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| 41 Comments
Nov. 11, 2014, 4:52 PM
- A Phase 3 study evaluating Amgen's (NASDAQ:AMGN) brodalumab versus Janssen's (NYSE:JNJ) Stelara (ustekinumab) and placebo at week 12 in patients with moderate-to-severe plaque psoriasis met its primary endpoints. Brodalumab was superior to ustekinumab in achieving total clearance of skin disease as measured by PASI-100. Compared to placebo, a significantly greater proportion of patients treated with brodalumab achieved at least a 75% improvement from baseline in disease severity at week 12 (measured by PASI-75). All key secondary endpoints were also met.
- Proportion of patients achieving total clearance of disease: brodalumab-210 mg: 36.7%; brodalumab-140 mg: 27.0%; Stelara: 18.5%; placebo: 0.3%.
- Proportion of patients achieving PASI-75: brodalumab-210 mg: 85.1%; brodalumab-140 mg: 69.2%; Stelara: 69.3%; placebo: 6.0%.
- Amgen plans to present the complete results at a future medical conference.
- Related tickers: (NYSE:AZN) (NYSE:GSK) (NASDAQ:CELG) (NYSE:NVS) (NASDAQ:DERM) (NASDAQ:IDRA) (NYSE:HSP) (NYSE:PFE) (NYSEMKT:CANF) (NYSE:MRK)
Oct. 23, 2014, 4:12 PM
- Celgene (CELG +5.9%) likes its partnership with privately-held Sutro Biopharma so much that is has inked another deal with the antibody-based therapeutics developer. Under the terms of the agreement, Sutro receives a upfront payment of $95M that includes an equity stake, $90M during the research phase and potentially more than $1B, including milestones.
- Celgene also has an option to buy Sutro under undisclosed terms.
- The partners will work on PD-1 and PD-L1 inhibitors, the most promising cancer immunotherapy area. Sutro's value proposition is a better way to build antibody-drug conjugates that are more selective in their binding targets. Its technology enables a simpler method of making biologics, more akin to small molecule drugs.
Oct. 23, 2014, 8:24 AM
- Celgene (NASDAQ:CELG) Q3 results ($M): Total Revenues: 1,982.2 (+18.4%); Product Revenues: 1,956.8 (+19.0%); COGS: 97.7 (+13.3%); R&D Expense: 675.1 (+15.5%); SG&A Expense: 497.6 (+10.9%); Operating Income: 646.6 (+41.9%); Net Income: 508.5 (+36.5%); EPS: 0.61 (+41.9%); Quick Assets: 6,860.7 (+20.6%); CF Ops: 901.0.
- Gross Profit: 1,884.5 (+18.7%); COGS: 4.9% (-4.3%); Gross Margin: 95.1% (+0.2%); Operating Earnings Yield: 35.9% (+8.3%); Net Earnings Yield: 25.7% (+15.3%).
- Revenue By Product: Revlimid: 1,300.0 (+19.3%); Abraxane: 212.2 (+25.1%); Vidaza: 157.8 (-28.4%); Promalyst/Imnovid: 181.1 (+102.3%).
- 2014 Guidance: Total Revenue: >$7.6B; Net Product Revenue: >$7.5B; Revlimid Revenue: >$4.9B; Abraxane Revenue: ~$850M; EPS: $2.38 - 2.48 from $2.46 - 2.55; non-GAAP EPS: $3.65 - 3.70 from $3.60 - 3.65.
Oct. 23, 2014, 7:35 AM
Oct. 22, 2014, 5:30 PM
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Oct. 21, 2014, 7:32 AM
- The Dermatologic and Ophthalmic Drugs Advisory Committee votes unanimously in favor of approving Novartis' (NYSE:NVS) interleukin-17A inhibitor secukinumab for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. A final decision by the FDA is expected in early 2015.
- Novartis has also submitted its regulatory application with the European Medicines Agency. A decision is expected in late 2014 to early 2015.
- Psoriasis-related tickers: (NYSE:JNJ) (NASDAQ:DERM) (NYSE:MRK) (NASDAQ:CELG) (NASDAQ:IDRA) (NYSE:HSP) (NYSEMKT:CANF) (NASDAQ:AMGN) (NYSE:AZN) (NYSE:PFE)
Oct. 16, 2014, 11:46 AM
- The Dermatologic and Ophthalmic Drugs Advisory Committee meets on Monday, October 20 to review Novartis' (NVS -1.7%) BLA for secukinumab, a human mAb, for the treatment of adults with moderate-to-sever plaque psoriasis who are candidates for systemic therapy or phototherapy.
- Briefing docs
- Psoriasis-related tickers: (JNJ -1%)(DERM -5%)(MRK -2.2%)(CELG -0.9%)(IDRA +6.8%)(HSP +1.1%)(CANF)(AMGN -1.5%)(AZN -1.1%)(PFE -1.3%)
Oct. 7, 2014, 9:54 AM
- Menlo Park, CA-based Virobay (VBAY) is set for its IPO of 3.8M shares at $12 - 14.
- The clinical stage biopharmaceutical firm develops drugs based on its cysteine cathepsin platform. Cysteine cathepsins are important enzymes in the biology of many diseases. The company believes that inhibiting these enzymes produces safer, more effective therapies. It currently focuses its efforts on inhibitors of cathepsins S and B.
- Its lead product candidates are cathepsin S inhibitors: VBY-036 for neuropathic pain and Crohn's disease and VBY-891 for psoriasis. Phase 2 development for all three indications should commence in 1H 2015 which means that meaningful product revenues are far in the distance.
- In 2013, the company generated $9.9M in collaboration revenue. Its operating loss was ($2.3M). In 1H 2015, collaboration revenue dropped to $1.1M and the loss from operations increased to ($3.6M).
- Crohn's disease-related tickers: (ABBV -1.6%)(MRK -1.2%)(RDHL +0.4%)(VBLX)(OTCPK:TKPHF)(OTCPK:TKPYY)(CNDO +1.1%)(OTCQB:SNGX)(PSTI +2.3%)
- Neuropathic pain-related tickers: (DARA -4.4%)(AVNR -3.4%)(ZLCS +0.9%)(IPCI -2%)(BLRX -1.9%)(MNOV +0.6%)(PFE -0.3%)(OTCPK:NGSX)
- Psoriasis-related tickers: (DERM -0.5%)(NVS -2.5%)(CELG -1.4%)(LLY -1.3%)(CANF -2.3%)(IDRA -1.4%)(JNJ -0.8%)(XNPT +0.5%)(HSP -0.2%)
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