Released on = April 25, 2007, 7:15 am

Press Release Author = La Merie Business Intelligence

Industry = Biotech

Press Release Summary = The biogenerics industry consolidates with Indian players
emerging in Western countries; pegylation, protein engineering, drug delivery and
oral small molecules feed the pipeline of next generation competitors of therapeutic
proteins

Press Release Body = BARCELONA, Spain | April 24, 2007 | The Business Intelligence
firm La Merie S.L. reported today that the consolidation process in the biogenerics
industry has commenced after first approvals of biogeneric human growth hormone
products in the US and the EU and first filings of biogeneric erythropoietin and
insulin in the EU. Smaller biogeneric companies have been taken over by generic
players from India and Eastern Europe. Large generic and hospital specialist
companies have entered the field by acquisition and licensing deals. Apart from
biogenerics, the US$ 42 bln market of the major therapeutic proteins (EPO, insulin,
coagulation factors, interferons, G-CSF, hGH, enzyme replacement and FSH) is being
challenged by competitor projects arising from various technologies. Oral small
molecules or oral delivery of packaged or engineered proteins can bypass
conventional next generation solutions such as pegylation, fusion proteins or
non-invasive drug delivery technologies. These results and more were found in a
competitor analysis conducted by La Merie Business Intelligence. The competitor
analysis of Biogenerics & Therapeutic Proteins can be acquired at
pipelinereview.com, La Merie's News Center and Online Store.

Manufacturing of biopharmaceuticals is getting a commodity in non-regulated
countries as local investors paid for technology transfer and infrastructure.
Countries such as Egypt, Tunisia and Iran are joining pioneer countries such as
Argentina, Cuba, India, South Korea and China which so far service domestic and
other non-regulated and less developed countries. Indian companies such as Biocon
now are on the move to the European Union with biogeneric proteins and are favored
by a less costly local, yet GMP approved infrastructure. Biogeneric proteins not
only may directly compete with first generation therapeutic proteins, but also serve
for drug delivery solutions requiring larger amounts of protein. Cost-efficient
manufacture by an advantageous infrastructure or less expensive expression systems
may become crucial in future market competition.

The major therapeutic proteins are not only being challenged by biogeneric
developments in the Western countries, but also by innovative investigational new
drugs. A state of the art approach is pegylation or glycopegylation of the parent
protein, but protein engineering technologies may lead to the same effect of a
longer half-life and also result in improved pharmacodynamic properties. Oral
delivery approaches for hGH, insulin, and interferon are currently being evaluated
while oral small molecules stimulating thrombopoiesis or erythropoiesis are already
in advanced clinical testing. The use of clinical stage peptide agonist or peptibody
molecules are an alternative to proteins such as EPO or TPO. Progress in protein
engineering and expression made available recombinant plasmin becoming an attractive
alternative to plasminogen activators because it directly degrades fibrin, but yet
is readily neutralized.


About La Merie

La Merie S.L. is a Business Intelligence enterprise fully dedicated to provide high
quality R&D information to the biopharmaceutical industry. La Merie offers
individual consultancy services and publishes reports and periodicals. For more
information visit www.lamerie.com.


About PipelineReview.com

Pipelinereview.com is the News Center and Online Store of La Merie Business
Intelligence focused on Research and Development in the Biopharmaceutical Industry.
Visitors of PipelineReview.com will find R&D relevant press releases and can receive
selected R&D news from one or more of the site's News Channels. A free R&D Newletter
conveniently brings via e-mail a daily selection of the most interesting news from
biopharmaceutical R&D. For more information visit pipelinereview.com

SOURCE: La Merie Business Intelligence

Web Site = http://www.pipelinereview.com/joomla/content/view/11339/103/

Contact Details = Jorge Márquez
La Merie Business Intelligence
C/ Caspe, 33B, 4º, 2ª
E-08010 Barcelona
Tel +34-93-342 91 97
Fax +34-93-342 91 98
e-mail: jorge.marquez@lamerie.com
Website: http://www.lamerie.com
Online Store: www.pipelinereview.com