Sun, Mar. 1, 11:53 PM
- An interim analysis of a Phase 3 clinical trial comparing Amgen's (NASDAQ:AMGN) Kyprolis (carfilzomib) to Takeda's (OTCPK:TKPHF) (OTCPK:TKPYY) Velcade (bortezomib) in patients with relapsed multiple myeloma (MM) met its primary endpoint of progression-free survival (PFS).
- Patients treated with carfilzomib plus dexamethasone lived twice as long (median PFS: 18.7 months) as those treated with bortezomib plus dexamethasone (median PFS: 9.4 months).
- The carfilzomib cohort also demonstrated superiority over bortezomib in the secondary endpoints of higher overall response rate and lower neuropathy events. Investigators continue to monitor overall survival (OS) data because it is not yet mature.
- Full data will be submitted for presentation at the American Society of Clinical Oncology meeting, May 29 - June 2, in Chicago.
- Velcade is ranked in the top 50 of the best-selling drugs in the world, generating $2.7B in sales in 2013. The FDA approved it in 2003 for progressive MM after previous treatment, in 2005 as a second-line treatment for MM and in 2008 as a first-line treatment of MM.
- The FDA approved Kyprolis in July 2012 for the treatment of patients with MM who have received at least two prior therapies, including bortezomib and an immunomodulatory agent.
Fri, Feb. 27, 10:48 AM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion to extend the marketing authorization for Amgen's (AMGN -0.6%) Vectibix (panitumumab) to include combination with the chemotherapy regimen FOLFIRI as first-line treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC), which constitutes ~50% of mCRC patients.
- Vectibix is currently cleared Europe for the treatment of adult patients with wild-type RAS mCRC as first-line treatment in combination with the chemo regimen FOLFOX; as second-line treatment in combination with FOLFIRI in patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) and as monotherapy after failure of fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemotherapy regimens.
- A final decision from the European Commission usually takes ~60 days.
- Vectibix generated $505M in sales last year.
Fri, Feb. 27, 9:23 AM
- The European Medicines Agency (EMA) accepts Amgen's (NASDAQ:AMGN) Marketing Authorization Application (MAA) seeking approval for the use of Kyprolis (carfilzomib) for the treatment of patients with relapsed multiple myeloma (MM) who have received at least one prior therapy. The EMA will review the MAA under its accelerated assessment protocol.
- Approximately 90K Europeans are living with MM. There are ~40K new cases diagnosed each year and ~24K deaths.
- Kyprolis, a proteasome inhibitor, was cleared by the FDA in July 2012. It generated $331M in sales for Amgen in 2014.
Wed, Feb. 25, 8:30 PMAmgen's IV drug candidate for SHPT in CKD patients on dialysis non-inferior to Sensipar in Phase 3 trial
- A Phase 3 study comparing Amgen's (NASDAQ:AMGN) AMG 416 to cinacalcet (Sensipar) met its primary endpoint of non-inferiority (no worse than) as measured by the achievement of a greater than 30% reduction from baseline in mean pre-dialysis serum intact parathyroid hormone (PTH) levels.
- Additionally, AMG 416 was statistically significantly superior to cinacalcet in the proportion of patients achieving greater than 30% and 50% PTH reduction from baseline during the Efficacy Assessment Period.
- AMG 416 is a novel calcimimetic agent in development for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) receiving hemodialysis. The intravenously administered drug binds to and activates the calcium-sensing receptor on the parathyroid gland, thereby decreasing serum intact PTH levels.
- This therapeutic area is not without risks. Fatal adverse events were reported in 2.7% of the AMG 416 arm and 1.8% in the cinacalcet arm. The incidences of serious adverse events were 25.1% and 27.3%, respectively.
Mon, Feb. 23, 12:07 PM
- Among the additions to the index (which fuels the IBLN ETF) are EMC, Google (GOOG, GOOGL), Goodyear (NASDAQ:GT), Mohawk Industries (NYSE:MHK), PVH, Time Warner (NYSE:TWX), and Yahoo (NASDAQ:YHOO). There are three health care additions as well: Allergan (NYSE:AGN), Amgen (NASDAQ:AMGN), and HCA. The lone energy name added is Consol Energy (NYSE:CNX).
- Exiting the index are energy names Halliburton (NYSE:HAL) and National-Oilwell Varco (NYSE:NOV), along with healthcare companies AbbVie (NYSE:ABBV), Aetna (NYSE:AET), Humana (NYSE:HUM), and Tenet Healthcare (NYSE:THC). Citigroup (NYSE:C), CBS, Crown Castle (NYSE:CCI), and Michael Kors (NYSE:KORS) round out those subtracted.
- IBLN tracks the highest-conviction S&P 500 picks by hot-handed billionaires who built their fortunes through hedge funds and investing. The list of billionaires tracked is updated each October, and the equity components are rebalanced each quarter after sifting through regulatory filings.
- IBillionaire Index Rebalance
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%)
Thu, Feb. 12, 12:56 PM
- Johnson & Johnson (JNJ -1.6%) slumps on double normal volume after U.S. Patent Office upholds the rejection of its Remicade 2018 patent. Biosimilar makers rally as a result, including thinly-traded nano cap Epirus Biopharmaceuticals (EPRS +15.1%) whose lead product is BOW015, a biosimilar version of Remicade (infliximab).
- Biosimilar-related tickers: (PFE +1.3%)(HSP +0.1%)(AMGN -0.4%)(CHRS +0.2%)(PFNX +14.5%)(NVS -0.2%)
Thu, Feb. 12, 7:27 AM
- The FDA will have two advisory committees jointly review Amgen's (NASDAQ:AMGN) Biologics License Application (BLA) for talimogene laherparepvec for the treatment of patients with regionally or distantly metastatic melanoma. The Cellular, Tissue and Gene Therapies Advisory Committee and the Oncologic Drugs Advisory Committee will meet on April 29 to discuss the BLA.
- The PDUFA date is now October 27 instead of the previously announced July 28.
- The company submitted its Marketing Authorization Application (MAA) to the European Medicines Agency in early September.
- Previously: Amgen submits MAA for cancer immunotherapeutic (Sept. 2, 2014)
- Previously: Amgen and Merck team up in melanoma (Dec. 8, 2014)
Tue, Feb. 3, 9:49 PM
- A Phase 3 clinical trial assessing Amgen's (NASDAQ:AMGN) biosimilar to AbbVie's (NYSE:ABBV) Humira (adalimumab), ABP-501, achieved its primary and key secondary endpoints demonstrating equivalence to adalimumab in patients with moderate-to-severe rheumatoid arthritis.
- The primary endpoint compared ACR20 values at Week 24, which was within the specified margin for clinical equivalence. In addition, safety and immunogenicity were comparable to adalimumab.
- This is the second successful Phase 3 trial for ABP-501. Amgen has nine biosimilars in development and expects to launch five of them between 2017 and 2019.
Tue, Jan. 27, 5:21 PM
- Amgen (NASDAQ:AMGN) submits a Supplemental New Drug Application (sNDA) to the FDA and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the use of Kyprolis (carfilzomib) to treat patients with relapsed multiple myeloma (MM) who have received at least one prior therapy.
- Kyprolis is currently cleared for the treatment of patients with MM who have already received at least two other treatments including bortezomib and an immunomodulatory agent such as lenalidomide and/or thalidomide.
Tue, Jan. 27, 4:57 PM
- Amgen (NASDAQ:AMGN) Q4 Results ($M): Total Revenues: 5,331 (+6.4%); Product Sales: 5,174 (+7.8%), U.S.: 4,003 (+8.6%), Intl: 1,171 (+5.3%).
- Sales By Product: Neulasta/Neupogen: 1,454 (+3.3%), Neulasta: 1,180 (+7.5%), Neupogen: 274 (-11.3%), Enbrel: 1,337 (+11.4%), Aranesp: 479 (+1.9%), Epogen: 539 (+2.7%), Sensipar/Mimpara: 317 (+3.3%), Vectibix: 132 (+29.4%), Nplate: 119 (-0.8%), Xgeva/Prolia: 640 (+22.6%), Xgeva: 325 (+13.6%), Prolia: 315 (+33.5%), Kyprolis: 91 (+24.7%).
- COGS: 1,183 (+15.0%); R&D Expense: 1,234 (-1.2%); SG&A Expense: 1,327 (-12.8%); Net Income: 1,294 (+26.7%); EPS: 1.68 (+26.3%); CF Ops: 2,445 (+33.2%), Quick Assets: 27,026 (+39.3%).
- Gross Profit: 4,148 (+4.2%); COGS: 22.2% (+8.1%); Gross Margin: 77.8% (-2.1%); Operating Earnings: 1,587 (+30.9%); Operating Earnings Yield: 29.8% (+23.1%); Net Earnings Yield: 24.3% (+19.1%).
- 2015 Guidance: Revenues: $20.8B - 21.3B; EPS: $7.48 - 7.87; Non-GAAP EPS: $9.05 - 9.40; CAPEX: ~$800M; Tax Rate: 18 - 19%.
Tue, Jan. 27, 4:03 PM
Mon, Jan. 26, 5:35 PM
Mon, Jan. 26, 7:31 AM
- Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NYSE:SNY) announced that the FDA has accepted under priority review the Biologics License Application (BLA) for Praluent (alirocumab) for the treatment of hypercholesterolemia.
- Priority review status shortens the review time to six months so the PDUFA date is July 24.
- The European Medicines Agency accepted the companies' Marketing Authorization Application (MAA) several weeks ago.
- Alirocumab is an investigational monoclonal antibody targeting proprotein subtilisin/kexin type 9 (PCSK9). It will be competing with Amgen's (NASDAQ:AMGN) evolocumab for supremacy in the post-statin anti-cholesterol market. The PDUFA date for the FDA's review of evolocumab is August 27.
- Previously: European regulator accepts Regeneron/Sanofi application for cholesterol-lowering med (Jan. 12)
- Previously: FDA OK with Amgen's BLA for cholesterol-lowering drug (Nov. 10, 2014)
Thu, Jan. 22, 4:07 PM
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)
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