CHICAGO, Ill., June 23 /PRNewswire/ — VeroScience, LLC, in conjunction with its commercialization partner S2 Therapeutics, Inc., reported today the results of its Phase IIIb clinical trial supporting the overall and cardiovascular safety of Cycloset(TM) (A quick release formulation of bromocriptine mesylate) in subjects with type 2 diabetes. The study, which highlighted a significant reduction in the risk of diabetic cardiovascular complications in subjects treated with Cycloset(TM) compared to placebo, also confirmed the drug’s ability to improve glycemic control in subjects failing metformin plus sulfonylurea therapy.
The data were presented by the principle investigator, J. Michael Gaziano, MD, MPH, Cardiologist at Brigham and Women’s Hospital and Veteran Affairs Boston Healthcare System, Boston, MA as a late-breaking poster at the 67th Scientific Sessions of the American Diabetes Association in Chicago, Ill. (June 22-26, 2007).
Cycloset(TM) is being investigated as a once-daily, timed oral therapy for type 2 diabetes that acts upon the central nervous system (CNS) to impact peripheral metabolism. The Phase IIIb trial was conducted in response to an approvable letter from the FDA requesting additional data on Cycloset(TM)’s cardiovascular safety.
The double-blind, multi-center trial’s 3,070 participants included subjects with type 2 diabetes between the ages of 30 and 80 with HbA1c less than or equal to 10.0 and BMI less than or equal to 43. Participants randomized into the study were all on a treatment regimen for their diabetes, which could include either diet alone, up to two oral hypoglycemic agents, insulin alone, or insulin with no more than one oral agent. Participants were randomized in a 2:1 ratio to Cycloset(TM) (2,054 subjects; titrated from 1.6 mg/day to a maximum tolerated dose of up to 4.8 mg/day) or placebo (1,016 subjects) and followed for 52 weeks. Primary and secondary endpoints were time to first all cause serious adverse event (SAE) and cardiovascular SAE, respectively; all SAEs were adjudicated by an independent review committee.
“This cohort was selected to provide a real-world view of the safety of Cycloset(TM) in a group of patients with diabetes receiving a wide variety of diabetes regimens,” said J. Michael Gaziano, MD, MPH. “We were particularly interested in assessing the potential of a cardiovascular benefit and we were excited to see that in this population and in a relatively short time period there were indications of a reduction in cardiovascular events among those treated with Cycloset(TM) compared to placebo.”
The rate of any serious adverse event was similar between Cycloset(TM) subjects (8.6%) and placebo subjects (9.6%). Furthermore, fewer subjects experienced a cardiovascular endpoint in the Cycloset(TM) arm (31 out of 2,054; 1.5%) compared to the placebo arm (31 out of 1,016; 3.0%). Results of the Cox regression revealed a 43% reduction in the cardiovascular endpoint, pre-specified as the composite of myocardial infarction, stroke, and hospitalization for either angina, congestive heart failure, or coronary revascularization surgery events (hazard ratio 0.57 and 95% confidence interval of 0.34 – 0.93; P = 0.025). The most frequently observed non-serious adverse events included nausea, dizziness, and fatigue.
Participants on a combined therapy of metformin and sulfonylurea with a baseline HbA1c greater than or equal to 7.5, indicating suboptimal glycemic control (mean baseline HbA1c of 8.3), were subjected to a pre-specified secondary analysis focused on Cycloset(TM)’s ability to reduce HbA1c after 24 weeks of therapy. Those receiving Cycloset(TM) and completing 24 weeks of therapy (121 subjects) experienced a mean HbA1c reduction of 0.69 (P = 0.0002) compared to respective placebo (71 subjects) and a mean HbA1c reduction from baseline of 0.67. Moreover 39% of these Cycloset(TM) subjects, versus 11% of these placebo subjects, reached the American Diabetes Association
Diabetes Association target goal of an HbA1c level of 7.0 (P = 0.0004). “Several decades of preclinical and clinical research have focused on investigating circadian neuroendocrine regulation of metabolism,
particularly in relation to metabolic disease states such as obesity, metabolic syndrome and type 2 diabetes,” said Anthony H. Cincotta, PhD, President and Chief Scientific Officer of VeroScience, LLC and a developer
of Cycloset(TM) and its platform technology along with Dr. Albert H. Meier.
“These study data build on our earlier investigations that suggested a beneficial impact of timed bromocriptine administration on cardiovascular risk factors apart from its influence on fasting glucose level.”
“With the favorable conclusion of this large one year safety study and additional information from other clinical studies, VeroScience intends to file an amended NDA with the FDA targeting late third or fourth quarter of 2007,” according to Richard E. Scranton, MD, MPH, Chief Medical Officer, VeroScience and co-principle investigator of the Cycloset(TM) Safety Trial.
Charles P. Sutphin, Co-chairman and CEO of S2 Therapeutics, Inc., holder of an exclusive global license for the manufacture, marketing, and distribution of Cycloset(TM), stated that “the commercial opportunity for
Cycloset(TM) has dramatically expanded with the outcome of this trial. As a result, we are exploring strategies for Cycloset(TM)’s commercialization opportunities both within North America and globally by partnering with a
large multinational pharmaceutical company.” Data presented at the 67th Scientific Sessions of the American Diabetes Association during the Clinical Therapeutics/New Technology – Pharmacologic
Treatment of Diabetes or its Complications and displayed Saturday, Sunday and Monday, June 23-25, in the General Poster Session: Poster # 50-LB, Effects of Timed Cycloset(TM) (A Quick Release Formulation of Bromocriptine Mesylate) Administration on Safety, Cardiovascular Event Rate, and Glycemic
Control in Subjects with Type 2 Diabetes Receiving Diet, Oral Hypoglycemic, and/or Insulin Treatment Regimens. JM Gaziano, M Ezrokhi, AH Cincotta, RE Scranton.
About Cycloset(TM) (A Quick Release Formulation of Bromocriptine Mesylate) Cycloset(TM) is an oral, quick-release formulation of bromocriptine, a centrally-acting dopamine D2 receptor agonist. When given as a single timed (morning) daily dose, Cycloset(TM) is believed to act on circadian neuronal
activities within the hypothalamus to reset abnormally elevated hypothalamic drive for increased plasma glucose, triglyceride, and free fatty acid levels in fasting and postprandial states in insulin resistant
subjects. Results of published clinical studies suggest that treatment with Cycloset(TM) may improve hyperglycemia, glucose intolerance, hyperlipidemia, or aspects of insulin resistance, while maintaining body
fat neutrality or inducing body fat reduction. Cycloset(TM) is currently under investigation as a potential therapy for type 2 diabetes and has been studied in several Phase II and three
Phase III studies. An NDA for the drug’s use in the treatment of type 2 diabetes has received an approvable letter from the FDA detailing the remaining data required for approval, primarily a large, simple safety
trial. VeroScience anticipates filing an amended Cycloset(TM) NDA (a complete response to the approvable letter) in the late third or fourth quarter of 2007.
Da ne bi bilo zabune, radi se o Plivinom famoznom PLD – 165!!!!
PLIVA d.d. – Objava rezultata za 2. tromjesečje 2007. godine
(2007-07-19)
PLIVA d.d. je danas objavila da će rezultate poslovanja za 2. tromjesečje 2007. godine objaviti u petak, 10. kolovoza 2007.
Objava će uslijediti nakon sastanka Uprave i Nadzornog odbora, planiranog za 09. kolovoza 2007., na kojima će se raspravljati rezultati poslovanja kompanije za prvih šest mjeseci, zaključno s 30. lipnjem 2007.
PLIVA d.d. je danas objavila kako je Paul M. Bisaro, predsjednik i glavni operativni direktor kompanije Barr Pharmaceuticals, Inc. (“Barr”), PLIVINE majke kompanije, i član Uprave PLIVE d.d., dao ostavku.
Bruce L. Downey, predsjednik i glavni izvršni direktor kompanije Barr, do daljnjega će preuzeti njegove odgovornosti glavnog operativnog direktora. Iako je Barr izrazio žaljenje što je g. Bisaro odlučio napustiti kompaniju, menadžment je uvjeren da njegov odlazak neće negativno utjecati na poslovanje u SAD-u ili na međunarodnoj razini te da neće odgoditi ili spriječiti skori završetak integracije PLIVE.
http://www.zse.hr
Hoćemo li ikada dočekati i da Čović ode?
Iz tiska:
Barr Pharmaceuticals prijavila je u drugom kvartalu pad dobiti unatoč tome što je gotovo udvostručila prihode. Pad dobiti je gotovo isključivo vezan uz akviziciju Plive u listopadu prošle godine.
Barr je ostvario dobit od 45,3 milijuna dolara, odnosno 41 cent po dionici, što je znatan pad u odnosu na isto razdoblje prošle godine kada je dobit iznosila 82,3 milijuna dolara, odnosno 76 centi po dionici. Dobit je manja od očekivanja analitičara.
Ipak, u istom periodu prihodi su porasli na 637 milijuna dolara što je značajan rast kad se usporede s 351,7 milijuna dolara prihoda iz prošle godine.
Izašli rezultati 1H.
Savršenstvo ili ……????
Nek’ se nađe: http://www.poslovni.hr/53217.aspx
Američka multinacionalka ALLERGAN preuzela Esprit Pharmu ( SANCTURA XR ) za 370 milijuna dolara!!!
Pliva isti lijek PRODALA za cca 140 milijuna dolara, s tim da je primitke od 90 milijuna vezala uz prodajne rezultate!!!
Prodaja SANCTURE izazvala je i velike gubitke u poslovanju koji su KATASTROFALNO djelovali na cjelokupno poslovanje i CIJENU DIONICE postupku preuzimanja od strane Barra.
Tko će odgovarati BIVŠIM I SADAŠNJIM dioničarima za ovakvo poslovanje, pitam se!
Američka multinacionalka ALLERGAN preuzela Esprit Pharmu ( SANCTURA XR ) za 370 milijuna dolara!!! Pliva isti lijek PRODALA za cca 140 milijuna dolara, s tim da je primitke od 90 milijuna vezala uz prodajne rezultate!!! Prodaja SANCTURE izazvala je i velike gubitke u poslovanju koji su KATASTROFALNO djelovali na cjelokupno poslovanje i CIJENU DIONICE postupku preuzimanja od strane Barra. Tko će odgovarati BIVŠIM I SADAŠNJIM dioničarima za ovakvo poslovanje, pitam se!
Nitko.
Čović je mogao prodati Istraživački institut putem IPO! Ne vjerujem da putem javne ponude ne bi skupio neophodan kapital kojim bi mogao financirati kapitalna Plivina istraživanja.
Time bi namaknuo novce i za SANCTURU XR. Danas bi imao lijek koji može prihodovati minimalno 200 milijuna dolara godišnje. Pliva bi i dalje bila neovisna kompanija s daleko većim učešćem hrvatskog kapitala u vlasničkoj strukturi.
a tko će odgovarati za gubitak silnih kadrova koje je Pliva izgubila tijekom zadnjih 10 godina. Samo jedan je ostao i taj je izgleda nezmjenjiv. Svaka mu čast.
izaslo izvjesce, dobit 842 milje povecanje od 113% u odnosu na proslu godinu… [smiley1]