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Pharma news in brief

Our weekly round-up of news affecting the industry.

Novartis moves closer to generics vision

Swiss drugs group Novartis has completed its acquisition of Germany-based generics company Hexal AG and has started integrating it into the Sandoz division of the firm. The move takes Novartis a step closer to achieving its aspiration of becoming the world's leading generic products provider. The plan also includes the acquisition of Eon Labs which, along with the Hexal transaction, will provide Sandoz (Novartis) with a portfolio of more than 600 active ingredients. Novartis is awaiting the green light from the US Federal Trade Commission - which had requested more information on the deal - to acquire Eon, though if successful the total combined company will employ more than 20,000 people.

Elan nosedives again

Just as beleaguered Irish firm Elan lifted its hopes that its new multiple sclerosis drug, Tysabri, could return to the market as monotherapy, after two patients taking it combined with Avonex developed fatal brain conditions, its shares took another nose dive on reports in the Boston Globe newspaper that another patient (on monotherapy) had contracted a deadly disease. Neither Elan nor partner Biogen would confirm the scenario, announcing simply that they expected to announce the findings from a safety evaluation by the end of August. The news comes less than two weeks after Elan CEO, Kelly Martin, said he was confident that Tysabri would return to the market and contribute to the firm's future growth. Shares dropped by almost 27 per cent on the latest news.

Adverse reaction reports open to `abuse'

Pharma firms marketing branded drugs may be in a position to manipulate reports of adverse drug reactions (ADRs) to rival generic products, according to the World Health Organisation's Uppsala Monitoring Centre which is responsible for international drug scrutiny. Concern was raised based on a case in Poland in which a spuriously high number of ADRs were filed by several physicians relating to a generic psychiatric drug: notably a lack of efficacy and some serious side effects. When the reports were followed up, many of the doctors were unavailable to explain their decision or could not expand on it, according to reports. Professor Ralph Edwards, director of the WHO centre, said that, while there was no overt proof of malpractice, he wished to highlight the distinct vulnerability of the ADR system to interference by pharma marketing operations. He described any manipulation of the system for competitive reasons as ìappallingî.

Sanofi-aventis may see mixed mid-term wobble

Pharma analysts are unsure how to call the near- to mid-term health of French group Sanofi-aventis, with some concerned about patent expiries on four of its six current top earners despite strong growth and positive reports from the company announced at its recent AGM. The firm, whose stock has gained more than 30 per cent since Sanofi acquired former rival Aventis 10 months ago, looks to have a well-stocked pipeline and is expecting to provide up to 10 late-stage clinical trial updates and submit up to eight drugs for marketing approval during the rest of 2005. However, with significant patent expiries or legal challenges looming by 2006-07, concern was raised that the group's pipeline won't be ready to deliver in time to fill the gap.

Follow up safety studies sidelined

A number of pharma companies taking advantage of the US Food and Drug Administration's (FDA) accelerated approval system for drugs that treat life-threatening conditions are delaying or even forgoing their required confirmatory post-marketing studies, according to US officials. Under the accelerated programme, companies can seek and gain marketing approval without submitting the standard breadth of safety and efficacy information on the proviso that these studies are completed subsequently. Yet, patient safety is being put at risk by firms failing to provide this information, said Edward Markey, a senior member of the House of Representatives US Energy and Commerce Committee. He noted, from FDA data, that just 50 per cent of 42 studies that should be complete have not yet been started, and less than half (46 per cent) of 91 studies started since 1992 were never finished.

30th September 2008

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