Replies to post #138060 on Biotech Values

[mcbio]

Galapagos - ABT deal CC notes

1. Galapagos hopes its JAK1 RA drug will be on the market in 2017. Phase 2a results will be out Q4 this year. Phase 2b expected to begin in 2013 with results in 2H2014, at which time ABT would make its decision on whether or not to exercise its option on the drug and carry it forward (and pay Galapagos an additional $200M).

2. Props to the analyst who asked for more color behind the tiered double-digit royalty rate by noting that double-digit can mean anywhere from 10-99%. Unfortunately, as expected, there was no further detail offered on the range other than Galapagos is "very pleased."

3. Galapagos had multiple comparable deal sheets on the table for the drug. Given this, hopefully the terms due Galapagos are more like those due RIGL from AZN on fostamatinib (20-35%; see #msg-55725991) and not just in the 10-15% range.

4. Galapagos did not get interest from potential parties on a buyout; discussions were centered around a partnership. This is what they prefer as the company wants to remain independent. Galapagos believes the potential for a buyout is now reduced given the ABT deal.

[mcbio]

Galapagos held discussions with 12 potential partners for the drug, said Van de Stolpe. The company chose Abbott because “they are innovative, they’re a dominant player, and they were willing to pay premium terms.” [Unlike the CEO’s assertion earlier in this post, this one is entirely believable.]

Just another comment on this deal. Isn't ABT the partner one would want given their colossal success with Humira in the RA space? Really do think Galapagos has the right partner here. They just need to deliver on the data.

[mcbio]

Galapagos - commences GLPG0634 Phase 2a trial

http://finance.yahoo.com/news/galapagos-initiates-phase-iia-study-053900236.html

Galapagos initiates Phase IIa study with GLPG0634

MECHELEN, BELGIUM--(Marketwire -05/14/12)-


* Selective JAK1 profile differentiates from other compounds in development

* Follows successful outcome of Proof of Concept study in rheumatoid arthritis patients

* Phase IIa study designed to assess efficacy and safety in rheumatoid arthritis patients over wide dose range and in multiple countries by the end of 2012

Galapagos NV (GLPGF.PK) announced today that it has started its second Phase IIa clinical study with GLPG0634, a novel Janus kinase 1 (JAK1) inhibitor being developed to treat multiple autoimmune diseases, such as rheumatoid arthritis (RA). In this clinical study, the efficacy and safety of GLPG0634 will be evaluated for four weeks in RA patients, with completion planned by the end of 2012.

"The promising results from our Proof of Concept study clearly differentiate GLPG0634 from other JAK inhibitors in development in RA, both in terms of efficacy and safety. With the start of a broader Phase IIa study, we look forward to gathering dose-range finding data from 90 patients across multiple countries, adding to our understanding of the candidate drug's differentiation," said Dr Piet Wigerinck, Chief Scientific Officer of Galapagos. "Meanwhile, the expansion of our development team is progressing on track, as we also prepare for the global Phase IIb study that should start next year."

Details of the Phase IIa clinical study

The Phase IIa study for GLPG0634 will enroll 90 patients with active rheumatoid arthritis, showing an insufficient response to the standard-of-care treatment, methotrexate (MTX). The aim is to evaluate the efficacy, safety, tolerability and pharmacokinetics of once-daily dosing of 30 to 300mg of GLPG0634 in treating rheumatoid arthritis. Five groups of 18 patients with active disease will take the once-daily regimen of GLPG0634 or placebo for a period of four weeks, while all will continue to take their stable background therapy of MTX. The primary efficacy endpoint will be the ACR20 response rate[1], the standard primary endpoint for early response in RA clinical studies. Secondary endpoints include improvements in DAS28, ACR50 and ACR70 rates. Galapagos has received approvals to start the study in multiple sites across 4 different countries (Hungary, Moldova, Russia, and Ukraine), with patient recruitment currently underway. The study has been designed and is anticipated to deliver data by the end of 2012.

About candidate drug GLPG0634

GLPG0634 is an orally-available, novel Janus kinase (JAK) inhibitor with selectivity for JAK1 developed by Galapagos. JAKs are critical components of signaling mechanisms utilized by a number of cytokines and growth factors, including those that are elevated in rheumatoid arthritis patients. JAK inhibitors have shown long-term efficacy in rheumatoid arthritis studies with an early onset of action. GLPG0634 differentiates from other JAK inhibitors in development by specifically targeting JAK1, a strategy which could result in a better efficacy and safety profile. GLPG0634 is a fully proprietary program. Upon successful completion of the RA Phase IIb studies, Abbott will license the program and will assume sole responsibility for Phase III clinical development and global manufacturing.

About Galapagos

Galapagos (Euronext: GLPG; OTC: GLPYY) is a mid-size biotechnology company specialized in the discovery and development of small molecule and antibody therapies with novel modes-of-action. The Company is progressing GLPG0634, as well as one of the largest pipelines in biotech, with four programs in development and over 50 discovery programs. The Galapagos Group has about 800 employees and operates facilities in six countries, with global headquarters in Mechelen, Belgium. More info at: www.glpg.com