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Lilly Buys Alnara to Acquire Registrational-Stage Non-Porcine ERT for Pancreatic Insufficiency

Recombinant oral therapy comprises lipase, protease, and amylase. Lilly is buying Alnara Pharmaceuticals in order to get a foothold in the enzyme replacement therapy market. The acquired firm’s lead product liprotamase is an oral, nonporcine pancreatic enzyme

Written by Peptide Therapy Guide Editorial Team
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This guide cannot diagnose a condition or recommend a personal treatment plan. Discuss medical questions with a qualified professional.

Recombinant oral therapy comprises lipase, protease, and amylase.

Lilly is buying Alnara Pharmaceuticals in order to get a foothold in the enzyme replacement therapy market. The acquired firm’s lead product liprotamase is an oral, nonporcine pancreatic enzyme replacement therapy (PERT), which is currently under FDA review for the treatment of exocrine pancreatic insufficiency.

“The acquisition of Alnara provides Lilly with a promising entry into enzyme replacement therapy,” commented Bryce Carmine, executive vp of Lilly and president of Lilly BioMedicines. “Alnara has been very successful in the development of liprotamase, as indicated by its recent submission to FDA, and we look forward to partnering with Alnara’ experts during the regulatory review process.”

Liprotamase comprises the digestive enzymes lipase, protease, and amylase, and is produced using recombinant technology. It has been formulated so patients need only take 1–2 small capsules per meal or snack, Alnara states.

The firm’s process development and production partner for liprotamase is Lonza, which has provided the microbial fermentation, process optimization, technical, and regulatory support for generating the product. Lonza is manufacturing Liprotamase at its FDA-registered facility in the Czech Republic.

The development of liprotamase over the last 12 months has been carried out by Alnara in collaboration with Cystic Fibrosis Foundation Therapeutics, the nonprofit drug discovery and development affiliate of the Cystic Fibrosis Foundation (CFF). The product was acquired by Alnara from the Cystic Fibrosis Foundation (CFF) in 2009, which earlier the same year had taken the product over from Altus Pharmaceuticals.

The clinical development program for liprotamase included some 500 patients with exocrine pancreatic insufficiency due to cystic fibrosis, chronic pancreatitis or pancreatectomy. Alnara claims the Phase II and Phase III clinical trials represent the largest body of prospective clinical data for any pancreatic enzyme, with both pivotal efficacy trials demonstrating that the treatment significantly improves both fat and protein absorption.

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Related questions

01What to expect from your doctor

After getting detailed information about the symptoms and your family's medical history, your healthcare professional may order tests to help with diagnosis and plan treatment. Your healthcare professional also may ask questions, such as: What symptoms are you or your child having? When did the symptoms start? Does anything make the symptoms better or worse? Has anyone in your family ever had cystic fibrosis? Has growth been average and weight been stable? Cystic fibrosis. National Heart, Lung, and Blood Institute. https://www.nhlbi.nih.gov/health/cystic-fibrosis. Accessed Aug. 8, 2024. Bronchiectasis. National Heart, Lung, and Blood Institute. https://www.nhlbi.nih.gov/health/bronchiectasis. Accessed Aug. 8, 2024. FAQs: Cystic fibrosis: Prenatal screening and diagnosis. American College of Obstetricians and Gynecologists. https://www.acog.org/womens-health/faqs/cystic-fibrosis-prenatal-screening-and-diagnosis. Accessed Aug. 8, 2024. Ferri FF. Cystic fibrosis. In: Ferri's Clinical Advisor 2025. Elsevier; 2025. https://www.clinicalkey.com. Accessed Aug. 8, 2024. Kliegman RM, et al., eds. Cystic fibrosis. In: Nelson Textbook of Pediatrics. 22nd ed. Elsevier; 2025. https://www.clinicalkey.com. Accessed Aug. 8, 2024. Kellerman RD, et al. Cystic fibrosis. In: Conn's Current Therapy 2024. Elsevier; 2024. https://www.clinicalkey.com. Accessed Aug. 8, 2024. Lockwood CJ, et al., eds. Respiratory diseases in pregnancy. In: Creasy and Resnik's Maternal-Fetal Medicine: Principles and Practice. 9th ed. Elsevier; 2023. https://www.clinicalkey.com. Accessed Aug. 8, 2024. Ong T, et al. Cystic fibrosis: A review. JAMA. 2023; doi:10.1001/jama.2023.8120. Rubin R. Tackling the misconception that cystic fibrosis is a "white people's disease." JAMA. 2021; doi:10.1001/jama.2021.5086. Care centers. Cystic Fibrosis Foundation. https://www.cff.org/managing-cf/care-centers. Accessed Aug. 8, 2024. Trikafta (prescribing information). Vertex Pharmaceuticals Inc.; 2023. https://www.trikafta.com/. Accessed Aug. 8, 2024. Symdeko (prescribing information). Vertex Pharmaceuticals Inc.; 2023. https://www.symdeko.com/. Accessed Aug. 8, 2024. Orkambi (prescribing information). Vertex Pharmaceuticals Inc.; 2023. https://www.orkambi.com/. Accessed Aug. 8, 2024. Kalydeco (prescribing information). Vertex Pharmaceuticals Inc.; 2023. https://www.kalydeco.com/. Accessed Aug. 8, 2024. Pilewski JM. Update on lung transplantation for cystic fibrosis. Clinics in Chest Medicine. 2022; doi:10.1016/j.ccm.2022.07.002. Fridell JA, et al. Pancreas transplantation for cystic fibrosis: A frequently missed opportunity. Clinical Transplantation. 2021; doi:10.1111/ctr.14371. Wadsworth LE, et al. Non-invasive ventilation is associated with long-term improvements in lung function and gas exchange in cystic fibrosis adults with hypercapnic respiratory failure. Journal of Cystic Fibrosis. 2021; doi:10.1016/j.jcf.2021.05.011. Allscripts EPSi. Mayo Clinic. Medical review (expert opinion). Mayo Clinic. Oct. 18, 2024.

Source: www.mayoclinic.org ↗
02What Is Cystic Fibrosis?

Cystic fibrosis (CF) is a genetic disorder, which means you get it from your parents at birth. It affects your lungs, pancreas, and other organs. CF changes the way chloride (salt) moves through the cells of your body. This causes the mucus (which should be thin and slippery) in various organs to become thick and sticky. Over time, this thick mucus builds up inside your airways, making it hard to breathe. The mucus traps germs and leads to infections and inflammation. It can also cause severe, long-term damage to the lungs and lead to respiratory failure (inability to breathe normally) and death. In the pancreas, the thick mucus caused by CF prevents the release of digestive enzymes when you eat. This leads to malnutrition and poor growth. CF can also cause liver disease, reproductive problems, and cystic fibrosis-related diabetes (CFRD). More than 40,000 people in the U.S. live with CF. Doctors diagnose about 1,000 new cases each year. Today, more than half of the CF population is aged 18 or older, and new treatments have expanded the life expectancy by decades.

Source: www.webmd.com ↗
03What is cystic fibrosis? A Mayo Clinic expert explains

Learn more from pulmonologist Sarah Chalmers, M.D. Cystic fibrosis (CF) is a condition passed down in families that causes damage to the lungs, digestive system and other organs in the body. CF affects the cells that make mucus, sweat and digestive juices. These fluids, also called secretions, are usually thin and slippery to protect the body's internal tubes and ducts and make them smooth pathways. But in people with CF, a changed gene causes the secretions to become sticky and thick. The secretions plug up pathways, especially in the lungs and pancreas. CF gets worse over time and needs daily care, but people with CF usually can attend school and work. They often have a better quality of life than people with CF had in past decades. Better screening and treatments mean that people with CF now may live into their mid- to late 50s or longer, and some are being diagnosed later in life.

Source: www.mayoclinic.org ↗
04How Do I Know if Alyftrek Is Working?

Your health care provider will monitor your progress while you are taking Alyftrek to make sure the treatment is effective. One key test used to measure progress is lung function testing (like FEV₁%), which checks how well your lungs are working. If Alyftrek is working, your FEV₁% may get better or remain the same over time. Another important measure is sweat chloride levels. Higher sweat chloride levels are a sign of cystic fibrosis, and Alyftrek may help lower these levels by helping the CFTR protein work better. Your health care provider may order sweat chloride tests to track improvements. In addition to lab tests, you may notice fewer lung infections, better breathing, less coughing, and increased energy levels. Your health care provider will also monitor for any side effects and may adjust your treatment plan if needed. Always follow up with your health care team to discuss any changes in symptoms or concerns about your treatment. Do not stop taking Alyftrek without talking to your health care provider first. Your symptoms may get worse again if you stop or change any of your medicines.

Source: www.webmd.com ↗
05Will I need to do anything to prepare for the test?

You don't need any special preparations for a sweat test, but you should avoid applying any creams or lotions to the skin for 24 hours before the test.

Source: medlineplus.gov ↗
Research context

Read sources and limitations before applying a claim.

Research and Statistics: Who Has Cystic Fibrosis?

About 40,000 people are living with cystic fibrosis in the United States, and there are approximately 105,000 people with CF worldwide. (3) More than 75 percent of people with the disease are diagnosed by age 2, and more than half of all people living with cystic fibrosis are 18 or older. CF occurs predominantly in white populations, at a rate of 1 in 2,500 births. Between 2 and 5 percent of white people are carriers of the CFTR gene variant but have no overt clinical signs of disease. The disease is less common among African Americans, occurring at the much lower frequency of approximately 1 out of 17,000 births. (15) CF gene variants are most prevalent in persons of northern and central European ancestries or of Ashkenazi Jewish descent. They are rarely found in Native Americans, Asians, or native Africans. (16) CF is equally common among men and women, but women patients fare significantly worse than male patients with the disease. The median survival age for female CF patients is about three years younger than it is for men, but the reasons for the poorer survival rates among women are not completely understood. (17)

Source: everydayhealth.com ↗
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Peptide Therapy Guide Editorial Team

Editorial team for Peptide Therapy Guide.

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