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http://www.drugdevelopment-technology.com/contractors/contract_research/cfpie/press9.html Fri, 28 Nov 2008 14:16:11 GMT http://www.drugdevelopment-technology.com/contractors/contract_research/cfpie/press9.html The Center for Professional Innovation &Education Launches Training Course for Marketing &Advertising Personnel in the Life Sciences November 28, 2007 - WAYNE, PA - The Center for Professional Innovation &Education (CfPIE) is pleased to announce a new training program geared towards professionals involved with Pharmaceutical, Medical Device and Biotech Marketing and Advertising initiatives. The course, Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices is scheduled for January 14 &15, 2007 at The Desmond Hotel &Conference Center in Malvern, PA. This two-day program will give participants a comprehensive overview of the regulatory requirements binding Pharmaceutical and Medical Device marketers and insights on how to develop and maintain a successful marketing/advertising plan. Participants will also gain valuable perspective on how regulators and the courts view compliance and the issues inherent with staying compliant. “The compliance issues surrounding marketing and advertising of products in the life sciences are many, and the regulations continue to change and evolve.” said Bill Beyer, Director of Marketing for CfPIE. “By drawing on the experience of industry experts and those most closely connected with these issues, we have been able to develop a thorough, practical curriculum which will help Marketing and Regulatory personnel face even the toughest compliance strategies.” This course will be of benefit to anyone involved in Marketing, Advertising, Regulatory Affairs or those that need or want insight into the regulations and best practices for compliance. More information about this program or other CfPIE courses can be found by calling +1-610-765-1128, emailing info@cfpie.com or visiting www.cfpie.com. About CfPIE: CfPIE currently offers over 250 public courses in Malvern, PA, Costa Mesa, CA, Dublin, Ireland and Berlin, Germany each year and another 250 customized client-site programs annually. For personnel looking for professional advancement as well as technical/regulatory training, CfPIE offers convenient delivery options for the following course types: ? Pharmaceutical Training ? Medical Device Training ? Skin/Cosmetic Product Training ? Biotech Training Course topics include all regulatory, technical and compliance issues from product discovery, development, manufacturing and clinical trial concerns through post-approval challenges. CfPIE has been the preferred training partner for most of the top 100 life science firms globally and a critical component to personnel development efforts of smaller organizations and start-up companies. Press Inquiries: Morgan Litsky Marketing Coordinator The Center for Professional Innovation &Education 992 Old Eagle School Road, Suite 913 Wayne, PA 19087 Phone: 1-610-688-1708 Fax: 1-610-688-7817 Email: mlitsky@cfpie.com Web: www.cfpie.com http://www.drugdevelopment-technology.com/contractors/contract_research/biovian/press3.html Mon, 21 Apr 2008 15:02:10 GMT http://www.drugdevelopment-technology.com/contractors/contract_research/biovian/press3.html Meet Biovian at BIO 2008, June 17-20, 2008 in San Diego Biovian's CEO, Mr Sakari Heyno, will be available for the face to face partnering offered at the conference. To request a meeting please contact Mr. Sakari Heyno at sakari.heyno@biovian.com or at the BIO 2008 conference partnering website. ABOUT BIOVIAN Biovian is a one-stop-shop in cGMP contract manufacturing of biopharmaceuticals covering services from early development to aseptic fill and finish. Biovian's inspected 1600 m² cGMP facilities contain EU grade A, B, C and D class clean rooms and warehouse under full quality control as well as extensively equipped laboratories. Biovian cGMP services include: Fermentation and cell culture Viral vector production Protein purification Formulation Fill and finish Lyophilization Analytical quality control services Biovian complementary services include: Process development Analytical development Proteins for research purposes Diagnostic reagents http://www.drugdevelopment-technology.com/contractors/contract_research/pharmatest/press1.html Tue, 15 Apr 2008 12:09:27 GMT http://www.drugdevelopment-technology.com/contractors/contract_research/pharmatest/press1.html Fast Results in Preclinical Bone Research Pharmatest Services Ltd, a Finnish pharmaceutical contract research organization, has developed novel in vitro human bone cell assays as research tools for pharmaceutical companies developing new therapies against osteoporosis and cancer-induced bone disease. These assays can be used to test vast amounts of new drug compounds for their effects on bone formation and bone resorption in vitro. "Our bone cell assays are unique in a sense that they are based on the use of human bone cells (osteoclasts and osteoblasts). All similar previously commercially available models have either been performed in animals, or based on the use of rodent cells", says Pharmatest CEO and Scientific Director Dr. Jussi Halleen. These unique models offered exclusively by Pharmatest have various advantages over the commonly used techniques. These in vitro models improve the early preclinical drug discovery research, when already the early efficacy research can be performed with human cells. Being in vitro models, they are also extremely fast and allow pharmaceutical companies to screen multiple drug candidates for most potential compounds quickly and effectively. This, in turn, translates into lower preclinical drug discovery costs and accelerated preclinical throughput. The use of human cells instead of animal cells also decreases the number of laboratory animals needed for preclinical research. "These in vitro models form the foundation of our mission, which is to provide our customers with everything they might need when it comes to preclinical bone biology. First we help them sift through large sets of compounds with the in vitro efficacy assays, and the most potential compounds are further tested in our disease animal models. Some of these models' results can even be used in drug approval process as such", adds Halleen and concludes "I think it's safe to say that we really are a one-stop-shop when it comes to bone biology." http://www.drugdevelopment-technology.com/contractors/synthesis/bachem/press3.html Tue, 15 Apr 2008 09:21:38 GMT http://www.drugdevelopment-technology.com/contractors/synthesis/bachem/press3.html Record Year for Bachem at all Levels in 2007 Sales grow to CHF198.3 million - up 17.0% in local currencies and 15.5% in CHF respectively Operating profit up 29.9%, net income up 37% Operating margin rises sharply to 36.5%, net income margin now at 32.3% Prosposed increase in dividend by 50% to CHF3.00 per share Positive trend in demand and systematic expansion of the portfolio and capacity promise continued growth in 2008 The Bachem Group (SWX: BANB) today announced results for the business year 2007. The company achieved a new sales record of CHF198.3 million in 2007. Compared with 2006, sales grew by 17.0% in local currencies or 15.5% in CHF. The weakening of the US dollar against the Swiss franc during 2007 outweighed the positive development of the Euro to the Swiss franc. As expected, sales in the second half of 2007 of CHF 95.3 million did not quite reach the level of the first half of CHF 103.0 million. After a first-half growth of 26.3% in local currencies or 25.4% in CHF, growth in the second half of 2007 amounted to 8.6% in local currencies or 6.4% in CHF. The main driver of growth last year was again the active pharmaceutical ingredients (APIs) business, which grew by 21.0% in local currencies or 19.1% in CHF. Patent protected new chemical entities (NCEs), in particular, showed above-average growth of 33.7% in local currencies or 29.2% in CHF. Generics grew by 14.0% in local currencies or 13.5% in CHF. It was very gratifying that, after two years of decline, the non-peptide generics also returned to high single digit growth. Research chemicals, however, only increased slightly by 2.0%. Declines in the catalog business were offset by double-digit growth in custom synthesis. Both Europe and North America posted double-digit sales growth in 2007. Sales in Europe increased by 11.4% in local currencies and 12.3% in CHF. This development is in line with the increasingly dynamic momentum in Europe, where more and more pharmaceutical and biotech companies are becoming active in the field of peptidebased substances. The share of sales in this region thus amounts to 60.4%. Sales in North America showed strong growth of 25.6% in local currencies and 20.6% in CHF. The additional capacity available since the previous year contributed substantially to the good performance in this region. But also the sales of products manufactured in Switzerland for the American market increased again. The US share of total sales consequently increased to 39.6%. Rolf Nyfeler, CEO of Bachem Holding AG, commented: "Once again we can look back on an extremely successful year with undiminished growth. In terms of both sales and profitability, the results achieved have even exceeded our optimistic forecast after the first half-year." In the past business year, Bachem increased its operating income by 29.9% or CHF 16.7 million compared to the previous year. The EBIT thus reached the record level of CHF 72.4 million compared to CHF 55.8 million in the previous year. The EBIT margin was again substantially increased and amounted to 36.5% in 2007. Compared to the previous year's figure of 32.5%, this represents an increase of four percentage points. A major part of the improvement in the operating margin results from the reduction in the cost of goods sold in relation to sales of around two percentage points. This improvement is partly due to shifts in the product mix, but in particular was also achieved through economies of scale and process optimization. The gross margin thus improved by more than two percentage points from 53.1% to 55.4% compared to the previous year. The general administrative costs not only fell in relation to sales from 11.7% to 10.1%, but also slightly in absolute terms from CHF 20.2 million to CHF 20.0 million. This optimization constitutes the second main component of the increase in the operating margin, with the general administrative costs contributing almost two percentage points to the improvement in the margin in 2007. In relation to sales, selling costs slightly declined while research and development costs showed a modest increase. In 2007, Bachem increased the number of employees by 42 to 651 full-time equivalents (FTEs). In Switzerland, 50 new jobs were created in Bubendorf, while the UK saw three new jobs created. By contrast, after strong expansion in the USA during the previous year, the number of FTEs here was reduced by 11 as part of a drive to optimize the organization and increase production efficiency. The growth in personnel corresponds to a 6.9% increase in FTEs, which is an underproportionately low increase in relation to the sales growth. The rise in net income, increasing by 17.3 million or 37.0% from CHF46.6 million to CHF63.9 million, results from the excellent operating performance, the gratifying financial result and the positive contribution from associated companies. The net income margin thus likewise improved significantly from 27.2% to 32.2%. Earnings per share (EPS) consequently rose sharply from CHF 3.54 in the previous year to CHF 4.81 in 2007. Investments in fixed and intangible assets were at CHF 35.3 million in 2007. After the main focus was on the USA in 2006, investments made during the year under review were predominantly in the expansion of capacity at the headquarters in Bubendorf. The Board of Directors has decided to propose an increase in dividend from CHF2.00 to CHF3.00 for approval by the Annual General Meeting. This is in line with the dividend policy of granting shareholders a share of the funds that are not needed in operational terms. Peter Grogg, Chairman of the Board, said: "In view of the excellent results, we propose that again a significant increase in the ordinary dividend by 50% to CHF3.00 per share be approved at the Annual General Meeting for 2007. In addition to having shareholders participate in the financial success of the company, we are also planning to further enhance the inner value of our company by significant investments to be funded entirely from the cash flow." Outlook Thanks to the increasing interest in peptides and the excellent portfolio of products and services, perspectives for the future development of the business remain very favourable. Particularly the NCE business, for which the company made considerable progress in the expansion of its project portfolio especially in Europe, promises to further drive growth. For the generics business Bachem expects a continued increase in demand both for peptide as well as non-peptide active pharmaceutical ingredients. Open orders remain at a high level. Barring any unforeseen events, Bachem therefore anticipates to clearly increase sales and income again in 2008. For the business year 2008, the company expects sales growth in the range of 8% to 12% in local currencies, which is in line with the long-term growth objectives. However, the EBIT-margin target is raised to 33% to 37%. In order to achieve these ambitious objectives, Bachem will continue to invest substantially in further expanding its business over the coming years. The Annual General Meeting of Bachem Holding AG for the business year 2007 takes place on April 23, 2008. The comprehensive Bachem Annual Report 2007 is available on the website. http://www.drugdevelopment-technology.com/contractors/synthesis/bachem/press2.html Tue, 15 Apr 2008 09:11:47 GMT http://www.drugdevelopment-technology.com/contractors/synthesis/bachem/press2.html Action Pharma and Bachem Cooperate on AP214 - Now Ready to Enter Phase 2 Clinical Trials Action Pharma A/S and Bachem (SWX: BANB) today announced their cooperation on AP214, Action Pharma's lead compound, about to enter Phase 2 clinical trials in post-surgical organ failure. Since 2002, Bachem has supported Action Pharma by producing the peptide active ingredient of this drug candidate, by analytical method development, analytical method validation as well as by regulatory services. For the upcoming Phase 2 clinical trial, Bachem also supplies finished dosage forms under its Clinalfa® brand. Prof. Søren Nielsen, CEO and Co-founder of Action Pharma, commented: "For years, Bachem has supported us as a full-service provider on the active ingredient of our lead compound, a very valuable contribution for our start-up company. The service has been highly professional and efficient throughout. Now, that we enter Phase 2, we are particularly pleased that Bachem can also provide us with the necessary finished dosage forms. This helps us not only to save cost but also to speed up time to market." Rolf Nyfeler, CEO of Bachem, said: "The collaboration with Action Pharma is a case in point for our unique business model: our comprehensive service offer, ranging from the development and manufacture of peptides and complex organic molecules through regulatory support up to the production of clinical trial samples, makes us a reliable long-term partner for bio-pharmaceutical companies of any size. At the same time it allows us to share in the success of our partners, as they progress their drug candidates through the development process." The cooperation between Action Pharma and Bachem has been particularly close and also included involvement of Bachem in direct discussions with the US Food and Drug Administration (FDA) last year. Action Pharma has completed clinical Phase 1A, 1B and 1C studies and filed an Investigational New Drug Application with the FDA in November 2007. With AP405, Action Pharma has a second peptide-based development compound in its pipeline. This project, targeted at atopic dermatitis, is currently in pre-clinical development. Also for AP405, Bachem is the partner for process development, production and related services. http://www.drugdevelopment-technology.com/contractors/it/id/press28.html Fri, 11 Apr 2008 10:37:26 GMT http://www.drugdevelopment-technology.com/contractors/it/id/press28.html Boehringer Ingelheim Chooses IDBS' PredictionBase IDBS, a provider of drug discovery data management solutions, today announced that the global pharmaceutical company Boehringer Ingelheim (Ingelheim, Germany) has purchased IDBS' predictive modelling technology PredictionBase for use at its Biberach an der Riss research site. Scientists at the Biberach facility, where research into diseases of the Central Nervous System (CNS), metabolic diseases and respiratory diseases is centred, will use PredictionBase to build and deploy and distribute predictive ADME QSAR models using existing data. Boehringer Ingelheim sought a solution that would help reduce the effort required for scientists to perform prediction manually, while also efficiently distributing valuable drug discovery knowledge throughout the company. PredictionBase provided the required predictive technology to integrate with existing Boehringer Ingelheim IT tools to form an automated workflow, allowing scientists to save time by prioritizing work, so improving efficiency. Neil Kipling, founder and CEO of IDBS, commented: "Increasingly, organizations are opting for predictive technologies that help reduce costs incurred by failed candidates by weeding out potential failures before screening begins. Boehringer Ingelheim sought to increase efficiency of the candidate identification process by introducing an automated workflow. Use of PredictionBase has helped its scientists streamline working practises when dealing with larger volumes of data." He added: "By providing scientists with a tool to create, analyze and validate predictive models, PredictionBase enables the easy generation and distribution of knowledge across organizations." http://www.drugdevelopment-technology.com/contractors/antibodies/antiprot/press1.html Tue, 08 Apr 2008 16:49:13 GMT http://www.drugdevelopment-technology.com/contractors/antibodies/antiprot/press1.html News in Plant Protein Science Antimicrobial peptides Plants produce a high number of various antimicrobial peptides such as defensins, thionins, lipid transfer proteins and snakins. It had been recently found that these classes of genes account of approximately 2% - 3% of the gene repertoire of each model species (Egorov et al., 2005, Peptides 26, 2064 - 2073; Silverstein et al., 2007, Plant J. 51, 262 - 280; Rossi et al., 2008, J. Pharm. Sci. 97, 1060 - 1070). Related antibodies against plant proteins: Anti-hellethionin - H13H-1 New! Anti-hellebrin - H14H-1 New! Highlights in protein phosphorylation in chloroplasts Two thylakoid protein kinases (STN7/Stt7) and (STN8/Stll) control the phosphorylation of light-harvesting antenna and photosystem II proteins (D1, D2, CP43, PsbH) (Bellafiore et al., 2005, Nature 433, 892 - 895; Bonardi et al., 2005, Nature 437, 1179 - 1182; Varionen et al., 2005, JBC 280, 33679 - 33686; Rochaix J-D, 2007; FEBS Lett. 581, 2768 - 2775). STN8 is involved in the phosphorylation of the novel light-regulated phosphoprotein of thylakoid membranes, CaS (Vainonen et al., FEBS J, March 2008). Related antibodies against photosynthetic proteins: Anti-kinase STN7 - K03A-1, K03A-2 New! Anti-kinase STN8 - K04A-1, K04A-2 New! Anti-serine/threonine protein kinase TAK1 - K02A-1 Anti-PsbA-Nt (D1) - P22A-1 Anti-D2 protein (PsbD) - P12S-1 Anti-cyclophilin AtCYP37 - I02A-1, I02A-2 Anti-cyclophilin AtCYP38 - I01A-1, I01A-2 Small Cab-like proteins of cyanobacteria Small Cab-like proteins (SCP or also known as HLI, high-light inducible polypeptides) were found to be associated with photosystem II of Synechocystis sp. PCC 6803 (Yao et al., 2007, JBC 282, 267 - 276; Kufryk et al., 2008, Photosynth. Res. 95, 135 - 145). These proteins are not involved in the stability of functional photosystem II but retard the degradation of photosystem II-associated chlorophyll (Vavilin et al., 2008, JBC 282, 37660 - 37668). Related antibodies against photosynthetic proteins: Anti-HliA - H01S-1, H01S-2 Anti-HliD - H02S-1, H02S-2 Anti-PsbA-int (D1) - P21S-1 http://www.drugdevelopment-technology.com/contractors/it/id/press27.html Tue, 01 Apr 2008 14:40:28 GMT http://www.drugdevelopment-technology.com/contractors/it/id/press27.html ID Business Solutions - from Bench to Boardroom IDBS is proud to announce the upcoming releases of E-WorkBook Suite 8.0, ActivityBase 7.0 and ActivityMart 3.0. The forthcoming releases are to be delivered in early 2008 as part of IDBS' continued commitment to developing and integrating its industry-leading product suites. ActivityBase is IDBS' flagship product and since its inception has become the industry-standard screening solution, employed by over 75% of the world's leading biotechnology and pharmaceutical companies. Enhancements to ActivityBase 7.0 include simplified plate creation, time savings in results processing and report generation and support for chemical tautomer searching. Following the success of the ActivityBase Suite, IDBS launched its comprehensive electronic laboratory notebook (ELN), the E-WorkBook Suite, in 2005. The imminent release of E-WorkBook 8.0 will deliver major enhancements in searching and reporting and increased support for chemistry. ActivityMart drives the decision-making process by providing rapid and intuitive access to complex research data. Integrating data from ActivityBase and BioBook, ActivityMart 3.0 further simplifies the searching of results data by presenting it in an intuitive business context. This solution consolidates the high value summary test data stored in various LIMS, ActivityBase and BioBook databases, retaining rich contextual data. ActivityMart provides a rapid querying tool and is vital when searching high volumes of data. Neil Kipling, founder and CEO of IDBS, commented: "We are currently doing a lot of ongoing work to improve the integration capabilities of our solutions and our aim for 2008 is to continue to deliver revolutionary products and services to the marketplace. Research organizations need an adequate means of managing their data to meet increasing regulatory requirements. Informatics providers must continue to improve their systems to deal with the magnitude of data generated. The importance of having an integrated framework cannot be under-estimated." http://www.drugdevelopment-technology.com/contractors/it/id/press26.html Tue, 01 Apr 2008 14:37:16 GMT http://www.drugdevelopment-technology.com/contractors/it/id/press26.html Customer Focus and Product Development Leads to Substantial Revenue Growth and Continued Profitability for IDBS In 2007 IDBS, provider of data management, analysis and decision support software, is proud to report double-digit revenue growth and profitability for 2007 despite increasingly challenging market conditions. Sales revenues have increased by almost 50% since 2005, on the back of major developments to core product lines such as the ActivityBase Suite. Much of the revenue also coming from existing customers who have invested in new technologies such as the E-WorkBook Suite, with a consistently high level of renewals and substantial market expansion to new customers. "The excellent sales performance over the past few years reflects the innovations we have made in the management of discovery data," commented Neil Kipling, founder and CEO of IDBS. "Innovation, supported by a proven ability to deliver and perform according to customer expectations, has made IDBS a trusted partner to an increasing number of, not only pharmaceutical companies, but also other companies who realize the value we can deliver." IDBS' sustained financial growth has enabled continued investment in both customer support and development. IDBS has complemented its existing consultancy function with more dedicated chemistry and biology specialists in both the EU and US. Investment in software development has resulted in major new product features and expansions to our product line. Neil Kipling added: "I am delighted at our financial success and am confident this will continue, as long as we continue to deliver first-class products and services. Many other informatics providers are failing because they have become too preoccupied with the balance sheet and have forgotten about the customer. Being customer-focused has brought IDBS growth and given us a reputation as the leading supplier of data management solutions to pharmaceutical and beyond. This is a reputation we are extremely proud of and determined to protect." http://www.drugdevelopment-technology.com/contractors/contract_research/lab-research/press1.html Mon, 10 Mar 2008 14:45:17 GMT http://www.drugdevelopment-technology.com/contractors/contract_research/lab-research/press1.html Welcome to LAB Research Hungary LAB Research Hungary has over 30 years of toxicology experience and offers the leading pharmaceutical and biotechnology companies the complete range of pre-clinical services, from acute to carcinogenicity. A newly completed building increases the capacity of the facility to 62 state-of-the-art rodent animal rooms with its large animal housing increasing to 480, all in full compliance with EU animal housing requirements. In addition, this facility specializes in ecotoxicology, offering technical solutions that address regulatory and environmental issues. It is an authorized REACH Ready facility. Today, LAB Research Hungary is home to scientific and business teams that blend significant expertise from Europe, North America and the Far East. Drawing on the wealth of experience from our qualified scientists and senior management, LAB Research Hungary provides a wealth of expert advice and consultancy on a wide array of pre-clinical services. THIS ISSUE'S FOCUS: INHALATION TOXICOLOGY With experience of over 600 GLP studies, LAB Research Hungary offers extensive experience in inhalation studies of pharmaceuticals, biotech products, agrochemicals and chemicals. The inhalation equipment is state of the art nose only exposure and is less than 2 years old. We are able to offer our clients the latest exposure technology and methodology and can administer solids, powders and liquids to both rodents and non-rodents. Our team of qualified analytical chemists can provide support to measure the concentrations of these products in the atmospheres produced using LC-MS-MS, LC-UV and GC. We offer dedicated, purpose-built laboratories, which ensure complete physical and spatial separation of study groups to eliminate potential contamination. Each exposure system is contained within its own room and has separate airflow entering the room and exiting the room. http://www.drugdevelopment-technology.com/contractors/biochemicals/biouetikon/press2.html Thu, 06 Mar 2008 15:13:30 GMT http://www.drugdevelopment-technology.com/contractors/biochemicals/biouetikon/press2.html BioUETIKON's Official Launch BioUETIKON Ltd, the new biotech services division of Chemie Uetikon (CU) and Chemie + Papier Holding (CPH), will be officially launched on Monday 28th April in Dublin, Ireland by the Taoiseach, Mr. Bertie Ahern TD. BioUETIKON Ltd provides upstream/downstream development and GMP CMO services to the biopharmaceutical, medical device and related industries. Located in a flexible, high quality facility approximately 15 minutes from Dublin Airport on the Dublin City University (DCU) campus, BioUETIKON is ideally situated to serve international and local clients. As a DCU spin-out, BioUETIKON had over 10 years' experience of biopharmaceutical production prior to CPH investment in late 2006. This investment allowed the expansion and development of their services and facilities throughout 2007, with the aim of achieving a leading position in development and execution of efficient bioprocessing systems. CPH see biotechnology CMO as an important strategic innovation for their fine chemicals business. Biotech products are a key and growing component of the pharmaceuticals marketplace and will provide a strong addition to CPH's existing fine chemicals CMO experience and expertise. BioUETIKON is the first investment in Ireland for CPH. The country was chosen for the government's approach and commitment to the pharmaceuticals industry, its market accessibility to Europe and the USA, skilled workforce and business friendly environment. The location also enables BioUETIKON to take advantage of a strong network of local institutes (DCU, NICB, NIBRT, CBAS) and companies (Fusion Antibodies,Life Scientific, Biolin) for joint work on projects such as cell engineering, final release testing etc. Also in attendance at the launch are Dr Heinz Sieger, CEO Chemie Uetikon and the President of Dublin City University, Professor Ferdinand von Prondzynski along with the German and Swiss Ambassadors to Ireland. http://www.drugdevelopment-technology.com/contractors/contract_research/neurofit/press7.html Wed, 05 Mar 2008 14:00:03 GMT http://www.drugdevelopment-technology.com/contractors/contract_research/neurofit/press7.html Neurofit at BIO-SQUARE 2008 Neurofit is pleased to announce its participation at BIO-SQUARE 2008 from March 12 to 14, 2008, Basel, Switzerland. Neurofit is a preclinical CRO offering in vitro and in vivo drug screening services in the area of pain, psychiatry, neurology, multiple sclerosis and oncology. For more information and details of our screening tests, please visit our website at http://www.neurofit.com. If you are attending the meeting, our CEO, Dr. Frank Sams-Dodd will be very pleased to meet with you to discuss possible areas of collaboration or alternatively contact Frank directly (sams-dodd@neurofit.com) to set-up a time for a telephone conference. http://www.drugdevelopment-technology.com/contractors/it/id/press25.html Wed, 27 Feb 2008 12:31:03 GMT http://www.drugdevelopment-technology.com/contractors/it/id/press25.html IDBS Improves Global Helpdesk's Customer Service with Hornbill's Supportworks Leading provider of software solutions to the life sciences industry increases customer satisfaction with improved call management and customer self-service. IDBS, the independent software vendor (ISV) specialising in drug discovery solutions, has selected Hornbill's Supportworks to provide support services to customers of its data management software. The IDBS customer support team will be using Hornbill's solution to support thousands of users at over 250 companies using its software. Using Supportworks, IDBS expects improved customer satisfaction through a more efficient customer service. IDBS selected Supportworks from a shortlist of five other suppliers for the solution's out-of-the-box functionality, open integration capabilities and ease of configuration. Particular features that the Support team required included integrated and automated email, workflow functionality, knowledgebase and SelfService portal. According to Adam Paton, Customer Support Manager at IDBS, "Hornbill's Supportworks provides us with a powerful tool to support our business goals. We wanted to provide our customers with improved access to information and a much better support service." "Supportworks will enable us to respond very quickly to customer queries and track them to resolution. It has all of the features that we need - the ability to customise it to meet our specific requirements will help us meet our goal of providing a more comprehensive, accessible service to our global users via the SelfService portal and knowledgebase." Supportworks is not just used for call tracking, but has been integrated into the company's work processes. Incoming calls will be logged against IDBS' software versions, enabling the team to quickly pinpoint and resolve issues relating to specific software releases. Problems that are recorded by the support team will be passed to the development team for resolution and then routed to the testing team for confirmation that the issue has been resolved. The automated workflow will enable calls to be effectively tracked throughout the support and development lifecycle, improving response to customers. The IDBS team has also populated the Supportworks knowledgebase with technical documents, frequently asked questions and support documents addressing known issues. These documents are accessible through the SelfService portal, which has been customised to reflect IDBS' corporate branding with the goal of providing a 'one-stop shop' for customers. Gerry Sweeney, CEO of Hornbill Systems commented, "IDBS provides software applications that bridge the gap between IT and science. Their customers require support that varies from simple usage queries to complex technical issues. Supportworks has been designed to provide a comprehensive tool for ISVs to track and resolve service requests, streamline workflow and improve communication with customers, leading to increased satisfaction and customer retention." http://www.drugdevelopment-technology.com/contractors/biochemicals/biouetikon/press1.html Wed, 27 Feb 2008 10:21:05 GMT http://www.drugdevelopment-technology.com/contractors/biochemicals/biouetikon/press1.html BioUETIKON to Attend Biosquare 2008 BioUETIKON, a bioprocess development, optimiztion and GMP production CMO will be attending the Biosquare 2008 conference in Basel, Switzerland from the 12th to the 14th of March 2008 to introduce its range of services ahead of the company's official launch in April 2008. Biosquare is one of the most prominent events in the pharmaceutical and life science industry calendar, playing host to some 800 market-leading companies from 34 different countries such as JBA, Ernst & Young, and Swiss Biotech. The three-day event will feature a full program including panels and workshops led by corporate executives and biotech experts. Mike Mulcahy, Managing Director, BioUETIKON will be available for one-to-one meetings at the conference, where he will represent BioUETIKON's commitment to the pharmaceutical and life sciences through their competitive range of bioprocess development, scale up and GMP production services. http://www.drugdevelopment-technology.com/contractors/contract_research/biovian/press2.html Mon, 25 Feb 2008 11:59:27 GMT http://www.drugdevelopment-technology.com/contractors/contract_research/biovian/press2.html Meet Biovian at BioEurope Spring 2008 Conference, Madrid 7-9th April 2008. Biovian's Director of Projects and Marketing, Dr Knut Ringbom, will be available for the one-to-one partnering offered at the conference. To request a meeting please contact Dr Ringbom at knut.ringbom@biovian.com or at the BioEurope Spring 2008 conference partnering website. ABOUT BIOVIAN Biovian is a one-stop-shop in cGMP contract manufacturing of biopharmaceuticals covering services from early development to aseptic fill and finish. Biovian's inspected 1600 m° cGMP facilities contain EU grade A, B, C and D class clean rooms and warehouse under full quality control as well as extensively equipped laboratories. Biovian cGMP services include: Fermentation & cell culture Viral vector production Protein purification Formulation Fill & finish Lyophilization Analytical quality control services Biovian complementary services include: Process development Analytical development Proteins for research purposes Diagnostic reagents http://www.drugdevelopment-technology.com/contractors/synthesis/trimen Tue, 06 May 2008 00:00:00 GMT http://www.drugdevelopment-technology.com/contractors/synthesis/trimen TriMen Chemicals With nine years of experience in organic synthesis and medicinal chemistry, TriMen Chemicals assists its clients in shortening the time and lowering the cost of the early stages of the drug discovery process. Our objective is to create a long-term relationship with our customers by supplying excellent value-for-money services. LABORATORY-SCALE DRUG AND CHEMICAL SYNTHESIS To help our partners in their drug discovery and chemical development efforts, TriMen provides custom synthesis of compounds for multiple drug discovery applications. TriMen personnel provide extensive experience in synthesis, synthetic route design, and execution. TriMen staff members offer a variety of services, including: Synthesis on milligram to 50g+ scale Execution of the established synthetic routes, design of new synthetic routes, troubleshooting of existing synthetic routes, optimisation of synthetic routes for scale up to support pre-clinical leads Synthesis of lead compounds, intermediates and reference compounds Synthesis of metabolites or standards Synthesis of analogue libraries TriMen offers laboratory-scale synthesis and medicinal chemistry services (from milligrams to grams). Our research model favours a problem-solving and project-management approach, which focuses on client deliverables. Typical projects are research-oriented and require a multi-step organic synthesis. We have the ability to exercise an existing synthesis, or design a new synthesis when there is no developed chemical plan. We work quickly and efficiently while maintaining full confidentiality regarding our clients' intellectual property. We provide complete documentation and support according to each specific customer&squo;s requirements. TriMen Chemicals possesses the state-of-the-art analytical equipment necessary for successful accomplishment of the custom synthesis and small-molecule medicinal chemistry projects: LC-MS Waters chromatogram with a detection of molecular mass up to 2,500 Daltons Bruker 500MHz NMR spectrometer (optionally, TriMen has an access to the 700MHz apparatus) Preparative HPLC allowing for purification of small amounts of polar compounds when the very high purity of the compound is required ADVAMACS CATALOGUE OF UNUSUAL AMINO ACIDS Optimisation of the lead structure is an important stage of each and every medicinal chemistry project. Understanding the ever-increasing demand for the molecular diversity elements and capitalising on the unique know-how developed especially in the field of amino acid chemistry, TriMen Chemicals has created a new brand dedicated to the catalogue sale of unusual amino acids called Advamacs. The name of this brand is derived from advanced amino acids and the product categories offered at the moment include: η-2-substituted amino acids η-3-substituted amino acids α-disubstituted amino acids N-methyl amino acids Amino alcohols New classes of building blocks and molecular diversity elements are continuously introduced to our catalogue. http://www.drugdevelopment-technology.com/contractors/synthesis/alsachim Wed, 30 Apr 2008 00:00:00 GMT http://www.drugdevelopment-technology.com/contractors/synthesis/alsachim ALSACHIM ALSACHIM is an independent contract research and development organisation that specialises in stable isotope-labelled compounds, metabolites and pharmaceutical related substances, and rare chemicals for medicinal chemistry research and analytical purposes. We supply our products to customers all over the world, spread throughout the chemical discipline including the pharmaceutical and biotech industry, clinical and bio-analytical CROs and related research institutions. ALSACHIM&squo;s team of highly experienced scientists can effectively support your research with services that include custom synthesis and chemical development complemented by integrated state-of-the-art analytical services (NMR, MS, HPLC-MS). CUSTOM STABLE ISOTOPE LABELLING Pharmacokinetic studies have traditionally used radio-labelled compounds as a means of evaluating body Absorption, Distribution, Metabolism and Excretion (ADME). New analysis technologies now make it possible to use compounds enriched with stable isotopes such as carbon-13 and deuterium as alternatives to radioisotopes. If you are interested in stable isotopes, only a limited number and variety of isotopically enriched intermediates are readily available. The intermediates used in the synthesis route for your desired target compound may not exist as labelled compounds; thus, a whole new synthesis will be needed for incorporation of the isotope of interest. CUSTOM SYNTHESIS OF STABLE ISOTOPICALLY LABELLED MOLECULES ALSACHIM is your complete source for isotopically labelled compounds of high purity and high isotopic enrichment, with specific labelling patterns in complex molecules and drugs for metabolism and biochemical studies. ALSACHIM offers custom synthesis of stable isotopically labelled molecules including: Pharmaceutical Intermediates Peptides Biologically active molecules Controlled drug standards (DEA) NMR reference standards Metabolites Isotopically-labelled reference standards RARE PHARMACEUTICAL BUILDINGS BLOCKS ALSACHIM specialises in multi-step custom synthesis of compounds that are not commercially available. We synthesize novel and rare drug-like molecules in the scale ranging from milligram to 100g quantities every day. Rare buildings blocks are available from ALSACHIM&squo;s catalogue and will provide our customers with original NCEs for their drug discovery programs. FOCUSED LIBRARY SYNTHESIS ALSACHIM has expertise in the design and synthesis of small molecules, heterocyclic-based peptidomimetics and drug-like libraries, using both solution and solid-phase synthesis approaches. Our efforts are focused on working with customers to generate moderate-sized focused libraries. PET PRECURSORS The world's need for PET tracers is growing steadily. The key to growth and greater utilization of molecular imaging is the development of new and more specific biomarkers. At ALSACHIM, we also provide PET precursors and PET standard for your research studies. ANALYTICAL LAB EQUIPMENT AND SYNTHETIC FACILITIES ALSACHIM has excellent laboratory facilities at its disposal, including modern analytical equipment (high-field NMR 400MHz, MS), chromatography systems (HPLC, preparative and analytical LCMS), combinatorial chemistry facilities, 1L, 2L, and 4L reactors, and microwave systems. SYNTHESIZED COMPOUND CATALOG The catalog reports the compounds we have synthesized for different customers. For your information, since September 2006, we offer to our customers the desired labeled molecule with a minimum of four isotopes. Indeed, we prefer to offer to our customers 13C labeled drugs rather than 2H drugs to ensure the stability of the labeling and to allow NMR studies as CP-MAS studies. In addition the price remains the same with ALSACHIM. Moreover we may perform custom syntheses of your desired drugs. The timeline is usually four weeks. Please feel free to contact us for further information. http://www.drugdevelopment-technology.com/contractors/contract_research/indigo Tue, 29 Apr 2008 00:00:00 GMT http://www.drugdevelopment-technology.com/contractors/contract_research/indigo Indigo Biosciences Indigo Biosciences is a preclinical contract research organization, serving clients involved in pharmaceutical and nutraceutical R&D, biotechnology, and related sectors. We offer reliable, high quality, and confidential screening services for drug discovery / drug development, characterization of active ingredients, and molecular toxicology. We specialize in evaluation of the effects of small molecules on nuclear receptors, a major class of therapeutic drug targets. Indigo Biosciences offers a quality alternative to the development of expensive in-house analyses outside your company's specific expertise. We offer practical experience in high-throughput and high-content screening assays, professional consultation, rapid response and turnaround, and confidential, well-documented results. We can save you time and money as you expand your business in new research directions, and we can provide you with the opportunity to explore new scientific frontiers without compromising your bottom line. CONTRACT SCREENING SERVICES FOR NUCLEAR RECEPTORS Indigo Biosciences specializes in analyzing the effect of drug candidates or other small molecules on gene expression controlled by nuclear receptors. These receptors are involved in cancer, diabetes, obesity, metabolic syndrome, and other diseases. Members of the Nuclear Receptor (NR) superfamily are intracellular transcription factors that directly regulate gene expression in response to small molecules. Due to their role in maintaining cellular homeostasis, NRs are excellent targets for intervention in a variety of diseases. Certain NRs are involved in the toxic response and drug-drug and nutrient-drug interactions. We serve clients interested in addressing diseases or side effects regulated by NRs and triaging potentially harmful drug candidates. Indigo Biosciences provides screening services, in whole-cell reporter gene assay format, for numerous nuclear receptors including the following targets: Peroxisome Proliferator-Activated Receptor-alpha (PPARalpha) Peroxisome Proliferator-activated Receptor-beta (PPARbeta) Peroxisome Proliferator-Activated Receptor-gamma (PPARgamma) Pregnane X Receptor (PXR) Constitutive Androstane Receptor (CAR) Farnesoid X Receptor (FXR) Retinoid X Receptor-alpha (RXRalpha) Estrogen related Receptor-alpha (ERRalpha) Thyroid hormone Receptor-alpha (TRalpha) Progesterone Receptor (PR) Estrogen Receptor-alpha (ERalpha) Estrogen Receptor-beta (ERbeta) Androgen Receptor (AR) Glucocorticoid Receptor (GR) Mineralocorticoid Receptor (MR) Liver X Receptor-alpha (LXRalpha) Liver X Receptor-beta (LXRbeta) Vitamin D Receptor (VDR) RAR-related Orphan Receptor-alpha (RORalpha) PREFORMATTED NUCLEAR RECEPTOR REPORTER ASSAYS We offer for sale several of the whole-cell reporter-gene assays listed above. These assays typically comprise frozen transfected cells preformatted on 96-well plates. Binding of small molecules to nuclear receptors expressed by these cells affects expression of the enzyme luciferase, which can be used to determine EC50 or IC50 values for agonists or antagonists. Please inquire for additional information. QUANTITATIVE ANALYSIS OF GENE EXPRESSION USING MICROARRAYS AND REAL-TIME PCR We offer services for quantitative analysis of the effect of drug candidates, nutrients or other small molecules on gene expression in cells, tissues, and animal models of disease using microarrays and real-time PCR methods. CUSTOM ASSAY DEVELOPMENT Our experienced research team can work with you to create high-throughput reporter gene assays for diverse targets. SAVE TIME AND MONEY Take advantage of our cost-effective bioassay screening and preclinical compound profiling services. Our clients maintain title to, ownership of, and all proprietary rights to data provided by Indigo Biosciences. Allow Indigo to complement your strengths by saving you time and money on what we do best. Contact one of our scientists today to discuss your outsourcing needs. http://www.drugdevelopment-technology.com/projects/oritavancin/ Tue, 06 May 2008 00:00:00 GMT http://www.drugdevelopment-technology.com/projects/oritavancin/ Oritavancin - Glycopeptide Antibiotic Oritavancin is an investigational glycopeptide antibiotic currently being developed by Targanta Therapeutics for the treatment of serious gram-positive bacterial infections. It was originally discovered and developed by scientists at Eli Lilly as a potential replacement for vancomycin. Targanta Therapeutics acquired worldwide rights to oritavancin from Intermune Inc in 2005, to which the drug had previously been licensed in 2001. In February 2008, Targanta Therapeutics filed an NDA with the US FDA for use of oritavancin in the treatment of complicated skin and soft tissue infections (cSSIs). Other potential indications for this new antibiotic include bacteraemia and osteomyelitis. MEETING THE CHALLENGE OF GRAM-POSITIVE RESISTANCE The emergence of strains of gram-positive bacteria such as Streptococcus pneumoniae, Staphylococcus aureus, Staphylococcus epidermidis and enterococci resistant to common antibiotics poses a major therapeutic challenge. "The emergence of strains of gram-positive bacteria resistant to common antibiotics poses a major therapeutic challenge." For many years the glycopeptide vancomycin was the mainstay of treatment of infections such as methicillin-resistant S aureus (MRSA) and difficult-to-treat enterococcal infections. However, reduced susceptibility of S aureus to vancomycin and resistance to vancomycin among strains of enterococci now limit its clinical usefulness. The advent of the oxazolidinone, linezolid, and the streptogramin combination, quinupristin-dalfopristin, as well as more recent additions such as the glycylcycline tigecycline and glycopeptide, dalbavancin have expanded treatment options for serious resistant gram-positive infections. However, evidence has emerged of resistance to both linezolid and quinupristin-dalfopristin; additionally, quinupristin-dalfopristin lacks intrinsic activity against Enterococcus faecalis. Consequently there remains a need for more agents to combat multidrug-resistant gram-positive infections. GLYCOPEPTIDES A GROWING CLASS OF ANTIBIOTICS The glycopeptides are an important class of antibiotics for the treatment of serious gram-positive infections, including those due to staphylococci and enterococci. Today this class contains not only vancomycin, approved by the US FDA in 1964, but also teicoplanin and dalbavancin. Oritavancin is semi-synthetic derivative of a precursor drug closely related to vancomycin. Although it has a similar mode of action to vancomycin, important differences exist such as that oritavancin has activity against vancomycin-resistant pathogens. For example, oritavancin inhibits the transglycosylation step of bacterial cell-wall biosynthesis. In contrast to vancomycin, oritavancin possesses concentration-dependent bactericidal activity against enterococci, S pneumoniae, and staphylococci, including MRSA. Importantly, it is not affected by the vanA, vanB, and vanC-encoded alterations in the bacterial cell wall that confer vancomycin resistance. EFFICACY IN cSSIs Oritavancin has demonstrated clinical effectiveness in two pivotal phase III trials in patients with cSSIs due to gram-positive pathogens. The first was a 517-patient randomised, double-blind, parallel-group trial, in which three-days i.v. oritavancin (1.5 and 3.0mg/kg/day) was compared with i.v. vancomycin 10&dash;15mg/kg twice daily for three to seven days followed by oral cephalexin 500&dash;1,000mg twice daily to complete up to 14 days therapy. "Oritavancin has demonstrated clinical effectiveness in two pivotal phase III trials in patients with cSSIs due to gram-positive pathogens." The second trial, of similar design, enrolled 1,267 patients with cSSIs who were randomised to either i.v. oritavancin 200mg/day for three to seven days followed by oral placebo, or i.v. vancomycin 15mg/kg twice/day for three to seven days followed by oral cephalexin 1,000mg twice daily. In both trials the primary endpoint (clinical cure in clinically evaluable patients at first follow-up with 10% non-inferiority margin) was met with the advantage of a shorter duration of therapy for patients in the oritavancin treatment arm. In the larger of the two trials, treatment with oritavancin was associated with a 19.2% relative reduction in the overall incidence of adverse events compared with vancomycin/cephalexin (p<0.001). MARKETING COMMENTARY In an era of rising rates of bacterial resistance to commonly used antibiotics, new agents are urgently needed to treat bacterial infections effectively and halt the spread of resistant strains. This need is arguably greatest in the hospital environment where rates of bacterial resistance are highest. MRSA is a particular problem because it displays resistance to most classes of antibiotics. Although the hospital antibacterial market represents only a third of all antibacterial sales, increasing antibiotic resistance in the hospital environment has increased the demand for more effective antibiotics making it an attractive sector for new antibacterial agents. http://www.drugdevelopment-technology.com/projects/valtorcitabine/ Mon, 07 Apr 2008 00:00:00 GMT http://www.drugdevelopment-technology.com/projects/valtorcitabine/ Valtorcitabine - Combination Drug Therapy for Chronic Hepatitis B In partnership with Novartis Pharma, Idenix Pharmaceuticals is developing valtorcitabine (L-deoxycytidine) as part of a fixed-dose combination therapy with telbivudine for the treatment of chronic hepatitis B virus (HBV) infection. Like telbivudine, valtorcitabine is a highly specific and selective inhibitor of HBV replication in vitro. It specifically targets HBV DNA polymerase without inhibiting human cellular polymerases. "At a dose of 900mg/day, valtorcitabine achieved a 99.9% reduction in viral load." Valtorcitabine is still in early-stage development, where it is being investigated in proof-of-concept trials in combination with telbivudine. Preclinical studies have shown the drugs act synergistically in inhibiting HBV replication and thus support the development of the two drugs in combination therapy. THE BURDEN OF CHRONIC HBV INFECTION HBV, sometimes termed serum hepatitis, is one of several viruses that can cause infectious hepatitis, a disease of the liver. Among the most common infectious diseases in the world, HBV is transmitted through contact with infected blood and other body fluids as well as from mother to child. Chronic HBV infection develops when the host immune response fails to eradicate the primary infection. Estimates suggest that worldwide 350&dash;400 million people have chronic HBV infection, placing them at increased risk of liver cirrhosis (scarring), hepatocellular carcinoma (liver cancer), liver failure and death. Prevalence is particularly high in Asia: China alone accounts for about one third of all cases of chronic HBV infection. While active immunisation against HBV infection is effective in preventing a primary infection, it is of no effect once HBV infection becomes established. Currently, over a million deaths occur annually from HBV-related chronic liver disease. PHASE I TRIAL SUPPORTS VALTORCITABINE EFFICACY The initial efficacy and safety of valtorcitabine was demonstrated in a phase I randomised, double-blind, placebo-controlled dose escalation study, in which valtorcitabine (50&dash;1,200mg/day) was administered orally once daily for four weeks to chronic HBeAg positive HBV patients. Over the 12-week follow-up period, treatment with valtorcitabine produced marked, dose-dependent reductions in HBV-DNA (viral load). At a dose of 900mg/day, valtorcitabine achieved a 99.9% reduction in viral load. Treatment with valtorcitabine was well tolerated by HBV patients in this study, with a safety profile comparable to placebo. Based on these early clinical findings, studies are now underway to explore the clinical benefits of combining valtorcitabine with telbivudine with the aim of developing an effective fixed-dose combination regimen for patients unable to achieve an optimal therapeutic response with single-agent therapy. A 12-month phase II trial is underway to compare the effects of telbivudine 600mg/day with telbivudine 600mg plus valtorcitabine 900mg/day in compensated HBeAg positive HBV patients with high viral loads. EXPANDING TREATMENT OPTIONS FOR CHRONIC HBV Current treatments for chronic HBV infection include injectable interferon-alpha, which has been available for more than a decade. More recently, treatment has expanded to include the nucleotide analogues, orally administered drugs that directly inhibit HBV replication. They include lamivudine, adefovir, entecavir and, most recently, telbivudine. "Despite important advances in treatment, chronic HBV infection remains an area of significant unmet clinical need." Although effective in a high proportion of patients, and generally well tolerated, drug resistance is a problem, leading to viral breakthrough and increased risk of liver disease. Of the available drugs, lamivudine has the least favourable resistance profile; up to 70% of patients develop resistance within three to four years of treatment. Despite important advances in treatment, chronic HBV infection remains an area of significant unmet clinical need. The search continues to develop drugs with increased antiviral potency, good tolerability and reduced propensity to induce resistance. In addition to the potential to improve treatment outcome, combination therapy may also help reduce the risk of drug resistance. MARKETING COMMENTARY The advent of oral nucleotide analogues represents an important advance in the treatment of chronic HBV infection, a disease that affects about 5% of the world's population. Significant opportunities exist in the HBV market for more drugs of this and other classes that can offer greater viral suppression, are well tolerated, and slower to induce resistance. Longer-term the market for HBV therapies is expected to evolve towards the use of combination therapies, analogous to the use of HAART in HIV infection. If clinical trials prove successful, fixed-dose combination therapy with telbivudine and valtorcitabine may help to bridge current treatment gaps. http://www.drugdevelopment-technology.com/projects/pertuzumab/ Wed, 02 Apr 2008 00:00:00 GMT http://www.drugdevelopment-technology.com/projects/pertuzumab/ Pertuzumab -Cancer Therapy Roche/Genentech's pertuzumab is a humanised monoclonal antibody (MAb) to the HER2 receptor that is currently in phase III development for the treatment of advanced breast cancer. Progression to phase III clinical trials comes on the back of encouraging phase II data, which suggest that the addition of pertuzumab to trastuzumab (Herceptin) can benefit breast cancer patients no longer responsive to standard therapy (trastuzumab plus chemotherapy). HER DIMERISATION INHIBITORS (HDIs) &dash; A NEW THERAPEUTIC CLASS The HER family of transmembrane tyrosine kinase receptors, most especially HER2, have been identified as an important therapeutic target in breast cancer. The HER signalling pathway is known to play a pivotal role in neoplastic cell growth, differentiation, malignant transformation and resistance to chemotherapy. "Trials suggest that the addition of pertuzumab to trastuzumab can benefit breast cancer patients no longer responsive to standard therapy." In patients with HER2-positive breast cancer, amplification of the HER2 oncogene leads to over-expression of the receptor on cancer cells and promotion of tumour cell growth. It affects about 20&dash;30% of breast cancer patients and is associated with aggressive disease and poor prognosis. Roche's trastuzumab (Herceptin), which targets the HER 2 receptor protein, is now an established treatment for patients with HER2-positive breast cancer. Pertuzumab also targets the HER2 receptor but as a HER dimerisation inhibitor, or HDI, it inhibits the dimerisation or 'pairing' of the HER2 protein with other members of the HER family of receptors: HER1/EGFR, HER3 and HER4. For example, in response to mitogenic signals, HER1 and HER3 form heterodimers with HER2 and act as strong oncogenic signals. WORKING IN COMBINATION WITH HERCEPTIN With complementary modes of action, potential exists to combine pertuzumab with trastuzumab in the treatment of HER2-positive breast cancer. Early results from a non-randomised phase II study have shown evidence of meaningful activity from pertuzumab in combination with trastuzumab in a cohort of patients with late-stage cancer whose disease had progressed during trastuzumab therapy. At study entry, all patients had measurable progressive HER2 positive breast cancer and had received up to three courses of prior chemotherapy plus trastuzumab. Preliminary results showed that approaching 20% of patients responded to pertuzumab plus trastuzumab, while a further 21% experienced disease stabilisation lasting for at least six months. Phase III trials will explore the effectiveness of pertuzumab in combination with trastuzumab as first-line therapy in metastatic disease as well as in the neoadjuvant setting in early breast cancer (prior to surgical removal of the tumour). POTENTIAL IN OVARIAN CANCER Encouraging preliminary results have been reported with pertuzumab in patients with ovarian cancer, in which HER2 over-expression also occurs. A phase II double-blind, placebo-controlled trial enrolled 130 women with advanced ovarian, primary peritoneal or fallopian tube cancer who had experienced disease progression within six months of receiving platinum-based chemotherapy. Patients were randomised to pertuzumab plus gemcitabine or gemcitabine alone. In this difficult-to-treat population, overall progression-free survival increased by 52% in the combination treatment arm. Median progression free survival was 3.0 months (0&dash;8.7 months) versus 2.6 months (0&dash;9+ months) and progression-free survival rate at four months 49% versus 34% in the combination and gemcitabine alone arms respectively. "Encouraging preliminary results have been reported with pertuzumab in patients with ovarian cancer." Adverse events were consistent with previous clinical trials of pertuzumab and included fatigue, diarrhoea, back pain and neutropenia. MARKETING COMMENTARY Although there have been major advances in the treatment of breast cancer in the last ten to 15 years, it remains a disease for which additional treatments are still needed to improve outcome. It is still the leading cause of cancer mortality in women. Roche/Genentech's pertuzumab derives from the companies' expertise in therapeutic MAb research and development, which has seen trastuzumab (Herceptin) become a standard therapy for different stages of HER2-positive breast cancer. Researchers suggest that the potential to exploit synergism by combining trastuzumab with pertuzumab may offer a more effective therapeutic approach to breast cancer than treatment with a single HER2 MAb.