LONDON – MeiraGTx Holdings plc (NASDAQ:MGTX), a gene therapy company, has announced the initiation of an extension study for its Phase 3 LUMEOS clinical trial, which has triggered a $50 million milestone payment from Janssen Pharmaceuticals, Inc., part of Johnson & Johnson (NYSE:JNJ). This payment is part of an asset purchase agreement between the two companies regarding botaretigene sparoparvovec, also known as bota-vec, a treatment for X-linked retinitis pigmentosa (XLRP).
The initiation of the LUMEOS extension study marks a significant milestone for MeiraGTx, as stated by Dr. Alexandria Forbes, the president and CEO of MeiraGTx. Under the terms of the agreement with J&J, MeiraGTx is also set to receive an additional $15 million in near-term milestone payments later in 2024. Moreover, the company could receive up to $285 million upon the first commercial sales of bota-vec in the U.S. and EU, as well as for transferring manufacturing technology.
In addition to the milestone payments, MeiraGTx has entered into a commercial supply agreement with J&J for the manufacturing of bota-vec. The company expects this will generate further revenue during the product's launch phase.
MeiraGTx's expertise extends to a range of late-stage clinical programs, supported by comprehensive manufacturing capabilities. The company has developed its own manufacturing process and facilities, which are equipped to handle all stages from plasmid production to viral vector production and quality control, suitable for both investigational new drug applications and commercial supply.
The company's innovative technologies include a Riboswitch gene regulation platform, which enables precise control of gene expression through oral small molecules. MeiraGTx is applying this technology to a variety of treatments, initially focusing on conditions affecting the eye, central nervous system, and salivary gland, with potential applications for more prevalent diseases.
The information provided in this article is based on a press release statement from MeiraGTx.
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