Yesterday, 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.
Thu, Nov. 19, 9:42 AM
- Top-line results from three Phase 3 clinical trials assessing Teva Pharmaceutical Industries' (TEVA +0.4%) fluticasone propionate/salmeterol, a combination inhaled corticosteroid and long-acting beta agonist delivered via a multidose dry powder inhaler, and fluticasone propionate as monotherapy delivered via the same inhaler in adolescent and adult patients with asthma showed all met their primary efficacy endpoints.
- The combo product demonstrated clinically relevant and greater improvement in lung function at all doses (50/12.5, 100/12.5, 200/12.5) compared to placebo and fluticasone propionate monotherapy as measured by the change from baseline in trough Forced Expiratory Volume in one second (FEV1) at week 12.
- Fluticasone propionate monotherapy demonstrated clinically relevant and greater improvement in lung function at all doses (50 mcg, 100 mcg, 200 mcg, twice per day) compared to placebo.
- Complete results will be presented at future scientific meetings. Regulatory submissions are planned for 2016.
Mon, Nov. 9, 10:48 AM
- The FDA designates Teva Pharmaceutical Industries' (TEVA -0.3%) SD-809 (deutetrabenazine) a Breakthrough Therapy for the treatment of patients with moderate-to-severe tardive dyskinesia, a disorder affecting ~500K Americans characterized by involuntary movements of the tongue, lips, face, trunk and extremities in patients on long-term dopamine-related therapy. There are no currently approved treatments for the condition.
- Breakthrough Therapy status provides for more intensive guidance on development from the FDA, the involvement of more senior agency personnel and a rolling review of the New Drug Application (NDA).
- 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.
- The company's NDA for chorea associated with Huntington disease is currently under FDA review.
Mon, Nov. 2, 3:46 PM
- Melbourne, Australia-based Mesoblast (OTCPK:MEOBF)(OTCPK:MBLTY) is set for its U.S. IPO of 5,742,510 American Depositary Shares at ~$12 per ADS. Each ADS represents five ordinary shares and will trade on the Nasdaq Global Select Market under the symbol "MESO."
- The regenerative medicine firm develops products based on mesenchymal lineage adult stem cells (MLCs). According to the company, it has the most advanced regenerative medicine portfolio in world, with five MLC product candidates in Stage 3 development (ongoing or planned). Its lead programs include MPC-150-IM for chronic heart failure (partnered with (TEVA +2.9%)); MPC-06-ID for chronic low back pain caused by disc degeneration; and TEMCELL/MSC-100-IV for acute graft versus host disease.
- F2015 Financials ($M): Revenues: 19.8 (-15.5%); Operating Expenses: 131.4 (+20.5%); Net Loss: (96.2) (-27.4%); CF Ops: (101.0) (-34.9%).
Sun, Nov. 1, 10:38 PM
- Alexza Pharmaceuticals (NASDAQ:ALXA) will reacquire the U.S. rights to ADASUVE (loxapine) inhalation powder from commercial partner Teva Pharmaceuticals (NYSE:TEVA) effective January 1. Teva apparently felt the going was a bit rough considering the comment below.
- Alexza CEO Thomas Kings says, "ADASUVE is an effective product. There are considerable challenges in launching a hospital product, especially one as complex as ADASUVE. We appreciate the efforts that Teva has made to date and are looking forward to continuing to build the ADASUVE brand. We remain confident in ADASUVE's long-term commercial prospects and plant to work with Teva to effect a smooth transition. It is our intention to work diligently in 2016 to identify a new U.S. commercial partner for ADASUVE."
- ADASUVE, approved by the FDA in December 2012, is indicated for the acute treatment of adults with agitation associated with schizophrenia or bipolar I disorder.
- Previously: Alexza Pharmaceuticals (ALXA) announces an exclusive U.S. license deal for Adasuve with Teva... (May 8, 2013)
Thu, Oct. 29, 9:56 AM
- Teva Pharmaceutical (TEVA +1.4%) Q3 results: Revenues: $4,823M (-4.6%); COGS: $2,052M (-8.8%); R&D Expense: $361M (-12.4%); SG&A: $1,096M (-11.8%); Operating Income: $1,010M (-9.2%); Net Income: $103M (-88.2%); EPS: $0.12 (-88.2%); Quick Assets: $928M (-58.3%).
- 2015 Guidance: Total Revenues: $19.4B - 19.6B from $19.0B - 19.4B; Gross Margin: 61.5% - 62.5% from 60.0 - 62.0% ; Non-GAAP EPS: $5.40 - 5.45 from $5.15 - 5.40.
Thu, Oct. 29, 7:25 AM
Wed, Oct. 28, 5:30 PM
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Wed, Oct. 28, 11:00 AM
Wed, Oct. 14, 10:10 AM
- The FDA approves Lannett's (LCI +0.6%) generic memantine hydrochloride oral solution 2 mg/mL, a therapeutic equivalent to Actavis' [now Teva's (NYSE:TEVA)] Namenda (memantine HCl), for the treatment of dementia associated with Alzheimer's disease.
- According to IMS, the wholesale market in the U.S. is ~$12M.
Mon, Oct. 12, 9:44 AM
- Teva Pharmaceutical Industries (TEVA -0.3%) launches its generic equivalent to Glaxo's (GSK -0.3%) Avodart (dutasteride) capsules, 0.5 mg, in the U.S. for the treatment of men with benign prostate hyperplasia (enlarged prostate). The company was the first to file so it will be exclusive for several weeks.
- According to IMS, Avodart generated almost $470M in sales over the 12-month period ending in July.
Thu, Oct. 1, 8:42 AM
- Teva Pharmaceutical Industries (NYSE:TEVA) acquires Mexico City-based Representaciones e Investigaciones Medicas, S.A. de C.V. (Rimsa) for $2.3B. The transaction establishes Teva as the leading pharma firm in Mexico and positions it for long-term growth in Latin America.
- Rimsa's revenues for 2014 were $227M with an annual top-line growth rate of over 10%.
- The deal, funded with cash on hand and lines of credit, should close in Q1. It is expected to be accretive to Teva's non-GAAP earnings starting Q1 2017.
- TEVA is up 2% premarket on average volume.
Wed, Sep. 30, 12:49 PM
- Bruised and battered biotech investors get some welcome buying today as bargain hunters open their wallets. The iShares Nasdaq Biotech Index Fund (IBB +2%) is up nicely, albeit on average volume.
- Key tickers: (AMGN +1.6%)(BIIB +2.5%)(GILD +1%)(CELG +0.7%)(DEPO +12.4%)(HZNP +8.6%)(NVO +0.7%)(AGN +4.9%)(VRX +6.4%)(REGN +0.9%)(TEVA +2%)(SHPG +2.6%)
Mon, Sep. 28, 4:53 PM
- Allergan (NYSE:AGN) says it will begin reporting its Global Generic business as discontinued operations in Q3, ahead of the closing of its deal with (NYSE:TEVA), which is expected to close in Q1 2016.
- Its forecast for H2 for continuing operations (U.S. Brands, U.S. Medical, International Brands and Anda distribution) calls for revenues greater than $8B, non-GAAP EBIT between $3.8B - 4.0B and non-GAAP EPS between $6.25 and 6.65.
- After the TEVA deal closes, the company expects 10% branded revenue per year, non-GAAP gross margins of 77 - 79%; non-GAAP SG&A as a percentage of revenue of 21 - 24% and a non-GAAP tax rate of ~15%.
Mon, Sep. 28, 7:53 AM
- The Japanese Ministry of Health, Labour and Welfare approves Teva Pharmaceutical Industries' (NYSE:TEVA) COPAXONE (glatiramer acetate injection) 20 mg for the prevention of relapse of multiple sclerosis (MS). The product will be commercialized there by Takeda Pharmaceutical (OTCPK:TKPHF) (OTCPK:TKPYY).
- COPAXONE is Teva's biggest seller by far, generating $4.2B in sales over the past four quarters.
Fri, Sep. 25, 9:38 AM
- Teva Pharmaceutical Industries (NYSE:TEVA) acquires Cambridge, MA-based Gecko Health Innovations for an undisclosed sum. Gecko creates smart solutions that help patients with chronic diseases to better manager their condition. With an initial focus on COPD and asthma, it has designed and built hardware and software solutions to collect and present important data in a high-value-added way using behavioral tools to promote better disease management. It launched CareTRx this year, which is a cloud-based solution designed to simplify chronic respiratory disease management via connecting patients and caregivers through remote monitoring and real-time adherence tools.
- The acquisition will allow Teva to explore innovative ways to apply the CareTRx technology to its pipeline and portfolio of respiratory products with the aim of improving clinical outcomes for patients.
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