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June 12, 2013 - Jerusalem And Lund, Sweden

· Laquinimodshowed additive effect in improving renal function when combined with thestandard of care treatment· Results provide rationale for further studies of laquinimodin active lupus nephritis to confirm the safety and efficacy profileobserved in this study

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) and Active Biotech(NASDAQ OMX NORDIC: ACTI) announced today the results of a Phase IIa studyof oral laquinimod designed to assess safety, tolerability and clinicalefficacy in patients with active lupus nephritis, one of the mostserious manifestations of systemic lupus erythematosus (SLE orlupus)that can lead to chronic kidney failure(1). Treatment withlaquinimod provided an additive effect in improving renal functionwhen combined with current standard of care for active lupus nephritis(mycophenolate mofetil and corticosteroids), compared with standard ofcare alone. The data will be presented during the European League AgainstRheumatism (EULAR) Annual European Congress of Rheumatology in Madrid,12-15 June, 2013 as part of the late-breaking news session.

"The favorable trends towards laquinimod treatment in the renalend-points, coupled with the safety and tolerability profile,provide a rationale for further Phase III clinical studies," saidPrincipal Investigator Dr. David Jayne, Vasculitis and Lupus Clinic,Addenbrooke's Hospital, Cambridge.

"The results from this clinical study further our understanding ofhow the immunomodulatory profile of laquinimod may benefit patients withlupus," said Dr. Michael Hayden, President of Global R&D and ChiefScientific Officer of Teva. "The development program for laquinimod,which also includes clinical studies for other auto-immune disorderslike multiple sclerosis and Crohn's disease, underscores Teva'scontinued commitment to bringing innovative and differentiated medicinesto improve patients' lives."

The clinical trial, NCT01085097, was a multicenter, double-blind,placebo-controlled, exploratory study of 46 patients with active lupusnephritis that evaluated oral laquinimod (0.5 and 1mg/day) versus placeboin combination with standard of care treatment. The study showed that at 24weeks, 62.5% of patients with active lupus nephritis who received0.5mg/day of laquinimod achieved renal response, compared to 33.3% ofpatients who were administered placebo. Renal response is a compositeend point that measures several parameters of renal improvement.

Reported adverse events (AEs) were comparable in both the activetreatment and placebo patient groups. Serious AEs were reported in 12patients (four in each treatment group) and were attributed toinfection, thromboembolic events or lupus-related complications. One deathoccurred in the active treatment arm due to pan-lobar pneumonia & sepsisin a patient with advanced disease. The death was not attributed to thestudy drug.

A larger clinical trial of laquinimod in combination with standard ofcare (mycophenolate mofetil and corticosteroids), compared to standard ofcare alone, is planned in patients with lupus nephritis to furtherevaluate the safety and efficacy profile observed in study NCT01085097.

Lupus is a chronic and often disabling autoimmune disease. An estimatedfive million people worldwide, including 1.5 million Americans, havea form of lupus.(2) Most people who are affected by lupus are women ofchildbearing age, who suffer from symptoms including intense fatigue andexhaustion, joint pain, thinking and memory problems and skin rashes.(3)Lupus is two to three timesmore common among people of African, Hispanic, Caribbean and Asianorigin.(2) Many patients fail to respond or respond only partially to thecurrent standard of care treatments.(4)


Laquinimod is an oral, investigational, CNS-active immunomodulator with anovel mechanism of action being developed for the treatment ofrelapsing-remitting multiple sclerosis (MS). Laquinimod showed efficacy inanimal models for both MS and Lupus Nephritis. The global Phase IIIclinical development program evaluating oral laquinimod in MSincludes two pivotal studies, ALLEGRO and BRAVO. A third Phase IIIlaquinimod trial, CONCERTO, is evaluating two doses of the investigationalproduct (0.6mg and 1.2mg) in approximately 1,800 patients for up to 24months. The primary outcome measure will be confirmed disabilityprogression as measured by the Expanded Disability Status Scale (EDSS).


Systemic Lupus Erythematosus (SLE) is an autoimmune disease, in which thebody's immune system turns on itself, attacking healthy tissue, which canlead to chronic inflammation and damage to various body tissues. SLE canaffect many parts of the body, including joints, skin, kidneys, heart,lungs, blood vessels and the brain. Although people with SLE may experiencedifferent symptoms, some of the more common symptoms include extremefatigue, painful or swollen joints (arthritis), unexplained fever, skinrashes and kidney problems.(5) SLE can be severe and life threatening.(6)


Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) is a leading globalpharmaceutical company, committed to increasing access to high-qualityhealthcare by developing, producing and marketing affordable generic drugsas well as innovative and specialty pharmaceuticals and activepharmaceutical ingredients. Headquartered in Israel, Teva is the world'sleading generic drug maker, with a global product portfolio of more than1,000 molecules and a direct presence in about 60 countries. Teva's brandedbusinesses focus on CNS, oncology, pain, respiratory and women's healththerapeutic areas as well as biologics. Teva currently employsapproximately 46,000 people around the world and reached $20.3 billion innet revenues in 2012.


Active Biotech AB (NASDAQ OMX NORDIC: ACTI) is a biotechnology companywith focus on autoimmune/inflammatory diseases and cancer. Projects inpivotal phase are laquinimod, an orally administered smallmolecule with unique immunomodulatory properties for the treatment ofmultiple sclerosis, TASQ for prostate cancer and ANYARA primarily for thetreatment of renal cell cancer. In addition, laquinimod is in Phase IIdevelopment for Crohn's and Lupus. The company also has one additionalproject in clinical development, the orally administered compound57-57 for Systemic Sclerosis. Please visit www.activebiotech.comfor more information.

Teva's Safe Harbor Statement under the U. S. Private SecuritiesLitigation Reform Act of 1995:

This release contains forward-looking statements, which express thecurrent beliefs and expectations of management. Such statementsare based on management's current beliefs and expectations and involve anumber of known and unknown risks and uncertainties that could cause ourfuture results, performance or achievements to differ significantlyfrom the results, performance or achievements expressed or implied bysuch forward-looking statements. Important factors that could cause orcontribute to such differences include risks relating to: our abilityto develop and commercialize additional pharmaceutical products,competition for our innovative products, especiallyCopaxone®(including competition from innovative orally-administeredalternatives, as well as from potential purported generic equivalents),competition for our generic products (including from otherpharmaceutical companies and as a result of increased governmentalpricing pressures), competition for our specialty pharmaceuticalbusinesses, our ability to achieve expected results through our innovativeR&D efforts, the effectiveness of our patents and other protections forinnovative products, decreasing opportunities to obtain U.S. marketexclusivity for significant new generic products, our ability toidentify, consummate and successfully integrate acquisitions, theeffects of increased leverage as a result of recent acquisitions,the extent to which any manufacturing or quality control problemsdamage our reputation for high quality production and require costlyremediation, our potential exposure to product liability claims to theextent not covered by insurance, increased government scrutiny in boththe U.S. and Europe of our agreements with brand companies, potentialliability for sales of generic products prior to a final resolution ofoutstanding patent litigation, including that relating to the genericversion of Protonix®, our exposure to currency fluctuations andrestrictions as well as credit risks, the effects of reforms in healthcareregulation and pharmaceutical pricing and reimbursement, any failures tocomply with complex Medicare and Medicaid reporting and paymentobligations, governmental investigations into sales and marketingpractices (particularly for our specialty pharmaceutical products),uncertainties surrounding the legislative and regulatory pathways for theregistration and approval of biotechnology-based products, adverse effectsof political or economical instability, corruption, major hostilities oracts of terrorism on our significant worldwide operations, interruptionsin our supply chain or problems with our information technology systemsthat adversely affect our complex manufacturing processes, any failure toretain key personnel or to attract additional executive and managerialtalent, the impact of continuing consolidation of our distributors andcustomers, variations in patent laws that may adversely affect ourability to manufacture our products in the most efficient manner,potentially significant impairments of intangible assets and goodwill,potential increases in tax liabilities, the termination or expiration ofgovernmental programs or tax benefits, environmental risks and otherfactors that are discussed in our Annual Report on Form 20-F for the yearended December 31, 2012 and in our other filings with the U.S.Securities and Exchange Commission. Forward-looking statements speak onlyas of the date on which they are made and the Company undertakes noobligation to update or revise any forward-looking statement, whether as aresult of new information, future events or otherwise.

Active Biotech's Safe Harbor Statement in Accordance with the SwedishSecurities Market Act:

This press release contains certain forward-looking statements. Suchforward-looking statements involve known and unknown risks, uncertaintiesand other important factors that could cause the actual results,performance or achievements of the company, or industry results, to differmaterially from any future results, performance or achievement implied bytheforward-looking statements. The company does not undertake any obligationto update or publicly release any revisions to forward-looking statementsto reflect events, circumstances or changes in expectations after the dateof this press release.

Active Biotech is obligated to publish the information contained in thispress release in accordance with the Swedish Securities Market Act. Thisinformation was provided to the media for publication 2:00 p.m. CET on June12, 2013.

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References:1. MedlinePlus. National Library of Medicine National Institutes ofHealth. Lupus nephritis. Available at: Accessed April18, 2013.

2. U.S. Department of Health and Human Services Office of MinorityHealth. Lupus Data/Statistics. Available at: April 18, 2013.

3. Lupus Research Institute. About Lupus. Available at: Accessed April 18, 2013.

4. Study Protocol 201; March 9, 2011; p 21.

5. National Institutes of Health, National Institute of Arthritis andMusculoskeletal and Skin Diseases. Handout on Health: Systemic LupusErythematosus. August 2011. Available at: Accessed April 19, 2013.

6. Bernatsky S, Bovin J-F, Joseph L, et al. Mortality in systemiclupus erythematosus. Arthritis Rheum 2006;54:2550-7.


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Source: Active Biotech via Thomson Reuters ONE[HUG#1708272]

IR Contacts:
Kevin C. Mannix
United States
215) 591-8912

Tomer Amitai
972 (3) 926-7656

PR Contacts:
Iris Beck-Codner
972 (3) 926-7687

Denise Bradley
United States
215) 591-8974

Active Biotech:
Tomas Leanderson
Active Biotech AB

Hans Kolam
Active Biotech AB


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