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News For NVO;VPHM;INFI;MRK;AGN;SHPG;SGEN;OREX;AMGN;SNY;JNJ;PFE From The Last 14 Days
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December 10, 2014
08:32 EDTMRKMerck announces early findings showing 18.5% overall response rate with Keytruda
Merck announced early study findings demonstrating an overall response rate of 18.5% with KEYTRUDA, the company’s anti-PD-1 therapy, as assessed by RECIST v1.1, central review in PD-L1 positive, advanced triple-negative breast cancer – one of the most aggressive forms of breast cancer. At the time of analysis, the median duration of response had not been reached with three of five responders on therapy for 11 months or more. These early findings, from the ongoing Phase 1b KEYNOTE-012 study, were shared today for the first time as part of the official press program at the 2014 San Antonio Breast Cancer Symposium and will be presented in an oral session at 10:45 a.m. CST by Dr. Rita Nanda, the University of Chicago. Data presented were from a cohort of the ongoing Phase 1b KEYNOTE-012 study which evaluated KEYTRUDA monotherapy at 10 mg/kg every two weeks in patients with advanced TNBC whose tumors were determined to be positive for PD-L1 expression. As measured by Merck’s proprietary PD-L1 immunohistochemistry clinical trial assay, tumors were considered to be PD-L1 positive if staining was present in the stroma or in greater than or equal to one percent of tumor cells. In the study, 58 percent of patients screened had tumors determined to be positive for PD-L1 expression. Most patients enrolled in this study had received two or more prior chemotherapies for metastatic disease and 87.5 percent had received prior neo-adjuvant or adjuvant therapy.
08:31 EDTPFETeva announces launch of first generic Celebrex capsules in the U.S.
Teva Pharmaceutical Industries (TEVA) announces the launch of the first FDA-approved generic equivalent to Celebrex Capsules in the United States. Teva is offering 50, 100, 200, and 400 mg strengths of Celecoxib Capsules. Celebrex Capsules, marketed by Pfizer (PFE) had annual sales of approximately $2.56B in the United States, according to IMS data as of October 2014.
07:38 EDTPFEMylan launches generic version of Pfizer's Celebrex capsules
Mylan (MYL) announced the U.S. launch of its Celecoxib Capsules, 50 mg, 100 mg, 200 mg, and 400 mg, one of the first available generic versions of Pfizer's (PFE) Celebrex Capsules, indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and for the management of acute pain in adults. Celecoxib Capsules had U.S. sales of approximately $2.5B for the 12 months ending September 30, 2014.
December 9, 2014
16:28 EDTMRKOn The Fly: Closing Wrap
Stocks on Wall Street opened in the red on the heels of a sharp sell-off in China and amid continued concern over tumbling oil prices. The domestic economic calendar offered little in the way of a catalyst and the market moved in a narrow range throughout the morning. However, the averages began to pare their losses once the European markets closed. By mid-afternoon the averages had turned mixed with the Nasdaq higher, the S&P flat, and the Dow the laggard, which is the way the trading day closed. ECONOMIC EVENTS: In the U.S., the National Federation of Independent Business' optimism index rose to 98.1 from a prior reading of 96.1. The JOLTS report showed job openings increased 149K to 4.83M in October, which was above the expectation for 4.795M openings. Wholesale sales increased 0.2% in October and inventories grew 0.4%, both of which were better than expected. In Asia, China's Shanghai composite index plunged 5.4%, making for the stock market's sharpest selloff in years, after the country’s securities clearing house raised the threshold for the type of collateral used for short-term loans and policymakers warned about potentially slower economic growth. In Europe, Greek stocks and bonds also tumbled after a move to bring forward presidential elections, which could potentially derail Greece’s bailout and austerity efforts. COMPANY NEWS: Verizon (VZ) was among the Dow's worst performers, sinking $1.98, or 4.05%, to $46.92 after the company warned that Q4 impacts of its promotional offers, together with the strong customer volumes this quarter, will put short-term pressure on its earnings per share. After last night's commentary from the company, Robert W. Baird downgraded Verizon shares to Neutral from Outperform and lowered its price target on the stock to $50 from $54... Merck (MRK) also weighed on the Dow, as the drugmaker fell $1.87, or 3.02%, to $60.01 after a Delaware court denied Cubist's (CBST) bid to stop Hospira (HSP) from selling a generic version of Cubicin in 2016. Merck announced just yesterday morning that it had agreed to buy Cubist in a transaction with a total value of approximately $9.5B. The news is a "tough start" to Merck's takeover and makes the $9.5B buyout price look $2B to $3B too high, according to analysts at Leerink. Shares of Cubist also fell $xxx, or xxx%, to $xxx following the court ruling. MAJOR MOVERS: Among the notable gainers was bluebird bio (BLUE), which surged $35.39, or 72.39%, to $84.28 after the company announced data from eight subjects treated with its LentiGlobin drug product and Piper Jaffray more than doubled its price target for the shares to $112 from $52. Among the noteworthy losers was Conn's (CONN), which plunged $14.26, or 40.64%, to $20.83 after unexpectedly reporting losses for its third fiscal quarter, withdrawing its FY15 guidance and announcing the departure of its CFO. Also lower was Spirit Airlines (SAVE), which slid $10.70, or 12.67%, to $73.77 after the company said last night that since late October there has been compression in the fare structure for close-in bookings, believed to be driven by the industry’s willingness to trade lower fuel prices for lower fares. Also, this morning, Raymond James downgraded Spirit Airlines to Market Perform from Outperform, citing valuation, European deflation headwinds, and earnings that are still being revised down. INDEXES: The Dow fell 51.28, or 0.29%, to 17,801.20, the Nasdaq rose 25.77, or 0.54%, to 4,766.46, and the S&P 500 slipped 0.49, or 0.02%, to 2,059.82.
13:08 EDTMRKMerck may have paid $2B-$3B too much for Cubist, analyst says
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12:25 EDTMRKOn The Fly: Midday Wrap
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12:22 EDTPFE, NVO, SHPGPiper Jaffray biopharm analyst holds an analyst/industry conference call
Senior Research Analyst Schimmer, along with Biopharmaceuticals Analyst Breazzano, discuss gene therapy for hemophilia on an Analyst/Industry conference call to be held on December 11 at 10 am.
11:31 EDTINFIInfinity Pharmaceuticals reports results from Phase 1 study of duvelisib
Infinity Pharmaceuticals reported updated data from a Phase 1 monotherapy study of duvelisib, an inhibitor of phosphoinositide-3-kinase-delta and PI3K-gamma, which showed activity among patients with relapsed/refractory indolent non-Hodgkin lymphoma, a fatal type of blood cancer. In the study, duvelisib demonstrated an overall response rate of 72%, including a 33% complete response rate, among 18 patients with iNHL who received the dose administered in ongoing registration-focused studies. In a separate presentation, updated Phase 1 data were also reported showing the activity of duvelisib in patients with relapsed/refractory T-cell lymphoma.
11:19 EDTSNYSanofi reportedly ready to make acquisitions in animal medicine, Bloomberg says
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10:32 EDTPFEPfizer says in talks with FDA on path forward for Mylotarg
Pfizer announced the presentation of encouraging early- and late-stage data from clinical studies across several hematologic malignancies, including acute myeloid leukemia, acute lymphoblastic leukemia and chronic myeloid leukemia. Among the highlights are results from several investigator-led, large, randomized studies evaluating the antibody-drug conjugate MYLOTARG in select adult AML populations. Research was presented at the 56th Annual Meeting of the American Society of Hematology in San Francisco, December 6-9. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology, said “In particular, we are encouraged by the significant clinical evidence emerging from large randomized trials, such as AML-19 and ALFA-0701, demonstrating a positive impact of MYLOTARG when added to standard first-line treatment for patients with acute myeloid leukemia. We are engaging in discussions with the U.S. FDA and other health authorities to determine the best path forward for MYLOTARG. In addition, we plan to initiate an expanded access protocol for the therapy by the end of 2014 in the United States in patients with relapsed or refractory acute myeloid leukemia for whom there are no other treatment options.”
10:23 EDTSHPGOn The Fly: Analyst Downgrade Summary
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10:10 EDTMRKMerck trades sharply lower, levels to watch
The stock is down over 4.3% to $59.23 at time of writing. At that price next support is at $57.95. Resistance is at $60.25.
09:31 EDTAGNZoetis drops after report of Valeant abandoning growth by acquisitions strategy
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08:25 EDTMRKBristol-Myers data positive, says BMO Capital
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08:23 EDTMRKMerck has 'no way out' of Cubist deal after court decision, says Leerink
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08:12 EDTMRKMerck still sees Cubist acquisition neutral to modestly accretive to 2015 EPS
Merck (MRK) issued the following statement regarding the decision of the U.S. District Court for the District of Delaware. The decision, which upheld the patent for CUBICIN that expires on June 15, 2016 and invalidated four others, is subject to appeal. The company continues to believe the acquisition of Cubist (CBST) will create strong fundamental value for Merck’s shareholders. The combined strength of both companies will provide both incremental and long-term value, and Merck expects the transaction to add more than $1B of revenue to its 2015 base, with strong growth potential thereafter. The court’s decision does not change Merck’s expectation that the transaction will be neutral to modestly accretive to 2015 non-GAAP EPS. The company also continues to expect that the transaction will contribute mid-single digit accretion on a percentage basis to non-GAAP EPS in 2016, and will continue to be accretive thereafter.
08:11 EDTMRKCubist downgraded to Sector Perform from Outperform at RBC Capital
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07:44 EDTPFE, AMGNAmerican Association for Cancer Research to hold a symposium
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06:14 EDTAGNAllergan price target raised to $245 from $210 at Citigroup
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05:50 EDTJNJPharmacyclics data demonstrates safety, durability response
New, 27-month IMBRUVICA median follow-up data announced by Pharmacyclics (PCYC) support the use of IMBRUVICA over longer periods of time in patients with relapsed/refractory mantle cell lymphoma, or MCL, an aggressive type of lymphoma. More than 30% of IMBRUVICA patients remained progression-free after two years with no new or unexpected adverse events occurring during that time. Nearly half of the 111 patients treated were still living at the time of the data analysis. A second Phase II trial looked at IMBRUVICA's efficacy and safety as a single-agent treatment for MCL patients who previously had received rituximab combination therapy and at least two cycles of bortezomib. IMBRUVICA combination therapy resulted in an 88% overall response rate in MCL patients with a complete response rate of 40%. IMBRUVICA is jointly developed and commercialized by Pharmacyclics and Janssen Biotech, a unit of Johnson and Johnson (JNJ).
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