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News Breaks
February 18, 2014
08:37 EDTBAYRY, OMEDOncoMed begins second Phase 1b clinical trial for OMP-54F28 with sorafenib
OncoMed Pharmaceuticals (OMED) announced that it has started a multi-center Phase 1b clinical trial of OMP-54F28 with sorafenib in hepatocellular cancer, or HCC. OMP-54F28 is a first-in-class Wnt-pathway-targeting decoy receptor and is part of OncoMed's collaboration with Bayer Pharma AG (BAYRY). This is the second of three Phase 1b trials for OMP-54F28 to begin patient enrollment; earlier this year OncoMed initiated a Phase 1b of OMP-54F28 with nab-paclitaxel and gemcitabine in pancreatic cancer. The Phase 1b clinical trial is a dose-escalation study of OMP-54F28 in combination with sorafenib in patients with first-line locally advanced or metastatic HCC. Primary objectives of the trial are to evaluate safety of this combination regimen and determine a recommended Phase 2 dose for OMP-54F28 in combination with sorafenib. Key secondary and exploratory objectives include evaluation of the pharmacokinetics and pharmacodynamics of OMP-54F28, as well as the efficacy of this combination. Tumor tissue from patients will be used to explore predictive biomarker hypotheses related to the efficacy of OMP-54F28.
News For OMED;BAYRY From The Last 14 Days
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July 31, 2015
09:32 EDTBAYRYFoamix says FDA approves Finacea Foam 15% for mild to moderate rosacea
As announced by Bayer HealthCare (BAYRY), the U.S. FDA has approved Finacea Foam, 15% for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. Papulopustular rosacea is a skin disease causing inflammatory lesions on the nose, cheeks, chin and forehead. Finacea Foam was developed as part of a research and development collaboration between Foamix Pharmaceuticals Ltd. (FOMX) and Bayer HealthCare, utilizing Foamix's proprietary foam technology platform. According to a license agreement between the two companies, Foamix is entitled to royalties and certain milestone payments upon commercialization of Finacea Foam. Finacea Foam will be available by prescription beginning in September, and will be marketed in the United States by Bayer HealthCare.
July 29, 2015
05:47 EDTBAYRYBayer cuts FY15 sales to EUR 47B from EUR 48B- EUR 49B
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05:42 EDTBAYRYBayer reports Q2 Healthcare sales up 28% to EUR 5.91B
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05:40 EDTBAYRYBayer reports Q2 net income EUR 1.52B vs. EUR 953M last year
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July 28, 2015
08:51 EDTOMEDOncoMed initiates Phase 1 clinical trial for Anti-RSPO3 antibody
OncoMed Pharmaceuticals announced dosing of the first patient in its anti-RSPO3 antibody Phase 1a/1b clinical trial. Anti-RSPO3 is the first drug in its class to target the R-spondin-LGR pathway, an important cancer stem cell pathway identified by OncoMed researchers. The Phase 1a/1b clinical trial is initially enrolling patients with advanced refractory solid tumors. Patients will receive escalating doses of anti-RSPO3 until disease progression. The open-label study is designed to assess the safety, pharmacokinetics, pharmacodynamics and initial evidence of efficacy of the anti-RSPO3 antibody. Once a single-agent dose has been identified, biomarker-selected patients will be enrolled in a Phase 1a expansion arm to obtain additional preliminary information on possible anti-tumor activity. In the Phase 1b portion of the trial, anti-RSPO3 will also be tested in second-line colorectal cancer patients in combination with the chemotherapeutic standard of care in metastatic colon cancer, known as FOLFIRI. The trial is being conducted at five sites in the United States.
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.
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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