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April 17, 2014
08:38 EDTPFE, TEVATeva settles patent ligitigation with Pfizer on Celebrex
Teva (TEVA) announced that its subsidiary Teva Pharmaceuticals USA, Inc. has entered into a settlement with Pfizer (PFE) related to Teva’s generic version of Celebrex 50, 100, 200 and 400 mg capsules in the United States. Under the terms of the settlement, Teva may launch its generic versions in December 2014 or earlier under certain circumstances. Teva has received tentative approval from the U.S. Food and Drug Administration for all strengths and believes that it is first-to-file on at least the 100, 200 and 400 mg capsules. Sales of Celebrex were $2.2B in the U.S. according to IMS data as of December, 2013.
News For TEVA;PFE From The Last 14 Days
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December 15, 2014
08:02 EDTPFEPfizer, OPKO Health enter into global agreement for hGH-CTP
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December 12, 2014
10:01 EDTTEVAOn The Fly: Analyst Upgrade Summary
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08:49 EDTTEVATeva upgraded at Sterne Agee
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07:06 EDTTEVATeva upgraded to Buy from Neutral at Sterne Agee
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December 11, 2014
09:39 EDTTEVATeva FY15 outlook appears strong, reasonable, says BMO Capital
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07:24 EDTTEVATeva to host conference call
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07:12 EDTTEVATeva sees FY15 Copaxone sales $3.5B-$3.7B
Sees FY15 Treanda sales $670M-$750M. Sees FY15 ProAir family sales $470M-$580M, Azilect sales $350M-$400M and Nuvigil sales $300M-$330M. Erez Vigodman, President & CEO of Teva, said, "Generics remain at the heart of our business, both as the cornerstone of the Company, but also as an area that has great impact on society. At the same time, we anticipate four specialty product approvals and five submissions in 2015 – which we believe will improve treatment options for patients, and add value for all of our stakeholders." The company expects 2015 generic revenues in the United States to be $4.2B-$4.6B, $2.6B-$3.0B in Europe and $2.0B-$2.3B in its ROW markets. Results of its specialty segment are expected to be impacted by the introduction of two AB-rated generic competitors to Copaxone in the U.S. beginning in September 2015, which is a modeling assumption only, as well as by increased competition from oral products for the treatment of multiple sclerosis. In addition, the company is expecting to invest in a significant number of product launches and in its specialty pipeline. "All of these will result in lower profit and profitability, as we focus on generating growth over the next few years," Teva said.
07:08 EDTTEVATeva sees FY15 gross profit 59.5%-61.5%
Teva sees FY15 cash flow from operations $4.3B-$4.7B and free cash flow $3.5B-$3.7B.
07:07 EDTTEVATeva sees spending $1B-$1.2B on share buybacks in 2015
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07:02 EDTTEVATeva sees FY15 EPS $5.00-$5.30, consensus $5.06
Sees FY15 revenue $19B-$19.4B, consensus $20.07B.
December 10, 2014
08:31 EDTTEVA, PFETeva 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
12:22 EDTPFEPiper 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.
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.”
07:44 EDTPFE, TEVAAmerican Association for Cancer Research to hold a symposium
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December 8, 2014
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.
11:30 EDTTEVALeerink generics pharmaceutical analyst holds analyst/industry conference call
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08:21 EDTTEVAMerck says looked at all risks, including patent litgation, before Cubist deal
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08:03 EDTPFEPfizer announces agreement with Spark Therapeutics to develop SPK-FIX
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06:47 EDTTEVAArena says Teva files marketing authorization of Belviq in Israel
Arena Pharmaceuticals (ARNA) disclosed late Friday that Teva Pharmaceutical's (TEVA) local Israeli subsidiary, Abic Marketing Limited, has filed for marketing authorization of Belviq in Israel. In connection with the filing, Arena will receive a milestone payment of $250K.
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