Date: 2016-12-03
Type of information: Product acquisition
Compound: crizanlizumab (anti-P-selectin antibody SelG1)
Company: Novartis (Switzerland) Selexys Pharmaceuticals (USA - OK)
Therapeutic area: Genetic diseases - Blood diseases
Type agreement: product acquisition
Action mechanism: monoclonal antibody. SelG1 (crizanlizumab) is an investigational humanized monoclonal antibody directed against P-selectin, a key member of the adhesion molecule family known as the selectins. In preclinical studies, inhibition of P-selectin has been shown to effectively prevent vasoocclusion by blocking critical cell-cell interactions that drive this process. Therapeutic blockade of P-selectin may therefore reduce or prevent vasoocclusive crises in patients with sickle cell disease.
Disease: sickle cell disease
Details: Selexys Pharmaceuticals has entered into an agreement with Novartis Pharmaceuticals whereby Novartis has been granted an exclusive option to acquire Selexys and its lead asset, the anti-P-selectin antibody SelG1, following the successful completion of a Phase 2 clinical study in patients with sickle cell disease.
The SelG1 program for sickle cell disease is supported by Small Business Innovation Research (SBIR) fast-track award #5R44HL093893-02 and #2R44HL093893-03 through the National Heart, Lung and Blood Institute.
Selexys Pharmaceuticals is a privately held biopharmaceutical company that is focused on development of therapeutics for the treatment of inflammation, thrombosis and metastasis across a broad range of severe diseases. Selexys is also developing an antibody directed against PSGL-1 for the treatment of Crohn\'s disease, multiple myeloma, and other inflammatory disorders.
Financial terms: Including upfront, acquisition and milestone payments, the agreement with Novartis could reach up to $665 million (€ 509.7 million).
Latest news:
- • On December 3, 2016, results from the Phase II SUSTAIN study show that SEG101 (crizanlizumab, formerly SelG1) reduced the median annual rate of sickle cell-related pain crises (SCPC) by 45.3% compared to placebo (1.63 vs 2.98, p=0.010) in patients with or without hydroxyurea therapy[1]. Novartis announced that the data have been presented at the 58th American Society of Hematology (ASH) Annual Meeting and presented during the Plenary Scientific Session tomorrow (Abstract #1, 2:00 - 4:00 p.m. PST). The results also are being published simultaneously in The New England Journal of Medicine. The SUSTAIN trial was a multicenter, multinational, randomized, placebo-controlled, double-blind, 12-month study to assess safety and efficacy of the anti-P-selectin antibody SEG101 with or without hydroxyurea therapy in sickle cell disease patients with sickle cell-related pain crises. Patients included in the study had a history of 2 to 10 pain crises in the previous 12 months. Patients receiving hydroxyurea or erythropoietin were included if prescribed for the preceding 6 months and dose was stable for at least 3 months. The trial randomized 198 patients age 16 to 65 to receive high dose SEG101, low dose SEG101 or placebo. In the study, patients were assigned to high-dose (5.0 mg/kg), low-dose (2.5 mg/kg) and placebo arms. The study met its primary endpoint, reduction of the annual rate of SCPC in the high-dose arm by 45.3% vs. placebo (medians of 1.63 vs. 2.98, p=0.010). In the low- dose arm, the annual rate of SCPC was reduced by 32.6% vs. placebo (medians of 2.01 vs. 3.0, p = 0.180). For patients in the high dose arm, time to first SCPC vs. placebo was 2.9 times longer (medians of 4.07 vs. 1.38 months, p = 0.001) and time to second SCPC was 2.0 times longer than placebo (medians of 10.32 vs. 5.09 months, p = 0.022). Despite its availability, hydroxyurea often is not utilized primarily due to concerns about patient compliance and potential adverse events.
- • On November 21, 2016, Novartis announced it has acquired Selexys Pharmaceuticals, a company specializing in development of therapeutics in certain hematologic and inflammatory disorders. Novartis obtained the exclusive right to acquire Selexys and SelG1 in 2012. Terms of the deal could total up to $665 million in upfront, acquisition and milestone payments.
Is general: Yes
