BTECH NEWS
Circa 2001 -2002


 

In the early 2000's the BTECH NEWS website highlighted selected events in the life sciences sector that the Btech Investor team believed were particularly relevant to biotechnology investors. Btech Investor consulting services included expert analysis and critical appraisal of biotechnology and pharmaceutical products and technologies, market analysis, and scientific and financial due diligence.
Content is from the site's 2001 -2002 archived pages providing a glimpse of what Btech offered its readership and clients.

 

Subscription to BtechNews is free. The news updates are published 3 to 5 times a week by email.

Btech Investor provides consulting on the biotechnology industry to the financial and biotechnology communities and publishes the Btech Investor Reports and Btech Investor News. Btech Investor Reports provide in-depth analysis of the biotechnology industry and consist of company reports on the leaders of the biotechnology industry and emerging scientific trends in the biotechnology industry. Btech News, published several times a week, highlights selected events in the life sciences sector that the Btech Investor team believes are particularly relevant to biotechnology investors. Consulting services include expert analysis and critical appraisal of biotechnology and pharmaceutical products and technologies, market analysis, and scientific and financial due diligence.

The Btech Investor team, which brings together scientific, clinical and business experience, is uniquely qualified to perform comprehensive analysis of the biotechnology industry and to identify the future industry leaders.

Btech Investor Reports

The Btech Investor Reports provide in-depth analysis of the biotechnology industry. Reports cover either individual companies or sectors.

Subscription to Btech Investor Reports is $200 per year and includes 20 new reports as well as access to our archives. Individual reports can be purchased for $50 each. Four sample reports are available from the box at the right. 

Disclaimer: Btech Investor aims to provide reliable, insightful analysis on the biotechnology industry. However, this information is provided "as is" and no representations or warranties, either express or implied of completeness, accuracy, or of any other nature are made with respect to this information. This information is neither an offer to sell nor a solicitation to buy the securities of any company. This article contains forward-looking statements, which involve risks and uncertainties which may not be listed. The biotechnology industry is an emerging industry and the securities of the companies mentioned in this report have a very high degree of risk and volatility. For this reason, this information is supplied on the condition that the reader will make his or her own determination as to its suitability for any purpose prior to any use of the information contained within this report. The employees and officers of Btech Investor may hold positions in some or all of the stocks discussed in this article.

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SPECTRAL'S SEPSIS DIAGNOSTIC TEST BACK ON TRACK FOR U.S. APPROVAL

April 4, 2002

Wednesday, the FDA outlined processes required for Spectral Diagnostics (Toronto: SDI) to successfully advance the Endotoxin Activity Assay (EAA) diagnostic and prognostic product through U.S. regulatory review. EAA measures a specific toxin-related feature of the early inflammatory response in patients at risk for severe sepsis. The test is being developed to allow physicians to better risk-stratify septic patients in the intensive care unit (ICU). Although approved in Canada, the FDA's medical device committee did not recommend U.S. approval of EAA after its initial October 2001 meeting. Spectral and partner Élan (NYSE: ELN) are expected to weigh the possibilities for a Canadian launch given this relatively encouraging U.S. regulatory meeting.

The FDA agreed to a submission path for the EAA as a 510(k)-de novo classification process. This submission will include a description of EAA's appropriate use to risk stratify patients in the ICU for the development of severe sepsis. Moreover, the FDA has accepted that the 510k submission be based on clinical data from the already completed MEDIC (Multicenter Endotoxin Detection in Critical Illness) trial.

At the recently concluded 22nd International Symposium on Intensive Care and Emergency Medicine in Brussels, Spectral presented data from the MEDIC pivotal trial of the EAA. The MEDIC trial demonstrated that an elevated endotoxin level identifies patients who are at greater risk for infection, greater risk for severe sepsis, and more likely to die in the ICU. Patients at risk for developing severe sepsis can potentially be identified earlier than with classical microbial cultures. However, less-promoted data from the MEDIC trial revealed that while ruling out high risk is facilitated by this highly sensitive test, ruling it in (confirming severe sepsis risk) is less certain.

Though imperfect and not approaching the test characteristics of a "gold standard," the EAA is a valid diagnostic and prognostic tool. Spectral and Élan should be able to accurately outline its strengths and limitations in a way not only regulators, but also intensivists, are used to seeing. We anticipate 510k acceptance.

Though an incremental advance in sepsis care, EAA paves the way for increasingly more practical and precise methods for measuring the degree of early inflammatory response in sepsis. Besides Spectral, Interleukin Genetics (NASDAQ: ILGN) and Immunetrics (privately held) are working on this field. 

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Improving Monoclonals - Payload Technologies

January 29, 2002

Monoclonal antibodies represent the most promising type of therapeutic currently being developed by the biotech industry. Hundreds of monoclonals are currently in clinical trials. Yet for every successful monoclonal antibody such as Rituxan, Herceptin, Remicade, or ReoPro, there are several monoclonals that fail clinical trials. For failed monoclonals as well as for successful ones, several techniques have been developed to improve their properties as therapeutics. To reduce rejection of the therapeutic by patients, several companies have developed technology to make monoclonals look more human to patients’ immune systems. These companies, led by Abgenix, Medarex, Cambridge Antibody Technologies, and Protein Design Labs, have seen a large increase in valuation over the past two years as most companies developing monoclonals have enlisted their expertise.

A second, and equally promising, method for improving monoclonals is to attach a payload, making the monoclonal more potent. Although several years behind and more diverse in technology compared to technology for reducing immunogenicity of antibodies, small companies with expertise in payload technology are beginning to attract the attention of antibody developers. We expect leaders in this area – Seattle Genetics, Peregrine, Immunomedics, and ImmunoGen – to follow a path similar to Abgenix, Medarex, Cambridge Antibody Technologies, and Protein Design Labs.

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Meeting Alert: ASH

December 4, 2001

The American Society of Hematology (ASH) meeting in Orlando December 7-11, 2001 will highlight advances in the treatment of various disorders of the blood. IDEC and Genentech’s Rituxan will dominate the meeting, with over 150 presentations. Almost all data will support both continued use in non-Hodgkin lymphoma (NHL) and expanded use in related indications. We will also be looking closely at presentations involving IDEC’s Zevalin, Corixa’s Bexxar, Celltech’s Mylotarg, Protein Design Labs’ Remitogen, Novartis’s Simulect, Human Genome Sciences’ Repifermin, Amgen’s Aranesp, Amgen’s Neupogen SD, and Genta’s Genasense.

This meeting preview outlines the most important results we expect to see, highlighting important abstracts for attendees of the conference interested in tracking these results. Immediately following the meeting, we will publish a follow-up report that details new insight from the meeting.

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Out of the ASHes: The Resurrection of Anticoagulant Therapy

Meeting Report from The 43rd Annual American Society of Hematology (ASH) Meeting

December 18, 2001

Our pre-meeting ASH alert focused on lymphoma and other hematologic malignancies, but at the meeting we found positive news and buzz in the field of anticoagulation, due to several new and promising therapeutics. The three agents featured most prominently at ASH were Sanofi-Synthélabo and Organon’s Arixtra, AstraZeneca’s Exanta, and Aventis’s Lovenox. Analysis of the data generated by these agents is complex, but we expect continued sales growth for Lovenox, excellent first year momentum for Arixtra, and continued evidence of approvability from Exanta. Arixtra, and eventually Exanta, should not only grab market share from Lovenox and Coumadin, but also contribute to an increase in the overall anticoagulation market.

In hematologic malignancies (cancer that begins in blood cells), Novartis’s Gleevec and Millennium’s LDP-341 demonstrated outstanding results. These two drugs demonstrate the value of a good drug target, especially important in the new world of genomics based drug discovery.

Monoclonal antibodies generally performed well, led by IDEC and Genentech’s Rituxan. One notable exception was Remitogen, which demonstrated disappointing results in treating non-Hodgkin lymphoma.

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Refining Targets And Training Neurons – The 2001 Society For Neuroscience Meeting Report

November 30, 2001

While no biotech breakthroughs were reported at the 2001 Society for Neuroscience meeting in San Diego, November 10-15, the sheer volume of research presented by some 24,000 neuroscientists highlights the progress being made in the understanding of Alzheimer disease, Parkinson disease, neuronal development, and many other areas. As the molecular mechanisms of neural function and dysfunction are worked out, some drug targets, such as beta-secretase in Alzheimer disease, appear more fundamental to disease processes, while others, such as presenilins, look less promising. New understanding of Parkinson disease is highlighting the need for developing stem cell therapeutics at the same time many researchers are working out how to develop such therapeutics.

Although most of the work presented was basic science, companies with strong neuroscience programs will benefit from rapid advances in the field. Élan, Amgen, and Eli Lilly have particularly strong programs in neurodegenerative disease. Stem cell therapy for Parkinson is looking more promising, and companies such as Stem Cells, Inc. should be able to capitalize in this area. Finally, many studies support the use of cholesterol lowering drugs in Alzheimer patients, which may become a growth driver for statins produced by Merck, Pfizer, Bristol-Myers Squibb, and Novartis.

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Fighting Disease with DNA and RNA

November 9, 2001

Antisense and other therapeutics made from nucleic acids (RNA or DNA) attack diseases by interacting with the most fundamental of biological processes. The inherent specificity and predictability of DNA and RNA interactions exquisitely targets nucleic acid therapeutics to fundamental molecules responsible for disease progression. However, their development has encountered many problems, including the difficulty of getting enough drug to the appropriate cells. Companies developing nucleic acid therapeutics have realized this and, to some extent, have altered their business plans to compensate for this limitation.

Nucleic acid therapeutics will initially be successful in applications such as chemosentization and immunomodulation, in which a modest alteration of the level of protein production from a certain gene, at times in combination with another therapeutic, can have large therapeutic effects. These initial successes are unlikely to be blockbuster drugs, but will serve to validate this technology and attract investment from large pharmaceutical and biotechnology companies. Such investment will allow companies specializing in nucleic acid therapeutics to make the necessary advances, some of which are already occurring, that will allow this class of drugs to mature. Nucleic acid therapeutics, including antisense, ribozymes, and transcription factor decoys, are likely to become as large a factor in biotechnology in the next ten years as monoclonal antibodies are today.

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Biotech Trends

October 11, 2001

Anticipation of new medical and technological innovations is critical to successful investment in biotechnology and pharmaceutical companies. This report identifies 9 trends as well as 4 technologies that we expect to capture investors' attention in 2002 and beyond. Companies poised to take advantage of each trend are identified.

Monoclonal antibodies are becoming successful therapeutics, and two of our trends relate to technological advances that will improve monoclonals. Three trends cover investment choices in specific therapeutic areas: neurodegenerative disease, cancer, and diabetes. Three trends - pharmacogenomics, genetic diagnostics, and target validation - relate to applications stemming from knowledge of the human genome. Finally, antisense as a new approach to drug development is profiled.

In addition to these trends, four technologies - stem cells, gene therapy, proteomics, and DNA microarrays / bioinformatics - are discussed for their long term investment potential.

 

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The Btech Investor Team

Leon Henderson, M.D. - Dr. Henderson is a physician geneticist in Internal Medicine and Medical and Clinical Genetics at Cedars Sinai Medical Center and an Assistant Clinical Professor of Medicine at the University of California, Los Angeles Medical School.  Dr. Henderson has consulted for academia and industry on the biotechnology industry, medical literature, and health care economics literature.  Dr. Henderson earned a doctor of medicine from Cornell University and a bachelor of arts in Linguistics from Northwestern University.

Bennett Weintraub, Ph.D. - Prior to joining Btech Investor Team, Dr. Weintraub was senior scientific editor for the biology research journals Cell and Molecular Cell. Dr. Weintraub performed biochemistry and immunology research at Stanford University and the John Curtin School of Medical Research in Canberra, Australia.  Dr. Weintraub earned a doctorate in Biology from the University of California, San Diego and a bachelor of science in Life Science from the Massachusetts Institute of Technology.

Christopher Martin - Mr. Martin is president of Btech Investor and provides financial analysis for the Btech Investor Reports.  Mr. Martin's prior experience includes healthcare consulting with McKinsey & Company and business development in the aerospace and e-learning industries.  Mr. Martin earned a bachelor of science in Mechanical Engineering from Cornell University and a master in Business Administration from Harvard University.

Frances Thronson, M.F.A., M.A., is a writer, editor, and publications specialist

 

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Sector Reports:

Improving Monoclonals - Payload Technologies
   January 29, 2002   

Out of the ASHes: The Resurrection of Anticoagulant Therapy - Meeting Report from The 43rd Annual American Society of Hematology (ASH) Meeting
   December 18, 2001

Meeting Alert: ASH
   December 4, 2001

Refining Targets And Training Neurons – The 2001 Society For Neuroscience Meeting Report
   November 30, 2001

Fighting Disease with DNA and RNA
   November 9, 2001

Biotech Trends
   October 11, 2001

Progress in Alzheimer Disease Therapeutics                
   September 28, 2001

Inhaled Insulin
   June 21, 2001

Trends in Oncology
   May 25, 2001

Recombinant Proteins
   May 17, 2001

Genomic Based Drug Discovery
   April 9, 2001

The Monoclonal Antibody Gold Rush
   March 6, 2001

New Solutions to Neurodegenerative Diseases
   February 26, 2001

Stem Cells: Repairing the Irreparable
   Novemeber 27, 2000

The Promise of Gene Therapy
   November 6, 2000

Company Reports:

Abgenix 
   September 10, 2001

Vertex Pharmaceuticals
   June 12, 2001

Rosetta Inpharmatics
   March 1, 2001

EntreMed
   February 8, 2001

Élan
   January 31, 2001

Targeted Genetics
   January 8, 2001

IDEC Pharmaceuticals
   January 2, 2001

Myriad Genetics
   November 15, 2000

 

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