BUSINESS INSIGHTS

Ligand and GSK Expand Global Collaboration and License Agreement

Ligand Pharmaceuticals | December 22, 2021

Ligand Pharmaceuticals Incorporated announced today the expansion of an existing collaboration and license agreement between its subsidiary, Icagen, and GlaxoSmithKline. The expansion will leverage Icagen’s ion-channel-based discovery technology and unique expertise in small molecule therapeutics targeting transmembrane proteins. This new agreement builds upon the initial December 2020 agreement to identify and develop inhibitors of a specific genetically-validated molecular target relevant to neurological diseases.

We are very pleased to expand our collaboration with GSK to include a second neurological target. Over the past year this has been a productive relationship combining our technologies and expertise with GSK’s history of successfully working with others to access innovation and deliver next-generation transformational medicines.

 Matt Foehr, President and COO of Ligand

“We look forward to strengthening our collaboration to identify genetically-validated targets for neurological diseases utilizing Icagen’s technology,” said John Lepore, Senior Vice President, Head of Research, GSK. “Our expanded collaboration provides a framework to advance drug discovery by maximizing the strengths of our two scientific organizations to develop novel drug candidates efficiently and effectively.”

In addition to all payments available under the original 2020 collaboration and license agreement, under the terms of the expanded collaboration and license agreement, Ligand will receive an upfront payment of $10 million and is eligible for development and regulatory milestones up to $67.5 million. Furthermore, should the potential new medicine receive regulatory approval in major markets, the deal provides for commercial milestone payments to Ligand of up to $60 million at first commercial sale, and up to $120 million in sales-related milestone payments. Ligand will receive tiered royalties on net sales of any drug that is commercialized by GSK.

Ligand will be responsible for most preclinical activities up to lead optimization, with Ligand and GSK collaborating to identify candidates for entry into IND-enabling studies. GSK has the exclusive option to license any identified molecules and will be responsible for the further development and commercialization of any drug candidates identified through the collaboration.

About Icagen Ion Channel Technology
The Icagen technology is focused primarily on ion channel and transporter novel drug discovery. Ion channels and transporters are key components in a wide variety of biological processes that involve rapid changes in cells and have broad therapeutic applicability including oncology, metabolic disease, pain, neurological diseases, infectious diseases and others. The Icagen technology leverages proprietary expertise in the combination of biological assays, medicinal chemistry, and in silico and computational chemistry applications to enable the discovery of ion channel targeting therapeutics. Partners in the pharmaceutical industry leverage Icagen’s platform to develop first-in-class therapies for patients in need, typically under collaborative arrangements through the time of clinical candidate selection, with partners responsible for subsequent clinical development and commercialization.

About Ligand Pharmaceuticals
Ligand is a biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. Our business model creates value for stockholders by providing a diversified portfolio of biotech and pharmaceutical product revenue streams that are supported by an efficient and low corporate cost structure. Our goal is to offer investors an opportunity to participate in the promise of the biotech industry in a profitable, diversified and lower-risk business than a typical biotech company. Our business model is based on doing what we do best: drug discovery, early-stage drug development, product reformulation and partnering. We partner with other pharmaceutical companies to leverage what they do best (late-stage development, regulatory management and commercialization) ultimately to generate our revenue. Ligand’s OmniAb® technology platform is a patent-protected transgenic animal platform used in the discovery of fully human monoclonal and bispecific therapeutic antibodies. The Captisol platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Ligand’s Pelican Expression Technology is a robust, validated, cost-effective and scalable platform for recombinant protein production that is especially well-suited for complex, large-scale protein production where traditional systems are not. Ab Initio™ technology and services for the design and preparation of customized antigens enable the successful discovery of therapeutic antibodies against difficult-to-access cellular targets. Ligand has established multiple alliances, licenses and other business relationships with the world’s leading pharmaceutical companies including Amgen, Merck, Pfizer, Sanofi, Janssen, Takeda, Servier, Gilead Sciences and Baxter International. 

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BUSINESS INSIGHTS

ARS Pharmaceuticals Expands Executive Leadership Team with Addition of Pharmaceutical Commercialization Veterans

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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PHARMACY MARKET

Edenbridge Pharmaceuticals Announces the Launch of DARTISLA ODT

Edenbridge Pharmaceuticals | March 01, 2022

Edenbridge Pharmaceuticals, LLC announced that DARTISLA ODT is now available by prescription in the United States through Phil, the commercialization partner and eHub for DARTISLA ODT, as well as in retail pharmacies throughout the country. To ensure access to patients in need, Edenbridge is sponsoring the DARTISLA ODT Copay Program, which allows eligible patients to obtain the product for as little as $0 when filled through Phil or $20 when filled at other pharmacies. “DARTISLA ODT is the first and only FDA-approved orally disintegrating tablet of glycopyrrolate, and we are excited to introduce this novel formulation of glycopyrrolate to patients and healthcare providers,” noted Daniel G. Worley Jr., Edenbridge’s Vice President of Business Development and General Counsel. “Further, Edenbridge is committed to ensuring patient access to this product, and we are pleased to be sponsoring the DARTISLA ODT Copay Program to facilitate getting DARTISLA ODT into the hands of people that need it most.” “Phil is proud to support Edenbridge’s commitment to providing broad access to this innovative therapy by simplifying the patient onboarding process allowing affordable, fast, broad-based distribution of Dartisla ODT,” Deepak Thomas, Founder and CEO of Phil The U.S. Food and Drug Administration (FDA) approved Dartisla ODT for adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer on December 16, 2021. DARTISLA ODT is manufactured by Catalent using their proprietary Zydis® orally disintegrating tablet delivery technology to create a freeze-dried tablet that disperses almost instantly in the mouth without water. Patients receiving the 2 mg dosage strength of another oral tablet dosage form of glycopyrrolate may be switched to the 1.7 mg dosage strength of DARTISLA ODT. DARTISLA ODT is not recommended for patients initiating treatment or receiving maintenance treatment with a lower dosage strength of another oral glycopyrrolate product (e.g., tablet strength of 1 mg). Patients who are at risk for anticholinergic toxicity due to various underlying medical conditions or who have hypersensitivity to glycopyrrolate or the inactive ingredients should not take DARTISLA ODT. Adverse reactions include blurred vision, drowsiness, decreased sweating, flushing, vomiting, constipation, dry mouth, tachycardia, and urinary retention. About Edenbridge Edenbridge is a specialty pharmaceutical company focused on identifying, developing, and marketing prescription pharmaceutical products. Edenbridge’s goal is to create a broad portfolio of limited source branded and generic pharmaceutical products that will provide high-quality, affordable, and accessible alternatives in the healthcare market. Edenbridge’s approach is to work with best-in-class and like-minded industry partners to deliver its products to physicians and patients everywhere. Founded in 2008, Edenbridge launched its first product in February 2010 and has sold its commercial products through every major channel of the U.S. prescription pharmaceutical supply chain. In addition, Edenbridge has a robust product development pipeline that includes 505(b)(2) NDAs, ANDAs, and foreign filings. About Phil Phil is a commercialization partner for innovative life sciences companies, offering pharmaceutical manufacturers a modern alternative to traditional access, affordability and distribution options. Through its digital stakeholder experiences, patient access services, market access solutions and distribution models, pharma manufacturers can provide patients with more affordable and timely therapy access.

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PHARMA TECH

The IMA Group Announces Acquisition of Redlink, Inc., a Social Security Disability Evaluation Company

IMA Group | January 27, 2022

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