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Dec. 3, 2015, 1:46 PM
- Britain's National Institute for Health and Care Excellence (NICE), which advises the National Health Service (NHS) on costs, procedures and technologies with the aim of better managing the cost/benefit of services, thinks Alexion Pharmaceuticals' (ALXN -3.9%) Strensiq (asfotase alfa) is a bit too expensive for its tastes. The enzyme replacement therapy for pediatric-onset hypophosphatasia, affecting only seven people a year there, is priced at a hefty ₤366,912 ($552,000).
- NICE says the company has yet to provide an adequate justification for the high price. Luckily for Alexion, its decision is still in the draft stage and is open to further consultation. The company will, no doubt, take advantage of the opportunity to try to change NICE's opinion.
- Alexion is not alone. A few weeks ago, NICE rejected Amgen's (AMGN -3.4%) Repatha (evolocumab) saying, among other things, that it doubted the company's cost-effectiveness data.
- Previously: Advisor to Britain's NHS gives thumbs down to Amgen's Repatha (Nov. 18)
Dec. 3, 2015, 7:41 AM
- Thinly traded micro cap Foamix Pharmaceuticals (NASDAQ:FOMX) announces positive top-line results from a 24-subject Phase 2 clinical trial assessing FDX104 for the prevention of moderate-to-severe skin rashes in patients receiving epidermal growth factor receptor antibody inhibitors (EGFRI) [Eli Lilly's (NYSE:LLY) Erbitux (cetuximab) or Amgen's (NASDAQ:AMGN) Vectibix (panitumumab)] for the treatment of cancers such as colon and head and neck. The acne-like (acneiform) rash is the most common side effect from EGFRI drugs and, if severe enough, treatment should be withheld, reduced or discontinued.
- Each randomized patient in the study acted as their own control by treating one side of the face with FDX104 and the other with a foam vehicle (placebo) in a blinded manner.
- Results showed the side treated with FDX104 was better overall than the placebo-treated side. The mean maximal rash severity favored FDX104, 1.33 versus 1.71. 37.5% of patients (n=9/24) developed a Grade 3 rash (severe) on the placebo side compared to 16.7% (n=4/24) on the FDX104 side. The difference in the prevention of severe rash was statistically valid (p<0.05) in favor of FDX104 as measured by the Wilcoxon Signed-Rank test. Other exploratory analyses also trended positively.
- FDX104, a doxyocycline foam, appeared safe and well-tolerated with no drug-related systemic adverse events observed. Local reactions were noted in six patients with five resolved before the end of the study.
- The company will host a conference call this morning at 8:30 am ET to discuss the results. Shares are up 9% premarket on light volume.
Dec. 1, 2015, 12:53 PM
- In a shining example of the beauty of competition, Amgen (AMGN +0.5%) is battling fiercely with Sanofi (SNY) and Regeneron (REGN -0.4%) for favored status of its cholesterol fighter Repatha (evolocumab) versus Praluent (alirocumab) in the leading pharmacy benefit managers (PBMs).
- Amgen won preferred listing in CVS Health (CVS +1.4%) and an exclusive deal with Harvard Pilgrim Health System. Express Scripts (ESRX +1.2%) covers both PCSK9 inhibitors while UnitedHealth's (UNH +2.5%) Oxford unit is taking a different approach. Plan members will have to try Praluent first. If it fails to do the job after 12 weeks, then they can try Repatha.
- UnitedHealth and its OptumRx PBM are largest unsigned accounts and are, no doubt, getting substantial exposure to the companies' representatives.
Nov. 25, 2015, 4:23 PM
- Amgen (NASDAQ:AMGN) submits its first biosimilar Biologics License Application (BLA) to the FDA for ABP 501, a biosimilar version of AbbVie's (NYSE:ABBV) Humira (adalimumab).
- EVP of R&D Sean Harper, M.D., says, "The submission of Amgen's first biosimilar application to the FDA is an exciting milestone, expanding our inflammation portfolio to provide additional therapeutic options to patients. Patients with chronic inflammatory conditions are faced with a significant burden of disease requiring long-term treatment. Amgen's branded biologic medicines and biosimilars are developed and manufactured according to the same high standards and we are committed to delivering high quality medicines to patients with serious inflammatory diseases."
- Previously: Amgen's ABP 501 equivalent to Humira in late-stage RA study (Nov. 9)
Nov. 24, 2015, 7:23 AM
- As expected, the European Commission grants conditional marketing authorization for Amgen's (NASDAQ:AMGN) Orphan Drug-tagged BLINCYTO (blintumomab) for the treatment of adults with Philadelphia chromosome-negative relapsed/refractory B-precursor acute lymphoblastic leukemia.
- Conditional marketing authorization requires the annual renewal of the license until post-licensing commitments have been fulfilled. BLINCYTO is subject to additional monitoring in light of its side effects. The data supporting approval was generated in two Phase 2 trials (Study '206 and Study '211) instead of the typical Phase 3s.
- Previously: European Ad Comm gives thumbs up to Amgen's Kyprolis and BLINCYTO (Sept. 25)
Nov. 23, 2015, 9:18 AM
- Round one in the Repatha (evolocumab) versus Praluent (alirocumab) competition goes to Amgen (NASDAQ:AMGN). After evaluating both PCSK9 inhibitors, Pharmacy benefit manager CVS Health (NYSE:CVS) exclusively adds Amgen's Repatha to its commercial formularies, effectively shutting out Sanofi (NYSE:SNY) and Regeneron's (NASDAQ:REGN) Praluent.
- No word yet on the decisions from other PBMs.
Nov. 20, 2015, 6:51 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Samsung Bioepis' Benepali, a biosimilar version of Amgen's (NASDAQ:AMGN) Enbrel (etanercept), for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis.
- This is the first time CHMP has backed an etanercept biosimilar. A final decision by the European Commission usually takes ~60 days.
- Samsung Bioepis is a joint venture between Samsung Biologics and Biogen (NASDAQ:BIIB).
Nov. 19, 2015, 4:13 PM
- As expected, the European Commission approves Amgen's (NASDAQ:AMGN) Kyprolis (carfilzomib), in combination with lenalidomide and dexamethasone, for the treatment of adults with multiple myeloma who have received at least one prior line of therapy.
- Previously: European Ad Comm gives thumbs up to Amgen's Kyprolis and BLINCYTO (Sept. 25)
Nov. 18, 2015, 1:14 PM
- Britain's National Institute for Health and Care Excellence (NICE), which advises the National Health Service (NHS) on costs, procedures and technologies with the aim of better managing the cost/benefit of services, issues draft guidance not recommending Amgen's (AMGN +0.7%) Repatha (evolocumab) for the treatment of high cholesterol and mixed dyslipidemia.
- The committee determined that Repatha was effective in lowering LDL cholesterol ("bad" cholesterol) in patients with primary hypercholesterolemia, but cited the lack of evidence that it reduces the risk of cardiovascular disease-related events such as heart attacks, strokes and angina, which claim 150K English lives each year. It also doubted the reliability of the company's cost-effectiveness data, citing the use of the Framingham risk equations, which overestimate CVD risk in the UK population, and an unrealistically high factor to adjust the CVD risk in people with heterozygous-familial hypercholesterolemia.
- "The Committee concluded that the degree of uncertainty in the cost-effectiveness evidence was too high for it to be able to make well-founded recommendations about evolocumab." The public has until December 8 to comment on the draft guidance, which will be reviewed and discussed at the next NICE meeting on January 13.
- Sharpen that pencil, Amgen.
- Related tickers: (SNY +1.6%)(REGN +1.7%)
Nov. 18, 2015, 8:13 AM
- A Phase 1b clinical trial assessing Oncolytics Biotech's (NASDAQ:ONCY) REOLYSIN, in combination with Amgen's (NASDAQ:AMGN) KYPROLIS (carfilzomib) and dexamethasone, in patients with relapsed/refractory multiple myeloma in underway. The first stage of the study will enroll three to six patients in two cohorts, each at a different dose.The second stage will enroll up to 12 patients at the maximum tolerated dose determined in the first stage.
- The principal investigator is Kevin Kelly, M.D., Ph.D., from the University of Southern California.
- Multiple myeloma is the second most common type of blood cancer with ~27K new cases in the U.S. each year.
Nov. 11, 2015, 1:00 PM
- Alnylam Pharmaceuticals (ALNY +1.1%) and development partner The Medicines Company (MDCO -0.8%) announce positive results from their ongoing Phase 1 clinical trial evaluating ALN-PCSsc for the potential treatment of high cholesterol. The data were presented at the American Heart Association Scientific Sessions in Orlando, FL.
- As previously reported, subcutaneous administration of ALN-PCSsc reduced LDL-C (bad cholesterol) up to 83% (average maximum: 59 - 69%). New data showed the effects were highly durable and could support a twice/year dosing regimen, significantly longer than Amgen's (AMGN +0.6%) Repatha (evolocumab), dosed every two weeks or once/month, and Sanofi (SNY +0.3%)/Regeneron's (REGN +1%) Praluent (alirocumab), dosed every two weeks.
- Specifically, the maximum PCSK9 knockdown was 89% (average 80.3 - 84.3%) and the maximum LDL-C reduction was up to 78% (average 54.3 - 64.3%) after a single injection of ALN-PCSsc. At day 180, LDL-C reduction was as high as 53% (average 47%) in the 300 mg cohort. No clinically significant drug-related adverse events were seen.
- In the multiple dose cohorts (n=45), the maximum PCSK9 knockdown and LDL-C reduction were 94% (av. 86.9 - 90.1%) and 83% (av. 59.0 - 69.8%), respectively. At day 208, the LDL-C reduction was as high as 60% (av. 44.4%). In clinical trials, the mean LDL-C reductions observed for Repatha and Praluent were 64% (week 12) and 58% (week 24), respectively.
- Both Repatha and Praluent bind to PCSK9 in the blood. ALN-PCSsc turns off PCSK9 synthesis in the liver.
- The Medicines Company plans to initiate a Phase 2 study by year end with a Phase 3 trial to follow in 2017.
- The companies will host a conference call this afternoon at 4:30 pm ET to discuss the data.
Nov. 9, 2015, 7:23 PM
- Results from a head-to-head Phase 3 study comparing Amgen's (NASDAQ:AMGN) biosimilar candidate ABP 501 to AbbVie's (NYSE:ABBV) Humira (adalimumab) in patients with moderate-to-severe rheumatoid arthritis (RA) showed ABP 501 was equivalent to Humira. The data were presented at the 2015 American College of Rheumatology/Association of Rheumatology Health Professionals Annual Meeting in San Francisco.
- The study met is primary endpoint of equivalent ACR20 (20% improvement in RA symptoms) at week 24 compared to Humira. The proportion of patients achieving ACR20 in the ABP 501 group was 74.6% versus 72.4% for the Humira group. For ACR50, the proportions were 49.2% and 52.0%, respectively. For ACR70, the proportions were 26.0% and 22.9%, respectively. All were within the predefined equivalence margin.
- The incidence of treatment-emergent adverse events (TEAEs) was 50% for ABP 501 and 55% for Humira. The most frequently reported TEAEs were nasopharyngitis (6.4% vs. 7.3%), headache (4.5% vs. 4.2%), joint pain (3.0% vs. 3.4%), cough (2.7% vs. 3.1%) and upper respiratory tract infection (1.5% vs. 3.8%). Serious adverse events (3.8% vs. 5.0%) were lower in the ABP 501 cohort as were serious infections (0.8% vs. 1.1%). By week 24, binding antibodies were similar (38.3% vs. 38.2%) while neutralizing antibodies were a bit lower in the ABP 501 arm (9.1% vs. 11.1%).
- Amgen has nine biosimilars in development. It expects to launch its portfolio beginning in 2017.
- Previously: Phase 3 successful for Amgen's adalimumab biosimilar (Oct. 8, 2014)
Nov. 9, 2015, 5:20 PM
- Results from a confirmatory, randomized, double-blind, controlled, two-part Phase 3 study assessing the etanercept biosimilar CHS-0214 to Amgen's (NASDAQ:AMGN) Enbrel (etanercept) in patients with moderate-to-severe chronic plaque psoriasis showed that CHS-0214 was equivalent to Enbrel.
- The efficacy endpoints were the change from baseline in PASI 75 score at week 12 and the proportion of patients achieving PASI 75 from baseline at week 12. The results were within pre-specified margins for demonstrating equivalence. There were also no clinically meaningful differences in the safety profiles between the products.
- The study will continue as planned until week 52. The psoriasis study is one of two large Phase 3 trials that will support global regulatory applications. Results from the second Phase 3 study in rheumatoid arthritis are expected in Q1.
- CHS-0214 is being co-developed by Coherus BioSciences (NASDAQ:CHRS) and Baxalta (NYSE:BXLT).
Nov. 8, 2015, 8:48 PM
- Final results from the expansion phase of a Phase 2 study, COSMIC-HF, evaluating Cytokinetics' (NASDAQ:CYTK) and collaboration partner Amgen's (NASDAQ:AMGN) omecamtiv mecarbil in patients with chronic heart failure were presented today at the American Heart Association Scientific Sessions in Orlando, FL. The study met is primary endpoints of determining the maximum and pre-dose plasma concentration of omecamtiv mecarbil and met all secondary endpoints of improvements in various measures of cardiac function compared to placebo.
- The expansion phase was designed to assess orally available omecamtiv mecarbil in 448 subjects with chronic heart failure with left ventricular systolic dysfunction. Patients were randomized 1:1:1 to receive placebo, omecamtiv mecarbil 25 mg twice daily or omecamtiv mecarbil 25 mg twice daily titrated up to 50 mg twice daily after two weeks at 25 mg. ~60% of the titrated subjects escalated to the 50 mg dose.
- After 20 weeks of treatment, statistically significant improvements versus placebo were observed in the dose titration group in six measures of cardiac function, highlighted by an increase in systolic ejection time by 25.0 msec (p<0.001), increase in stroke volume by 3.63 mL (p=0.022) and a decrease in heart rate of 2.97 beats/min (p=0.007). The effects were slightly less profound in the 25 mg cohort with statistically significant improvements in systolic ejection time, stroke volume and a heart failure biomarker called NT-proBNP.
- Adverse events were comparable to placebo although there was an increase in unstable angina (0.34%) in the omecamtiv mecarbil group versus placebo (0%). There was also a 62% (n=278/448) incidence of increased troponin in the omecamtiv mecarbil cohorts. Troponins are proteins found in heart muscle that are released into the blood when the heart is damaged.
- Omecamtiv mecarbil is a cardiac myosin activator. Myosin is a protein in heart muscle this is responsible for converting chemical energy into the mechanical energy that results in a heart beat. Cardiac myosin activators increase systolic ejection time which results in an increase in cardiac contractility and more oxygen-efficient cardiac function.
- Previously: Amgen and Cytokinetics' omecamtiv mecarbil shows positive effect in mid-stage heart failure study (Oct. 27)
- Previously: Patient enrollment complete in trial expansion phase of Cytokinetics' heart drug (March 13)
Nov. 6, 2015, 4:22 PM
- The FDA accepts for review Amgen's (NASDAQ:AMGN) New Drug Application (NDA) seeking approval of etelcalcetide (AMG 416) for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on hemodialysis. The PDUFA date is August 24, 2016.
- Etelcalcetide is a novel calcimimetic that suppresses the secretion of parathyroid hormone. It acts by binding to and activating the calcium-sensing receptor on the parathyroid gland, which causes a decrease in the hormone.
- Previously: Amgen's AMG 416 shows efficacy in reducing PTH in pooled data from two Phase 3 studies (May 29)
Oct. 28, 2015, 4:30 PM
- Amgen (NASDAQ:AMGN) Q3 results ($M): Total Revenues: 5,723 (+13.8%); Product Sales: 5,516 (+13.8%).
- Net Income: 1,863 (+49.8%); EPS: 2.44 (+51.6%); Non-GAAP EPS: 2.72 (+18.3%); CF Ops: 2,874 (+4.9%).
- Key Product Sales: Enbrel: 1,459 (+30.3%); Neulasta: 1,267 (+6.2%); Epogen: 489 (-5.6%); Xgeva: 378 (+18.9%); Sensipar/Mimpara: 353 (+29.3%); Kyprolis: 137 (+45.7%).
- 2015 Guidance: Total Revenues: $21.4B - 21.6B from $21.1B - 21.4B; Non-GAAP EPS: $9.95 - 10.10 from $9.55 - 9.80.
- 2016 Guidance: Total Revenues: $21.7B - 22.3B; Non-GAAP EPS: $10.35 - 10.75.
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