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Pharma news in brief

Our weekly round up of news from the pharmaceutical industry.

Data transparency may ward off regulation

As the global pharmaceutical industry continues to become more open about results of clinical trials in response to growing public concerns regarding safety, more companies have announced plans to freely publish trial data. Following closely in the footsteps of Lilly, who recently announced data of more than 40 trials available on a bespoke website (www.lillytrials.com), GlaxoSmithKline (GSK) and Bristol-Myers Squibb (BMS) are also preparing to publish data. GSK said it would make details of all clinical trials since 2000 available on the internet by the end of the year.

Yet the recent initiatives of the companies have been branded as attempts to ward off the possibility of future legislation. Peter Dolan, CEO of BMS, said the publication of trial data may make it unnecessary for governments to tighten the rules on disclosure. However, MPs at the Health Select Committee inquiry heard that all pharma firms will be obliged to publish trial data through a common portal.

Shire in triple patent battle

Shire Pharmaceuticals is taking US generics company, Impax, to court to battle over patent protection for its hyperactivity treatment, Adderall XR, after Impax sought approval from US regulators to launch a generic alternative, in a move that could see a sharp fall in Shire's market share. Shire has already sued Impax and Barr Laboratories over efforts to produce a generic version of Adderall XR, but may also have to challenge a third US generics company, Colony Pharmaceuticals. Analysts predict that Shire will lose its patent on the product, which accounts for more than 40 per cent of total sales, in 2006. However, recent restructuring, licensing deals and acquisitions would give Shire a 'soft landing', it was noted.

Protection for US pharma in class actions

New laws being drawn up in the US could prevent American patients who have suffered severe side-effects from drugs suing pharmaceutical companies, and in turn protect pharma firms from paying out huge litigation costs. Presidents Bush's second administration plans to introduce a Medical Malpractice Bill which could deny patients recourse through the courts by preventing class-action lawyers from suing pharma firms on behalf of patients, as long as US regulators had approved the drug for marketing.

The Bill could save each company hundreds of millions of dollars, as indicated by recent large payouts including £1.3bn from Wyeth and more than £1bn from Bayer for drugs which were quickly withdrawn from the market following the start of legal claims. Critics have suggested that removing the threat of legal action could mean companies' incentive to ensure the highest standards of drug safety are diminished.

Strong sales performance in pharma

Global pharmaceutical sales grew by a strong seven per cent last year, according to IMS Health data. Sales through retail pharmacies totalled $345bn in the 12-month period to November 2004. Although the rate of market growth has slowed considerably in recent years due to generic competition and the squeeze on prices from some governments, the data reveals a steady growth. Sales in the top European markets showed an average 6 per cent constant exchange growth, while North America grew by 8 per cent and Japan by 2 per cent. The best-selling drug class was cholesterol busters, which grew by 12.2 per cent, selling $26.2bn. Pfizer's Lipitor remained the world's best-selling drug with sales of $10.4bn.

Mylan & King deal on hold

Mylan laboratories, one of the world's largest generic drug makers, said its plans to acquire King Pharmaceuticals were put in jeopardy following King's need to restate earnings for 2002, 2003, and the first half of 2004, due to accounting errors. The deal for $3.4bn was opposed by Wall Street analyst, Carl Icahn, a minority shareholder of Mylan, who suggested King had a poor pipeline and would soon face steep competition from generic drug makers in relation to its muscle relaxant, Skelaxin. Icahn offered to acquire the remaining shares of Mylan for $4.9bn, but the offer was rejected by the firm, which admitted it was unlikely to complete a deal with King by the end of February deadline. Shares in King fell 84 cents to $11.15 on the news, while shares in Mylan rose by 31 cents to $17.48.

30th September 2008

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