Teva and Active Biotech Announce Discontinuation of Higher Doses of Laquinimod in Two Multiple Sclerosis Trials
4.1.2016 15:01 | NASDAQ OMX
CONCERTO and ARPEGGIO Trials Continue Study of Lower-dose Laquinimod
Jerusalem & Lund, Sweden - January 4, 2016 - Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and Active Biotech (NASDAQ Stockholm: ACTI) today announced the discontinuation of higher doses of laquinimod in two ongoing studies in multiple sclerosis after the occurrence of cardiovascular events, none of which was fatal, in eight patients.
The change comes at the recommendation of the data monitoring committee (DMC) overseeing two active clinical studies in MS. The DMC identified an imbalance in the number of cardiovascular events in the studies. Seven events were observed in patients receiving laquinimod daily at 1.2mg for treatment of relapsing-remitting MS (RRMS) in the CONCERTO trial. No events occurred in the 0.6mg or placebo groups. CONCERTO has 2,199 patients with 3,070 years of patient experience. One event was observed in the 1.5mg daily-dose arm of the ARPEGGIO trial in primary-progressive MS (PPMS). ARPEGGIO has enrolled 191 patients and has 35 years of patient experience. Teva is notifying trial sites to discontinue the higher doses immediately in both trials and will encourage participants to continue follow ups.
Both trials, CONCERTO and ARPEGGIO, are continuing the lower-dose arms (0.6mg daily), and participants in the trials will be provided with an update to confirm re-consent for participation. The DMC did not identify a cardiovascular signal with the lower dose but recommended long-term monitoring. Teva has completed large trials and is conducting long-term extension studies at the 0.6mg dose currently without cardiovascular concerns.
Through a licensing agreement, Teva has global rights to develop and commercialize laquinimod, a small-molecule entity discovered by Active Biotech.
Laquinimod is a once-daily oral, investigational, CNS-active immunomodulator with a novel mechanism of action being developed for the treatment of relapsing-remitting MS (RRMS), primary-progressive MS (PPMS) and Huntington disease.
Details about clinical trials with laquinimod can be found at clinicaltrials.gov. Trials mentioned in this release and the clinicaltrials.gov reference number follow:
CONCERTO (RRMS) - NCT01707992
ARPEGGIO (PPMS ) - NCT02284568
ALLEGRO extension (RRMS) - NCT00988052
BRAVO extension (RRMS) - NCT01047319
LAQ/5063-OL (RRMS) - NCT00745615
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions to millions of patients every day. Headquartered in Israel, Teva is the world's largest generic medicines producer, leveraging its portfolio of more than 1,000 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has a world-leading position in innovative treatments for disorders of the central nervous system, including pain, as well as a strong portfolio of respiratory products. Teva integrates its generics and specialty capabilities in its global research and development division to create new ways of addressing unmet patient needs by combining drug development capabilities with devices, services and technologies. Teva's net revenues in 2014 amounted to $20.3 billion. For more information, visit www.tevapharm.com.
About Active Biotech
Active Biotech AB (publ) (NASDAQ Stockholm: ACTI) is a biotechnology company with focus on neurodegenerative/inflammatory diseases and cancer. Laquinimod, an orally administered small molecule with unique immunomodulatory properties, is in pivotal phase III development for the treatment of relapsing-remitting multiple sclerosis. Also, laquinimod is in phase II development for the treatment of primary-progressive multiple sclerosis and Huntington disease. Furthermore, commercial activities are ongoing for the projects ISI, ANYARA and paquinimod. Please visit www.activebiotech.com for more information.
Teva's Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995:
This release contains forward-looking statements, which are based on management's current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to develop and commercialize additional pharmaceutical products; competition for our specialty products, especially Copaxone® (including competition from orally-administered alternatives, as well as from generic equivalents such as the recently launched Sandoz product) and our ability to continue to migrate users to our 40 mg/mL version and maintain patients on that version; our ability to identify and successfully bid for suitable acquisition targets or licensing opportunities (such as our pending acquisitions of Allergan's generic business and Rimsa), or to consummate and integrate acquisitions; the possibility of material fines, penalties and other sanctions and other adverse consequences arising out of our ongoing FCPA investigations and related matters; our ability to achieve expected results from the research and development efforts invested in our pipeline of specialty and other products; our ability to reduce operating expenses to the extent and during the timeframe intended by our cost reduction program; the extent to which any manufacturing or quality control problems damage our reputation for quality production and require costly remediation; increased government scrutiny in both the U.S. and Europe of our patent settlement agreements; our exposure to currency fluctuations and restrictions as well as credit risks; the effectiveness of our patents, confidentiality agreements and other measures to protect the intellectual property rights of our specialty medicines; the effects of reforms in healthcare regulation and pharmaceutical pricing, reimbursement and coverage; governmental investigations into sales and marketing practices, particularly for our specialty pharmaceutical products; adverse effects of political or economic instability, major hostilities or acts of terrorism on our significant worldwide operations; interruptions in our supply chain or problems with internal or third-party information technology systems that adversely affect our complex manufacturing processes; significant disruptions of our information technology systems or breaches of our data security; competition for our generic products, both from other pharmaceutical companies and as a result of increased governmental pricing pressures; competition for our specialty pharmaceutical businesses from companies with greater resources and capabilities; the impact of continuing consolidation of our distributors and customers; decreased opportunities to obtain U.S. market exclusivity for significant new generic products; potential liability in the U.S., Europe and other markets for sales of generic products prior to a final resolution of outstanding patent litigation; our potential exposure to product liability claims that are not covered by insurance; any failure to recruit or retain key personnel, or to attract additional executive and managerial talent; any failures to comply with complex Medicare and Medicaid reporting and payment obligations; significant impairment charges relating to intangible assets, goodwill and property, plant and equipment; the effects of increased leverage and our resulting reliance on access to the capital markets; potentially significant increases in tax liabilities; the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business; variations in patent laws that may adversely affect our ability to manufacture our products in the most efficient manner; environmental risks; and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2014 and in our other filings with the U.S. Securities and Exchange Commission.
Active Biotech's Safe Harbor Statement in Accordance with the Swedish Securities Market Act
This press release contains certain forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause the actual results, performance or achievements of the company, or industry results, to differ materially from any future results, performance or achievement implied by the forward-looking statements. The company does not undertake any obligation to update or publicly release any revisions to forward-looking statements to reflect events, circumstances or changes in expectations after the date of this press release.
Active Biotech is obligated to publish the information contained in this press release in accordance with the Swedish Securities Market Act and/or the Financial Instruments Trading Act. This information was provided to the media for publication at 15:00 CET on Jan 4, 2016.
|IR Contacts:||Kevin C. Mannix||United States||(215) 591-8912|
| United States
| (215) 591-3033
972 (3) 926-7656
|PR Contacts||Iris Beck Codner||Israel||972 (3) 926-7687|
| United States
| (215) 591-8974
|Active Biotech||Tomas Leanderson||Active Biotech AB||+46-46-19-20-95|
|Hans Kolam||Active Biotech AB||+46-46-19-20-44|
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Active Biotech via Globenewswire
Följ NASDAQ OMX
Skriv in din e-postadress så får du ett mejl när vi har något nytt att berätta.
Senaste pressmeddelandena från NASDAQ OMX
Nasdaq Welcomes I-AM Capital Acquisition Company (Nasdaq: IAMXU) to The Nasdaq Stock Market17.8.2017 18:50 | Pressmeddelande
NEW YORK, Aug. 17, 2017 (GLOBE NEWSWIRE) -- I-AM Capital Acquisition Company (Nasdaq:IAMXU), a blank check company formed for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization or similar business combination with one or more businesses, celebrated its initial public offering (IPO) on The Nasdaq Stock Market. I-AM Capital's founders, Chief Executive Officer F. Jacob Cherian and Chief Financial Officer Suhel Kanuga, have been focused on investing into India over the last decade, with the distinction of completing the first listed-SPAC investment in India. "Through our keen focus and unique accomplishments in India over the last decade, we have seen our investment thesis bear fruit: India's prominence and rise on the world stage, its distinction as being one of the fastest growing major economies of the world, and its strong vibrant consumer demographics. We believe these factors are aligning well now,
Tetraphase Pharmaceuticals Announces Submission and Validation of IV Eravacycline Marketing Authorization Application by European Medicines Agency17.8.2017 14:30 | Pressmeddelande
WATERTOWN, Mass., Aug. 17, 2017 (GLOBE NEWSWIRE) -- Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a clinical-stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug- resistant (MDR) infections, today announced that the Marketing Authorization Application (MAA) for IV eravacycline for the treatment of complicated intra-abdominal infections (cIAI) has been submitted and was validated by the European Medicines Agency (EMA). Eravacycline is a novel, fully-synthetic fluorocycline antibiotic being developed for the treatment of serious infections, including those caused by multidrug-resistant (MDR) pathogens. The MAA filing is based on data from the phase 3 IGNITE1 clinical trial in which eravacycline was well tolerated and demonstrated statistical non-inferiority to ertapenem using the primary endpoint of clinical response at the test-of-cure (TOC) visit. "The MAA filing represents a significant milestone for Tetraphase as it is our
RedHill Biopharma Announces U.S. Commercialization Agreement for FDA-Approved GI Product Esomeprazole Strontium Delayed-Release Capsules17.8.2017 13:00 | Pressmeddelande
RedHill was granted the exclusive rights to promote Esomeprazole Strontium Delayed-Release (DR) Capsules to gastroenterologists in certain U.S. territories Esomeprazole Strontium DR Capsules 49.3 mg is an FDA-approved, proprietary, prescription proton pump inhibitor (PPI), indicated for adults for the treatment of gastroesophageal reflux disease (GERD) and other gastrointestinal (GI) conditions RedHill expects to initiate the U.S. promotion of Esomeprazole Strontium DR Capsules 49.3 mg in the coming weeks Esomeprazole Strontium DR Capsules 49.3 mg will be the third commercial GI product to be promoted by RedHill in the U.S. RedHill's GI-focused sales force currently promotes two GI s
Brand Industrial Services Announces Agreement to Acquire Venko Groep BV16.8.2017 19:40 | Pressmeddelande
Complementary core strengths provide broader range of services for customers KENNESAW, GA, Aug. 16, 2017 (GLOBE NEWSWIRE) -- Brand Industrial Services, known as BrandSafway, has signed an agreement to acquire Venko Groep BV, a portfolio company of Mentha Capital. Venko will become a part of the Brand Energy & Infrastructure Services (Brand) group. "We are very pleased to announce the agreement with Venko," said Bill Hayes, President and CEO of BrandSafway. "Our combined customers in Europe will benefit from a broader range of solutions and greater depth of expertise in access, insulation and coatings. Bringing Venko's highly specialized knowledge in coatings to BrandSafway will provide the expertise we need to expand our services in the offshore market worldwide." Based in the Netherlands, with a focus on operations in the North Sea area, Venko is a leading offshore and onshore coatings maintenance provid
Abeona Therapeutics Announces Pivotal Expansion of ABO-102 Gene Therapy Clinical Trials in Sanfilippo Syndrome Type A16.8.2017 15:38 | Pressmeddelande
NEW YORK and CLEVELAND, Aug. 16, 2017 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq:ABEO), a leading clinical-stage biopharmaceutical company focused on developing novel gene therapies for life-threatening rare diseases, today announced the pivotal expansion of its gene therapy clinical trials for patients with MPS IIIA in the USA, Europe and Australia. "We have completed the necessary regulatory and ethical committee approvals and site initiations in Europe and Australia in order to accelerate enrollment," stated Juan Ruiz, M.D., Ph.D., Abeona's Chief Medical Officer. "We remain very encouraged by the improvements observed in clinically relevant biomarkers post-dosing of ABO-102, including durable reductions in heparan sulfate measured in the CNS, reduction of organ disease pathology, and signals of CNS improvement or stabilization at one-year follow-up in Cohort 1 subjects, and look forward to providing a more fulsome clinical update at important clinical
CallidusCloud Wins Eight Gold Stevies® in the 2017 International Business Awards16.8.2017 14:00 | Pressmeddelande
CallidusCloud Lead to Money suite recognized as Best B2B New Product of the Year. LeadRocket voted Best New Product or Service of the Year in the Software - Lead Generation Solution category. DUBLIN, Calif., Aug. 16, 2017 (GLOBE NEWSWIRE) -- Callidus Software Inc. (NASDAQ:CALD), a global leader in cloud-based sales, marketing, learning, and customer experience solutions, announced today that it was named the winner of eight Gold Stevie® awards in the 2017 International Business Awards. "The eight Stevie® awards earned highlight CallidusCloud's momentum, commitment to excellence, passion for innovation and customer orientation," said Leslie Stretch, president and CEO of CallidusCloud. "They also recognize the benefits that the Lead to Money suite, honored as the Best New Product in Business-to-Business, accrues to its customers in terms of enabling faster, bigger, and more profitable sales." CallidusCloud's Go
I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.Besök vårt pressrum