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Teva Pharmaceutical Industries Limited (TEVA)

  • Mon, Jul. 27, 5:19 AM
    • Teva Pharmaceuticals (NYSE:TEVA) has agreed to buy the generic-drug business of Allergan (NYSE:AGN) for about $40.5B in cash and stock, ending its effort to acquire rival Mylan (NASDAQ:MYL).
    • Allergan will receive $33.75B in cash and shares in Teva valued at $6.75B, giving it a 10% stake in the enlarged company.
    • The acquisition further extends a wave of mergers that has swept over the healthcare industry. Pharmaceutical deals so far this year have topped $180B, on pace to beat the $200B announced in 2014.
    • TEVA +12.1% premarket
  • Mon, Jul. 27, 3:40 AM
    • The Tel Aviv Stock Exchange has suspended trading in Teva Pharmaceutical (NYSE:TEVA) because the company is about to make a significant announcement.
    • Reports surfaced over the weekend suggesting Teva is in advanced talks to buy Allergan's (NYSE:AGN) generic drug business for about $45B.
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  • Sun, Jul. 26, 6:37 AM
  • Thu, Jul. 23, 1:06 PM
    • An independent Dutch foundation, Stichting Preferred Shares Mylan, exercises its call option allowing it to purchase 50% of Mylan's (MYL -1.4%) shares, giving it temporary control of half the company. The call option (i.e., poison pill), a common feature in Netherlands-based foundations, is a mechanism by which these groups can block unwelcome bids like the one from Teva Pharmaceutical Industries (TEVA). According to Stichting, it is acting to "safeguard Mylan's stakeholder interests." Mylan rejected Teva's $40B offer in April.
    • In a statement, Teva said it has the power to challenge to foundation's action in court and that it would "take the necessary actions at the appropriate time."
  • Mon, Jul. 13, 8:53 AM
    • ANI Pharmaceuticals (NASDAQ:ANIP) acquires 22 previously marketed generic drugs from Teva Pharmaceutical Industries (NYSE:TEVA) for $25M in cash plus a percentage of future gross profits from product sales. According to IMS Health, the total market value of the portfolio is $650M. The deal is being financed with cash on hand.
  • Wed, Jul. 8, 2:22 PM
    • Teva Pharmaceutical Industries (TEVA -1.3%) launches its generic version of Janssen's (JNJ -0.8%) Axert (almotriptan malate), 6.25 mg and 12.5 mg, in the U.S. for the acute treatment of migraine. According to IMS, Axert generated $31M in sales for the 12-month period ending in March.
    • Teva markets over 375 generic medicines.
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  • Tue, Jul. 7, 10:27 AM
    • Biotie (BITI +0.6%) initiated with Buy rating and $26 (33% upside) price target by Roth Capital and a Buy rating with $30 (53% upside) price target by Stifel Nicolaus.
    • Boston Scientific (BSX -0.1%) initiated with Overweight rating and $21 (20% upside) price target by Stephens & Co.
    • Ophthotech (OPHT +1.9%) initiated with Outperform rating and $80 (49% upside) price target by Cowen & Co.
    • Teva Pharmaceutical Industries (TEVA -0.5%) initiated with Buy rating and $77 (25% upside) price target by BTIG Research.
    • Axovant Sciences (AXON -1.1%) initiated with Buy rating and $31 (64% upside) price target by Jefferies.
    • PRA Heath Sciences (PRAH) initiated with Sector Weight rating and $36.06 (0% upside) price target by KeyBanc.
    • Baxalta (BXLT -0.4%) initiated with Neutral rating and $36 (14% upside) price target by Goldman Sachs.
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  • Tue, Jul. 7, 8:45 AM
    • The U.S. Department of Justice reports that AstraZeneca (NYSE:AZN) has agreed to pay $46.5M to the U.S. and certain states to resolve allegations that it underpaid rebates owed under the Medicaid Drug Rebate Program.
    • Under a separate settlement in the same case, Cephalon (NYSE:TEVA) agrees to pay $7.5M to resolve the same allegations.
    • Drug makers are required to pay quarterly rebates to state Medicaid programs in exchange for Medicaid's coverage of their drugs. The rebates are based, in part, on the Average Manufacturer Prices (AMPs) that the companies report to the government for each of their covered medicines. The higher the reported AMP, the higher the rebate. The allegations in this case were that the two firms underreported AMPs by improperly reducing the reported AMPs for service fees they paid to wholesalers which resulted in the government being overcharged for the products.
    • The settlements partially resolve a whistleblower suit brought by pharmacist Ronald Streck.
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  • Mon, Jul. 6, 12:25 PM
    • Mylan N.V. (MYL +0.4%) jumps on the news that Teva Pharmaceutical Industries (TEVA +0.2%) intends to raise its offer for the firm to $88 per share from $86. The offer should come this week.
  • Wed, Jul. 1, 10:49 AM
    • Teva Pharmaceutical Industries (TEVA +2.2%) launches its generic version of Boehringer Ingelheim's Aggrenox (aspirin/extended-release dipyridamole) in the U.S. to lower the risk of stroke in patients who have had a transient ischemic attack (mini-stroke) or stroke due to a blood clot.
    • According to IMS, branded Aggrenox generated ~$457M in sales in the U.S. for the twelve-month period ending in April.
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  • Wed, Jul. 1, 9:25 AM
    • Thinly traded micro cap Xenon Pharmaceuticals (NASDAQ:XENE) drops 22% premarket on increased volume in response to its announcement that a Phase 2b trial run by development partner Teva Pharmaceutical Industries (NYSE:TEVA) evaluating TV-45070 (formerly XEN402) in patients with pain due to osteoarthritis of the knee failed to demonstrate a statistically significant difference from placebo.
    • TV-45070, a small molecule inhibitor of the sodium channel Nav1.7 and other sodium channels that are expressed in the pain-sensing peripheral nervous system, is a topical cream being developed for the treatment of nociceptive (pain arising from nerve cell stimulation) pain.
    • Top-line results from another Phase 2b study in post-herpetic neuralgia are expected in H2 2016.
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  • Thu, Jun. 25, 10:03 AM
    • Teva Pharmaceutical Industries (TEVA -0.1%) and co-developer Active Biotech (OTC:ATVBF) announce that patient enrollment is complete (n=2,199) in a Phase 3 study, called CONCERTO, evaluating laquinimod (0.6 mg/day or 1.2 mg/day) in patients with relapsing-remitting multiple sclerosis (RRMS) for up to 24 months. The primary endpoint is time to three-month confirmed disability progression as measured by the Expanded Disability Status Scale (EDSS). Final data collection is projected to occur in May 2018. The study's completion date is June 2018. Regulatory filings will follow thereafter.
    • The sample size of the trial will be re-assessed to confirm that the original assumptions related to completion remain valid. Per the Special Protocol Assessment (SPA) with the FDA, study completion will occur when either 260 events are reached or all patients complete 24 months of treatment. Assuming the former occurs first, then results could be available as soon as mid-2017.
    • Laquinimod, a CNS-active immunomodulator, has had a rough ride on its road to approval. It has been in late-stage development for MS since late 2007. Earlier Phase 3 trials failed to demonstrate a significant reduction in relapses.
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  • Fri, Jun. 19, 10:42 AM
    • Teva Pharmaceutical Industries (TEVA +0.2%) completes its accumulation of a 4.61% stake on Mylan N.V. (MYL -0.3%) which enables Teva to commence proceedings before the Dutch Enterprise Chamber, should it become necessary.
    • In addition, Teva commits to limit its stake to less than 5% if Mylan holds its shareholders meeting no later than August 31.
  • Thu, Jun. 18, 7:11 PM
    • Sandoz (NYSE:NVS) announces the U.S. launch of Glatopa, the first generic equivalent of Teva Pharmaceutical Industries' (NYSE:TEVA) Copaxone (glatiramer acetate injection) 20 mg/ml for the treatment of patients with relapsing forms of multiple sclerosis.
    • Glatopa was developed in collaboration with Momenta Pharmaceuticals (NASDAQ:MNTA). Under the terms of their agreement, the first commercial sale will trigger a $10M payment to Momenta, which is also eligible to receive up to $120M in remaining sales-based milestones.
    • Copaxone is Teva's top seller by far, generating ~$4.1B in sales the past four quarters.
    • TEVA is down 1% after hours on light volume. MNTA is up 3% on increased volume.
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  • Thu, Jun. 18, 10:07 AM
    • Teva Pharmaceutical Industries (TEVA -0.6%) enters into a partnership with privately-held Lexington, MA-based Microchips Biotech to explore ways to apply Microchips' implantable drug delivery device to Teva's portfolio of products with the goal of improving clinical outcomes.
    • Microchips' device is comprised of microchip arrays that can store hundreds of therapeutic doses of drugs for months or years and can be programmed to release each dose at a specific time.
    • Under the terms of the agreement, Teva will make a $35M upfront payment in the form of an equity investment in Microchips and a technology access fee. The partnership will focus initially on a single disease area but Teva will have the option to expand into additional areas. Microchips will be eligible for development and commercial milestones and royalties on net sales. It will also receive funding to develop products for new indications that Teva may develop. Teva will be responsible for Phase 2 and 3 development and regulatory filings.
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  • Thu, Jun. 18, 9:31 AM
    • New data from additional analyses of a Phase 2b study evaluating Teva Pharmaceutical Industries' (NYSE:TEVA) TEV-48125 for the prevention of high frequency episodic migraine (8-14 migraines per month) and chronic migraine (at least 15 per month) show that patients receiving a once-monthly injection of TEV-48125 experienced significant reductions in the number of migraines compared to placebo. The data will be presented on June 20 at the 57th Annual Scientific Meeting of the American Headache Society in Washington, DC.
    • 297 patients were randomized to receive TEV-48125 (225 mg or 675 mg) or placebo. Patients were allowed to continue using other preventative migraine medications if in stable doses. Both TEV-48125 treatment arms met the primary endpoint of superiority compared to placebo as measured by the decrease in monthly migraines at month 3 versus baseline. Also, a single injection of either dose of TEV-48125 resulted in a statistically significant separation from placebo.
    • The proportion of patients receiving 225 mg or 675 mg of TEV-48125 who experienced at least a 50% reduction in migraine days for the duration of the study (three months) was 53% and 59%, respectively, compared to 28% for placebo. For patients experiencing at least a 75% reduction in migraine days, the proportions were 34%, 31% and 11%, respectively.
    • TEV-48125 is a monoclonal antibody that binds to calcitonin gene-related peptide (CGRP), a well-validated target in migraine. The company plans to advance the product candidate to Phase 3 development.
    • Previously: Teva migraine candidate successful in Phase 2 study (March 23)
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Company Description
Teva Pharmaceutical Industries Ltd develops, produces and markets generic, branded & OTC medicines. Some of its products are Copaxone, Azilect & Provigil.
Sector: Healthcare
Country: Israel