It’s a very rewarding trading day for investors in Protalix Biotherapeutics Inc (NYSEAMERICAN:PLX) with shares up over 35%, making the stock Wall Street’s bull of the day. The reason? The Israeli drug maker said it has entered into Ex-US license and collaboration agreement with Chiesi Farmaceutici S.p.A., or Chiesi, for pegunigalsidase alfa, or PRX-102, the Company’s chemically modified version of the recombinant protein alpha-Galactosidase-A protein that is currently being evaluated in phase III clinical trials for the treatment of Fabry disease.
Under the terms of the agreement, Protalix has licensed PRX-102 to Chiesi for all markets outside of the United States, and Protalix will receive an upfront payment of $25 million from Chiesi and additional payments of up to $25 million in development costs, capped at $10 million per year. Protalix is also eligible to receive an additional up to $320 million, in the aggregate, in regulatory and commercial milestone payments, and tiered royalties ranging from 15% to 35% on net sales. Protalix will continue to be the manufacturer of PRX-102 for clinical development purposes and commercial purposes after marketing approvals.
Protalix’s CEO Moshe Manor commented, “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 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.”
Chiesi’s CEO Ugo Di Francesco stated, “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.”
On the ratings front, H.C. Wainwright analyst Ram Selvaraju reiterated a Buy rating on PLX, with a price target of $5, in a report issued on August 10. The current price target implies an upside of 669% from current levels. According to TipRanks.com, Selvaraju has a yearly average loss of 7.4%, a 38% success rate, and is ranked #4630 out of 4692 analysts.
Protalix engages in the development and commercialization of recombinant therapeutic proteins based on ProCellEx plant cell based expression system. It offers Taliglucerase alfa injections under the brand name Elelyso, an enzyme replacement therapy for Gaucher disease. Its drug candidates also include Oral Glucocerebrosidase for potential treatment of Gaucher disease; therapeutic proteins for Fabry disease, and immune diseases such as rheumatoid, psoriatic and juvenile idiopathic arthritis, ankylosing, spondylitis, and plaque psoriasis; and protein for biodefense and other indications.