Glaxo to enter packed field of diabetes drugs
The pharmaceutical company filed with the FDA to sell its experimental treatment albiglutide.
GlaxoSmithKline (GSK) filed with the US to sell its experimental diabetes drug as the company hopes to compete in a market full of other large pharmaceutical makers.
UK-based Glaxo applied with the Food and Drug Administration to sell albiglutide, a once-a-week diabetes drug that would compete with Novo Nordisk's (NVO) Victoza and Bristol-Myers Squibb's (BMY) Byetta and Bydureon.
Sanofi (SNY) has its own experimental drug, Lyxumia, that it hopes to eventually sell in the U.S. and Europe. AstraZeneca (AZN) also is a player in diabetes treatments, partnered with Bristol-Myers for the development and sales of new drugs.
Glaxo's albiglutide controls blood-sugar levels in diabetics and belongs to a class of drugs known as GLP-1 agonists.
Like Bydureon, albiglutide can boast the convenience of once-weekly dosing. But similar to Bydureon, it also was shown to be inferior to Victoza's once-daily treatment when tested for effectiveness in company studies. For that reason, the prospects for the drug's success are questionable. According to estimates tallied by Thomson Reuters, Wall Street analysts expect less than $370 million in yearly sales for albiglutide by 2017. That's far short of the $1 billion in annual revenue for a drug to be considered a blockbuster.
Still, the drug is important for Glaxo's overall strategy of bringing new medicines to market. The company last month boasted that it can launch 15 new drugs in the next three years, according to Leerink Swann analyst Seamus Fernandez.
U.S. shares of Glaxo fell 1% to $44.12 in midday trading Monday. The stock is down almost 4% in the past three months.
Diabetes is not a new treatment area for the pharmaceutical giant. Glaxo's diabetes drug Avandia was once a big-selling product until the FDA in 2010 restricted its use due to links to heart attacks and strokes. The Avandia risks made the FDA rethink its view of new diabetes treatments.
Heart safety was an important topic of conversation at a government panel reviewing Johnson & Johnson's (JNJ) experimental diabetes drug Invokana last week. FDA advisers endorsed the J&J treatment but also indicated they were concerned about the risks posed by the drug. Invokana works differently than GLP-1 agonists. The medicine is part of class known as SGLT2 inhibitors. Bristol-Myers and AstraZeneca are studying a similar drug as is Eli Lilly (LLY) and partner Boehringer Ingelheim.
For its part, Lilly ended a partnership for Amylin's Bydureon before that drug was approved in early 2012. Bristol-Myers subsequently bought Amylin last year.
Glaxo's albiglutide was co-developed with Human Genome Sciences, which the drug maker acquired last year for $3.6 billion.
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