Tue, Mar. 24, 4:52 PM
- Teva Pharmaceutical Industries (NYSE:TEVA) subsidiary Teva Pharmaceutical Finance Netherlands II B.V. issues €2B in senior notes in two tranches: €1.3B 1.250% senior notes due March 2023 at €990.01/€1,000 principal amount and €700M 1.875% senior notes due 2027 at €995.01/€1,000 principal amount.
- Net proceeds will be used for general corporate purposes.
Mon, Mar. 23, 12:25 PM
- A Phase 2b clinical trial evaluating Teva Pharmaceutical Industries' (TEVA +1.3%) TEV-48125 for the prevention of high frequency episodic migraine (8 - 14 days of headache per month) met its primary and secondary endpoints achieving significant reductions in mean monthly migraine days and monthly headache days compared to baseline. Full results will be presented at a future scientific meeting.
- The 297 patients in the randomized, double-blind, placebo-controlled, parallel group study received an injection of either low or high dose TEV-48125 or placebo once per month for three months. They were allowed to continue their existing migraine prevention therapy.
- TEV-48125 is the first therapy to demonstrate efficacy in both chronic, based on earlier results in this setting, and episodic migraine, and at multiple doses. It is a monoclonal antibody that binds to calcitonin gene-related peptide (CGRP), a well-validated target in migraine.
- Teva intends to advance TEV-48125 to Phase 3 development.
Wed, Mar. 18, 7:45 AM
- Two 24-week Phase 3 trials (PINNACLE 1 & 2) evaluating AstraZeneca's (NYSE:AZN) PT003 in patients with chronic obstructive pulmonary disease (COPD) achieved their primary efficacy endpoints of statistically significant improvement in lung function compared to placebo.
- PT003 is a twice-daily fixed-dose combination of glycopyrronium, a long-acting muscarinic antagonist (LAMA) and formoterol fumarate, a long-acting beta-2 agonist (LABA). It is the first LAMA/LABA combination to be delivered in a pressurized metered dose inhaler using the porous particle co-suspension technology developed by Pearl Therapeutics, which AZN acquired in 2013. The successful outcomes of the PINNACLE studies are the first from a series of pipeline candidates using Pearl's technology.
- PT003 was assessed in over 3,700 patients in over 275 study sites. The primary efficacy endpoint was trough forced expiratory volume in one second (FEV1). PT003 demonstrated statistically significant improvements in FEV1 versus placebo and the individual components glycopyrronium (PT001) and formoterol fumarate (PT005). PT001 and PT005 also showed statistically significant improvements in FEV1 compared to placebo.
- The company plans to file regulatory applications beginning this year. It will present the study results at a scientific meeting later this year.
- Related tickers: (NYSE:GSK) (NASDAQ:THRX) (NYSE:NVS) (NASDAQ:REGN) (NYSE:SNY) (NYSE:TEVA) (OTCQX:RHHBY)
Tue, Mar. 17, 4:37 PM
- Ignyta (NASDAQ:RXDX) acquires the worldwide rights and assets to four oncology development programs from Teva Pharmaceutical Industries (NYSE:TEVA) for 1.5M shares of Ignyta stock (6% stake).
- Concurrently, the companies entered into a stock purchase agreement whereby Teva will buy an additional 1.5M shares of RXDX at $10 per share. Other investors will buy an additional 2.7M RXDX shares also at $10, valuing the total offering at $41.6M.
- The four programs bought by Ignyta are: CEP-32496 (RXDX-105) - a Phase 1/2 small molecule inhibitor of BRAF, EGFR and RET; CEP-40783 (RXDX-106) - a preclinical pseudo-irreversible inhibitor of AXL and cMET; CEP-40125 (RXDX-107) - a preclinical nanoformulation of modified bendamustine and TEV-44229 (RXDX-108) - a preclinical selective inhibitor of the atypical kinase RKCiota plus next generation PKCiota inhibitors.
- Ignyta Chairman & CEO Jonathan Lim, M.D., says, "Acquiring these four development stage programs from Teva is truly transformational for Ignyta and well aligned with our strategic focus on developing first-in-class and best-in-class precision medicines to help cancer patients with unmet needs."
- RXDX is up 31% after hours on light volume.
Wed, Mar. 11, 10:01 AM
- Based on feedback from the FDA, Egalet (EGLT) now plans to submit a New Drug Application (NDA) for its abuse-deterrent, extended-release oral morphine product, Egalet-001, by the end of the year.
- The company will initiate a pivotal bioequivalence study comparing the 60 mg dose to Purdue's MS Contin later this month. Bioequivalence to MS Contin has already been demonstrated at the 15 mg and 30 mg doses.
- Egalet-001 incorporates the company's Guardian Technology to deter abuse. It utilizes injection molding to create a hard matrix and shell that is designed to be difficult to crush, grind, chew or dissolve. It also turns to gel when exposed to water.
- Related tickers: (ZGNX -23.4%)(ACUR)(ALKS +0.5%)(PFE +0.6%)(ABBV +0.7%)(LCI +1.6%)(ACT +1.7%)(MNK +1.6%)(TEVA +2.6%)
Tue, Mar. 10, 8:01 AM
- Privately-held Collegium Pharmaceutical raises $50M from institutional investors to fund the advancement of its abuse-deterrent product candidate, Xtampa ER (oxycodone extended-release capsules) through FDA clearance and commercial launch as well as fund operational growth and other pipeline programs.
- The FDA accepted the company's New Drug Application (NDA) for Xtampa ER in February. Its abuse-deterrent technology is called DETERx, which combines oxycodone with fatty acid and waxes to form small spherical beads which resist particle size reduction and dose dumping when subjected to breaking, crushing, chewing and dissolving.
- Previously: FDA accepts Collegium's NDA for abuse-deterrent opioid (Feb. 17)
- Related tickers: (NASDAQ:ZGNX) (NYSE:MNK) (NYSE:ACT) (NYSE:TEVA) (NYSE:ABBV) (NYSE:LCI) (NASDAQ:ALKS) (NASDAQ:EGLT) (NYSE:PFE) (NASDAQ:ACUR)
Tue, Mar. 10, 7:29 AM
- Vivus (NASDAQ:VVUS) receives notice from Teva Pharmaceutical Industries (NYSE:TEVA) that it has filed an Abbreviated New Drug Application (ANDA) with the FDA for a generic version of Qsymia (phentermine and topiramate extended release). The company is currently reviewed the notice but a patent infringement lawsuit will surely be initiated considering its suit against Actavis (NYSE:ACT) for its ANDA submission. Once filed, there is an automatic 30-month stay of regulatory clearance to allow for the legal process to play out.
- Previously: Vivus sues Actavis over generic version of Qsymia (March 9)
Wed, Mar. 4, 8:23 AM
- Based on the findings of an independent advisory panel, the FDA issues a formal announcement that restricts testosterone drug makers from promoting their products for age-related low testosterone, an ever-increasing target of prescriptions. The number of men being prescribed testosterone jumped over 75% between 2009 and 2013.
- The agency asks (not really a request) manufacturers to change their labeling to clarify that their products are only approved for men with specific medical conditions and that taking the drugs could increase their risk of heart attacks and strokes.
- The agency also requests that manufacturers of approved products, including skin patches, solutions, intramuscular injections and topical gels, conduct studies to determine if their treatments increase cardiovascular risk.
- Last year, the FDA mandated that testosterone product makers update their labeling to include a warning about the risk of blood clots.
- Related tickers: (NYSE:ABBV) (NASDAQ:ENDP) (NYSE:LLY) (NASDAQ:ATRS) (NASDAQ:RPRX) (NASDAQ:LPCN) (NYSE:TEVA) (NASDAQ:AUXL)
Mon, Mar. 2, 11:38 AM
- Pursuant to its previously announced cost reduction program, Teva Pharmaceutical Industries (TEVA -0.1%) divests its Sellersville, PA manufacturing facility to G&W Laboratories for an undisclosed sum.
- The transaction includes all buildings, land, equipment at the site. It also includes ~25 products from Teva's portfolio which will be manufactured and sold under the G&W label and exclusive rights to sell up to two additional Teva products in the U.S. under its own label, which Teva will produce at its Zagreb, Croatia site.
- Under the terms of the agreement, G&W will manufacture and supply products from the site to Teva until the latter can transfer them to other locations in its network.
- The deal is expected to close no later than April.
Thu, Feb. 26, 10:23 AM
- The European Commission approves Xadago (safinamide) for the treatment of idiopathic Parkinson's disease (PD). The drug was developed by Newron Pharmaceuticals S.p.A. and will be commercialized by privately-held Zambon S.p.A., both based in Italy.
- Xadago's specific indication is for the treatment of mid-to-late stage fluctuating patients as add-on therapy to a stable dose of Levodopa (L-dopa) alone or in combination with other PD medicines.
- Safinamide is a new chemical entity, the first approved in Europe in 10 years for PD, with a unique mode of action including selective and reversible MAO-B (monoamine oxidase) inhibition, use-dependent Na (sodium) channels blockade and Ca (calcium) channels modulation which enables it to modulate abnormal glutamate release. Glutamate is an important neurotransmitter that plays a key role in neural activation.
- PD-related tickers: (SNY -2.9%)(ABBV -0.2%)(IPXL -0.5%)(NDRM +1.2%)(XNPT)(OTCPK:BIOZF)(ACOR -1.6%)(OTCQX:RHHBY -0.4%)(PRTA -3.4%)(ADMS -2.5%)(TEVA)(OTCQX:CYNAF -0.9%)(OTCQB:TTNP +2.9%)
Wed, Feb. 25, 9:42 AM
- The FDA accepts for review the New Drug Application (NDA) from Teva Pharmaceutical Industries (TEVA -0.6%) for CEP-33237, its hydrocodone bitartrate extended release tablets for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment.
- The product is formulated with its proprietary abuse-deterrent technology, although it does not specify the nature of the technology or how it works. In an oral human abuse liability study (HAL) in nondependent recreational opioid users, the abuse potential of finely crushed CEP-33237 powder was significantly lower based on peak at-the-moment drug liking. An intranasal HAL study produced the same result.
- Related tickers: (ZGNX -0.6%)(EGLT)(OTCQB:ELTP)(PFE -0.7%)(ACUR)(MNK -0.6%)(ACT +0.7%)(ABBV -0.6%)(LCI +1%)(ALKS -1.7%)
Tue, Feb. 24, 10:18 AM
- A Phase 2b clinical trial evaluating Teva Pharmaceutical Industries' (TEVA +0.3%) investigational anti-calcitonin gene-related peptide (CGRP) monoclonal antibody, TEV-48125, for the prevention of chronic migraine (migraine with headache on at least 15 days per month) achieved its primary and secondary efficacy endpoints at one and three months.
- The results showed a significant and clinically relevant reduction in both the number of monthly cumulative headache hours and the number of headache days of at least moderate severity, compared to baseline.
- The trial compared two doses of TEV-48125 to placebo in 261 patients, 172 receiving TEV-48125. Full results from the study will be presented at an upcoming medical meeting and will be submitted to a peer-reviewed journal for publication. This is why the numerical results were not disclosed.
- Teva is developing TEV-48125 for the treatment of chronic migraine and high frequency episodic migraine. Data from a Phase 2b trial in the latter indication will be reported in Q2.
Tue, Feb. 17, 10:06 PM
- Elite Pharmaceuticals (OTCQB:ELTP) plans to commence a Phase 3 study in late March evaluating its abuse-deterrent opioid product candidate, ELI-200. The company has submitted a study protocol to the FDA and expects to receive its comments by mid-March. Patient dosing should start shortly thereafter.
- The multi-center, randomized, double-blind, placebo-controlled, parallel group clinical trial will assess the safety and efficacy of abuse-deterrent ELI-200 for the treatment of adult patients with moderate-to-severe pain following surgery. The study will enroll ~150 patients and will take ~eight weeks to complete.
- Elite projects submitting a New Drug Application (NDA) in Q3 and achieving regulatory clearance by early 2016.
- The company's abuse-deterrent technology is a multi-particulate capsule that contains an opioid agonist in addition to the opioid antagonist, naltrexone. If the multi-particulate beads are crushed or dissolved, the naltrexone is released which blocks the effects of the opioid. The technology is the firm's top priority, expected to add considerably to its modest revenues to date. Fiscal Q3's top line was only $1.4M.
- Related tickers: (NYSE:PFE) (NASDAQ:ACUR) (NASDAQ:ZGNX) (NYSE:MNK) (NYSE:ACT) (NYSE:TEVA) (NYSE:ABBV) (NYSE:LCI) (NASDAQ:ALKS) (NASDAQ:EGLT)
Tue, Feb. 17, 1:03 PM
- Teva Pharmaceutical Industries (TEVA +0.4%) launches its generic version of Sanofi's (SNY -0.6%) Lovenox (enoxaparin sodium injection) for the prophylaxis of deep vein thrombosis (DVT) and treatment of acute DVT. Lovenox generates ~$1.8B in U.S. sales.
- It also launches a generic version of Pfizer's (PFE -0.2%) Zyvox (linezolid) for the treatment of infections caused by Gram-positive bacteria. Zynox generates ~$465M in U.S. sales.
- As of January 22, Teva had 120 product registrations pending FDA approval, representing U.S. sales of over $86B.
Tue, Feb. 17, 10:05 AM
- Eagle Pharmaceuticals (EGRX +9.7%) and Teva Pharmaceutical Industries (TEVA +0.3%) enter into an exclusive license agreement for EP-3102, Eagle's bendamustine hydrochloride rapid infusion product for the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL).
- Teva will be responsible for all U.S. commercial activities while Eagle will manage all regulatory approvals, post-approval studies and, if necessary, initially supplying the product to Teva.
- Eagle has submitted a New Drug Application (NDA) to the FDA for rapid infusion bendamustine for both indications and has requested Priority Review for both of the Orphan Drug-designated uses.
- Under the terms of the agreement, Teva will waive its orphan drug exclusivities for NHL and CLL for EP-3102 to enable the product to come to market more quickly. Eagle will receive an upfront payment of $30M, up to $90M in future milestones and double-digit royalties on net sales.
- The companies will also settle the pending patent infringement litigation between them regarding Teva's U.S. Patent No. 8,791,270.
Tue, Feb. 17, 8:40 AM
- The FDA accepts for review the New Drug Application (NDA) from privately-held Canton, MA-based Collegium Pharmaceuticals for Xtampza ER, its abuse-deterrent extended-release oxycodone formulation for the treatment of chronic pain.
- Its abuse-deterrent technology is called DETERx, which preserves the extended-release properties following common methods of tampering. It also avoids the use of antagonists (Pfizer's (NYSE:PFE) ALO-02 and Embeda) and aversive agents (Acura's (NASDAQ:ACUR) AVERSION), thereby minimizing the risks to legitimate patients.
- Related tickers: (NASDAQ:ZGNX) (NYSE:MNK) (NYSE:ACT) (NYSE:TEVA) (NYSE:ABBV) (NYSE:LCI) (NASDAQ:ALKS) (NASDAQ:EGLT)
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