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European BioPharmaceutical Review
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Investors have big hopes for the generics industry. The market capitalisation of leading generics companies increased during the last decade, more so than that of major pharma companies, resulting in return-to-shareholders-to-earnings ratios close to the pharma average. This outperformance indicates the expectations for the future of the generics industry. Although many changes in industry structure are expected to trigger strong growth - such as internationalisation of European companies; consolidation; and innovation in pharmaceutical drug development - the most prominent challenge so far is the product pipeline.A look at published drug patent tables reveals a huge wave of patent expiry over the next four years, worth an estimated US$40 billion in product sales, and including as many as 18 blockbusters (1). For the first time, these tables also include pharmaceuticals that were biotechnologically developed and produced. These biopharmaceuticals are also expected to be launched by generics companies, as they account for about one-quarter of the US$40 billion total and represent one of the fastest growing segments in the pharmaceutical market (see Figure 1). In fact, 'biogenerics' will represent a US$2 billion market for the generics industry, assuming a similar penetration rate as that for traditional drugs. |
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By Klaus Maleck, Chief Financial Officer, and Federico Pollano, Head
of Business Development, at BioGeneriX AG
Dr Klaus Maleck studied biotechnology in Braunschweig, Strasbourg and Chapel Hill, and holds a PhD in Biochemistry from the Max-Planck-Institute in Cologne. After four years as a Genomics Scientist at Novartis Inc. in the US, he joined the McKinsey team in Munich to consult diverse life science companies on strategy and M&A activities. He is currently employed as Chief Financial Officer at BioGeneriX AG.
Federico Pollano started his career (after studying biology and computer science) in clinical research for the Zambon group in Munich. He then worked for Glaxo Wellcome in clinical research, pharmacoeconomics and disease management fields, before joining the business development unit in Germany, focusing on licensing and M&A. In 2001, he took over as Head of Business Development at BioGeneriX AG.
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Industry Events |
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4th Annual Patient Recruitment and Retention in Clinical Trials
13-15 October 2008, Amsterdam
Patient recruitment
is now consuming thirty percent of clinical trial time - more time than any
other clinical trial activity - and almost half of all trial delays result from
patient recruitment problems.
As the
recruiting culture becomes more sophisticated and the forces affecting patient
enrollment grow more numerous and complex, pharmaceutical companies are
striving to discover new strategies to facilitate enrollment in clinical
trials.
With
increasing industry pressure to develop, test and market greater numbers of new
drugs faster, pharmaceutical companies need to perform clinical trials as
quickly as possible. Inefficient patient recruitment processes is a formidable
barrier to pharmaceutical companies' success in launching new products.
Improving the patient recruitment process is imperative to avoid wasted
investments and eliminate costly delays in bringing new drugs to market --
today and even more so in the not-so-distant future. Improved patient
recruitment presents one of the largest opportunities for pharmaceutical
companies to eliminate delays in clinical trials, thereby making it possible to
reduce time to market. With patent time limits and large overheads
meaning that any delays in the development timeline can be disastrous, a good
understanding of how to successfully recruit patients for trials is vital for
any company looking to succeed.
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News and Press Releases |
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