Protalix BioTherapeutics, Inc. (NYSEMKT: PLX) is having an overwhelmingly strong start to the trading session in the pre-market this morning, and for good reason. The company announced that it has entered into a license and collaboration agreement, leading to excitement among investors and sending the stock toward the top. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. At the moment (9:20), PLX is trading at $0.899 per share after a gain of $0.25 per share or 37.46% thus far today.
PLX Gains On License And Collaboration Agreement
As mentioned above, Protalix BioTherapeutics is having an incredibly strong start to the day in the pre-market hours after the company announced that it has entered into ta license and collaboration agreement. The agreement was signed with Chiesi Farmaceutici S.p.A., also known as Chiesi. The agreement surrounds PRX-102 (pegunigalsidase alfa), a chemically modified version of the recombinant protein alpha-Galactosidase-A. The treatment is currently being evaluated in Phase III clinical trials as a treatment of Fabry disease. So far, PRX-102 has demonstrated a significantly enhanced circulatory half-life and higher enzyme activity in the target organs that are generally affected by Fabry disease when compared to currently available versions of the molecule. PLX has also released data showing that the treatment is safe and effective through a completed Phase I/II clinical trial.
According to the agreement, PLX has licensed PRX-102 to Chiesi for all markets outside of the United States. In exchange, the company will receive an upfront payment of $25 million from Chiesi as well as additional payments of up to $25 million in development costs, which will be capped at $10 million per year. Protalix also has the opportunity to earn an additional $320 million under the agreement based on regulatory and commercial milestones. Finally, under the terms of the agreement, PLX will receive royalties on net sales ranging from 15% to 35%. In a statement, Moshe Manor, President and CEO at PLX, had the following to offer:
“We are pleased to partner with Chiesi, an international privately-held company with more than 80 years of experience and a strong focus on the development and commercialization of innovative medicines with commercial presence in virtually all markets outside of the United States… The $50 million commitment made by Chiesi before any of our ongoing phase III clinical trial results read-out is not only a significant non-dilutive cash infusion for us, it also represents Chiesi’s commitment to the Fabry market in general and our PRX-102 program in particular. With this transaction, we have secured significant and important funding while maintaining full rights to PRX-102 in the U.S. market.”
The above statement was followed up by Ugo Di Francesco, CEO at Chiesi. Here’s what he had to say about the agreement with PLX:
“With revenues of approximately $1.8 billion, the Chiesi Group is among the top 50 pharmaceutical companies in the world. By combining the respective strengths of Chiesi and Protalix to advance PRX-102, we look forward to bringing a novel, differentiated therapeutic option to patients suffering from Fabry disease who have a true need for an alternative treatment with an improved safety and efficacy profile… PRX-102 complements our existing product portfolio in rare diseases and underscores our commitment to bringing novel therapeutics to patients across the globe.”
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on PLX. In particular, we’re interested in following the story surrounding PRX-102 as the treatment has proven to be safe and effective in the Phase I/II trials. We’re excited to learn the results of the Phase III clinical trials and watch as this much needed treatment is brought to the market. Nonetheless, we’ll continue to follow the story and bring the news to you as it breaks!
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