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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 9, 2014
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).
05:43 EDTJNJPharmacyclics reports IMBRUVICA data shows 84% PFS rate at one year
Pharmacyclics (PCYC) announced new, longer term data in IMBRUVICA patients with relapsed/refractory chronic lymphocytic leukemia, or CLL, including high-risk CLL patients with deletion 17p. Results from the Phase III RESONATE trial demonstrated an 84% progression-free survival, or PFS, rate in all patients with previously treated CLL or small lymphocytic lymphoma, or SLL, who received IMBRUVICA and a 94% PFS rate in patients who received only one prior therapy at 12 months. Separately, follow-up data was reported from Phase II RESONATE-17, or PCYC-1117, the largest prospective trial dedicated to studying CLL or SLL patients with del 17p. The data showed that IMBRUVICA was associated with an 83% overall response rate, or ORR, at a median follow up of 11.5 months. At 12 months, the estimated PFS was 79%. These results and additional data were presented here at the 56th American Society of Hematology, or ASH, Annual Meeting, highlighting IMBRUVICA's sustained efficacy in relapsed/refractory patients who have received at least one prior therapy. 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).
05:40 EDTAMGNAmgen presents new BLINCYTO Phase 2 study data at ASH meeting
Amgen announced that new data from a pivotal Phase 2 study evaluating BLINCYTO for the treatment of adult patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia, or ALL was presented at the 56th American Society of Hematology, or ASH, Annual Meeting and Exposition. In one analysis from the '211 study, 40% of patients treated with BLINCYTO who achieved a complete remission, or CR, or complete remission with partial hematologic recovery, or CRh, were enabled to proceed to allogeneic hematopoietic stem cell transplant, or HSCT. Additionally, a secondary analysis from the study found that 82% of patients who had a CR or CRh also had a minimal residual disease, or MRD, response, a measure used to predict disease recurrence in patients with ALL. In one analysis of the '211 study, 40% of patients treated with BLINCYTO who achieved a CR or CRh were enabled to proceed to HSCT, including both patients who had received prior HSCT and patients who had not received prior HSCT. A secondary analysis of the study demonstrated that, among patients receiving BLINCYTO who had a CR or CRh and had evaluable MRD data, 82% had an MRD response, with 70% of those patients achieving a complete MRD response. Median overall survival was longer among patients who had a CR or CRh and an MRD response compared to patients who didn't have an MRD response.
05:38 EDTSHPGShire downgraded to Neutral from Buy at BofA/Merrill
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05:27 EDTJNJPharmacyclics IMBRUVICA Phase II combination data shows positive profile
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December 8, 2014
19:42 EDTSGENSeattle Genetics says Adcetris 'demonstrates antitumor activity'
Seattle Genetics highlighted two separate Adcetris data presentations in relapsed/refractory and frontline diffuse large B-cell lymphoma, or DLBCL, at the 56th American Society of Hematology, or ASH, Annual Meeting and Exposition. Adcetris is an antibody-drug conjugate directed to CD30, which is expressed in classical Hodgkin lymphoma, anaplastic large cell lymphoma and several other types of non-Hodgkin lymphoma. Seattle Genetics CEO Clay Siegall said, “The updated phase 2 data at ASH demonstrate encouraging activity of Adcetris in relapsed/refractory DLBCL, even when CD30 is undetectable by standard immunohistochemistry methods. In addition, our data show that Adcetris can be safely combined with RCHOP in the frontline setting with a strong complete remission rate in high-intermediate and high-risk patients. The activity observed supports our plans to initiate a randomized phase 2 clinical trial of Adcetris for relapsed CD30-positive DLBCL patients during 2015 and to pursue possible frontline DLBCL combination trials."
19:41 EDTSGENSeattle Genetics says planning phase 1b combination trial for SGN-CD33A
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19:00 EDTMRKCubist CEO says Cubicin patent ruling will not affect Merck transaction
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18:00 EDTMRKCubist loses bid to stop Hospira's generic Cubicin after 2016, Bloomberg says
Cubist's (CBST) patent for Cubicin that expires in June 2016 upheld by judge, Bloomberg added. Note that this morning Merck (MRK) and Cubist Pharmaceuticals announced that the companies have entered into a definitive agreement under which Merck will acquire Cubist for $102 per share in cash.
17:54 EDTMRKFour Cubist Cubicin patents invalidated as Hospira wins ruling, Bloomberg says
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17:30 EDTMRKMerck acquisition of Cubist could be a 'winner', Barron's says
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17:30 EDTMRKMerck shares lower after reports of judge decision in Cubist/Hospira case
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16:24 EDTMRKOn The Fly: Closing Wrap
Stocks on Wall Street were lower amid another drop in crude oil prices, which tumbled to five-year lows. The market opened slightly lower following weaker than expected data from China and Japan, with nothing of note on the domestic calendar to get buyers involved in the day’s activity. Near noon, the averages gained downside momentum and though the market pared its losses several times, it was never able to gain any steam to pull the indexes back into the green. ECONOMIC EVENTS: In the U.S., no major economic data was released. In Asia, Chinese exports rose 4.7% from a year earlier in November, which missed the consensus estimate for an 8% increase. Chinese imports fell 6.7% from the prior year last month, compared with projections for a 3.8% increase. Additionally, Japan's revised third quarter gross domestic product estimate showed the economy shrank more than initially thought, with growth contracting an annualized 1.9%. COMPANY NEWS: Shares of Cubist Pharmaceuticals (CBST) surged $26.24, or 35.29%, to $100.60 after Merck (MRK) agreed to acquire the maker of next-generation antibiotics for $102 per share in cash, or $8.4B and the assumption of $1.1B in debt. A number of other antibiotic makers also climbed, including Tetraphase (TTPH), which rose $2.45, or 8.82%, to $30.24, and Cempra (CEMP), which advanced $1.64, or 11.37%, to $16.06, while shares of Merck finished fractionally higher, adding 39c, or 0.63%, to $61.88 following the deal announcement. MAJOR MOVERS: Among the notable gainers following their presentations at the American Society of Hematology, or ASH, annual meeting were Calithera Biosciences (CALA), which gained $2.38, or 22.52%, to $12.95, and Acceleron Pharma (XLRN), which jumped $5.11, or 13.6%, to $42.67. Among the noteworthy losers was McDonald's (MCD), which fell $3.70, or 3.84%, to $92.61 after the Dow member reported a 2.2% decline in global same-restaurant sales in November. Additionally, the fast-food giant warned that its fourth quarter results would be hurt by its sales pressures, supplier issues in China and a stronger U.S. dollar. Also lower were shares of Liquidity Services (LQDT), which plunged $2.77, or 27.0%, to $7.49 after the company disclosed that Wal-Mart (WMT) had terminated a deal to provide it with surplus merchandise. INDEXES: The Dow fell 106.31, or 0.59%, to 17,852.48, the Nasdaq dropped 40.06, or 0.84%, to 4,740.69, and the S&P 500 slipped 15.06, or 0.73%, to 2,060.31.
16:24 EDTAMGN, MRKAmgen initiates new combination trial for talimogene laherparepvec with KEYTRUDA
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13:32 EDTPFEPfizer, Bristol-Myers announce results of human study on Eliquis
Bristol-Myers Squibb Company (BMY) and Pfizer (PFE) announced results of the first human study evaluating the reversal of the anticoagulant effect of Eliquis by 4-factor prothrombin complex concentrates in healthy subjects. The study results demonstrated that both PCCs, Sanquin’s Cofact and CSL Behring’s Beriplex P/N reversed the steady-state pharmacodynamic effects of Eliquis in several coagulation assessments, including endogenous thrombin potential. The full data will be presented today during the Antithrombotic Therapy: Anticoagulant Therapy session at the 56th annual meeting of the American Society of Hematology in San Francisco, CA. The study was an open label, randomized, placebo-controlled, three-period crossover study in 15 healthy, adult subjects. Within each period, subjects received Eliquis 10 mg twice daily. On day four, three hours after Eliquis administration, subjects received a 30-minute infusion of 4-factor PCCs, either 50 IU/kg Cofact or Beriplex P/N, or an equivalent volume of saline solution. The effect of Cofact and Beriplex P/N on the pharmacodynamics of Eliquis was based upon changes in endogenous thrombin potential, a measure of thrombin-mediated coagulation. Treatment periods were separated by an 11-day washout, after which the alternate treatment was administered. In this study, no serious adverse events, bleeding-related events or signs of thrombosis were reported with Eliquis administration with or without PCC treatment. Overall, these data demonstrate that Cofact and Beriplex P/N reversed the steady-state pharmacodynamic effects of Eliquis as measured by ETP and support further evaluation of PCCs in the management of patients treated with Eliquis who require reversal of its anticoagulant effect.
13:12 EDTMRKMerck paid full price but made good deal for Cubist, says UBS
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12:40 EDTMRKOn The Fly: Midday Wrap
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12:25 EDTMRKAntibiotic makers rise after Merck agrees to buy Cubist
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10:47 EDTINFIInfinity reports updated Phase 1 data from duvelisib study, says well tolerated
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