Lu AA24530 shows positive results in major depressive disorder phase
II study>
Lu AA24530 shows positive results in major depressive disorder phase II study
(Thomson Reuters ONE) - H. Lundbeck A/S (Lundbeck) today announced positive headline resultsfrom a dose finding clinical trial with the compound Lu AA24530 forthe treatment of major depressive disorder (MDD).The primary objective of the study was to compare the efficacy ofthree doses of Lu AA24530, 5, 10 and 20 mg, to that of placebo interms of change from baseline on the Montgomery- ÿsberg DepressionRating Scale (MADRS) total score after six weeks of treatment inpatients with MDD. Duloxetine was included as an active referencecompound in the trial.Lu AA24530 consistently produced statistically significantimprovements on the primary efficacy endpoint and on key secondaryendpoints. The active reference compound, duloxetine, also producedsignificant improvement compared to placebo, thereby validating thestudy. This trial also demonstrated that Lu AA24530 waswell-tolerated. Drop-out rates due to serious adverse events were lowin groups treated with Lu AA24530 and were similar to those ofduloxetine."These findings demonstrate the potential value of Lu AA24530 in thetreatment of major depressive disorders", says Executive VicePresident Anders Gersel Pedersen, Head of Drug Development atLundbeck. "We are pleased with the combination of efficacy and goodtolerability for Lu AA24530 which clearly supports the development ofthe compound as a future treatment option for physicians andpatients."About the studyThe clinical trial was the first study to test the efficacy of thedrug in patients with MDD. It was designed as a multicenter,double-blinded, dose-finding trial and included 652 patients withmajor depression. Three doses of Lu AA24530 that were predicted to beefficacious based on pre-clinical and phase I data were used in thetrial (5, 10 and 20 mg) and 60 mg duloxetine was used as activereference.The primary endpoint was the difference in change from baseline toend of treatment on the MADRS total score after six weeks of dailytreatment. The secondary endpoints included response rate, remissionrate, HAM-D17, Clinical Global Impression (CGI), quality of life andsafety and tolerability.Financial guidanceThe content of this release will have no influence on the LundbeckGroup's financial result for 2009.About Lu AA24530In pre-clinical studies, Lu AA24530 has demonstrated activities as amonoamine enhancer with reuptake inhibition at monoaminetransporters, and antagonist activity at 5-HT3 and 5-HT2c receptors.In vivo rat studies have demonstrated that treatment with Lu AA24530leads to increases in acetylcholine (ACh), noradrenaline (NA),dopamine (DA) and 5-HT levels in brain regions that play a key rolein the regulation of mood.About depressionDepression is a very common, debilitating illness affecting around121 million people worldwide. Major depression is not at allrecognised by society as the serious disorder it actually is. Thesymptoms of depression can be chronic or recurrent, and impactpatients both mentally and physically. Depression has a significantimpact on patient quality of life and imposes a considerable burdenon society, yet it is still under-recognised and under-treated.Symptoms include feelings of sadness, anxiety, loss of interest inactivities, decreased energy, impaired sleep, impaired concentration,hopelessness, guilt, persistent physical symptoms such as pain anddigestive disorders, and in more severe cases, suicidal thoughts andsuicide attempts.Takeda and Lundbeck allianceIn September 2007, H. Lundbeck A/S and Takeda Pharmaceutical CompanyLimited formed a strategic alliance for the exclusive co-developmentand co-commercialization in the United States and Japan of severalcompounds in Lundbeck's pipeline for the treatment of mood andanxiety disorders. The partnership initially focuses onco-development and co-commercialization of the two most advancedcompounds in Lundbeck's pipeline for mood and anxiety disorders, LuAA21004 and Lu AA24530. Once approved, the companies will co-promotethe products in the United States and Japan.Lundbeck contactsInvestors: Media:Jacob Tolstrup Mads KronborgDirector, IR & Communication Media Relations+45 36 43 30 79 +45 36 43 28 51Palle Holm OlesenHead of Investor Relations+45 36 43 24 26Magnus Thorstholm JensenInvestor Relations Officer+45 36 43 38 16About LundbeckH. Lundbeck A/S (LUN.CO, LUN DC, HLUKY) is an internationalpharmaceutical company highly committed to improve the quality oflife for people suffering from central nervous system (CNS)disorders. For this purpose Lundbeck is engaged in the research anddevelopment, production, marketing and sale of pharmaceuticals acrossthe world, targeted at disorders like depression and anxiety,schizophrenia, insomnia, Huntington's, Alzheimer's and Parkinson'sdiseases.Lundbeck was founded in 1915 by Hans Lundbeck in Copenhagen, Denmark,and employs today over 5,500 people worldwide. Lundbeck is one of theworld's leading pharmaceutical companies working with CNS disorders.In 2008, the company's revenue was DKK 11.3 billion (approximatelyEUR 1.5 billion or USD 2.2 billion). For more information, pleasevisit www.lundbeck.com.http://hugin.info/130085/R/1326803/312416.pdfThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
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Datum: 02.07.2009 - 07:00 Uhr
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