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News Breaks
March 31, 2014
13:41 EDTMRK, NVSNovartis rises after committee recommends early closure of study
Shares of drug maker Novartis (NVS) are climbing after the Data Monitoring Committee of its PARADIGM-HF study, which tested LCZ696 in comparison to patients who received standard care with enalapril, unanimously recommended early closure of the trial due to the drug's efficacy. WHAT'S NEW: Novartis announced that the committee unanimously recommended early closure of the study, indicating patients with chronic heart failure with reduced ejection fraction who received LCZ696 lived longer without being hospitalized for heart failure than those who received standard care with ACE-inhibitor enalapril. Based on the compelling efficacy and primary endpoint having been met, the trial was closed early. This follows two previous interim analyses that showed the safety profile of LCZ696 was acceptable. One of the two principal investigators, Dr. Milton Packer, said, "The finding that treatment with LCZ696 was superior to currently recommended doses of enalapril has profound implications for the care of patients with chronic heart failure. We now have compelling evidence that supports LCZ696 as a new cornerstone in the management of chronic heart failure." The company said the results of PARADIGM-HF will be submitted to a major medical conference for presentation and Novartis will now initiate discussions with global health authorities regarding approval for marketing. WHAT'S NOTABLE: Novartis said that the PARADIGM-HF study was initiated in December 2009 and currently is the largest clinical trial in heart failure ever undertaken. LCZ696 is a medicine that acts in multiple ways on the neurohormonal systems of the heart, blocking receptors exerting harmful effects while simultaneously promoting protective mechanisms. LCZ696 is thought to reduce the strain on the failing heart, promoting the ability of the heart muscle to recover. LCZ696 is the second treatment being developed by Novartis for patients with heart failure, along with RLX030 for acute heart failure. The standard ACE-inhibitor enalapril has been marketed as VASOTEC in the U.S. by Merck (MRK). Several companies sell generic enalapril under the name enalapril maleate tablets. PRICE ACTION: During afternoon trading, shares of Novartis were up by $3.31 or 4%, to $84.90.
News For NVS;MRK From The Last 14 Days
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July 28, 2015
07:03 EDTMRKMerck reports Q2 EPS 86c, consensus 81c
Reports Q2 revenue $9.8B, consensus $9.8B.
06:49 EDTMRKMerck to acquire cCam Biotherapeutics for $95M
Merck and cCAM Biotherapeutics announced that the companies have signed a definitive agreement under which Merck will acquire cCAM Biotherapeutics, a privately held biopharmaceutical company focused on the discovery and development of novel cancer immunotherapies. Under terms of the agreement, Merck, through a subsidiary, will acquire all outstanding stock of cCAM in exchange for an upfront payment of $95M in cash. In addition, cCAM shareholders of record are eligible to receive a total of up to $510M associated with the attainment of certain clinical development, regulatory and commercial milestones. The transaction is subject to certain closing conditions.
06:32 EDTMRKMerck's grazoprevir/elbasvir application accepted by FDA
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July 27, 2015
15:03 EDTMRKNotable companies reporting before tomorrow's open
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14:43 EDTMRKEarnings Watch: Merck's Keytruda sales will be focus in Q2 results
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08:32 EDTMRKMerck receives 'positive' CHMP opinion for Zerbaxa
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07:37 EDTMRKAeterna Zentaris starts promoting Saizen for injection in 25 U.S. territories
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July 24, 2015
10:56 EDTNVSNovartis announces FDA approval of Odomzo
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09:02 EDTNVSLigand says Revolade recommended by CHMP for EU approval for SAA
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07:17 EDTNVSNovartis combination therapy Tafinlar, Mekinist achieves regulatory milestones
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July 23, 2015
11:04 EDTMRKMerck announces EMA acceptance of MAA for grazoprevir/elbasvir
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July 22, 2015
07:04 EDTMRKMerck's Keytruda approved by EU for treatment of advanced melanoma in adults
Merck announced that the European Commission has approved KEYTRUDA, the company’s anti-PD-1 therapy, for the treatment of advanced melanoma in adults. The European Commission approval of pembrolizumab is based on data from three clinical studies conducted in more than 1,500 first-line and previously-treated patients with advanced melanoma. Pembrolizumab received European Commission regulatory approval based on Phase 3 data which showed it is the first and only anti-PD-1 therapy to provide a statistically superior survival benefit as a monotherapy compared to ipilimumab, the current standard of care for advanced melanoma. Today’s approval allows marketing of pembrolizumab in all 28 EU member states at the approved dose of 2 mg/kg every three weeks. The European Commission’s approval is based on data from three studies -- KEYNOTE-001, KEYNOTE-002 and KEYNOTE-006. These studies evaluated the efficacy and safety of pembrolizumab in advanced melanoma patients – across treatment lines, prognostic factors, tumor characteristics, and BRAF mutational status – and established 2 mg/kg every three weeks as the approved dose.
07:03 EDTNVSIgnyta names Bernard Parker as Chief Commercial Officer
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06:05 EDTMRKMerck, Ablynx expand immuno-oncology collaboration
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July 21, 2015
11:49 EDTNVSNovartis may sell Amgen's cancer drug as soon as September, Bloomberg says
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05:20 EDTNVSNovartis backs FY15 revenue guidance of up mid-single digit
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05:17 EDTNVSNovartis reports Q2 core EPS $1.27, consensus $1.24
Reports Q2 revenue $12.7B, consensus $12.44B. Further strengthening of USD impacted sales by -11% and core operating income by -13%. Growth Products, an indicator of the rejuvenation of the portfolio, contributed 35% of continuing operations net sales in Q2, and were up 24%. In Pharmaceuticals, Growth Products contributed 44% of division net sales in the quarter, and sales for these products were up 38%.
July 20, 2015
08:25 EDTNVSNovartis management to meet with JPMorgan
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07:32 EDTNVSAlzheimer's Association to hold a conference
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July 15, 2015
07:58 EDTNVSAnalysts break down impact of $7.2B Receptos buyout
After Celgene (CELG) announced last night that the company has agreed to acquire Receptos (RCPT) for $232 per share in cash, or a total of about $7.2B net of cash acquired, research firms have chimed in with their opinions on how the proposed deal may impact others in the biotech space. Receptos key asset is Ozanimod, which is being studied in Phase III trials for relapsing multiple sclerosis and ulcerative colitis. DERIVATIVE CALLS: Piper Jaffray analyst Edward Tenthoff told investors that he views Celgene's deal for Receptos as good for Arena Pharmaceuticals (ARNA). The analyst notes that Arena's APD334 is already showing dose-dependent decreases in circulating lymphocyte counts and that the company will initiate Phase II studies in ulcerative colitis and Crohn's disease this year. Tenthoff reiterates an Overweight rating and $7.50 price target on Arena, which has a market capitalization around $1B and closed yesterday up 8c to $4.47. In its own note to investors this morning, Nomura said Celgene's deal could put downward pressure on Biogen's (BIIB) long-term multiple sclerosis estimates. Nomura's M. Ian Somaiya contended that one-year Phase II efficacy data for Ozanimod looked as good as Novartis’s (NVS) Gilenya and Biogen's Tecfidera’s Phase III at year 2. Somaiya also wondered if rival Gilead (GILD) could be "looking for something bigger" than Receptos for its own deal, telling investors that the firm views Incyte (INCY) as Gilead's most likely takeout target. Incyte's shares closed up $4.46 at $117.46 yesterday, giving the company a market cap of about $20B. RIVAL BID?: Wedbush analyst Liana Moussatos believes another bidder may seek to acquire Receptos, noting that she previously estimated Receptos could be valued at $348 per share, or about $10.9B, in a buyout. Moussatos noted that Celgene said it expects annual peak sales for Ozanimod to reach about $4B-$6B for RMS and UC, making its acquisition price of $7.2BN only a bit more than about 1X peak sales without accounting for other possible indications or the rest of its pipeline. Moussatos told investors she sees "plenty" of potential upside to justify a rival bidder stepping in and reiterated the firm's Outperform rating on Receptos shares. PRICE ACTION: In pre-market trading, Receptos rose 10% to $228.61 while Gilead gained 1.4% to about $119 per share.
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