Weekend round-up

GSK

Both drug approvals and restrictions by the FDA, alongside reports of a renewed, more targeted focus on "pharmerging" markets have impacted the pharmaceutical industry over the weekend, beginning what could be a interesting week for the sector.

Since Friday, Global pharmaceutical giant GlaxoSmithKline (GSK) has been busy defending their blockbuster drug Advair after the US Food and Drug Administration (FDA) included the drug as one of four asthma treatments that they believe should be used less often.

The FDA warned that long-acting beta agonists (LABAs) should never be used alone in the treatment of asthma and have now ordered that manufacturers include a warning on product labels. Following their announcement at the end of last week, the drug makers now have just 30 days to agree to the label changes or provide evidence as to why they are not warranted. In response, GSK have already made a case apposing the label changes.

According to a statement released by GSK at the weekend: "There is no evidence from more than 10 years of data [...] that suggest that Advair is associated with an increased risk of asthma-related death, hospitalization or other serious respiratory-related outcomes in any age group."

However, the issue remains of particular concern to GSK given than Advair is still such a big earner. Fourth-quarter sale reached US$2.11 billion compared with rival AstraZeneca's same period sales for Symbicort only reaching US$1 billion.

Rituxan approved in US

But while GSK battle their issues, Roche and Biogen Idec have been celebrating as their blockbuster Rituxan receives yet another approval from the FDA, this time for the most common form of adult leukaemia.

According to reports from Friday, the approval is for Rituxan (rituximab) in combination with the chemotherapy regime fludarabine and cyclophosphamide (FC) for people with previously untreated as well as treated CD20-positive chronic lymphocytic leukaemia (CLL).

The approval is particularly noteworthy when looking at data from the American Cancer Society, which says there are nearly 90,000 people in the USA living with CLL, accounting for one-third of all leukemia cases. Last year, more than 15,000 new cases were expected to be diagnosed in the country.

Rituxan is also indicated for rheumatoid arthritis and had sales of almost US$6 billion last year and this latest approval can only help boost this figure further.

Concerns over liver trial

Leading specialty pharmaceutical company Salix Pharmaceuticals saw a decline in shares on Friday after the FDA cited concerns with its clinical trials looking at a new use of its diarrhea drug Xifaxan to treat a liver disorder.

According to a memo released on Friday, while results from a single clinical trial look promising, the results are hard to interpret. Possible liver side effects, including two deaths, are also a concern. The memo comes ahead of a public meeting to be held tomorrow.

The specialty pharmaceutical company is seeking expanded FDA approval of its Xifaxan diarrhea drug as a maintenance treatment for hepatic encephalopathy patients in remission. However the FDA said while the trial's "outcome on its face is persuasive, even for a single trial," the method used to assess the results "requires a subjective assessment and depends on clinician judgment."

According to FDA analysis, the company also "did not gather follow-up data on patients who developed adverse events."

The release of the data saw shares fall as much as 14 percent on Friday, though they have since improved. Tomorrow an FDA panel of outside experts will weigh whether to recommend wider approval.

Focus on Indian market

Big Pharma are reportedly moving to India with greater force, that's according to reports from the weekend. Sujay Shetty, associate director of professional services firm PricewaterhouseCoopers (PwC), detailed how "the domestic pharmaceutical landscape will rapidly change after the next two to three years, with multinationals gaining significant clout.

"In the next three years, Indian drug makers will continue playing a dominant role, but it will change after that," he warned.

Currently, according to regional data, Indian companies hold a 75 percent share in the domestic market, while the rest is held by multinationals, In the next five years this figure is expected to change, with the share of both foreign and Indian companies in the domestic market set to become more or less equal.

Big pharma are already growing a significant presence in the region, with Novartis having already introduced the Arogya Parivar model, which aims at ensuring availability of products at same prices but with different pack sizes; Eli Lilly, offering a project with the Self-Employed Women’s Association (Sewa) in Ahmedabad to educate people on tuberculosis and encourage them to take treatment; and sanofi-aventis introducing the initiative "Prayas", aimed at boosting generic drug sales in towns and rural India.

Matthew Buttell

Matt Buttell graduated from Bath Spa University in 2006. Since then he has written for several publications, before moving to the web. He now writes solely for the internet, continuing to cover key business issues while managing his own personal blog.

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