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%)
Dec. 8, 2014, 11:51 AM
- At the American Society of Hematology meeting in San Francisco, preliminary results from a Phase 2 study evaluating Acceleron Pharmaceuticals' (NASDAQ:XLRN) luspatercept for the treatment of beta-thalassemia were presented.
- Nine of 12 patients (75%) with dose levels of 0.8 or 1.0 mg/kg met the primary endpoint of an erythroid response. Six of six (100%) transfusion-dependent patients achieved a reduction in transfusion burden of at least 60% over a 12-week period. Three of six (50%) non-transfusion-dependent patients had a sustained hemoglobin increase of at least 1.5 g/dL for >=2 weeks.
- Reductions in liver iron concentration were observed in both groups. Two patients with persistent leg ulcers, a complication of beta-thalassemia, experienced rapid healing of the ulcers following treatment with luspatercept.
- Acceleron is collaborating with Celgene (CELG +4.3%) on the development and commercialization of luspatercept.
Dec. 1, 2014, 4:49 PM
- Celgene (NASDAQ:CELG) urges shareholders to ignore TRC Capital's unsolicited mini-tender offer to buy 1M shares of CELG common stock at $101.75, a discount of over 10% from today's close of $113.43.
- TRC's offer has contingencies, including obtaining sufficient funding to buy the shares.
- TRC has made mini-tender offers to other companies in the past. The offers are deliberately under 5% of the float in order to avoid regulatory requirements and investor safeguards.
Nov. 25, 2014, 8:18 AM
- Pharmacy benefits manager Express Scripts (NASDAQ:ESRX) is at the forefront of an increasing wave of resistance to the high prices of new drugs from pharma and biotech firms, some which cost as much as $50K per month. Pharmaceutical spending in the U.S. is $270B and may breach $500B in five years. ESRX's method of controlling costs is to refuse to pay for them. For 2015, for example, it is excluding 66 branded drugs from its main formulary, an increase of 18 from 2014's 48. On the list is Johnson & Johnson's (NYSE:JNJ) rheumatoid arthritis drug Simponi (golimumab) which costs $3K per month.
- Other prescription benefits managers are employing similar tactics. CVS Health (NYSE:CVS) will exclude 95 drugs from its 2015 formulary including Pfizer's (NYSE:PFE) multiple sclerosis med Rebif (interferon beta-1a) which costs $5K for a four-week supply.
- Governments are pushing back as well. Among 42 state Medicaid programs, 27 pay for Gilead Sciences' HCV med Sovaldi (sofosbuvir) only for patients with severe liver damage while others impose coverage limitations for patients with recent substance-abuse problems. In the U.S., the full regimen cost is $84K. Recently, Britain's National Institute for Health and Care Excellence (NICE) balked at recommending reimbursement for Roche's (OTCQX:RHHBY) blood cancer drug Gazyvaro (obinutuzumab).
- Ninety percent of commercial health plans require pre-approval of specialty drugs, up from 82% in 2011.
- Previously: Roche's Gazyvaro not NICE in the UK
- Previously: Global drug tab will breach trillion dollar mark this year
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
- Related tickers: (NYSE:NVS) (NYSE:AZN) (NASDAQ:AMGN) (NASDAQ:BIIB) (NASDAQ:CELG) (NYSE:LLY) (NYSE:SNY) (NYSE:ABT) (NYSE:ABBV) (NYSE:BMY) (NYSE:MRK) (NYSE:GSK)
Nov. 21, 2014, 8:04 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion supporting approval of Celgene's (NASDAQ:CELG) Otezla (apremilast) for two indications: 1. the treatment of adult patients with moderate-to-severe plaque psoriasis who failed to respond to, or who are contraindicated for or are intolerant to, other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA); 2. alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs) for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy. A final decision from the European Commission usually takes about 60 days.
- Apremilast is a PDE4 inhibitor specific for cyclic AMP (cAMP). PDE4 inhibition results in increased cAMP levels which is thought to indirectly modulate the production of inflammatory mediators.
- The FDA approved Otezla in March.
- Previously: FDA approves Otezla
- Previously: Otezla label expansion cleared in the U.S.
- Related tickers: (NYSE:PFE) (NYSE:SNY) (OTCQB:SNYNF) (NYSEMKT:PLX) (NASDAQ:SHPG)
Nov. 18, 2014, 10:05 AM
- At the American College of Rheumatology/Association of Rheumatology Health Professionals annual meeting in Boston, Celgene (CELG +1.7%) presented results from long-term (104-week) efficacy and safety analyses of Otezla (apremilast) from the open-label phase of two Phase 3 clinical trials. Otezla is a PDE4 inhibitor approved for the treatment of adult patients with moderate-to-severe plaque psoriasis or active psoriatic arthritis.
- In the Palace 1 study, 84% of patients who completed one year of 30 mg twice daily therapy continued receiving Otezla at two years (104 weeks). Improvements in efficacy observed at 52 weeks were sustained through 104 weeks of treatment. At week 104, the ACR20, ACR50 and ACR79 response rates were 65.3%, 34.0% and 19.6%, respectively.
- In the Palace 4 study, almost 84% of DMARD-naive patients who completed one year of Otezla 30 mg twice daily monotherapy continued receiving Otezla at two years. At week 104, the ACR20, ACR50 and ACR70 response rates were 61.4%, 40.7% and 19.2%, respectively.
- The primary endpoint of the studies was ACR20 at week 16.
Nov. 14, 2014, 12:00 PM| Nov. 14, 2014, 12:00 PM | 41 Comments
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