Open Label Randomized, Multicentre, Controlled Trial of Pancreatic Enzyme Replacement Therapy (PERT) for Pancreatic Exocrine Insufficiency (PEI) in Patients With Unresectable Pancreatic Cancer. The PERTseverance Trial.

- This will a be an open label, multicentre, randomized, controlled study in patients with unresectable pancreatic cancer, locally advanced or metastatic, with significant weight loss, and the tumour located in the head of the pancreas associated with dilated main pancreatic duct. Pancreatic Exocrine Replacement Therapy (PERT) in these patients will be given on top of other required therapies (best standard of care, BSC), including oncologic therapies, diabetes mellitus therapies and acid suppressants and nutritional support as appropriate. The duration of the study will be up to six months.
Consecutive patients meeting inclusion criteria and none of the exclusion criteria will be evaluated for the study. Those patients signing the informed consent for study participation will be randomized to one of the following two arms:
The experimental arm will receive the best standard of care (BSC) and PERT (capsules containing pancreatin 35,000 Ph.U.) at a fixed dose of 3 capsules with main meals (breakfast, lunch and dinner) and 2 capsules with snacks over 6 months.
The control arm will receive the BSC over 3 months, followed by a further 3-month open uncontrolled phase of BSC + PERT at the dose mentioned above.
All patients will receive in addition a proton pump inhibitor (PPI) bid (any PPI at standard dose is acceptable -omeprazole 20 mg, lansoprazole 30 mg, pantoprazole 40 mg, rabeprazole 20 mg, esomeprazole 40 mg) while on PERT, 20-30 minutes before breakfast and dinner.
To make the two arms comparable, patients will be stratified in two groups (locally advanced and metastatic pancreatic cancer) for randomization using computer generated random numbers.

Start Date01 Nov 2023

Sponsor / Collaborator

Hospital Clinico Universitario de Santiago

[+3]

NCT05642962 / RecruitingPhase 1/2IIT

A Randomized Double Blind Study of Pancreatic Enzyme Replacement Therapy for Patients With Metastatic Pancreatic Ductal Adenocarcinoma

The main purpose of this study is to see how pancrelipase affects the body mass index (BMI) in people with metastatic PDAC. BMI is a measure based on a person's height and weight. Other study goals are to explore two different dosing schedules of pancrelipase and to evaluate pancrelipase in people who do not have symptoms of EPI.

Start Date30 Nov 2022

Sponsor / Collaborator

Memorial Sloan Kettering Cancer Center

NCT05266963 / Enrolling by invitationEarly Phase 1IIT

Pancreatic Enzyme Replacement and Glucose Regulation in Type 1 Diabetes

Recent studies have demonstrated reduced pancreatic volume is present within months of T1D diagnosis in children, adolescents, and adults. As the pancreatic beta cells constitute only 1-2% of the pancreas, the degree of reduction in pancreas volume at disease onset suggests exocrine involvement, challenging the established paradigm of T1D being solely a disease of the endocrine pancreas.
To date there has not been an investigation of the potential for pancreatic enzyme replacement therapy in the management of T1D. In individuals with cystic fibrosis-related diabetes, enzyme replacement has been shown to reduce post-prandial glycemia excursions, which are reflected in improved GLP-1 responses to mixed meal tolerance testing. As post-prandial excursions and glucose variability are a significant challenge in T1D, how enzyme replacement may impact these parameters is an important question.
The investigators hypothesize that patients with T1DM who have reduced pancreatic volume will have improved glycemic responsiveness, reduced hypoglycemia, and improved symptoms of pancreatic exocrine insufficiency when treated with pancreatic enzyme replacement (CREON).

Start Date02 Sep 2022

Sponsor / Collaborator

Vanderbilt University Medical Center

100 Clinical Results associated with Pancrelipase(AbbVie, Inc.)

100 Translational Medicine associated with Pancrelipase(AbbVie, Inc.)

100 Patents (Medical) associated with Pancrelipase(AbbVie, Inc.)

617

Literatures (Medical) associated with Pancrelipase(AbbVie, Inc.)

15 Dec 2023·Food chemistry

The impact of heating and drying on protease activities of ruminant milk before and after in vitro infant digestion.

Article

Author: Roy, Nicole C ; Montoya, Carlos A ; Loo, Trevor S ; McNabb, Warren C ; Loveday, Simon M ; Leite, Juliana A S ; Mullaney, Jane A

This study investigated the effect of heating (63°C/30 min or 75°C/15 s) and drying (spray-drying or freeze-drying) on plasmin, cathepsin D, and elastase activities in bovine, ovine, and caprine milk, compared to non-dried raw milk counterparts. Protease activities and protein hydrolysis were assessed before and after in vitro infant digestion with or without gastric and pancreatic enzymes. At 75°C/15 s, plasmin activity in caprine and ovine milk decreased (69-75%, p<0.05), while cathepsin D activity in spray-dried bovine milk heated increased (2.8-fold, p<0.05). Plasmin and cathepsin D activities increased (<1.2-fold, p<0.05) after in vitro digestion with pancreatin, regardless of milk species. Endogenous milk enzymes hydrolyzed more proteins than gastric enzymes during gastric digestion and contributed to small intestinal digestion. In summary, milk proteases remained active after processing with effects dependent on the species of milk, and they contributed to in vitro protein hydrolysis in the stomach and small intestine.

01 Dec 2023·Pain

GluCl.CreON enables selective inhibition of molecularly defined pain circuits

Article

Author: Zuberi, Sana ; Weir, Greg A ; Bennett, David L ; Hu, Huimin ; Middleton, Steven J ; Perez-Sanchez, Jimena ; McGrath Williams, Joseph

Abstract:

Insight into nociceptive circuits will ultimately build our understanding of pain processing and aid the development of analgesic strategies. Neural circuit analysis has been advanced greatly by the development of optogenetic and chemogenetic tools, which have allowed function to be ascribed to discrete neuronal populations. Neurons of the dorsal root ganglion, which include nociceptors, have proved challenging targets for chemogenetic manipulation given specific confounds with commonly used DREADD technology. We have developed a cre/lox dependant version of the engineered glutamate-gated chloride channel (GluCl) to restrict and direct its expression to molecularly defined neuronal populations. We have generated GluCl.CreON that selectively renders neurons expressing cre-recombinase susceptible to agonist-induced silencing. We have functionally validated our tool in multiple systems in vitro, and subsequently generated viral vectors and tested its applicability in vivo. Using Nav1.8Cre mice to restrict AAV-GluCl.CreON to nociceptors, we demonstrate effective silencing of electrical activity in vivo and concomitant hyposensitivity to noxious thermal and noxious mechanical pain, whereas light touch and motor function remained intact. We also demonstrated that our strategy can effectively silence inflammatory-like pain in a chemical pain model. Collectively, we have generated a novel tool that can be used to selectively silence defined neuronal circuits in vitro and in vivo. We believe that this addition to the chemogenetic tool box will facilitate further understanding of pain circuits and guide future therapeutic development.

01 Nov 2023·Food research international (Ottawa, Ont.)

Effect of pH and protein composition on proteolysis of goat milk proteins by pepsin and pancreatin

Article

Author: Pellis, Linette ; Hettinga, Kasper ; Du, Xiaogu ; Rombouts, Wolf ; Grigorean, Gabriela ; Lönnerdal, Bo

The roles of protein composition, pH and enzymes in goat milk protein hydrolysis is still unclear and the proteolysis of low abundant goat milk proteins has received limited attention. The aim of this study was to study the impact of protein composition and proteolytic conditions on goat milk protein hydrolysis in a simplified digestion model. Both whole milk and infant formula were hydrolyzed at pH 2 and 4, using pepsin as well as pepsin combined with pancreatin. Intact proteins were separated from digests using spin filters, followed by bottom-up proteomics of the separated proteins. Results show that under all conditions, caseins are hydrolyzed quickly. Goat casein hydrolysis in infant formula was slightly faster than in goat whole milk, possibly due to less casein coagulation during pepsin hydrolysis at both pH 2 and 4. Several low abundant immunoactive goat milk proteins, especially immunoglobulins, GLYCAM-1 and osteopontin, resisted proteolysis more than high abundant proteins, independent of the pH and enzyme used for hydrolysis. Fast hydrolysis of casein and slow hydrolysis of immunoactive proteins may indicate a good balance between protein utilization and protection of the infant by goat milk proteins.

News (Medical) associated with Pancrelipase(AbbVie, Inc.)

07 Nov 2022

·www.prnewswire.com

Viatris Reports Strong Third Quarter 2022 Results

Reaffirms 2022 Guidance Ranges [1] Across Total Revenues, Adjusted EBITDA and Free Cash Flow; Driven by Solid Operating Momentum Despite Foreign Exchange Headwinds and Absorbing Inflation Impact to Date Reports Total Revenues of $4.08 billion; U.S. GAAP Net Earnings of $354 million; Adjusted EBITDA of $1.50 billion; U.S. GAAP Net Cash Provided by Operating Activities of $869 million; and Free Cash Flow of $765 million Strong Year-to-Date Cash Flow; Approximately $2.81 billion of U.S. GAAP Net Cash Provided by Operating Activities and Approximately $2.56 billion in Free Cash Flow Meets Annual Target of Paying Down Approximately $2.1 billion of Debt Year to Date, One Quarter Ahead of Schedule Board of Directors Declares Quarterly Dividend of $0.12 Per Share [1] Viatris is not providing forward-looking guidance for U.S. GAAP net earnings (loss) or a quantitative reconciliation of its 2022 adjusted EBITDA guidance. U.S. GAAP net cash provided by operating activities for 2022 is estimated to be between $3.1 billion and $3.3 billion. Please see "2022 Financial Guidance" and "Non-GAAP Financial Measures" for additional information. PITTSBURGH, Nov. 7, 2022 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS) today reported strong results for the third quarter of 2022 and reaffirmed its 2022 financial guidance. The Company also announced that its Board of Directors declared a quarterly dividend of twelve cents ($0.12) for each issued and outstanding share of the Company's common stock. The dividend is payable on December 16, 2022, to shareholders of record at the close of business on November 23, 2022. Viatris CEO Michael Goettler said: "We are very pleased with our seven quarters of strong financial performance, which allow us to continue to deliver on our Phase 1 financial commitments and lay a solid foundation for our return to growth in Phase 2." Viatris President Rajiv Malik said: "In addition to the strong quarterly performance, we continue to progress our pipeline of complex and novel products. I am most proud of a major milestone we achieved during the quarter, along with our partner Mapi Pharma, in announcing our positive top-line results from our Glatiramer Acetate Depot Phase III clinical trial." Viatris CFO Sanjeev Narula said: "We are extremely pleased with our momentum and how the business is performing after another strong quarter of operational results and free cash flow generation. For the third quarter we generated more than $765 million in free cash flow, and more than $2.5 billion year to date. We have paid down approximately $2.1 billion of debt year-to-date and have delivered on our 2022 debt paydown target one quarter ahead of schedule. This supports our commitment to maintaining our investment grade rating." Third Quarter Highlights Third quarter 2022 net sales totaled $4.1 billion, down 1% on an operational basis compared to Q3 2021 results but performed better than expectations, with strong performance across all segments. Base business brands increased 1% on an operational basis compared to Q3 2021 results, and performed better than expectations, driven by products such as Lipitor®, Brufen®, and Creon®. Complex generics and biosimilars performed slightly below expectations due to increased competition and customer buying patterns. Revenues from the biosimilars portfolio to be contributed to Biocon Biologics totaled approximately $185 million in the quarter. Generics, which include diversified product forms such as extended-release oral solids, injectables, transdermals and topicals, performed in line with expectations, including solid performance across the broader North America portfolio, including the launch of lenalidomide in the U.S. The Company generated approximately $144 million in new product revenues (as defined in "Certain Key Terms" below) in the third quarter (approximately $350 million for the year) primarily driven by lenalidomide, unbranded insulin glargine and interchangeable Semglee® in the U.S. and is on track to achieve approximately $525 million in new product revenues in 2022, below expectations due to timing of launches, but with better-than-expected margins. The Company generated $765 million of free cash flow in the third quarter ($2.56 billion for the year), primarily driven by solid U.S. GAAP net cash provided by operating activities of $869 million in the quarter ($2.81 billion for the year) and the timing of planned capital expenditures. Viatris paid quarterly cash dividends of twelve cents ($0.12) per share on the Company's issued and outstanding common stock on March 16, 2022, June 16, 2022 and September 16, 2022. On November 3, 2022, the Company's Board of Directors declared a quarterly dividend of twelve cents ($0.12) per share on the Company's issued and outstanding common stock, which will be payable on December 16, 2022, to shareholders of record as of the close of business on November 23, 2022. The Company paid down approximately $614 million in debt in the third quarter (approximately $2.1 billion for the year), in line with our 2022 target. The Company remains committed to maintaining its investment grade credit rating. 2022 Financial Guidance Viatris is reaffirming its 2022 financial guidance that was previously provided on August 8, 2022, as set forth below. The Company is not providing forward-looking guidance for U.S. GAAP net earnings (loss) or a quantitative reconciliation of its 2022 adjusted EBITDA guidance to the most directly comparable U.S. GAAP measure, U.S. GAAP net earnings (loss), because it is unable to predict with reasonable certainty the ultimate outcome of certain significant items, including integration and acquisition-related expenses, restructuring expenses, asset impairments, litigation settlements and other contingencies, such as changes to contingent consideration and certain other gains or losses, as well as related income tax accounting, because certain of these items have not occurred, are out of the Company's control and/or cannot be reasonably predicted without unreasonable effort. These items are uncertain, depend on various factors, and could have a material impact on U.S. GAAP reported results for the guidance period. U.S. GAAP net cash provided by operating activities for 2022 is estimated to be between $3.1 billion and $3.3 billion, with a midpoint of $3.2 billion. The Company expects to be at the lower end of the adjusted EBITDA guidance range due to negative foreign exchange impacts and expects to be around the mid-point of the range for free cash flow. Conference Call and Earnings Materials Viatris Inc. will host a conference call and live webcast, today at 8:30 a.m. ET, to review the Company's financial results for the third quarter ended September 30, 2022, and provide an update on its February 28 Investor Event. Investors and the general public are invited to listen to a live webcast of the call at investor.viatris.com or by calling 800.225.9448 or 203.518.9708 for international callers (Conference ID: VTRSQ322). The "Viatris Q3 Earnings Presentation", which will be referenced during the call, can be found at investor.viatris.com. A replay of the webcast also will be available on the website. Certain Key Terms New product sales, new product launches or new product revenues refer to revenue from new products launched in 2022 and the carryover impact of new products, including business development, launched within the last twelve months. Operational change refers to constant currency percentage change and is derived by translating amounts for the current period at prior year comparative period exchange rates, and in doing so shows the percentage change from 2022 constant currency net sales, revenues and adjusted EBITDA to the corresponding amount in the prior year. Non-GAAP Financial Measures This press release includes the presentation and discussion of certain financial information that differs from what is reported under accounting principles generally accepted in the United States ("U.S. GAAP"). These non-GAAP financial measures, including, but not limited to, adjusted gross profit, adjusted gross margins, adjusted net earnings, EBITDA, adjusted EBITDA, free cash flow, adjusted R&D and as a % of total revenues, adjusted SG&A and as a % of total revenues, adjusted earnings from operations, adjusted interest expense, adjusted other (income) expense, net, adjusted effective tax rate, constant currency total revenues, constant currency net sales and constant currency adjusted EBITDA are presented in order to supplement investors' and other readers' understanding and assessment of the financial performance of Viatris Inc. ("Viatris" or the "Company"). Free cash flow refers to U.S. GAAP net cash provided by operating activities, less capital expenditures. Adjusted EBITDA margin refers to adjusted EBITDA divided by total revenues. Management uses these measures internally for forecasting, budgeting, measuring its operating performance, and incentive-based awards. Primarily due to acquisitions and other significant events which may impact comparability of our periodic operating results, Viatris believes that an evaluation of its ongoing operations (and comparisons of its current operations with historical and future operations) would be difficult if the disclosure of its financial results was limited to financial measures prepared only in accordance with U.S. GAAP. We believe that non-GAAP financial measures are useful supplemental information for our investors and when considered together with our U.S. GAAP financial measures and the reconciliation to the most directly comparable U.S. GAAP financial measure, provide a more complete understanding of the factors and trends affecting our operations. The financial performance of the Company is measured by senior management, in part, using adjusted metrics included herein, along with other performance metrics. In addition, the Company believes that including EBITDA and supplemental adjustments applied in presenting adjusted EBITDA is appropriate to provide additional information to investors to demonstrate the Company's ability to comply with financial debt covenants and assess the Company's ability to incur additional indebtedness. The Company also believes that adjusted EBITDA better focuses management on the Company's underlying operational results and true business performance and, is used, in part, for management's incentive compensation. We also report sales performance using the non-GAAP financial measures of "constant currency", also referred to herein as "operational change", total revenues, net sales and adjusted EBITDA. These measures provide information on the change in total revenues, net sales and adjusted EBITDA assuming that foreign currency exchange rates had not changed between the prior and current period. The comparisons presented at constant currency rates reflect comparative local currency sales at the prior year's foreign exchange rates. We routinely evaluate our net sales, total revenues and adjusted EBITDA performance at constant currency so that sales results can be viewed without the impact of foreign currency exchange rates, thereby facilitating a period-to-period comparison of our operational activities and believe that this presentation also provides useful information to investors for the same reason. The "Summary of Total Revenues by Segment" table below compares net sales on an actual and constant currency basis for each reportable segment for the quarters and nine months ended September 30, 2022 and 2021 as well as for total revenues. Also, set forth below, Viatris has provided reconciliations of such non-GAAP financial measures to the most directly comparable U.S. GAAP financial measures. Investors and other readers are encouraged to review the related U.S. GAAP financial measures and the reconciliations of the non-GAAP measures to their most directly comparable U.S. GAAP measures set forth below, and investors and other readers should consider non-GAAP measures only as supplements to, not as substitutes for or as superior measures to, the measures of financial performance prepared in accordance with U.S. GAAP. For additional information regarding the components and uses of Non-GAAP financial measures refer to Management's Discussion and Analysis of Financial Condition and Results of Operations—Use of Non-GAAP Financial Measures section of Viatris' Quarterly Report on Form 10-Q for the three months ended September 30, 2022. About Viatris Viatris Inc. (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020, Viatris brings together scientific, manufacturing and distribution expertise with proven regulatory, medical, and commercial capabilities to deliver high-quality medicines to patients in more than 165 countries and territories. Viatris' portfolio comprises more than 1,400 approved molecules across a wide range of therapeutic areas, spanning both non-communicable and infectious diseases, including globally recognized brands, complex generic and branded medicines, a portfolio of biosimilars and a variety of over-the-counter consumer products. With approximately 37,000 colleagues globally, Viatris is headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at viatris.com and investor.viatris.com, and connect with us on Twitter at @ViatrisInc, LinkedIn and YouTube. Forward-looking Statements This release contains "forward-looking statements". These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may include, without limitation, statements about Viatris' 2022 financial guidance; reaffirms 2022 guidance ranges across total revenues, adjusted EBITDA and free cash flow; driven by solid operating momentum despite foreign exchange headwinds and absorbing inflation impact to date; Viatris' Board of Directors declared a quarterly dividend of twelve cents ($0.12) for each issued and outstanding share of the company's common stock payable on December 16, 2022, to shareholders of record at the close of business on November 23, 2022; we are very pleased with our seven quarters of strong financial performance, which allow us to continue to deliver on our Phase 1 financial commitments and lay a solid foundation for our return to growth in Phase 2; in addition to the strong quarterly performance, we continue to progress our pipeline of complex and novel products; we are extremely pleased with our momentum and how the business is performing after another strong quarter of operational results and free cash flow generation; our commitment to maintaining our investment grade rating; the Company expects to be at the lower end of the adjusted EBITDA guidance range due to negative foreign exchange impacts and expects to be around the mid-point of the range for free cash flow; that the Company is on track to achieve approximately $525 million in new product revenues in 2022, below expectations due to timing of launches, but with better-than-expected margins; statements about the pending transaction between Viatris and Biocon Biologics Limited ("Biocon Biologics") pursuant to which Viatris will contribute its biosimilars portfolio to Biocon Biologics (the "Biocon Biologics Transaction"), statements about the transaction pursuant to which Mylan N.V. ("Mylan") combined with Pfizer Inc.'s Upjohn business (the "Upjohn Business") in a Reverse Morris Trust transaction (the "Combination") and Upjohn Inc. became the parent entity of the combined Upjohn Business and Mylan business and was renamed "Viatris Inc.", the benefits and synergies of the Combination or our global restructuring program, the Company's strategic initiatives, including but not limited to potential divestitures and recently announced acquisitions, future opportunities for the Company and its products and any other statements regarding the Company's future operations, financial or operating results, capital allocation, dividend policy and payments, debt ratio and covenants, anticipated business levels, future earnings, planned activities, anticipated growth, market opportunities, strategies, competitions, commitments, confidence in future results, efforts to create, enhance or otherwise unlock the value of our unique global platform, and other expectations and targets for future periods. Forward-looking statements may often be identified by the use of words such as "will", "may", "could", "should", "would", "project", "believe", "anticipate", "expect", "plan", "estimate", "forecast", "potential", "pipeline", "intend", "continue", "target", "seek" and variations of these words or comparable words. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the possibility that the Company may be unable to achieve expected benefits, synergies and operating efficiencies in connection with the Combination or its global restructuring program within the expected timeframe or at all; the pending Biocon Biologics Transaction and other strategic initiatives, including potential divestitures, may not achieve their intended benefits; operational or financial difficulties or losses associated with the Company's reliance on agreements with Pfizer in connection with the Combination, including with respect to transition services; the potential impact of public health outbreaks, epidemics and pandemics, including the ongoing challenges and uncertainties posed by the COVID-19 pandemic; the Company's failure to achieve expected or targeted future financial and operating performance and results; actions and decisions of healthcare and pharmaceutical regulators; changes in relevant laws and regulations, including but not limited to changes in tax, healthcare and pharmaceutical laws and regulations globally (including the impact of potential tax reform in the U.S.); the ability to attract and retain key personnel; the Company's liquidity, capital resources and ability to obtain financing; any regulatory, legal or other impediments to the Company's ability to bring new products to market, including but not limited to "at-risk launches"; success of clinical trials and the Company's or its partners' ability to execute on new product opportunities and develop, manufacture and commercialize products; any changes in or difficulties with the Company's manufacturing facilities, including with respect to inspections, remediation and restructuring activities, supply chain or inventory or the ability to meet anticipated demand; the scope, timing and outcome of any ongoing legal proceedings, including government inquiries or investigations, and the impact of any such proceedings on the Company; any significant breach of data security or data privacy or disruptions to our information technology systems; risks associated with having significant operations globally; the ability to protect intellectual property and preserve intellectual property rights; changes in third-party relationships; the effect of any changes in the Company's or its partners' customer and supplier relationships and customer purchasing patterns, including customer loss and business disruption being greater than expected following the Combination; the impacts of competition, including decreases in sales or revenues as a result of the loss of market exclusivity for certain products; changes in the economic and financial conditions of the Company or its partners; uncertainties regarding future demand, pricing and reimbursement for the Company's products; uncertainties and matters beyond the control of management, including but not limited to general political and economic conditions, inflation rates and global exchange rates; and inherent uncertainties involved in the estimates and judgments used in the preparation of financial statements, and the providing of estimates of financial measures, in accordance with U.S. GAAP and related standards or on an adjusted basis. For more detailed information on the risks and uncertainties associated with Viatris, see the risks described in Part I, Item 1A in the Company's Annual Report on Form 10-K for the year ended December 31, 2021, as amended, and our other filings with the SEC. You can access Viatris' filings with the SEC through the SEC website at or through our website, and Viatris strongly encourages you to do so. Viatris routinely posts information that may be important to investors on our website at investor.viatris.com, and we use this website address as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's Regulation Fair Disclosure (Reg FD). The contents of our website are not incorporated into this release or our other filings with the SEC. Viatris undertakes no obligation to update any statements herein for revisions or changes after the date of this release other than as required by law. SOURCE Viatris Inc.

Financial StatementGeneric DrugBiosimilarAcquisition

24 Oct 2022

·www.prnewswire.com

AbbVie to Present Data from Extensive Portfolio at American College of Gastroenterology Annual Scientific Meeting

Data illustrates AbbVie's commitment to providing research and innovative solutions that support patients with high disease burden and unmet need Oral presentations address treatment of moderate to severe Crohn's disease, including efficacy and safety outcomes from the SKYRIZI® (risankizumab-rzaa) pivotal clinical program as well as late-breaking Phase 3 investigational data from the upadacitinib 52-week maintenance trial Poster presentations include an analysis of the impact of CREON® (pancrelipase) on patient-reported daily symptoms in exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatic surgery NORTH CHICAGO, Ill., Oct. 24, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that 26 abstracts across its gastroenterology portfolio will be presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting, October 21-26, 2022, in Charlotte, N.C., and virtually. AbbVie's oral and poster presentations at ACG 2022 will highlight data in digestive disorders and inflammatory bowel diseases, including Crohn's disease (CD), ulcerative colitis (UC), irritable bowel syndrome with constipation (IBS-C), irritable bowel syndrome with diarrhea (IBS-D), chronic idiopathic constipation (CIC) and exocrine pancreatic insufficiency (EPI). AbbVie is deeply committed to providing research and innovative solutions to support patients in their journey to manage their gastrointestinal disease. "At AbbVie, our thoughtfully designed clinical programs focus on creating bodies of evidence that elevate our understanding of immune-mediated GI conditions," said Celine Goldberger, MD, PhD, vice president, head of US Medical Affairs, AbbVie. "Pioneering research presented at ACG illustrates our dedication to enhancing scientific understanding of how to improve disease activity and shape the future of GI management, beyond only managing symptoms and aiming to improve standards of care." AbbVie will share oral presentations from the SKYRIZI® (risankizumab-rzaa) and RINVOQ® (upadacitinib) Phase 3 clinical trial programs including late-breaking data. Notable poster data include data on SKYRIZI®, LINZESS® (linaclotide), RINVOQ® (upadacitinib) and CREON® (pancrelipase), as well as the impact of inflammatory bowel disease. A database with all 26 AbbVie abstracts accepted for presentation at ACG 2022 can be found here. AbbVie abstracts presented at the 2022 ACG Annual Scientific Meeting are outlined below. SKYRIZI (risankizumab) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization of SKYRIZI globally. Use of RINVOQ (upadacitinib) in Crohn's disease is not approved and its safety and efficacy have not been evaluated by regulatory authorities. LINZESS (linaclotide) is part of a collaboration between AbbVie and Ironwood Pharmaceuticals to share development and commercialization of LINZESS in the United States. U.S. Use and Important Safety Information About SKYRIZI® (risankizumab-rzaa) 1 SKYRIZI is a prescription medicine used to treat adults with: moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy). active psoriatic arthritis (PsA). moderate to severe Crohn's disease What is the most important information I should know about SKYRIZI® (risankizumab-rzaa)? SKYRIZI is a prescription medication that may cause serious side effects, including: Serious Allergic Reactions: Stop using SKYRIZI and get emergency help right away if you get any of the following symptoms of serious allergic reaction: Fainting, dizziness, feeling lightheaded (low blood pressure) Swelling of your face, eyelids, lips, mouth, tongue, or throat Trouble breathing or throat tightness Chest tightness Skin rash, hives Itching Infections: SKYRIZI may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with SKYRIZI and may treat you for TB before you begin treatment with SKYRIZI if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with SKYRIZI. Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including: fever, sweats, or chills muscle aches weight loss cough warm, red, or painful skin or sores on your body different from your psoriasis diarrhea or stomach pain shortness of breath blood in your mucus (phlegm) burning when you urinate or urinating more often than normal Do not use SKYRIZI if you are allergic to risankizumab-rzaa or any of the ingredients in SKYRIZI. Before using SKYRIZI, tell your healthcare provider about all of your medical conditions, including if you: have any of the conditions or symptoms listed in the section "What is the most important information I should know about SKYRIZI?" have an infection that does not go away or that keeps coming back. have TB or have been in close contact with someone with TB. have recently received or are scheduled to receive an immunization (vaccine). Medications that interact with the immune system may increase your risk of getting an infection after receiving live vaccines. You should avoid receiving live vaccines right before, during, or right after treatment with SKYRIZI. Tell your healthcare provider that you are taking SKYRIZI before receiving a vaccine. are pregnant or plan to become pregnant. It is not known if SKYRIZI can harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if SKYRIZI passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What are the possible side effects of SKYRIZI? SKYRIZI may cause serious side effects. See "What is the most important information I should know about SKYRIZI?" Liver problems in people with Crohn's disease: A person with Crohn's disease who received SKYRIZI by intravenous infusion developed changes in liver blood tests with a rash that led to hospitalization. Your doctor will do blood tests to check your liver before, during, and up to 12 weeks of treatment and may stop treatment with SKYRIZI if you develop liver problems. Tell your doctor right away if you notice any of the following symptoms: unexplained rash, nausea, vomiting, stomach(abdominal) pain, tiredness(fatigue), loss of appetite, yellowing of the skin and eyes (jaundice) and dark urine. The most common side effects of SKYRIZI in people treated for Crohn's Disease include: upper respiratory infections, headache, joint pain, stomach (abdominal) pain, injection site reactions, and fungal skin infections. The most common side effects of SKYRIZI in people treated for plaque psoriasis and psoriatic arthritis include: upper respiratory infections, headache, feeling tired, injection site reactions, and fungal skin infections. These are not all the possible side effects of SKYRIZI. Call your doctor for medical advice about side effects. Use SKYRIZI exactly as your healthcare provider tells you to use it. SKYRIZI is available in a 150 mg/mL prefilled syringe and pen, a 600mg/10mL vial for intravenous infusion, and a 180 mg/1.2 mL or 360mg/2.4mL single-dose prefilled cartridge with on-body injector. This is the most important information to know about SKYRIZI. For more information, talk to your HCP. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more. Please click here for Full Prescribing Information and Medication Guide for SKYRIZI. Globally, prescribing information varies; refer to the individual country product label for complete information. U.S. Uses and Important Safety Information About RINVOQ® (upadacitinib)2 RINVOQ is a prescription medicine used to treat: Adults with moderate to severe rheumatoid arthritis (RA) when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or could not be tolerated. Adults with active psoriatic arthritis (PsA) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated. Adults with moderate to severe active ulcerative colitis (UC) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated. Adults with active ankylosing spondylitis (AS) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated. Adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation when a TNF blocker medicine has been used, and did not work well or could not be tolerated. It is not known if RINVOQ is safe and effective in children with juvenile idiopathic arthritis, psoriatic arthritis, ulcerative colitis, ankylosing spondylitis or non-radiographic axial spondyloarthritis. Adults and children 12 years of age and older with moderate to severe eczema (atopic dermatitis [AD]) that did not respond to previous treatment and their eczema is not well controlled with other pills or injections, including biologic medicines, or when the use of other pills or injections is not recommended. RINVOQ is safe and effective in children 12 years of age and older weighing at least 88 pounds (40 kg) with atopic dermatitis. It is not known if RINVOQ is safe and effective in children under 12 years of age with atopic dermatitis. What is the most important information I should know about RINVOQ? RINVOQ may cause serious side effects, including: Serious infections. RINVOQ can lower your ability to fight infections. Serious infections have happened while taking RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider (HCP) should test you for TB before starting RINVOQ and check you closely for signs and symptoms of TB during treatment with RINVOQ. You should not start taking RINVOQ if you have any kind of infection unless your HCP tells you it is okay. If you get a serious infection, your HCP may stop your treatment until your infection is controlled. You may be at higher risk of developing shingles (herpes zoster). Increased risk of death in people 50 years and older who have at least 1 heart disease (cardiovascular) risk factor. Cancer and immune system problems. RINVOQ may increase your risk of certain cancers. Lymphoma and other cancers, including skin cancers, can happen. Current or past smokers are at higher risk of certain cancers, including lymphoma and lung cancer. Follow your HCP's advice about having your skin checked for skin cancer during treatment with RINVOQ. Limit the amount of time you spend in sunlight. Wear protective clothing when you are in the sun and use sunscreen. Increased risk of major cardiovascular (CV) events, such as heart attack, stroke, or death, in people 50 years and older who have at least 1 heart disease (CV) risk factor, especially if you are a current or past smoker. Blood clots: Blood clots in the veins of the legs or lungs and arteries can happen with RINVOQ. This may be life-threatening and cause death. Blood clots in the veins of the legs and lungs have happened more often in people who are 50 years and older and with at least 1 heart disease (CV) risk factor. Allergic reactions. Symptoms such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, that may mean you are having an allergic reaction have been seen in people taking RINVOQ. Some of these reactions were serious. If any of these symptoms occur during treatment with RINVOQ, stop taking RINVOQ and get emergency medical help right away. Tears in the stomach or intestines and changes in certain laboratory tests. Your HCP should do blood tests before you start taking RINVOQ and while you take it. Your HCP may stop your RINVOQ treatment for a period of time if needed because of changes in these blood test results. Do not take RINVOQ if you are allergic to upadacitinib or any of the ingredients in RINVOQ. See the Medication Guide or Consumer Brief Summary for a complete list of ingredients. What should I tell my HCP BEFORE starting RINVOQ? Tell your HCP if you: Are being treated for an infection, have an infection that won't go away or keeps coming back, or have symptoms of an infection such as: Fever, sweating, or chills Shortness of breath Warm, red, or painful skin or sores on your body Muscle aches Feeling tired Blood in phlegm Diarrhea or stomach pain Cough Weight loss Burning when urinating or urinating more often than normal Have TB or have been in close contact with someone with TB. Are a current or past smoker. Have had a heart attack, other heart problems, or stroke. Have had any type of cancer, hepatitis B or C, shingles (herpes zoster), blood clots in the veins of your legs or lungs, diverticulitis (inflammation in parts of the large intestine), or ulcers in your stomach or intestines. Have other medical conditions including liver problems, low red or white blood cell counts, diabetes, chronic lung disease, HIV, or a weak immune system. Live, have lived, or have traveled to parts of the country, such as the Ohio and Mississippi River valleys and the Southwest, that increase your risk of getting certain kinds of fungal infections. If you are unsure if you've been to these types of areas, ask your HCP. Have recently received or are scheduled to receive a vaccine. People who take RINVOQ should not receive live vaccines. Are pregnant or plan to become pregnant. Based on findings in animal studies, RINVOQ may harm your unborn baby. Your HCP will check whether or not you are pregnant before you start RINVOQ. You should use effective birth control (contraception) to avoid becoming pregnant during treatment with RINVOQ and for 4 weeks after your last dose. Are breastfeeding or plan to breastfeed. RINVOQ may pass into your breast milk. Do not breastfeed during treatment with RINVOQ and for 6 days after your last dose. Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RINVOQ and other medicines may affect each other, causing side effects. Especially tell your HCP if you take: Medicines for fungal or bacterial infections Rifampicin or phenytoin Medicines that affect your immune system If you are not sure if you are taking any of these medicines, ask your HCP or pharmacist. What should I do or tell my HCP AFTER starting RINVOQ? Tell your HCP right away if you have any symptoms of an infection. RINVOQ can make you more likely to get infections or make any infections you have worse Get emergency help right away if you have any symptoms of a heart attack or stroke while taking RINVOQ, including: Discomfort in the center of your chest that lasts for more than a few minutes or that goes away and comes back Severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw Pain or discomfort in your arms, back, neck, jaw, or stomach Shortness of breath with or without chest discomfort Breaking out in a cold sweat Nausea or vomiting Feeling lightheaded Weakness in one part or on one side of your body Slurred speech Tell your HCP right away if you have any signs or symptoms of blood clots during treatment with RINVOQ, including: Swelling Pain or tenderness in one or both legs Sudden unexplained chest or upper back pain Shortness of breath or difficulty breathing Tell your HCP right away if you have a fever or stomach-area pain that does not go away, and a change in your bowel habits. What are other possible side effects of RINVOQ? Common side effects include upper respiratory tract infections (common cold, sinus infections), shingles (herpes zoster), herpes simplex virus infections (including cold sores), bronchitis, nausea, cough, fever, acne, headache, increased blood levels of creatine phosphokinase, allergic reactions, inflammation of hair follicles, stomach-area (abdominal) pain, increased weight, flu, tiredness, lower number of certain types of white blood cells (neutropenia, lymphopenia), muscle pain, flu-like illness, rash, increased blood cholesterol levels, and increased liver enzyme levels. Separation or tear to the lining of the back part of the eye (retinal detachment) has happened in people with atopic dermatitis treated with RINVOQ. Call your HCP right away if you have any sudden changes in your vision during treatment with RINVOQ. These are not all the possible side effects of RINVOQ. How should I take RINVOQ? RINVOQ is taken once a day with or without food. Do not split, crush, or chew the tablet. Take RINVOQ exactly as your HCP tells you to use it. RINVOQ is available in 15 mg, 30 mg and 45 mg extended-release tablets. This is the most important information to know about RINVOQ. For more information, talk to your HCP. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more. Please click here for the Full Prescribing Information and Medication Guide. Globally, prescribing information varies; refer to the individual country product label for complete information. U.S. Uses and Important Safety Information About LINZESS ® (linaclotide) 3 USES LINZESS® (linaclotide) is a prescription medication used in adults to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC). "Idiopathic" means the cause of the constipation is unknown. It is not known if LINZESS is safe and effective in children less than 18 years of age. IMPORTANT RISK INFORMATION Do not give LINZESS to children who are less than 2 years of age. It may harm them. LINZESS can cause severe diarrhea and your child could get severe dehydration (loss of a large amount of body water and salt). Do not take LINZESS if a doctor has told you that you have a bowel blockage (intestinal obstruction). Before you take LINZESS, tell your doctor about your medical conditions, including if you are: Pregnant or plan to become pregnant. It is not known if LINZESS will harm your unborn baby. Breastfeeding or plan to breastfeed. You and your doctor should decide if you will take LINZESS and breastfeed. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Side Effects LINZESS can cause serious side effects, including diarrhea, which is the most common side effect and can sometimes be severe. Diarrhea often begins within the first 2 weeks of LINZESS treatment. Stop taking LINZESS and call your doctor right away if you get severe diarrhea during treatment with LINZESS. Other common side effects of LINZESS include gas, stomach-area (abdominal) pain, swelling, or a feeling of fullness or pressure in your abdomen (distension). Call your doctor or go to the nearest hospital emergency room right away if you develop unusual or severe stomach-area (abdominal) pain, especially if you also have bright red, bloody stools or black stools that look like tar. These are not all the possible side effects of LINZESS. For more information, ask your doctor or pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. If you are having difficulty paying for your medicine, AbbVie and Ironwood may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more. Please see full Prescribing Information including Boxed Warning. U.S. Use and Important Safety Information About CREON® (pancrelipase)4 CREON® (pancrelipase) is a prescription medicine used to treat people who cannot digest food normally because their pancreas does not make enough enzymes due to cystic fibrosis, swelling of the pancreas that lasts a long time (chronic pancreatitis), removal of some or all of the pancreas (pancreatectomy), or other conditions. Important Safety Information CREON may increase your chance of having a rare bowel disorder called fibrosing colonopathy. Tell your doctor if you have a history of intestinal blockage, or scarring or thickening of your bowel wall (fibrosing colonopathy). The risk of having this condition may be reduced by following the dosing instructions that your doctor gave you. Do not crush or chew CREON capsules or their contents, and do not hold the capsule or capsule contents in your mouth. Crushing, chewing, or holding the CREON capsules in your mouth may cause irritation in your mouth. Talk to your doctor or consult the CREON Medication Guide for how to take CREON if you have trouble swallowing capsules. Always take CREON with a meal or snack and enough liquid to swallow CREON completely. Take CREON exactly as your doctor tells you. Tell your doctor right away if you have unusual or severe: stomach (abdominal) pain, bloating, trouble passing stool, nausea, vomiting, diarrhea, worsening of painful, swollen joints (gout), or allergic reactions, including trouble with breathing, skin rashes, or swollen lips. The most common side effects include increased (hyperglycemia) or decreased (hypoglycemia) blood sugars, pain in your stomach area (abdominal area); frequent or abnormal bowel movements, gas; vomiting, dizziness, and sore throat and cough. CREON and other pancreatic enzyme products are made from the pancreas of pigs, the same pigs people eat as pork. These pigs may carry viruses. Although it has never been reported, it may be possible for a person to get a viral infection from taking pancreatic enzyme products that come from pigs. Refer to the CREON Medication Guide and full Prescribing Information every time you refill your prescription because information may change. Tell your healthcare provider if you have any symptom or side effect that bothers you or that does not go away. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. If you are having difficulty paying for your medication, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more. 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. For more information about AbbVie, please visit us at . Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2021 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. US-IMMG-220338 References: SKYRIZI (risankizumab-rzaa) [Package Insert]. North Chicago, Ill.: AbbVie Inc. RINVOQ (upadacitinib) [Package Insert]. North Chicago, Ill.: AbbVie Inc. LINZESS (linaclotide) [Package Insert]. Madison, NJ.: Allergan USA, Inc. CREON (pancrelipase) [Package Insert]. North Chicago, Ill.: AbbVie Inc. SOURCE AbbVie

VaccineAcquisition

31 Mar 2021

·www.globenewswire.com

AzurRx BioPharma Provides Key Takeaways from Phase 2b

DELRAY BEACH, Fla., March 31, 2021 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ: AZRX), (“AzurRx” or the “Company”), a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today provided key takeaways from its conference call reporting on the topline results from its Phase 2b OPTION 2 clinical trial investigating MS1819 in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (EPI). The conference call, held on March 31, 2021, at 4:30 p.m. ET, featured James Sapirstein, President, CEO and Chairman of AzurRx, and Dr. James Pennington, Chief Medical Officer, discussing the recently completed OPTION 2 study, and the company’s plans to develop an optimized formulation of MS1819 for ongoing clinical investigation. OPTION 2 was designed as a Phase 2b multi-center study to investigate the safety, tolerability and efficacy of MS1819 (in enteric capsules) in a head-to-head comparison against the current porcine enzyme replacement therapy (PERT) standard of care for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis. The primary efficacy endpoint was the coefficient of fat absorption (CFA), with secondary endpoints of stool weight, signs and symptoms of malabsorption and coefficient of nitrogen absorption (CNA). The trial also included an extension arm that used an immediate release MS1819 capsule, allowing the Company to compare data from the existing arm that uses enteric (delayed release) capsules with data from the new arm, and ultimately select the optimal delivery method. Discussing the topline results of OPTION 2 during the conference call, Mr. Sapirstein commented, “To summarize, the best word to describe the OPTION 2 topline results is mixed. MS1819 demonstrated itself to be safe and well-tolerated and data from OPTION 2, and other Phase 2 clinical trials, clearly demonstrate drug activity. However, OPTION 2 did not consistently meet the primary efficacy endpoint. Some patients were able to achieve CFA at levels beyond what is required to demonstrate non-inferiority with PERT therapies, but the majority did not, and as such, we did not meet our trial goal.” Mr. Sapirstein continued, “The underlying cause of the drug’s uneven efficacy performance in OPTION 2, we believe, lies with the enteric capsule formulation. While the enteric coating protects the capsule from breaking down in the stomach acid, it also appears to dissolve too slowly in the small intestine to release the lipase enzyme in time to aid with proper digestion and nutrient absorption.” “To that end, we are planning to pursue a new formulation for MS1819, this one a capsule filled with acid-resistant granules, or microbeads, similar to what is used in CREON®, ZENPEP® and other PERT therapies. Such a capsule would dissolve in the stomach, disperse the beads, and then pass through to the small intestine where the beads would break down and release the lipase enzyme so that it thoroughly mixes with food as it is being digested.” Mr. Sapirstein concluded, “We are moving full force with developing the optimal formulation technology for MS1819 and have already initiated discussions with contract manufacturers to accelerate the process. This will require additional time and resources. Yet we are fortunate, through financing efforts that have raised an aggregate of approximately $22.5 million in the first quarter of 2021, to have sufficient capital currently on hand to fund this development and, within the next year or so, initiate a further Phase 2 study to evaluate efficacy, without substantially delaying our clinical development initiatives in other areas. We firmly believe the cost-benefit ratio with MS1819 is clearly in our favor. The drug’s mechanism of action is known and proven, it offers numerous therapeutic, safety and compliance advantages over today’s standard of care, and remains less cumbersome to manufacture. Based on these factors, we believe that should this optimized formulation prove successful in the clinic – and we have every reason to believe it will – MS1819 could eventually become the gold standard treatment for EPI in patients with cystic fibrosis and chronic pancreatitis.” An audio webcast of the conference call will be accessible via the Investors section of the AzurRx website at . An archive of the webcast will remain available for approximately 90 days. Phase 2 OPTION 2 Trial DesignThe Phase 2b OPTION 2 multi-center trial was designed to investigate the safety, tolerability and efficacy of MS1819 (2.2 and 4.4 gram doses in enteric capsules) in a head-to-head comparison versus the current standard of care, porcine pancreatic enzyme replacement therapy pills. The OPTION 2 trial was an open-label, crossover study, conducted in 15 sites in the U.S. and Europe. A total of 30 CF patients 18 years or older were enrolled. MS1819 was administered in enteric capsules to provide gastric protection and allow optimal delivery of enzyme to the duodenum. Patients were first randomized into two cohorts: to either the MS1819 arm, where they received a 2.2 gram daily oral dose of MS1819 for three weeks; or to the PERT arm, where they received their pre-study dose of PERT pills for three weeks. After three weeks, stools were collected for analysis of coefficient of fat absorption. Patients were then crossed over for another three weeks of the alternative treatment. After three weeks of cross-over therapy, stools were again collected for analysis of CFA. A parallel group of patients were randomized and studied in the same fashion, using a 4.4 gram daily dose of MS1819. All patients were followed for an additional two weeks after completing both crossover treatments for post study safety observation. Patients were assessed using descriptive methods for efficacy, comparing CFA between MS1819 and PERT arms, and for safety. About MS1819MS1819 is a recombinant lipase enzyme for the treatment of exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis. MS1819, supplied as an oral non-systemic biologic capsule, is derived from the Yarrowia lipolytica yeast lipase and breaks up fat molecules in the digestive tract of EPI patients so that they can be absorbed as nutrients. Unlike the standard of care, the MS1819 synthetic lipase does not contain any animal products. About Exocrine Pancreatic InsufficiencyEPI is a condition characterized by deficiency of the exocrine pancreatic enzymes, resulting in a patient’s inability to digest food properly, or maldigestion. The deficiency in this enzyme can be responsible for greasy diarrhea, fecal urge and weight loss. There are more than 30,000 patients in the U.S. with EPI caused by cystic fibrosis according to the Cystic Fibrosis Foundation and approximately 90,000 patients in the U.S with EPI caused by chronic pancreatitis according to the National Pancreas Foundation. Patients are currently treated with porcine pancreatic enzyme replacement pills. About AzurRx BioPharma, Inc.AzurRx BioPharma, Inc. (NASDAQ: AZRX) is a clinical stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases. The Company has a pipeline of three gut-restricted GI assets. The lead therapeutic candidate is MS1819, a recombinant lipase for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis and chronic pancreatitis, currently in two Phase 2 CF clinical trials. AzurRx is launching two clinical programs using proprietary formulations of niclosamide, a pro-inflammatory pathway inhibitor; FW-1022, for COVID-19 gastrointestinal infections, and FW-420, for grade 1 Immune Checkpoint Inhibitor-Associated Colitis and diarrhea in oncology patients. The Company is headquartered in Delray Beach, Florida with clinical operations in Hayward, California. For more information visit . Forward-Looking StatementThis press release may contain certain statements relating to future results which are forward-looking statements. It is possible that the Company’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements, depending on factors including whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; and the impact of the coronavirus (COVID-19) pandemic on the Company’s operations and current and planned clinical trials, including potential delays in clinical trial recruitment and participation. Additional information concerning the Company and its business, including a discussion of factors that could materially affect the Company’s financial results are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 under the heading “Risk Factors,” as well as the Company’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware. For more information: AzurRx BioPharma, Inc.1615 South Congress AvenueSuite 103Delray Beach, Florida 33445Phone: (646) 699-7855info@azurrx.com Media contact: Tiberend Strategic Advisors, Inc.Johanna Bennett/Ingrid Mezo(212) 375-2665/(646) 604-5150jbennett@tiberend.com/imezo@tiberend.com

Financial Statement

100 Deals associated with Pancrelipase(AbbVie, Inc.)

External Link

KEGG	Wiki	ATC	Drug Bank
D05349	-	A09AA02	DB00085

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Dyspepsia	CN	Abbott Laboratories GmbH	13 Sep 2017
Exocrine Pancreatic Insufficiency	US	AbbVie, Inc.	30 Apr 2009

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hypopituitarism	Phase 3	CN	Abbott Laboratories Trading (Shanghai) Co. Ltd.	17 Aug 2017
Hypopituitarism	Phase 3	CN	Viatris Healthcare GmbH	17 Aug 2017
Hypopituitarism	Phase 3	CN	AbbVie Pharmaceuticals GmbH	17 Aug 2017
Pancreatic Cancer	Phase 3	CN	Viatris Healthcare GmbH	17 Aug 2017
Pancreatic Cancer	Phase 3	CN	Abbott Laboratories Trading (Shanghai) Co. Ltd.	17 Aug 2017
Pancreatic Cancer	Phase 3	CN	AbbVie Pharmaceuticals GmbH	17 Aug 2017
HIV Infections	Phase 3	RO	Abbott Laboratories	01 Jan 2009
Steatorrhea	Phase 3	RO	Abbott Laboratories	01 Jan 2009
Cystic Fibrosis	Phase 3	US	Solvay Pharmaceuticals, Inc.	01 Nov 2007
Cystic Fibrosis	Phase 3	IL	Solvay Pharmaceuticals, Inc.	01 Nov 2007

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03924947 (CTgov)	Phase 4	Cystic Fibrosis \| Exocrine Pancreatic Insufficiency	36	DB (Part 1 DB Creon)	djlldqrlxa(mmucayrffq) = gymioycxar osggdyxqeu (ewjzpmuvog, aypljohcvm - zfycsbpsun) View more	-	28 Sep 2023
NCT03924947 (CTgov)	Phase 4	Cystic Fibrosis \| Exocrine Pancreatic Insufficiency	36	Creon MP (Part 1 DB Creon MP)	djlldqrlxa(mmucayrffq) = zuzqvbvokt osggdyxqeu (ewjzpmuvog, desoduolma - hrtyxvwsbg) View more	-	28 Sep 2023
NCT03859869 (CTgov)	Phase 4	Exocrine Pancreatic Insufficiency \| Pancreatic Cancer	1	Placebo+pancrelipase (Resected Participants Receiving Low Dose (12,000/6,000 Units Lipase) Pancrelipase)	lzwhjylfza(mkigvtujxv) = dgtqafqefi mdlbfazfeg (rrdmdnhiwu, vqqutamrbz - jfktgjpxkp) View more	-	05 Jun 2023
NCT03859869 (CTgov)	Phase 4	Exocrine Pancreatic Insufficiency \| Pancreatic Cancer	1	Placebo+pancrelipase (Resected Participants Receiving High Dose (72,000/36,000 Units Lipase) Pancrelipase)	qlndvubiyi(hbfatzffch) = biueqqgmdv aurnlknayb (fpqsgidkol, dgjqqnueri - fikozgwvrg) View more	-	05 Jun 2023
NCT03469258 (CTgov)	Phase 2	Pancreatic Ductal Adenocarcinoma \| Pancreatic adenocarcinoma	4	Pancrelipase	bqqyczghnl(brkuyrgyct) = byzvyhaqeg avfnilevoj (qtxtpfmitr, wqqturywev - svwbrdahhb) View more	-	03 Aug 2020
NCT03097029 (CTgov)	Phase 2	Short Bowel Syndrome	16	Pancreatic Enzyme	mvoukoawyp(agofgdhakw) = sqgurqsrfj owmwpopnqk (bcuibmmild, hmmbeudrlw - tikutyeefb) View more	-	03 Mar 2020
PICNIC (Pubmed \| Support Care Cancer)	Not Applicable	Exocrine Pancreatic Insufficiency \| Pancreatic Cancer	18	Pancreatic extract (Creon®)	aakvpcyunn(aqzwysadgj) = uvgkwejrqa braouedisb (xpaizmikij, 14.1 - 98.4) View more	-	01 Jun 2017
PICNIC (Pubmed \| Support Care Cancer)	Not Applicable	Exocrine Pancreatic Insufficiency \| Pancreatic Cancer	18	Placebo	aakvpcyunn(aqzwysadgj) = wgtpnurlix braouedisb (xpaizmikij, 8.1 - 48.7) View more	-	01 Jun 2017
NCT00510744 (CTgov)	Not Applicable	Obesity \| Malnutrition	5	pancreatic enzyme supplement	qgybhhdifm(uotjyehtki) = tmpkphoglo xuueznzfeu (unbsgrgkvj, uoraeaggda - obpaxstmun) View more	-	02 Jun 2016
NCT02415959 (CTgov)	Phase 2	Cystic Fibrosis \| Exocrine Pancreatic Insufficiency	70	Creon IR (Creon IR Low Dose)	jqiphhklsu(dwknyomcpj) = fikyhovppi pyiqvodtns (gcofrmdmiw, cajjueygee - ebdekldccb) View more	-	17 Feb 2016
NCT02415959 (CTgov)	Phase 2	Cystic Fibrosis \| Exocrine Pancreatic Insufficiency	70	Creon IR (Creon IR Medium Dose)	jqiphhklsu(dwknyomcpj) = soedmpfomh pyiqvodtns (gcofrmdmiw, wbazgpvnlm - jmarrksfmd) View more	-	17 Feb 2016
NCT01747330 (CTgov)	Phase 3	Exocrine Pancreatic Insufficiency \| Cystic Fibrosis	40	Pancreatin	otkpcyztrv(mieewljfdw) = wrwduafjhl oegudxapxj (gnfzypoocn, jffkkiimnv - xpmunbybbw) View more	-	15 Jul 2014
NCT00775528 (CTgov)	Phase 3	Exocrine Pancreatic Insufficiency \| Cystic Fibrosis	19	Pancrelipase	awannrjwzd(tchtyxogmx) = kzonukkhtl spchmyemsz (ehkwwzrlbh, oznjtblkyk - fduvkhbylb) View more	-	01 Oct 2010

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Pancrelipase(AbbVie, Inc.)

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