Independent education resourceInformation here does not replace care from a qualified health professional.
Peptide Therapy GuideClear peptide education

Educational guide

AbbVie Takes Control of Cystic Fibrosis Collaboration with Galapagos

AbbVie will assume full development and commercialization responsibilities for all cystic fibrosis (CF) programs partnered with Galapagos, under a restructuring of the companies’ five-year-old collaboration that could generate more than $245 million for the Be

Written by Peptide Therapy Guide Editorial Team
For education only

This guide cannot diagnose a condition or recommend a personal treatment plan. Discuss medical questions with a qualified professional.

AbbVie will assume full development and commercialization responsibilities for all cystic fibrosis (CF) programs partnered with Galapagos, under a restructuring of the companies’ five-year-old collaboration that could generate more than $245 million for the Belgian biotech.

Under the restructuring, AbbVie will continue development of a CF therapy combining three Galapagos candidates—as well as oversee several clinical and preclinical compounds originally discovered and developed jointly by AbbVie and Galapagos.

The triple combination—Galapagos’ C2 corrector GLPG2737, C1 corrector GLPG2222, and potentiator GLPG2451— are intended to collectively increase the activity of the mutated copies of the cystic fibrosis transmembrane conductance regulator (CFTR) protein that causes CF.

The triple combination showed no additional enhancement of CFTR activity over a dual combination of GLPG2222 and GLPG2451 following two weeks of treatment, according to topline interim results of Part 1 of the Phase I FALCON trial (NCT03540524) announced by Galapagos.

And after a previous two-week period, treatment with the dual combination resulted in a mean increase in percent predicted FEV1 of just approximately 3%, and mean decrease from baseline in sweat chloride concentration of approximately 25 mmol/L.

The triple combination candidates are three of five clinical-phase CFTR modulators identified by Galapagos in a June 7 investor presentation; the other two were potentiator GLPG3067, and C1 corrector GLPG2851. Also identified was a preclinical candidate, the C2 corrector GLPG3748.

‘Promising Candidates’

“Our previous work with Galapagos has identified a number of promising candidates and we thank them for their contribution to our partnership,” Michael Severino, M.D., AbbVie EVP of R&D and CSO, said yesterday in a company statement. “We have a proven track record working with challenging molecular targets across a wide range of life-threatening illnesses and will harness this expertise to progress the next-generation of CF treatment.”

AbbVie agreed to pay Galapagos $45 million upfront, and up to $200 million tied to achieving development, regulatory, and commercial milestones. Upon receiving regulatory approval and attaining commercial sales in CF, AbbVie has agreed to pay Galapagos royalties ranging from the single digit to low teen percentages.

Galapagos said it retains exclusive global commercial rights to develop GLPG2737 in all indications outside of CF. Should GLPG2737 or other candidates be approved for indications other than CF, Galapagos has agreed to pay AbbVie future milestone payments and tiered single digit royalties on future global commercial sales.

“We are very pleased with the outcome of our discussions with AbbVie regarding the future of the CF portfolio,” stated Galapagos CEO Onno van de Stolpe. “We believe that AbbVie is well-equipped to further develop this CF portfolio and to come up with a competitive triple combination product for CF patients.”

Galapagos and AbbVie launched their collaboration in September 2013, focused on treating CF by discovering, developing, and commercializing potentiator and corrector molecules. At the time, AbbVie paid Galapagos $45 million upfront and agreed to pay up to $405 million.

In April 2016, citing expansion of their CF portfolio, the companies expanded their CF collaboration by nearly doubling the size of AbbVie’s total potential payments to Galapagos tied to achieving Phase I and Phase II milestones.

Connected reading

Helpful context for this guide

Source-derived material selected through this article’s indexed topics.

Related questions

01What 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 ↗
02What 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 ↗
03What you can do

You might want to take a friend or family member with you to the appointment to help you remember information. Before your appointment, make a list of: Symptoms and when they started. Include anything that makes symptoms worse or better. All medicines, vitamins, herbs and supplements that you or your child take. Include the doses. Family history, such as whether anyone in your family has cystic fibrosis. Treatment you or your child have had for CF, if any. Include what the treatment was and if it helped. Any other medical conditions and their treatments. Questions to ask your healthcare professional. Questions to ask may include: What is likely causing these symptoms? What kinds of tests are needed? What treatment do you recommend? I or my child have other health conditions. How will cystic fibrosis affect them? Are there any limits needed? Feel free to ask other questions during your appointment.

Source: www.mayoclinic.org ↗
04How Strong Is the Evidence for Alyftrek?

Based on the current clinical studies, Alyftrek is a safe and effective treatment for people with cystic fibrosis. The Cystic Fibrosis Foundation published a CFTR modulator therapy care guideline in 2018. Alyftrek is not included in these guidelines since it was approved by the FDA after these guidelines were published.

Source: www.webmd.com ↗
05What is a sweat test?

A sweat test measures the amount of chloride in your sweat . Chloride is a type of electrolyte . Electrolytes are electrically charged minerals  that help control the amount of fluids and the balance of acids and bases (pH balance) in your body. Chloride and sodium form the salt found in your sweat.

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 ↗
P

About the author

Peptide Therapy Guide Editorial Team

Editorial team for Peptide Therapy Guide.

View all articles →