Replies to post #163316 on Biotech Values

[ariadndndough]

RBC on aria today

ARIA, Iclusig launch is tracking above expectations to beat Q2 with potential for EGFR data at ESMO (expectations are rightfully low here given too short of follow-up time on first tumor scan) and 1st line EPIC data in Q3:14. Either EGFR responses or clean safety/efficacy in EPIC could significantly improve ARIA takeout prospects since the company is unencumbered by any partnerships

[ghmm]

Peter do you have any thoughts on targeting JAK3? VRTX I believe is going after JAK3 but I don't know of any JAK1/3 compounds is there a reason we don't see someone going after JAK1/3?

[mcbio]

Although in that case the Galapagos compound comes into play as well. There was some good discussion over on SI about the long-lasting metabolite of the Galapagos drug.

Can you point me to when and where this was discussed on SI? Curious if "long-lasting metabolite" is a good or bad thing for the Galapagos drug.

[mcbio]

I personally have high hopes for a JAK1 drug in autoimmune disease. The basis for this is that inhibiting JAK1 in theory blocks STAT3, which in turn is one of the critical pathways for TH17, which I have come to believe is one of the key players in autoimmunity.

Do you have just as much confidence in the Galapagos JAK1 for Crohn's as you do RA?

[mcbio]

Galapagos - GLPG1205 enters clinic

http://finance.yahoo.com/news/galapagos-initiates-phase-1-trial-053707708.html

Galapagos initiates Phase 1 trial as part of its alliance with Janssen Pharmaceutica NV

MECHELEN, BELGIUM--(Marketwired - Jul 2, 2013) -

* GLPG1205 is a first-in-class molecule to enter the clinic
* Candidate drug targets inflammation of the bowel
* Galapagos receives EUR6.6 million milestone payment

Galapagos NV (GLPGF) announced today that it has initiated a First-in-Human (FIH) Phase 1 study with GLPG1205 as part of its alliance with Janssen Pharmaceutica NV. This achievement triggered a milestone payment of EUR6.6 million to Galapagos, which will contribute to H1 2013 revenues.

In 2007, Galapagos announced an alliance agreement with Janssen Pharmaceutica NV providing the option to worldwide, commercial licenses to certain Galapagos internal inflammatory disease programs. These programs include a novel target for inflammatory disorders that was identified and validated by Galapagos using its proprietary target discovery engine. Subsequent Galapagos research led to the discovery of GLPG1205, a first-in-class molecule that enters the clinic for inflammatory disorders. Galapagos will be responsible for execution of Phase 1 and Phase 2A studies with GLPG1205.

"With GLPG1205, Galapagos has moved another proprietary molecule with a novel mode-of-action into the clinic. This program has the potential to unlock a new class of drugs to treat inflammatory disorders. Consistent with our strategy of bringing innovative molecules to the clinic, this is the fourth First-in- Human study with a novel mode-of-action," said Onno van de Stolpe, CEO of Galapagos. "The alliance with Janssen is the second where Galapagos has brought programs from target to the clinic. Today's achievement brings Galapagos' pipeline to five clinical programs, and we are pleased we will be driving the Phase 1 and 2A studies forward with this potential new therapy in inflammatory disease."

The aim of this FIH study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of oral single and multiple ascending doses of GLPG1205. The randomized, double-blind, placebo-controlled, single center study will be conducted in 40 healthy volunteers in Belgium. In the first part of the study, single ascending doses will be evaluated. In the second part, the new compound will be administered daily for 14 days. Galapagos expects to disclose topline results from the study by the end of this year.

About Galapagos

Galapagos (Euronext: GLPG; OTC: GLPYY) is specialized in novel modes-of- action, with a large pipeline of five clinical, six pre-clinical, and 30 discovery small-molecule and antibody programs in cystic fibrosis, inflammation, antibiotics, metabolic disease, and other indications. GLPG0634 is an orally-available, selective inhibitor of JAK1 for the treatment of rheumatoid arthritis and potentially other inflammatory diseases, currently in Phase 2B studies in RA and about to enter Phase 2 studies in Crohn's disease. AbbVie and Galapagos signed a worldwide license agreement whereby AbbVie will be responsible for further development and commercialization after Phase 2B. Galapagos has another selective JAK1 inhibitor in Phase 2 in lupus and psoriasis, GSK2586184 (formerly GLPG0778, in-licensed by GlaxoSmithKline in 2012). GLPG0187 is a novel integrin receptor antagonist currently in a Phase 1B patient study in metastasis. GLPG0974 is the first inhibitor of FFA2 to be evaluated clinically for the treatment of IBD; this program is currently in a Proof of Concept Phase 2 study. GLPG1205 is a first-in-class molecule that targets inflammatory disorders and is currently in a First-in-Human Phase 1 study.

The Galapagos Group, including fee-for-service companies BioFocus, Argenta and Fidelta, has 800 employees and operates facilities in five countries, with global headquarters in Mechelen, Belgium. Further information at: www.glpg.com