III trial involving 222 patients undergoing elective spine or abdominal surgery. The main purpose of this phase III trial was to demonstrate that Fibrinogen concentrate improves clotting function and reduces blood loss in the management of severe haemorrhage as effectively as standard of care. The efficacy and safety of Fibrinogen concentrate was compared with the centres' standard of care, either fresh frozen plasma or cryoprecipitate.

"We are very pleased to have successfully completed this clinical trial. Our focus is now on preparing the marketing authorization applications," said Dr Silke Aigner, Senior Director Clinical Strategy & Development at Biotest AG. "There is a high medical need for additional fibrinogen concentrates to ensure availability of fibrinogen for more patients in this severe medical situation.”

The results of Biotest’s two clinical trials, the AdFIrst trial and the completed phase I/III trial in patients with congenital fibrinogen deficiency, will serve as the basis for approval of Fibrinogen concentrate for the treatment of patients with congenital and acquired fibrinogen deficiency. Initial applications for marketing authorisations are planned in Europe and US.

This would be the first fibrinogen concentrate approved for an acquired fibrinogen deficiency indication in the US. In much of the world today, standard of care to control severe surgical bleeding is fibrinogen replacement through cryoprecipitate or fresh frozen plasma, treatments that contain not only fibrinogen but also other proteins and elements that a patient might not need. Worldwide, there are only two other fibrinogen concentrates authorised in multiple countries for acquired fibrinogen deficiency, but they are not approved in the US.

As part of the Grifols Group, Biotest intends to play a leading role in making this therapy available in a broader patient population.

Compared with congenital fibrinogen deficiency, where efficacy has been demonstrated in an earlier trial, the market size for the treatment of acquired fibrinogen deficiency is many times larger. There is a worldwide market potential of USD 800 million. The market in the US, in particular, has great development potential, as therapy with fibrinogen concentrate is not established there.

Detailed results of the trial will be presented later this year.

About Biotest’s Fibrinogen concentrate

The newly developed manufacturing process of the fibrinogen concentrate leads to high-purity fibrinogen with a defined concentration, high level of viral safety and good solubility.

About AdFIrst trial no. 995

The AdFIrst trial was a prospective, active-controlled, multicentre phase III trial investigating the efficacy and safety of the Fibrinogen concentrate (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 Fibrinogen concentrate (BT524) or fresh frozen plasma (FFP)/Cryoprecipitate. To evaluate the efficacy of BT524, blood loss was compared between the both treatment options. Further information about the trial design can be found at www.clinicaltrialsregister.eu (EudraCT number: 2017-001163-20).

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 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 Biotest

Biotest is a provider of biological therapeutics derived from human plasma. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of clinical immunology, haematology and intensive care medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. Biotest has more than 2,400 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German stock exchange. Since May 2022, Biotest has been a part of the Grifols Group, based in Barcelona, Spain (www.grifols.com).

IR contact

Dr Monika Baumann (Buttkereit)

Phone: +49-6103-801-4406

Mail: ir@biotest.com

PR contact

Dirk Neumüller

Phone: +49-6103-801-269

Mail: pr@biotest.com

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Disclaimer
This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and assets position of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developments from expected developments. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.