Roche’s HEMLIBRA_ A Game Changer in Hemophilia A Treatment Landscape

1. How Roche’s HEMLIBRA will help in the Hemophilia Treatment Landscape? Hemophilia A Treatment Landscape Despite historical ups and downs, hemophilia A patient treatment has significantly improved over the past 40 years. The modern advancement of hemophilia therapies began with the revolutionary discovery of cryoprecipitate in 1964. Several years later, scientists discovered that plasma-derived factors are focused on FVIII products. This category saw the approval of a number of hemophilia A drugs that were easier to administer than cryoprecipitate or fresh-frozen plasma, such as FEIBA (Pfizer), MONOCLATEP (CSL Behring), and HEMOFIL-M. The development of recombinant therapy in the 1980s changed the situation for those who have hemophilia A. There were only short half-life (SHL) recombinant medicines available prior to the approval of the first extended half-life (EHL) in the US (ELOCTATE; 2014). Other treatments avoid using the inhibitor-specific drugs utilized in hemophilia A. One of the most profitable bypass agents is Novonordisk's NOVOSEVEN, which holds the majority of the hemophilia A market share in comparison to Takeda's FEIBA and OBIZUR (not yet approved in Japan). Due to the adoption and use of EHL treatments, which reduced the frequency of injection to a deplorable

2. level, the market for plasma-derived FVIII has already fallen and sales of SHL products have started to decline. HEMLIBRA: Target patient population and strong uptake The hemophilia A market products have remained quite fragmented because no one therapy has been able to capture a sizable portion of the market; however, the release of HEMLIBRA in 2017 changed this situation. With or without factor VIII inhibitors, HEMLIBRA, a bispecific factor IXa and factor X-directed antibody, is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency), who are aged newborn and older. For hemophilia A patients taking inhibitors, HEMLIBRA was first approved in the US (November 2017), then in Europe (February 2018), and finally in Japan (March 2018). Patients Switching to HEMLIBRA For the non-inhibitor market, HEMLIBRA was introduced in 2018, and the hemophilia The significant uptake of HEMLIBRA over the past few years, where it crossed a billion in opportunity in 2019, makes it clear that a patient share has started to shift from EHL medicines to HEMLIBRA. HEMLIBRA had 17,000 patients receiving treatment worldwide as of the first quarter of 2022, according to the Global Pharma Survey 2022. Factors contributing to Patient Switching to HEMLIBRA Patients move to HEMLIBRA primarily on the advice of their doctors; at the moment, 50–60% of doctors view HEMLIBRA as the first-line hemophilia A treatment. Low administration frequency (as little as once per month) and longer reaction times are the key drivers of patient switching and doctor referrals. Upcoming competition for HEMLIBRA Fitusiran, a small interfering RNA treatment from Sanofi that is approved and delivered subcutaneously, is anticipated to hit the US market in 2025. A siRNA called fitusiran is made to reduce antithrombin levels in order to encourage enough thrombin production to stop bleeding. One of the main benefits of this therapy is that it can be administered once or twice a month to patients with hemophilia A or B. Despite this, we are still dubious about the drug's future due to safety concerns. Additional hemophilia A therapies are expected to reach the 7MM in the following years and address the unmet needs of hemophilia A patients, including Valrox (Biomarin Pharmaceutical), BIVV001 (Sanofi), SPK-8011 (Roche/Spark Therapeutics), and giroctocogene fitelparvovec (Pfizer/Sangamo Therapeutics).

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