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
Thu, Apr. 28, 4:04 PM
Wed, Apr. 27, 5:35 PM
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Wed, Apr. 20, 11:18 AM
- According to Leerink's Geoff Porges, drug makers appear to be taking little heed to politicians' outcries over high prices. In a research note, he says, "The price increases for established brands across our coverage have been substantial indeed. To the surprise of many investors, it now appears these price increases are likely to flow through to actual sales growth, with such growth more than offsetting any volume weakness in Q1 and resulting in significant positive revenue surprises for those companies when they report Q1 results."
- He cites Johnson & Johnson's (JNJ +0.8%) Q1 results released yesterday. Its total business was flat (+0.6%) but its pharmaceuticals unit was up 12.9%. His analysis showed as much as 90% of the list price increases are flowing through to reported sales, some as high as 100%.
- Over the past year, Amgen (AMGN +0.7%) increased its drug prices 8 - 28%, Gilead Sciences (GILD +0.9%) 10 - 18% for its HIV drugs and Biogen (BIIB -1.6%) 10 - 18%, according to Mr. Porges.
- Biogen reports tomorrow. Eli Lilly (LLY -0.3%), Baxalta (BXLT -1.4%), AbbVie (ABBV +0.9%), Celgene (CELG +0.4%), Bristol-Myers Sqibb (BMY +0.3%) and Shire (SHPG -1.6%) report next week. Pfizer (PFE +1%) and Merck (MRK -0.2%) report the week after. Amgen (AMGN +0.7%) is due to report shortly as is Gilead.
Tue, Apr. 19, 4:58 PM
- Data from a Phase 3 clinical trial assessing Amgen's (NASDAQ:AMGN) Nplate (romiplostim) for the treatment of children with symptomatic immune thrombocytopenia (low blood platelets)(ITP) showed a statistically valid treatment benefit compared to placebo. The results were recently published in The Lancet.
- The double-blind, placebo-controlled trial randomized 62 children who had ITP for at least six months to receive weekly Nplate or placebo for 24 weeks. The primary endpoint was durable platelet response as defined by achieving weekly increases in platelets without rescue medication in at least six of the final eight weeks. Results showed 52% of the Nplate group achieved a durable platelet response compared to 10% for placebo (p=0.002). Rates of overall platelet response favored Nplate, 71% versus 20% (p=0.0002), as did the rates of any platelet response, 81% versus 55% (p=0.0313).
- Serious adverse events (SAEs) were observed in 23.8% of Nplate recipients compared to 5.3% for placebo. SAEs included epistaxis (nose bleed), contusion, headache (two each), nausea, bronchiolitis, petechia (red or purple spot on the skin caused by bleeding), epilepsy, fever, thrombocytosis, urinary tract infection and vomiting (one each).
- Nplate, a thrombopoietin receptor agonist, was approved in the U.S. in August 2008 for the treatment of adults with chronic ITP. It is designed to mimic the body's natural thrombopoietin, a protein produced by the liver and kidneys that regulates the production of platelets.
Sun, Apr. 3, 10:36 AM
- In a late-breaking clinical trial session at the American College of Cardiology’s 65th Annual Scientific Session, Amgen's (NASDAQ:AMGN) Repatha trial showed that in patients with reproducible statin intolerance due to muscle-related side effects, Repatha vs. ezetimibe (NYSE:MRK) resulted in significantly greater reduction in low-density lipoprotein cholesterol (LDL-C) after 24 weeks.
- The mean LDL-C reduction from baseline at weeks 22 and 24 was 54.5% for Repatha vs. 16.7% for ezetimibe.
- Muscle-related side effects were reported in 20.7% of Repatha patients and 28.8% of ezetimibe patients.
- Now read Regeneron - A Review: Strong Returns Look Likely For 2016 And Beyond »
Fri, Apr. 1, 3:45 PM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of FLIXABI (infliximab), a biosimilar to Johnson & Johnson's (JNJ +0.9%) Remicade (infliximab), developed by Samsung Bioepis, the joint venture between Samsung BioLogics and Biogen (BIIB).
- If approved, it will be the second biosimilar developed by Samsung Bioepis to be cleared in the EU. BENEPALI, a biosimilar to Amgen's (AMGN +2.8%) Enbrel (etanercept), was approved in January.
- A final decision from the European Commission usually takes ~60 days.
- Previously: First Enbrel biosimilar cleared in Europe (Jan. 17)
- Read now Samsung Bioepis And Biogen: A Profitable Case For SB2 and Enbrel
- Update: On May 30, Biogen announced that FLIXABI was approved by the European Commission.
Fri, Apr. 1, 9:35 AM
- A Phase 3 clinical trial, SPIRE-AI, assessing Pfizer's (PFE -0.2%) bad cholesterol fighter, bococizumab, in patients with hyperlipidemia or mixed dyslipidemia on statin therapy and whose LDL-C (low density lipoprotein cholesterol) was at least 70 mg/dL (less than 100 mg/dL is optimal) met its co-primary endpoints of a statistically valid percent change from baseline in LDL-C and the proportion of patients successfully operating the pre-filled pen.
- SPIRE-AI is the second of six SPIRE Phase 3s that will support the company's regulatory applications. The 299-subject, randomized, double-blind, placebo-controlled, parallel-group study evaluated the safety, tolerability and efficacy of subcutaneous administration of 75 mg and 150 mg of bococizumab via a pre-filled pen.
- Bococizumab is a PCSK9 inhibitor under development for lowering LDL-C and improving cardiovascular outcomes in a broad range of high-risk patients.
- There are two PCSK9 inhibitors currently available in the U.S.: Amgen's (NASDAQ:AMGN) Repatha (evolocumab) and Praluent (alirocumab), co-developed by Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NYSE:SNY).
- Complete results will be presented at a future medical conference.
- According to clinicaltrials.gov, Pfizer's SPIRE-1 study of bococizumab in reducing cardiovascular events will run until April 2018. SPIRE-LL and SPIRE-LDL should be completed by July of this year. SPIRE-HR should wind up this month.
- Now read Pfizer: 30%+ Discount with 4% Yield
Thu, Mar. 31, 4:27 PM
- The prioritization of its strategic portfolio prompts Johnson & Johnson (NYSE:JNJ) Janssen Research & Development, LLC, to terminate its development of fulranumab for the treatment of osteoarthritis pain and return the rights to Amgen (NASDAQ:AMGN).
- Amgen licensed fulranumab, an anti-nerve growth factor (NGF) monoclonal antibody, to Ortho-McNeil-Janssen Pharmaceuticals (now Janssen Pharmaceuticals) in 2008. The neuroscience therapeutic area of Janssen Research & Development continues its discovery and development programs in Alzheimer's and serious mental illness.
- The FDA placed a hold on the development of anti-NGFs in April 2011 due to safety concerns, specifically a heightened risk of joint damage. The hold was subsequently lifted. The company said its decision was based on strategic priorities and not safety concerns from its ongoing Phase 3 study.
Wed, Mar. 30, 11:19 AM
- "What concerns us most is the continued extreme overweight in lower quality stocks," says BAML's Savita Subramanian. A strategy of buying the ten most underweight stocks and selling the ten most overowned stocks has generated an average alpha of 15 percentage points per year, she says.
- This chart from the BAML report shows the 11 most overowned stocks based on percentage of funds holding vs. their weighting in the S&P 500. At the top is PCLN, followed by MA, BIIB, V, MDT, TWX, ESRX, BA, AMGN, CELG, AMZN.
- Among those underowned are: AGL Resources (NYSE:GAS) and Diamond Offshore (NYSE:DO).
- via Scott Barlow
Wed, Mar. 23, 7:04 AM
- Results from a Phase 3 clinical trial, ODYSSEY ESCAPE, evaluating Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi' s (NYSE:SNY) Praluent (alirocumab) Injection in patients with heterozygous familial hypercholesterolemia (HeFH) who require chronic apheresis therapy showed those who added Praluent to their existing treatment regimen reduced the frequency of their apheresis therapy by 75% compared to placebo (p<0.0001). In addition, 63% of patients receiving Praluent no longer required apheresis compared to zero for placebo. This is the first time a PCSK9 inhibitor has demonstrated that it can reduce the frequency of apheresis therapy.
- The study involved 62 HeFH patients in the U.S. and Germany. They were randomized to receive either 150 mg of Praluent subcutaneously every two weeks or placebo. During the first six weeks patients remained on their established apheresis schedule. The following 12 weeks the frequency of apheresis was adjusted based on their LDL-C response to treatment.
- Heterozygous familial hypercholesterolemia is an inherited form of high cholesterol that leads to early heart attacks in both men and women. Many required routine (1 - 2 times/week) apheresis therapy to remove LDL-cholesterol from their blood. Apheresis is a procedure in which the patient's blood is passed through an apparatus to remove a particular constituent. It is time-consuming (takes ~three hours) and expensive ($100k/year).
- Praluent was cleared in the U.S. in July 2015 and in the EU two months later.
- Related ticker: (NASDAQ:AMGN)
Mon, Mar. 21, 7:20 AM
- Amgen (NASDAQ:AMGN) and co-developer UCB (OTCPK:UCBJF)(OTCPK:UCBJY) announce that the Phase 3 study, BRIDGE, assessing romosozumab in men with osteoporosis met its primary endpoint of a statistically significant increase in bone mineral density (BMD) at the lumbar spine compared to placebo at month 12.
- All secondary endpoints were also met. Subjects receiving romosozumab showed statistically valid increases in BMD at the femoral neck and total hip at month 12 and statistically valid increases in BMD at the lumbar spine, femoral neck and total hip at month 6, both versus placebo.
- The study enrolled 245 men who were randomized 2:1 to receive either a monthly subcutaneous injection of romosozumab (210 mg) or placebo for 12 months.
- The incidence of adverse events was comparable between the arms. The most frequent (>5%) were nasopharyngitis, back pain, hypertension, headache and constipation. Injection site reactions were reported in 5.5% of patients in the romosozumab cohort compared to 3.7% in the placebo group. Most were mild in severity. The incidence of confirmed cardiovascular (CV) serious adverse events (SAEs) was 4.9% (n=8/163) for romosozumab and 2.5% (n=2/81) for placebo. Both arms had one confirmed CV death.
- The results will be submitted for presentation at a future medical conference. The companies intend to discuss the data with global regulators.
- 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.
- Related ticker: (NASDAQ:RDUS)(NYSE:LLY)
Thu, Mar. 17, 5:21 PM
- Thinly traded nano cap CymaBay Therapeutics (NASDAQ:CBAY) is down 16% after hours on robust volume in response to its announcement of results in a Phase 2 pilot study assessing Orphan Drug-tagged MBX-8025 in patients with homozygous familial hypercholesterolemia (HoFH), an inherited disorder characterized by abnormally high levels of bad LDL cholesterol (LDL-C) leading to premature cardiovascular disease.
- The 12-week, open-label, dose escalation trial enrolled 13 HoFH patients. All were receiving ezetimibe [Merck's (NYSE:MRK) Zetia] and were on maximum statin therapy. None were being treated with lomitapide [Aegion's (NASDAQ:AEGN) Juxtapid], mipomersen [Sanofi's (NYSE:SNY) Kynamro] or a PSCK9 inhibitor. The average baseline LDL-C level was 368 mg/dL (optimal level: less than 100 mg/dL). Subjects received 50 mg of MBX-8025 once daily for four weeks.
- Two per-protocol analyses were performed on 12 subjects (one was excluded due to missed apheresis visits). A responder analysis showed three patients experienced a reduction in LDL-C greater than 30%, five patients at least 20% and seven patients at least 15%. The average maximum decrease was 19%. A second analysis, averaging values across all doses and dosing periods, showed an overall average decrease in LDL-C of 10%, with eight subjects showing a mean decrease of 16% and three greater than 20%. Four patients showed a mean increase in LDL-C of 4%.
- Mean PCSK9 was elevated at baseline and increased significantly during treatment by an average of 43%, which was unexpected, and creates the need to assess the combination of MBX-8025 and a PCSK9 inhibitor [Amgen's (AMGN +0.1%) Repatha (evolocumab) or Regeneron (NASDAQ:REGN) and Sanofi's Praluent (alirocumab)] in a pilot study.
- MBX-8025 is an agonist of peroxisome proliferator-activated receptor delta, a nuclear receptor that regulates genes involved in lipid transport, storage and metabolism in liver and muscle.
- Previously: CymaBay product candidate an Orphan Drug for severe hypertriglyceridemia (April 22, 2015)
Wed, Mar. 16, 3:30 PM
- Amgen (AMGN +0.4%) chief Robert Bradway says, "We are thankful that the jury weighed the evidence carefully and recognized the validity of Amgen's patents on Repatha (evolocumab), our innovative biologic molecule that reduces LDL [bad] cholesterol."
- Earlier today, a jury in a Delaware federal court found the defendants Regeneron Pharmaceuticals (REGN +0.5%) and Sanofi (SNY -1.1%) failed to prove Amgen's patents, Nos. 8,829,165 and 8,859,741, invalid for lack of written description and enablement. In patent law, description and enablement means that, in order to to be considered for a patent, the product specification must clearly describe the manner and process of making and using the invention such that it enables another party skilled in the art to make and use it, which the jury believed Amgen had done.
- Prior to the case going to jury, the Court dismissed the defendants' case on obviousness, meaning there is no combination of "prior art" (previously patented products) that would bring the patentability of evolocumab into question.
- Prior to the trial, both Regeneron and Sanofi acknowledged infringing on seven patent claims of '165 and '741. They intend to appeal today's ruling.
Wed, Mar. 16, 11:52 AM
- Nasdaq has suspended trading in Regeneron Pharmaceuticals (REGN +2.6%) pending news. One possibility is a ruling on its patent fight with Amgen (AMGN -0.4%) over their PCSK9 inhibitors [Praluent (alirocumab) versus Repatha (evolocumab)].
- Here's an SA article by Markman Advisors for background.
- Update: Amgen patents upheld per report by Evercore ISI's Mark Schoenebaum. Permanent injunction hearing set for March 23 - 24. Regeneron to appeal. Judge ruled that Amgen failed to establish sufficient evidence of willful infringement (win for Regeneron).
- Update #2: Judge ruled that two Amgen patents covering antibodies targeting PCSK9 are valid. Regeneron and development/commercialization partner Sanofi (SNY -1.7%) intend to appeal the decision. The availability of Praluent is not affected at this time. Trading in REGN to resume at 1:00 pm ET. Initial trading has shares down only 1%.
Wed, Mar. 16, 7:56 AM
- Citing evolving standards of care and applicable patient population, Provectus Biopharmaceuticals (NYSEMKT:PVCT) amends the protocol of its Phase 3 clinical trial assessing lead cancer candidate, PV-10, for the treatment of melanoma.
- The changes include the addition of Amgen's (NASDAQ:AMGN) IMLYGIC (talimogene laherparepvec) as an option for use as a comparator drug, the inclusion of Stage IV M1a patients having no active nodal or distant cutaneous or subcutaneous metastatic melanoma (similar prognosis to Stage IIIB and IIIC patients that are already in the study) and an updated protocol clarifying the eligibility for patients not having access to immune checkpoint inhibitors or targeted therapy due to standard of care and those who have failed targeted therapy.
- CTO Dr. Eric Wachter says, "These kinds of amendments are commonplace in Phase 3 studies and serve to fine-tune the patient population and study procedures to match changing care standards for a large global study. The most obvious amendment addresses approval in late October of IMLYGIC by the FDA as the first and only oncolytic viral therapy. As we implement the amended protocol we will assess [the] potential impact on study timelines."
- According to clinicaltrials.gov, the current estimated final data collection date for the primary endpoint, progression-free survival, is September 2017. The estimated study completion date is October 2017.
- Orphan Drug-tagged PV-10 is an injectable formulation of rose bengal, a water-soluble xanthene dye that is used to prepare slides of certain microorganisms for analysis with a microscope.
Wed, Mar. 2, 4:23 PM
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
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