Galapagos (GLPG) Gives Update on Cystic Fibrosis Program

Galapagos NV GLPG, with partner AbbVie Inc. ABBV, announced its aim to develop a triple cystic fibrosis transmembrane conductance regulator (CFTR) combination therapy for the treatment of patients with cystic fibrosis (CF).

In order to identify the triple combination, the companies will develop multiple candidates and backups for each of the three components (1st generation correctors, next generation correctors, and potentiators).

Currently, Galapagos is evaluating GLPG2222, a 1st generation corrector, in a phase I study. Initiation of the study triggered a milestone payment of $10 million from AbbVie. Top-line data is expected in the second quarter of 2016. Galapagos expects to initiate a phase I study on GLPG2851, another 1st generation corrector, by 2016 end.

Meanwhile, the company expects to initiate a phase I study on GLPG2665, the first next-generation corrector, by mid 2016. An additional next-generation corrector, GLPG2737, is also expected to enter a phase I study in the fourth quarter of 2016.

Moreover, the company received approval in several countries to initiate an exploratory phase II program on GLPG1837, as a potentiator. A phase I study on an additional potentiator, GLPG2451, is expected to be initiated in the second quarter of 2016.

We remind investors that in Sep 2013, Galapagos and AbbVie had entered into a global collaboration agreement for the development and commercialization of potentiator and corrector molecules for the treatment of patients with CF. As per terms of the agreement, after the successful completion of phase II development conducted by Galapagos, AbbVie will be responsible for conducting phase III development, with Galapagos responsible for the financial contribution.

Till date, Galapagos has received upfront payment of $45 million and milestone payments of $20 million from AbbVie. In addition, Galapagos is eligible to receive up to $340 million of total additional payment for developmental and regulatory milestones, sales milestones, and additional tiered royalty payments, ranging from mid-teens to 20%.

According to information provided by the company, approximately 80,000 and 30,000 patients are affected by CF in the world and the U.S., respectively.

Galapagos currently carries a Zacks Rank #2 (Buy), while AbbVie has a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector are Horizon Pharma plc HZNP and Ligand Pharmaceuticals Incorporated LGND,  both sporting a Zacks Rank #1 (Strong Buy).

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