10:33 PM
Sep 12, 2018
 |  BC Extra  |  Financial News

Galapagos follows positive RA data with $300M round

Editor's Note: This article was updated on Sep 13, 2018 at 10:45 AM PDT

On the heels of positive Phase III data for rheumatoid arthritis therapy filgotinib, Galapagos N.V. (Euronext:GLPG; NASDAQ:GLPG) raised $300 million through the sale of 2.6 million ADSs at $116.50 on NASDAQ. Morgan Stanley, Citigroup, Kempen & Co., Nomura and Stifel are underwriters.

On Tuesday, Galapagos and Gilead Sciences Inc. (NASDAQ:GILD) said both once-daily 100 and 200 mg doses of filgotinib met the primary endpoint of improving ACR20 response rate at week 12 vs. placebo in the Phase III FINCH 2 trial to treat moderate to severe RA (57.5% and 66%, respectively, vs. 31.1%, p<0.001 for both). Filgotinib is an oral Janus kinase-1 (JAK-1) inhibitor (see "Filgotinib Meets in Phase III FINCH 2 Study for RA").

Gilead gained exclusive, worldwide rights to co-develop and commercialize filgotinib to treat inflammatory diseases from Galapagos in December 2015, less than three months after AbbVie Inc. (NYSE: ABBV) declined its option to the compound to develop its own JAK-1 inhibitor, upadacitinib (see "Growing up Galapagos").

In September 2017, AbbVie said once-daily 15 and 30 mg doses of upadacitinib led to ACR20 response rates at week 12 of 65% and 56%, respectively, vs. 28% for placebo (p<0.001 for both) in the Phase III SELECT-BEYOND trial to treat moderate to severe RA.

While filgotinib's response rates in FINCH 2 are comparable to that of upadacitinib in SELECT-BEYOND, there were no adverse events of deep vein thrombosis (DVT) or pulmonary embolism (PE) reported with filgotinib, compared with six cases of PE in patients who received upadacitinib in the trial as reported at the European Congress of Rheumatology in June. Additionally, there were no deaths in filgotinib-treated patients in FINCH 2, while adverse events led to two deaths in upadacitinib-treated patients in SELECT-BEYOND.

While filgotinib's development timeline is trailing behind, analysts believe its superior safety profile could give it a leg up over upadacitinib in the market.

FINCH 2 was the first of three registrational trials for filgotinib; Gilead expects data in 1H19 from the Phase III FINCH 1 and FINCH 3 trials of filgotinib to treat RA in patients who had an inadequate response to methotrexate and in methotrexate-naïve patients, respectively.

AbbVie plans to submit regulatory applications for upadacitinib in 4Q18.

Galapagos, which announced the offering after market close on Wednesday, added $0.51 to $120.22 on NASDAQ on Thursday. The company lost €2.55 to €102 on Euronext.

Gilead was up $0.72 to $74.12 on Thursday.

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