Humira: Will AbbVie's Patents Keep Out Biosimilars For Its TNF-Blocker Blockbuster?
Markman Advisors • 21 Comments
Markman Advisors • 21 Comments
Fri, Dec. 2, 9:16 AM
- Amgen (NASDAQ:AMGN) and collaboration partner Allergan (NYSE:AGN) announce the filing of a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) seeking approval of ABP 215, a biosimilar candidate to Roche's (OTCQX:RHHBY) cancer drug Avastin (bevacizumab).
- Under a 2011 collaboration agreement, the companies (then Watson Pharmaceuticals) agreed to develop and commercialize four oncology-focused biosimilars. Amgen has primary responsibility for developing, manufacturing and initially commercializing the products.
- Watson acquired Actavis in 2013 which acquired Allergan in 2015.
Thu, Dec. 1, 12:33 PM
- Amgen (AMGN -0.7%) initiates a Phase 3 cardiovascular outcomes (CV) study, GALACTIC-HF, assessing omecamtiv mecarbil in patients with high-risk chronic heart failure and reduced ejection fraction. The trial will determine if omecamtiv mecarbil, when added to standard-of-care (SOC) treatment, is superior to placebo plus SOC in reducing CV death or heart failure events.
- The study will be conducted across 800 sites in 34 countries. Target enrollment is ~8,000.
- The action triggers a $26.7M milestone payment to discoverer Cytokinetics (CYTK -4.2%).
- Omecamtiv mecarbil is a cardiac myosin activator. Myosin is a protein in heart muscle that 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.
- The companies inked a strategic alliance to develop cardiac myosin activators in January 2007.
Wed, Nov. 30, 4:11 PM
- The European Medicines Agency (EMA) accepts for review Coherus BioSciences' (NASDAQ:CHRS) Marketing Authorization Application (MAA) seeking approval of CHS-1701, a biosimilar to Amgen's (NASDAQ:AMGN) Neulasta (pegfilgrastim). This is the first EMA submission and acceptance for the company.
- Shares are off a fraction on average volume.
Tue, Nov. 29, 4:23 PM
- Arrowhead Pharmaceuticals (NASDAQ:ARWR) sets a new direction in its product development strategy by focusing on the development of RNAi therapeutics that utilize its proprietary subcutaneous (subQ) and extra-hepatic delivery systems. The redeployment of resources kills clinical-stage drug candidates ARC-520, ARC-521 and ARC-AAT that utilize the DPCiv (EX1) delivery vehicle. In addition, the company will eliminate 30% of its workforce.
- A few weeks ago, the company's mid-stage study assessing ARC-520 in hepatitis B was placed on clinical hold by the FDA due to concerns with toxicology related to EX1.
- Existing preclinical subQ and extra-hepatic programs with Amgen (NASDAQ:AMGN) are unaffected.
- Management will host a conference call and webcast at 4:30 pm ET today to discuss its plans.
- Shares are unchanged after hours on light volume.
- Previously: FDA places clinical hold on Arrowhead's mid-stage study of lead product candidate in hepatitis B e antigen-positive patients (Nov. 8)
- Update: Shares are down 60% after hours on robust volume.
Mon, Nov. 28, 1:20 PM| Mon, Nov. 28, 1:20 PM | 2 Comments
Wed, Nov. 16, 6:41 PM
- A Phase 3 clinical trial, STRIVE, assessing Amgen's (NASDAQ:AMGN) erenumab (AMG 334) for the prevention of migraine met its primary endpoint of a statistically valid change from baseline in mean monthly migraine days at week 24 compared to placebo.
- STRIVE randomized participants to receive either 70 mg or 140 mg of erenumab or placebo administered subcutaneously once per month for six months. At baseline, patients were experiencing an average of 8.3 migraine days per month. At week 24, the average reductions in migraine days per month for the 70 mg, 140 mg and placebo arms were 3.2, 3.7 and 1.8, respectively.
- Erenumab's safety profile was comparable to placebo and was consistent with previous studies. The most common adverse events were nasopharyngitis, upper respiratory infection and sinusitis.
- The analysis of the data is ongoing. Detailed results will be submitted for publication and for presentation at a future medical conference.
- It was also successful in another Phase 3 study called ARISE. Regulatory submissions are on tap for 2017.
- Erenumab, a fully human monoclonal antibody, inhibits the calcitonin gene-related peptide (CGRP) receptor, which is believed to transmit signals that cause incapacitating pain. It is being co-developed with Novartis (NYSE:NVS). Amgen retains commercial rights in the U.S., Canada and Japan and Novartis has commercial rights elsewhere.
- Shares are up 1% after hours on average volume.
- Previously: Amgen's erenumab (AMG 334) successful in late-stage study in migraine prevention (Sept. 28)
Tue, Nov. 15, 4:10 PM
- Amgen (NASDAQ:AMGN) and development partner Allergan plc (NYSE:AGN) announce the submission of a Biologics License Application (BLA) to the FDA seeking approval of a biosimilar to Roche's (OTCQX:RHHBY) cancer med Avastin (bevacizumab). The biosimilar, ABP 215, is the most advanced of the four oncology biosimilars that the companies are collaborating on under their December 2011 agreement.
- Under the terms of the partnership, Amgen has primary responsibility for developing, manufacturing and initially commercializing the products.
Sun, Nov. 13, 7:52 PM
- Results from a Phase 3 clinical trial, BRIDGE, assessing Amgen (NASDAQ:AMGN) and co-developer UCB's (OTCPK:UCBJF)(OTCPK:UCBJY) romosozumab (AMG 785) in men with osteoporosis showed statistically significant bone mineral density (BMD) gains compared to placebo. The data were presented at the American College of Rheumatology and Association of Rheumatology Health Professionals Annual Meeting in Washington, D.C.
- The study randomized 245 men 2:1 to receive either 210 mg romosozumab or placebo subcutaneously once per month for 12 months. The primary endpoint, the increase in BMD at the lumbar spine at Month 12 versus placebo, was achieved (12.1%; p<0.01). All secondary endpoints were also met.
- Romosozumab is a monoclonal antibody that inhibits sclerostin, a protein that has anti-anabolic effects on bone formation. It has a dual effect of increasing bone formation and decreasing bone breakdown.
- Worldwide, 20% of men over the age of 50 will experience an osteoporosis-related fracture.
- The companies plan to discuss the data with global regulatory authorities.
- Previously: Amgen's romosozumab successful in late-stage study in men with osteoporosis (March 21)
Sun, Nov. 13, 7:26 PM
- As expected, the European Commission approves Amgen's (NASDAQ:AMGN) Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease on hemodialysis. It is the first calcimimetic agent that can be administered intravenously three times per week at the end of a hemodialysis session.
- The company says that ~88% of dialysis patients and ~79% of hemodialysis patients will develop sHPT. About 2M people worldwide receive dialysis.
- The approval follows a positive opinion by the advisory committee CHMP in September.
- Previously: European Ad Comm backs Amgen's Parsabiv (Sept. 16)
Sat, Nov. 12, 5:00 PM
- Johnson & Johnson (NYSE:JNJ) says experimental sirukumab treatment for rheumatoid arthritis showed mixed results against AbbVie (NYSE:ABBV) top-selling Humira in a large trial.
- By one measure, patients with moderate to severe disease who took sirukumab showed significantly greater improvement in the Phase III study than those taking Humira. But another comparison showed no significant benefit of one drug over the other.
- Results of the study were reported today at the annual meeting of the American College of Rheumatology in Washington.
- Humira, and other older medicines such as Amgen (NASDAQ:AMGN) Enbrel and J&J's Remicade, works by blocking a protein called tumor necrosis factor ("TNF") that is involved in inflammation. Sirukumab is a member of an emerging new class of treatments that work instead by blocking IL-6, another protein involved in the inflammation process.
Thu, Nov. 10, 9:39 AM
- Amgen (AMGN +3.8%) and Janssen Pharmaceuticals (JNJ -0.3%) will collaborate in multiple clinical trials assessing the combination of KYPROLIS (carfilzomib) and DARZALEX (daratumumab) in patients with multiple myeloma (MM).
- Under the terms of the agreement, each company will supply its product and share development costs on a study-specific basis.
- The first trial initiated under the partnership is an open-label Phase 3 study assessing the combination of KYPROLIS and DARZALEX with dexamethasone compared to KYPROLIS and dexamethasone alone in MM patients who have been previously treated with one - three prior lines of therapy. The primary endpoint is progression-free survival. Secondary endpoints include overall survival, overall response rate and minimal residual disease. Enrollment should commence in April of next year.
Wed, Nov. 9, 8:08 AM
- Biotechs and Big Pharma look like they will jump out of the blocks this morning. Most leading names are up premarket.
- Sampling: (NASDAQ:AMGN) +4%; (NASDAQ:GILD) +2%; (NASDAQ:REGN) +3%; (NASDAQ:BIIB) +4%; (NASDAQ:VRTX) +2%; (NASDAQ:CELG) +3%; (NYSE:BMY) +2%; (NYSE:PFE) +5%; (NYSE:MRK) +2%; (NYSE:AZN) +1%; (NYSE:GSK) +1%; (NYSE:JNJ) +2%; (NYSE:ABBV) +4%; (NYSE:LLY) +3%; (NYSE:NVS) +3%; (NYSE:AGN) +4%; (NASDAQ:TEVA): +6%
Mon, Nov. 7, 6:34 AM
- Bayer (OTCPK:BAYRY) submits marketing applications in the U.S. Europe and Japan seeking approval of Stivarga (regorafenib) for the second-line treatment of patients with unresectable hepatocellular carcinoma (HCC), the third type of cancer for the kinase inhibitor. It is currently approved for the treatment of metastatic colorectal cancer and metastatic gastrointestinal stromal tumors.
- The data supporting the filings were generated in the Phase 3 RESORCE study that showed HCC patients who progressed during treatment with Nexavar (sorafenib) who received regorafenib experienced significantly improved overall survival (OS) compared to placebo with 37% less risk of death. Median OS in the regorafenib plus best supportive care (BSC) group was 10.6 months versus 7.8 months for placebo plus BSC.
- The U.S. application has Fast Track status.
- Bayer developed regorafenib under its 2011 license agreement with now-Amgen (NASDAQ:AMGN) subsidiary Onyx Pharmaceuticals. Onyx receives a royalty on global net oncology sales of regorafenib.
Sat, Nov. 5, 5:10 PM
- Brian Belski, chief investment strategist at BMO Capital Markets, says investors too often focus on "yield alone." Instead, he says they should look for companies with proven track records of steady payout growth.
- In a recent screen he developed, he looked for companies that had no dividend cuts in each of the past five completed fiscal years, and filetered for stocks with yields higher than that of the S&P 500 (~2.2%); payout ratios below the market's 50.4% level; FCF yields that exceed their dividend yields; and one-year dividend-per-share growth better than the S&P 500's median of 7.7%.
- Names it turned up include Amgen (NASDAQ:AMGN), Cisco (NASDAQ:CSCO), Harley-Davidson (NYSE:HOG), Home Depot (NYSE:HD), Illinois Tool Works (NYSE:ITW), KeyCorp (NYSE:KEY), Motorola Solutions (NYSE:MSI), and Texas Instruments (NYSE:TXN).
- Source: Barron's
Fri, Nov. 4, 6:33 PM
- The FDA approves Amgen's (NASDAQ:AMGN) Enbrel (etanercept) for the treatment of pediatric patients (ages 7 - 17) with chronic moderate-to-severe plaque psoriasis (PS). Enbrel's original indication applied to adults with chronic moderate-to-severe PS.
- About 100M people worldwide suffer from plaque psoriasis, about 30M of which are pediatric.
- Enbrel is Amgen's top seller, responsible for almost 27% ($5.8B) of the company's product sales over the past four quarters.
Thu, Nov. 3, 8:24 AM