Humira: Will AbbVie's Patents Keep Out Biosimilars For Its TNF-Blocker Blockbuster?
Markman Advisors • 21 Comments
Markman Advisors • 21 Comments
Amgen: Equity Report And Stock Valuation
Wed, Mar. 2, 6:54 AM
- Merck KGaA (OTCPK:MKGAF)(OTCPK:MKGAY) commences a Phase 3 clinical trial assessing MSB11022, a biosimilar to AbbVie's (NYSE:ABBV) Humira (adalimumab), for the treatment of moderate-to-severe plaque psoriasis. The 400-subject study, called AURIEL-Psoriasis, will compare MSB11022 to Humira at sites in Europe, Asia, North Central America. The primary endpoint is number of patients achieving a 75% improvement in symptoms (PASI 75) at Week 16.
- According to clinicaltrials.gov, the estimated final data collection date for the primary endpoint is December 2016. The estimated study completion date is September 2017.
- Amgen's (NASDAQ:AMGN) Humira biosimilar, ABP 501, is currently under FDA and EMA review.
- Previously: Amgen submits MAA in Europe for Humira biosimilar ABP 501 (Dec. 4, 2015)
- Previously: FDA accepts Amgen's BLA for Humira biosimilar (Jan. 25)
Fri, Feb. 26, 1:53 PM
- GlaxoSmithKline (GSK -0.9%) initiated with Hold rating and 1400p price target (-0.7% downside risk) by Cantor Fitzgerald.
- Shire plc (SHPG -0.6%) initiated with Buy rating by Cantor Fitzgerald.
- Insulet (PODD +8.7%) initiated with Sell rating and $15 (53% downside risk) price target by Empire Asset Management.
- MacroGenics (MGNX +2.2%) initiated with Equal Weight rating and $20 (29% upside) price target by Morgan Stanley.
- Biogen (BIIB +0.8%) initiated with Buy rating and $345 (30% upside) price target by Citigroup.
- Boston Scientific (BSX -0.3%) initiated with Buy rating and $21 (22% upside) price target by SunTrust Robinson Humphrey.
- Other initiations by Citigroup: Amgen (AMGN +1.1%) Neutral rating and $165 (11% upside) price target; Celgene (CELG +1.4%) Buy rating and $130 (25% upside) price target; Regeneron Pharmaceuticals (REGN) Buy rating and $480 (22% upside) price target; Alexion Pharmaceuticals (ALXN +0.1%) Neutral rating and $165 (18% upside) price target.
- IMS Health Holdings (IMS +0.2%) initiated with Outperform rating and $31 (19% upside) price target by Leerink Swann.
- Ocera Therapeutics (OCRX +5.7%) initiated with Buy rating and $10 (229% upside) price target by Brean Capital.
- Repligen (RGEN +3.8%) initiated with Buy rating and $36 (35% upside) price target by Craig-Hallum.
- Mesoblast (MESO -2.2%) initiated with Neutral rating and $5.50 (12% downside risk) price target by Chardan Capital.
- Ultragenyx Pharmaceutical (RARE +1.2%) initiated with Buy rating and $80 (29% upside) price target by Leerink Swann.
- Teva Pharmaceutical Industries (TEVA -0.2%) initiated with Outperform rating with $68-71 (21% upside from midpoint) price target by Wells Fargo.
- Medivation (MDVN +9.8%) initiated with Buy rating and $46 (28% upside) price target by Bank of America.
- Collegium Pharmaceutical (COLL -0.1%) initiated with Outperform rating and $35 (83% upside) price target by William Blair.
Thu, Feb. 25, 7:31 AM
Tue, Feb. 23, 7:55 AM
- In a regulatory filing, Amgen (NASDAQ:AMGN) reports that it has commenced an offering of CHF 700M ($693M) bonds due 2023 in Switzerland that will pay annual interest of 0.410%. The debt will not be offered or sold in the U.S.
- At this interest rate, the company should consider a larger offering. It's almost free money.
Mon, Feb. 22, 12:03 PM
- Micro cap Unilife (UNIS +14.3%) is up double normal volume in response to its announcement that it has entered into a strategic collaboration with Amgen (AMGN -1.3%) for injectable drug delivery systems centered on its portfolio of prefilled, customizable wearable injectors.
- Under the terms of the agreement, Unilife grants Amgen exclusive rights to its wearable injectors within select drug classes for use with certain Amgen drugs and non-exclusive rights to all Unilife delivery systems within oncology, inflammation, nephrology, cardiovascular and neuroscience. Previously granted rights to other Unilife customers are unaffected.
- Unilife is eligible to receive up to $75M, including an upfront license fee of $20M. It also sold Amgen a $30M senior secured convertible note. Amgen may buy up to an additional $25M in senior secured convertible notes over the next two years ($15M in 2017 and $10M in 2018). These amounts are in addition to the $15M it paid to Unilife in December 2015 in connection with the exclusivity letter.
- Unilife expects to earn additional revenues from Amgen from the development, production and supply of its delivery systems.
Mon, Feb. 22, 7:43 AM
- Amgen (NASDAQ:AMGN) and co-developer UCB (OTCPK:UCBJF) announce positive top-line results from a Phase 3 clinical trial assessing the bone-forming monoclonal antibody, romosozumab, in reducing the incidence of new vertebral fracture in postmenopausal women with osteoporosis. The study, called FRAME, met it co-primary endpoints of demonstrating statistically valid reductions in vertebral fracture at months 12 and 24 compared to placebo.
- The trial also met a secondary endpoint of a statistically valid reduction in the incidence of clinical fracture (composite of vertebral and non-vertebral fracture) through month 12 versus placebo, but fell short of demonstrating a statistically significant reduction in the incidence of non-vertebral fracture through months 12 and 24.
- Results showed women treated with monthly injections of romosozumab experienced a 73% reduction in the risk of spine fracture through 12 months versus placebo. The beneficial effect persisted after both arms were transitioned to denosumab (XGEVA) from months 12 through 24. Patients treated with romosozumab followed by denosumab showed a 75% reduction in vertebral fracture through month 24 compared to placebo. Patients in the romosozumab arm also experienced a 36% reduction in the risk of clinical fracture through month 12 versus placebo.
- The most common adverse events (>10%) were arthralgia (joint pain), nasopharyngitis (inflammation of the nose and pharynx) and back pain. Injection site reactions were reported in 5.2% of patients receiving romosozumab compared to 2.9% for placebo.
- Further analysis of the study results is ongoing and will be reported at a future medical conference and for publication. Global regulatory filings should be made this year.
- Romosozumab inhibits sclerostin, a protein that has anti-anabolic effects on bone formation.
Tue, Feb. 16, 11:53 AM
- Data from a Phase 2 clinical trial assessing FibroGen's (FGEN +4.9%) oral agent roxadustat for the treatment of anemia in patients with chronic kidney disease (CKD) showed that patients on hemodialysis who were previously receiving epoetin alfa [Amgen's (AMGN +1.1%) EPOGEN or J&J's (JNJ +0.3%) PROCRIT] but switched to roxadustat maintained hemoglobin (Hb) levels regardless of iron deletion status, degree of inflammation or prior iron regimen over six or 19 weeks. The results were published in the American Journal of Kidney Disease.
- In the first part of the study, lasting six weeks, lowest dose roxadustat (1.0 mg/kg 3x/week) maintained hemoglobin levels on par with epoetin alfa. Some separation was seen at higher doses of at least 1.5 mg/kg with 79% of patients showing a hemoglobin response compared to 33% for epoetin alfa.
- In the second part of the study, 51% of the roxadustat cohort achieved a Hb level of at least 11.0 g/dL compared to 36% for epoetin alfa (normal range is 13.5 - 17.5 for men and 12.0 - 15.5 for women). In addition, maintenance dosing of roxadustat was not correlated with levels of the inflammatory biomarker C-reactive protein (CRP). Decreases in cholesterol and hepcidin (key regulator of iron) were also observed in the roxadustat group.
- Roxadustat is an orally administered small molecule inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase. HIF is a protein transcription factor that "turns on" the production of red blood cells (erythropoiesis). Its value proposition is the ability to maintain hemoglobin levels in CKD patients without affecting inflammation and potentially avoiding the need for ongoing intravenous iron repletion therapy as needed with epoetin alfa.
- It is currently in Phase 3 development through collaborations with AstraZeneca (NYSE:AZN) and Astellas Pharma (OTCPK:ALPMF) (OTCPK:ALPMY).
- Previously: Data from mid-stage study show CKD patients with anemia respond to FibroGen's roxadustat in dose-related manner (Aug. 13, 2015)
Fri, Feb. 12, 7:38 AM
- Gilead Sciences (NASDAQ:GILD) initiated with Outperform rating and $120 (37% upside) price target by Oppenheimer.
- CareDx (NASDAQ:CDNA) initiated with Buy rating and $12 (137% upside) price target by Janney Capital.
- Shire plc (NASDAQ:SHPG) initiated with Neutral rating by Guggenheim.
- Ultragenyx Pharmaceutical (NASDAQ:RARE) initiated with Buy rating and $104 (95% upside) price target by H.C. Wainwright.
- Depomed (NASDAQ:DEPO) initiated with Buy rating and $22 (38% upside) price target by UBS.
- ACADIA Pharmaceuticals (NASDAQ:ACAD) initiated with Buy rating and $40 (128% upside) price target by Bank of America.
- Leerink restarts coverage on eight stocks: four Outperforms: Alexion Pharmaceuticals (NASDAQ:ALXN); Regeneron Pharmaceuticals (NASDAQ:REGN); Vertex Pharmaceuticals (NASDAQ:VRTX) and Gilead Sciences (GILD); four Market Performs: Celgene (NASDAQ:CELG); Biogen (NASDAQ:BIIB); Medivation (NASDAQ:MDVN) and Amgen (NASDAQ:AMGN).
- TESARO (NASDAQ:TSRO) initiated with Buy rating by Lake Street.
- AbbVie (NYSE:ABBV) initiated with Outperform rating by William Blair.
- Seattle Genetics (NASDAQ:SGEN) upgraded to Buy with $38 (41% upside) price target by Cantor Fitzgerald.
- Shire plc (SHPG) upgraded to Outperform with price target of $240 (59% upside) by RBC.
- Amedisys (NASDAQ:AMED) upgraded to Outperform with $40 (15% upside) price target by Oppenheimer.
- Smith & Nephew (NYSE:SNN) downgraded to Neutral from Buy by UBS. Price target lowered to 1,100p (4% upside) from 1,250p.
- Quidel (NASDAQ:QDEL) downgraded to Hold from Buy by Canaccord. Price target lowered to $18 (18% upside) from $22.
- BioCryst Pharmaceuticals (NASDAQ:BCRX) downgraded Neutral from Overweight by JP Morgan. Price target lowered to $5 (201% upside) from $16.
Thu, Feb. 4, 5:02 PM
- Amgen's (NASDAQ:AMGN) cholesterol-lowering med Repatha (evolocumab) met its co-primary endpoints in another Phase 3 study, GAUSS-3, in patients with high cholesterol who cannot tolerate statins. Results showed patients receiving Repatha experienced significant lower LDL-C levels compared to baseline during six months of therapy.
- The data will be submitted for presentation at a future scientific conference and for publication.
- The FDA approved Repatha in August 2015.
- Previously: FDA approves Amgen cholesterol drug Repatha (Aug. 27, 2015)
Thu, Feb. 4, 4:48 PM
- Results from a Phase 3 study, TOWER, assessing Amgen's (NASDAQ:AMGN) blood cancer drug BLINCYTO (blinatumomab) versus standard-of-care treatment in adult patients with Philadelphia chromosome-negative relapsed/refractory B-cell precursor acute lymphoblastic leukemia showed a statistically significant treatment benefit favoring BLINCYTO as measured by the improvement in overall survival (OS), the primary endpoint. Accordingly, the trial was stopped early as recommended by the independent data monitoring committee.
- BLINCYTO is called a T-cell engager because it acts as a connector between CD19, a protein found on the surface of most B-cell lymphoblasts and CD3, a protein on T-cell lymphocytes. It was approved five months ahead of its May 19, 2015 PDUFA date by virtue of its Breakthrough Therapy, Priority Review and Orphan Drug designations.
- It was approved in Europe for the same indication in November 2015.
- Previously: FDA clears Amgen blood cancer immunotherapy (Dec. 3, 2014)
- Previously: Amgen's BLINCYTO cleared in Europe (Nov. 24, 2015)
Fri, Jan. 29, 5:47 PM
- The best-performing U.S. stock over the past 30 years is one that few have heard of: Balchem (NASDAQ:BCPC), a New York-based maker of flavorings, fumigating gases and nutritional additives for animal feed.
- Since the end of 1985, Balchem has gained an average of 26.2%/year - a total gain of 107,099% - vs.10.3% for the S&P 500.
- But with flattening profitability and shares at a lavish 27x earnings, Balchem looks expensive for now, WSJ's Jason Zweig writes.
- Over the past 30 years, 44 U.S. stocks generated cumulative total returns of 10,000% or more; the 10 behind Balchem are HD, AMGN, NKE, UNH, DHR, OTCPK:ATCD, KSU, JKHY, AAPL and MO.
Thu, Jan. 28, 4:23 PM
- Amgen (NASDAQ:AMGN) Q4 results ($M): Total Revenues: 5,536 (+3.8%); Total Product Sales: 5,329 (+3.0%).
- Net Income: 1,800 (+39.1%); EPS: 2.37 (+41.1%); Non-GAAP EPS: 2.61 (+20.8%); CF Ops: 2,060 (-15.7%).
- Key Product Sales: Enbrel: 1,441 (+7.8%); Neulasta: 1,156 (-2.0%); EPOGEN: 342 (-36.5%); Neupogen: 263 (-4.0%); XGEVA: 356 (+9.5%); Sensipar/Mimpara: 384 (+21.1%); Aranesp: (+4.2%); Prolia: 380 (+20.6%); Kyprolis: 148 (+62.6%).
- 2016 Guidance: Total Revenues: $22.0B - 22.5B from $21.7B - 22.3B; Non-GAAP EPS: $10.60 - 11.00 from $10.35 - 10.75.
- Shares are up 1% after hours on robust volume.
Thu, Jan. 28, 4:03 PM
- Amgen (NASDAQ:AMGN): Q4 EPS of $2.61 beats by $0.32.
- Revenue of $5.54B (+3.9% Y/Y) in-line.
Wed, Jan. 27, 5:35 PM| Wed, Jan. 27, 5:35 PM | 9 Comments
Wed, Jan. 27, 3:30 PM
- As if biotech investors need reminding, biotechs (and healthcare stocks) are getting some rude treatment today, the market's foul mood notwithstanding. The Nasdaq Composite Index is down 2.5%,but the SPDR S&P Biotech ETF (XBI -4.7%) almost twice as much. The iShares Nasdaq Biotechnology ETF (IBB -3.5%) is faring a bit better, but still down more than the broad market.
- Only Biogen and Abbott have bucked the trend.
- Sample of tickers: (AMGN -2.5%)(BIIB +5.7%)(CELG -3.9%)(GILD -3.3%)(ALXN -1.2%)(ABT +0.3%)(BMY -1.8%)(MRK -3%)(VRX -4%)(PFE -0.9%)
- ETFs: BIB, BIS, CNCR
Wed, Jan. 27, 1:13 PM
- Tomorrow is a busy day for healthcare large caps with six firms reporting Q4 results. Companies and consensus views are:
- Premarket: Eli Lilly (LLY +1.1%): EPS of $0.78 on revenues of $5.3B; Zimmer Biomet Holdings (ZBH +1.1%): EPS of $2.04 on revenues of $2.0B; Abbott Laboratories (ABT +2.3%): EPS of $0.61 on revenues of $5.3B; Celgene (CELG -1%): EPS of $1.22 on revenues of $2.5B and Bristol-Myers Squibb (BMY -0.5%): EPS of $0.28 on revenues of $4.1B.
- After the close: Amgen (AMGN): EPS of $2.29 on revenues of $5.5B.
Amgen, Inc. is a biotechnology medicines company, which discovers, develops, manufactures and markets medicines for grievous illnesses. The company focuses on human therapeutics and concentrates on innovating novel medicines based on advances in cellular and molecular biology. It markets... More
Country: United States
Other News & PR