BIOTECHNOLOGY

2007-10-28T07:30:00.000-07:00

CLINICAL DATA ACQUIRES EPIDAUROS BIOTECHNOLOGIE AG.

2007-10-28T07:28:00.000-07:00

Abstract:Clinical Data, Inc. (NASDAQ:CLDA), Newton, Mass., has acquired privately held Epidauros Biotechnologie AG of Bernried, Germany, in a cash transaction valued at 8.75 million euros (or approximately $11.84 million). Epidauros brings to Clinical Data an established portfolio of proprietary genetic biomarkers, expertise in genetic biomarker discovery, relationships with leading diagnostic companies, and a fast- growing pharmacogenomics services business.

Among the strategic assets acquired by Clinical Data in the transaction is a significant intellectual property portfolio that includes biomarkers in genes relating to prominent drug transporters such as MDR1, OCT1, MRP1, and important cytochrome P450 drug metabolizing genes, such as CYP2B6 and CYP2D6. MDR1 encodes P-glycoprotein, a key protein involved in drug transport that is known to modulate drug disposition. In addition, the genes CYP2B6, OCT1, and MRP1 are implicated in the absorption, distribution, and metabolism of many drugs that span a variety of therapeutic classes and indications, and are likely to be important in both response and safety profiles for these drugs.Clinical Data's president and CEO, Drew Fromkin, said, "We are pleased to ...

COPYRIGHT 2007 Worldwide VideotexArticle Information:Published in: Worldwide BiotechIssue Number:

10Volume Number: 19Date Published: 01 October 2007Language: EnglishWord Count:

930The subject scope of this article includes:Medical equipment industryCytochrome P-450Companies mentioned in this article include:Clinical Data Inc.Tickers related to this article include:CLDAProduct Codes and Terms related to this article:

3840000 : Medical Instruments & SuppliesNAIC Codes and Terms related to this article:

3391 : Medical Equipment and Supplies ManufacturingSIC Codes and Terms related to this article:3840 : Medical Instruments and Supplies

Biology in Space and Life on Earth: Effects of Spaceflight on Biological Systems

2007-10-28T07:27:00.000-07:00

This concise yet comprehensive treatment of the effects of spaceflight on biological systems includes issues at the forefront of life sciences research, such as gravitational biology, immune system response, bone cell formation and the effects of radiation on biosystems. Edited by a leading specialist at the European Space Agency (ESA) with contributions by internationally renowned experts, the chapters are based on the latest space laboratory experiments, including those on SPACELAB, ISS, parabolic flights and unmanned research satellites.An indispensable source for biologists, medical researchers and astronautics experts alike.

The results of Space flight experiments, ground controls and flight simulations pave the way for a better understanding of gravity reactions in various organisms down to molecular mechanisms. This publication marks also the beginning of a new Space flight era with the construction and exploitation of the International Space Station (ISS) which provides a platform for an in-depth continuation of experiments under weightlessness in Low Earth Orbit and beyond. Spaceborne platforms, namely SPACELAB, provide opportunity to study the effects of spaceflight on biological systems, of both plants and human beings.

One objective is the investigation of reactions to long-term space voyages, another a better understanding in general - e.g. of the immune system, of bone formation, and of radiation effects. Especially bone cell, immune system and radiation effects research are key issues for the fight against aging and diseases and at the focus of current medical research.

The market lacks a concise review on the latest research results obtained e.g. during the SPACELAB missions. Enno Brinckmann is leading scientist with ESA. He has assembled excellent experts in the fields outlined and edited an indispensable source for astrobiologists, medical researchers and astronautics experts alike.About the author:Enno Brinckmann, PhD, is the Senior Biologist at the European Space Agency (ESA) and served as Project Scientist for about 100 experiments in ESA's biological research facility BIORACK, that flew six times in SPACELAB and SpaceHab. His experience of active mission control and experiment support contributed to the development of new research facilities for the International Space Station (ISS).

Biomedical Applications of Nanotechnology

2007-10-28T07:26:00.000-07:00

This book provides a comprehensive survey of nanotechnology that reviews recent advances in nanotechnology-based drug and gene delivery systems and imaging approaches, and includes their biomedical significance, future prospects, and economic impact on pharmaceutical and biotechnological industries. Authors from different disciplines representing pharmaceutical sciences, biology, physics, engineering, medicine, and others investigating nanotechnology for various biomedical applications contributed book chapters.

An overview of nanotechnology and its potentialThe field of nanotechnology is undergoing rapid developments on many fronts. This reference provides a comprehensive review of various nanotechnologies with a view to their biomedical applications. With chapters contributed by distinguished scientists from diverse disciplines, Biomedical Applications of Nanotechnology:- Reviews recent advances in the designing of various nanotechnologies based on nucleic acids, polymers, biomaterials, and metals- Discusses biomedical nanotechnology in areas such as drug and gene delivery- Covers advanced aspects of imaging and diagnosticsIncludes a chapter on the issue of nanotoxicologyComplete with figures and tables, this is a practical, hands-on reference book for researchers in pharmaceutical and biotech industries, biomedical engineers, pharmaceutical scientists, pharmacologists, and materials scientists as well as for the policymakers who need to understand the potential of nanotechnology.

It is also an excellent resource book for graduate-level students in pharmaceutical sciences, biomedical engineering, and other fields in which nanotechnology is playing an increasingly important role.About the author(s):Vinod Labhasetwar, PHD, is a Professor in the Department of Biomedical Engineering, Lerner Research Institute at the Cleveland Clinic, where he leads the Cancer NanoMedicine Program, a collaborative effort jointly sponsored by the Department of Biomedical Engineering and the clinic's Taussig Cancer Center. Dr. Labhasetwar's research interest is in translational nanomedicine.

His laboratory investigates various nanosystems for drug/gene delivery in cancer therapy, stroke, cardiovascular conditions, and other age-related disorders. In addition, his group investigates magnetic nanoparticles for imaging applications. Dr. Labhasetwar has published over one hundred peer-reviewed articles and book chapters.

He has several U.S. and foreign patents on drug delivery.Diandra L. Leslie-Pelecky, PHD, is Associate Professor of Physics and Astronomy and a member of the Nebraska Center for Materials and Nanoscience at the University of Nebraska – Lincoln. She works with nanostructured magnetic materials having applications in biomedicine, magnetic recording, and permanent magnets, as well as with fundamental understanding of disordered magnetic systems. She has forty peer-reviewed articles and book chapters.

Biosimilars: a market coming of age?

2007-10-28T07:22:00.000-07:00

Biosimilars: a market coming of age? is a new, critical strategic management report which addresses these and other key issues of concern. The 175-page report is packed with authoritative statistics, case studies and detailed arguments on every aspect of the global biosimilar market and its potential.“Given the combined logic of rising drug expenditure and the biological direction of drug development, it seems certain that for the generic industry to thrive it will need to contain a biosimilar element.”The biosimilar sector continues to attract interest and controversy. Most generic manufacturers are actively involved in it, either directly or indirectly. The successful ones will be those with the patience, resources and above all money to invest now, in order to gain in the future.

Even for the vanguard those gains are some years off but positive developments are being made.USA: PROGRESS AT LAST?The US badly needs to establish a regulatory framework for biosimilars. As the rest of the world moves on, the US has been bogged down in legislative initiatives that have come to nothing. But there could be light at the end of the tunnel. On June 22nd 2007 a bill was announced in the Senate to provide a pathway for FDA regulation of biosimilars. The Biologics Price Competition and Innovation Act of 2007 (S. 1695, or BPCIA), is the first to command significant bi-partisan support. In particular, Orrin Hatch is one of the sponsors of the new bill.

This is an important move; Mr Hatch, one of the architects of the 1984 Hatch Waxman Act, had not supported previous moves in Congress. He has been trying to create a bill which balances the needs of generic companies with continued incentives for the originator industry, and felt that previous Democrat-led efforts had not done this. EUROPE: EPO APPROVAL IS A SIGNIFICANT STEPThe settled regulatory regime in the EU has seen progress in new approvals, most notably that of biosimilar EPO. In August 2007, the EMEA approved biosimilar EPO for Sandoz and two partner companies. The approval represents a major advance for Sandoz and in September 2007 it was reported that the CEO of Sandoz, Andreas Rummelt, said that new EPO will be launched ‘in the coming weeks’ in Germany and the UK, at a price discount of 25%-30%.INDIAN COMPANIES LEAD EXPANSION WITH LAUNCH OF BIOSIMILAR MABs If the biosimilar industry is going to progress beyond the first generation biologics then it needs to target more high profile therapies. For example, monoclonal antibiodies are a fast-growing biologic therapy area, and rituximab is one of the oldest, first having been approved in 1997.

Sales of rituximab were worth US$3.8 billion to the developer Roche in 2006. It was to some industry surprise then when Dr Reddy’s announced its version of the drug in its home market in April 2007 under the Reditux name. While it is the only such version in India and arguably the only ‘biosimilar’ MAB in the world, the move demonstrates the progress made by the industry. In another move, Ranbaxy-backed Zenotech are conducting clinical trials on rituximab as part of their growing biosimilar portfolio. What’s in a name?What to call biosimilars has generated a whole controversy of its own.

The term 'biogeneric' is a useful shorthand, but is not in favour with regulators or anyone else seeking a precise definition. To describe something as 'generic' implies a product that has proven bioequivalence with an originator drug. Even the generic industry now accepts that this is not quite possible for biologics; instead, regulators talk about proving a high degree of 'similarity'.Hence the term 'biosimilar'. This is the official name given in the EU pharmaceutical directives. The USA, having no defined regulatory path for these products, has no firm terminology.

2007-10-28T07:17:00.000-07:00

Biotechnology Timeline: Important Events And Discoveries In Biotechnology

2007-09-03T03:47:00.000-07:00

1977:
The Age of biotechnology arrives with “somatostatin” - a human growth hormone-releasing inhibitory factor, the first human protein manufactured in bacteria by Genentech, Inc. A synthetic, recombinant gene was used to clone a protein for the first time.

1978:
Genentech, Inc. and The City of Hope National Medical Center announce the successful laboratory production of human insulin using recombinant DNA technology. Hutchinson and Edgell show it is possible to introduce specific mutations at specific sites in a DNA molecule.

1979:
Sir Walter Bodmer suggests a way of using DNA technology to find gene markers to show up specific genetic diseases and their carriers. John Baxter reports cloning the gene for human growth hormone.

1980:
The prokaryote model, E. coli, is used to produce insulin and other medicine, in human form. Researchers successfully introduce a human gene - one that codes for the protein interferon- into a bacterium. The U.S. patent for gene cloning is awarded to Cohen and Boyer.

1981:
Scientists at Ohio University produce the first transgenic animals by transferring genes from other animals into mice. The first gene-synthesizing machines are developed. Chinese scientists successfully clone a golden carp fish.

1982:
Genentech, Inc. receives approval from the Food and Drug Administration to market genetically engineered human insulin. Applied Biosystems, Inc. introduces the first commercial gas phase protein sequencer.
1983:
The polymerase chain reaction is invented by Kary B Mullis. The first artificial chromosome is synthesized, and the first genetic markers for specific inherited diseases are found.

1984:
Chiron Corp. announces the first cloning and sequencing of the entire human immunodeficiency virus (HIV) genome. Alec Jeffreys introduces technique for DNA fingerprinting to identify individuals. The first genetically engineered vaccine is developed.

1985:
Cetus Corporation's develops GeneAmp polymerase chain reaction (PCR) technology, which could generate billions of copies of a targeted gene sequence in only hours. Scientists find a gene marker for cystic fibrosis on chromosome number 7.

1986:
The first genetically engineered human vaccine - Chiron's Recombivax HB - is approved for the prevention of hepatitis B. A regiment of scientists and technicians at Caltech and Applied Biosystems, Inc. invented the automated DNA fluorescence sequencer.

1987:
The first outdoor tests on a genetically engineered bacterium are allowed. It inhibits frost formation on plants. Genentech's tissue plasminogen activator (tPA), sold as Activase, is approved as a treatment for heart attacks.

1988:
Harvard molecular geneticists Philip Leder and Timothy Stewart awarded the first patent for a genetically altered animal, a mouse that is highly susceptible to breast cancer

1989:
UC Davis scientists develop a recombinant vaccine against the deadly rinderpest virus. The human genome project is set up, a collaboration between scientists from countries around the world to work out the whole of the human genetic code.

1990:
The first gene therapy takes place, on a four-year-old girl with an immune-system disorder called ADA deficiency. The human genome project is formally launched.

1991:
Mary-Claire King, of the University of California, Berkeley, finds evidence that a gene on chromosome 17 causes the inherited form of breast cancer and also increases the risk of ovarian cancer. Tracey the first transgenic sheep is born.

1992:
The first liver xenotransplant from one type of animal to another is carried out successfully. Chiron's Proleukin is approved for the treatment of renal cell cancer.

1993:
The FDA declares that genetically engineered foods are "not inherently dangerous" and do not require special regulation. Chiron's Betaseron is approved as the first treatment for multiple sclerosis in 20 years.

1994:
The first genetically engineered food product, the Flavr Savr tomato, gained FDA approval. The first breast cancer gene is discovered. Genentech's Nutropin is approved for the treatment of growth hormone deficiency.

1995:
Researchers at Duke University Medical Center transplanted hearts from genetically altered pigs into baboons, proving that cross-species operations are possible. The bacterium Haemophilus influenzae is the first living organism in the world to have its entire genome sequenced.

1996:
Biogen's Avonex is approved for the treatment of multiple sclerosis. The discovery of a gene associated with Parkinson's disease provides an important new avenue of research into the cause and potential treatment of the debilitating neurological ailment.

1997:
Researchers at Scotland's Roslin Institute report that they have cloned a sheep--named Dolly--from the cell of an adult ewe. The FDA approves Rituxan, the first antibody-based therapy for cancer.

1998:
The first complete animal genome the C.elegans worm is sequenced. James Thomson at Wisconsin and John Gearhart in Baltimore each develop a technique for culturing embryonic stem cells.
1999:
A new medical diagnostic test will for the first time allow quick identification of BSE/CJD a rare but devastating form of neurologic disease transmitted from cattle to humans.

2000:
"Golden Rice," modified to make vitamin A. Cloned pigs are born for the first time in work done by Alan Coleman and his team at PPL, the Edinburgh-based company responsible for Dolly the sheep.

2001:
The sequence of the human genome is published in Science and Nature, making it possible for researchers all over the world to begin developing genetically based treatments for disease.

2002:
Researchers sequence the DNA of rice, and is the first crop to have its genome decoded.

2003:
The sequencing of the human genome is completed.