PRACTICE MANAGEMENT

Azurity Pharmaceuticals to Acquire and Merge with Arbor Pharmaceuticals

Azurity Pharmaceuticals, Inc. | August 24, 2021

Azurity Pharmaceuticals, Inc. and Arbor Pharmaceuticals, Inc. today announced they have entered into a definitive agreement in which Azurity will be acquiring Arbor from existing investors including JW Asset Management and KKR. Following the completion of the transaction, which is subject to regulatory approvals, Azurity and Arbor will merge, creating a leading company offering innovative, high-value products to meet the unique needs of patients with underserved conditions. Financial details of the transaction were not disclosed.

“I am proud of the business that our team has built over the last ten years and am confident that the combined entity will enhance our success and provide more treatment options for patients.”

“Arbor is excited to be joining forces with Azurity to further our goal of bringing innovative products to the market that improve patients’ lives,” commented Ed Schutter, CEO of Arbor. “I am proud of the business that our team has built over the last ten years and am confident that the combined entity will enhance our success and provide more treatment options for patients.”

The combined company, operating as Azurity, will have a portfolio of products serving the unmet needs of patients in the cardiovascular, central nervous system, endocrinological, gastrointestinal, and institutional markets. Azurity will build upon each company’s legacy of success through a distinctive portfolio of 10 exclusively promoted, FDA-approved, branded product families, more than 30 total commercialized products, and a robust pipeline of mid and late-stage products under development. Azurity will continue to develop and commercialize its portfolio of products and deliver them at the right time, in the right way, to the right patients, through a spectrum of healthcare professionals.

“We are proud to continue our partnership with Azurity,” said Jeff Edwards, Partner at NovaQuest Private Equity, the majority owner of Azurity. “This combination accelerates our shared vision of building the leading patient-centric company that differentiates itself by bringing distinctive, high-value products that meet the unique needs of our patients, through state-of-the-art innovation and commercialization capabilities.”

“Today is a tremendous milestone for both Arbor and Azurity, and a strong validation of the products that they provide to patients in need,” said Jason Wild, Chairman of Arbor and Chief Investment Officer of JW Asset Management.

“We are proud to have supported Arbor and its management team and are excited for the company’s next phase of growth in partnership with Azurity,” added Ali Satvat, Co-Head of Americas Health Care Private Equity and Global Head of Health Care Strategic Growth at KKR.

JPMorgan Chase Bank, N.A. and Truist Securities, Inc. are financing sources for the transaction for Azurity. Smith Anderson served as legal advisor to Azurity. MTS Health Partners, L.P. served as exclusive sell-side financial advisor and King & Spalding served as legal advisor to Arbor. Simpson Thacher & Bartlett LLP served as legal advisor to KKR. Pending regulatory approvals, the companies anticipate closing the transaction in September.

About Azurity Pharmaceuticals:
Azurity Pharmaceuticals is a privately-held, specialty pharmaceutical company focusing on the needs of patients requiring customized, user-friendly drug formulations and dosage forms. Azurity’s patient centric products span the cardiovascular, neurology, gastro-intestinal and institutional markets. Azurity’s products have benefited millions of patients for which conventional oral dosage forms are not ideal and whose needs are not served by other commercially available therapies.

About Arbor Pharmaceuticals:
Arbor Pharmaceuticals, headquartered in Atlanta, Georgia, is a specialty pharmaceutical company marketing FDA-approved prescription products in the neuroscience, cardiovascular, and institutional markets. In addition to an extensive pipeline, the company actively pursues growth through acquisition and licensing of late-stage development products.

About NovaQuest Private Equity:
NovaQuest Private Equity is a leading investor in technology and services companies in the life sciences and healthcare sectors. NovaQuest was formed in 2000 with the vision of building an investment platform to provide strategic capital and operational leverage in partnership with strong management teams. The investment team consists of highly seasoned operational and investment professionals with significant investment experience and deep life science and healthcare expertise. Furthermore, NovaQuest benefits from an extensive network of industry experts and relationships that assist in identifying, analyzing and growing NovaQuest portfolio companies and investments.

About JW Asset Management:
JW Asset Management is a New York based fund manager with combined assets under management in excess of $1.5 billion. Jason Wild, the firm’s founder and Chief Investment Officer, is a registered pharmacist and Chairman of Arbor Pharmaceuticals and TerrAscend Corp. JW Asset Management has a history of finding attractive investment opportunities and actively invests in both public and private markets.

About KKR:
KKR is a leading global investment firm that offers alternative asset management and capital markets and insurance solutions. KKR aims to generate attractive investment returns by following a patient and disciplined investment approach, employing world-class people, and supporting growth in its portfolio companies and communities. KKR sponsors investment funds that invest in private equity, credit and real assets and has strategic partners that manage hedge funds. KKR’s insurance subsidiaries offer retirement, life and reinsurance products under the management of The Global Atlantic Financial Group. References to KKR’s investments may include the activities of its sponsored funds and insurance subsidiaries.

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BUSINESS INSIGHTS

NeuroBo Pharmaceuticals, Inc. and Dong-A ST Co. Ltd. Announce Strategic Collaboration

NeuroBo Pharmaceuticals, Inc. | September 16, 2022

NeuroBo Pharmaceuticals, Inc. and Dong-A ST Co., Ltd. announced that they have entered into a conditional exclusive license agreement for NeuroBo to develop and commercialize DA-1241 and DA-1726, which are currently being evaluated for the treatment of nonalcoholic steatohepatitis obesity and type 2 diabetes. DA-1241 is a novel G-Protein-Coupled Receptor 119 agonist, which promotes the release of key gut peptides GLP-1, GIP and PYY, which, in turn, play an important role in glucose metabolism, lipid metabolism and weight loss. DA-1241 is a synthetic, selective small molecule, suitable for oral administration and has been shown to be well tolerated in phase 1 studies. Further, its multimodal mechanism appears to induce strong anti-NASH effects, supported by potential best-in-class efficacy, as demonstrated in pre-clinical studies. DA-1726 is a novel oxyntomodulin analogue functioning as a glucagon-like peptide-1 receptor and glucagon receptor dual agonist. OXM is a naturally-occurring, 37-amino acid peptide hormone that is released from the gut after ingestion of a meal, activating both the GLP-1 and glucagon receptors, prompting reduced food intake as well as an increase in energy expenditure, potentially resulting in superior body weight loss compared to selective GLP-1 receptor agonists. The beneficial effects of this dual mechanism of DA-1726 on weight loss compared to selective GLP-1 activity has been demonstrated in animal models. Additionally, DA-1726 has shown the ability to improve hepatic steatosis, inflammation and fibrosis when compared to the GLP-1 agonist, semaglutide in these same models. Under the license agreement, NeuroBo will be responsible for global development, regulatory and commercial activities other than for certain Asian-Pacific geographies. Dong-A will manufacture clinical supplies and initial commercial supplies of the product at its manufacturing facility in Korea. "The acquisition of these two cardiometabolic assets marks a seismic shift for NeuroBo, providing us with a highly promising, diversified pipeline with several upcoming value inflection points in the NASH and obesity space -- areas with enormous market opportunity," stated Gil Price, M.D., President and Chief Executive Officer of NeuroBo. "Through this agreement, Dong-A, one of our largest shareholders, has reaffirmed its commitment to remain a long-term strategic partner of NeuroBo. Dong-A is dedicated to our success and we are grateful it has also committed to provide continued support to facilitate the clinical development of the licensed assets. Once the transaction has closed, which is contingent upon certain closing conditions, we will be uniquely positioned to initiate a phase 2a study of DA-1241 in NASH in the first half of 2023, with data expected in the second half of 2024. We also intend to initiate a phase 1a safety study of DA-1726 in the first half of 2023, for which data is expected in the second half of 2023. We are truly excited about the prospects of NeuroBo as we transition to a cardiometabolic company across the large and growing markets of obesity and NASH." "We are highly enthusiastic about this opportunity to accelerate development of our novel treatments in partnership with NeuroBo. Dong-A plans to continue to strengthen its R&D capability and to seek additional collaboration opportunities to establish ourselves in the US market", Min Young Kim, Chief Executive Officer of Dong-A About the Proposed Licensing Transaction Under the terms of the license agreement, Dong-A will receive an upfront payment of $22 million in Series A convertible preferred stock, which will automatically convert into common stock upon receipt of requisite stockholder approval, and will be eligible to receive commercial- and regulatory-based milestone payments, dependent upon the achievement of specific regulatory and commercial developments. Dong-A will also be entitled to single digit royalties on net sales of the two assets. Dong-A has also agreed to commit $15,000,000 toward financing the assets, subject to NeuroBo's ability to obtain additional financing under the terms of the license agreement. The license agreement has been approved by the board of directors of NeuroBo. The transaction is expected to close in the third quarter of 2022, subject to obtaining third party financing for development of the assets and other customary closing conditions. About NeuroBo Pharmaceuticals NeuroBo Pharmaceuticals, Inc., is a clinical-stage biotechnology company historically focused on therapies for neurodegenerative, infectious, and, upon closing of the license agreement, cardiometabolic diseases. Its therapeutics programs currently include ANA001, an oral niclosamide formulation, which is in Phase 2/3 clinical trials to treat patients with moderate coronavirus disease (COVID-19); NB-01 for the treatment of painful diabetic neuropathy; NB-02 for the treatment of symptoms of cognitive impairment and to modify the progression of neurodegenerative diseases associated with the malfunction of tau protein; and gemcabene currently being assessed as an acute treatment for COVID-19 in combination with ANA001. NeuroBo Pharmaceuticals, Inc. is headquartered in Boston, Massachusetts. About Dong-A Dong-A ST Co. is a leading healthcare company in South Korea with a business focus on developing, manufacturing and distributing pharmaceutical products and medical devices worldwide. Dong-A has successfully developed and marketed several products globally and continues to develop prospective clinical candidates. Dong-A also provides licensed-in and licensed-out drugs, and medical devices, including high-technology medical devices, custom-made products, and sets of artificial cardiac circuits for use in open-heart surgery. Dong-A has over 5,500 employees including 2,300 in the pharmaceutical sector. Dong-A was founded in 1932 and is headquartered in Seoul, South Korea.

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PHARMACY MARKET

Baseball Legend John Smoltz Featured on PLx Pharma’s Social Channels

PLx Pharma Inc. | September 13, 2022

PLx Pharma Inc. is a commercial-stage drug delivery platform technology company focused on its clinically-validated and patent-protected PLxGuard™ that has the potential to improve the absorption of many drugs currently on the market and to reduce the risk of stomach injury associated with certain drugs. The Company, with its lead products VAZALORE 81 mg and VAZALORE 325 mg liquid-filled aspirin capsules has launched a new VAZALORE 325 mg advertising campaign on Facebook featuring legendary professional baseball pitcher and avid golfer John Smoltz. “From baseball to golf, I don’t want aches and pains to slow me down,” said Smoltz. “VAZALORE is the only pain reliever I have found that works quickly on my aches and pains and doesn’t upset my stomach.” “September is Pain Awareness Month, a time dedicated to raising awareness of pain and pain management options, like aspirin. We are very excited to launch our new Facebook campaign with John, a current VAZALORE user and believer in its many benefits. Millions of people rely on aspirin for the temporary relief of minor aches and pains. The unique complex inside VAZALORE capsules allows for targeted release of aspirin to temporarily relieve minor aches and pains and is specially designed to help protect the stomach.” Natasha Giordano, President & CEO of PLx Pharma PLx Pharma’s VAZALORE is the first and only U.S. Food and Drug Administration (FDA)-approved liquid-filled aspirin capsule. The product was launched in August 2021 and is available over the counter in more than 30,000 drugstores, supermarkets, mass merchandisers and e-commerce sites nationwide. About VAZALORE VAZALORE is an FDA-approved liquid-filled aspirin capsule, available in 81 mg and 325 mg doses. VAZALORE delivers aspirin differently from plain and enteric coated aspirin products. The special complex inside the capsule is designed for targeted release of aspirin, limiting its direct contact with the stomach. VAZALORE delivers fast, reliable absorption for pain relief plus the lifesaving benefits of aspirin. About PLx Pharma Inc. PLx Pharma Inc. is a commercial-stage drug delivery platform technology company focused on improving how and where active pharmaceutical ingredients (APIs) are absorbed in the gastrointestinal (GI) tract via its clinically validated and patent protected PLxGuard™ technology. PLx believes this platform has the potential to improve the absorption of many drugs currently on the market or in development, and to reduce the risk of stomach injury associated with certain drugs.

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BUSINESS INSIGHTS

AbbVie Secures Positive CHMP Opinion for Risankizumab (SKYRIZI®) for the Treatment of Adults with Moderate to Severe Crohn's Disease

AbbVie | September 19, 2022

AbbVie announced the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion recommending the approval of risankizumab for the treatment of adults with moderately to severely active Crohn's disease who have had inadequate response, lost response or were intolerant to conventional or biologic therapy. "We continue to raise the bar in researching treatments for immune-mediated gastroenterological conditions through more stringent and innovative clinical trial design, such as the first time a Phase 3 trial has reported co-primary endpoints, endoscopic response and clinical remission. With the recent CHMP recommendation for risankizumab in Crohn's disease, we're getting closer toward helping patients find sufficient disease control for this disruptive condition." Neil Gallagher, M.D., Ph.D., vice president, development, chief medical officer, AbbVie AbbVie's application for the approval of risankizumab in Crohn's disease is supported by data from three Phase 3 clinical trials — ADVANCE, MOTIVATE (induction studies) and FORTIFY (maintenance study).1,2 Across all three studies, significantly more patients treated with risankizumab achieved the co-primary endpoints of endoscopic response and clinical remission.1,2,5-10 This includes statistically significant improvements in these endpoints at week 12 compared to placebo with 600 mg intravenous infusions for the ADVANCE and MOTIVATE induction studies.1,8,9 Additionally, a significantly greater proportion of patients treated with risankizumab 360 mg subcutaneous injections achieved endoscopic response and clinical remission at 52 weeks compared to placebo (patients treated with placebo after risankizumab induction) in the FORTIFY maintenance study.2,10 Safety results of risankizumab in Crohn's disease were consistent with the known safety profile of risankizumab, with no new safety risks observed.1,2,8-13 "Living with Crohn's disease can pose many challenges and significantly impact a patient's health-related quality of life," said Marc Ferrante, M.D., Ph.D., Department of Gastroenterology and Hepatology, University Hospitals Leuven, Belgium. "Risankizumab could be an encouraging option for adult patients that continue to have moderately to severely active Crohn's disease and I look forward to the European Commission's final decision." Use of risankizumab in Crohn's disease is not approved in the European Union, and its safety and efficacy remain under evaluation. Risankizumab (SKYRIZI) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally. About Crohn's Disease Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal tract, causing persistent diarrhea and abdominal pain.3,4 It is a progressive disease, meaning it gets worse over time in a substantial proportion of patients or may develop complications that require urgent medical care, including surgery.3,4 Because the signs and symptoms of Crohn's disease are unpredictable, it causes a significant burden on people living with the disease—not only physically, but also emotionally and economically.14,15 About the ADVANCE and MOTIVATE Inductions Studies, and the FORTIFY Maintenance Study1,2,8-10 The three Phase 3 studies are multicenter, randomized, double-blind, placebo-controlled studies to evaluate the efficacy and safety of risankizumab 600 mg and 1200 mg as induction therapy, and risankizumab 180 mg and 360 mg as maintenance therapy in subjects with moderately to severely active Crohn's disease. Topline results of the ADVANCE and MOTIVATE induction studies were announced in January 2021 and topline results of the FORTIFY maintenance study were announced in June 2021. About SKYRIZI® (risankizumab) SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit.11,16 IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including Crohn's disease.11,16 The approved dose for SKYRIZI for moderate to severe plaque psoriasis and active psoriatic arthritis in the European Union is 150 mg (either as two 75 mg prefilled syringe injections or one 150 mg prefilled pen or prefilled syringe) administered by subcutaneous injections at week 0 and 4 and every 12 weeks thereafter.11 The use of risankizumab in Crohn's disease is not approved in the European Union and its safety remains under review with the global regulatory authorities. Phase 3 trials of SKYRIZI in psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis are ongoing.12,13,17 EU Indications and Important Safety Information about SKYRIZI® (risankizumab)11 SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. SKYRIZI, alone or in combination with methotrexate is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs. SKYRIZI is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. SKYRIZI may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, SKYRIZI should be used with caution. Treatment with SKYRIZI should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated. Prior to initiating treatment with SKYRIZI, patients should be evaluated for tuberculosis (TB) infection. Patients receiving SKYRIZI should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating SKYRIZI in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Prior to initiating therapy with SKYRIZI, completion of all appropriate immunizations should be considered according to current immunization guidelines. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with SKYRIZI. Patients treated with SKYRIZI should not receive live vaccines during treatment and for at least 21 weeks after treatment. The most frequently reported adverse reactions were upper respiratory infections. Commonly (greater than or equal to 1/100 to less than 1/10) reported adverse reactions included tinea infections, headache, pruritus, fatigue and injection site reactions. About AbbVie in Gastroenterology With a robust clinical trial program, AbbVie is committed to cutting-edge research to drive exciting developments in inflammatory bowel diseases (IBD), like ulcerative colitis and Crohn's disease. By innovating, learning and adapting, AbbVie aspires to eliminate the burden of IBD and make a positive long-term impact on the lives of people with IBD. About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across our Allergan Aesthetics portfolio.

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