Monoclonal Antibody Therapeutics to Fill Vacuum Left by Ineffective Conventional Therapies

London, UK - 25th January, 2005 - Currently, the limited efficacy of conventional therapies, especially in the case of
several oncology and autoimmune and inflammatory disorders (AIID), is creating the need for safe and effective treatment
alternatives. While this situation has promoted demand for monoclonal antibodies (mAbs), market success will depend on
clearly establishing their clinical and cost benefits.


Unlike several conventional (small molecule) therapies that offer only short-term symptomatic relief and can potentially
cause serious side effects, biopharmaceuticals, such as mAbs, provide effective treatments with greater efficacy and
tolerability.


Amongst the most important attributes of mAbs is their high specificity. The ability to target specific antigens (within
cells, tissues and organs) involved in the pathology of disease, while minimising side effects has underlined the popularity
of mAbs in clinical applications.


Earlier, the attribute of high specificity had restricted the target population that could be treated with mAbs. Now,
numerous mAbs therapeutic products in clinical development are being investigated for the treatment of more than one disease
or for different forms of the same disease.


For instance, Remicade, which initially gained marketing authorisation for the treatment of severe and active Crohn's
disease, was later approved for reducing the signs and symptoms associated with rheumatoid arthritis. Thus, while most
products are expected to be approved initially for specific forms of a disease, label expansion is likely to follow, thereby
expanding the patient population that can be treated and boosting revenue potential.


The improved side effect profile of mAbs offers the patient a well-tolerated therapy, while also lowering overall
disease-management costs. mAbs have also provided significant benefits in terms of extending the survival rate of terminally
ill patients. In contrast, small molecule drugs have been liable to producing undesired side effects that extract heavy costs
in terms of both patient health and financial outlays.


However, even as pharmaceutical and biotechnology companies move towards 'biotech drugs' model from the 'small molecule
blockbuster' model, lower priced small molecule drugs remain the first line treatment choice in comparison to highly priced
mAbs alternatives.


Due to the sizeable development costs involved, most companies have adopted premium pricing for mAb products. High costs
assume increased relevance when mAbs are used in combination with conventional drugs, or in cases where continuous treatment
is required resulting in only very specific patient populations receiving mAbs, and uptake being slow.















"While costs are expected to go down as competition increases and development procedures are refined, the benefits of the
drugs need to be clearly demonstrated in terms of overall cost savings and effectiveness," remarks Frost & Sullivan (healthcare.frost) Industry Manager Dr. Raju Adhikari.



"Biopharmaceutical and pharmaceutical companies should assess themselves and provide detailed and clear pharmacoeconomic
analysis of these products so that mAbs may become less restricted, reimbursement may be granted to additional patient
groups, the rate of uptake enhanced and the potential revenue generated increased," he adds.


Estimated at USD 1.47 billion in 2004, Frost & Sullivan expects the total European monoclonal antibody therapeutics market to
grow at a compound annual growth rate (CAGR) of 34.1 per cent to amass USD 11.4 billion in 2011. There are currently ten
products commercially available in Europe including Remicade, Zevalin, Campath, Herceptin, Rituxan, Simulect, Zenapax
Synagis, ReoPro and the fully human mAb Humira. While chimeric mAbs currently control the market, humanised and human mAbs
are expected to dominate in future.


Over the next four to five years, oncology and AIID are projected to be the primary areas of commercial focus. Oncology is
likely to remain the leading revenue generator with sales of approximately USD 6.5 billion forecast in 2011. AIID indications
are set to follow with estimated sales of USD 4.5 billion in 2011. Other indication areas such as cardiovascular disorder,
organ transplantation and infectious diseases are likely to show less encouraging growth.


As competition intensifies, strategic alliances between mAb developers and big pharmaceuticals companies are accelerating
market growth. To capitalise on rising demand, the pharmaceutical and biotechnology industry will need to continue to evolve
towards technology integration and market expansions, even as they work towards offering competitive pricing, developing
holistic solutions - from diagnosis to treatment to after care and providing technical and efficient customer care.


"Success will depend on a medley of key factors including innovative molecular engineering, shorter development times, higher
success rates, robust and efficient intellectual property (IP) protection and development of cost-effective manufacturing,"
concludes Dr. Adhikari.


If you are interested in an analysis overview providing an introduction into the European Monoclonal Antibodies Therapeutics
Market - then send an email to Katja Feick -Corporate Communications at katja.feickfrost with the following
information: Full name, Company Name, Title, Contact Tel Number, Email. Upon receipt of the above information, an overview
will be emailed to you.


The European Monoclonal Antibodies Therapeutics Market

Code: B421-52


Background

Frost & Sullivan, an international growth consultancy, has been supporting clients' expansion for more than four decades. Our
market expertise covers a broad spectrum of industries, while our portfolio of advisory competencies includes custom
strategic consulting, market intelligence, and management training. Our mission is to forge partnerships with our clients'
management teams to deliver market insights and to create value and drive growth through innovative approaches. Frost &
Sullivan's network of consultants, industry experts, corporate trainers, and support staff spans the globe with offices in
every major country.


Media Contacts:


Europe:

Katja Feick

Corporate Communications

P: +44 (0) 20 7915 7856

F: +44 (0) 20 7730 3343

E: katja.feickfrost


Americas:

Danielle White

Corporate Communications

North America Team Leader

P: 210.247.2403

F: 210.348.1003

E: dwhitefrost


APAC:

Radhika Menon Theodore

Corporate Communications

P: +91 44 24314263 Ext:312

E: rmtheodorefrost


India:

Surbhi Dedhia

Corporate Communications

P: +91 22 2832 4705 Ext: 131

E: sdedhiafrost


List of key industry participants: Abbott Laboratories, Alexion Pharmaceuticals Inc., Amgen Inc., Antisoma Plc, Biogen Idec,
Bristol-Myers Squibb, Cambridge Antibody Technology, Celltech Group plc, Centocor Inc., Chugai Pharmaceutical Co. Ltd, Corixa
Corporation, Elan Corporation plc, Eli Lilly and Company, Genentech Inc., Genmab A/S, Genzyme Corporation, GlaxoSmithKline,
IDEC (Biogen), Immuno-Designed Molecules (IDM), ILEX Oncology, ImClone Systems Incorporated, Immunex (Amgen), Immunomedics
Inc., Johnson & Johnson, Medarex Inc., MedImmune Inc., Merck KGaA, Millenium Pharmaceuticals Inc., Novartis AG, Pfizer Inc.,
Pharmacia (Pfizer Inc.), Protein Design Labs Inc., Roche, Schering-Plough Corporation, Serono S.A., Wyeth, XOMA


View drug information on Campath; Herceptin; Humira.