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Fly News Breaks for June 13, 2018
Jun 13, 2018 | 08:06 EDT
After HHS Secretary Alex Azar spoke at a two-hour Senate hearing, Morgan Stanley analyst David Risinger noted that Azar suggested that U.S. drug pricing needs to move to a system without rebates and said payments from drugmakers to PBMs should be eliminated. In listing four HHS actions that could hurt manufacturers, Risinger pointed out that Azar said he is interested in removing 100% cap on Medicaid rebates; he would like to adjust the Part D protected drug classes so that plans can extract rebates from manufacturers; HHS wants to require manufacturers to disclose drug list prices in TV ads; and HHS is focused on transitioning Part B to lower-priced private sector management. In summary, the analyst said that for drugmakers there was "no fire, but smoke signals worth noting." Publicly traded large-cap drugmakers include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY).
Nov 12, 2018 | 10:39 EDT
Piper Jaffray analyst Edward Tenthoff believes new data presented by Arrowhead (ARWR) at the AASLD meeting on ARO-AAT and ARO-HBV validate the company's proprietary TRiM platform. He expects a potentially registrational Phase 2/3 trial for ARO-AAT to start in the first quarter of 2019 and noted that partner Janssen (JNJ) intends to begin Phase 2 studies of ARO-HBV in the first half of next year. Tenthoff keeps an Overweight rating and $25 price target on Arrowhead shares.
Nov 12, 2018 | 08:37 EDT
Theravance Biopharma (TBPH) highlighted that the European Commission authorized an expanded label for once-daily Trelegy Ellipta, recognizing the product's effect on exacerbations and making it the first single-inhaler triple therapy indicated for patients with moderate to severe chronic obstructive pulmonary disease not adequately treated with dual bronchodilation or with an inhaled corticosteroid and a long-acting beta2-agonist. Trelegy Ellipta is a product in which Theravance Biopharma has an economic interest in future payments that may be made by GlaxoSmithKline (GSK) or one of its affiliates pursuant to its agreements with Innoviva. Theravance Biopharma is entitled to receive an 85% economic interest in the royalties paid by GSK on worldwide net sales. Those royalties are upward-tiering from 6.5% to 10%, resulting in cash flows to Theravance Biopharma of approximately 5.5% to 8.5% of worldwide net sales of Trelegy Ellipta.
Nov 12, 2018 | 07:10 EDT
Akcea Therapeutics (AKCA) and Ionis Pharmaceuticals (IONS) announced that data from the Phase 2 clinical study of AKCEA-APO(a)-LRx in patients with established cardiovascular disease (CVD) and elevated levels of lipoprotein(a), or Lp(a), were presented in a late-breaking clinical trial presentation at the American Heart Association Scientific Sessions in Chicago November 10. The study met all primary and secondary efficacy endpoints analyzed at 6 months. Approximately 98% of patients in the 20mg weekly cohort and approximately 81% of patients in the 60mg every 4 week cohort achieved clinically significant reductions in Lp(a) levels bringing them below the recommended threshold of risk for CVD events. Treatment with AKCEA-APO(a)-LRx was associated with decreases in LDL-C, apoB, OxPL-apoB, OxPL-apo(a). Most adverse events were mild. The most frequent adverse events were injection site reactions. ISRs occurred in 26% of patients and were mostly mild and one patient discontinued due to an ISR. There were no safety concerns related to platelet counts, liver function or renal function. "These data show that AKCEA-APO(a)-LRx significantly reduces Lp(a) in patients with pre-existing cardiovascular disease due to elevated Lp(a) levels. AKCEA-APO(a)-LRx is the first and only drug to show a clinically significant reduction of Lp(a) levels and a favorable safety and tolerability profile in patients with this genetic condition," said Dr. Louis O'Dea, chief medical officer at Akcea Therapeutics. "This is a particularly important advancement as elevated Lp(a) can cause cardiac events for patients as early as in their 30s and 40s. We are actively working with Novartis to prepare for an end of Phase 2 meeting with FDA. We look forward to advancing this important development program into Phase 3."
Nov 11, 2018 | 13:28 EDT
AstraZeneca announced positive full results from the DECLARE-TIMI 58 cardiovascular outcomes trial for FARXIGA. The data were presented as a late-breaking abstract at the American Heart Association Scientific Sessions 2018 in Chicago, IL, and simultaneously published in the New England Journal of Medicine. Results from DECLARE-TIMI 58, the largest SGLT-2 inhibitor CVOT conducted to date, including more than 17,000 patients across 33 countries, showed that FARXIGA significantly reduced the risk of hospitalization for heart failure or CV death composite vs. placebo by 17%, one of the two primary efficacy endpoints. The reduction in hHF or CV death was consistent across the entire patient population, which included those with CV risk factors and those with established CV disease. FARXIGA is not indicated to reduce the risk of CV events or hHF. Additionally, there were fewer major adverse cardiovascular events observed with FARXIGA for the other primary efficacy endpoint, however this did not reach statistical significance. DECLARE-TIMI 58 also confirmed the well-established safety profile for FARXIGA, which met the primary safety endpoint of non-inferiority versus placebo, demonstrating no increase in the composite of MACE, defined as CV death, heart attack, or stroke. Further, on other relevant safety measures, the trial showed no imbalance with FARXIGA versus placebo in amputations, fractures, bladder cancer or Fournier's gangrene. The respective incidences of diabetic ketoacidosis and genital infections were rare. Although secondary endpoints were only nominally significant, the renal composite endpoint showed that FARXIGA reduced the rate of new or worsening nephropathy by 24% vs. placebo across the broad patient population studied, and there were fewer all-cause mortality events with FARXIGA vs. placebo. FARXIGA is not indicated to reduce the risk of HF, other CV outcomes, nephropathy or all-cause mortality.