Bio Screening Industry News

LONDON–(BUSINESS WIRE)–The drug discovery process has changed dramatically over the past decade and continues to evolve in response to new discoveries and technologies. There is also increasing demand to produce more drug candidates and decrease attrition during drug development. Recent advances in cell culture robotic technology have grown out of the need to maximise efficiency and minimise the possibility of errors, contamination and failure associated with high-throughput cell culture.

In addition, the trends towards assay miniaturisation and multiplexing for high-throughput and ultrahigh-throughput have been triggered by the necessity to reduce development and operational costs. Despite advances in cell based assay technology, numerous bottlenecks still need to be addressed in drug discovery for the identification of novel drug candidates.

New analysis from Frost & Sullivan (http://www.drugdiscovery.frost.com), European Cell Based Assays Markets, finds that the market for cell based assay kits earned revenues of $66.2 million in 2007 and estimates this to reach $220.1 in 2014.

As pharmaceutical companies strive to improve the cost effectiveness of their drug discovery programmes, it is becoming apparent that considerable amounts of money are lost on compounds that fail late in the drug discovery process because of their toxicity.

“Over the past decade, various initiatives have been taken to improve the science of predicting toxicity and improving extrapolation to humans, including the use of cell based assays to enhance predictions,” notes Frost & Sullivan Research Analyst Dr. Laleh Safinia. “The revolution in the drug discovery process has recently demonstrated emerging lab disciplines and technology platforms in the area of cell based assay screening, holding great promise for the discovery of new drug targets.”

Drug targets derived from genomics and proteomics projects have sparked the interest of pharmaceutical, biotechnology and drug discovery companies in screening large numbers of compounds using cell based assays in an ultrahigh-throughput format. Progress and advances in a number of technologies have made the utilisation of live cells in high-throughput screening and high-content screening assays an attractive option in the drug discovery process.

Partnerships and alliances between active participants within this industry will allow the acquisition of new molecules, increase profitability and offer a pipeline of other drugs in development as well as remove some of the bottlenecks within drug discovery.

Cell based assays are an important aspect of the drug discovery process. However, there is a growing need for reliable and robust assay kits to enable the effective standardisation of assays and a reduction in variability. For researchers using automated screening systems, the stability and compatibility of reagents with robotic components is often a concern, resulting in high cost of operation.

“The assay reagent must be stable at ambient temperature; signal generated by the assay should be stable for an adequate period of time to be able to monitor cells over a period of time,” says Dr. Safinia. “Thus, HTS requires the optimisation of HTS assays and protocols. Approximately $200 million could be saved through more productive discovery programs or cell based assay screens that boost clinical success rates.”

With the increase in demand for new drugs, the degree of competition among the drug discovery companies is also intensifying. The initial investment is considerable; however, the scope for new drug target and profit margins is also high.

“There is, therefore, a heightened need for target validation technology to verify the correct target through advances in assay protocols, novel technologies and reliable data analyses,” comments Dr. Safinia. “Identifying the correct drug target through the use of genomics, proteomics and chemical libraries for drug discovery is a critical bottleneck in the pharmaceutical and biotechnology industries.”

There have been tremendous efforts by the pharmaceutical industry to improve cell based screening platforms to expedite target validation as well as for use in preclinical trials. In order to understand the complexity of biological systems and accelerate the hit-to-lead process, recent advances in microfluidic technologies and automation have attracted a lot of attention with promising applications in cell based biosensors and drug screening.

In addition, considerable efforts are being made to improve the science of predicting the toxicology of emerging clinical candidates to reduce the ADME/Tox failure of drug candidates.

If you are interested in a virtual brochure, which provides manufacturers, end users, and other industry participants with an overview of the European cell based assays markets, then send an e-mail to Patrick Cairns, Corporate Communications, at pcairns_pr@frost.com, with your full name, company name, title, telephone number, company e-mail address, company website, city, state and country. Upon receipt of the above information, an overview will be sent to you by e-mail.

European Cell Based Assays Markets is part of the Drug Discovery Technologies Growth Partnership Service programme, which also includes research in the following markets: Contract Research Organisations (CROs) Markets in Europe, Nucleic Acid Isolation Markets in Europe and Advances in Laboratory Automation Markets in Europe. All research included in subscriptions provide detailed market opportunities and industry trends that have been evaluated following extensive interviews with market participants. Interviews with the press are available.

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European Cell Based Assays Markets

HAMBURG, Germany and OXFORD, England and OSLO, March 12, 2008 /PRNewswire-FirstCall/ — Evotec AG announced today that Spermatech A/S has chosen them as a partner to identify small molecule therapeutics for their pharmaceutical discovery project.

Through the study of the physiology of sperm motility, more specifically of “rapid swimmers” that cause fertilisation, Spermatech have identified biological targets that could be exploited in the development of non-hormonal reversible male contraceptives. On this basis, Evotec and Spermatech have defined a strategy for a tailored drug discovery project. Evotec will apply its expertise and proprietary technologies in assay development, high throughput screening and NMR (Nuclear Magnetic Resonance) screening to identify inhibitors of the sperm specific target protein. The screening will be performed with Evotec’s screening library of 250,000 drug-like compounds. Compounds will be identified that reduce sperm motility and will be used in the development of non-hormonal reversible male contraceptives at Spermatech. In addition, compounds that promote target activity may be evaluated as supporters of male fertility.

Dr Mark Ashton, Executive Vice President Business Development Services at Evotec, said: “We are extremely pleased that Spermatech has selected Evotec for this interesting project. It will allow us to use our combined technologies in assay development, high-throughput screening and NMR screening to identify the most promising candidates in the therapeutic field. Evotec’s highly diverse compound library is a good starting point to identify such active molecules and the additional results from NMR investigations of the hits with the target protein will provide the medicinal chemists with useful information to support subsequent drug design.”

“We were impressed by Evotec’s highly specialized and integrated capabilities. The collaboration will provide us with access to state-of-the-art assay development and screening technology and expertise together with a high quality library of small molecules. We are confident that this will provide an excellent starting point and valuable information to progress the molecules into more advanced stages. We really appreciated that during the initial scientific discussions of the project Evotec clearly demonstrated a results-oriented spirit in support of our project.” commented Eirik Naess-Ulseth, Chief Executive Officer, Spermatech.

Forward looking statements

Information set forth in this report contains forward-looking statements, which involve a number of risks and uncertainties. Such forward-looking statements include, but are not limited to, statements about the anticipated benefits of Evotec’s products and services, the payments that Evotec may receive under its collaboration agreement with Spermatech, the anticipated timing and results of Evotec’s clinical and pre-clinical programs, and other statements that are not historical facts. Evotec cautions readers that any forward-looking information is not a guarantee of future performance and that actual results could differ materially from those contained in the forward-looking information as a result of risks and uncertainties. These include risks and uncertainties relating to: Evotec’s ability to complete the merger because conditions to the closing of the merger may not be satisfied; the failure to successfully integrate the businesses of Evotec and Renovis; unexpected costs or liabilities resulting from the merger; the risk that synergies from the merger may not be fully realized or may take longer to realize than expected; disruption from the merger making it more difficult to maintain relationships with customers, employees or suppliers; competition and its effect on pricing, spending, third-party relationships and revenues; the need to develop new products and adapt to significant technological change; implementation of strategies for improving internal growth; development, use and protection of intellectual property; general worldwide economic conditions and related uncertainties; future legislative, regulatory, or tax changes as well as other economic, business and/or competitive factors; and the effect of exchange rate fluctuations on international operations.

The risks included above are not exhaustive. The Registration Statement on Form F-4 filed by Evotec with the Securities and Exchange Commission contains additional factors that could impact the combined company’s businesses and financial performance. The parties expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in the parties’ expectations or any change in events, conditions or circumstances on which any such statement is based.

Roche has entered into an agreement to provide drug compounds for cardiotoxicity testing using a cell-based platform that could play a major role in the preclinical safety evaluation of drugs and newly developed compounds.

The deal aims to detect any drug-induced changes in the electrical activity of the heart, such as prolongation of the QT interval, which could cause faster, slower, or irregular beating.

Cardiotoxicity has been cited as the reason 30 per cent of all drug compounds fail during testing and with this new deal Roche aim to build predictive models of toxicology to reduce this failure rate.

Under the terms of the deal, Roche will supply Cellular Dynamics International two sets of 25 compounds to test on its platform, that uses human cardiomyocytes derived from human embryonic stem cells. Financial terms of the agreement were not released.

“The validation of the company’s platform through this collaboration is the first step in using these cells in routine toxicology testing,” said Chris Kendrick-Parker, CDI’s vice president of business development.

The late detection of cardiotoxic side effects, such as QT prolongation, caused by pharmacological compounds can impede drug discovery and development projects, and consequently increase their cost.

Drug development can take anywhere between 8 to 16 years, and average cost of developing a drug is now around $500m-$800m with the cost expected to hit the $1bn mark within the next four years.

Market analysis firm Frost & Sullivan has estimated the price of failure at $50m-$70m with approximately 90 per cent of clinical candidates failing at development stage

The launch of new drugs with undetected cardiotoxic side effects could have hazardous consequences and could trigger lethal cardiac dysrhythmias in patients. Testing for the potential cardiotoxic side effects of compounds at an early stage of drug development has therefore been the goal of many pharmaceutical and biotechnology companies.

Electrophysiological test systems and cellular-based fluorometric high-throughput assays are now the test of choice for cloned human cardiac ion channels.

When you consider that every drug nowadays has to undergo testing for hERG block and electrophysiological effects, the potential for this market is huge.

According to Frost and Sullivan, a better understanding of pharmacokinetic properties motivates the use of innovative solutions and early ADME/Tox screening. As a result the European ADME/Tox technologies market is expected to grow from its current size of $384m to $776m by 2011.

Copenhagen & Aarhus Denmark, March 11, 2007 — CLC bio and Department of Biology, Faculty of Science at University of Copenhagen, have signed a site license agreement for CLC bio’s premier bioinformatics software solution, CLC Combined Workbench, in combination with CLC bio’s Educational Suite. The deal runs for five years and is for several hundred seats, giving every researcher, student and teacher access to the software at all times.

The Head of Department of Biology at University of Copenhagen, Professor Dr. Lene Lange states,
‘We chose CLC bio as our solution provider as CLC Combined Workbench provides cutting edge algorithms and analyses of a high scientific standard, which is fundamental for our research. Also the wide range of tools available in this single application will eliminate a lot of tedious tasks, importing, exporting, and converting data between various applications - and thus help us improve our workflow, freeing up valuable time for research. We’re also looking forward to using CLC Educational Suite as a solid backbone for our bioinformatics courses.’

University of Copenhagen’s Department of Biology is organized in different Research Centers which are involved in international top tier research collaborations. They are funded from sources like the European Union and the Bill & Melinda Gates Foundation, among others. The many projects range from retrieval of ancient DNA from fossils (Center for Ancient Genetics), bioinformatics, gene regulations and SNP (Cancer Research), complex dependent mutations, primates genome evolution (The Genomics Group), whole genome sequencing of hyperthermophilic archaea bacteria (Archaea Biology Group), muscle biology (Copenhagen Muscle Research Center) to studies of how climate changes affects distribution of life on Earth (Center for Macroecology).

CLC Combined Workbench is a comprehensive software solution for advanced DNA, RNA, and protein analyses, containing all features of CLC DNA Workbench, CLC RNA Workbench, and CLC Protein Workbench in one, integrated software package. The program will replace the whole range of outdated and expensive tools, which the research centers have been using previously. CLC Combined Workbench is available for Mac OS X, Windows, and Linux

About CLC bio
CLC bio is the world’s leading full-service bioinformatics solution provider, solely focusing on the development of bioinformatics: software, hardware, data analysis, and custom-designed bioinformatics algorithms.

CLC bio’s mission is to be among the most innovative bioinformatics companies in the 21st century. This is realized through:

Development of bioinformatics software and hardware based on the latest scientific findings
User-friendly, integrated and intuitive cross-platform software solutions
Continuous focus on customer needs and superior customer service
Frequent product updates including the latest IT technologies and bioinformatics algorithms
A flexible IT architecture, enabling customers to buy or develop individualized solutions at a reasonable price

Hamburg, Germany | Oxford, UK- Evotec AG (Frankfurt Stock Exchange: EVT) today announced that InterMune, Inc., has signed a second drug discovery contract with Evotec.

Evotec will support InterMune’s research efforts using their medicinal chemistry know-how. In addition, they will utilize their expertise and technologies in computational chemistry, protein production, X-Ray crystallography and ADMET to further characterize active compounds and optimize their potency and selectivity to generate lead molecules for subsequent progression into clinical trials.

This contract expands Evotec’s existing collaboration with InterMune which was initiated in early 2007. This collaboration applies Evotec’s fragment-based drug discovery platform, EVOlutionTM, in combination with their ultra-high-throughput screening (uHTS) technologies to InterMune’s targets.  To date new lead series have been identified for further optimization. Evotec also provides medicinal chemistry, secondary screening, protein production, X-ray crystallography and ADMET. The financial terms include a technology access fee for access to Evotec’s fragment-based drug discovery platform, EVOlutionTM, plus ongoing research funding.

“With the support of Evotec, InterMune has made considerable progress in their Hepatitis C drug discovery and development program. We are pleased that InterMune saw the value in our proprietary fragment-based drug discovery technology and that it has contributed to the success to their research efforts,” said Dr Mark Ashton, Executive Vice President Business Development Services at Evotec.