People, Mergers and Acquisitions, Drug Development, Legislation

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Affym etrix,Arcturus Enterinto Strategic Relationship Affymetrix (Santa Clara, CA; www.affymetrix.com) and Arcturus Engineering (Mountain View, CA) announced in November that they have entered into a strategic relationship linking microarray technology with laser capture microdissection. Under the agreement, Arcturus gets access to Affymetrix’s GeneChip brand arrays, instrumentation, and software to monitor gene expression for R&D efforts to develop microgenomics array-based diagnostic products. Affymetrix invested $3 million in Arcturus as a part of Arcturus' recent $11 million private financing.

Invitrogen Chief Steps Dow n Lyle Turner, founder, CEO, and chair of Invitrogen (Carlsbad, CA; www. invitrogen.com), stepped down effective January 1. James Glynn, Invitrogen’s executive vice president and former CFO, was named president and COO. Glynn assumed the role of interim CEO until a permanent chief is hired. Bradley Lorimier, a current board member, became chair. Invitrogen hopes to have a new CEO in place before the end of June, though it has no specific timeline.

M edarex Initiates Phase IITrials Medarex (Princeton, NJ; www.medarex.com), a biopharmaceutical company focused on the discovery and development of therapeutics to treat life-threat-

© 2003 American Chemical Society

ening and debilitating diseases, announced in October the initiation of two Phase II clinical trials for MDX-010, one in patients with metastatic melanoma and one in patients with hormone refractory prostate cancer. Both studies are designed to assess the potential antitumor activity of MDX-010. MDX-010 is a human antibody against human CTLA-4, a molecule on T cells that is responsible for suppressing the immune response. In preclinical research, MDX-010 has been shown to enhance immune responses and prevent tumor growth.

PerkinElm erGranted FDA Certification PerkinElmer (Boston; http:// lifesciences.perkinelmer.com) announced that it has received FDA 510(k) certification to market a screening system to identify a newborn’s risk of becoming developmentally impaired or dying prematurely. The NeoGram Phenylalanine Test System will be used in the identification of phenylketonuria (PKU) in newborns. PKU, a metabolic disorder characterized by the lack of phenylalanine dehydrogenase, can result in excess phenylalanine in the bloodstream, which can lead to irreversible mental retardation and premature death. Approximately 1 in 10,000 infants is PKU-positive. Receipt of FDA certification allows PerkinElmer to commercially market the system worldwide. The NeoGram Phenylalanine Test System includes a reagent kit with standards, controls, and reagents manufactured under GMP and FDA guidelines and

Aventis Gets FDA ApprovalforLung CancerDrug Aventis Pharmaceuticals (Bridgewater, NJ; www.aventisus.com) announced that its chemotherapeutic agent Taxotere was approved by the FDA as a first-line therapy, in combination with cisplatin, for patients who have unresectable, locally advanced or metastatic, non-small-cell lung cancer (NSCLC) and who have not received prior chemotherapy. This approval makes Taxotere the only agent for both patients with newly diagnosed NSCLC, in combination with cisplatin, and those with previously treated, advanced NSCLC, as a single agent. FDA approval was based on a clinical trial comparing the effect of Taxotere plus cisplatin versus Taxotere plus carboplatin versus a standard regimen of vinorelbine plus cisplatin in patients with advanced NSCLC who had not received prior chemotherapy. Patients in the Taxotereplus-cisplatin group had overall response rates (complete and partial shrinkage of tumors) of 31.6%, versus 24.4% for those in the vinorelbine-plus-cisplatin group. The Alliance for Lung Cancer Advocacy, Support, and Education (Vancouver, WA; www.alcase.org), a not-for-profit organization dedicated to helping those living with lung cancer or at risk for the disease, applauds the FDA’s decision.

designed to run exclusively on tandem mass spectrometry equipment.

Organon,Entelos Collaborate To Fight Arthritis Organon, a pharmaceutical company based in Oss, The Netherlands, and Entelos (Foster City, CA; www. entelos.com), makers of predictive biosimulation for in silico drug discovery, have entered into a research collaboration to expand their research program in rheumatoid arthritis using Entelos’ RA Physiolab technology. Organon will pay up-front fees, milestone payments, and royalties on the sale of immunological and inflammatory drugs resulting from the collaboration. Organon will also provide funding for the development of the next generation of RA PhysioLab technology.

Biacore Receives Drug Discovery Aw ard Biacore AB (Uppsala, Sweden) received the Frost & Sullivan Award for Drug Discovery Enabling Technology of the Year 2002 and the Product Innovation award in the field of protein arrays. The awards were presented in November 2002 at the Excellence in Healthcare Awards banquet in La Jolla, CA. Biacore was recognized as a company that has shown excellence in its launch of new products and technologies, based on an evaluation of the world drug discovery and protein array markets by the management consultant firm Frost & Sullivan. In its recent report analyzing the “World Protein Array Market”, Frost & Sullivan shows that Biacore is well positioned to benefit from the explosive growth of the global protein array market, which is expected to expand

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by more than 50% per annum over the next five years to be worth $665 million in 2007. (PRNewswire)

Serenex N am es N ew CEO Serenex(www.serenex.com), a Durham, NC-based drug discovery company, recently announced the appointment of Richard S. Kent as president and CEO. Kent is a former GlaxoSmithKline executive, holding positions there including chief medical officer. Most recently he served as president and CEO of Ardent Pharmaceuticals (Durham, NC). He succeeds Robert Dishman, Serenex’s founding president, CEO, and chair.

Scim agix,Am ersham Develop Inform atics Solutions Scimagix (San Mateo, CA; www.scimagix.com), a developer of enterprise-class image information solutions for pharmaceutical and biotechnology R&D, announced that it will collaborate with Amersham Biosciences, the life sciences business of Amersham plc. Scimagix will improve its scientific image management system for use with Amersham’s IN Cell Analyzer 2000 detection platform for highcontent screening.

StructuralBioinform atics Recruits Sem ple Structural Bioinformatics (San Diego; www.strubix.com) announced in December that J. Edward Semple was recruited as executive director of medicinal chemistry. Semple will report directly to Ruth F. Nutt, acting head of drug discovery. He will be responsible for leading multidisciplinary teams that are developing novel classes of receptor antagonists for the treatment of asthma, phosphatase inhibitors to treat diabetes/obesity, metallo-

protease inhibitors to turn off the lethal factor in anthrax, and kinase inhibitors to treat breast cancer. Semple previously served as executive director of chemical research at Corvas International, Inc., where he contributed to a broad range of cardiovascular and cancer drug programs.

Can In Silico Biology Revolutionize the Drug Discovery Process? Front Line Strategic Consulting (San Mateo, CA; www. frontlinesmc.com), a management consulting and market research firm for the life sciences industries, released a strategic market report entitled In Silico Biology: A Strategic Business Outlook and Market Analysis. Front Line's report includes an in-depth analysis of the market drivers, current and future applications, key companies and market shares, and strategic analysis of the in silico biology market. The compound annual growth rate (CAGR) in this category will more than double from 2002 to 2007, with a CAGR of 50% worldwide. The current worldwide breakdown is estimated for the United States at 70%, Europe at 20%, Japan at 5%, and the rest of the world at 5%.

M itscherJoins Sunesis Board Sunesis Pharmaceuticals (www.sunesis.com), a discovery-based company located in South San Francisco, CA, recently announced the election of Lester Mitscher to its scientific advisory board. Mitscher is a Distinguished Professor in the Department of Medicinal Chemistry at the University of Kansas (Lawrence) whose illustrious career has focused on the development of new therapeutic agents. With the addition of

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Consortium Aw arded $6.5 M illion from N IH A major structural genomics consortium recently received a third year of funding from the U.S. National Institutes of Health (NIH). The National Institute of General Medical Sciences, a unit of NIH, through its Protein Structures Initiative awarded more than $6.5 million to a Rutgers University-led collaborative research partnership—the Northeast Structural Genomics Consortium. This one-year grant represents the third year of funding for a five-year, $27 million pilot project. NIH initially funded the project on a year-by-year basis; but, based on progress to date, NIH has assured the project’s funding for the entire five years. NIH has even added a $1.5 million supplement to this year’s funding for new robotic equipment that will eliminate a serious process bottleneck in protein sample production. The consortium, which includes researchers at Rutgers University (Piscataway, NJ; http://ur.rutgers.edu), Columbia University (New York), Cornell University (Ithaca, NY), Pacific Northwest National Labs (Battelle, WA), and the State University of New York at Buffalo, is working to reveal new 3-D protein structures and to improve protein structure determination methods. Consortium members hope to lower the cost of solving a protein structure from $300,000 to $20,000.

Mitscher, Sunesis’ scientific advisory board is now composed of 11 members.

Protein Patterns M ay PredictProstate Cancer Protein patterns found in the blood serum of men may help differentiate between prostate cancer and benign conditions, according to scientists from the National Cancer Institute and the FDA reporting in the Journal of the National Cancer Institute (96, 20, 1576–1578). The technique relies on a test that uses a drop of blood and may help decide if a biopsy should be done in men with elevated prostate specific antigen (PSA) levels. The test analyzes the patterns of small proteins in about 30 min. The researchers were able to distinguish between samples taken from patients diagnosed with cancer and those from patients diagnosed with benign prostate disease. The technique was effective not only in men with normal and high PSA levels, but also in those whose PSA levels were marginally elevated (4–10 ng of antigen per ml of fluid), in

whom it is difficult to rule out cancer without a biopsy. The technique is still under evaluation, but researchers think the analysis of protein patterns will be a useful tool for deciding whether men with marginally elevated PSA levels should undergo biopsy. PSA levels are commonly used as a preliminary screen for prostate cancer, but 70–75% of men who undergo biopsy because of an abnormal PSA level do not have cancer.

Beckm an Coulter Acquires Orchid’s SN P Business Orchid BioSciences (Princeton, NJ; www.orchid.com) and Beckman Coulter (Fullerton, CA) recently announced that Beckman Coulter has acquired Orchid’s SNP genotyping instrumentation business. Under the agreement, Orchid received a combination of cash payments and certain debt assumption from Beckman Coulter and Beckman Coulter also assumed certain third-party obligations to Orchid’s reagents and instrument leases.