March 28, 2017 5:39 AM ET

Biotechnology

Company Overview of Celgene International Sárl

Company Overview

Celgene International Sárl discovers, develops, and commercializes therapies to treat cancer and immune-inflammatory related diseases in the United States and internationally. The company was incorporated in 2003 and is headquartered in Boudry, Switzerland. Celgene International Sárl operates as a subsidiary of Celgene Corporation.

Route de Perreux 1

Boudry,  2017

Switzerland

Founded in 2003

Phone:

41 32 729 85 00

Fax:

41 32 729 85 08

Key Executives for Celgene International Sárl

President of Europe, Middle East and Africa Region
Compensation as of Fiscal Year 2016.

Celgene International Sárl Key Developments

Celgene International Sárl Receives Positive CHMP Opinion to Expand REVLIMID (Lenalidomide) Indication as Monotherapy

Celgene International Sárl announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the use of REVLIMID as monotherapy for the maintenance treatment of adult patients with newly diagnosed multiple myeloma (MM) who have undergone autologous stem cell transplantation (ASCT). Once approved by the European Commission, REVLIMID will be the first and only licensed maintenance treatment available to these patients. Multiple myeloma is an incurable and life-threatening blood cancer that is characterised by tumour proliferation and suppression of the immune system. It is a rare but deadly disease—around 39,000 people are diagnosed with MM in Europe, and around 24,000 people die from the disease each year. The median age at diagnosis in Europe is between 65 and 70 years. In Europe, patients who are under 65 years, fit and in good clinical condition are typically considered eligible for ASCT. For newly diagnosed, transplant-eligible MM patients, key treatment goals are to obtain and to maintain a deep response to therapy, with the ultimate objective of delaying disease progression. These patients typically receive induction therapy and high-dose chemotherapy with melphalan followed by ASCT. This treatment approach has been an established standard of care for over 20 years. Considering that over half of patients relapse within 2 to 3 years after ASCT, trials have been conducted to assess whether maintenance therapy following ASCT could enable more durable remissions.

Celgene International Sárl Announces Data from the Open-Label Extension of the TOUCHSTONE Phase 2 Clinical Trial of Ozanimod in Patients

Celgene International Sàrl announced that data from the open-label extension of the TOUCHSTONE phase 2 clinical trial of ozanimod in patients with moderate to severe ulcerative colitis are to be presented at the United European Gastroenterology Week (UEGW) in Vienna, Austria and at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Las Vegas. Ozanimod is an investigational selective S1P 1 and 5 receptor modulator. TOUCHSTONE evaluated the efficacy and safety of 0.5 mg and 1 mg doses of ozanimod compared with placebo after eight weeks of treatment (induction phase) in 197 patients with moderate to severe active ulcerative colitis. Patients who achieved a clinical response at week 8 continued with their original treatment through week 32 in a maintenance phase. The primary endpoint was the proportion of patients in remission at week 8. Secondary endpoints were: the proportion of patients achieving a clinical response, the proportion of patients with mucosal improvement and the change from baseline in Mayo score. Previously reported results showed TOUCHSTONE met its primary endpoint and secondary endpoints with statistical significance for patients on the 1 mg dose of ozanimod versus placebo. TOUCHSTONE participants in all three treatment arms entered the open-label extension if they did not respond to treatment after the induction phase, relapsed during the maintenance phase or completed the maintenance phase (170 of the 197 patients). The objective of the open-label extension phase is to evaluate the long-term efficacy and safety of daily ozanimod 1 mg. During the extension period, treatment with ozanimod 1 mg resulted in a decrease in mean partial Mayo Score (pMS) in all treatment arms. For patients who had been treated with ozanimod 0.5 mg during the double-blind portion of the study and were switched to ozanimod 1 mg for the extension phase of the study, mean pMS score decreased from 4.5 at entry into the extension period to 1.7 at week 44. For patients who had been initially treated with ozanimod 1 mg and stayed on ozanimod 1 mg for the extension phase of the study, mean pMS score decreased from 3.3 at entry into the extension period to 1.9 at week 44. For patients who had been initially treated with placebo and were switched to ozanimod 1 mg for the extension phase of the study, mean pMS score decreased from 4.6 at entry into the extension period to 1.7 at week 44. Treatment with ozanimod 1 mg in the extension phase also showed a decrease in the proportion of patients with rectal bleeding and moderate or severe diarrhea. During the safety follow-up in the extension phase, which ranged from 44 weeks to over two years, the most common adverse events (>2.0%) noted in the extension period were ulcerative colitis flare (5.9%), upper respiratory tract infection (4.1%), anemia (3.5%), nasopharyngitis (3.5%), transaminase elevation (3.5%), back pain (2.9%), arthralgia (2.4 %) and headache (2.4%). No notable cardiac, ophthalmologic or infectious TEAEs were observed. Serious adverse events occurred in 16 of 170 patients (9.4%). Serious AEs occurring in two or more patients were anemia (1.2%) and ulcerative colitis flare (2.4%). Alanine aminotransferase and aspartate aminotransferase elevations more than three times the upper limit of normal occurred in 4 of 170 patients (2.4%); all elevations were asymptomatic, less than five times the upper limit of normal, transient and resolving during ongoing treatment.

Celgene International Sàrl Announces Data from Randomized, Double-Blind, Multicenter, Exploratory Phase 1B Study

Celgene International Sàrl announced that data from a randomized, double-blind, multicenter, exploratory phase 1b study evaluating the effects of investigational oral GED-0301 (mongersen) 160 mg on both endoscopic response and clinical remission in patients with active Crohn’s disease will be presented in Vienna, Austria at the United European Gastroenterology Week (UEGW). Patients with active Crohn’s disease [Crohn’s disease activity index (CDAI) score 220-450], a total simple endoscopic score for Crohn’s disease (SES-CD) =7, or an ileal disease SES-CD =4, were randomized to three different active treatment regimens of four, eight or 12 weeks of GED-0301 160 mg daily, followed by an observation period off treatment. Endoscopic and clinical assessments were reported through week 12. A total of 63 patients were enrolled in the study. The study was designed to further enhance the understanding of GED-0301 activity in a difficult-to-treat, moderate to severe patient population. This population was more diverse than prior GED-0301 studies and included patients with endoscopically confirmed mucosal damage at entry and those who had previous surgeries. The study also included both biologic-exposed and biologic-naïve patients, as well as patients with a diagnosis of Ileitis, Ileocolitis or colitis. Clinical improvement was seen by week 2, and clinical response (CDAI decrease =100) and remission (CDAI <150) rates were high in the 12-week treatment group at 67 and 48% respectively, at week 12. The mean CDAI reduction from baseline at week 12 in the 12-week treatment group was 133 points. Of the patients with evaluable endoscopies at week 12 (n=52), 37% had an endoscopic response (=25% reduction in SES-CD score from baseline), with no meaningful difference across treatment groups. In addition, of those patients with greater endoscopic disease activity at baseline (SES-CD score of >12; n=16), 63% exhibited a reduction =25% in SES-CD score and 31% had a reduction of =50%. The rates of adverse events and serious adverse events were low and similar across treatment groups. There were no new safety signals for oral GED-0301 160 mg daily reported in this study.

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