Mon, Mar. 2, 10:47 AM
- The European Commission approves the use of Celgene's (CELG -0.5%) Abraxane (nab-paclitaxel) for the first-line treatment, in combination with carboplatin, of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy. This adds to the product's currently-cleared indications in Europe for metastatic pancreatic and breast cancers.
- Abraxane is a nanotechnology agent contains albumin-bound paclitaxel nanoparticles. It is the company's second best seller after Revlimid. Sales were $624.5M last year.
- Previously: European Ad Comm supports expanded label for Abraxane (Jan. 23)
Fri, Feb. 20, 7:02 AM
- The European Commission approves the use of Celgene's (NASDAQ:CELG) Revlimid (lenalidomide) for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. This adds to Revlimid's current marketing authorization for the treatment, in combination with dexamethasone, of multiple myeloma in adult patients who have received at least one prior therapy.
- Multiple myeloma strikes ~39K Europeans each year. The mortality rate within the first year of diagnosis is over 60%.
- In a 1,623-patient Phase 3 trial, patients treated with Revlimid plus dexamethasone showed a median overall survival of 58.9 months compared to 48.5 months for those receiving melphalan-prednisone-thalidomide therapy.
Thu, Feb. 19, 10:10 AM
- Facing ever-increasing pushback from payers over the high price of new treatments, some biotech firms are working on a new payment model that rewards them for the long-term performance of their drugs. Gene therapy developers, including BioMarin Pharmaceuticals (BMRN +0.4%) and Sangamo BioSciences (SGMO -0.1%), are leading the effort.
- The industry says that a one-time cure, even if priced greater than $1M, saves money over the long term but acknowledges that payers will balk at paying the cost upfront. The general consensus is that an upfront payment over $1M will be unacceptable.
- Under a pay-for-performance scheme, the annuity-like payments would cease if medical testing showed that the therapy was not working. Much work remains to be done, though, before this approach could be implemented. For example, legislation may be required to force insurers to pick up the tab for patients that switch coverage.
- Some proponents of the new scheme say that the payment streams could be securitized and sold to investors, like consumer debt.
- Gene therapies represent the highest priced treatments. Only one has cleared the regulatory hurdle to date, UniQure's (QURE +1.5%) Glybera, which costs 850K euros ($1M) in Germany. It will be sold for a one-time payment because it is too difficult to measure how well it works (this reasoning will undoubtedly pop up again).
- Previously: UniQure sets price record with Glybera (Nov. 26, 2014)
- Related tickers: (CELG +1.3%)(AMGN -0.2%)(BIIB +0.5%)(GILD +0.1%)(MRK -0.3%)(GSK -0.2%)(AZN +0.9%)(LLY +0.3%)(NVS +0.1%)(PFE -0.5%)(JNJ -0.3%)(OTCQX:RHHBY +1.4%)(BMY -0.4%)(ABT)(BAX -1.1%)
Wed, Feb. 18, 10:54 AM
- The FDA approves a label expansion for Celgene's (CELG +1.3%) Revlimid (lenalidomide) to now include the treatment, in combination with dexamethasone, of patients with newly diagnosed multiple myeloma (NDMM).
- Revlimid's other indications are for the treatment of previously treated multiple myeloma, relapsed/refractory mantle cell lymphoma and transfusion-dependent anemia due to low-or intermediate-1-risk myelodysplastic syndromes.
- Revlimid is the company's top selling product, generating $1.3B in sales in Q4.
Thu, Jan. 29, 7:57 AM
- Celgene (NASDAQ:CELG) Q4 results ($M): Total Revenues: 2,085.5 (+18.8%); Net Product Sales: 2,054.9 (+19.1%); U.S.: 1,232,5 (+21.2%); Intl: 822.4 (+16.2%).
- Key Product Sales: Revlimid: 1,322.5 (+16.4%); Abraxane: 235.9 (+16.9%); Pomalyst/Imnovid: 202.1 (+66.7%); Vidaza: 153.7 (-8.2%).
- COGS: 103.2 (+11.2%); R&D Expense: 584.9 (-20.0%); SG&A Expense: 544.4 (+21.3%); Net Income: 613.9 (+186.3%); EPS: 0.74 (+196.0%); CF Ops: 832.0 (+51.0%); Quick Assets: 7,546.7 (+32.7%).
- Gross Profit: 1,982.3 (+19.2%); COGS: 4.9% (-6.4%); Gross Margin: 95.1% (+0.4%); Operating Earnings: 853.0 (+76.5%); Operating Earnings Yield: 40.9% (+48.6%); Net Earnings Yield: 29.4% (+141.1%).
- 2015 Guidance: Net Product Sales: $9.0B - 9.5B; Revlimid: $5.6B - 5.7B; Abraxane: $1.00B - 1.25B; Non-GAAP Operating Margin: ~52%; Non-GAAP EPS: $4.60 - 4.75; GAAP EPS: $3.68 - 3.92.
Thu, Jan. 29, 7:33 AM
Wed, Jan. 28, 5:30 PM
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Fri, Jan. 23, 7:44 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use adopts a positive opinion recommending approval of Celgene's (NASDAQ:CELG) Abraxane (nab-paclitaxel) for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.
- A final decision by the European Commission usually takes ~60 days.
- Abraxane is also approved for the treatment of advanced breast cancer and advanced pancreatic cancer.
Mon, Jan. 19, 5:11 PM
- As expected, the European Commission approves Novartis' (NYSE:NVS) Cosentyx (secukinumab) as a first-line systemic treatment for adult patients with moderate-to-severe psoriasis. It is the first interleukin-17A inhibitor cleared in Europe.
- Cosentyx is also cleared for sale in Australia and Japan. FDA approval is imminent considering the unanimous positive vote by the Dermatologic and Ophthalmic Drugs Advisory Committee in October.
- Previously: Europe Ad Comm gives thumbs up to Novartis psoriasis drug (Nov. 21, 2014)
- Previously: Ad Comm backs approval of secukinumab (Oct. 21, 2014)
- Psoriasis-related tickers: (NYSE:JNJ) (NASDAQ:DERM) (NYSE:MRK) (NASDAQ:CELG) (NASDAQ:IDRA) (NYSE:HSP) (NYSEMKT:CANF) (NASDAQ:AMGN) (NYSE:AZN) (NYSE:PFE)
Fri, Jan. 16, 9:36 AM
- As expected, the European Commission approves Celgene's (CELG +1.8%) Otezla (apremilast) for two indications:
- For the treatment of adult patients with moderate-to-severe plaque psoriasis who failed to respond to or who have a contraindication to or are intolerant of other systemic therapies, including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA).
- For the treatment, alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), of adult patients with active psoriatic arthritis who have had an inadequate response to or are intolerant of a prior DMARD therapy.
- The European commercial launch will commence in the coming months. The FDA approved Otezla in March of last year.
- Previously: Europe Ad Comm recommends approval of Celgene's Otezla (Nov. 21, 2014)
Wed, Jan. 14, 9:13 AM
- Express Scripts' (NASDAQ:ESRX) success in containing the prices of new HCV therapies by pitting Gilead Sciences (NASDAQ:GILD) against AbbVie (NYSE:ABBV) is sending shock waves through the biotech/pharma industry. Most of the big players slumped yesterday as investors fear that ESRX's tactics will spread to other high cost areas like cancer and cholesterol.
- At JPM15 yesterday, CEO George Paz said that the new cholesterol-lowering post-statin PCSK9 inhibitors will be the next big opportunity to pit drug firms against each other in order to drive costs down. FDA clearance of the first two therapies, one from Amgen (NASDAQ:AMGN) and the other from Regeneron Pharmaceuticals (NASDAQ:REGN) (NYSE:SNY), is expected to occur at about the same time.
- The prices of emerging cancer therapies will also be in payers' crosshairs. Amgen's Blincyto, for example, costs $178,000 per standard course of treatment while Merck's (NYSE:MRK) Keytruda is close behind at $150,000.
- Related tickers: (NYSE:AZN) (NYSE:GSK) (NYSE:LLY) (ABBV) (NYSE:PFE) (NASDAQ:BIIB) (NYSE:ABT) (NASDAQ:CELG) (NYSE:BMY) (OTCQX:RHHBY) (NYSE:JNJ) (NYSE:NVS) (OTCPK:BAYRY)
Mon, Jan. 12, 11:48 AM
- On a preliminary basis, Celgene's (CELG +1%) net product sales for 2014 were $7.56B (Q4: $2.05B), including Revlimid: $4.98B (+16%), Abraxane: $848M (+31%), Pomalyst/Imnovid: $680M (+123%) and Otezla: $70M. Non-GAAP EPS is expected to be ~$3.71 and GAAP EPS $2.38 - 2.41.
- Q4: EPS: $0.71 - 0.74; non-GAAP EPS: ~$1.01.
- 2015 Guidance: Net product sales: $9.0B - 9.5B; Revlimid: $5.6B - 5.7B; non-GAAP EPS: $4.60 - 4.75; EPS: $3.68 - 3.92.
Sun, Jan. 11, 10:29 PM
- Based on an assessment by the independent Data Monitoring Committee, Bristol-Myers Squibb (NYSE:BMY) stops its Phase 3 trial, CheckMate-017, evaluating Opdivo (nivolumab) versus docetaxel in previously treated patients with advanced squamous cell non-small cell lung cancer (NSCLC). The committee concluded that the study met its primary endpoint of demonstrating superior overall survival (OS) compared to docetaxel. This is the first time a PD-1 inhibitor has shown a survival advantage in lung cancer.
- Eligible patients will be informed of the opportunity to continue or start treatment with Opdivo in an open-label extension.
- The company will complete a full analysis of the data and work with investigators on the future presentation and publication of the results.
- PD-1-related tickers: (NASDAQ:MDVN) (NYSE:MRK) (NASDAQ:FPRX) (NASDAQ:CELG) (OTCQX:RHHBY) (NYSE:AZN)
Dec. 19, 2014, 9:16 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion supporting the approval of Celgene's (NASDAQ:CELG) Revlimid (lenalidomide) for the continuous oral treatment on adult patients with previously untreated multiple myeloma who are not eligible for stem cell transplantation.
- In the EU, Revlimid is currently approved in combination with dexamethasone as a second-line treatment for multiple myeloma.
- A final decision by the European Commission usually takes about 60 days.
Dec. 9, 2014, 8:28 AM
- At the American Society of Hematology meeting in San Francisco, data were presented from a Phase 3b study of Celgene's (NASDAQ:CELG) pomalidomide (Pomalyst/Imnovid) plus low-dose dexamethasone in 599 patients with relapsed or refractory multiple myeloma who had previously failed treatment with lenalidomide and bortezomib.
- The primary endpoint was safety. Secondary endpoints were overall response rate (ORR >=partial response), duration of response (DOR), progression-free survival (PFS), overall survival (OS) and cytogenic analyses.
- The most frequent grade 3-4 adverse events (AE) were hematologic - neutropenia (42%), anemia (29%) and thrombocytopenia (22%). The most common non-hematologic AEs were infections (29%) and pneumonia (12%). Dose reductions due to AEs were required in 18% of patients and 9% had therapy discontinued.
- At a median followup of 6.8 months with a median of four treatment cycles, median PFS was 4.2 months, median OS was 11.9 months, ORR was 35% with 8% of patients achieving at least a very good partial response and median DOR was 6.8 months.
Dec. 8, 2014, 12:37 PM
- Biotech investors are giving Seattle Genetics (SGEN -8.4%) the cold shoulder today on increased volume. It appears that all the love is being directed to the potential of competitors' PD-1 inhibitors in fighting cancer despite the company's presentations at the American Society of Hematology meeting of positive results for Adcetris (brentuximab vedotin), an antibody-drug conjugate directed to CD30 in Hodgkin lymphoma (HL).
- Long-term data from a Phase 1 trial of Adcetris combined with AVD (adriamycin, vinblastine, dacarbazine) demonstrated a 100% overall survival rate at year three and 92% failure-free survival rate at year 3 in frontline HL.
- Adcetris in combination with bendamustine as a second-line therapy demonstrated an objective response rate of 96% and a complete remission rate of 83% in patients with relapsed or refractory HL.
- In a Phase 2 trial in previously untreated HL patients aged 60 and older, Adcetris showed a 93% objective response rate.
- The company is collaborating with Takeda Pharmaceutical Co. (OTCPK:TKPHF) (OTCPK:TKPYY) on the development of the product.
- Previously: Positive results in Adcetris Phase 3 label expansion trial (Sept. 29, 2014)
- PD-1 inhibitor-related tickers: (BMY +0.2%)(FPRX +4.8%)(MRK -0.2%)(CELG +4.2%)(OTCQX:RHHBY -0.5%)(AZN -0.6%)
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