Teva Pharmaceutical Industries LimitedNASDAQ
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  • Yesterday, 6:37 PM
    • Mallinckrodt (NYSE:MNK) and Lannett Company (NYSEMKT:LCI) are tussling with the FDA over its withdrawal of previously approved abbreviated New Drug Applications (ANDAs) for generic versions of Janssen Pharmaceuticals' (NYSE:JNJ) CONCERTA (methylphenidate HCl) for the treatment of attention deficit hyperactivity disorder (ADHD).
    • The agency pulled the approvals due to the lack of bioequivalence. Although bioequivalence was the basis for the original approvals, field reports of insufficient therapeutic effect surfaced after the products were launched. In an analysis of reports from the FDA's adverse event reporting system, FAERS, the reported therapeutic failures of the generics in question were almost 10x higher than Actavis' (NASDAQ:TEVA) generic version, the reference drug. Further analyses showed differences in the rates of drug release and absorption. Specifically, the companies' products delivered the active ingredient at a slower rate 7 - 12 hours after dosing.
    • Lannett has requested a hearing with the FDA on the matter. Mallinckrodt will have to do the same after an appeals court removed its pending litigation with the agency from its oral argument calendar. It has filed a Motion to Reconsider in an attempt to be put back on the docket. Both firms insist that their generic versions are safe and effective.
    | Yesterday, 6:37 PM | 9 Comments
  • Thu, Oct. 20, 9:16 AM
    • The FDA accepts for review Teva Pharmaceutical Industries' (NASDAQ:TEVA) resubmitted New Drug Application (NDA) seeking approval of deutetrabenazine (SD-809) for the treatment of chorea (involuntary movements) associated with Huntington's disease, an Orphan Drug indication. The action date (PDUFA) is April 3, 2017.
    • The company received a Complete Response Letter (CRL) in May regarding its original filing. The CRL citing the need to re-analyze blood levels of certain metabolites.
    • SD-809 is an orally available small molecule inhibitor of vesicular monoamine 2 transporter (VMAT2) that is designed to regulate the levels of the neurotransporter dopamine in the brain.
    • Previously: Teva receives CRL in response to SD-809 NDA (May 31)
    | Thu, Oct. 20, 9:16 AM
  • Tue, Oct. 18, 10:14 AM
    • Teva Pharmaceutical Industries (TEVA +0.7%) receives a Warning Letter from the FDA regarding deficiencies in manufacturing operations and laboratory controls and in its data integrity program at its Godollo, Hungary manufacturing site. In June, the company voluntarily stopped production of sterile injectables made there after the FDA banned most of the products in the U.S. The plant was opened in 2012.
    • The company says it is taking corrective actions and will respond to the Warning Letter on November 4.
    | Tue, Oct. 18, 10:14 AM | 8 Comments
  • Mon, Oct. 17, 8:07 AM
    • The FDA has placed a clinical hold on a Phase 2b clinical trial assessing Regeneron Pharmaceuticals (NASDAQ:REGN) and Teva Pharmaceutical Industries' (NASDAQ:TEVA) fasinumab for the treatment of chronic low back pain. The agency has also requested an amendment to the study protocol after observing a case of confirmed arthropathy (joint disease) in a patient with advanced osteoarthritis who was receiving high dose fasinumab. Regeneron has stopped dosing in the study after completing an unplanned interim review of the data which showed clear evidence of efficacy over placebo at the eight- and 12-week time points. Patients will continue to be followed for up to 36 weeks.
    • There are three fasinumab dose cohorts in the study: 6 mg and 9 mg subcutaneously once/month and 9 mg intravenously every two months. Enrollment was 70% completed (target: 800). Updated results will be presented at an upcoming medical conference.
    • Based upon the data, the companies intend to design a Phase 3 trial in chronic low back pain that excludes patients with advanced osteoarthritis.
    • Results from a previously reported Phase 2/3 study in osteoarthritis pain, a potential dose-dependent rate of arthropathy was observed. Consequently, only the lower doses will be advanced in Phase 3 studies.
    • Fasinumab is a fully human monoclonal antibody that targets Nerve Growth Factor, a protein that plays a key role in the regulation of pain signaling.
    • Regeneron and Teva are co-developing and co-commercializing fasinumab under an agreement inked last month.
    • Regeneron is down 1% premarket on light volume. Teva is up a fraction.
    • Previously: Regeneron's fasinumab successful in mid-stage study in treatment-resistant arthritis (May 2)
    | Mon, Oct. 17, 8:07 AM | 11 Comments
  • Mon, Oct. 17, 6:54 AM
    • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Teva Pharmaceutical Industries' (NASDAQ:TEVA) Trisenox (arsenic trioxide) for the treatment of newly diagnosed low-to-intermediate risk acute promyelocytic leukemia (APL), a rare type of acute myeloid leukemia that can rapidly be life-threatening due to uncontrollable bleeding. It affects 1,500 - 2,000 Europeans each year.
    • Trisenox was first approved in the EU in March 2002 for the treatment of relapsed/refractory APL. It was approved in the U.S. in 2000.
    • A final decision from the European Commission usually takes ~60 days.
    | Mon, Oct. 17, 6:54 AM | 1 Comment
  • Wed, Oct. 12, 10:44 AM
    • Teva Pharmaceutical Industries (TEVA -0.6%) begins the U.S. commercial launch of RAJANI (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.02 mg/0.451 mg and levomefolate calcium tablets, 0.451 mg), its generic version of Bayer's (OTCPK:BAYRY -0.4%) Beyaz.
    • According to IMS, the American market is ~$133M.
    | Wed, Oct. 12, 10:44 AM | 8 Comments
  • Thu, Oct. 6, 10:12 AM
    • Teva Pharmaceutical Industries (TEVA) and South Korea's Celltrion enter into an exclusive partnership to commercialize two of Celltrion's biosimilar candidates in the U.S. and Canada: CT-P10, a biosimilar to Roche and Biogen's Rituxan (rituximab) and CT-P6, a biosimilar to Roche's Herceptin (trastuzumab). Both are in Phase 3 development.
    • Under the terms of the agreement, Celltrion will receive an upfront payment of $160M of which $60M is refundable or creditable under certain circumstances. The companies will share the commercial profits, but the split is not disclosed.
    | Thu, Oct. 6, 10:12 AM
  • Wed, Oct. 5, 12:09 PM
    • With the aim of securing the European Commission's nod to its $35B acquisition of Actavis Generics, Teva Pharmaceutical Industries (TEVA -0.6%) sells Actavis' UK and Ireland assets and operations to Intas Pharmaceuticals unit Accord Healthcare Limited for ₤603M ($766M).
    • The deal includes a portfolio of generic medicines and a manufacturing plant in Barnstaple, England. Teva retains certain non-overlapping generics and certain specialty medicines and OTC products.
    • The transaction should close within the next three months.
    | Wed, Oct. 5, 12:09 PM | 3 Comments
  • Mon, Oct. 3, 12:29 PM
    • September monthly performance was: +0.25%
    • AUM of $8.65B
    • 52-week performance vs. the S&P 500 is: -6%
    • No dividends were paid in September
    • Top 10 Holdings as of 6/30/2016: RELX PLC (OTC:RLXXF): 2.98184%, Sky PLC (OTCQX:BSYBF): 2.94851%, British American Tobacco PLC (OTCPK:BTAFF): 2.66638%, Teva Pharmaceutical Industries Ltd ADR (TEVA): 2.50786%, WPP PLC (OTCPK:WPPGF): 2.36147%, Taiwan Semiconductor Manufacturing Co Ltd (2330): 2.35528%, CGI Group Inc A (GIB): 2.31975%, Roche Holding AG Dividend Right Cert. (OTCPK:RHHVF): 2.27147%, Broadcom Ltd (AVGO): 2.25054%, Deutsche Boerse AG (OTCPK:DBOEF): 2.18513%
    | Mon, Oct. 3, 12:29 PM
  • Fri, Sep. 30, 3:45 PM
    • Depomed (DEPO +4.5%) perks up on increased volume in response to the news that a court has issued an an injunction against potential competitor Allergan (AGN +0.1%) from selling a generic version of NUCYNTA (tapentadol). Actavis (TEVA -0.2%) and Roxane have also lost bids to invalidate NUCYNTA patents, which are valid until 2022 to 2028.
    • In the first half of 2016, NUCYNTA products accounted for almost 64% of the company's product sales ($141.3M/221.1M).
    | Fri, Sep. 30, 3:45 PM | 15 Comments
  • Wed, Sep. 28, 9:46 AM
    • Teva Pharmaceutical Industries (TEVA +0.5%) announces its U.S. commercial launch of a generic equivalent to ViiV Healthcare's Epzicom (abacavir and lamivudine) tablets, 600 mg/300 mg. It is indicated, in combination with other antiretroviral agents, for the treatment of HIV-1 infection.
    • According to IMS, the U.S. market for the branded product is ~$450M.
    • ViiV Healthcare is the HIV-focused company formed by GlaxoSmithKline (GSK +0.9%) and Pfizer (PFE +0.1%).
    | Wed, Sep. 28, 9:46 AM | 1 Comment
  • Thu, Sep. 22, 8:53 AM
    • Top-line data from a Phase 3 clinical trial, AIM-TD, assessing Teva Pharmaceutical Industries' (NASDAQ:TEVA) SD-809 (deutetrabenazine) for the treatment of tardive dyskinesia (TD) showed a statistically valid treatment benefit. The positive data follow successful results from an earlier Phase 3, ARM-TD, announced in June 2015. The company plans to file a New Drug Application (NDA) in the U.S. by year end.
    • The primary endpoint was the reduction in involuntary movements versus placebo as measured by the Abnormal Involuntary Movement Scale (AIMS) from baseline to Week 12 for three fixed doses of SD-809 (12 mg, 24 mg and 36 mg tablets titrated for four weeks to the targeted randomized dose then maintained for eight weeks). Placebo tablets were administered twice daily for 12 weeks.
    • At Week 12, the improvements in AIMS scores for 12 mg, 24 mg, 36 mg and placebo were -2.1, -3.2, -3.3 and -1.4, respectively. All were statistically significantly greater than placebo except the 12 mg dose. The 24 mg and 36 mg doses also demonstrated superiority to placebo as measured by the Clinical Global Impression of Change (CGI), an investigator-generated metric. Complete data will be presented at a future medical conference.
    • SD-809 is an orally available small molecule inhibitor of vesicular monoamine 2 transporter (VMAT2) that is designed to regulate the levels of the neurotransporter dopamine in the brain.
    • TD is a difficult-to-treat neurological disorder characterized by involuntary repetitive body movements. It commonly occurs in patients on long-term high-dose antipsychotic drugs.
    • Previously: Teva's SD-809 successful in mid-stage study in movement disorder (June 16, 2015)
    | Thu, Sep. 22, 8:53 AM
  • Wed, Sep. 21, 1:04 PM
    • As previously reported, Bayer (OTCPK:BAYRY) aims to jettison its dermatology business in order to help fund its Monsanto buy. Although discussions are in the early phase, there appears to be plenty of interested parties. In addition to skincare-focused players like Allergan (NYSE:AGN), Almirall (OTC:LBTSF) and Nestle (OTCPK:NSRGY)(OTCPK:NSRGF), Teva Pharmaceutical Industries (NASDAQ:TEVA), Perrigo (NASDAQ:PRGO) and Sun Pharma (OTC:SMPQY) are also reportedly in the mix.
    • On the institutional investor side, KKR (NYSE:KKR), Nordic Capital, Bain Capital, Blackstone Group (NYSE:BX) and Cinven may also be eyeing the unit which, analysts say, could fetch $1.1B.
    • Previously: Bloomberg: Bayer eyes sale of $1.1B dermatology business (Sept. 8)
    | Wed, Sep. 21, 1:04 PM | 7 Comments
  • Tue, Sep. 20, 7:40 AM
    • Teva Pharmaceutical Industries (NASDAQ:TEVA) and Regeneron Pharmaceuticals (NASDAQ:REGN) enter into a global agreement to develop and commercialize Regeneron's fasinumab, currently in Phase 3 for osteoarthritis pain and Phase 2 for chronic lower back pain.
    • Under the terms of the deal, Regeneron will receive an upfront payment of $250M plus milestones and will equally share the global commercial value as well as the ~$1B R&D costs. It will lead global development and U.S. commercialization while splitting the U.S. profits 50/50. Outside of the U.S., exclusive of the territory (11 countries in Asia) covered in a previous collaboration between Regeneron and Mitsubishi, Teva will be responsible for development and commercialization and will pay Regeneron a specific purchase price for the product.
    • Fasinumab is a fully human monoclonal antibody that targets Nerve Growth Factor (NGF), a protein that plays a key role in the regulation of pain signaling.
    | Tue, Sep. 20, 7:40 AM | 4 Comments
  • Mon, Sep. 19, 8:50 AM
    • Top-line results from an exploratory dose-ranging Phase 2 clinical trial, PRIDE-HD, assessing Teva Pharmaceutical Industries' (NASDAQ:TEVA) pridopidine for the treatment of Huntington's disease (HD) failed to demonstrate an improvement in motor function compared to placebo at Week 26. The company says the culprit was an unexpectedly high placebo effect.
    • Teva didn't give up, though. It says there was evidence of a symptomatic impact in a subpopulation of early-stage HD patients as evidenced by improvements in Total Motor Score (TMS) and dystonia (involuntary muscle movements) at Week 26 and Week 52. This discovery prompted the company to change the design of of PRIDE-HD to a 52-week study focused on pridopidine's impact on disease progression as measured by Total Functional Capacity (TFC). On this metric, pridopidine was successful at certain doses compared to placebo.
    • The data were presented yesterday at the 9th European Huntington Disease Network Plenary Meeting in The Hague. Complete results will be submitted for publication in a scientific journal.
    • Teva intends to advance pridopidine into Phase 3 development.
    • Pridopidine is a small molecule agonist of the Sigma 1 Receptor (S1R) which plays a key role in protecting neurons through the increased production of a protein called brain-derived neurotrophic factor (BDNF). Abnormally low levels of BDNF characterize HD, Parkinson's, Alzheimer's and ALS.
    | Mon, Sep. 19, 8:50 AM
  • Thu, Sep. 15, 11:30 AM
    • Teva Pharmaceutical Industries (TEVA +0.1%) commences the U.S. commercial launch of its generic version of Merck's (MRK +1.5%) antibiotic CUBICIN (daptomycin for injection) 500 mg. It is indicated for the treatment of complicated skin and skin structure infections caused by certain Gram-positive bacteria and bloodstream infections caused by Staphylococcus aureus.
    • The U.S. market is ~$1.2B/year according to IMS.
    | Thu, Sep. 15, 11:30 AM