This study investigates if pancreatic enzymes in combination with oral nutritional supplement can improve nutrient bioavailability in older people with malnutrition or at risk of malnutrition.

Start Date01 Feb 2025

Sponsor / Collaborator

Kantonsspital Aarau AG

NCT06477159

/ RecruitingPhase 4IIT

Pancreatic Enzyme Replacement Therapy for Acute Pancreatitis-Associated Exocrine Pancreatic Insufficiency: the PERT-AP Trial

This study aims to evaluate if a 6-month course of pancrelipase (CREON) treatment improves symptoms of exocrine pancreatic insufficiency (EPI) after an attack of acute pancreatitis. Diagnosis of EPI is measured by a fecal elastase value of <200, and patients must have a qualifying symptom burden based on the EPI symptom tracker survey. Blood and stool will be analyzed as part of this study, and other surveys of health status will be used to track improvement of symptoms.

Start Date01 Feb 2024

Sponsor / Collaborator

The Ohio State University

[+5]

NCT01682421

/ WithdrawnNot ApplicableIIT

Investigation of Treatment With Topical Corticosteroid After Posterior Lamellar Corneal Transplantation

After corneal transplantation, topical corticosteroids are used to reduce the risk of rejection.
However, the optimal postoperative treatment regimen is unknown. In most cases, a topical steroid is administered for at least 6 months after surgery, but it remains to be determined whether potent steroids offer better protection than weak steroids. Also, the length of the treatment is debated.
Since the use of steroids is not without potential serious ocular side effects, it is of considerable importance to investigate these problems.
The study aims to examine the frequency of rejection episodes after posterior lamellar keratoplasty; specifically comparing a short course of potent steroids versus a long course of weak steroids.

Start Date01 Sep 2012

Sponsor / Collaborator

Århus Universitetshospital

100 Clinical Results associated with Pancrelipase(Eurand)

100 Translational Medicine associated with Pancrelipase(Eurand)

100 Patents (Medical) associated with Pancrelipase(Eurand)

Literatures (Medical) associated with Pancrelipase(Eurand)

01 Apr 2023·Journal of Pharmacy Practice

Efficacy of a Viokace Pancreatic Enzyme Protocol for Clearing Occluded Enteral Feeding Tubes: A Quality Assurance Evaluation

Article

Author: Kurish, Heena P. ; Bruck, Cheryl L. ; Gabriel, Jacenta M. ; Stumpf, Janice L.

Background: A previous retrospective study documented restored patency to 48.2% of occluded enteral feeding tubes using alkalinized Creon pancreatic enzyme capsules. In light of the low efficacy rate, the institutional enteral feeding tube clearance protocol was subsequently revised to incorporate a newly marketed non–enteric-coated Viokace pancreatic enzyme tablet, despite the lack of published data for this indication. Objective: This study aims to evaluate the effectiveness of a Viokace-based alkalinized pancreatic enzyme protocol to clear occluded enteral feeding tubes in a university health system. Methods: This retrospective, cohort quality assurance study included adult and pediatric patients receiving a Viokace-based pancreatic enzyme protocol for enteral feeding tube occlusions in a university health system during a 12-month period. The primary outcome was effectiveness in enteral tube clearance as documented in the electronic medical record. Efficacy of the new protocol was also compared with a Creon-based alkalinized solution using historical data. Results: The Viokace protocol successfully cleared 176 of the 277 (63.5%) occluded enteral feeding tubes occurring in 205 patients included in the analysis. The revised protocol was significantly more effective at clearing occluded enteral feeding tubes ( P = 0.0056) than a protocol using Creon pancreatic enzyme capsules. Conclusion: According to this retrospective evaluation, an alkalinized Viokace pancreatic enzyme protocol was effective in clearing 63.5% of occluded enteral feeding tubes. This significantly higher success rate than previously documented with a Creon-based protocol supports the change in pancreatic enzyme formulations in the institutional protocol.

01 Sep 2020·PancreatologyQ3 · MEDICINE

Study of the gastrointestinal bioavailability of a pancreatic extract product (Zenpep) in chronic pancreatitis patients with exocrine pancreatic insufficiency

Q3 · MEDICINE

Article

Author: Karnik, Nihaal ; Toskes, Phillip P ; Patel, Dhruvan ; Lieb, John G

INTRODUCTIONThe Food and Drug Administration in 2006 required that all pancreatic enzyme products demonstrate bioavailability of lipase, amylase, and protease in the proximal small intestine.METHODSIn this phase I open-label, randomized, crossover trial, 17 adult chronic pancreatitis (CP) patients with severe exocrine pancreatic insufficiency (EPI) underwent two separate gastroduodenal perfusion procedures (Dreiling tube suctioning and [¹⁴C]-PEG instillation by an attached Dobhoff tube in the duodenal bulb). Patients received Ensure Plus® alone and Ensure Plus with Zenpep (75,000 USP lipase units) in random order. The bioavailability of Zenpep was estimated by comparing the recovery of lipase, amylase, chymotrypsin activity in two treatment conditions. ¹⁴C-PEG was used to correct duodenal aspirates volume. The primary efficacy endpoint was lipase delivery in the duodenum after Zenpep administration under fed conditions. Secondary efficacy endpoints included chymotrypsin and amylase delivery, serum CCK levels, and measuring duodenal and gastric pH.RESULTSZenpep administration with a test meal was associated with significant increase in duodenal aspiration of lipase (p = 0.046), chymotrypsin (p = 0.008), and amylase (p = 0.001), compared to the test meal alone, indicating release of enzymes to the duodenum. Lipase delivery was higher in the pH subpopulation (the efficacy population with acid hypersecretors excluded) (p = 0.01). Recovery of [¹⁴C]-PEG was 61%. Zenpep was generally well tolerated. All adverse events were mild and transient.CONCLUSIONSIn CP patients with severe EPI, lipase, chymotrypsin and amylase were released rapidly into the duodenum after ingestion of Zenpep plus meal compared to meals alone. Results also reflected the known pH threshold for enzyme release from enteric coated products.

01 Sep 2016·Journal of Cystic FibrosisQ2 · MEDICINE

Comparison of two pancreatic enzyme products for exocrine insufficiency in patients with cystic fibrosis

Q2 · MEDICINE

Article

Author: Magnus, L ; Gommoll, C ; Fleming, R ; Taylor, C J ; Shiff, S ; Thieroff-Ekerdt, R

BACKGROUNDZenpep (APT-1008) is a pancreatic enzyme product for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF).METHODSZenpep and Kreon, both containing 25,000 lipase units, were compared in a randomised, double-blind, crossover, non-inferiority study for CF-associated EPI in patients aged ≥12years. Patients on a standardised diet and stabilised treatment were randomised to two treatment sequences: Zenpep/Kreon or Kreon/Zenpep. The primary efficacy endpoint was the coefficient of fat absorption over 72h (CFA-72h).RESULTS96 patients (mean age 19.2years, 60.4% males) were randomised with 83 completers of both sequences comprising the efficacy population. Zenpep demonstrated non-inferiority and equivalence to Kreon in fat absorption (LS mean CFA-72h: Zenpep, 84.1% [SE 1.1] vs. Kreon, 85.3% [SE 1.1]; p=0.297). Safety and tolerability were similar.CONCLUSIONSZenpep is comparable with Kreon in efficacy and safety for the treatment of adolescents and adults with CF-associated EPI. NCT01641393.

News (Medical) associated with Pancrelipase(Eurand)

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

08 Jul 2022

·www.biospace.com

Report: Merck in Advanced Talks to Acquire Seagen for $40B

Merck is in late-stage discussions to acquire Seagen for about $40 billion, sources told The Wall Street Journal. Seagen is an appealing oncology target for Merck at a time when the latter is looking to bolster its cancer portfolio as mega-blockbuster Keytruda (pembrolizumab) teeters on the patent cliff. The WSJ report suggests Merck is offering more than $200 per share and hopes to close the deal on or before its quarterly earnings report on July 28. On Wednesday, Seagen’s stock closed at $175.13 per share. Rumors about the talks have been ongoing for several weeks. Seagen’s market cap is above $32 billion. In September 2020, the two companies inked a co-development pact to advance ladiratuzumab vedotin, a potential cancer therapy. Merck threw $600 million into the deal up front and acquired 5 million shares of Seagen stock for $1 billion. They also have a licensing deal for Tukysa in countries outside the U.S., Canada and Europe, for which Merck paid $125 million at the outset. Merck’s Keytruda, an anti-PD-1 checkpoint inhibitor, brought in $7.2 billion last year alone. In Q1 this year, the drug raked in $4.7 billion, up 23% from last year over the same period. Keytruda will lose exclusivity in 2028. Last year it made up 35.2% of Merck’s total revenue. Seagen’s focus is on antibody-drug conjugates (ADCs). These therapies link cancer-specific antibodies to cancer toxins. Its best-known drug is Adcetris. Merck is one of the top oncology companies in the world but doesn’t have much of a focus on ADCs. Its market cap is $233 billion. In a note to investors in June, Wells Fargo analyst Mohit Bansal wrote, “The real value to MRK (Merck) is qualitative as SEGEN (Seagen) adds durability and diversity to the company beyond Keytruda,” according to Seeking Alpha. If Merck and Seagen do close on a deal, they can expect regulators to take a close look. The U.S. Securities and Exchange Commission has increased its scrutiny of larger mergers and is taking a hard look at competing products, sometimes forcing companies to divest drugs before the deal is approved. As an example, in 2020, when AbbVie acquired Allergan, the SEC and other regulators required the companies to divest brazikumab and Zenpep (pancrelipase). If they do manage to pull the deal together, it will be the largest life science M&A activity for the year to date. So far, the largest deal has been Pfizer’s acquisition of Biohaven for $11.6 billion. It’s been a relatively quiet year, with M&A activity in the sector down 58% compared to the first half of 2021, with a valuation of $61.7 billion. In the first half of this year, there have been 137 deals, down 33% from the same period in 2021. Other deals include Bristol Myers Squibb’s acquisition of Turning Point Therapeutics for $4.1 billion, GSK's takeover of Affinavax for $3.3 billion and Biocon Biologics’ acquisition of Viatris’ biosimilar portfolio and related commercial and operational capabilities for $3.3 billion. There are numerous factors behind the slow M&A market, including ongoing supply chain problems, inflation, political uncertainty globally with the Russia-Ukraine war, and higher input costs, especially around packaging, due to inflationary pressures. Still, many biopharma companies have plenty of cash, especially if they have had any COVID-19-related products approved over the last two years. A recent PwC report noted that “pharma is in a good position to combat this issue as most companies have plenty of cash on hand and can take more risks by purchasing early-stage assets. With capital becoming harder to come by for most biotechs, pharma is in a good position to acquire many of these companies at a discount from their highs of just a couple of years ago.”

AcquisitionAntibodyBiosimilarADC

24 Jun 2022

·www.biospace.com

Merck, Seagen Talks Heat Up Under Cloud of Regulatory Scrutiny

Kena Betancur/Getty Images Talks between Merck and Seagen are heating up as the former looks to buy the latter, according to a report from The Wall Street Journal. If the merger-and-acquisition deal did go through, it would likely be a sizable one, since Seagen has a market cap above $32 billion. This follows last week’s report published by WSJ that stated Merck was exploring purchasing the biotech company. In September 2020, Merck and Seagen entered into an agreement to co-develop ladiratuzumab vedotincancer, a cancer treatment, with Merck pitching in $600 million upfront and acquiring 5 million shares of Seagen stock for $1 billion. They also have a licensing deal for Tukysa in countries outside the U.S., Canada and Europe, and Merck dropped $125 million upfront for that cancer drug. Both companies are strong players in the oncology space. Merck’s lead product is its blockbuster anti-PD-1 checkpoint inhibitor Keytruda (pembrolizumab). The drug brought in $17.2 billion in 2021 alone. In the first quarter of this year, Keytruda brought in $4.7 billion, an increase of 23% from the previous year. Seagen focuses on antibody-drug conjugates (ADCs). These drugs have onco-toxins attached to an antibody that delivers the drugs directly to the tumors. Its best-known drug is Adcetris. On June 6, Seagen and Genmab announced interim data from the innovaTV 205 trial of Tivdak (tisotumab vedotin) in combination with Keytruda in patients with recurrent or metastatic cervical cancer who have not received previous systemic therapy. The interim data demonstrated a confirmed objective response rate (ORR) of 41% and median durability of response that was not achieved within almost 19 months of median follow-up. Tivdak is an ADC made up of Genmab’s human monoclonal antibody directed to tissue factor (TF) and Seagen’s ADC technology. “With Genmab, we will continue to investigate tisotumab vedotin in combination with other therapies because there is still an unmet need for more effective first-line treatment for advanced cervical cancer patients,” Marjorie Green, M.D., senior vice president and head of late-stage development at Seagen, said in a statement. “We’re also researching innovative new tools to help increase awareness of the disparities and unmet needs that cervical cancer patients experience in order to better support this community in the future.” Although Merck is a powerhouse in the oncology space, it doesn’t really focus on ADCs. It has a significantly larger market cap than Seagen, at about $233 billion. According to Seeking Alpha, Seagen's shares have risen considerably since the WSJ report, and Wells Fargo analyst Mohit Bansal wrote in a note that the value of a deal would be within the $200-$220/share range. "The real value to MRK (Merck) is qualitative as SGEN (Seagen) adds durability and diversity to the company beyond Keytruda," Bansal said in the note obtained by Seeking Alpha. Although picking up Seagen would certainly beef up its already strong oncology portfolio, Merck is reportedly concerned that regulators might block the deal. The Securities and Exchange Commission has taken a close look at competing products with merging companies, sometimes forcing companies to divest drugs for the deals to go through. For example, in 2020, when AbbVie acquired Allergan, regulators required the companies to divest brazikumab and Zenpep (pancrelipase). A recent report on the industry by PwC notes that one of the reasons M&A activity has been so slow this year is concern over increased regulatory scrutiny. On the other hand, a driving factor for M&A interest is an increasing number of patent expirations. Although Keytruda is still growing, its patents start to expire in 2028. Keytruda has been approved for a long list of cancer indications, both as a monotherapy and in combination with numerous other cancer drugs. Amidst all of this, Seagen is undergoing some changes. In May, the company’s president, CEO and board member, Clay Siegall, resigned after domestic violence allegations, which had resulted in a leave of absence earlier in the month. The board is currently conducting a search for a replacement. Meanwhile, Roger Dansey, M.D., the company’s chief medical officer, is acting as interim CEO.

AntibodyADCAcquisitionPatent Expiration

100 Deals associated with Pancrelipase(Eurand)

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-	-	A09AA02	DB00085

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Exocrine Pancreatic Insufficiency	United States	Eurand Pharmaceuticals, Inc.	27 Aug 2009

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Exocrine Pancreatic Insufficiency	Preclinical	Liechtenstein	Allergan Pharmaceuticals International Ltd.	29 Jun 2016
Exocrine Pancreatic Insufficiency	Preclinical	European Union	Allergan Pharmaceuticals International Ltd.	29 Jun 2016
Exocrine Pancreatic Insufficiency	Preclinical	Iceland	Allergan Pharmaceuticals International Ltd.	29 Jun 2016
Exocrine Pancreatic Insufficiency	Preclinical	Norway	Allergan Pharmaceuticals International Ltd.	29 Jun 2016
Steatorrhea	Preclinical	United States	Forest Laboratories LLC	01 Nov 2006
Cystic Fibrosis	Preclinical	United States	Forest Laboratories LLC	01 May 2006

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00880100 (CTgov)	Phase 3	Steatorrhea \| Exocrine Pancreatic Insufficiency \| Cystic Fibrosis	49	Ultrase® MT12	isrubxogne(vmvwwwfysl) = tlfahniqiq tydnhwgogm (uzgcsfutud, zejszhhdvx - lrvcgeskvk) View more	-	19 Feb 2015
NCT01100606 (CTgov)	Phase 4	Cystic Fibrosis \| Exocrine Pancreatic Insufficiency	15	EUR-1008 (APT-1008) (EUR-1008 (APT-1008) in Apple Juice)	udilzgiaoh(qknkcerhjd) = zytwtrgzrg vvapxmxkjd (ovstgevyra, qdwkynnrxu - nnqzgkqjzc) View more	-	10 Apr 2014
NCT01100606 (CTgov)	Phase 4	Cystic Fibrosis \| Exocrine Pancreatic Insufficiency	15	EUR-1008 (APT-1008) (EUR-1008 (APT-1008) in Apple Sauce)	udilzgiaoh(qknkcerhjd) = itligtdxwy vvapxmxkjd (ovstgevyra, plfxavfdfw - moiyhuwxbg) View more	-	10 Apr 2014
NCT00981214 (CTgov)	Phase 3	Exocrine Pancreatic Insufficiency \| Cystic Fibrosis	19	EUR-1008 (APT-1008)	wdbfhzifak(hzcfllvkli) = jynewhmadr epluqpdshd (xlfkewxsuo, nhvjlchmjh - uprtexfyur) View more	-	04 Apr 2014
NCT00788593 (CTgov)	Phase 3	Pancreatitis, Chronic \| Exocrine Pancreatic Insufficiency	82	EUR-1008 (APT-1008) Low Dose (EUR-1008 (APT-1008) Low Dose)	fpkrnqjcic(avekakwgar) = lgsmufzbvt fswulckwyy (gsenndsaxq, euomydgtbk - zuoermuiot) View more	-	12 Mar 2014
NCT00788593 (CTgov)	Phase 3	Pancreatitis, Chronic \| Exocrine Pancreatic Insufficiency	82	EUR-1008 (APT-1008) High Dose (EUR-1008 (APT-1008) High Dose)	fpkrnqjcic(avekakwgar) = qfkugttazv fswulckwyy (gsenndsaxq, ahhvbetftv - gcnmvjnvhp) View more	-	12 Mar 2014
NCT00559364 (CTgov)	Phase 3	Pancreatitis, Chronic \| Steatorrhea \| Exocrine Pancreatic Insufficiency	50	Proton pump inhibitor (PPI)+Omeprazole	gvvqmcbhry(qiunhadalx) = fvhfyqtlje zqitmbkiqf (rwcarllpen, pyiggrzxdf - ozqepdqbrk) View more	-	12 Mar 2014
NCT00408317 (CTgov)	Phase 3	Steatorrhea \| Cystic Fibrosis \| Exocrine Pancreatic Insufficiency	36	Ultrase® MT20 (Ultrase® MT20)	zomxzvrdrd(iesrfzbeka) = ypfbgybljy rbsnnbplui (qgsxgfthst, qiirezuznj - nowtgnxwol) View more	-	12 Mar 2014
NCT00408317 (CTgov)	Phase 3		36	Placebo (Placebo)	zomxzvrdrd(iesrfzbeka) = zcenyvaerc rbsnnbplui (qgsxgfthst, zriakvknst - vcavuhxjjm) View more	-	12 Mar 2014
NCT01131507 (PR-018, CTgov)	Phase 4	Exocrine Pancreatic Insufficiency \| Cystic Fibrosis	15	EUR-1008 (APT-1008)	aceoqeguwr(icciftseld) = hujojxmiol iknifgwwju (xlrtithkdx, wxnlywfhqy - nvlvxesiqd) View more	-	07 Mar 2014
IAS2002	Not Applicable	Diarrhea	22	Ultrase MT-20	jzglfazkzj(ukcqrgwcja) = lxunuciaij mqdhrnevdz (mtoidltsic )	-	01 Jan 2002

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