Celgene (CELG) has entered into an alliance worth up to €628M, excluding royalties, with Germany's MorphoSys (MPSYF.PK) to develop the latter's MOR202 drug, including for treating the blood cancer multiple myeloma. Celgene will pay €70.8M upfront, €46.2M for new shares in MorphoSys and milestones, while the companies will also share profits. Earlier this month, MorphoSys signed a major licensing deal with GlaxoSmithKline. (PR)
Celgene (CELG) announces the presentation of two studies evaluating a Revlimid/ rituximab combo in non-Hodgkins lymphomas. The company's executive vice president for Hematology and Oncology says "The increasing volume of clinical evidence evaluating [these] combinations … provide us powerful insight into the potential of antibody-dependent cellular cytotoxicity in lymphomas." (PR)
The European Commission amends the marketing authorization for Celgene's (CELG -0.2%) REVLIMID to include patients with MDS-related transfusion-dependent anemia when other treatments have failed or proven insufficient. The company has pursued clearance for the indication for some 7 years. (previous)
Bristol-Myers Squibb's (BMY) and AbbVie's (ABBV) Elotuzumab helped patients with previously-treated multiple myeloma live for a median 33 months without the blood cancer getting worse in a Phase II trial. The drug was given with Celgene's (CELG) Revlimid and the steroid dexamethasone. Elotuzumab is also being tested in two Phase III trials for multiple myeloma. (PR)
Celgene's (CELG -0.1%) Apremilast drug significantly improved the signs and symptoms of patients with psoriatic arthritis in the company's "Palace 3" Phase III study. The results come a day after Celgene reported a positive outcome from "Palace I". In total, the company is conducting four Phase III "Palace" trials. (PR)
Moody's raises Celgene's (CELG) outlook to Positive from Stable citing the "expanding use of Revlimid" (I, II) and "pending approvals of Apremilast in psoriatic arthritis and Abraxane in pancreatic cancer" (I, II) as catalysts for "good growth momentum."
Celgene's (CELG +1.6%) board has authorized the repurchase of up to an extra $3B in shares, having exhausted a previous $2.5B buyback program. So far this year, the company has repurchased $1.8B in stock. (See apremilast results) (PR)
Celgene (CELG) says 52-week results demonstrate apremilast produces "meaningful improvements" in ACR scores for patients with psoriatic arthritis. The company will present the data at the European Congress of Rheumatology later today. SA contributor Todd Campbell says the drug "offers upside" for CELG shares and notes that "analysts expect apremilast may generate sales of $300-500M/year." Shares +1.5% premarket.
Biotech startup Agios Pharmaceuticals has filed to raise $86M in an IPO. The company has raised over a quarter of a billion dollars from VC firms and Celgene (CELG), which has invested $37.5M and made $141.2M in collaboration payments. Celgene has also committed to buying stock in the IPO. Agios has been developing a new approach to treating cancer and metabolic diseases, but has yet to start clinical trials for any of its drug candidates. (S1)
Celgene (CELG -4.3%) gets FDA approval for its supplemental new drug application for Revlimid to treat mantle cell lymphoma. The drug is already cleared for multiple myeloma, another white blood cell cancer. Analysts estimate the drug could generate around $5.9B in sales in 2016.
Celgene (CELG -1.5%) trades lower after presentations at ASCO. The company says high-dose chemotherapy and tandem autologous stem cell transplant demonstrated longer median progression-free survival and overall survival than REVLIMID, melphalan, and prednisone. However, a maintenance analysis showed followup treatments with REVLIMID increased progression-free survival and overall survival. (PR)
The EMA's Committee for Medicinal Products for Human Use (CHMP) gives its blessing to Celgene's (CELG) oral multiple myeloma treatment pomalidomide based on data from a Phase 3 trial. The committee also adopts a positive opinion for Aegerion's (AEGR) HoFH treatment LOJUXTA and says new data does not support the contention that Sanofi's (SNY) Lantus increases the risk of cancer. AEGR + 0.92% premarket.
Celgene (CELG +0.5%) says Apremilast achieves statistical significance for its primary endpoint in the first company-sponsored study of psoriatic arthritis patients who had not previously received oral DMARDs. This is the fourth randomized Phase III study of the treatment to show promising results. Last month, Deutsche Bank called the drug a potential "blockbuster" in a note accompanying an upgrade.
Celgene (CELG) says based on a Phase III trial, the Committee for Medicinal Products for Human Use has recommended REVLIMID for approval regarding the treatment of transfusion-dependent anemia due to MDS when other therapies aren't sufficient or prove inadequate. Shares +.85% premarket after falling marginally Thursday following Q1 results.