Biotest and SteinCares partner to improve access to plasma-derived products in Latin America

PRESS RELEASE

Biotest and SteinCares partner to improve access to plasma-derived products in Latin America

• Financial and strategic reliability is key driver of partnership to start to penetrate Latin American markets with plasma-derived Factor VIII products
• Agreement will be the first step to its expand our commercial footprint in the area

Dreieich, Germany, October 29, 2024. Biotest announced today, that it has signed a new distribution agreement with SteinCares, a leading specialty healthcare company in Latin America, for the commercialization and distribution of Haemoctin^® in selected Latin American countries (Chile, Colombia, Costa Rica, Ecuador, Mexico and Peru).

The plasma-derived factor VIII product Haemoctin^®, indicated for the treatment and prophylaxis of bleeding in patients with hemophilia A, offers an accessible alternative compared to other available treatments. As a plasma-derived product, it ensures fast and reliable efficacy, high purity and a favorable safety profile and thus reduces the risk of long-term complications of hemophilia.

Hemophilia therapies are essential for the management of this disease, which affects approximately 56,000 people in Latin America. However, according to the World Federation of Hemophilia, only 57% of these patients are diagnosed and approximately 40% have access to prophylactic treatment. With the introduction of Haemoctin^®, Biotest reaffirms its commitment to improving patient access to high-quality, cost-effective specialty care treatments.

"We are pleased to partner with SteinCares, whose financial and strategic reliability is a key driver for us to begin penetrating the Latin American markets with our products, where economic and political challenges have historically presented opportunities for resilient and innovative growth,” indicates Enrico D’Aiuto, Senior Vice President Commercial Operations at Biotest AG. “With this first agreement we are making our Factor VIII product available to hemophilia patients in Latin America. SteinCares' deep-rooted presence and established operations throughout the region, gives us confidence that this agreement will be a success and will be the first step in expanding our commercial footprint in the LATAM region” highlights Carolin Shah, Vice President responsible for the Business Unit Distribution Partners at Biotest.

"The addition of the Factor VIII to our portfolio underscores our commitment to making a meaningful impact on the well-being of hemophilia patients in Latin America. By offering a high-quality treatment alternative, we not only improve the economics of healthcare systems through budget balancing and cost-effectiveness, but also expand access to safe and effective therapies for patients with rare diseases," said Sebastian Katz, Chief Strategy Officer at SteinCares.

About Haemoctin^®

Haemoctin^® is a von Willebrand factor containing coagulation factor VIII preparation obtained from blood plasma from qualified voluntary donors. It is manufactured from a pool of up to 20,000 plasma donations using state-of-the-art concentration and purification techniques. The injection solution consisting of powder and solvent has been successfully used for more than 25 years for the treatment and prophylaxis of bleeding in patients with congenital factor VIII deficiency (Haemophilia A) and is appreciated for its good tolerability and low immunogenicity. Haemoctin^® is storable for two years at room temperature and available in three different strengths. Dosage and duration of treatment with Haemoctin^® depend on the indication and the severity of the disease.

About Hemophilia

As a lifelong inherited bleeding disorder, hemophilia affects about 1 in 10,000 people worldwide. Hemophilia is one of a number of such disorders that prevent blood from clotting properly. People with hemophilia experience prolonged internal bleeding that can result from a seemingly minor injury. Bleeding into joints and muscles causes severe pain and disability while bleeding into major organs, such as the brain, can cause death. Treating the bleeding episodes involves the prompt and proper use of clotting factor concentrates. Hemophilia A is caused by a deficiency of clotting factor VIII. Therefore, intravenously administered therapeutic factor VIII is often recognized as a foreign protein (antigen) by the patient's immune system. As a consequence up to 30% of patients with severe hemophilia develop antibodies against the therapeutic factor VIII. These antibodies are called inhibitors because they reduce or eliminate the therapeutic effect of factor VIII. Most inhibitors develop during early childhood and compromise the ability to effectively prevent or manage hemorrhages, resulting in a greater rate of disability, morbidity, complications and costs of therapy. The formation of inhibitors is the most serious complication of today's hemophilia treatment. Avoiding the risk of inhibitor development would be the most effective prerequisite for a continuous therapy enabling hemophilia patients to live an almost normal life without irreversible joint damage. For more information on hemophilia and FVIII, please visit the World Federation of Hemophilia website at https://www.wfh.org/en/home.

About SteinCares

SteinCares is a leader in commercializing and distributing specialty healthcare products in Latin America, including innovative pharmaceuticals, biosimilars and complex generics. With over 40 years of progressive healthcare experience and operations in over 30 countries in Latin America and the Caribbean, SteinCares serves as a bridge between global pharmaceutical companies and the region’s healthcare providers. The company is deeply committed to creating healthcare opportunities that positively impact the lives of patients and their families in Latin America, with a vision of increasing access to innovative and cost-effective healthcare for patients in the region.

For more information, visit http://www.steincares.com/ or follow the company on LinkedIn.

About Biotest

Biotest (www.biotest.com) is a provider of biological therapeutics derived from human plasma. With a value-added chain that extends from preclinical and clinical development to worldwide sales, Biotest has specialized primarily in the areas of clinical immunology, hematology 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 hematopoietic 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, headquartered 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

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com

Ordinary shares: securities’ ID No. 522720; ISIN DE0005227201
Preference shares: securities’ ID No. 522723; ISIN DE0005227235
Listing: Frankfurt (Prime Standard)
Open Market: Berlin, Düsseldorf, Hamburg/ Hanover, Munich, Stuttgart, Tradegate

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.