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Scrip Yearbook 2008: 24th Edition
Informa Healthcare, Jan 2007
Scrip’s annual review of the year, Scrip Yearbook 2008 is your guide to all the key facts, events and issues of the last 12 months from across the pharmaceutical and biotechnology industries.
Collected and organised from coverage in Scrip World Pharmaceutical News, the respected source of biopharmaceutical industry news, this new updated report provides a complete and concise tool, covering all levels of the industry and recent developments.
Scrip Yearbook 2008 will help you to:
- Identify which significant mergers and acquisitions were completed
- Analyse the strategic and financial performance of your competitors
- Track the latest clinical developments and key product launches across all therapeutic areas
- Review the latest industry regulations imposed on the industry
- Gain insight from leading industry analysts and commentary from senior editors
- Keep abreast of global healthcare initiatives and market movements
2007 will, unhappily, be remembered as the year that counterfeit and contaminated medicines finally made their way into the supply chains of developed nations. As consumers in the US, UK and elsewhere in the west continued to seek access to innovative prescription medicines which they believed were being denied them by their prescribers, governments or economic forces, industry leaders warned that the illegal trade, which has already cost countless lives in developing nations, would be only too ready to exploit the new opportunities now presenting in the developed world.
Even as US Food and Drug Administration (FDA) commissioner Andrew von Eschenbach cautioned repeatedly that the agency could not guarantee the efficacy or safety of imports - often obtained over the Internet and without the need for a prescription - US Members of Congress continued their battle to legalise importation of prescription drugs from Canada and elsewhere, urged on by seniors and other consumer groups. Then the warnings became reality, when dangerously substandard imported products were found to have originated in China, one of the world’s leading sources of counterfeit drugs. And the world looked on in shock at the execution of a former director of China’s State Food and Drug Administration (SFDA) after substandard drugs approved by the agency led to the deaths of Chinese consumers.
China has since announced extensive new steps to tighten drug safety controls and root out corruption, but the extent of the damage done to the country’s ambitions - and those of India, another major supplier of fake drugs - to become the global industry’s location of choice for low-cost manufacturing, R&D and clinical trials, remains to be seen.
Governments and manufacturers have been taking unprecedented steps to protect consumers from the risk of receiving dangerous fakes; an anxious US Congress granted the FDA significant new powers as part of the reauthorised Prescription Drug User Fee Act (PDUFA), while in the UK, the wholesale supply system was turned upside down by Pfizer’s announcement that it would in future distribute its products through a single supplier, in order, it said, to protect the supply chain from counterfeiters. Other drug majors have since announced similar moves.
Another major upset in the UK came in February, when market watchdog the Office of Fair Trading (OFT) advised the government that the much-admired Pharmaceutical Price Regulation Scheme (PPRS) was “no longer fit for purpose.” Its price and profit controls need to be replaced by value-based pricing which, said the OFT, would provide value for money for the NHS and better investment incentives for companies.
Globally, leading innovative drugmakers saw their intellectual property come under further pressure, faced with generic competition for many of their blockbuster products as patents on these long-time money-spinners began to expire, and with little in the way to replace them; in 2006 the FDA approved just 18 new molecules, compared with 36 in 2004. More and drug majors began divesting non-core activities and slashing their workforces worldwide - 10,000 going at Pfizer, over 6,000 at Bayer, 3,000 at AstraZeneca, 3%-4% of staff at Johnson & Johnson, unspecified numbers at Bristol-Myers Squibb, early retirements at Astellas, etc.
However, approval highlights of the year included: Acambis’ ACAM200 smallpox vaccine, the first approved biodefence vaccine; Centocor (J&J)’s Remicade (infliximab), the first biologic to be approved in the EU for paediatric Crohn’s patients; at GlaxoSmithKline, the first European approval of Tyverb/Tykerb (lapatinib) in the treatment of metastatic breast cancer in combination with Roche’s chemotherapeutic agent Xeloda (capecitabine), plus the first major launch, in Australia, of the cervical cancer vaccine Cervarix, and US approval of Alli (orlistat), the over-the-counter version of Roche’s diet drug Xenical; Novartis’ Lucentis (ranibizumab) approved Europe-wide for the treatment of wet agerelated macular degeneration; at Pfizer, extended US approval for Sutent (sunitinib) to include treatment of first-line advanced renal cell carcimoma, plus US and EU approvals for the novel HIV entry inhibitor Sezentry/Celsentri (maraviroc); Roche’s Avastin (bevacizumab), approved in the EU for use in combination with paclitaxel as first-line treatment for metastatic breast cancer; Roche/Genentch’s Herceptin (trastuzumab) becoming, in Europe, the first approved combination of targeted therapies for breast cancer; and Wyeth’s Torisel (temsirolimus), a novel kidney cancer treatment which received US approval, its first, for use in patients with advanced renal cell carcinoma. Merger and acquisition activity continued strongly through 2007, often involving hard-fought battles. The victors have not only been majors, but mid-sized companies, particularly within Europe, plus generics and biotechs. But analysts at PricewaterhouseCoopers are forecasting one “mega-merger” before the end of 2008.
Scrip Yearbook 2008 charts the progress of the pharmaceutical industry as reported in Scrip World Pharmaceutical News over the 12 months up to the end of November 2007.
The Scrip Yearbook 2008 is split into three sections. The first section focuses on the activities of key companies throughout 2007 - the top 20 pharmaceutical companies, the top biotechnology companies and the leading generic companies, as defined in the Scrip Yearbook’s sister report Scrip Pharmaceutical Company League Tables 2007. It looks at their financial progress, strategic decisions and product development during 2007. Also under this section we look at the merger and acquisition activity of these major companies and the reasons behind the decisions.
The second section focuses on developments in the top 40 major markets around the world and charts the regulatory and policy development and market trends in each.
The third section, under the general heading of ‘Therapeutics’, covers issues of disease prevalence (by A to Z), clinical trials conducted during the year.
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