Teva Pharmaceutical: Bold Markets, Bold Moves
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Mon, Jan. 4, 11:33 AM
- The occurrence of an inordinate number of cardiovascular (CV) events in certain multiple sclerosis (MS) patients receiving higher daily doses of laquinimod prompts the independent Data Monitoring Committee (DMC) to recommend that Teva Pharmaceutical Industries (TEVA -0.9%) discontinue the dosing regimens in two clinical studies.
- Specifically, seven patients with relapsing-remitting MS in the 2,199-subject CONCERTO trial who were receiving 1.2 mg of laquinimod per day experienced CV events compared to zero CV events in the cohorts receiving 0.6 mg per day or placebo. One CV event was observed in the 191-subject ARPEGGIO study in primary-progressive MS in a patient receiving 1.5 mg of laquinimod per day.
- Both trials will continue the low dose (0.6 mg) arms. All participants will be provided an update to confirm their consent to continued treatment. The DMC did not identify a CV signal with the 0.6 mg dose but recommended long-term monitoring. Teva has completed large studies and is conducting long-term extension trials at the 0.6 mg dose and is not concerned about the CV risk at this strength.
- Laquinimod is a CNS-active immunomodulator under development for the treatment of relapsing-remitting MS, primary-progressive MS and Huntington's disease. Teva has global rights to the product candidate via a licence agreement with Active Biotech.
Mon, Jan. 4, 9:02 AM
- Teva Pharmaceutical Industries (NYSE:TEVA) secures an additional $658M in net proceeds from its previously announced equity offering via the full exercise of the underwriters over-allotment of 5.4M ADSs and 337.5K Mandatory Convertible Preferred Shares, increasing the company's take to $7.24B.
- Net proceeds will partially fund its acquisition of Actavis Generics, its acquisition of Rimsa and the repayment of debt.
- Previously: Teva prices equity $6.75B offering (Dec. 3, 2015)
Dec. 28, 2015, 7:05 AM
- The joint venture in Japan between Teva Pharmaceutical Industries (NYSE:TEVA) and Takeda Pharmaceutical (OTCPK:TKPHF)(OTCPK:TKPYY), originally announced in November, should commence sometime around April. Teva will own 51% via Teva Takeda Pharma while Takeda will own 49% via Teva Takeda Yakuhin, both established by an absorption-type company split.
- Takeda will transfer products representing 7% of its revenue to the venture, including BLOPRESS, TAKEPRON and BASEN. As a result, Takeda's 2016 revenue will decrease by ~50B yen.
- The deal will be both EPS and cash flow accretive for Takeda in 2016 and thereafter and will be accretive to Teva's non-GAAP EPS this year and beyond.
- Previously: Teva and Takeda form JV in Japan to drive generics business (Nov. 30)
Dec. 22, 2015, 7:54 AM
- Noting significant short interest and recent selloffs, analyst Randall Stanicky makes INSY and SGNT his top "out of consensus" picks for 2016. INSY's short interest is 46% of the float and SGNT's is 4.4%.
- Though M&A will continue next year, there will be greater deal scrutiny and fewer targets, and Stanicky favors the targets vs. the accretive acquirers.
- Mylan (NASDAQ:MYL) and Impax Labs (NASDAQ:IPXL) are seen as most likely to pursue "transformative" deals, while Teva (NYSE:TEVA), Perrigo (NYSE:PRGO), Sagent, Eagle (NASDAQ:EGRX), Depomed (NASDAQ:DEPO), and Endo (NASDAQ:ENDP) are likely to pursue bolt-on purchases.
- Most likely targets: Akorn (NASDAQ:AKRX) and Flexion (NASDAQ:FLXN).
- Top large-cap picks: Endo and Teva.
- Related: 45% Upside For 2016's Top Takeover Target (Dec. 1)
Dec. 14, 2015, 8:49 AM
- Egalet (NASDAQ:EGLT) grants exclusive marketing and commercialization rights for SPRIX (ketorolac tromethamine) Nasal Spray to Teva Pharmaceutical Industries (NYSE:TEVA) for the territory of Israel, Gaza and the West Bank. Under the terms of the agreement, Egalet will receive an undisclosed upfront payment, sales-based milestones and a portion of the profits.
- SPRIX Nasal Spray is a non-steroidal anti-inflammatory drug indicated for the short term (up to five days) management of moderate-to-severe pain in adult patients.
Dec. 14, 2015, 7:57 AM
- CTI BioPharma (NASDAQ:CTIC) receives a $10M milestone payment from Teva Pharmaceutical Industries (NYSE:TEVA) for the achievement of sales milestones for TRISENOX (arsenic trioxide). It is eligible to receive up to an additional $70M in sales and development milestones pursuant to an agreement with Cephalon, which Teva acquired in October 2011.
- TRISENOX is indicated for induction of remission and consolidation in patients with a certain genetic profile of acute promyelocytic leukemia (APL) who are refractory to or have relapsed from retinoid and anthracycline chemotherapy.
Dec. 10, 2015, 7:11 AM
- The FDA's Pulmonary-Allergy Drugs Advisory Committee voted 11-3 that Teva Pharmaceutical Industries' (NYSE:TEVA) reslizumab's safety profile supports approval for the relief of symptoms of asthma and the improvement in lung function in adult patients who are inadequately controlled on inhaled corticosteroids. It voted 13-1 that Teva provided substantial evidence of clinically meaningful benefit in patients at least 18 years old.
- The committee voted 14-0 against approval in adolescents aged 12-17, however, citing the lack of substantial evidence of a clinically meaningful benefit in this age group.
- There were four reported cases of anaphylaxis (potentially life-threatening allergic reaction) in the 3 mg/kg treatment group which could potentially trip up approval or affect the approved dosing range.
- Previously: Ad Comm tomorrow for Teva's asthma candidate reslizumab (Dec. 8)
Dec. 8, 2015, 4:21 PM
- The FDA's Pulmonary-Allergy Drugs Advisory Committee meets tomorrow to discuss Teva Pharmaceutical Industries' (NYSE:TEVA) Biologics License Application (BLA) seeking clearance of reslizumab to reduce exacerbations, relieve symptoms and improve lung function in patients at least 12 years old with asthma and elevated eosinophils who are inadequately controlled on inhaled corticosteroids.
- Reslizumab is a humanized monoclonal antibody that binds to interleukin-5 (IL-5), a cytokine that plays a key role in the activation and growth of eosinophils, a type of white blood cell that is elevated in the lungs and blood in many asthmatics. High levels of eosinophils correlate with disease severity so binding to IL-5 inhibits its ability to stoke eosinophil levels.
- FDA briefing doc
- FDA errata
- Teva briefing doc
- Teva addendum
- Draft questions
Dec. 8, 2015, 7:53 AM
- The FDA approves Eagle Pharmaceuticals' (NASDAQ:EGRX) Orphan Drug-tagged BENDEKA (bendamustine hydrochloride) for the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab (Roche's Rituxan) or a rituximab-containing regimen.
- Teva Pharmaceutical Industries (NYSE:TEVA) is responsible for commercialization in the U.S. under its February 2015 exclusive license agreement with Eagle. The launch will commence in Q1.
- Regulatory clearance triggers a $15M milestone payment from Teva. Eagle will also receive a royalty rate of 20% on BENDEKA net sales. Royalties may be stepped up based on the achievement of future sales-based milestones.
- Previously: FDA accepts Eagle Pharma's NDA for rapid infusion bendamustine (April 14)
Dec. 7, 2015, 3:07 PM
- The European Patent Office upholds the validity of Teva Pharmaceutical Industries' (TEVA +0.3%) European Patent No. 2405749 covering COPAXONE (glatiramer acetate) 40 mg/mL administered 3x per week. Generics firms Synthon, Actavis and Mylan (MYL -1%) had challenged the patent on various grounds. The ruling is subject to appeal. Teva's patent expires in 2030.
Dec. 3, 2015, 11:53 AM
- According to sources close to the matter, Teva Pharmaceutical Industries (TEVA +2.2%) is currently divesting $1B in assets in order to address antitrust concerns related to its intended $40.5B acquisition of Allergan's (AGN -0.2%) generics business, Actavis Generics. The move will help ensure that the deal goes through in Q1 as planned.
- Previously: Teva to buy Allergan Generics for $40.5B (July 27)
Dec. 3, 2015, 6:48 AM
- Teva Pharmaceutical Industries (NYSE:TEVA) prices its public offering of 54M American Depositary Shares (ADSs), each representing one ordinary share, at $62.50 per ADS. It also prices its public offering of 3.375M 7.00% Mandatory Convertible Preferred Shares at $1,000 per share, each automatically converting to between 13.3333 and 16.0000 ADSs on December 15, 2018.
- Net proceeds of ~$3.29B each will help fund the cash portion of its previously announced acquisition of Allergan's (NYSE:AGN) generics business (Actavis Generics).
- Previously: Teva initiates equity offering in connection with Actavis Generics transaction (Nov. 30)
Nov. 30, 2015, 10:10 AM
- Teva Pharmaceutical Industries (TEVA -2.2%) commences concurrent offerings of $3.375B of American Depositary Shares (ADSs), each representing on Teva ordinary share, and $3.375B of Mandatory Convertible Preferred Shares. Final amounts of the securities will be determined based on market (and other) conditions. Terms of the convertibles are not disclosed.
- Net proceeds will help fund its previously announced $40.5B acquisition of Allergan's (AGN -1.7%) generics business.
Nov. 30, 2015, 6:51 AM
- Teva Pharmaceutical Industries (NYSE:TEVA) and Takeda Pharmaceutical (OTCPK:TKPHF)(OTCPK:TKPYY) form a joint venture in Japan with the aim of building a leadership position in the fast-growing generic medicines there. The government, trying to address the medical needs of its aging population, intends to reach 80% generic penetration in its drugs market by the end of fiscal year 2020.
- The new business, expected to start operating in Q2 2016, will leverage Teva's extensive generics portfolio with Takeda's brand presence and distribution capabilities. Teva will be the majority owner with a 51% stake while Takeda will own 49%.
Nov. 27, 2015, 10:43 AM
- The FDA's Psychopharmacologic Drugs Advisory Committee will meet on Tuesday, December 1, to review privately held Fabre-Kramer Pharmaceuticals' New Drug Application (NDA) for gepirone hydrochloride extended-release tablets for the treatment of major depressive disorder (MDD).
- FDA briefing doc
- Company briefing doc
- Draft questions
- MDD-related tickers: (OTCQB:VSTA)(OTCPK:OTSKY)(OTCPK:TKPYY)(NYSE:PFE)(NASDAQ:ALKS)(NASDAQ:AVNR)(NYSE:TEVA)(NASDAQ:SHPG)(NYSE:LLY)(NYSE:GSK)
Nov. 25, 2015, 7:44 AM
- Teva Pharmaceutical Industries (NYSE:TEVA) enters into a licensing and drug discovery agreement with Sosei Group's (OTCPK:SOLTF) Heptares Therapeutics for exclusive global rights to develop, manufacture and commercialize novel, small molecule calcitonin gene-related peptide (CGRP) antagonists discovered by Heptares for the treatment of migraine.
- Under the terms of the agreement, Heptares will receive an upfront payment of $10M, research funding, milestones up to $400M and royalties on commercial sales.
- Teva President of Global R&D and CSO Michael Hayden, M.D., Ph.D., says, "CGRP antagonism represents an exciting opportunity to treat migraine. We believe small molecule CGRP antagonists offer further opportunities that are highly complementary to our promising candidate, TEV-48125, an anti-CGRP antibody."
- About 36M Americans, 55M Europeans and 8M Japanese suffer from migraine.
Teva Pharmaceutical Industries Ltd. engages in the provision of pharmaceutical services. It operates through the following business divisions: Generic, Specialty Medicine, and Over-the-Counter (OTC). The Generic division involves the manufacture and sale of generic products such as tablets,... More
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