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News Breaks
April 9, 2014
07:09 EDTSNY, MRK, BAYRY, RBGPF, NVSReckitt Benckiser may be frontrunner for Merck unit, Bloomberg reports
Reckitt Benckiser (RBGPF) is said to have an edge over rivals in bidding for Merck's (MRK) over-the-counter health business, Bloomberg reports. Reckitt is competing against Novartis (NVS), Bayer (BAYRY) and Sanofi (SNY), sources say, and could be the frontrunner because it will be able to generate the most cost savings and have fewer antitrust issues than others. Final bids for the Merck unit are expected on April 16 and sources believe the unit could fetch $10B-$12B.Reference Link
News For MRK;NVS;BAYRY;SNY;RBGPF From The Last 14 Days
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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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07:21 EDTSNYRegeneron, Sanofi say CHMP recommends Euro approval of Praluent treatment
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the European Medicine Agency's Committee for Medicinal Products for Human Use, or CHMP, has adopted a positive opinion for the marketing authorization of Praluent, recommending its approval for use in certain adult patients with hypercholesterolemia. Praluent is an investigational fully human monoclonal antibody targeting PCSK9. The European Commission is expected to make a final decision on the Marketing Authorization Application for Praluent in the European Union in late September. The CHMP opinion was based on the benefit-risk profile of Praluent, following review of efficacy and safety data from more than 5,000 patients across 10 pivotal Phase 3 double-blind trials ranging from six months to two years. Clinical data from the ODYSSEY Phase 3 program show consistent, positive results in reducing LDL-C. The U.S. Food and Drug Administration has set a target action date of July 24 for the Biologics License Application of Praluent. The safety and efficacy of Praluent have not been fully evaluated by any other regulatory authority.
07:18 EDTSNYRegeneron and Sanofi's Praluent recommended for approval in Europe
Regeneron (REGN) and Sanofi (SNY) announced that the European Medicine Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion for the marketing authorization of Praluent, recommending its approval for use in certain adult patients with hypercholesterolemia. Praluent is an investigational fully human monoclonal antibody targeting PCSK9. The European Commission is expected to make a final decision on the Marketing Authorization Application for Praluent in the European Union in late September.
07:17 EDTNVSNovartis combination therapy Tafinlar, Mekinist achieves regulatory milestones
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07:16 EDTSNYFDA PDUFA Date for Regeneron and Sanofi BLA for Praluent is July 24, 2015
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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
12:47 EDTSNYPiper confident in Regeneron approval by Friday
After Amgen's (AMGN) Repatha received marketing authorization in Europe, making it the first of the anti-PCSK9 antibody to be approved worldwide, Piper Jaffray analyst Edward Tenthoff expressed confidence that Regeneron (REGN) and Sanofi's (SNY) anti-PCSK9 antibody Praluent will be approved by Friday's FDA action date. Tenthoff believes Praluent will eventually be a blockbuster drug, but anticipates the launch to be slow. He keeps a Neutral rating on Regeneron with a $484 price target.
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
10:00 EDTBAYRYOn The Fly: Analyst Downgrade Summary
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08:38 EDTBAYRYAnalyst predicts Zoetis merges with Bayer unit, not Valeant
Zoetis (ZTS) in recent months has been the subject of takeover speculation, possibly for Valeant (VRX), but a Jefferies analyst told investors today in a research note that he views a deal with a unit of healthcare giant Bayer (BAYRY) as "highly likely" for the animal medicine company. BACKGROUND: Bill Ackman of Pershing Square, who owns stakes in both Zoetis and Valeant, said in early May while speaking on CNBC that Zoetis is a "great” business on a standalone basis, but he also spoke of the company's strategic value. Ackman added, however, that he was "not sure" that Valeant was the best acquirer of Zoetis. Subsequently, in late June, The Wall Street Journal reported that Valeant made a preliminary approach regarding a potential deal to buy Zoetis. CNBC's David Faber said the next day, citing his own sources, that Valeant reached out to Zoetis as a courtesy to common shareholder Ackman and was unlikely to pursue an acquisition of the company, though he cautioned then Valeant could change its approach and pursue a deal. BAYER: Jefferies analyst Jeffrey Holford said in a note today that he views a tie-up between Zoetis and Bayer's Animal Health business in 2016 as "highly likely." He sees Mylan's (MYL) acquisition of Abbott's (ABT) non‑U.S. developed markets specialty and branded generics business as a potential proxy for how a transaction could be structured, adding that such a "spinversion" could achieve up to 36% long-term earnings accretion for Zoetis. Holford reiterated a Buy rating on Zoetis with a $60 price target, while downgrading Bayer to Hold, citing valuation following the recent outperformance of its shares. IDEXX: While being discussed as a target, some analysts have also opined on companies that Zoetis could pursue as a buyer. On June 29, Canaccord said that in investor meetings with IDEXX (IDXX) executives declined to comment on Zoetis' potential interest in scaling up its animal health diagnostics business. Canaccord added that it thought Zoetis could make a bid for IDEXX. The firm reiterated its Buy rating and $80 price target on IDEXX shares at that time. PRICE ACTION: Since June 25, the day the Journal first reported on Valeant's preliminary takeover approach to Zoetis, the animal health company's shares have dropped nearly 4%. Zoetis closed down 20c to $47.80 on Friday.
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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07:30 EDTBAYRYZoetis 'highly likely' to merge with Bayer unit in 2016, says Jefferies
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05:21 EDTBAYRYBayer downgraded to Hold from Buy at Jefferies
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