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Archive for September, 2005

Logistics for Biopharmaceuticals

Strategies for Efficient and Compliant Supply Chain Operations,
Cold Chain Management and Technology Transfer
December 12-13, 2005 · Hyatt Regency Reston, VA

IBC’s 2nd Annual Logistics for Biopharmaceuticals conference will provide you with an opportunity to learn best-practices from experts in technology transfer, supply chain operations, cold chain management, outsourcing, packaging and distribution. You will learn the latest requirements and guidelines straight from the regulatory agencies and hear first-hand experiences from Amgen, Pfizer, Wyeth Biopharma, Chiron, Genentech, BioReliance, Cytogen, and Immunogen on strategies they developed to minimize risk and maximize the bottom line.

This conference will help you to evaluate and improve upon your current logistics and supply chain operations from conception through commercialization. Don’t miss this opportunity to ensure the quality and integrity of your products.

Shared Keynote Presentations

Using Risk Management to Enable Innovative Technologies in Pharmaceutical Manufacturing
Ronald F. Tetzlaff , Ph.D.,
Corporate Vice President,
PAREXEL Consulting
Perspectives on Pharmaceutical Manufacturing: The Changing Regulatory & Technological Environment
James Agalloco,
President,
Agalloco & Associates

Program highlights include:

FDA, USP, MHRA and PCCDG perspectives on cold chain control for biopharmaceuticals
Developing systems for the packaging, handling and distribution of biopharmaceuticals – Critical factors to consider
Building and maintaining a world class supply chain and logistics function to drive operational excellence
Strategies for effective planning and management of technology transfer projects
Effectively executing a strategic sourcing plan – Best practices for contract issues, service and quality agreements

The BMD Summit includes FOUR 2-Day Conferences featuring

37 Case Studies
Reports from Regulatory Agencies
3 Interactive Panel Discussions
Shared keynote sessions and exhibit/poster hall
For additional details on the other BMD Summit conferences please Download the Summit Brochure (PDF). When you register for the Disposables conference you will gain access and materials to all FOUR BMD Summit conferences. If you have any questions regarding this event, please contact IBC’s Client Services Department at 508-616-5550.

Take advantage our Mix and Match Team Discount – When 2 members of the same company register for any of the four conferences at the same time, the 3rd attends for FREE!

http://www.ibclifesciences.com

LifePharms, Inc. Receives Approval for Phase II SBIR Grant for Cancer Research from NIH

GROTON, Conn. (Sept. 25, 2005) – LifePharms, Inc., has received approval for the second phase of a 2 year, $903,000 Small Business Innovation Research (SBIR) grant from the National Institutes of Health’s National Cancer Institute to continue development of its leading anti-cancer compound. The Phase I grant was used to identify promising anti-cancer compounds from LifePharms’ natural product collections, as part of a larger effort by the National Cancer Institute to develop compounds that show selectivity in affecting cancer cells. The compounds under development at LifePharms thus far appear to demonstrate both the potency and selectivity that researchers are seeking in compounds that target and destroy cancer cells without affecting surrounding normal, healthy cells.
Lifepharms, Inc. is a biotechnology company headquartered at the University of Connecticut’s Technology Incubation Program at Avery Point in Groton. LifePharms’ research focuses on discovering novel natural product compounds from basidiomycetes and ascomycetes (mushrooms). Its collection consists of more than 16,000 samples of these fungi that have been collected from sites over the entire North American continent.
As an additional component of SBIR II grant, LifePharms will be developing a unique library containing up to 100,000 purified compounds from its fungal extracts. This library will allow the company and its research collaborators to rapidly identify new lead compounds targeting cancer and other therapeutic areas. The majority of the species in its collection have never been cultured or catalogued and are unavailable in any fermentation collection. Estimates indicate that 40 percent of drugs have been discovered from natural sources, and an even greater percent of the novel structural classes of compounds are from natural products.
The isolation and chemical identification of active lead compounds will be carried out at the Natural Products Laboratory of RTI International, which has a long history of natural product drug discovery that includes the discoveries of camptothecin and Taxol. These compounds and their chemical derivatives are two of the most universally used anticancer agents on the market. RTI’s discoveries represent nearly one-third of the anti-cancer therapeutic market. Dr. Nicholas Oberlies leads the project at the institution.
According to E. Edward Mena, Ph.D., President and Chief Scientific Officer of Life Pharms, “This grant is a welcomed validation of our approach to drug discovery through our novel natural product library. Not only are we investigating several anti-cancer compounds with unique and interesting properties, but our lead compound has a novel structure that is distinct from other cancer therapeutics in use or in devlopment. . We welcome the support from the NIH to bolster our research efforts.” Mena, is the principle investigator of the project.
In the past year the company has announced two other research collaborations. LifePharms is the lead institution along with Memorial Sloan-Kettering Institute and RTI on a project funded by a five-year research grant from the National Institute of Allergy and Infectious Diseases. The grant funds research to discover small-molecule therapeutics for smallpox infections. LifePharms also has entered into a Collaborative Research and Development Agreement (CRADA) with the Natural Products Utilization Research Unit of the U.S. Department of Agriculture’s Agriculture Research Service for the joint development of agricultural fungicides and herbicides.

The SBIR program is a highly competitive peer-reviewed grant program that provides support to small businesses with innovative technologies that possess significant commercial potential.

For more information, contact Dr. Mena at lifepharms@aol.com or at (860) 405-9219.

DATAMONITOR: 1 million Hep C patients could respond to therapy by 2014

NEW YORK, September 27, 2005- In 2004 around 366,000 patients infected with chronic hepatitis C (CHC) responded to pegylated interferon + ribavirin therapy, with 110,000 estimated in the key US market. However recent research by independent market analyst Datamonitor* (DTM.L) predicts that this number could increase three fold globally by 2014 due to increases in the rate of diagnosis and treatment. The most dramatic changes will occur if the new hepatitis C (HCV) protease and polymerase inhibitors reach the market in 2011.

The HCV virus was first characterized in 1989 and for the most part is transmitted by blood-to-blood contact, especially through transfusion (prior to widespread screening) and the sharing of needles among intravenous drug users (IVDUs). The WHO estimates that the average worldwide prevalence of HCV infection is around 3% or 170-200 million people, and variation between regions can be substantial. Areas of low prevalence (1-2.4%) tend to be within richer economies including the US, Japan, most European countries and Scandinavia whereas areas with high HCV prevalence (10%+) are located in Asia and Africa. Egypt is a notable case having a prevalence of 12%, translating into approximately 7.2 million infected individuals.

A hidden ticking time bomb

HCV remains a serious threat to present and future public health. In the US, HCV is the most common blood-bourne viral infection with an estimated 3.9 million individuals infected, 70% of which have chronic infection (1). HCV infection is assymptomatic for 90% of its history, a characteristic that not only hampers epidemiological survey of the disease, but also suggests a large number of individuals are unaware of their infection and are not receiving treatment, says Datamonitor infectious diseases lead analyst Dr John Savopoulos. “Currently 40% of chronic liver disease and 80% of hepatocellular carcinoma (HCC) is estimated to be HCV related, with the virus being the most common cause of liver transplantation in the US.”

Because the peak of HCV infection occurred during the 1970s-80s, the rate of patients presenting with HCV associated complications is expected to increase dramatically over the next 10? years. In fact, the US Centers for Disease Control (CDC) projects a four-fold increase in the number of those infected for 20 years with CHC from 750,000 to 3 million individuals from 1990-2015. Studies also suggest liver related mortality due to HCV will increase 180% in this timeframe, with HCV related direct medical costs estimated to reach $10.7billion by 2019. Clearly, better therapies for HCV eradication or those that can regress or stabilize liver disease are desperately needed.

Pharmaceutical companies Roche and Schering-Plough manufacture the latest generation of HCV treatments or pegylated-interferons known as Pegasys (peg-interferon 2a) and PEG-Intron (peg-interferon 2b). When used in combination with the broad-spectrum antiviral ribavirin (RBV), these molecules can eradicate the HCV virus in around 50% of cases. Eradication is defined as a sustained virological response (SVR) where HCV remains undetectable in a patient’s blood 24-weeks after cessation of treatment, Dr Savopoulos says. “Although not exclusively used for HCV treatment, pegylated interferons (and ribavirin) form the bulk of an estimated $2b global market for HCV treatments predicted to grow to around $4b in 2013. Datamonitor research suggests that in the US 70 – 200,000 patients per year receive pegylated interferons for HCV-therapy (compliant with the full course).”

A blunt edged tool, a growing “non responder” pool

The success of HCV combination therapy is highly genotype dependent. SVR is achieved in up to 88% of patients with genotypes 2 and 3 and but only around 48% of those infected with the less responsive ‘difficult-to-treat’ genotypes 1, 4, 5 and 6. Importantly, up to 75% of Americans are infected with genotype 1 which is thought to be more aggressive with regard to disease progression, associated with more severe liver disease and a higher risk for hepatocellular carcinoma. Patients not achieving SVR are known as ‘non responders’ and have few recommended options, Dr Savopoulos says. “Datamonitor estimates there are around 35- 100,000 non-responders to therapy per year in the US, which are predicted to number 1.4m by 2014. Without further intervention this pool will exceed the number of new diagnoses by 2013.”

New treatments in the long term?

The limitations of current HCV therapy and the growing non-responder pool provide the necessary stimulus for new product development. Datamonitor estimates there are currently around 22 compounds within clinical development falling into four main classes: the immunomodulators, interferons, small molecule antivirals and host enzyme inhibitors. More importantly, over the last year major manufacturers have openly put money on the table to join the race in finding better treatments. Novartis has established strong relationships with Idenix (NM283, valopicitabine) and Anadsys (Isatoribine, other immune enhancers); Pfizer acquired Idun for the caspase inhibitor IDUN-6556; Roche spent around $150m investing in Pharmasett’s HCV compounds (PS-6130); Schering-Plough moved closer to Migenix’s Celgosivir (MX-3253) and Gilead have recently entered the fray with GS-9132.

Because most new experimental compounds are at an early stage of development, it is still unclear how they might be used in light of the current standard of care. However Datamonitor’s research with leading HCV experts consistently found that new agents will raise current levels of awareness, thus impacting on the current rate of diagnosis and treatment. In some cases with difficult-to-treat patients, specialists might even be delaying current therapy:

“Because as we have new drugs, we will have more opportunities and of course, that’s what many patients are waiting for.” – EU Opinion Leader

“If they, again, have mild disease and very low elevations of LFTs and a bad genotype people are deferring therapy, because I think there’s a realization that probably by 2008, 2009 there’s going to be some new compounds which do much better.” – US Opinion Leader

In the US, only 20-25% of all HCV infections are actually diagnosed – a key obstacle to limiting the impact of the disease, Dr Savopoulos says. “Therefore a key message is that this predicted era of new treatments will in effect bring more patients into the treated pool, allowing more to respond to therapy regardless of whether treatment is significantly enhanced or not.”

New uses of pegylated interferons in medium term?

As well as longer term new product launches, there is the possibility that some selected ongoing trials may bring further options that benefit difficult-to-treat HCV patients. Trials such as the HALT-c and COPILOT are investigating the possibility that keeping patients on prolonged interferon or maintenance therapy may reduce progression of liver disease. Other trials, such as the Roche sponsored REPEAT trial will investigate whether patients that fail to respond to PEG-Intron after 12 weeks will respond if treated with Pegasys. Datamonitor’s HCV epidemiology model has assessed the possible impact of these events on various disease parameters taking into account comments from HCV experts:

“If this is independent, so interferon alpha acts independently of the viral load, then it [maintenance interferon] may be an option for patients in the next upcoming 5-10 years and this time, we will perhaps need them, the interferon maintenance therapy because we do not already have five drugs to make a combination therapy with antiviral drugs to inhibit the viral replication on a long term basis.” – EU Opinion Leader

“also I think you have to say would the patient put up with that [maintenance interferon]. And I think you have to look much more, not just to the benefits, but the problems of toxicity. In the UK, cost of long term interferon is costly, it’s a costly drug, and we wouldn’t actually be able to pay for it.” – EU Opinion Leader

The main results from pegylated interferon maintenance and retreatment trials are due in 2007. If positive they should drive further uptake of PEG-Intron and Pegasys which most believe have peaked for HCV use in the key US market after a decline in 2004, Dr Savopoulos says. “Nevertheless Roche, after gaining further indications in HCV/HIV coinfection and chronic hepatitis B (EU and USA), has reported that over the first half of 2005 they maintained their market leadership in pegylated interferon with sales growth of 15%.”

“This current data supports Datamonitor’s long term outlook – that unless a generic pegylated interferon reaches the market and/or a cocktail of safe HCV antivirals proves more effective, the current standard of care is here to stay for a good many years,” he says.

Ends

Notes for editors * Hepatitis C epidemiology model

(1)NHANES III Datamonitor’s Hepatitis C epidemiology model features patient flow analysis of the HCV population over 10 year forecast period. The model includes segmentation by line of therapy along with quantification of responder, non repsonder and re treatment pools.

Dr John Savopoulos, Datamonitor infectious diseases lead analyst is available for comment

To arrange an interview or for further details regarding the report contact Matthew Dick in the Datamonitor Press Office on + 44 20 7675 7824, or email mdick@datamonitor.com

For US, please call Suzanna Eygabroat on +1 585-374-6326 x17 For Asia-Pacific, please call Denis Mason on +61 2 9006 1526.

Datamonitor plc (DTM.L) is a premium business information company specialising in industry analysis. We help our clients, 5000 of the world’s leading companies, to address complex strategic issues. Through our proprietary databases and wealth of expertise, we provide clients with unbiased expert analysis and in-depth forecasts for six industry sectors: Automotive, Consumer Markets, Energy, Financial Services, Healthcare, Technology. Datamonitor maintains its headquarters in London and has regional offices in New York, San Francisco, Sydney, Tokyo, Frankfurt, Shanghai and Hong Kong. See www.datamonitor.com for further details.

Gossypol. What is it?

What is it?

Gossypol is an herbal medicine used to treat cancer and a female problem called endometriosis. It may also be used by women and men to prevent pregnancy.

Other names for Gossypol include: Gossypium hirsutum and Cottonseed oil.

Ask your doctor, nurse, or pharmacist if you need more information about this medicine or if any information in this leaflet concerns you.

Before Using: Tell your doctor if you.

* are taking medicine or are allergic to any medicine (prescription or over-the-counter (OTC) or dietary supplement)
* are pregnant or plan to become pregnant while using this medicine
* are breastfeeding
* have other health problems, such as high blood pressure or heart or blood vessel disease

Dosage: There are many doses for this medicine. The most common doses for Gossypol are listed below. Ask your doctor if your health problem is not on the list or if the dose is not given for a product you want to use.

* Cancer (adrenal), tablet: 40 to 60 milligrams daily, by mouth (1)
* Cancer (glioma), tablet: Racemic Gossypol 10 milligrams twice daily, by mouth (2)
* Female birth control, gel: put application of a Gossypol acetic acid gel 0.5 milligram/milliliter into vagina before having sex (3)
* Male birth control, tablet: 10 to 20 milligrams (mg) daily for 75 to 180 days or until adequate reduction in sperm count is reached, followed by 35 to 65 mg weekly, by mouth (4-8)

To store this medicine: Keep all medicine locked up and away from children. Store medicine away from heat and direct light. Do not store your medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down and not work the way it should work. Throw away medicine that is out of date or that you do not need. Never share your medicine with others.

Drug and Food Interactions: Do not take Gossypol without talking to your doctor if you are taking:

* Chloroquine (9)
* Digoxin (1,7,10-12)
* Diuretic (1,7,11)
* Ethanol (13-15)
* Iron (16)
* Isoproterenol (10,17,18)
* Nonsteroidal anti-inflammatory medicine (1,19,20)
* Potassium (7,11,12)

Warnings:

* Do not take Gossypol if you are pregnant or breastfeeding

Side Effects: Stop taking your medicine right away and talk to your doctor if you have any of the following side effects. Your medicine may be causing these symptoms which may mean you are allergic to it.

* Breathing problems or tightness in your throat or chest
* Chest pain
* Skin hives, rash, or itchy or swollen skin
* Severe tiredness (21)
* Muscle weakness or paralysis (21)
* Dry mouth or skin, nausea (upset stomach), vomiting (throwing up), hair loss, bowel problems (1)

References:
1. Flack MR, Pyle RG, Sullen NM et al: Oral gossypol in the treatment of metastatic adrenal cancer. J Clin Endocrinol Metab 1993; 76:1019-1024.
2. Bushunow P, Reidenberg NM, Wasenko J et al: Gossypol treatment of recurrent adult malignant gliomas. J Neuro-Oncology 1999; 43(1):79-86.
3. Ratsula K, Haukkamaa M, Wichmann K et al: Vaginal contraception with gossypol: a clinical study. Contraception 1983; 27(6):571-576.
4. Coutinho EM, Athayde C, Atta G et al: Gossypol blood levels and inhibition of spermatogenesis in men taking gossypol as a contraceptive. A multicenter, international, dose-finding study. Contraception 2000; 61(1): 61-67.
5. Gu ZP, Mao BY, Wang YX et al: Low dose gossypol for male contraception. Asian J Androl 2000; 2(4):283-287.
6. Coutinho EM & Melo JF: Clinical experience with gossypol in non-Chinese men: a follow-up. Contraception 1988; 37(2):137-151.
7. Liu GZ, Lyle KC & Cao J: Clinical trial of gossypol as a male contraceptive drug. Part I. Efficacy study. Fertil Steril 1987; 48(3):459-461.
8. Liu GZ, Lyle K & Cao J: Experiences with gossypol as a male pill. Am J Obstet Gynecol 1987a; 157(4 pt 2):1079-1082.
9. Nwoha PU & Aire TA: The effects of gossypol and chloroquine interaction on serum electrolytes of protein-malnourished rats. Contraception 1995a; 52(4):255-259.
10. Ye YX, Akera T & Ng YC: Modification of the positive inotropic effects of catecholamines, cardiac glycosides and Ca2+ by the orally active male contraceptive, gossypol, in isolated guinea pig heart. Life Sci 1989; 45(20): 1853-1861.
11. Liu GZ, Ch’iu-Hinton K, Cao J et al: Effects of potassium salt or a potassium blocker on gossypol-related hypokalemia. Contraception 1988; 37(2):111-117.
12. Shaozhen A, Guangwei J, Xiaoyun W et al: Gossypol related hypokalemia: clinicopharmacologic studies. Chin Med J 1980; 93:477-482.
13. Akingbemi BT, Rao PV & Aire TA: Chronic ethanol intake may delay the onset of gossypol-induced infertility in the male rat. Andrologia 1997; 29(4):201-207.
14. Messiha FS: Effect of gossypol on kinetics of mouse liver alcohol and aldehyde dehydrogenase. Gen Pharmac 1991; 22(4):573-576.
15. Messiha FS: Behavioral and metabolic interaction between gossypol and ethanol. Toxicol Lett 1991a; 57(2):175-181.
16. Herman DL & Smith FH: Effect of bound gossypol on the absorption of iron by rats. J Nutr 1973; 103(6):882-889.
17. Wu DF, Yu YW, Tang ZM et al: Pharmacokinetics of (+/-)-,(+)-, and (-)-gossypol in humans and dogs. Clin Pharmacol Ther 1986; 39(6):613-618.
18. Ye YX, Akera T & Ng YC: Direct actions of gossypol on cardiac muscle. Eur J Pharmacol 1987; 136(1):55-62.
19.Wagner H, Hikino H & Farnsworth NR (eds): Economic and Medicinal Plant Research. Academic Press, London, England; 1985.
20. DeSmet PAGM, Keller K, Hansel R et al (eds): Adverse Effects of Herbal Drugs 2. Springer-Verlag, Berlin, Germany; 1993:195-208.
21. Wooley RJ: Contraception-a look forward, part II: Mifepristone and gossypol. Contraception 1991; 4:103-113.

Source: Health Library
The information contained in this health library is for reference purposes only. Some services or procedures listed here may not be provided by Genesis Health System entities. Please consult your medical professional for further information.

Sigma-Aldrich Introduces the MyriaScreen Diversity Collection for Drug Discovery

TimTec and Sigma-Aldrich (NASDAQ:SIAL) are pleased to announce the availability of the MyriaScreen Diversity Collection of drug-like screening compounds produced in collaboration, as a result of careful evaluation, filtering, and refinement of selections from each of our screening compound collections. The MyriaScreen Diversity Collection is comprised of 10,000 high-purity screening compounds handpicked to maximize chemical diversity while maintaining drug-likeness.

The MyriaScreen Diversity Collection was assembled from a pool of over 300,000 screening compounds using a combination of filters, diversity predictors, and manual selection. The resulting 10,000 compounds are drug-like, chemically diverse, and amenable to follow-up chemistry and optimization. The collection is well suited for researchers that are looking for a small, cost-effective, ready-to-screen set of high-quality screening compounds.
“MyriaScreen will complement our customers’ existing screening collections and jump-start new collections by quickly adding interesting chemotypes,” said Michael Earley, Product Manager, Drug Discovery, Sigma-Aldrich. “Our collaboration with TimTec, Inc. resulted in a high-quality library that our customers will find useful.”

About Sigma-Aldrich

Sigma-Aldrich is a leading Life Science and High Technology company. Our biochemical and organic chemical products and kits are used in scientific and genomic research, biotechnology, pharmaceutical development, the diagnosis of disease and chemical manufacturing. We have customers in life science companies, university and government institutions, hospitals and in industry. Over one million scientists and technologists use our products. Sigma-Aldrich operates in 34 countries and has 6,000 employees providing excellent service worldwide. We are committed to the success of our Customers, Employees and Shareholders through leadership in Life Science, High Technology and Service.

To request information about MyriaScreen, please click here.

Forward Inquiries to:
Mrs. Kelley Euchner, 800-521-8956
Mr. Timothy Sommer, 314-286-7768

About TimTec

TimTec Corporation is a privately held company located in Newark Delaware, USA. It was founded in 1995 and began its work in the areas of acquisition and distribution of synthetic organic and natural compounds, custom synthesis, and laboratory equipment to become a full service partner for drug discovery. TimTec has established a global network of thousands of scientists from research centers around the world. The company has developed strong in-house expertise assembling general and targeted library collections for variety of research purposes. International customers include major pharmaceutical, biotech, agricultural, and educational companies and institutions, which use TimTec products for research and development programs.

For further information please contact:
TimTec Inc
301 A Ruthar Drive
Newark DE 19711
Tel 302 292 8500
Fax 302 292 8520
info@timtec.net
http://www.timtec.net

Welichem reports positive results with its lead anticancer agent

VANCOUVER, Sept. 23 /CNW/ – Welichem Biotech Inc. (the “Company”) (TSX-V:
WBI), a biotechnology company developing therapeutic drugs in the fields of
autoimmune diseases and cancer, today announces positive results on the
anticancer activity of its WBI-2000 series of compounds. These results, from
work done by Dr. M. Alaoui-Jamali at the Centre of Translational Research in
Cancer of the Jewish General Hospital in Montreal, showed a potent delay of
tumor growth following administration of the Company’s drug lead, WBI-2100, in
a human melanoma cancer model grown in mice. The results are consistent with
those from in vitro and in vivo studies on WBI-2100 conducted by the US
National Cancer Institute (“NCI”). The Company’s WBI-2100, a fully
synthesized, small molecule compound, delayed the growth of common cancers
such as breast, ovary and colon.
“These positive results of WBI-2100, in studies from different research
laboratories are very encouraging, and the nature of the data open-up
potential for use of this novel agent alone or in conjunction with existing
therapies” said President and CEO Dr. John M. Webster.
Activity against major types of cancer was demonstrated by NCI for
several members of the WBI-2000 series in vitro, and ten of them were selected
by the NCI for further in vivo testing, including in human xenograft models.
This group of compounds can be readily developed and formulated and have no
structural similarity to current therapeutic agents.
Welichem’s compounds in the WBI-2000 series are tested, under a November,
1996 screening agreement, with the Cancer Treatment and Diagnosis Division of
NCI, the principal agency for cancer research of the United States government.

About Welichem Biotech Inc.

Welichem Biotech Inc. is a pioneering Canadian biopharmaceutical company
that is developing proprietary small molecule drugs with large potential and
significant competitive advantages in areas of auto-immune/ inflammatory
diseases and cancer. The first lead compound is in formal preclinical
development for therapeutic application against psoriasis.

ON BEHALF OF THE BOARD

John M. Webster

President and CEO

The TSX Venture Exchange has not reviewed and does not accept
responsibility for the adequacy or accuracy of the content of this news
release. This press release contains forward-looking statements that include
our belief as to the potential of our WBI-2000 series compounds. Certain risks
and uncertainties such as results of pre-clinical tests of our products, the
availability of funds and resources to pursue research and development
projects, outcomes of our patent applications, and our ability to successfully
commercialize the products could cause the Company’s actual results to differ
materially from those in the forward-looking statements.
%SEDAR: 00021386E

For further information: Dr. John Webster, President & CEO,
(604) 432-1703, email: jwebster@welichem.com or Allan McGirr, Investor
Relations, (604) 317-2981, email: amcgirr@welichem.com

Scientists Develop New Surface Patterning Method for Carb Chip

Newswise — Although the application of microarray chip technology to the study of carbohydrates is relatively new, it holds great promise for disease detection and vaccine development in animals and humans.

A research team led by Nicola Pohl, an assistant professor of chemistry at Iowa State University, has developed a new surface patterning method to make carbohydrate chips for bioscreening.

“The success of DNA and protein microarrays in chip format for biosample screening using small sample volumes has led to a variety of technologies that diagnose many diseases,” Pohl said. “Extending this concept to other biomolecules has been challenging.”

The new method developed by Pohl and graduate students Kwang-Seuk and Firoz Jaipuri is based on a fluorous Teflon®-pan like surface interacting with fluorous-tagged compounds. Unlike most other molecules, these fluorous-tailed sugars stick to the Teflon-type surface, which allows the tagged carbohydrates to be immobilized in a microarray format on standard glass microscope slides.

“The surprising part was that this fluorous interaction was strong enough to allow standard bioassays on the chips without rinsing away the sugars,” Pohl said.

The Teflon-like tail also can be used to speed up the synthesis of complex carbohydrates. The fluorous-based microarray method should rival the speed and ease of solid-phase synthesis currently used for the commercial production of DNA and peptides, Pohl said.

“It will allow a whole range of carbohydrate chips to be produced, including chips that contain sugars of particular interest to plant scientists,” said Pohl, a researcher associated with Iowa State’s Plant Sciences Institute.

The method should also work with other molecules, such as peptides, on the same chip to screen for antibodies correlated with diseases such as bacterial or fungal infections and diseases with known biomarkers (molecular indicators) such as cancer. And the new chips can help screen new biocatalysts that act on carbohydrates and discover new proteins, such as plant lectins, that bind to specific carbohydrate sequences.

The researchers’ initial work demonstrating the fluorous-based carbohydrate chip method was published in the Sept. 2 online edition of the Journal of the American Chemical Society. The research showed how two plant proteins (from jack beans and a bushy plant) only bind to specific sugar structures.

“The same principle can be used to screen for antibodies that bind to certain sugar structures on pathogens to let us know that that person or animal has come in contact with the pathogen and to let us know which carbohydrates the person or animal generates an immune response against in order to develop carbohydrate-based human and animal vaccines,” Pohl said.

Alfred E. Slanetz, Ph.D. Named Corporate Development Representative for ESBATech AG

CEO Dr. Dominik Escher to Present at Upcoming Investor Meetings: 5th Annual
Biotech in Europe Investment Forum and Rodman & Renshaw

ZURICH, Switzerland and BOSTON, Sept. 22 /PRNewswire/ — ESBATech AG, a
developer of human antibody fragment therapeutics today named Alfred E.
Slanetz, Ph.D. as its corporate development representative. Alfred E.
Slanetz, Ph.D. of Slanetz Associates is now working with ESBATech on corporate
development activities. Dr. Slanetz was previously VP, Business Development
of Transgene and commercial leader on a number of Genentech’s product
development teams. Dr. Slanetz received his Ph.D. in immunology and molecular
biology from Yale University.
ESBATech’s CEO Dominik Escher, Ph.D. commented on today’s announcement,
“We are at an exciting time in ESBATech’s development as we progress ESBA105
into clinical development. Having representation in the US, in particular in
Boston, provides us with a larger pool of intellectual capital and potential
financiers. It makes sense to have a strong presence in the global center of
the biotechnology industry. With Dr. Slanetz on board for corporate
development and representation by the team at LaVoie Strategic Communications
Group, we have the beginnings of Boston office for ESBATech.”
ESBATech is developing its lead product, ESBA105, for several anti-
inflammatory indications with large unmet medical needs. ESBA105 neutralizes
the clinically validated target, TNF alpha. Using the Company’s proprietary
Immuna platform and its novel antibody fragments, ESBATech researchers
identified, characterized and optimized ESBA105 and demonstrated animal proof-
of-concept in less than twelve months. Based on strong pre-clinical data, the
Company is planning to begin clinical trials of ESBA105 in late 2006.
ESBATech is also applying small molecule, high throughput screening
systems (HTS) for efficient hit and lead compound identification and
optimization in the field of Proteases, Secretases and Receptor Tyrosine
Kinase (RTK) inhibitors. These small molecule inhibitors are to be developed
with biotech and pharma partners.
In the first quarter of 2005, the Company entered into a broad, non-
exclusive, drug discovery collaboration with The Novartis Institute for
Biomedical Research in Cambridge, MA. Under this agreement ESBATech uses its
cellular high-throughput screening technology to identify inhibitors of
receptor tyrosine kinases to provide compounds for future oncology drugs.
ESBATech is actively seeking to out-license all non-core applications of
its Immuna and HTS technologies and product development programs that are not
within its inflammatory disease area of focus. This includes ESBA212, a novel
therapeutic for passive immunization in Alzheimer’s disease.
For licensing information, please contact Alfred Slanetz, Ph.D, Slanetz
Associates, (781) 383-6603, or at aslanetz@comcast.net.

Upcoming Investor Meetings
Dominik Escher, Ph.D. will present at the 5th Annual Biotech in Europe
Investment Forum to be held on October 4-5, 2005 in Zurich as well as the
Rodman & Renshaw Techvest 7th Annual Healthcare Conference in New York City on
November 7-9, 2005. The 5th Annual Biotech in Europe Investor Forum and the
Rodman & Renshaw meetings are high profile events attended by an executive
level audience of institutional investors, venture investors, business
development executives, and scientific experts. http://www.esbatech.com

About ESBATech AG
Privately-held ESBATech AG is a drug discovery and development company
focused on advancing antibody-fragment therapeutics for inflammatory
applications. ESBATech AG has raised USD$15m to date from leading European
venture firms such as Novartis Venture Fund, BioMedinvest, Venture Incubator,
BSI, Difasa, Network Capital and Management. The Company is currently raising
additional venture financing in the US and Europe. ESBATech AG was founded in
September 1998 and currently has 30 employees.

SOURCE ESBATech AG
Web Site: http://www.esbatech.com

Diversity Orientated Synthesis (DOS) Agenda Complete

Combinatorial chemistry has evolved from the concept of producing massive numbers of compounds to smaller, more focused libraries. Now is a good time to review the current thinking and state-of-the art in Diversity Oriented Synthesis so, Select Conferences are pleased to announce their first conference focused in this area. To be held 22-23 Sept 2005 in Waltham, near Boston, MA, this will provide a major forum to present cutting edge work within this dynamic field and an un-missable event for those wishing to keep abreast of new developments.

Agenda sessions include:

Novel Synthetic Methodologies
- chaired by Dr. Gerard Rosse, Sanofi-aventis
High Throughput Strategies
- chaired by Dr. Thierry Masquelin, Lilly Corporate Center
Design and Synthesis Approaches
- chaired by Dr. Joseph M. Salvino, Cephalon, Inc.
Advances in Library Purification
- chaired by Dr. John J. Isbell, Novartis Research Foundation.

Keynote Speaker

Dr. John A. Porco, Jr., Department of Chemistry, University of Boston will deliver the keynote lecture entitled “Approaches to the Discovery of Novel Chemical Reactions and Chemotypes”.

For the full downloadable agenda please visit www.DOSconference.com

Selected media partnerships are available for this event.

About Select Conferences

www.SelectConferences.com

The Select Conferences division of Select Biosciences Ltd. is focused on organizing specialist biomedical meetings. Experts from both academia and commerce are invited to present timely information from current research through to commercial implementation of new technologies. These events also provide a unique networking facility and the opportunity to reach a highly targeted scientific audience.

Euroscreen awarded US patent on GPC receptor

21/09/2005 – Euroscreen has announced the issuance of a US patent, which covers the use of a human G-protein-coupled receptor (GPCR) human P2Y13. The patent protects screening processes using this receptor to find compounds that modulate its activity, thus having pharmaceutical potential.

Output of e-Science project helps GSK speed up drug discovery

The pharmaceutical company GSK is using an output of a UK e-Science project to speed up the process of drug discovery. Integrative analytics technology, originating from Discovery Net, is enabling GSK’s chemists to explore the world of virtual molecules and to select compounds of interest from the millions screened by modern high throughput devices.

Before such devices were common, just ten to 15 years ago, a chemist would have analysed hundreds of compounds annually. Now, he or she may be faced with data on tens of millions of compounds a year. “At GSK, we’re trying to look for opportunities to deliver drugs to patients more quickly. We’ve invested in automating the early phase of the drug discovery process, but this has presented us with lots of informatics challenges,” says Stephen Calvert, GSK Vice-President for Cheminformatics.

The new automated processes can be changed quickly in response to changes in scientific understanding, but the supporting software, built using traditional approaches, cannot be changed on the same timescale. “The IT has become the bottleneck in evolving the science,” says Stephen. So GSK decided to look for IT technologies that chemists, rather than computer scientists, could use to retrieve and analyse data rapidly. “We wanted to match the cycle of change and hand control of the decision-making process back to the scientists,” he says.

InforSense KDE, an output of Discovery Net, met these two challenges. Discovery Net is a pilot project funded by the Engineering and Physical Sciences Research Council’s e-Science Core Programme. “KDE is different from traditional technologies because you can build it as you go. The scientists now have an environment that they can modify themselves. We can build a new utility and plug it in to KDE without having to test the whole application. This means we can turn something around in a few weeks instead of three or more months. It is starting to make a significant difference to our ability to respond to the needs of scientists,” he says.

GSK has built a proof of concept for KDE in the area of ‘library design’, that is the process of selecting just a few hundred molecules from the universe of 1060 possible molecules. “The process is a bit like doodling,” says Stephen Calvert. “You want to doodle in the universe of molecules to find the best ones to make.” Now the company is exploring opportunities for using KDE in other areas of its business including screening molecules for particular activity and genetic research.

KDE has been developed for the commercial market by InforSense, a spin-out company from the Department of Computer Science at Imperial College, London. Designed to require little IT knowledge on the researcher’s part, it “uses IT to liberate scientists from IT,” according to Professor Yike Guo, Discovery Net principal investigator at Imperial College.

Via a variety of possible interfaces, including a web portal, KDE allows the researcher to build up or modify complex analytic workflows that, for example, compare new data with data stored in heterogeneous, distributed databases, access software for different types of data analysis, and perform visualisations. Workflows can be stored and audited for re-use by the originator or others via web services, portlets or other visual desktop applications.

By using grid technology, the researcher has access to data, software and other services held remotely and can also share his or her resources with others elsewhere. “Before Discovery Net, you would have to move the output from one analysis to the next by saving it in a file and moving it to another machine. Now, you can run analyses with complex analytic workflows that incorporate services running elsewhere. Using grid technologies, data mining workflows can be distributed all over the world,” says Professor Guo.

“Before, chemists would have had to learn five or six applications to achieve the same end point. Now, they’ve got a single environment in which to do it. This offers a huge improvement,” says Stephen Calvert.

###

To attend the e-Science All Hands meeting, or the media briefing at 3pm on Wednesday 21 September, go to http://www.allhands.org.uk/pr/index.html. Conference website http://www.allhands.org.uk/

Contacts

Stephen Calvert, Vice-President for Cheminformatics, GSK, tel. 01276622715 e-mail: Stephen.H.Calvert@gsk.com

Professor Yike Guo, Imperial College, London tel. 07900241068 e-mail: yg@inforsense.com

Judy Redfearn, e-Science/Research communications officer, JISC/e-Science Core Programme tel. 07768 356309 e-mail: judy.redfearn@epsrc.ac.uk

Links

EPSRC e-Science programme http://www.epsrc.ac.uk/ResearchFunding/Programmes/e-Science/PilotProjects/default.htm.

Discovery Net http://www.discovery-on-the.net/

UK e-Science Programme www.rcuk.ac.uk/escience

Notes for editors

1. e-Science is the very large scale science that can be carried out by pooling access to very large digital data collections, very large scale computing resources and high performance visualisation held at different sites.

2. A computing grid refers to geographically dispersed computing resources that are linked together by software known as middleware so that the resources can be shared. The vision is to provide computing resources to the consumer in a similar way to the electric power grid. The consumer can access electric or computing power without knowing which power station or computer it is coming from.

3. The UK e-Science Programme is a coordinated £230M initiative involving all the Research Councils and the Department of Trade and Industry. It has also leveraged industrial investment of £30M. The Engineering and Physical Sciences Research Council manages the e-Science Core Programme, which is developing generic technologies, on behalf of all the Research Councils.

4. The UK e-Science Programme as a whole is fostering the development of IT and grid technologies to enable new ways of doing faster, better or different research, with the aim of establishing a sustainable, national e-infrastructure for research and innovation. Further information at www.rcuk.ac.uk/escience.

New technologies enable effective drug discovery

Software screens for genotoxicity in potential drug compounds and helps to eliminate toxic compounds early in the drug discovery and development process, saving time and resources.

GE Healthcare showcased at the Society for Biomolecular Screening’s (SBS) 11th annual conference three advanced technologies currently in development that will help scientists understand disease, research fundamental biological processes, and discover new therapeutic agents. ‘These latest developments demonstrate GE Healthcare’s commitment to providing innovative tools for our customers working in biomolecular discovery and disease research. ‘We strive to help researchers continually improve their drug discovery and development processes,’ said Keiko Hattori, senior vice president for discovery systems at GE Healthcare.

Technology developments highlighted at SBS:.

Micronucleus, a new software application for GE Healthcare’s In Cell analyser 1000 and 3000 screens for genotoxicity in potential drug compounds and helps to eliminate toxic compounds early in the drug discovery and development process, saving time and resources.

The micronuclei assay identifies genotoxicity by finding breaks in DNA and is one of the most critical assays in the FDA approval process for new drugs.

Within ten minutes or less, the Micronucleus software application can analyse a 96 well plate when used with the In Cell analyser 3000.

more…

U-M researchers identify new blood test for prostate cancer

Test looks at 22 biomarkers; results more accurate than PSA
ANN ARBOR, Mich. — Researchers at the University of Michigan Comprehensive Cancer Center have identified a panel of 22 biomarkers that together provide a more accurate screening for prostate cancer than the current prostate specific antigen, or PSA, test.

The study appears in the Sept. 22 issue of the New England Journal of Medicine.

Researchers looked at blood samples taken from 331 prostate cancer patients prior to surgery, and from 159 control males with no history of cancer. They began by testing the samples against a library of 2,300 bacteriophage, organisms that express proteins on their surface, and were able to narrow the field to the 22 biomarkers that most often pinpointed the cancerous blood samples.

More than 230,000 men will be diagnosed with prostate cancer this year. Current screening methods involve a blood test to check for prostate specific antigen, an enzyme produced by the prostate. But the PSA test is controversial. A high level does not always indicate prostate cancer and some experts suggest a rise in PSA is more significant than a consistently high PSA. A high PSA level can also indicate benign prostate conditions.

“Initially, we envision this new test could be used as a supplement to PSA. A physician might suggest a patient with an elevated PSA have this test before a biopsy to better determine whether it’s a cancerous or benign condition. In the future, I think this could replace PSA,” says lead study author Arul Chinnaiyan, M.D., Ph.D., the S.P. Hicks Collegiate Professor of Pathology at the U-M Medical School.

In the current study, researchers first tested the blood serum samples of 39 men with prostate cancer and 21 controls to identify autoantibodies against prostate cancer. Cancer patients produce antibodies that fight against proteins that play a role in cancer. The researchers scanned 2,300 autoantibodies and initially narrowed it down to 186 that reacted with blood serum from the men with prostate cancer.

This discovery phase formed the basis for the next round of tests, in which 59 prostate cancer samples and 70 control samples were tested against the 186 autoantibodies. In this phase, the researcher identified a panel of 22 compounds that best distinguished the prostate cancer blood samples from the controls. Using these 22 markers, only two of 70 controls incorrectly tested positive for prostate cancer, and seven of 59 prostate cancer samples were falsely negative.

Next, the researchers validated their findings using the remaining 128 blood serum samples. They found eight of 68 controls and 11 of 60 prostate cancer samples were misclassified. This means 88 percent of the time, samples that were not cancerous were correctly identified and 81.6 percent of the time, samples that were cancerous tested positive.

“These 22 biomarkers appear to be the right number. If you used too many or too few, the accuracy went down a bit. Our findings held up when we tested the model on an independent set of blood serum samples,” Chinnaiyan says.

The results proved to be more reliable at predicting cancer than prostate specific antigen, which is a single biomarker. PSA testing results in a false positive around 80 percent of the time, leading to unnecessary prostate biopsies. The normal range for the PSA test is less than 4.0 nanograms per milliliter (ng/mL) in most men. For men over 40 years old with a family history of prostate disease or for African-American men over 40 years old, some doctors suggest that a level higher than 2.5 ng/mL should be checked with more tests, because these two groups of men have an increased risk of prostate cancer.

The 22-biomarker test was reliable at identifying prostate cancer even in the PSA ranges of 4-10 ng/ml or 2.5-10 ng/ml, intermediate PSA scores that do not always suggest cancer. The study authors suggest the 22 biomarkers could be used for patients in this range to help determine whether to undergo a biopsy.

The new test requires only a routine blood draw for patients. Most blood-processing laboratories could easily be equipped to scan for these 22 biomarkers, Chinnaiyan says. Researchers are conducting further studies to validate the findings with a larger, community-based group of patients.

###

In addition to Chinnaiyan, U-M study authors were Xiaoju Wang, Ph.D., research associate; Jianjun Yu, research assistant; Arun Sreekumar, Ph.D., research investigator; Sooryanarayana Varambally, Ph.D., Ronglai Shen, research assistant; Donald Giacherio, Ph.D., clinical associate professor of pathology; Rohit Mehra, M.D., pathology research fellow; James Montie, M.D., Valassis Professor of Urologic Oncology and professor and chair of urology; Kenneth Pienta, M.D., professor of internal medicine and director of Urologic Oncology; John Wei, M.D., associate professor of urology; and Debashis Ghosh, Ph.D., assistant professor of biostatistics. Additional authors were Martin Sanda, M.D., Beth Israel-Deaconess Medical Center; Philip Kantoff, M.D., Dana Farber Cancer Institute; and Mark Rubin, M.D., Dana Farber Cancer Institute and Brigham and Women’s Hospital.

Funding for the study is from the National Cancer Institute Early Detection Research Network Biomarker Developmental Lab, the U-M Prostate Cancer SPORE (Specialized Program of Research Excellence) grant, the American Cancer Society, the V Foundation and a U.S. Department of Defense Post-Doctoral Training Grant.

The University of Michigan has filed for a patent on the findings of this study on which Chinnaiyan and Wang are listed as inventors.

For more information about prostate cancer, visit www.cancer.med.umich.edu/learn/prostate.htm or call the Cancer AnswerLine at 800-865-1125.

Reference: New England Journal of Medicine, Vol. 353, issue 12

MerLion teams up with UK firm in anti-cancer drugs research

SINGAPORE : A Singapore-based drug discovery company, MerLion Pharmaceuticals, and UK’s Cancer Research Technology (CRT) are teaming up to identify new anti-cancer drugs from natural product chemistry.

Under the collaboration, MerLion will screen their natural compound collection against high throughput screens developed by scientists at CRT.

The aim is to isolate new therapeutic compounds against validated cancer targets.

Targets will be selected from research carried out by Cancer Research in the UK and CRT’s other partners.

MerLion and CRT will work closely throughout the target selection and screening process.

The results of the collaboration will be jointly owned.

The tie-up is the first since the Joint Statement on Science, Engineering and Technology signed by Prime Ministers Lee Hsien Loong and Tony Blair two months ago.

- CNA /ls

What’s Bubbling in Wisconsin’s Biotech Businesses?

Biotech is big here and growing bigger. There are 248 life- sciences companies in Wisconsin that employ 20,000 people and generate more than $6 billion in annual revenue, according to the Wisconsin Biotechnology and Medical Device Association.

And the fact that about one-third of these companies emerged in the last five years can be taken as a sign of healthy growth, especially considering the jittery economy.

It’s also evidence that Wisconsin biotech is getting closer to achieving the critical mass that industry analysts and venture capitalists speak of, where the industry has enough companies to spur activity and generate more start-ups and opportunities for employment and advancement.

“The atmosphere for biotech in Wisconsin is very accommodating,” says Thomas Primiano, president and CEO of Clonex Development Inc., a biotech firm that recently moved from Chicago to Madison.

“Wisconsin has a talented pool of scientists, entrepreneurs, and technical specialists who can really help start-up and early-stage companies grow rapidly. State government continues to foster the development of biotech through grants and loans. And University Research Park and the T.E.C. Center in Madison provide outstanding laboratory facilities that are relatively affordable.”

The hottest biotech trend in Wisconsin is, without question, embryonic stem-cell research.

“The energy coming from the stem cell center at UW-Madison, WiCell, and the Wisconsin Alumni Research Foundation provides a tremendous boost to stem-cell research in Madison,” says Primiano.

Dr. Robert Carlson, director of Marshfield Laboratories, is also excited about the rapid advances being made in molecular diagnostic techniques.

“These procedures will revolutionize our ability to combat infectious diseases,” says Carlson. “What used to take weeks to do with laboratory cultures can now be done in a matter of hours. This is especially valuable in fighting emerging infectious diseases like West Nile virus.”

Other groundbreaking research in Wisconsin is leading toward the production of clean and affordable alternative fuels, such as ethanol, through the application of unique biological catalysts.

Wisconsin has several biotech hotspots.

MADISON

Madison is by far the strongest biotech cluster in the state. More than 180 biotech companies are located in the area, drawn by the world-class research capabilities of UW-Madison and affordable high-tech incubators as mentioned earlier.

The Scientist magazine recently hailed Madison as a “low-key hotspot” for biotechnology, largely because of the city’s world- class research facilities, high quality of life, and affordable cost of living.

Although Madison’s biotech cluster is small by national standards, Madison companies are attracting national and international attention.

For example, Bayer HealthCare is teaming up with Madison’s EraGen Biosciences to manufacture and market EraGen’s test kit for cystic fibrosis. Bone Care International has been purchased by Cambridge, Mass.-based Genzyme Corp., and Lucigen Corp. is negotiating with Kikkoman Corp. of Japan, the world’s largest soy sauce producer, to use Lucigen enzymes for converting soybean waste into biofuel.

Finally, Mentor Corp., a Fortune 500 company based in California, recently set up a new manufacturing facility at University Research Park after acquiring the exclusive rights to a botulinum technology developed at UW-Madison.

According to The Scientist, UW-Madison ranked fifth in the country for earnings generated through its patented discoveries. That’s because the Wisconsin Alumni Research Foundation, which patents and licenses inventions made in UW-Madison labs and uses the proceeds to support more research, is one of the top organizations in the country when it comes to commercializing new technologies.

Biotech companies based on UW-Madison research patented by WARF include Cambria Bioscience, ConjuGon, eMetagen, Neoclone, Quintessence Biosciences, and Third Wave Technologies. WARF also has equity investments in these firms.

“WARF has added six new companies to its portfolio in the last 12 months,” says WARF spokesperson Andrew Cohn. “WARF presently has over 1,000 pending patent applications. Last year alone we took in 400 disclosures for new invention ideas from professors on campus.”

Madison has long been known for its highly educated workforce, including the hundreds of UW science and engineering graduates who enter the labor pool every year. Madison Area Technical College recently received a $450,000 grant from National Science Foundation to develop a new biotechnology certificate program. The purpose? To teach the advanced laboratory skills that are in demand by biotech companies to life-science graduates.

MILWAUKEE AREA

The Medical College of Wisconsin, a private academic institution, is emerging as a major biotech player in the state. Over the last 10 years, the federal funding it has attracted for research projects has grown from $53 million to $130 million. In 2004 the college ranked in the top third of the nation’s 125 medical schools for National Institutes of Health funding. Fifty-four invention disclosures were received during the 2003-2004 fiscal year.

Even though UW-Madison receives more federal funding than the Medical College of Wisconsin does, Milwaukee has a much larger employee base, which is a key site-location criterion for major biotech companies.

Milwaukee County Research Park is home to several biotech firms. The park is also the location for GE Healthcare’s new $90 million, 506,000-square-foot headquarters.

“It’s a great sign when the largest biomed company in Wisconsin decides to expand locally and not go somewhere else,” indicates Ron Kuehn, vice president of government relations for the Wisconsin Biotechnology and Medical Device Association.

UW-Milwaukee receives about $30 million every year for contract research, much of it going to biotech. Specialties include medical imaging, rehabilitative medicine, genomics, and medical informatics. Another key sector is chemical compounds.

“Right now we are in discussions with a major pharmaceutical company regarding licensing some of our chemical compounds for new medical applications, especially for the treatment of addictive behaviors,” says UW-Milwaukee chancellor Carlos Santiago.

The university has also launched the Biomedical Technology Alliance, a consortium led by UW-Milwaukee, the Medical College of Wisconsin, Marquette University, UW-Parkside, Milwaukee School of Engineering, and TechStar. With $1 million in seed money, the alliance has established a new research facility called the Wisconsin Institute for Biomedical and Health Technologies. An additional $15 million has already been leveraged from interested parties.

MARSHFIELD

Up north, another $24 million in R&D was spent last year by the Marshfield Clinic Research Foundation, the research division of the Marshfield Clinic. A portion of that money went to the rapidly evolving field of personalized medicine where researchers hope to find out why many new drugs only work in about 40-75% of the patients who use them. The right diagnostic tests could predict how patients will react to drugs based on their genetic profiles, allowing doctors to prescribe personalized medications with very low failure rates.

“Current Marshfield projects include identifying genes that increase the risk of Alzheimer’s disease, and how these genes interact with environmental factors,” says Cathy McCarty, interim director for the foundation’s Center of Human Genetics.

“Other studies are exploring genetic responses to medications such glaucoma drugs and the cholesterol drug Lipitor.”

Marshfield’s Lipitor research received over $1 million in funding from the National Institutes of Health. Other grants from the National Cancer Institute and Centers for Disease Control are financing research on screening cancers and assessing the effectiveness of flu vaccines.

ON THE LEGISLATIVE FRONT

Wisconsin means business when it comes to biotech – or does it?

Governor Jim Doyle has called for the funding of the $375- million Wisconsin Institute for Discovery on the UW-Madison campus, a $134-million interdisciplinary research complex near UW Hospital and Clinics, and a $132-million research facility at Medical College of Wisconsin and Children’s Hospital, plus $105 million to support public health, medical education and research at the UW Medical School and Medical College of Wisconsin. And Act 255, which was signed into law in the spring of 2004, provides tax credits to angel investors.

“The passage of Act 255 has definitely stimulated investment interest in Lucigen,” Burrell notes.

Yet the government still has Wisconsin Statute 180.0622(2)(b) on the books. Known as the “wage claim statute,” this law makes shareholders in a company personally liable for employee wages, up to the par value of their shares, should the company go bankrupt.

Top: University Research Park, MGE Innovation Center, Madison; Bottom: Milwaukee County Research Park

“This shareholder liability is a holdover from the nineteenth century,” says Peter Shively, an attorney with LaFollette Godfrey & Kahn SC in Madison.

“Wisconsin is now the only state that still has such a statute imposing liability on all shareholders for employee wage claims. The Wisconsin courts have further extended the reach of this anomalous law to corporations from other states that do business in Wisconsin, and in at le\ast one case the court expanded a shareholder’s liability beyond the limits set in the statute.”

Wisconsin’s wage claim statute clearly has a dampening effect on investment in Wisconsin corporations, including its biotechnology companies.

“Removing this statute would help reassure investors in Wisconsin’s biotechnology companies that they will not face personal liability for these claims, in addition to the potential loss of their investment,” adds Shively.

Then there’s the legislature’s position on restricting tax credits for stem-cell research, undoubtedly the state’s greatest biotech strength.

Bill AB206, which calls for more R&D tax credits, was recently amended on the floor of the Assembly to not allow credits to companies conducting stem-cell research.

“It’s ridiculous to create a tax credit for research, but then exclude the one thing that Wisconsin does extraordinary well and that gives us an international reputation – stem-cell research,” says Cohn.

Competition is heating up fast. California has pledged $3 billion over the next 10 years to embryonic stem-cell research. Connecticut has approved $1 billion for stem-cell research and Massachusetts has approved therapeutic embryo cloning.

“These states are trying to build their research infrastructure, but we’re already way ahead in Wisconsin, starting with the groundbreaking work of Dr. James Thomson at UW-[Madison],” Cohn adds. “This is something extraordinary to build on, not to take away.”

Cohn maintains that the legislature’s “anti-science” stance is scaring away venture capitalists, companies, and even scientists. “Governor Doyle has promised to veto the amended tax-credit bill if it passes, but even so, the bad message has already been sent.”

UW scientists, Cohn notes, are getting recruiting calls for California every day. “California has $3 billion to spend,” says Cohn. “They basically say, ‘What do you want?’ Just the other day someone offered to buy one of our scientists a house in California to go along with a big raise, which shows how fierce the competition is.”

THINKING REGIONAL

A recent study by the Milken Institute showed that the top biotech clusters are Boston, San Francisco, Philadelphia, New York, and Raleigh-Durham. Midwest clusters ranked eighth (Minneapolis) and ninth (Chicago).

Wisconsin’s biggest hurdle is its image of being remote. “We’re not a coastal state and that’s a challenge we have to overcome,” says Kuehn. “We have a certain ‘flyover problem.’ Even Chicago suffers from this perception.”

To fight this stereotype, the association markets Wisconsin as a “third coast” scientific community.

The majority of the big venture capitalists are on the East and West coasts, which are loaded with biotech investment opportunities.

“These biotech clusters are also more established and have track records,” says Harry Burrell, vice president of marketing and sales for Lucigen Corp. in Madison, whose core technology is genomics. “The Midwest biotech industry is much younger.”

Thus the Wisconsin biotech community is more dependent on angel investors, who typically invest from $250,000 to $1 million in biotech ventures.

Another drawback is that, so far, no big biotech anchor has ventured into the state.

“If a big pharma came to town, that would add huge credibility,” says Cohn. “Another advantage to having a major player would be the entrepreneurs that would eventually leave and start their own companies.”

Although the biotech field is very competitive, it’s still the most fertile when scientists are close to each other and communicate.

“We see a lot of this,” says Santiago. “The best part is that proximity leads to cross-discipline synergy. Physicists talk with doctors; biochemists talk with environmental scientists.

“Where disciplines touch is where progress happens – which means the future of biotech in Wisconsin is bright.”

“It’s a great sign when the largest biomed company in Wisconsin decides to expand locally.”

- Ron Kuehn, Wisconsin Biotechnology and Medical Device Association

Wisconsin’s biggest hurdle in attracting venture capital is its image of being remote.

Copyright Trails Media Group Sep 2005

Source: Corporate Report Wisconsin

Automation server streamlines cell-based screening

Software enables a personal cell analysis system to become a true walk-away cell-based screening system, intelligently automating hours of microplate processing with no user invention.

uavaLink Automation Server software has been developed to automate the processing of multiple microplates on Guava Personal Cell Analysis (PCA) systems. Intuitive in operation, the ultra-compact Guava PCA-96 and Easycyte systems are said to have set an international benchmark for single cell analysis and counting in the 96-well format. GuavaLink allows robot scheduling software to control and integrate Guava PCA systems with all physically compatible robotic arms and Liquid Handling systems – the result streamlined workflow and enhanced productivity.

Using a series of user-defined worklists, the robot scheduling software is able to send commands to the system while instructing the robotic arm to move microplates to and from a Guava PCA system.

This flexible worklist system allows users to interchange and process different cell-based assays within a microplate series.

GuavaLink enables a Guava PCA system to become a true walk-away cell-based screening system, intelligently automating hours of microplate processing with no user invention.

The Guava EasyCyte is a five-parameter system microplate cytometer microplate cytometer that is flexible, highly affordable, and ultra-compact.

Since it requires only a few microlitres of sample volume, it saves precious and expensive cells, reagents, and compounds.

The system is so easy to use, results are generated with less than a day’s training.

The Guava PCA-96 offers turnkey operation in an integrated system consisting of the compact Guava PCA-96 instrument, software to automatically analyse and archive data, and optimised reagents.

The Guava PCA-96 system simplifies cell monitoring and screening, only a few microlitres of samples are required for each experiment, saving precious cells and reagents and reducing potentially hazardous biological waste.

With the Guava PCA-96 experiments can be started sooner and finished faster streamlining the entire research and development process, the company says.

Current screening assays available for the Guava PCA-96 and Easycyte systems include cell counting and viability, cell marker expression, cytotoxicity, cell cycle, CD4/CD8 absolute counting and a suite of assays for apoptosis assessment and cell tracking.

Guava Technologies, a privately held biotechnology and Medical Device company, is a provider of on-demand, easy-to-use single cell analysis systems.

Guava Personal Cell Analysis (PCA) systems, including the Guava PCA, Guava PCA-96 and Guava EasyCyte systems, are described as integrated, fully optimised, micro-capillary cytometry systems with embedded absolute cell counting capability.

Used worldwide by the life sciences, biotechnology, and pharmaceutical industries, as well as clinical testing institutions (outside the United States and Europe), Guava’s products have broad applications in scientific research and throughout the drug discovery and lead optimisation process, as well as for cell counting and optimisation of commercial bio-pharmaceutical production.

Guava offers a variety of assays and dedicated software modules for the Guava PCA systems, enhancing the system’s overall ease-of-use.

BioFocus Boosts Ion Channel Screening Capability

Investment in new staff and high-throughput equipment increases workflow capability by two orders of magnitude

CHESTERFORD RESEARCH PARK, England, September 12, 2005 – BioFocus has signalled its commitment to enhance its ion channel drug discovery business by recruiting a number of leading specialists in this rapidly growing sector and investing in a new 384-well, high throughput electrophysiology system capable of screening up to 100 compounds per day against defined cell lines.

Most recently, Dr Iain James has been appointed Director of Biology and has taken overall responsibility for expanding the BioFocus ion channel drug discovery and screening services as well as providing input to the on-going development of complementary Soft FocusTM Ion Channel libraries.

Before joining BioFocus, Dr James spent 16 years at Novartis and four years at Ionix Pharmaceuticals, initially as Director of Biology before becoming Director of Drug Discovery. Having been a leader of ion channel projects and drug discovery teams at both Novartis and Ionix, Dr James brings a considerable depth of scientific and managerial experience to the BioFocus ion channel team. The appointment of Dr. James is testament to the continued determination at BioFocus to strengthen its capabilities in ion channel drug discovery, which has already been extensive over the past 18 months. During this period, the BioFocus ion channel team has been augmented through the appointment of several senior staff with significant hands-on ion channel and drug discovery experience acquired both in Biotech and Big Pharma.

To support its capabilities in discovering drugs that act at ion channels, BioFocus has recently commissioned an IonWorks Quattro(tm) high-throughput electrophysiology screening system. Based on Molecular Devices’ Population PatchPlateTM technology, and working with 384-well planar arrays, the Quattro allows rapid functional assessment of active molecules in critical electrophysiology assays prior to being scheduled for more in-depth evaluation, using conventional manual, patch-clamping technology.

In addition to its automated high throughput system, BioFocus has also invested extensively in ion flux and fluorescence-based systems for primary screening of very large assemblies of molecules.

Chris Newton, Chief Scientific Officer at BioFocus said “Although 5% of drugs are known to act through binding to ion channels, the technical difficulties relating to assessing the actions of molecules on ion channels, combined with the lack of an extensive knowledge base about how ion channels work, have prevented exploitation of this genomic class of target. This strategic investment in both senior staff and advanced screening equipment at BioFocus underlines our commitment to offering an unrivalled ion channel drug-discovery service, using either clients’ own compounds or those developed at BioFocus by Helical Domain Recognition Analysis (HDRA ™,) as part of our own SoftFocusTM libraries. Over the last 12 months, we have witnessed a marked upsurge of interest in our ion channel libraries from big pharma – so much so that they are now our one of our fastest selling compound libraries.” Dr Newton added, “With its impressive workflow, the IonWorks Quattro allows us to increase our electrophysiology screening capability by two orders of magnitude and offers our clients a true fast track into the promising ion channel field”.

About BioFocus

BioFocus offers a full range of pre-clinical expertise for discovery biology, medicinal chemistry and molecular informatics to pharmaceutical and biotechnology companies. Founded in 1997, BioFocus is now a recognised expert in three key areas of drug discovery – kinases, GPCRs and ion channels, and provides SoftFocus libraries targeted at all these gene families.

Renowned for generating the highest rate of tractable hit series for onward development into pre-clinical candidates, BioFocus has provided its services and/or products to 17 out of the top 20 pharmaceutical companies worldwide.

For further information, please contact:

BioFocus

David Phillips, Chief Business Officer

+44 (0)1799 533500

De Facto Communications

Kevin Payne

+44 (0)207 940 1000

k.payne@defacto.com

New Attractiveness of Plant-Derived Natural Products

BioPlanta GmbH and AnalytiCon Discovery GmbH announce their cooperation in the plant-based search for active ingredients.

Leipzig, 09/06/2005 – The aim of the cooperation between BioPlanta and AnalytiCon is to find and to develop new plant-derived active ingredients for use in medicinal therapy. The potential for continuous production of these plant-derived pure compounds – independent of seasonal variation – is of vital importance!

Cell and organ cultures of rare plant species featuring an interesting pattern of substances are produced in bioreactors under clean room conditions. The most promising species are identified by means of a meaningful analytical profiling program in combination with selected biotests and a database comparison of the results. Potential drug candidates contained in these species are efficiently purified and identified. The main focus of interest in this cooperation is on substances with antitumoral properties.

First tests have already shown that in vitro cultures can produce more active agents than plants from wild collections or greenhouse cultures and frequently also yield new ones. The two cooperation partners have combined their technologies, to create an exceptionally effective in vitro production and screening platform.

BioPlanta has gained reputation within the scientific community for the development of its worldwide unique bioreactor technology for the production of plants under clean room conditions and their commercial exploitation. In collaboration with AnalytiCon, this technology is now being used to produce entirely novel groups of natural active ingredients in premium quality and with reliable availability. Innovative active agents can now be rapidly identified and provided in amounts needed for preclinical studies.

For AnalytiCon, the cooperation with BioPlanta represents another significant step towards strengthening the company´s position as leading provider of natural product-based pure compound libraries and collections. From AnalytiCon´s point of view, the reliable resupply which is independent of seasonal variation is a crucial requirement which will considerably boost the attractiveness of herbal ingredients as starting points in the search for active agents.

About AnalytiCon.
AnalytiCon a brand and at the same time successful company is world’s first address for all needs in connection with natural product drug discovery. From prospecting for biosources, via fermentation, extraction and isolation to high throughput structure elucidation, the company provides a vast portfolio of first class services. Beyond that, AnalytiCon produces pure natural compound collections and libraries of synthetic, natural product based molecules carrying relevant bioactive structure elements. The natural product drug discovery platform is complemented by a portfolio of medicinal chemistry services.
For further information see www.ac-discovery.com.

About BioPlanta.
BioPlanta is one of the leading companies in applying bioengineered approaches for discovery, development, and commercialisation of fine chemicals and pharmaceutical compounds using it’s proprietary platform technology. This technology – the BioPlant-System – is particularly suitable for manipulating plant metabolism to generate active compounds with higher value than field plants. The control and variation of cultivation conditions enables customized content and spectra of the specific compounds. This innovative platform technology was installed to manufacture plant derived chemical compounds for pharmaceutical, flavour, and food related industries. It allows the production of high-quality drugs, cost-effective scale up, an efficient screening of new active compounds, and the design of novel drugs.
For further information see www.bioplanta-leipzig.de.

Contact Details:
BioPlanta GmbH
Contact Person: Dr. Dirk Wilken
Deutscher Platz 5
D-04103 Leipzig
Tel.: +49 341 224 58 30
Fax: +49 341 224 58 31
info@bioplanta-leipzig.de
www.bioplanta-leipzig.de

AnalytiCon Discovery GmbH
Contact Person: Dr. Lutz Müller-Kuhrt
Hermannswerder Haus 17
D-14473 Potsdam
Tel.: +49 331 2300 300
Fax: +49 331 2300 333
info@ac-discovery.com
www.ac-discovery.com

Three-dimensional culture will simulate tumor micro-environment, enable rapid testing for candidate drugs

(I-Newswire) – The National Foundation for Cancer Research ( “NFCR” ) has aligned with The Prostate Cancer Foundation to grant $200,000 in seed funding to The Burnham Institute’s NCI-designated Cancer Center to develop three-dimensional experimental culture systems that simulate a tumor’s micro-environment. The outcome of this pilot study is anticipated to provide a new model for discovery and pre-clinical evaluation of anti-cancer drugs.

“By collaborating with both the Burnham and the Prostate Cancer Foundation, we anticipate the outcomes and discoveries from this study to significantly accelerate both our understanding of cell-cell interactions and as a result, the pace at which drugs are made available to patients,” said Franklin C. Salisbury, Jr., President of the National Foundation for Cancer Research. “We know that our organizations’ joint work on these projects is a model for future research initiatives and collaborations.”

“We are delighted to partner with the NFCR and Burnham to help give investigators the ability to establish standards for a 3-dimensional culture, which we believe will have a significant effect on how pre-clinical evaluation of anti-cancer drugs can be tested in the future,” said Leslie Michelson, CEO, The Prostate Cancer Foundation. “We will follow their progress closely and look forward to sharing their results.”

Burnham investigators have developed a unique technique for culturing cancer cells into clusters, called spheroids, which links cellular biochemistry with tumor physiology. The 3-dimensional culturing of cancer cells is a significant advancement over conventional tissue culture methods in which cells are grown in two-dimension, as a flattened layer on plastic. The new method will expedite the drug discovery process, as thousands of compounds can be tested in three-dimensional cell culture to determine prime drug candidates before testing in animals.

The NFCR and Prostate Cancer Foundation partnership funding will enable the Burnham investigators to establish standards for 3-dimensional culture, which has potential applications beyond cancer, and develop new methods for high throughput screening with chemical compounds and high-throughput imaging of spheroids.

“We are grateful to NFCR and The Prostate Cancer Foundation for their vision, partnership, and support this project,” said Dr. John C. Reed, President and CEO of The Burnham Institute. “We anticipate that these studies will revolutionize our understanding of cell-cell interactions in the context of cancer physiology and responsiveness of the malignant cells to therapeutic agents. It would be impossible to start this creative and potentially far-reaching work without the seed funding granted by our partners, which includes individual donors who contribute to NFCR and the Prostate Cancer Foundation.”

The NFCR and Prostate Cancer Foundation each provided $100,000 for the project ( $200,000 total ). Seed funding, such as the grants provided by these two foundations, plays a critical role in launching innovative projects that are not yet sufficiently developed to be competitive for NIH or other government funding.

About National Foundation for Cancer Research

Since its founding, the NFCR has spent more than $210 million funding basic science cancer research and prevention education focused on understanding how and why cells become cancerous. NFCR is dedicated to funding scientists who are discovering cancer’s molecular mysteries and translating these discoveries into therapies that hold the hope for curing cancer. NFCR has established a powerful collaborative network of nine research centers and more than 30 laboratories around the world in the fight against cancer. NFCR scientists work together to share knowledge so that discoveries at the bench can be accelerated to the bedside. NFCR is “Research for a Cure”. For more information, visit http://www.NFCR.org. or call ( 800 ) 321-CURE.

About the Prostate Cancer Foundation

The Prostate Cancer Foundation is the world’s largest philanthropic source of support for prostate cancer research. Founded in 1993, the PCF has raised more than $230 million and provided funding for prostate cancer research to more than 1,200 researchers at more than 100 institutions worldwide. The PCF has a simple, yet urgent goal: to find better treatments and a cure for recurrent prostate cancer. For more information, visit ProstateCancer Foundation.org.

About the Burnham Institute

The Burnham Institute, founded in 1976, is an independent not-for-profit biomedical research institution dedicated to advancing the frontiers of scientific knowledge and providing the foundation for tomorrow’s medical therapies. The Institute is home to three major centers: the Cancer Center, the Del E. Webb Neuroscience and Aging Center, and the Infectious and Inflammatory Disease Center. Since 1981, the Institute’s Cancer Center has been a member of the National Cancer Institute’s prestigious Cancer Centers program. Discoveries by Burnham scientists have contributed to the development of new drugs for Alzheimer’s disease, heart disease and several forms of cancer. Today the Burnham Institute employs over 700, including more than 550 scientists. The majority of the Institute’s funding derives from federal sources, but private philanthropic support is essential to continuing bold and innovative research. For additional information about the Institute and ways to support the research efforts of the Institute, visit http://www.burnham.org.

Nancy Beddingfield
nbeddingfield@burnham.org
858-646-3146
Burnham Institute

http://www.burnham-inst.org

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KINEMATIC AND CHEMAXON ANNOUNCE STRATEGIC PARTNERSHIP AND SUCCESSFUL

September 1st, 2005. San Diego (CA) & Cork, Ireland and Budapest,
Hungary. KineMatik Ltd. and ChemAxon Ltd, announce a new strategic
partnership under which ChemAxon’s Java based chemistry components have
been implemented within KineMatik’s flagship product, eNovator.

KineMatik’s eNovator is a web based Electronic Laboratory Notebook (ELN)
integrated with a Project & Portfolio Management system and is used
within life science and other industries. With the integration of
ChemAxon’s JChem Cartridge for Oracle and Marvin toolkits, eNovator is
able to store, edit, search and retrieve chemical structures and
reactions within the ELN and Sample Tracking Module.

“The performance, quality of support and full API made ChemAxon a
natural choice to bring chemical awareness to the eNovator system” said
Tom Cassidy, Kinematik’s CEO. “As the capabilities and scope of eNovator
evolve we are well positioned to roll out ChemAxon’s advanced chemical
capabilities to maintain the relevance of eNovator to everyday research.”

“We are very happy to work with KineMatik in this fast moving knowledge
area. The implementation moved smoothly and quickly and I am sure users
will enjoy the seamless integration of ChemAxon’s cheminformatics
capabilities within the eNovator system” said Gyorgy Pirok, CTO of ChemAxon

About KineMatik:

KineMatik is the provider of the Collaborative eR&D (CeR&D) solution,
eNovator.

Collaborative eR&D is an integration framework which seamlessly links
all elements of R&D activity in a unified and integrated manner. eNovator is a web-based, integrated Electronic Laboratory Notebook (ELN)
and Portfolio & Program Management system.

eNovator increases a researcher’s ability to anticipate experimental
outcomes, interpret experimental data and build their fundamental
knowledge base while aiding them in the thought process involved in
designing experiments. eNovator offers managers a unique level of
visibility into the research pipeline, allowing them to look at ongoing
projects and comparatively assess them against each other, in terms of
likelihood of technical / market success, such that researchers are
always working on the most valuable projects in the pipeline.

KineMatik’s vision is to be the world leader in CeR&D solutions for
research organizations.

About ChemAxon

ChemAxon is a leader in providing Java-based chemical software
development platforms for the biotechnology and pharmaceutical
industries. With core capabilities including structure visualization and
management, property prediction, virtual synthesis, screening and drug
design, ChemAxon focuses upon active interaction with users and core
portability to create powerful, cost effective cross platform solutions
and programming interfaces to power modern cheminformatics and chemical
communication. For more information please visit http://www.chemaxon.com