TG Therapeutics is a fully integrated commercial stage biotechnology company focused on the acquisition development and commercialization of novel treatments for B cell diseases. The company’s lead product BRIUMVI is an anti CD20 monoclonal antibody approved by the FDA in December 2022 for the treatment of adults with relapsing forms of multiple sclerosis including clinically isolated syndrome relapsing remitting disease and active secondary progressive disease. TG…
TG Therapeutics is a fully integrated commercial stage biotechnology company focused on the acquisition development and commercialization of novel treatments for B cell diseases. The company’s lead product BRIUMVI is an anti CD20 monoclonal antibody approved by the FDA in December 2022 for the treatment of adults with relapsing forms of multiple sclerosis including clinically isolated syndrome relapsing remitting disease and active secondary progressive disease. TG Therapeutics advances a pipeline that includes subcutaneous ublituximab being evaluated in a Phase 3 study to compare its exposure to intravenous BRIUMVI and an allogeneic CAR T therapy azer cel targeting CD19 for autoimmune indications such as progressive multiple sclerosis. The subcutaneous ublituximab program aims to offer a less frequent dosing option with regimens of either eight weeks or twelve weeks while the azer cel program leverages donor derived T cells edited with ARCUS technology to avoid graft versus host disease. These efforts are supported by a global network of academic centers and biotech partners from which the company in licenses drug candidates that have shown proof of concept in B cell mediated diseases.
TG Therapeutics generates revenue principally from the sale of BRIUMVI in the United States and from its commercialization agreement with Neuraxpharm for markets outside the United States. Under the agreement TG Therapeutics received an upfront payment of $140 million and a $12.5 million payment upon launch in the first European Union country. The company is eligible to receive up to an additional $492.5 million in milestone payments tied to launch and commercial milestones and will receive tiered double digit royalties on net product sales up to a rate of 30%. TG Therapeutics also earns royalties on BRIUMVI sales under its license with LFB Group at a high single digit rate. Additionally the company may receive milestone payments from its collaboration with Precision for the development of azer cel and could realize future revenue from the commercialization of its pipeline candidates after regulatory approval.
In the multiple sclerosis therapy market TG Therapeutics competes with established anti CD20 antibodies such as ocrelizumab from Roche and ofatumumab from Novartis. Oral therapies including cladribine and dimethyl fumarate as well as emerging Bruton’s tyrosine kinase inhibitors also represent competitive alternatives. TG Therapeutics differentiates BRIUMVI by offering a dosing regimen of a one hour infusion every 24 weeks which provides a less frequent treatment schedule than many competitors. Clinical data from the ULTIMATE I and II trials show that BRIUMVI reduces the annualized relapse rate by approximately 60% compared to teriflunomide and maintains a consistent safety profile over six years of continuous use. The company benefits from patent protection that extends the composition of matter coverage for ublituximab to 2042 and from a twelve year exclusivity period under the Biologics Price Competition and Innovation Act that runs until December 2034. Manufacturing partnerships with Samsung Biologics and FUJIFILM Diosynth Biotechnologies support commercial supply while the company’s focus on B cell diseases allows it to leverage scientific expertise across its pipeline.
TG Therapeutics serves patients living with relapsing forms of multiple sclerosis which includes an estimated one million individuals in the United States and over 2.3 million worldwide. The company’s customers are neurologists multiple sclerosis treatment centers infusion clinics and specialty pharmacy distributors that dispense BRIUMVI to eligible patients. These healthcare providers rely on the product’s convenient dosing schedule and strong efficacy data to manage disease activity and improve patient outcomes. TG Therapeutics also works with advocacy groups and patient organizations to raise awareness and support education about multiple sclerosis and the availability of its therapies.
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Sector: Healthcare Industry: Biotechnology CIK: 0001001316