ALTANA R&D Day 2005.LONDON & BAD HOMBURG Bad Hom·burg A city of west-central Germany at the foot of the Taunus Mountains near Frankfurt. It is a famous spa and resort. Population: 53,200. , Germany -- At today's R&D Day in London, ALTANA AG (NYSE NYSE See: New York Stock Exchange :AAA AAA: see American Automobile Association. (Triple A) A common single-cell battery used in a myriad of electronic devices of all variety. Like its double A (AA) cousin, it provides 1.5 volts of DC power. When used in series, the voltage is multiplied. ) (FWB (Fixed Wireless Broadband) See fixed wireless. :ALT), gave an overview on the most important projects in research and clinical development of the pharmaceutical division ALTANA Pharma AG. The emphasis was on respiratory, in particular Daxas(R) (roflumilast) and Alvesco(R) (ciclesonide). In addition, R&D projects in gastroenterology gastroenterology Medical specialty dealing with digestion and the digestive system. In the 17th century Jan Baptista van Helmont conducted the first scientific studies in the field; William Beaumont published his own observations in 1833. (gastrointestinal tract gastrointestinal tract n. The part of the digestive system consisting of the stomach, small intestine, and large intestine. Gastrointestinal tract ) and oncology (cancer) were presented. "Thanks to our high R&D expenditure amounting to almost 20% of our therapeutics sales and to our focus on the core areas of gastroenterology, respiratory, inflammation, and oncology, we created a highly innovative pipeline and further advanced our clinical projects. This will contribute to strengthening ALTANA Pharma's ground-breaking power and thus create the basis for further growth in the future," said Dr. Ulrich Thibaut, member of the Management Board of ALTANA Pharma AG, who is responsible for R&D. Comparative studies on efficiency and tolerability of Alvesco(R) Alvesco(R) is a new generation inhaled corticosteroid corticosteroid /cor·ti·co·ster·oid/ (-ster´oid) any of the steroids elaborated by the adrenal cortex (excluding the sex hormones) or any synthetic equivalents; divided into two major groups, the glucocorticoids and with novel release and distribution properties resulting in lung-targeted anti-inflammatory effects. Inhaled corticosteroids Corticosteroids, Inhaled Definition Inhaled corticosteroids are glucocorticoids (a class of steroid hormones that are synthesized by the adrenal cortex and have anti-inflammatory activity) formulated to be used in the respiratory tract and lungs. (ICS (1) (Internet Connection Sharing) A Windows feature that enables two or more computers to share one Internet connection. First introduced in Windows 98 Second Edition, sharing is accomplished with network address translation (NAT), which is the common method. ) are considered to be the foundation of asthma treatment. They work by reducing inflammation - the underlying disease process - in the lungs and airways. Today, Alvesco(R) has been approved in more than 30 countries. It is now available in nine countries, among others Germany, UK, the Netherlands, Australia, and Brazil. Numerous other markets are to follow later in the year, with additional market launches planned for the first half of 2006. In addition, ALTANA Pharma expects the approval for children and adolescents in Europe in 2006. In the U.S., the cooperation partner for Alvesco(R), Sanofi-Aventis, filed for approval with the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. , and in October 2004 Sanofi-Aventis received an Approvable Letter. In total, data from more than 10,000 asthma patients were collected for Alvesco(R). --Once-daily administration of Alvesco(R) 320 mcg to patients with moderate asthma improved the lung function (FEV FEV forced expiratory volume. FEV abbr. forced expiratory volume FEV forced expiratory volume. 1) similar to a twice-daily administration of fluticasone 200 mcg. In this comparative clinical trial ("M1-133") the quality of life-parameters for patients treated with Alvesco(R) were higher than for the patients treated with fluticasone. --A dosage of 160 ug Alvesco(R) per day resulted in an improvement of lung function (FEV1) and asthma control similar to budesonide with double the dosage (400 mcg/day). Gadgil et al. already presented the outcome of the study with patients suffering from moderate to severe asthma at a scientific congress. --A study comparing children treated with Alvesco(R) 160 mcg or budesonide 400 mcg showed similar effects. However, the effects of Alvesco(R) on the HPA-axis were significantly lower which underlines Alvesco(R)'s excellent safety profile. The study also included recording the growth of the children. During the Alvesco(R) therapy they grew significantly more compared to the budesonide therapy. The most frequently reported adverse events seen in ciclesonide clinical trials were nasopharyngitis, headache, and upper respiratory tract infection upper respiratory tract infection URI Infectious disease A nonspecific term used to describe acute infections involving the nose, paranasal sinuses, pharynx, and larynx, the prototypic URI is the common cold; flu/influenza is a systemic illness involving the URT . In addition to the launched inhaler inhaler /in·hal·er/ (in-hal´er) 1. an apparatus for administering vapor or volatilized medications by inhalation. 2. ventilator (2). in·hal·er n. Alvesco(R), the ciclesonide product family also includes ciclesonide nasal spray Nasal sprays are used for the nasal delivery of a drug or drugs, generally to alleviate cold or allergy symptoms such as nasal congestion. Although delivery methods vary, most nasal sprays function by instilling a fine mist into the nostril by action of a hand-operated pump (phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA ), and ciclesonide as a fixed combination product with formoterol (phase II). Further phase III data on the efficiency of Daxas(R) for asthma and COPD COPD chronic obstructive pulmonary disease. COPD abbr. chronic obstructive pulmonary disease Chronic obstructive pulmonary disease (COPD) The product candidate Daxas(R) (roflumilast) is a selective phosphodiesterase phosphodiesterase /phos·pho·di·es·ter·ase/ (-di-es´ter-as) any of a group of enzymes that catalyze the hydrolytic cleavage of an ester linkage in a phosphoric acid compound containing two such ester linkages. 4 (PDE PDE Pennsylvania Department of Education PDE Plug-In Development Environment PDE Partial Differential Equation PDE Phosphodiesterases PDE Personal Digital Entertainment PDE Pulse Detonation Engine PDE Product Data Exchange PDE Present-Day English 4) inhibitor for treating chronic inflammatory respiratory conditions such as asthma or COPD (Chronic Obstructive Pulmonary Disease chronic obstructive pulmonary disease n. Abbr. COPD A chronic lung disease, such as asthma or emphysema, in which breathing becomes slowed or forced. ). Data from additional phase III clinical trials demonstrate a continuous improvement of the lung function and thus confirm the results of previous trials. In total, data of 3,172 COPD patients and of 3,365 asthma patients are now available. --The first one-year COPD study "RATIO/M2-112" proved the sustained improvement of lung function and a good safety profile throughout one year. The lung function (FEV1), a primary endpoint of the study, improved significantly with a roflumilast therapy over placebo. Compared to placebo roflumilast resulted in a difference of 39 +/- 12 ml (endpoint analysis; p=0.0005 o.s.) respectively 48 +/- 9 ml, with a comprehensive longitudinal analysis of the data (p<0.0001). The trial included 1,513 patients with severe and very severe COPD. 62% of the patients included in the RATIO study were simultaneously treated with inhalative steroids. The improvement of the lung function was also evident in the patients who were simultaneously treated with inhalative steroids. Another endpoint of the study was the incidence of moderate to severe exacerbations. The outcome of a primary analysis showed that the exacerbation rate was 7% lower (not statistically significant). The pre-specified secondary analysis of moderate exacerbations defined as requiring treatment with oral corticosteroids Corticosteroids Definition Corticosteroids are group of natural and synthetic analogues of the hormones secreted by the hypothalamic-anterior pituitary-adrenocortical (HPA) axis, more commonly referred to as the pituitary gland. (alone or plus antibiotics) showed that roflumilast 500 mcg significantly reduced moderate exacerbations (p=0.0147). The reduction was estimated to be 18% using the Poisson regression model. In this group the reduction of exacerbations was consistent, meaning it was also independent of the simultaneous use of inhalative steroids. For patients with very severe COPD (GOLD Stage IV), who have an increased exacerbation rate, the outcome of the sub-group analysis of the RATIO study was a reduction of the exacerbations by 36% for roflumilast versus placebo. Compared to previous studies the RATIO study showed extremely low exacerbation rates. --In a second placebo-controlled study in COPD ("PEGASUS1"), which was primarily conducted in the United States, the improvement of lung function by roflumilast treatment was again confirmed. 909 patients were treated for 6 months with either 500 mcg roflumilast once daily or placebo. The primary efficacy endpoint for the study, change from baseline to final visit in post-bronchodilator FEV1, was statistically significant with a between-treatment difference of 70 ml, favoring roflumilast (p<0.001 o.s.). --The "PRIME" study, comparing roflumilast 500 mcg and montelukast montelukast /mon·te·lu·kast/ (mon?te-loo´kast) a leukotriene antagonist used as the sodium salt in prophylaxis and chronic treatment of asthma. mon·te·lu·kast n. 10 mg in asthma patients was recently completed. This large asthma study was conducted in 10 different countries involving 957 patients treated for 6 months. Both treatments were effective in improving lung function. Non-inferiority of roflumilast to montelukast was demonstrated regarding the primary variable FEV1. --In addition a study ("ROMEO") investigating the efficacy of roflumilast 500 mcg in asthma patients receiving an underlying ICS therapy (fluticasone 250 mcg) was recently completed. This large asthma study included 661 patients treated for 6 months. Improvements in the primary variable FEV1 were numerically greater for fluticasone and roflumilast 500 mcg compared with fluticasone and placebo, which was significant in a pre-specified longitudinal analysis. The known safety profile of roflumilast was not changed by these studies. The most frequent adverse effects in connection with roflumilast treatment for both indications were headaches, nausea, and diarrhea. Gastroenterology and Oncology In gastroenterology the latest comparative data, which will very soon be scientifically presented by Bardhan et al., show the benefits of Pantoprazole 40 mg versus Esomeprazole 40 mg when treating GERD GERD gastroesophageal reflux disease. GERD abbr. gastroesophageal reflux disease GERD patients. After a 12 week treatment with Pantoprazole the number of patients who were endoscopically cured was higher (statistically significant). ALTANA Pharma not only focuses on the life-cycle management of Pantoprazole but also on so-called P-CABs (formerly APA (All Points Addressable) Refers to an array (bitmapped screen, matrix, etc.) in which all bits or cells can be individually manipulated. APA - Application Portability Architecture ), the next generation acid inhibitors with a better and faster mode of action than PPIs. Next to Soraprazan in phase II of clinical development there is another P-CAB in phase I. In oncology ALTANA Pharma focuses on a portfolio of SMOL anti-cancer drugs: --Development of anti-mitotic cancer agents to substitute current taxane-based chemotherapy --Next generation of HDAC inhibitors. ALTANA Pharma expects to be able to lead its own oncology projects into clinical phase I in the next two years. This press release contains forward-looking statements, i.e., current estimates or expectations of future events or future results. The forward-looking statements appearing in this press release include estimates for the achievement of certain milestones in the development of ALTANA's pharmaceuticals, their marketing approval, and ALTANA's expectations of further growth in the forthcoming years. These statements are based on beliefs of ALTANA's management as well as assumptions made by and information currently available to ALTANA. Many factors that ALTANA is unable to predict with accuracy could cause ALTANA's actual results, performance or achievements to be materially different from those that may be expressed or implied by such forward-looking statements. These factors include ALTANA's ability to develop and launch new and innovative pharmaceutical products, the level of ALTANA's investment in pharmaceuticals related R&D, decisions of the competent regulatory authorities, the sales and marketing methods used by ALTANA to distribute its pharmaceuticals and the composition of ALTANA's pharmaceuticals portfolio. Forward-looking statements speak only as of the date they are made. ALTANA does not intend, and does not assume any obligation, to update forward-looking statements to reflect facts, circumstances or events that have occurred or changed after such statements have been made. The Webcast of the R&D Day and this press release are also available on the Internet at www.altana.com. |
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