Jazz Pharmaceuticals | September 09, 2020
Jazz Pharmaceuticals plc today announced that the company has signed a new research collaboration agreement with Redx Pharma plc (AIM: REDX) to discover and develop drug candidates for two cancer targets in the Ras/Raf/MAP kinase (MAPK) pathway. This research collaboration follows the previously announced sale of Redx's pre-clinical pan-RAF inhibitor program to Jazz for the potential treatment of Raf and Ras mutant tumors in July 2019. Under the terms of the research collaboration agreement, Jazz will make an upfront payment to Redx of $10 million followed by another $10 million in year two, provided research work is continuing. Following delivery of an IND-ready molecule, Redx will be eligible to receive up to a further $200 million from Jazz in development, regulatory and commercial milestone payments for each program
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BUSINESS INSIGHTS
ARS Pharmaceuticals, Inc. | February 10, 2022
ARS Pharmaceuticals, Inc., a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis, today announced the expansion of its executive leadership team with the appointments of Harris Kaplan as executive vice president, commercial strategy and Daniel Relovsky as senior vice president, sales and marketing. Mr. Kaplan and Mr. Relovsky, accomplished industry veterans with proven track records of commercial strategy and launch execution, will be responsible for preparing for and leading the commercialization of neffy™, once approved. neffy, a proprietary composition of epinephrine, is a small, reliable, easy-to-use option that allows for needle-free intranasal delivery of epinephrine, the only drug approved for the emergency treatment of Type I allergic reactions, including anaphylaxis.
"The appointments of both Harris and Dan to the ARS team represent another building block in our ongoing commercialization preparations for neffy. We believe neffy's 'no needle, no pain' delivery, small size for convenient portability, and ease of use can provide a patient-friendly solution for individuals and caregivers to more easily and reliably administer epinephrine sooner, achieving more rapid symptom relief and preventing the allergic reaction from becoming severe or life-threatening. I'm excited to welcome Harris and Dan, both of whom bring decades of product launch and commercial leadership experience to our leadership team, and look forward to benefiting from their expertise as we progress toward our mission of being an innovative pharmaceutical leader in the treatment of severe allergy."
Richard Lowenthal, founder, chief executive officer and president of ARS
Harris Kaplan, MBA, executive vice president, commercial strategy, will join the ARS commercial team as lead for commercial strategy and oversee launch preparations for neffy. He brings more than 40 years of global experience across the pharmaceutical, biotechnology and healthcare consulting industries and most recently served as managing partner of Red Team Associates. Throughout his career, Mr. Kaplan has worked on the development, launch and commercialization of over 125 new products across more than 40 therapeutic categories, including LIPITOR®, Nexium, VIAGRA®, HUMIRA®, ALLEGRA®, HERCEPTIN® and Trikafta, and Yescarta. He has extensive experience in establishing and building new product planning initiatives, leadership and development programs and managing global strategic operations.
Mr. Kaplan earned an MBA in marketing and operations research from Temple University where he also taught in the MBA program for several years.
Daniel Relovsky, senior vice president, sales & marketing, will be responsible for leading the U.S. sales and marketing organization for neffy. He brings more than 30 years of commercial and operational experience, including product launch leadership in highly competitive markets and in establishing new standard-of-care therapies. Mr. Relovsky specializes in commercial planning and efficient team building to address complex executions, and brings a diverse background and success record in specialty, orphan, and major therapeutic markets. Prior to joining ARS, Mr. Relovsky held various senior commercial and operational leadership positions at MAIA Biotechnology, Inc., Clarity Global Solutions, LLC., Puma Biotechnology, Inc., Somaxon Pharmaceuticals, Inc., Cephalon, Inc. (now Teva Pharmaceuticals, Inc.), Salmedix, Inc., Maxim Pharmaceuticals, Inc., Agouron Pharmaceuticals, Inc. (now Pfizer, Inc.), Women First Healthcare, Inc., and IQVIA.
Mr. Relovsky earned his B.S. in business administration, finance from Drexel University.
About ARS Pharmaceuticals, Inc.
ARS Pharmaceuticals is dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis. The company is developing neffy™, an intranasal epinephrine spray with a unique absorption technology that could be easy-to-use, convenient, and more reliable for patients and loved ones at-risk of severe allergic reactions to food, medications and insect bites that could lead to life-threatening anaphylaxis.
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PHARMA TECH
Wavegate Corporation | January 14, 2022
Wavegate Corporation announced that the U.S. Food and Drug Administration has granted Breakthrough Device designation for its StimuLux™ optical reflectometry system for closed-loop adaptive modulation of spinal cord stimulation. The FDA's Breakthrough Device designation is designed to expedite the development and regulatory review of medical devices that are intended to treat serious or life-threatening diseases. To qualify for this designation, preliminary evidence must demonstrate a reasonable expectation that the device will provide improved effectiveness compared to the standard of care.
"We are pleased the FDA has granted Breakthrough Device designation for our novel StimuLux™ technology. This underscores the urgent need within our society for more effective treatments of chronic, debilitating pain. We are eager to closely collaborate with the FDA as Wavegate works toward advancing the state of the art."
Erich Wolf, MD, PhD, Chief Executive Officer
"This designation underscores the urgent need within our society for more effective treatments of chronic, debilitating pain."
StimuLux™ is a component of Wavegate Corporation's Ellipse neuromodulation platform which integrates multiple patented technologies which aim to systematically address unmet clinical needs within the neuromodulation industry.
About Wavegate Corporation
Wavegate Corporation is a privately-held start-up neuromodulation company focused on developing and commercializing a suite of technological innovations including: waveform-independent closed-loop adaptive stimulation, a stimulation paradigm for modulation of both ascending and descending spinal cord pain pathways, new implant geometry for reduced surface contact pressures, rapid lead anchoring, and others.
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