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June 18, 2014
10:17 EDTGILD, VRX, AMGN, ABBV, AGN, BIIB, BMY, SHPGShire rises after analyst predicts Allergan takeover
Shares of Irish drug maker Shire (SHPG) are climbing after an analyst at SunTrust predicted that Allergan (AGN) would soon look to buy the Irish company. WHAT'S NEW: A bid for Shire by Allergan is imminent, wrote SunTrust analyst John Boris in a note to investors earlier today. An acquisition of Shire would be more advantageous for Allergan shareholders than the proposed hostile takeover of the company by Valeant (VRX), Boris contended. An acquisition of Shire would boost Allergan's stock more than a Valeant deal, and would enable Allergan's shareholders to avoid the risk of holding Valeant's stock, the analyst stated. Following an acquisition of Shire by Allergan, the combined company would have sustainable, transparent revenue growth of about 10%, a diversified sales mix, high value research and development programs and a tax inversion, the analyst believes. Additionally, the transaction would boost Allergan's profit by 50% in its first year and would enable its profit growth to accelerate significantly, according to Boris. He kept a $200 price target and Buy rating on Shire shares. ALSO TODAY: Valeant announced that it has commenced an exchange offer for Allergan, taking its buyout proposal directly to stockholders. Under the terms of the offer, Allergan stockholders would be able to elect to exchange each of their Allergan shares for $72.00 in cash and 0.83 Valeant common shares, or an amount of cash, or a number of Valeant common shares, in each case subject to proration. The offer is scheduled to expire at 5:00 p.m., New York City time, on August 15. WHAT'S NOTABLE: On June 16, Reuters reported that Shire had hired Citigroup (C) as an adviser to prepare for takeover bids. Bankers believe that Shire could be an attractive takeover target for Bristol Myers (BMY), Abbvie (ABBV), Gilead (GILD), Biogen (BIIB) or Amgen (AMGN), the news service reported. PRICE ACTION: In early trading, Shire is up 4%, or $6.61, to $193.77 while Allergan is up 1%, or $1.27, to $161.80. Valeant is little changed at $118.90.
News For SHPG;AGN;VRX;BMY;ABBV;GILD;BIIB;AMGN From The Last 14 Days
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December 9, 2014
08:25 EDTBMYBristol-Myers data positive, says BMO Capital
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07:44 EDTAMGN, ABBVAmerican Association for Cancer Research to hold a symposium
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06:39 EDTVRXValeant to abandon growth by acquisitions strategy, Reuters says
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06:14 EDTAGNAllergan price target raised to $245 from $210 at Citigroup
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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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December 8, 2014
16:24 EDTAMGNAmgen initiates new combination trial for talimogene laherparepvec with KEYTRUDA
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16:00 EDTGILDOptions Update; December 8, 2014
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13:32 EDTBMYPfizer, 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.
10:02 EDTGILDGilead presents follow-up data from Zydelig registrational studies
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09:09 EDTAMGNAmgen announces FDA approval for XGEVA
Amgen announced that the FDA has approved a new indication for XGEVA for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. XGEVA was approved and granted Orphan Drug Designation by the FDA, which is reserved for drugs that are intended for the treatment of rare diseases affecting fewer than 200,000 people in the U.S. HCM is a serious complication in patients with advanced cancer, including those with hematologic malignancies, and indicates poor prognosis.1,2 The condition results from cancer-driven increases in bone resorption, and if untreated, can lead to renal failure, progressive mental impairment, coma and death. The approval of XGEVA is based on positive results from an open-label, single-arm study, which enrolled patients with advanced cancer and persistent hypercalcemia after recent bisphosphonate treatment. The primary endpoint was the proportion of patients with a response, defined as albumin-corrected serum calcium <11.5 mg/dLwithin 10 days after the first dose of XGEVA. Secondary endpoints included the proportion of patients who experienced a complete response (defined as CSC <10.8 mg/dL by day 10, time to response and response duration. The study achieved its primary endpoint with a response rate at day 10 of 63.6 percent in the 33 patients evaluated. The overall complete response rate was 63.6 percent. The estimated median time to response was nine days, and the median duration of response was 104 days.4,5
09:09 EDTAMGNAmgen announces FDA approval for XGEVA
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07:29 EDTAGNUBS to hold investor trip
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07:18 EDTAGNUBS to hold investor trip
2014 Annual West Coast Investor Trip travels on the West Coast on December 8-10.
05:53 EDTBMYStocks with implied volatility movement; BSX BMY
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05:42 EDTAMGNSandoz Phase III data shows filgrastim has similar safety, efficacy as NEUPOGEN
Sandoz, a Novartis (NVS) company, announced Phase III data that demonstrated similarity of its investigational biosimilar filgrastim compared to the US-licensed reference product, Amgen's (AMGN) NEUPOGEN in the prevention of severe neutropenia in patients with breast cancer receiving neoadjuvant myelosuppressive chemotherapy. The study also showed that repeated switching at each cycle between the investigational biosimilar and the originator filgrastim showed no impact on efficacy, safety or immunogenicity. The PIONEER study was a Phase III study designed to compare the efficacy and safety of the investigational biosimilar and the reference product with respect to mean duration of severe neutropenia following Cycle 1 chemotherapy. PIONEER was a randomized, double-blind, four-group, multi-center non-inferiority trial conducted at 27 centers. The trial randomized 218 breast cancer patients receiving neoadjuvant myelosuppressive chemotherapy.
December 7, 2014
14:38 EDTAMGNAmgen announces new data from Phase 2 BLINCYTO immunotherapy study
Amgen announced new data from the Phase 2 BLAST study which evaluated the bispecific T cell engager, BiTE, immunotherapy BLINCYTO in patients with minimal residual disease, MRD, positive B-cell precursor acute lymphoblastic leukemia, ALL. In the study, 78% of patients who received BLINCYTO experienced a complete MRD response , a measure of eradication of residual disease at the molecular level, after one treatment cycle. Nearly all complete responses occurred within the first treatment cycle. The results from the BLAST study will be featured during the 56th American Society of Hematology Annual Meeting and Exposition press briefing on Saturday, December 6, at 10 a.m. PT and will be presented in an oral session at ASH on Monday, December 8, at 10:30 a.m. PT. "BLINCYTO is the most advanced of Amgen's BiTE immunotherapies, a new and innovative approach that helps the body's own immune system fight cancer," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Achieving molecular complete remission is an important goal in the treatment of ALL, and the data presented at ASH demonstrates that BLINCYTO can produce deep responses in patients that have trace amounts of residual disease." MRD is a state of disease in which the microscopic analysis does not show malignant cells, but more sensitive techniques still detect disease at the molecular level. Patients who have persistent or recurrent MRD after their first therapy have a higher risk of relapse than those with no detectable MRD. In addition to the majority of patients achieving a compete MRD response within one cycle of treatment, 80% achieved a complete MRD response across all cycles. Responses occurred in all subgroups including older patients and patients with high MRD level; no predictive factor for MRD response was identified. In the study, adverse events of all grades occurring in 20% or more patients included pyrexia, tremor, chills, fatigue, nausea, vomiting and diarrhea. Grade =3 AEs occurring in five percent or more patients included neutropenia , pyrexia and tremor. Two fatal AEs occurred on treatment: subdural hemorrhage and pneumonitis in conjunction with influenza. Treatment interruptions due to AEs occurred in 31% of patients.
14:18 EDTAMGNAmgen, Onyx announce detailed results from Phase 3 ASPIRE study of Kyprolis
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14:10 EDTAMGN, BMYAmerican Society of Hematology to hold a meeting
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13:06 EDTBMYBMY announces positive results in Phase 1b trial evaluating Opdivo
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