Sep. 23, 2014, 3:37 PM
- The FDA approves Celgene's (CELG +1.3%) Otezla (apremilast) for the treatment of patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate. It is the only phosphodiesterase 4 (PDE4) inhibitor approved for this indication. It was cleared on March 21, 2014 for the treatment of adults with active psoriatic arthritis.
Sep. 17, 2014, 9:34 AM
- Concert Pharmaceuticals (CNCE) initiates a Phase 1 ascending dose clinical trial in 40 healthy volunteers to evaluate the safety, tolerability and pharmacokinetics of its investigational compound CTP-730. The trial should be completed in 2015.
- CTP-730 is the initial product candidate produced from Concert's collaboration with Celgene (CELG +0.6%).
Aug. 20, 2014, 11:33 AM
- The U.K.'s National Institute for Health and Care Excellence reverses its position and now supports the use of Celgene's (CELG +1.9%) Revlimid (lenalidomide) by the National Health Service for the treatment of myelodysplastic syndromes.
- The healthcare cost and quality of care advisor changed its opinion after the company submitted revised analyses and a proposal to limit the cost of the drug, including agreeing to provide Revlimid free of charge to anyone requiring more than 26 monthly cycles of treatment.
Aug. 20, 2014, 8:29 AM
- Bristol-Myers Squibb (NYSE:BMY) and Celgene (NASDAQ:CELG) collaborate in a Phase 1 clinical trial to evaluate the safety, tolerability and preliminary efficacy of a combination regimen of Bristol-Myers' Opdivo (nivolumab) and Celgene's Abraxane (paclitaxel) as a treatment for HER-2 negative metastatic breast cancer, pancreatic cancer and non-small cell lung cancer (NSCLC).
- Opdivo is a cancer immunotherapeutic that uses the body's own immune system to fight cancer while Abraxane works by interfering with cancer cells' ability to divide. The trial will explore if the combination of the two agents leads to an enhanced anti-tumor response.
- The clinical trial is slated to begin in Q4 and will be run by Celgene. HER-2 negative breast cancer patients will be treated with Abraxane and Opdivo, pacreatic cancer patients will be treated with the combination plus gemcitabine and NSCLC patients will be treated with the combination plus carboplatin.
Aug. 19, 2014, 8:31 AM
- The results from a Phase 2 trial evaluating the safety and efficacy of Celgene's (NASDAQ:CELG) Revlimid (lenalidomide) with R-CHOP as a treatment for treatment naive patients with diffuse large b-cell lymphoma (DLBCL) were recently published in the Journal of Clinical Oncology.
- Of the 60 patients eligible for evaluation, the overall response rate was 98% and the complete response rate was 80%. At 24 months, event-free survival (EFS) was 59% and the overall survival (OS) was 78%. EFS was identical to progression-free survival (PFS).
- The DLBCL patients were further classified as germinal B-cell (GCB) or non-GCB. The latter goup is characterized by poorer outcomes.
- The addition of Revlimid to R-CHOP resulted in similar PFS and OS rates between the subtypes which was an encouraging outcome for the non-GCB group.
- R-CHOP is rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate and prednisone.
Aug. 6, 2014, 11:52 AM
- Health Canada approves Celgene's (CELG +0.6%) Abraxane (albumin-bound paclitaxel) plus gemcitabine for the treatment of patients with metastatic pancreatic cancer.
- The approval is based on the results of a Phase 3 clinical trial that compared Abraxane plus gemcitabine to gemcitabine alone in metastatic pancreatic cancer. The median overall survival (OS) of the Abraxane cohort was 8.5 months compared to 6.7 months for the gemcitabine group. The results were statistically significant.
Aug. 4, 2014, 9:45 AM
- In an interim analysis of results from Amgen's (AMGN +1.6%) Phase 3 clinical trial to expand the label of Kyprolis (carfilzomib), the study achieved its primary endpoint of progression-free survival (PFS). The trial, called ASPIRE, evaluated the safety and efficacy of Kyprolis combined with Celgene's (CELG +1.8%) Revlimid (lenalidomide) and dexamethasone compared to Revlimid and dexamethosone alone to treat patients with relapsed multiple myeloma. The median PFS of the Kyprolis cohort was 26.3 months versus the non-Kyprolis cohort's 17.6 months. The results were statistically significant.
- Possibly dampening the mood is the secondary endpoint of overall survival (OS). While the data is not yet mature, the trend favored Kyprolis, but the results did not achieve statistical significance.
- The company intends to commence its regulatory submissions throughout the world in 1H 2015.
Jul. 24, 2014, 12:30 PM
- Celgene (CELG -3.6%) Q2 results: Total Revenues: $1,872.7M (+17.1%), Net Product Sales: $1,844.6M (+17.9%); COGS: 98.9M (+22.2%); R&D Expense: $456.9M (-0.3%); SG&A Expense: $491.8M (+17.6%); Operating Income: $825.1M (+28.5%); Net Income: $597.8M (+25.0%); EPS: $0.72 (-35.1%); Gross Profit: $1,773.8M (+16.8%); COGS: 5.3% (+4.4%); Gross Margin: 94.7% (-0.2%); Operating Earnings Yield: 44.1% (+9.7%); Net Earnings Yield: 31.9% (+6.8%); Quick Assets: $6,213.0M (+52.2%).
- Sales by product: Revlimid: $1,213.7M (+15.4%); Abraxane: $215.3M (+38.9%); Vidaza: $152.0M (-28.0%); Pomalyst/Imnovid: $160.9M (+143.8%).
- 2014 Guidance: Total revenue: ~$7.6B from ~7.5B; net product sales: >$7.5B from $7.3B - 7.4B; Revlimid sales: ~$4.95B from $4.9B - 5.0B; Abraxame sales: $850M - 900M (unch); operating margin: 36.0% (unch); adjusted diluted EPS: $3.60 - 3.65 from $3.50 - 3.60; GAAP diluted EPS: $2.46 - 2.55 from $2.47 - 2.59.
Jul. 24, 2014, 7:33 AM
Jul. 23, 2014, 5:30 PM
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Jul. 9, 2014, 7:28 AM
- Celgene's (CELG) phosphodiesterase 4 (PDE4) inhibitor Otezla (apremilast) failed to achieve its primary endpoint in a Phase 3 study in patients with active ankylosing spondylitis. The Otezla arm did not demonstrate statistically significant improvement versus placebo as measured by an Assessment of SpondyloArthritis 20 response at week 16.
- In a prespecified analysis meaningful efficacy was observed at week 24 in a large subset of patients with early-stage disease. A new Phase 3 is planned to assess the safety and efficacy of Otezla in patients with shorter disease duration contingent on further data analysis.
Jul. 3, 2014, 10:38 AM
- The FDA approves Spectrum Pharmaceuticals' (SPPI +4.9%) Beleodaq (belinostat) for the treatment of patients with peripheral T-cell lymphoma (PTCL) who have relapsed or who are refractory to previous treatment.
- This is the third drug the agency has cleared since 2009 for the treatment of PTCL. It approved Spectrum's Folotyn (pralatrexate) in 2009 and Celgene's (CELG -0.8%) Istodax (romidepsin) in 2011.
- The agency's approval triggers a $25M milestone payment to licensor TopoTarget A/S.
Jun. 19, 2014, 9:43 AM
- Shareholders of Celgene (CELG) approve a 2:1 stock split and increase in the number of authorized shares. The split will increase the total number of shares of common stock from 399M to 798M while the number of authorized shares grows to 1,150M from 575M.
- Shareholders of record June 18, 2014 will be entitled to receive an additional share per share held. Distribution date is June 25.
- This is the company's fourth stock split. There was a 3:1 split on April 17, 2000, a 2:1 split on October 25, 2004 and a 2:1 split on February 27, 2006.
Jun. 14, 2014, 12:34 PM
- Switzerland-based Celgene (CELG) subsidiary Celgene Interantional Sarl announces the results from a Phase 3 clinical trial evaluating the safety and efficacy of Vidaza (azacitidine for injection) compared to conventional care regimens (CCR) in elderly patients with newly-diagnosed acute myeloid leukemia (AML).
- The primary endpoint was median overall survival (OS). The OS for the azacitidine group (n=241) was 10.4 months (8.0 - 12.7 months; 95% CI) compared to 6.5 months (5.0 - 8.6 months; 95% CI) in the CCR group (n=247). The results failed to achieve statistical significance.
- One-year survival was 47% in the azacitidine cohort compared to 34% of patients receiving CCR.
- The clinical trial was conducted to support a possible label expansion for Vidaza. It is currently indicated for treatment of patients with certain types of refractory anemia.
Jun. 3, 2014, 5:03 PM
- NanoString (NSTG -2.9%) and Celgene (CELG +0.4%) collaborate on the development of a companion diagnostic assay using NSTG's nCounter Analysis System to support the clinical validation of CELG's Revlimid for the treatment of Diffuse Large B-Cell Lymphoma (DLBCL). Under the terms of the agreement, CELG will pay NSTG an upfront payment of $5.75M and up to $17M in milestone payments. NSTG may also earn an additional $22.25M in commercial payments if assay revenues do not exceed pre-specified levels during the first three years after regulatory approval.
- The test will be used to screen patients who are being enrolled in a clinical trial for Revlimid for DLBCL. After CELG completes the study, NSTG will pursue regulatory approval of the test in key global markets. It also retains the right to develop and commercialize additional indications for the assay.
May 27, 2014, 12:32 PM
- The U.S. District Court for the District of New Jersey releases its Markman Order regarding the patent suit between Celgene (CELG +1%) and Natco Pharma, Arrow International and Watson Labs. Celgene alleges that the generic competitors infringe on its Revlimid patents ('230, '554, '800, '219 and '598).
- A Markman hearing is a pretrial hearing that determines the interpretations of specific terms/key words in a patent.
- Unless you have an intimate understanding of the patents, it is unclear how much or little the judge's ruling favors Celgene.
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