MECHELEN, Belgium—Abbott and Galapagos NV have entered intoa global collaboration to develop and commercialize an oral, next-generationJAK1 inhibitor in Phase II development with the potential to treat rheumatoidarthritis (RA) and other autoimmune diseases such as psoriatic arthritis,inflammatory bowel disease and systematic lupus.
Under the terms of their agreement, Abbott will make aninitial upfront payment of $150 million for rights related to the globalcollaboration. Upon successful completion of the RA Phase II studies, Abbottwill license the program for a one-time fee of $200 million if the studies meetcertain pre-agreed upon criteria.
Galapagos will perform and fund the Phase IIa and Phase IIbtrials in RA. Abbott will assume sole responsibility for Phase III clinicaldevelopment and global manufacturing. Pending achievement of certaindevelopmental, regulatory, commercial and sales-based milestones, Galapagos iseligible to receive additional milestone payments, potentially amounting to $1billion, in addition to tiered double-digit royalties on net sales uponcommercialization. Galapagos retains co-promotion rights in Belgium, theNetherlands and Luxembourg.
JAK1 is one of a family of enzymes that play a key role inthe signaling mechanism used by a number of cytokines that are involved inautoimmune diseases. In previously reported results from a four-week Phase IIastudy, GLPG0634 demonstrated efficacy measures among the best reported in RA,according to Onno van de Stolpe, Galapagos' CEO.
"GLPG0634 achieved the primary endpoint in the Phase IIproof-of-concept study in rheumatoid arthritis patients, with a 42 to 58percent improvement in ACR20 scores compared to placebo," Stolpe observes."Although the study was not powered to achieve statistical significance, theimprovement observed in ACR20 scores (a 20-percent or more reduction intenderness and swelling) was so dramatic that the results were statisticallysignificant."
All patients completed the study, and few experienced anyside effects. No anemia, change in blood pressure or lipids were observed. Anadditional Phase IIa dose-range finding study with GLPG0634 is expected tobegin shortly.
"The addition of this novel, oral compound offers patientsthe potential for advanced treatment options and an improved patient experienceto address RA and other autoimmune diseases," notes Dr. John Leonard, Abbott'ssenior vice president of global research and development.
"This collaboration with Abbott, the global leader inautoimmune diseases, is a great recognition of the value of GLPG0634. We viewAbbott to be the best partner possible to deliver a complete clinical programand a powerful market introduction. We are excited to continue the Phase IItrials and expect to deliver to Abbott a complete Phase II package in 2014,"adds Stolpe. "With GLPG0634, we have proven that we can deliver from target toclinical proof of concept, and we aim to do the same on many novel target programsin our pipeline."
Stolpe notes the collaboration is transformational forGalapagos, providing the means to progress these innovative products into theclinic.
"This deal with Abbott really validates our entire approachto target and drug discovery and development," he states. "Also, the financialterms provide the company sufficient cash to fund other promising programs inour pipeline, which were discovered using the same approach as for GLPG0634. Wewill take the time to set the priorities going forward, but we have so manypromising programs to choose from, including novel mode-of-action programs incystic fibrosis, antivirals, atherosclerosis and respiratory diseases."
The Galapagos Group has about 800 employees—almost doublingits head count over the past three years—and operates facilities in sixcountries. More than half of the growth has come via the acquisitions ofArgenta and the Zagreb research center of GSK, Stolpe notes.
"These acquisitions allowed us to solidify the leadershipposition that BioFocus already had in the premium segment of drug discoveryservices, and provided much-needed additional and high-quality R&Dcapacity," Stolpe says. "The rest of the growth in personnel has comeorganically, as we expanded our alliance franchise and matured into a full-growndevelopment company."
Abbott's STARLIMS business acquires distribution partners
ABBOTT PARK, Ill.—As part of a series of strategic moves tobuild its laboratory information management system (LIMS) business in Europeand emerging markets in Latin America and Africa, STARLIMS Technologies, anAbbott company, has announced the acquisition of several longtime distributionpartners.
These acquisitions include STARLIMS's French distributorVarilab; operations of two privately held Spanish businesses, now operating asSTARLIMS Iberica; a privately held Dutch company, now operating as STARLIMSNetherlands, with a branch office in Solna, Sweden; and the business of itsIsraeli distribution partner, STARLIMS Israel Ltd. In addition, the companyestablished STARLIMS Germany GmbH, with offices in Witten, Germany, to providedirect support for its German and Swiss customers.
"The successful completion of these transactions representsAbbott's commitment to invest in and accelerate the growth of STARLIMS' corebusiness," says Isaac Friedman, head of Abbott's STARLIMS business. "With theseacquisitions, we now have more than 100 experienced LIMS engineers in theregion allowing us to better serve our fast-growing European customer base andfurther strengthen our position as a leading provider of laboratory informationmanagement systems in Europe and other important markets."