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Mar. 20, 2015, 7:56 AM
- The U.S. District Court of San Francisco denies Amgen's (NASDAQ:AMGN) preliminary injunction to block the sale of Novartis' (NYSE:NVS) Zarxio, a biosimilar of the former's $1.2B Neupogen (filgrastim) that was approved by the FDA several weeks ago, the first biosimilar to clear the regulatory hurdle in the U.S. Amgen intends to appeal the decision.
- Novartis previously agreed to delay Zarxio's U.S. launch until the court's decision or April 10, whichever came first. If it proceeds with the launch and Amgen wins its appeal, it would have to pay costly damages. In a statement, Novartis said, "Given the importance of this case for future biosimilars, we agreed with Amgen before this hearing to jointly request expedited review of any appeal to the Federal Circuit." It is unknown how long Amgen's appeal will take.
- Previously: FDA clears first biosimilar (March 6)
Mar. 16, 2015, 8:26 AM
- A Phase 3 study evaluating Regeneron Pharmaceuticals' (NASDAQ:REGN) Praluent (alirocumab) in patients with hypercholesterolemia showed that patients receiving Praluent 150 mg every two weeks lowered their low-density lipoprotein cholesterol (LDL-C) by an additional 62% (p<0.0001) at Week 24 compared to placebo, with consistent LDL-C lowering maintained over 78 weeks (56% reduction, p<0.0001).
- The trial, call ODYSSEY LONG TERM, assessed Praluent 150 mg (n=1,553) compared to placebo (n=788) in patients judged at high cardiovascular (CV) risk and who were receiving the maximum tolerated dose of statin therapy with or without other lipid-lowering treatment. Patients self-administered a subcutaneous injection of Praluent every two weeks via a pre-filled syringe.
- At Week 24, 81% of patients in the Praluent cohort achieved their pre-specified LDL-C goal compared to 8.5% for placebo (p<0.0001).
- Praluent is an investigational human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). Inhibiting PCSK9 frees up more LDL receptors on the surface of liver cells which enables the more LDL-C to be removed from the blood.
- Alirocumab and Amgen's (NASDAQ:AMGN) evolocumab are the front-runners to dominate the post-statin cholesterol-lowering market. They will be competing right out the blocks in the U.S. The FDA's PDUFA dates are July 24 alirocumab and August 27 for evolocumab. Praluent is being co-developed by Sanofi (NYSE:SNY).
Mar. 14, 2015, 9:17 PM
- A Phase 3 study, called YUKAWA-2, evaluating Amgen's (NASDAQ:AMGN) Repatha (evolocumab) in Japanese patients with high cardiovascular (CV) risk and high cholesterol showed that treatment with subcutaneous injections of Repatha 140 mg every two weeks, compared to placebo, in combination with different daily doses of atorvastatin (Pfizer's Lipitor), reduced low-density lipoprotein cholesterol (LDL-C) by 67 to 76% from baseline at Week 12 and the mean of Weeks 10 and 12. The data were presented at the American College of Cardiology's 64th Annual Scientific Session.
- In Japan, almost 50% of high-CV-risk patients on statins fail to reach their LDL-C goal. The company intends to submit its application for approval in Japan as soon as feasible. The PDUFA date from the FDA is August 27.
- Evolocumab is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). Inhibiting PCSK9 frees up more LDL receptors on the surface of the liver cells which enables more LDL-C to be removed from the blood.
- Previously: FDA OK with Amgen's BLA for cholesterol-lowering drug (Nov. 10, 2014)
Mar. 13, 2015, 9:19 AM
- Cytokinetics (NASDAQ:CYTK) reports that the enrollment of ~450 patients in the expansion phase of the Phase 2 COSMIC-HF trial evaluating omecamtiv mecarbil in heart failure patients is complete. In addition, over 200 patients have finished the protocol-specified 20-week duration of dosing with a data readout expected in H2. The trial is being run by collaboration partner Amgen (NASDAQ:AMGN).
- COSMIC-HF is a randomized, double-blind, placebo-controlled, multicenter study with two parts: a dose escalation phase and an expansion phase. The dose escalation phase, competed in 2013, assessed the pharmacokinetics and tolerability of three oral modified-release formulations of omecamtiv mecarbil in patients with heart failure and left ventricular systolic dysfunction. The expansion phase will assess the safety, tolerability and pharmacokinetics of omecamtiv mecarbil during 20 weeks of treatment at an initial dose of 25 mg and increasing to 50 mg depending on the patient's plasma concentration.
- 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.
Mar. 10, 2015, 8:24 AM
- Akebia Therapeutics (NASDAQ:AKBA) completes patient enrollment in the third and final cohort in its Phase 2 study evaluating its lead product candidate, AKB-6548, for the treatment of patients with anemia secondary to chronic kidney disease (CKD) who are undergoing dialysis. The company expects to report top-line results in Q3.
- The multi-center, open-label trial has three cohorts of ~30 CKD dialysis patients with anemia who have been switched from injectable recombinant erythropoiesis-stimulating agent therapy to AKB-6548. Patients in the first two cohorts receive once-daily doses of AKB-6548 while patients in the third cohort receive AKB-6548 three times per week. All patients will be evaluated for 16 weeks of treatment, including an assessment of hemoglobin (HGB) response to AKB-6548 during an eight-week dosing period, followed by an assessment of HGB response to algorithm-guided dose adjustments of AKB-6548 during an additional eight weeks of treatment.
- AKB-6548's value proposition is oral administration and lower peak erythropoietin (EPO) levels compared to injectable recombinant EPO-stimulating agents like Amgen's (NASDAQ:AMGN) Epogen (epoetin alfa).
- Approximately 30M Americans have CKD with ~1.8M with anemia.
Mar. 10, 2015, 3:55 AM
- Prescription drug spending rose by a record 13% in the U.S. last year, the biggest annual increase in over a decade.
- "For the past several years, annual drug spending increases have been below the annual rate of overall health-care inflation in the U.S.," said Glen Stettin, senior vice president at Express Scripts. "But that paradigm is shifting dramatically as prices for medications increase at an unsustainable rate."
- Spending on specialty medicines, such as those for inflammatory diseases, multiple sclerosis, cancer and hepatitis C rose an unprecedented 31%.
Mar. 6, 2015, 9:12 AM
- The FDA approves Sandoz's (NYSE:NVS) Zarxio, a biosimilar to Amgen's (NASDAQ:AMGN) Neupogen (filgrastim), for the same indications as Neupogen.
- Zarxio is approved for the treatment of patients with cancer receiving myelosuppressive chemotherapy, patients with acute myeloid leukemia receiving induction or consolidation chemotherapy, patients with cancer undergoing bone marrow transplantation, patients undergoing autologous peripheral blood progenitor cell collection and therapy and patients with severe chronic neutropenia.
- The placeholder nonproprietary name for Zarxio is "filgrastim-sndz."
- Previously: FDA Ad Comm gives thumbs up to Sandoz biosimilar filgrastim (Jan. 7)
- Related tickers: (NYSEMKT:PFNX) (NASDAQ:ESPR) (NYSE:HSP) (NASDAQ:CHRS)
Mar. 5, 2015, 8:52 AM
- AbbVie's (NYSE:ABBV) extraordinarily generous buyout of Pharmacyclics (NASDAQ:PCYC) is a crystal clear example of how keen big pharma is to boost its prospects with biotech drugs with blockbuster potential. The transaction's $20B tab, backing out PCYC's $1B cash balance, values Imbruvica (ibrutinib) at $40B since Pharmacyclics' commercial partner Johnson & Johnson (NYSE:JNJ) gets 50% of Imbruvica's revenue. This implies a multiple of almost 7x Imbruvica's projected peak sales of $6B. By comparison, Amgen's (NASDAQ:AMGN) takeout of Onyx Pharma and Sanofi's (NYSE:SNY) takeout of Genzyme were both at 5x premiums.
- The looming patent expiration for Humira ($12.5B in sales the past four quarters) undoubtedly provided AbbVie extra incentive to get the deal done.
- Adding 50% of Imbruvica's sales to AbbVie's top line should increase its revenue growth 3 - 7% and EPS growth 8 - 11% through 2020.
- According to RBC analyst Michael Yee, other biotechs on the big ticket acquisition radar are: BioMarin Pharmaceuticals (NASDAQ:BMRN), Dyax (NASDAQ:DYAX), Esperion Therapeutics (NASDAQ:ESPR), United Therapeutics (NASDAQ:UTHR), Vertex Pharmaceuticals (NASDAQ:VRTX), Intercept Pharmaceuticals (NASDAQ:ICPT), Juno Therapeutics (NASDAQ:JUNO), Kite Pharma (NASDAQ:KITE), PTC Therapeutics (NASDAQ:PTCT) and Receptos (NASDAQ:RCPT).
Mar. 4, 2015, 4:36 PM
- Amgen (NASDAQ:AMGN) declares $0.79/share quarterly dividend, in line with previous.
- Forward yield 1.99%
- Payable June 5; for shareholders of record May 14; ex-div May 12.
Mar. 2, 2015, 4:05 PM
- Thinly-traded Ligand Pharmaceuticals (LGND +15.5%) jumps on a 5x surge in volume in response to the positive news on Amgen's (AMGN +1.1%) Kyprolis (carfilzomib) study. Ligand is eligible to receive milestone and royalty payments on sales of Captisol, which carfilzomib's IV formulation utilizes. Ligand and Proteolix entered into a collaboration in 2005 to explore the use to Captisol. Onyx Pharmaceuticals acquired Proteolix in 2009 and Amgen acquired Onyx in 2013.
- Captisol is a formulation technology. It is a uniquely modified cyclodextrin, which improves the solubility, stability, bioavailability and dosing of active pharmaceutical ingredients.
- Previously: Amgen's Kyprolis beats Takeda's Velcade in head-to-head study (March 1)
Mar. 1, 2015, 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.
Feb. 27, 2015, 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.
Feb. 27, 2015, 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.
Feb. 25, 2015, 8:30 PM
- 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.
Feb. 23, 2015, 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
Feb. 19, 2015, 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%)
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