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Powering performance

David Stout, President, Pharmaceutical Operations

“Our performance in 2005 was undoubtedly due to the contributions from all our staff around the world, and they deserve congratulations on the year’s achievements. Their enthusiasm and passion about helping to improve healthcare is clear,” says David Stout, President, Pharmaceutical Operations.

Key growth drivers

GSK pharmaceutical sales in 2005 were £18.7 billion, an increase of 8% over 2004, led by the company’s key pharmaceutical growth drivers and vaccines. “Our biggest-selling product, Seretide/Advair, had another strong year and continued to gain market share across all regions, driven by its efficacy in treating these debilitating conditions,” says David. It achieved market share by value in the anti-asthma and COPD therapy class of 27% in Europe and 33% in the USA, an increase of two percentage points in both cases compared with 2004.

Sales of diabetes treatments were also strong. Diabetes affects more than 190 million people worldwide. GSK launched Avandia for the treatment of type 2 diabetes in 1999 and a combination product, Avandamet, for blood sugar control in 2002. “Avandia/Avandamet goes from strength to strength. We believe physicians accept and like it, and increasingly use it as a first-line treatment for many patients where the licence allows,” says David. The product group was expanded further in February 2006 with the launch in the USA of a fixed-dose combination treatment, Avandaryl, which combines Avandia with a sulfonylurea. In 2005, Avandia/Avandamet achieved a market share by value in oral anti-diabetics of 14% in Europe and 35% in the USA, up 3 and 6 percentage points respectively.

Other growth drivers included Lamictal, Valtrex and Coreg, which did well in their respective markets of bi-polar disorder and epilepsy, herpes and heart disease, delivering a total of over £2.1 billion in sales, up 25% over 2004. During the year new guidelines were published that reinforced the use of Lamictal as first-line maintenance treatment for bi-polar disorder where the licence allows, and GSK filed once-daily Coreg CR with the FDA towards the end of 2005.

New products

New products also started to deliver significant sales. Avodart for enlarged prostate, for example, performed well and accounted for over 40% of new prescription sales in its class in the USA. “This was exceptionally fast growth and Avodart will be an exciting product for us,” says David.

Osteoporosis, a disease in which bones become brittle and more likely to break, affects an estimated 75 million people in the USA, Europe and Japan. An estimated one in three women will sustain an osteoporosis-related fracture in their lifetime. Boniva/Bonviva, developed with Roche, was launched in the USA in April 2005, and in several countries in Europe in September 2005, as the first ever oral treatment administered as one tablet once-a-month for postmenopausal osteoporosis. Since its launch, Boniva has achieved 10% share of new prescriptions in the oral bisphosphonate market in the USA. The injectable form of Boniva/Bonviva was approved for use in the USA, and recommended for approval in Europe in January 2006. It is the first intravenous bisphosphonate to be approved for the treatment of postmenopausal osteoporosis.

Another launch in the USA in 2005 was Requip for Restless Legs Syndrome (RLS), a chronic and disruptive condition characterised by an urge to move the legs, particularly at night. The condition is common, under-diagnosed and can have a significant effect on sleep and daily activities. Since it was launched for RLS in the USA, the volume of new prescriptions for Requip has quadrupled, with sales of £156 million, up 34%. Approval in Europe for Requip/Adartrel as a treatment for RLS is expected in the first half of 2006.

Commercial and operational excellence

GSK continued to make good progress towards commercial and operational excellence to improve underlying performance, with tight cost control underpinning operations. Through the company’s Worldwide Sales Force Excellence initiative, sales representatives are in a position to strengthen the product knowledge of physicians so they can deliver patient-specific treatment options more efficiently and effectively.

In manufacturing and supply, GSK introduced the Vision Factory initiative which is identifying improvements in productivity and cost reduction. “We started the year with some manufacturing problems that stopped production of two medicines at our Cidra plant in Puerto Rico. Our people are working with the FDA to implement solutions and minimise the interruption to supply,” says David. “The learning from this, combined with the Vision Factory initiative, will increase the operational excellence of our manufacturing operations in the future, ensuring product quality and patient safety are paramount.”

Maintaining high standards

GSK audits its operations to ensure that relevant standards expected, such as those in marketing practices, are reached or exceeded. GSK has in place a number of mechanisms to support compliance with policies and procedures. These include direct communication from senior management to employees on areas where policy is changing or there are concerns about compliance; global induction courses that include training on the GSK Code of Conduct to ensure new employees understand the importance of ethical conduct from their first day; and an annual certification process which extends to all senior managers globally and all middle managers in the UK and USA.

“We are committed to ensuring our business practices meet high standards and that our employees behave ethically and honestly. We strive to operate to high ethical standards, act responsibly and comply with the law. This is vital because of the simple fact that GSK products are important to the health of people around the world,” says David.