GSK holds steady and looks to pipeline

by JoelLane 26. April 2012 14:45

Andrew Witty GlaxoSmithKline (GSK) has reported modest global sales growth and significant pipeline development in the first quarter of 2012.

The UK’s largest pharmaceutical company achieved 2% sales growth worldwide despite a 6% drop in European sales.

The company also highlighted positive phase III data for five assets in treatment of major diseases, pointing the way to future growth.

CEO Andrew Witty said that GSK had “returned to reported sales growth, delivered additional R&D pipeline output and maintained our focus on returns to shareholders” in Q1.

GSK’s performance “reflects the resilience of our business and the investments we have made to increase the breadth and mix of the Group,” he commented.

The company’s pharmaceuticals and vaccines business grew by 2% overall – due largely to 9% growth in the US, where a co-promotion deal for overactive bladder treatment Vesicare combined with successful product launches in oncology.

However, Witty noted that pharmaceuticals and vaccines sales fell by 6% in Europe due to “the continued implementation of government austerity measures”.

The EMAP market saw 2% growth in this product area, with pharmaceuticals up 6% but vaccines down 9%, and strong sales in China and Latin America compensating for the impact of political turmoil in Africa and the Middle East.

Witty emphasised that GSK’s future lies in its pipeline, echoing the recent words of Lilly CEO John Lechleiter. He pointed to positive results for five drug candidates:

• The first of three phase III studies for HIV drug dolutegravir, showing non-inferiority to raltegravir.

• Successful phase III studies for melanoma drugs BRAK and MEK, which are ready to be filed for approval (and to be trialled in combination).

• Ongoing successful phase III data for type 2 diabetes drug albiglutide.

• Completion of phase III studies of asthma and COPD treatment Relovair, which will be filed for both indications this summer.

These new products, Witty said, “together with the progress we have made with the broader late-stage pipeline since the beginning of 2011, underpins our growing confidence in our ability to grow sales on a sustainable basis.”

For a video interview with GSK’s CFO, Simon Dingemans, click here.

New GSK diabetes drug may outperform insulin

by JoelLane 3. April 2012 13:16

Pf product news GlaxoSmithKline (GSK) has reported successful phase III trials of its new diabetes drug albiglutide, which it intends to file for regulatory approval.

The injectable drug, taken weekly, outperformed a rapid-acting insulin when used in combination with a daily insulin to manage type 2 diabetes.

Analysts predict the drug will earn GSK $250m per year by 2016 – not a potential ‘blockbuster’, but a robust product in the diabetes market.

Albiglutide – awaiting a new brand name after GSK dropped the name Syncria – is the latest product in the class of glucagon-like peptide-1 (GLP-1) diabetes drugs that includes Victoza from Novo Nordisk and Byetta from Amylin and Lilly.

GLP-1 drugs stimulate insulin release when glucose levels are high, a flexible property that makes them a potential alternative to insulin in patients with severe type 2 diabetes.

They have the further advantage of stimulating weight loss, which is of clinical value to most people with type 2 diabetes.

The first phase III trial of albiglutide, reported in November 2011, found it to be less effective than daily Victoza in reducing blood glucose levels – a disappointing result for GSK.

However, armed with top-line results from seven of eight phase III studies, GSK said that the cumulative data support an application for the drug’s approval as a treatment for type 2 diabetes.

One trial tested albiglutide against Lilly’s rapid-acting insulin Humalog when used in combination with Sanofi’s daily insulin Lantus.

The patients taking albiglutide experienced a 0.82 reduction in HbA1c, compared to 0.66 in the Humalog group. In addition, The albiglutide patients also lost an average of 0.73 kg in weight, whereas the Humalog patients gained 0.81 kg.

GSK expects to have all the data it needs to apply for regulatory approval by the end of 2012.

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