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)
Tue, Feb. 17, 7:38 AM
- The U.S. District Court for the District of New Jersey rules that AstraZeneca's (NYSE:AZN) patent No. 7,524,834 (the '834 patent) protecting Pulmicort Respules is invalid. The patent, set to expire in 2018 and with pediatric exclusivity extending into 2019, will allow Actavis (NYSE:ACT) to release its generic version of the product. Teva Pharmaceutical Industries (NYSE:TEVA) has marketed a generic formulation for some time per a previous agreement with AstraZeneca.
- The court originally invalidated the '834 patent in April 2013 but the ruling was reversed and remanded in October 2013 by the U.S. Court of Appeals for the Federal Circuit.
- The company says the decision will not impact its 2015 guidance. Pulmicort generated $269M in sales in Q4 and $946M over the past 12 months. EVP, North America Paul Hudson says, "AstraZeneca strongly disagrees with the Court's decision. [The Company] has full confidence in the strength of its intellectual property rights protecting Pulmicort Respules. We are reviewing the decision and considering our legal options, including an appeal."
- Shares are down 1.5% premarket on light volume.
Fri, Feb. 13, 11:22 AM
- The FDA accepts for review Pfizer's (PFE -0.1%) New Drug Application (NDA) for ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
- ALO-02 incorporates abuse-deterrent technology. The capsules contain pellets consisting of the opioid, oxycodone, surrounding sequestered naltrexone hydrochloride, an opioid receptor antagonist. When used as directed, patients receive oxycodone in an extended release manner with no effect from the naltrexone. If the pellets are crushed in an attempt to misuse or abuse ALO-02, naltrexone is released, counteracting the effects of oxycodone.
- Related tickers: (ZGNX +1.8%)(MNK +1.8%)(ACT +1.1%)(TEVA -0.6%)(ABBV +1%)(LCI -1%)(ALKS -3.7%)
Thu, Feb. 12, 11:37 AM
- Teva Pharmaceutical Industries (TEVA +0.3%) initiates a $1B debt offering consisting of the following series of notes:
- Priority 1: 6.15% Senior Notes due 2036; Priority 2: 3.65% Senior Notes due 2021; Priority 3: 2.95% Senior Notes due 2022 and 2.40% Senior Notes due 2016.
- The offer will expire at 11:59 pm ET on March 12.
- The company is selling the debt in order to lower its overall interest expense.
Thu, Feb. 5, 3:23 PM
- The resignation of prominent healthcare investor/entrepreneur Dr. Phillip Frost, M.D., from Teva Pharmaceutical Industries' (TEVA +1.8%) Board of Directors prompts aggressive buying from speculators who think a potential deal is afoot with Opko Health (OPK +4.6%). Teva is up on 50% higher volume while Opko's turnover is 3x average.
Thu, Feb. 5, 9:20 AM| 1 Comment
Thu, Feb. 5, 7:58 AM
- Teva Pharmaceutical Industries (NYSE:TEVA) Q4 results ($M): Total Revenues: 5,168 (-4.8%); Generic Medicine: 2,469 (-7.9%); Specialty Medicine: 2,243 (+1.3%); Other: 456 (-14.9%); U.S.: 2,808 (+0.8%); Europe: 1,387 (-13.3%); ROW: 973 (-6.8%).
- COGS: 2,279 (-10.1%); R&D Expense: 379 (-7.8%); SG&A Expense: 1,006 (-11.1%); Net Income: 687 (+80.8%); EPS: 0.80 (+77.8%); CF Ops: 1,752 (+114.7%); Quick Assets: 2,226 (+114.5%).
- Gross Profit: 2,889 (-0.2%); COGS: 44.1% (-5.6%); Gross Margin: 55.9% (+4.9%); Operating Earnings: 1,504 (+11.3%); Operating Earnings Yield: 29.1% (+17.0%); Net Earnings Yield: 13.3% (+90.0%).
- Key Product Sales: Copaxone: 1,121 (-1.8%); Azilect: 108 (+10.2%); Nuvigil: 105 (+38.2%); Treanda: 226 (+27.7%); ProAir: 120 (+5.3%); Qvar: 77 (-13.5%); Women's Health: 115 (-9.4%).
Thu, Feb. 5, 7:03 AM
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