Shares of Perrigo Company plc Ordinary Shares (NYSE:PRGO) ended Monday session in green amid volatile trading. The shares closed up +1.45 points or 1.57% at $93.78 with 2.08 million shares getting traded. Post opening the session at $92.34, the shares hit an intraday low of $91.26 and an intraday high of $93.89 and the price vacillated in this range throughout the day. The company has a market cap of $13.23 billion and the numbers of outstanding shares have been calculated to be 143.28 million shares.
Perrigo Company plc Ordinary Shares (PRGO) announced an exclusive licensing agreement with Highland Pharmaceuticals, LLC for its Tarex® methamphetamine (“meth”) blocking technology and the distribution rights of Zephrex-D® (pseudoephedrine HCI 30 mg). Zephrex-D® was developed using the Tarex® technology and has been proven to be more than 98% effective at blocking one of the more common domestic methods of illegal meth production.
This agreement is part of Perrigo’s ongoing efforts in the fight against meth drug abuse. Perrigo plans to integrate the Tarex® technology into certain of its store brand and retailer own label pseudoephedrine HCI products in the future and will immediately begin distribution of Zephrex D® to its retail customers.
Perrigo’s Executive Vice President & President, Consumer Healthcare – Americas, Jeff Needham commented that, “Across the country, illegal methamphetamine use continues to be a significant issue. Our investment in Tarex® technology is another example of Perrigo’s commitment to help protect and promote healthier communities. We are committed to leveraging the Tarex® technology to extend our line of meth-resistant pseudoephedrine products in the future.”
Shares of Fate Therapeutics Inc (NASDAQ:FATE) ended Monday session in red amid volatile trading. The shares closed down -0.08 points or -2.56% at $3.04 with 84,189.00 shares getting traded. Post opening the session at $3.10, the shares hit an intraday low of $2.89 and an intraday high of $3.12 and the price vacillated in this range throughout the day. The company has a market cap of $90.75 million and the numbers of outstanding shares have been calculated to be 34.15 million shares.
Fate Therapeutics Inc (FATE) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for ProTmune™, the Company’s lead product candidate that is currently undergoing Phase 1/2 clinical investigation. The FDA designation is for “prevention of graft-versus-host disease in patients undergoing allogeneic hematopoietic cell transplantation” and broadly covers diseases, including blood cancers and genetic disorders, for which the procedure is performed.
“The granting of both orphan drug and Fast Track designations for ProTmune validates the product candidate’s unique therapeutic potential to address life-threatening complications and improve the curative potential of allogeneic HCT,” said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. “Graft-versus-host disease is a significant cause of morbidity and mortality in patients undergoing allogeneic HCT and there are no FDA-approved therapies to prevent its occurrence. Through our development of ProTmune, we seek to transform the allogeneic HCT paradigm by providing immunocompromised patients a therapeutically-optimized donor graft containing immune cells with reduced alloreactivity and enhanced infection-fighting and anti-tumor properties.”
Graft-versus-host disease (GvHD) is a severe immunological complication that arises when newly-transplanted donor immune cells attack the patient’s tissues and organs, resulting in a potentially fatal immune system reaction. Despite the use of protocols to prevent its occurrence, up to 50 percent of patients experience GvHD. Additionally, GvHD is treated systemically with immunosuppressive agents, with only about half of patients responding to treatment. The systemic use of these agents increases a patient’s risk of severe infection from bacteria, viruses and fungi as well as cancer relapse, further compromising the curative potential of allogeneic HCT.
The FDA provides orphan designation to drugs and biologics which are intended for the safe and effective treatment, diagnosis or prevention of rare diseases and disorders that affect fewer than 200,000 people in the United States. Orphan drug designation would provide seven years of market exclusivity in the United States, with certain exceptions, if market approval is granted for ProTmune. Orphan designation also qualifies a company for various development incentives, including tax credits for qualified clinical testing and a waiver of PDUFA filing fees.