Weekend round-up

Debates over data reliability, US regulatory concerns for GSK's asthma drug Advair and news of a potential vaccine for diabetes have rocked the pharmaceutical industry in what has proven to be a busy weekend for the sector.

On Friday, Swiss-based research and development company Basilea experienced a drop in shares after regulators in Europe announced they would be unable to recommend approval for the antibiotic ceftobiprole, having previously backed the drug.

According to the European Medicine Agency's Committee for Medicinal Products for Human Use, they have not adopted a negative opinion on the market authorisation application for the drug, which is used for the treatment of complicated skin and soft tissue infections.

The application had been submitted by Basilea's partner Johnson & Johnson unit Janssen-Cilag as long ago as June 2007 and had initially received positive opinion. However, the EMEA now admits that it had taken the "unusual step" of halting the authorisation process on ceftobiprolec "pending completion and assessment of Good Clinical Practice inspections."

Now the Swiss firm says it is "reviewing all strategic options to protect the interests of the company and its shareholders."

Shares remain down this morning (22 February).

GSK battle US restrictions

In other news from Friday, London-based pharmaceutical giant GlaxoSmithKline (GSK) has been defending its blockbuster drug Advair after US regulators included the drug as one of four asthma treatments that they believe should be used less often by suffering patients.

The US Food and Drug Administration (FDA) announced on Friday that long-acting beta agonists (LABAs) should never be used alone in the treatment of asthma in children or adults and ordered that manufacturers should include such a warning on product labels.

For GSK, the warning impacts them twice over, relating to both their Advair (fluticasone/salmeterol) and single agent Serevent (salmeterol) drugs. Now, say reports, the drug makers have just 30 days to agree to the label changes or provide evidence as to why they are not warranted. GSK has already spoken out.

"There is no evidence from more than 10 years of data from clinical trials, observational studies and worldwide clinical experience exceeding 30 million patient-years of use that Advair is associated with an increased risk of asthma-related death, hospitalisation or other serious respiratory-related outcomes in any age group," the group said in a statement at the weekend.

"It is important that doctors have flexibility to make the proper clinical decisions to help patients gain and maintain optimal control of their asthma," the statement added.

The news is of particular concern to GSK given than Advair remains such a big earner for the firm. In fact, fourth-quarter sales for chronic obstructive pulmonary disease as well as asthma, reached GBP£1.37 billion compared with rival AstraZeneca's Symbicort sales for the same period reaching only GBP£666 million.

New report says diabetes vaccine is "on horizon"

A new report published by Kalorama Information announced this weekend that a diabetes vaccine could be on the market by the end of the decade as several candidates are now in the drug pipeline. According to the report, Swedish firm Diamyd Medical is leading the way.

The report claims that there are at least seven diabetes vaccine candidates in development and most are in Phase I and address type 1 diabetes. However, the report does add that one being developed by Diamyd is currently in a global Phase III study and first results are expected in the spring of 2011.

The news of a potential vaccine is being heralded as excellent news for patients who suffer from the condition. Type I diabetes affects 700,000 people worldwide each year, while a further 200 million suffer from type II.

Shire strategy "harvests" drugs from rivals

And today, UK-based pharmaceutical company Shire, which specialises in treatments for rare diseases and symptomatic illnesses, is looking to pioneer a "search and development" strategy where - rather than developing drugs from scratch - the company collects promising drugs from other companies and then refine them in-house.

According to reports in today's edition of UK newspaper The Telegraph, the model of "niche researching" at first provoked hilarity from industry professionals, but now, the strategy is stirring an interest from pharmaceutical peers.

Shire Chief Executive Angus Russell told the paper that "working in rare diseases allowed [the company] to focus on a specific group of patients and develop strong relationships with clinicians", which had helped them to develop this trusted "search and develop" method.

What's more, Paul Cuddon, an analyst at KBC Peel Hunt added that while Big Pharma remains good at "late stage development, biotech is good at discovery and quick decisions on whether a drug is good or not." He added that a combination of the two makes for an "excellent strategic fit."

 

 

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