French firm LFB is targeting the lucrative US market with its hemophilia products and recently received two FDA approvals. Although launching new products in the midst of a global pandemic is not without challenges, LFB USA CEO Jose Antonio Moreno Toscano is optimistic that the launches will be a success and increase the options available to patients in the US with hemophilia.
The first signals from the market have been very positive, and we are extremely excited to bring this product to patients.
LFB USA, operating under the larger French biopharmaceutical firm of the same name, is in the process of ramping up the market launch of its newest product. The launch period kicked off with the April 2020 FDA approval of Sevenfact®, LFB’s new recombinant coagulation Factor VIIa, for the treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age and older with Hemophilia A or B with inhibitors. LFB’s aim is to fully launch by late 2020 or early 2021. In addition, LFB has received a new FDA approval for ATryn®, a recombinant antithrombin product that was previously withdrawn from the market after some manufacturing setbacks, and the firm plans to relaunch the product in upcoming months.
LFB specialises in biological medicinal products for serious, and often rare, diseases and operates in the fields of hemostasis, immunology and perinatal and intensive care. LFB’s US affiliate harnesses its proprietary rPRO Technology™ platform for protein production using recombinant DNA technology. This robust expression platform, according to CEO Jose Antonio Moreno Toscano, allows a “more natural, scalable and cost-effective process of protein production” and “avoids the limitations of conventional cell culture production methods.”
Being able to meet a largely unmet patient need in the rare disease area of hemophilia is propelling the team forward in the launch, as Toscano explained: “As you can imagine, we are currently in full launch preparations and it is an intense period. The first signals from the market have been very positive, and we are extremely excited to bring this product to patients. There is only one other product on the market so far for the treatment of bleeding episodes in patients with Hemophilia A or B with inhibitors, so we are happy to be able to offer to patients an alternative. In my eyes, this is the fulfilment of our vision and mission for patients as a pharma company.”
Launching a product in the midst of the global COVID-19 pandemic is not without its share of obstacles as medical congresses are moved online and face-to-face doctor visits are reduced for commercial teams and patients alike. Despite the hurdles to overcome, Toscano remained positive: “I do not think we will have a lot of trouble from the pandemic because the initial market response has been positive. Through HEMA Biologics, we have been interacting with key opinion leaders and patient associations for quite some time now in anticipation of Sevenfact®’s approval. We are in a good position in terms of the market launch. The objective now is about reinforcing those existing relationships.”
Toscano reinforced the company’s commitment to bringing their product to market despite potential impacts to the supply chain, “The Sevenfact®’s manufacturing stages are divided between the US and Europe. Some of these have been affected by COVID-19 so we want to ensure that we manage our supply chain in a careful and comprehensive manner. We are committed to bringing Sevenfact® to the US as soon as possible.”