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Jumping on JAK1
MECHELEN, Belgium—Abbott and Galapagos NV have entered into a global collaboration to develop and commercialize an oral, next- generation JAK1 inhibitor in Phase II development with the potential to treat rheumatoid arthritis (RA) and other autoimmune diseases such as psoriatic arthritis, inflammatory bowel disease and systematic lupus.
Under the terms of their agreement, Abbott will make an initial upfront payment of $150 million for rights related to the global collaboration. Upon successful completion of the RA Phase II studies, Abbott will license the program for a one-time fee of $200 million if the studies meet certain pre-agreed upon criteria.
Galapagos will perform and fund the Phase IIa and Phase IIb trials in RA. Abbott will assume sole responsibility for Phase III clinical development and global manufacturing. Pending achievement of certain developmental, regulatory, commercial and sales-based milestones, Galapagos is eligible to receive additional milestone payments, potentially amounting to $1 billion, in addition to tiered double-digit royalties on net sales upon commercialization. Galapagos retains co-promotion rights in Belgium, the Netherlands and Luxembourg.
JAK1 is one of a family of enzymes that play a key role in the signaling mechanism used by a number of cytokines that are involved in autoimmune diseases. In previously reported results from a four-week Phase IIa study, 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 II proof-of-concept study in rheumatoid arthritis patients, with a 42 to 58 percent improvement in ACR20 scores compared to placebo," Stolpe observes. "Although the study was not powered to achieve statistical significance, the improvement observed in ACR20 scores (a 20-percent or more reduction in tenderness and swelling) was so dramatic that the results were statistically significant."
All patients completed the study, and few experienced any side effects. No anemia, change in blood pressure or lipids were observed. An additional Phase IIa dose-range finding study with GLPG0634 is expected to begin shortly.
"The addition of this novel, oral compound offers patients the potential for advanced treatment options and an improved patient experience to address RA and other autoimmune diseases," notes Dr. John Leonard, Abbott's senior vice president of global research and development.
"This collaboration with Abbott, the global leader in autoimmune diseases, is a great recognition of the value of GLPG0634. We view Abbott to be the best partner possible to deliver a complete clinical program and a powerful market introduction. We are excited to continue the Phase II trials 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 to clinical proof of concept, and we aim to do the same on many novel target programs in our pipeline."
Stolpe notes the collaboration is transformational for Galapagos, providing the means to progress these innovative products into the clinic.
"This deal with Abbott really validates our entire approach to target and drug discovery and development," he states. "Also, the financial terms provide the company sufficient cash to fund other promising programs in our pipeline, which were discovered using the same approach as for GLPG0634. We will take the time to set the priorities going forward, but we have so many promising programs to choose from, including novel mode-of-action programs in cystic fibrosis, antivirals, atherosclerosis and respiratory diseases."
The Galapagos Group has about 800 employees—almost doubling its head count over the past three years—and operates facilities in six countries. More than half of the growth has come via the acquisitions of Argenta and the Zagreb research center of GSK, Stolpe notes.
"These acquisitions allowed us to solidify the leadership position that BioFocus already had in the premium segment of drug discovery services, and provided much-needed additional and high-quality R&D capacity," Stolpe says. "The rest of the growth in personnel has come organically, as we expanded our alliance franchise and matured into a full-grown development company."
Abbott's STARLIMS business acquires distribution partners
ABBOTT PARK, Ill.—As part of a series of strategic moves to build its laboratory information management system (LIMS) business in Europe and emerging markets in Latin America and Africa, STARLIMS Technologies, an Abbott company, has announced the acquisition of several longtime distribution partners.
These acquisitions include STARLIMS's French distributor Varilab; operations of two privately held Spanish businesses, now operating as STARLIMS Iberica; a privately held Dutch company, now operating as STARLIMS Netherlands, with a branch office in Solna, Sweden; and the business of its Israeli distribution partner, STARLIMS Israel Ltd. In addition, the company established STARLIMS Germany GmbH, with offices in Witten, Germany, to provide direct support for its German and Swiss customers.
"The successful completion of these transactions represents Abbott's commitment to invest in and accelerate the growth of STARLIMS' core business," says Isaac Friedman, head of Abbott's STARLIMS business. "With these acquisitions, we now have more than 100 experienced LIMS engineers in the region allowing us to better serve our fast-growing European customer base and further strengthen our position as a leading provider of laboratory information management systems in Europe and other important markets."