Under the agreement, CRELUX and ProQinase will establish and continuously expand an off-the-shelf crystal-grade protein kinase portfolio, optimized and quality-controlled for successful crystallization. In addition, the two companies will work closely together to provide new crystal-grade protein or crystal structures, tailored to meet customers’ needs.

Recombinant protein kinases, optimized for crystallization, will be produced and exclusively marketed by ProQinase, while CRELUX will continue to provide customers with crystallization and x-ray crystallography services. CRELUX will support ProQinase by performing crystallization quality control for each crystal grade protein batch. At the same time, ProQinase will grant CRELUX privileged direct access to kinase crystal-grade protein.

“This new joint crystal-grade kinase platform offers tremendous advantages: It enables us to continue to focus on our core expertise – complex structure solution – while leveraging the expertise of ProQinase to significantly strengthen our capacities in protein expression,” commented Dr. Michael Schäffer, CEO of CRELUX.

“The combination of CRELUX’s expertise in protein crystallography and ProQinase’s know-how in kinase cloning and expression makes the two companies the partners of choice for all customers interested in kinase crystallography,” noted Dr. Christoph Schächtele, CEO of ProQinase.

CRELUX has used its state-of-the-art structural biology platform to solve more than 250 crystal and co-crystal structures for pharma and biotech companies. This platform encompasses all steps – from target cloning and expression all the way to high-throughput protein crystallization and in-house x-ray crystallography.

ProQinase, as part of its integrated protein kinase technology platform, offers more than 150 recombinant human protein kinases – all produced in-house – and provides all types of in vitro testing services, with more than 220 protein kinases.

Notes to editors

CRELUX GmbH ( www.crelux.com) provides fast and affordable access to co-crystal structures for biotech and pharma companies worldwide. Three dimensional structures of target-compound complexes are unique sources of information during the rational drug discovery process. Straightforward availability of structural data at an early stage of the drug development process significantly enhances productivity and success rates during hit selection, lead generation, and lead optimization. CRELUX has streamlined the processes of structure generation and solved hundreds of co-crystal structures using an integrated technology platform. In addition to customer designed projects crystallization conditions of numerous relevant therapeutic targets are available within the Off-The-Shelf Program of CRELUX. Off-The-Shelf target structures are delivered at a fixed price and short turn around times, facilitating affordable access to structural information.

ProQinase GmbH ( www.proqinase.com) provides an Integrated Protein Kinase Technology (iProKiTe®) Platform for preclinical drug development of protein kinase inhibitors. More than 150 highly active recombinant kinases are offered for sale and more than 220 kinases are available for in vitro testing services (HTS and selectivity profiling etc.). Cellular and in vivo test systems including orthotopic tumor models allow further testing of lead compounds. A Clinical biomarker analysis service supports the evaluation of clinical trials.

Invitrogen researchers used RNA samples from BioServe’s OncoRNA (http://www.bioserve.com/products/oncoRNA.cfm) product line, a series of RNAs isolated from fresh-frozen, fully annotated tumor and adjacent normal tissues, to probe the Ncode(TM) Human miRNA microarray V3.  Ncode(TM) Profiler software identified miRNAs that were either up- or down-regulated in tumor versus healthy tissue, and researchers used quantitative PCR to validate the findings.

“Using the high quality RNA samples from BioServe, we were able to identify novel microRNA sequences that could potentially be involved in the generation of new tumor tissues, particularly in colorectal cancer,” said Chris Adams, research and development leader of Epigenetics at Invitrogen.  “If more stringently validated, these disease-related microRNAs may eventually serve as targets for diagnostic or therapeutic development.”

MicroRNAs are short RNA sequences that do not code for specific proteins but are extremely important in the regulation of gene expression; they are implicated in several disease states including cancer and heart disease.  Among the activity of miRNAs is the triggering of messenger RNA (mRNA) degradation and the inhibition of protein translation – the process of assembling amino acids into proteins based on the instructions contained in mRNA sequences.  Invitrogen’s Ncode(TM) Human miRNA microarray V3 consists of miRNA content from multiple sources, including the Sanger 10.0 miRNA database and novel miRNAs unavailable in public databases, giving users access to strong content for identification and study of miRNAs.

“MicroRNA is making headlines in drug discovery for its ability to fine tune the activity of genes and its part in the formation of cancer,” said Kevin Krenitsky, chief executive officer, BioServe. “This makes it all the more critical that researchers can be certain they are working with stable, highly annotated samples collected under rigorous ethical and scientific protocols. We created OncoRNA to respond to this need, providing bench-ready RNA for tomorrow’s discoveries.”

About BioServe

BioServe is a leader in the processing, development, and validation of diagnostic tests for the practice of personalized, predictive and preventive medicine. Leading pharma, biotech and diagnostic firms collaborate with BioServe to identify and validate markers that cause disease while correlating clinical and molecular data to develop new diagnostic tests promoting wellness around the world. BioServe offers the Global Repository(R), a growing library of over 600,000 human DNA, tissue and serum samples linked to detailed clinical and demographic data from 140,000 consented and anonymized patients from four continents. Leveraging BioServe’s robust genomic analytical services, technology, Global Repository and CLIA-certified laboratory, collaborators gain a complete, highly efficient platform for processing diagnostic test results and identifying genomic markers for powerful new assays. BioServe has headquarters in Beltsville, MD and Hyderabad, India. For more information please visit www.bioserve.com or call 301-470-3362.

About Invitrogen

Invitrogen Corporation (NASDAQ:IVGN) provides products and services that support academic and government research institutions and pharmaceutical and biotech companies worldwide in their efforts to improve the human condition. The company provides essential life science technologies for disease research, drug discovery, and commercial bioproduction. Invitrogen’s own research and development efforts are focused on breakthrough innovation in all major areas of biological discovery including functional genomics, proteomics, stem cells, cell therapy and cell biology — placing Invitrogen’s products in nearly every major laboratory in the world. Founded in 1987, Invitrogen is headquartered in Carlsbad, California, and conducts business in more than 70 countries around the world. The company employs approximately 4,700 scientists and other professionals and had revenues of approximately $1.3 billion in 2007. For more information, visit www.invitrogen.com.

Coordinating personalized medicine on an international level, Dr Edward Abrahams, Executive
Director of the Personalized Medicine Coalition believes that biomarkers will eventually impact all
disease areas.

“When they were validated, and when it can be understood how clinically useful they are, biomarkers will be the easier method to understand the etiology of disease and human wellness,” commented Abrahams.

While the science of personalized medicine is fairly new, it is already being demonstrated in successful approaches to treating breast cancer and HIV. In cancer research in particular, industry is realising the potential of a separate diagnostic readout for every patient to allow for more targeted therapeutics. Abrahams sees biomarkers as “the scalpel that opens the patient,” but despite current success there are also serious issues for the uptake of personalized medicine, such as barriers to market.

The Personalized Medicine Coalition has been set-up to deal with such barriers in all levels of
research across the various industries involved. Evolving business models, demonstrating clinical
utility, and improving training at the bedside are just a few of the barriers that have affected “a clear regulatory pathway to co-develop personalized products,” commented Abrahams.

Despite warning of the serious issue of probability when using biomarkers as predictive tools, Abraham’s view of the future is bright: “I and many foresee a day when we’ll have predictive
biomarkers across all of healthcare.” With successful validation and clinical usefulness, advancing the use of biomarkers in industry will be a key stepping stone towards a personalized approach and the success of the healthcare system in the future.

Reducing healthcare costs will be a vital step to ensuring an effective system is in place for our aging populations; “personalized targeted therapies” may be one way to improve outcomes, with products tailored to each patient group. Highlighting this is one of the goals of the Personalized Medicine Coalition.

“Even if the individual products might cost more money, the system might save money by getting the approach right the first time.”

Hear more from Dr Edward Abrahams during his plenary lecture at the upcoming Informa Life
Sciences’ conference on ‘Advancing Biomarkers for Industry.’ Running alongside a Molecular
Diagnostics meeting, this takes place on 24-25 June 2008 in Brussels, Belgium. Find out more at
www.informa-ls.com/biomarkers

Carlsbad, USA and Madrid, Spain, April 9, 2008 – Coming on the heels of BIO-Europe Spring 2008 in Madrid where delegates engaged in an incredible 5800 one-to-one meetings, EBD Group today announced that the third annual BIO-Europe Spring 2009 partnering conference will be returning to Milan, Italy, the site of its highly successful inaugural event. BIO-Europe Spring 2009 will open its doors at the Milano Convention Center (MIC), March 16-18, 2009

BIO-Europe Spring in only its second year has become the second largest dedicated partnering event in the biotechnology industry.  Biotechnology companies from around the world participate in BIO-Europe Spring to identify and meet with companies across the life science value-chain, from large biotech and pharma companies to financiers and innovative start-ups.

Commenting on the return of BIO-Europe Spring to Milan, Professor Rossi Bernardi, Commissioner for Research, Innovation and Human Capital, The City of Milan, stated: “The City of Milan, which has been recently chosen by BIE as host of the world exhibition EXPO 2015, is looking forward to host the 2009 edition of BIO-Europe Spring.”

“We are excited that BIO-Europe Spring is returning to Italy. The conference is a unique opportunity for leaders of the global biotech and pharma community to meet in a setting conducive to doing business,” said  Edoardo Richter, Director International Division, Angelini Group. “As an Italian pharmaceutical company, the BIO-Europe Spring event helps to shine more light on the rapid progress of our industry, the exceptional quality of our scientific programs and the great potential for partnering with Italian firms.

“We look forward to bringing BIO-Europe Spring back to the city of Milan and another highly productive and dynamic conference,” said Carola Schropp, President of EBD Group. “Partnering has become the life blood of our industry. This is a phenomenon readily apparent to anyone attending the currently in-session BIO-Europe Spring 2008 in Madrid, where 1400 delegates from 838 companies are engaging in over 5800 partnering meetings.

About EBD Group:

EBD Group is the leading partnering firm for the global biotechnology industry. Since 1993, firms in the life sciences have leveraged EBD Group’s partnering conferences, technology and services to identify opportunities and to develop strategic relationships that drive their business.

EBD Group’s conferences (run in collaboration with leading industry partners and international trade associations) include BIO-Europe, the world’s largest stand-alone life science partnering conference (organized with the support of the Biotechnology Industry Organization, BIO); BIO-Europe Spring(R); BioPharm America(TM) (EBD’s new North American partnering event); and BioEquity Europe (co-organized with BioCentury Publications and BIO).

EBD’s sophisticated web-based partnering service, partneringONE(TM), is also used at numerous third-party events around the world. Outside of the conference format, EBD’s consultants can provide hands-on assistance for firms seeking to in- or out-license products and technologies. EBD Group has offices in the USA and Europe.

For more information visit www.ebdgroup.com

Seeplex tests are based on a breakthrough multiplexing PCR technology capable of detecting multiple pathogens in a single tube. Seeplex-based tests deliver maximum specificity, reproducibility and sensitivity and can be applied to a broad range of molecular diagnostics, including human, animal, plant and microorganism. Currently, Seegene’s Seeplex multi-pathogen detection tests offer labs worldwide simple, cost-effective and comprehensive screening for STDs, respiratory viruses, human papillomaviruses, sepsis and pneumonia.

“Our broad portfolio of multi-pathogen detection tests being optimized for ScreenTape and the Caliper LC90 systems will make it easier for clinical and research labs of all sizes to take advantage of our technology,” said Dr. Jong-Yoon Chun, Founder and Chief Executive Officer, Seegene. “Both the Lab901 and Caliper LifeSciences systems represent the cutting edge of automated detection. Working in combination with these leading systems provides a powerful high-throughput method for analyzing test results.”

The ScreenTape system is the first fully automated, walk-away solution for gel electrophoresis. ScreenTape will automate the simultaneous analysis of eight or sixteen Seeplex PCR samples. Processing speed for 8 samples is completed within 10 minutes;  16 samples within 15 minutes. ScreenTape displays results using easy to interpret color codes. The ScreenTape system comprises the TapeStation (that carries out liquid handling, electrophoresis and imaging), ScreenTape (a consumable that contains the pre-cast, pre-packaged gel and running buffer) and bespoke software. With no gel or buffer preparation and no system priming, even untrained operators can rapidly generate accurate and reproducible test data.

The LabChip 90 System performs fast, automated, 1-D electrophoretic separations of protein, DNA, and RNA samples directly from a 96 or 384 well plate. The LC90 can load and read 96 Seeplex samples within 45 minutes or 384 Seeplex samples in 4 hours in easy-to-interpret reports.

Seegene is currently working to optimize Seeplex tests for other automated capillary electrophoresis systems. Seeplex’s compatibility with a wide range of automated detection systems will provide end-users with the flexibility to use the platform best suited for their purposes.

About Seeplex(R) System: Frontier of Multi-pathogen Detection

Seeplex(R) is a breakthrough multiplexing PCR technology that enables a new standard in simultaneous multi-pathogen detection. Seeplex works in combination with automatic detection systems such as Capillary Electrophoresis and delivers a benchmark in testing accuracy, efficiency and cost-effectiveness.

About Seegene

Seegene, Inc. is pioneering the field of multi-pathogen testing. Seegene applies its novel and proprietary Seeplex system utilizing “DPO (Dual Priming Oligo)” and “ACP (Annealing Control Primer)” to create multi-pathogen tests delivering maximum specificity, reproducibility and sensitivity. With over 260 citations and several patents and patents pending, Seegene has been offering advanced molecular diagnostics services to over 1,000 major global institutes in more than 25 countries. Seegene is actively working with both the scientific and OEM business community. Seegene’s mission is to integrate Seeplex with disease diagnostics to provide a new guideline for effectively treating patients. Seegene was founded in 2000 and is based in Rockville, MD and Seoul, Korea. For more information please visit www.seegene.com.

Dr. Rudy Potenzone, worldwide pharmaceutical industry technology strategist at Microsoft Corp. and director of the Bio IT Alliance, states,
‘We are delighted to work together with CLC bio, a member of the Bio IT Alliance and one of the world’s leading bioinformatics solution providers. This collaboration will ultimately help life sciences firms transition to the Microsoft platform throughout their research and development departments. CLC bio’s tools, fully integrated with the Microsoft Office System, increase ease of use and expand the number of potential users, while reducing administrative overhead and creating a lean workflow. Furthermore, CLC bio’s internationally renowned experts are available for consulting and customized development.’

Jan Lomholdt, Vice President at CLC bio, continues,
‘With our support for Microsoft’s server solutions, the first step in the process has already been taken. The second step is to further advance our collaboration in areas such as Next Generation Sequencing and high-performance computing, which ultimately can help realize the potential of personalized medicine. As a former member of Microsoft’s World Wide Advisory Council, I have first hand experience of the strength and potential Microsoft brings to the table with a collaboration like this, which of course is interesting for a company like ours.’

Windows HPC Server 2008, the successor to Windows Compute Cluster Server 2003, includes a common set of High Performance Computing productivity tools that reaches across desktop and clusters, including a new Parallel Computing Initiative for multicore development. CLC bio’s high-performance computing solution for servers and clusters, CLC Bioinformatics Cell, supports Microsoft’s Message Passing Interface (MPI) in order to run bioinformatics algorithms such as HMMER, ClustalW, and Smith-Waterman on Windows HPC Server 2008 installations.

All CLC bio’s solutions are cross-platform, running on Windows 2000, Windows XP, Windows Vista, as well as Mac OS X 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

Health organizations aren’t the only groups interested in Mumie. In Russia and many of the former USSR republics, Mumie is considered a strategic material and is used extensively as a performance enhancer within the armed forces (Spetnaz and other elite fighting groups) to help prepare cosmonauts before and during space travel, and as an important part in the restoration programs of national and Olympic-level athletes. It was surprising to me that Mumie was unknown to American athletes until recently when it was introduced by a Russian/American company in 1991.

To locate the origin for the word Mumie, one would have to go back 2,500 years to the time of the ancient philosopher and scientist Aristotle. He proposed the first procedures for testing the compound as well as its initial preparation in grape juice, honey and milk. Mumie is often used by ordinary persons to treat bone fractures and strains of muscles and ligaments, stomach disorders, nervous and cardiovascular problems, the inflammation of joints, and impotence. It is a good bio-stimulator, serves to elevate the immune system and neuro-hormonal regulation, controls oxidation-reduction processes, and has a positive influence on mineral metabolism. The most recent survey of the practical applications of Mumie have come from Moscow through the efforts of Drs. A.A. Altamyshev and B.K. Kortshubelkov and supported by the Russian Committee of Cosmonautics. To date, several hundreds research investigations have been conducted on Mumie which clearly point to its mechanisms of action and its usefulness.

Article about Mumie

Vice President of CLC bio, Jan Lomholdt, states, Having experienced massive pre-release interest from people within the Next Generation Sequencing segment, we’re confident that our cross-platform NGS solution which includes an intuitive graphical interface, numerous downstream analyses, and support for all the major NGS platforms, will become a hit. Especially when taking into consideration that we have assembled half a million 454 reads against the full E.coli reference genome, in around 2 minutes on a Dual-core laptop with 1 gigabyte RAM. In other words: This is FAST!”

“There is an explosion of interest in the next generation sequencing field right now, and I’m confident that CLC Genomics Workbench will become a valuable tool for the rapidly growing number of users in academia and industry who are using these new instruments for an amazing range of applications,” said Bio-IT World Editor-in-Chief Kevin Davies, PhD. “We’re also delighted that CLC bio has choosen this year’s Bio-IT World Expo in Boston to announce and introduce this product to the scientific and informatics communities.”

CLC Genomics Workbench includes accelerated assembly of Next Generation Sequencing data through use of High Performance Computing technology, making the assembly process very fast. The genomes to be assembled can be of any size, only limited by the number of gigabytes of RAM available on the computer running the assembly.

CLC Genomics Workbench takes full advantage of “paired end” data, and supports a number of features and work-tasks, such as reference assembly of genomes, De Novo assembly of genomes, SNP detection using advanced statistical models, Digital Gene Expression, metagenomics, clustering and assembly of EST and cDNA sequences, large amounts of genomics and transcriptomics downstream analyses, and workflow support. Some of the mentioned features will be implemented in future releases.

CLC Genomics Workbench has already been chosen as Next Generation Sequencing platform for all Danish universities. CLC bio will release CLC Genomics Workbench to the public in late May. To read more about CLC Genomics Workbench go to: www.clcbio.com/genomics

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

A central component of forensic analysis and drug testing, toxicological analyses of biological samples have traditionally been conducted using gas chromatography/mass spectrometry (GC/MS), with compounds identified by comparing the resultant mass spectra with reference mass spectra in spectral databases.

Although effective at identifying toxicological compounds, this approach has certain limitations, such as the fact that GC/MS is not very good at detecting polar and non-volatile compounds. Liquid chromatography (LC) coupled with MS offers a more flexible alternative, able to identify both polar and non-volatile compounds. However, it suffers from an inability to produce as detailed mass spectra as GC/MS, which has prevented the construction of large spectral databases for LC/MS. According to Aldo Polettini of the University of Verona, LC/MS databases generally contain spectra for only around 1200 compounds, compared to spectra for tens of thousands of compounds in GC/MS databases.

In recent years, however, a type of MS known as time-of-flight (TOF) has opened up another way of identifying toxicological compounds with LC/MS. TOF-MS measures the masses of charged molecules based on the time they take to travel along a chamber to a detector under the influence of an electric field, with smaller molecules travelling faster than larger molecules. This allows it to make measurements of molecular mass that are so accurate that they can be used to determine a compound’s chemical formula, and thereby also its identity.

The problem is that there aren’t any major databases containing information on molecular mass and chemical formulae specifically for toxicological compounds, so Polettini decided to create one. The easiest way to do this is to extract data for toxicological compounds from an existing chemical database and Polettini chose to do this with the US National Institutes of Health’s PubChem Compound. This is freely-available on the internet and comprises around 10 million entries, each of which contains information on a compound’s molecular mass and chemical formula.

Together with colleagues, Polettini created a subset of these entries by extracting all the compounds that could be classified as toxicological and then screening them based on their molecular mass and whether they contain elements such as hydrogen, nitrogen or fluorine. This resulted in a subset database containing entries for 50,500 toxicological compounds, including many drug molecules, both pharmaceutical and recreational, pesticides and poisons, as well as metabolites.

‘It contains a large number of metabolites,’ explains Polettini, ‘including glucuronides, which are very important in general unknown screening, especially when metabolite-rich biological matrices are used (e.g. urine).’

Once the database was up and running, all Polettini and his team needed to do to determine the chemical formula of an unknown toxicological compound was to match the molecular mass revealed by TOF-MS with the matching mass in their database. Testing this approach on hair, blood and urine samples from subjects that had taken pharmaceutical or recreational drugs, they found that they were able to identify a whole host of relevant toxicological compounds.

Predictably, the only problem they found was that a specific molecular mass can match more than one chemical formula and a specific chemical formula can match more than one toxicological compound. But the correct compound could usually be pinpointed by simply taking other available information into account, such as some of the spectral data produced by TOF-MS.

A molecule’s retention time in LC can also offer a way to chose between competing identities. To this end, Polettini is now attempting to enhance the database by incorporating an algorithm for estimating the retention time for proposed compounds. These estimates can then be compared with the actual retention time of the detected compound to help reveal the correct identity.

Following a decision to focus its resources on its immunomodulatory compounds, Active Biotech AB has discontinued its participation in the I-3D co-development program and granted Chelsea exclusive global rights to the portfolio in exchange for royalties on future sales. The I-3D portfolio, originally developed by Active Biotech and under joint development by both companies since 2006, consists of an extensive library of therapeutic compounds that have demonstrated, during preclinical testing, potent inhibition of DHODH activity while maintaining PK and safety properties superior to the marketed DHODH inhibitor. Inhibition of DHODH is the rate-limiting step in de novo pyrimidine biosynthesis, which is required for the proliferation of T-cells during clonal expansion. Potential indications for drug candidates in this library include transplant rejection, rheumatoid arthritis, psoriasis and systemic lupus erythematosus (SLE).

“We have greatly enjoyed our collaboration with Active Biotech and respect their decision to focus on their unique quinoline based therapeutic platform,” commented Dr. Simon Pedder, President and CEO of Chelsea. “We continue to believe that the I-3D portfolio of DHODH inhibitors may have value and have identified a cost-effective process for screening molecules in this portfolio which will require only a minimal investment of time and money. The results of this screening will permit us to make more informed decisions regarding our investment in the program for 2009 and beyond.”

About Chelsea Therapeutics

Chelsea Therapeutics is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases. The Company is currently developing a library of metabolically inert antifolate compounds engineered to have potent anti-inflammatory and anti-tumor activity to treat a range of immunological disorders. Early clinical data suggests that Chelsea’s lead antifolate compound, CH-1504, is a safe and effective treatment alternative to methotrexate for RA and may have further applications for psoriasis, IBD and certain cancers. Chelsea’s antifolate program is complemented by a strategic partnership with Active Biotech AB for the joint development of a portfolio of therapeutics targeting immune-mediated inflammatory disorders and transplantation. In addition to its autoimmune pipeline, Chelsea is developing Droxidopa, an orally active synthetic precursor of norepinephrine, for the treatment of neurogenic orthostatic hypotension. Currently approved and marketed in Japan, Droxidopa has accumulated over 15 years of proven safety and efficacy, historically generating annual revenues of approximately $50 million in Japan.

This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include reliance on collaborations and licenses, risks and costs of drug development, regulatory approvals, intellectual property risks, our reliance on our lead drug candidate CH-1504, our history of losses and need to raise more money, competition, market acceptance for our products if any are approved for marketing, reliance on key personnel including specifically Dr. Pedder, management of rapid growth, and the need to acquire or develop additional products.

The collaboration applies Evotec’s proprietary fragment-based drug discovery platform, EVOlutionTM to identify novel, small molecular weight compounds active against a protease target. The platform integrates, among other things, protein X-ray crystallography, computational chemistry, structural biology, biochemical, and NMR based fragment screening in combination with its high-quality fragment libraries. In the collaboration it is combined with Evotec’s expertise in medicinal chemistry and ADMET to further characterize active compounds identified and optimize their potency and selectivity to generate molecules for subsequent progression into clinical trials.

Under the agreement, Ono will pay to Evotec initial payments (technology access fee) for access to Evotec’s fragment-based drug discovery platform, EVOlutionTM, research funding as well as success-based milestones based on the research progress.

Dr Mark Ashton, Executive Vice President Business Development Services at Evotec, said: “We are extremely pleased that Evotec’s capabilities in drug discovery and, in particular, our proprietary EVOlutionTM platform for fragment-based drug discovery, have been so highly regarded by Ono and that they have chosen us as their partner for this collaboration.  We are confident that Evotec will contribute to Ono’s drug discovery program.”

“We have the highest regards for the wide range of drug discovery technologies Evotec possesses and highly anticipate the collaboration will result in identifying a novel drug having high potentials” said Daikichi Fukushima, Ph.D., Managing Director, Research Headquarters at Ono.

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 Ono, 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 satisfy the research-based milestones under the agreement with Ono, 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.

Through the study of the physiology of sperm motility, more specifically of “rapid swimmers” that cause fertilisation, Spermatech have identified bio-logical 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 com-bined 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 investi-gations 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 capabili-ties. 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 Næss-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.

On Nov. 20, 2007, FDA issued an Early Communication to the public and health care providers that the agency was evaluating postmarketing adverse event reports on Chantix related to changes in behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior.

As the agency’s review of the adverse event reports proceeds, it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms. As a result, FDA has requested that Pfizer, the manufacturer of Chantix, elevate the prominence of this safety information to the warnings and precautions section of the Chantix prescribing information, or labeling. In addition, FDA is working with Pfizer to finalize a Medication Guide for patients. This is an example of FDA working with drug manufacturers throughout products’ lifecycles to keep health care professionals and patients informed of new and emerging safety data.

“Chantix has proven to be effective in smokers motivated to quit, but patients and health care professionals need the latest safety information to make an informed decision regarding whether or not to use this product,” said  Bob Rappaport, M.D., director of the FDA’s Division of Anesthesia, Analgesia and Rheumatology Products. “While Chantix has demonstrated clear evidence of efficacy, it is important to consider these safety concerns and alert the public about these risks. Patients should talk with their doctors about this new information and whether Chantix is the right drug for them, and health care professionals should closely monitor patients for behavior and mood changes if they are taking this drug.”

Chantix was approved by FDA in May 2006 as a smoking cessation drug. Chantix acts at sites in the brain affected by nicotine and may help those who wish to stop smoking by providing some nicotine effects to ease the withdrawal symptoms and by blocking the effects of nicotine from cigarettes if users resume smoking.

In the Public Health Advisory and a Health Care Professional Sheet that was also issued today, FDA emphasized the following safety information for patients, caregivers, and health care professionals:

Patients should tell their health care provider about any history of psychiatric illness prior to starting Chantix. Chantix may cause worsening of current psychiatric illness even if it is currently under control. It may also cause an old psychiatric illness to reoccur. FDA notes that patients with these illnesses were not included in the studies conducted for the drug’s approval.

Health care professionals, patients, patients’ families, and caregivers should be alert to and monitor for changes in mood and behavior in patients treated with Chantix. Symptoms may include anxiety, nervousness, tension, depressed mood, unusual behaviors and thinking about or attempting suicide. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of varenicline therapy.

Patients should immediately report changes in mood and behavior to their doctor.

Vivid, unusual, or strange dreams may occur while taking Chantix.

Patients taking Chantix may experience impairment of the ability to drive or operate heavy machinery.

FDA will continue to update health care professionals with new information from FDA’s continuing review or if new information is received on Chantix and serious neuropsychiatric symptoms. FDA may consider requesting further revisions to the labeling or taking other regulatory action as the agency’s continuing reviews and conclusions warrant.

For more information:
http://www.fda.gov/cder/drug/infopage/varenicline/default.htm

The global purloiners of patents — led by Jamie Love — are thrilled to point out all of the new and important medicines that are the low hanging fruit of their property theft proposals — but are far less keen to explain how the fruit tree got there in the first place — or how they are nurtured.

In India, political leaders long cited former Prime Minister Indira Ghandi’s call for an end to “profiteering from life or death” in defense of their prohibition of patents on medicine. But in 2005, India reversed course and re-established patent protection for pharmaceutical products. The reason? Less than 10 percent of the nation’s estimated 3.5 million AIDS patients were receiving any medicine at all.

In other words, the elimination of patent rights doesn’t produce greater access to medicines.

There is a reason why virtually all the world’s “miracle drugs” have been developed in Western countries. It’s called incentive.

Intellectual property rights are the fertile soil that allowed the tree to grow in the first place — and to thrive. To borrow an over-used adjective from the world of global climate change — we must protect “sustainable” innovation.

Jamie Love and Company may very well say, “A world without patents, amen.” And they’re right, because minus pharmaceutical IPR we’d all better start saying our prayers — because that’s the only way we’re going to battle disease and improve the health of our global fraternity.

If the IGWG succeeds, pharmaceutical innovation dies. And that’s a Silent Spring we cannot afford.

Author: Peter Pitts
Source: DrugWonks

BIO’s lobbying efforts last year addressed a range of issues from patent reform to generics to FDA-related issues. The Associated Press reported as follows:

[BIO’s] lobbying efforts went toward cloning issues ahead of the Food and Drug Administration’s ruling that cloned meat and milk is safe for consumers. Several members of Congress tried to compel the agency to do more studies before issuing a ruling, but FDA cleared the products for consumption in January.

The biotech industry also lobbied on legislation to allow the Food and Drug Administration to approve generic copies of biotech drugs. Generic drug companies already market cheaper versions of regular, chemical drugs, but the FDA does not have the authority to approve copies of biotech drugs, which are more complicated. Biotech makers opposed a bill that would have made generic biotechs medically interchangeable with the originals. The industry also argued generic biotechs should be classified as similar, but not interchangeable.

They also want biotech medicines to be guaranteed at least 12 years on the market before having to compete with generic copies. Generic drug makers say any protection beyond five years is unreasonable. Senate lawmakers attempted to pass a compromise bill last year, but negotiations broke down over the length of exclusivity.

This report raises some interesting questions about how much various industries spend today on their Washington lobbying efforts. One of the issues that has repeatedly come up in the patent reform debate is how minimal the biotech industry’s lobbying efforts are in contrast with the high tech industry. The argument has been that the proposed patent reform legislation favors the high tech industry, which has traditionally had more of a voice and presence in Washington. However, as this report makes clear, the biotech industry’s expenditures on lobbying–at least BIO’s expenditures on behalf of the industry–are not inconsequential. So, this report begs the question: if biotech’s lobbying efforts pale in comparison to high tech’s lobbying efforts on Washington, just how much is the high technology industry spending on Washington lobbying? What kind of lobbying money is considered adequate to have a voice in Washington?

“Schering-Plough’s chief executive said yesterday the budget ax will fall first and hardest in New Jersey as the drugmaker cuts more than $1 billion in spending after the abrupt collapse of its top-selling cholesterol medicines.

“Fred Hassan said the global cost-cutting plan announced late Wednesday was still under development, but workers in the United States — particularly employees at the company’s Kenilworth headquarters — would bear the brunt of the projected 5,500 layoffs.

“‘The way it’s going to fall on the U.S., unfortunately, it’s going to fall on New Jersey,’ Hassan said in a telephone interview. ‘That’s the way the situation has unfolded.’”

“That’s the way the ball bounces, the cookie crumbles! Too bad for you! But, hey, I’m OK!”

A lot of families will be in trouble at the worst possible time as the entire US economy may be heading for a recession (according to Warren Buffet, Ben Bernanke, and other “insiders”).

Not all who are axed will be seeking jobs at other pharmaceutical companies, many of which are cutting back as well, but these are qualified people who can help pharmaceutical vendors work smarter and find potential clients within the drug industry. I propose, therefore, to help these people network with vendors — ad agencies, medical communications companies, solution providers, technology companies, etc — and possibly find at least some leads to a new career.

Source: Pharma Marketing Blog 

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.

Frost & Sullivan, the Global Growth Consulting Company, partners with clients to accelerate their growth. The company’s Growth Partnership Services, Growth Consulting and Career Best Practices empower clients to create a growth focused culture that generates, evaluates and implements effective growth strategies. Frost & Sullivan employs over 45 years of experience in partnering with Global 1000 companies, emerging businesses and the investment community from more than 30 offices on six continents. For more information about Frost & Sullivan’s Growth Partnerships, visit http://www.frost.com.

European Cell Based Assays Markets

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.

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.

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