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Delivering our product pipeline for patients

Our pipeline: from filling to flowing

Our approach to R&D is focused on letting innovation thrive and is delivering new breakthrough treatments for patients

“Effective R&D is all about being consistently excellent at all stages of the process,” says Moncef Slaoui, Chairman of R&D and the man who succeeded Tachi Yamada in June 2006. “We’ve been good – in fact very good – at filling our R&D pipeline in recent years, transforming the pipeline into one of the most powerful in the industry. But now we are focused on flowing products through that pipeline to patients.”

We now have 31 major product opportunities in phase III development or registration, comprising 13 new chemical entities (NCEs), 6 new vaccines and 12 product line extensions (PLEs).

“While 2006 was a year of considerable achievement, there were also some setbacks. R&D can be a risky business and we saw Redona, our diabetes drug, and brecanavir, a potential medicine for HIV/AIDS, both fall by the wayside. Setbacks like these go with the territory and are part of life at a pharmaceutical company.

“To offset this, we’ll continue to exploit our ability to reload the pipeline. When we fill the pipeline with more new compounds at one end, we dramatically increase the probability that more new medicines will be delivered from the other.

“In addition, in the last few months, we have in-licensed three assets in late-stage development, which will complement our existing pipeline:

Restructuring for tomorrow

“We need to work with the world’s best talent and globalise the R&D function. Having established a centre in Croatia in 2006, our next step will be to open a new research centre in China. We expect to announce further details on this during 2007,” says Moncef.

GSK led the industry with its creation of Centres of Excellence for Drug Discovery (CEDDs), which allow us to focus skills and resources on particular disease areas to speed up the drug discovery process. In 2007, we plan to open new CEDDs for both inflammation and infectious diseases. Also, with the acquisition of Domantis in December, we have strengthened our Biopharmaceuticals CEDD which investigates large molecules like monoclonal antibodies.

“Our Centre of Excellence for External Drug Discovery (CEEDD) has also continued to build entrepreneurial partnerships with world-class biotechnology companies, including EPIX Pharmaceuticals, Galapagos, Pharmacopeia and ChemoCentryx during 2006. The CEEDD’s goal is to supplement the GSK pipeline with assets developed through external alliances.

“In 2007, GSK’s new clinical imaging centre at Hammersmith hospital in London will be fully operational,” adds Moncef. “We have invested £46 million in the Centre. It is an exciting collaboration with Imperial College and evidence of our continuing commitment to experimental medicine. Research will focus on cancer, stroke, neurological diseases such as Parkinson’s and multiple sclerosis, and psychiatric diseases.

“Given everything we are working on, I am optimistic about the future."

Delivering hope to cancer patients

“2006 was a great year,” says Paolo Paoletti, Senior Vice President of our Oncology Medicine Development Centre. “Several promising new medicines for cancer are in late stage clinical trials and during the year we enrolled over 4,000 patients in trials, an increase of 185 per cent compared to 2004 and an indication of the strength of our cancer treatment pipeline.” The filing of Tykerb, our treatment for advanced breast cancer, was a landmark and is likely to be followed by a succession of other cancer-related products (see above).

Tykerb can improve the quality of life for patients, giving them the treatment they need at home with a simple, orally-taken tablet, whereas alternative treatments have to be injected or infused at a clinic. Not only is this more convenient for the patient, it also ties up fewer resources for the health provider.

Because Tykerb is a small-molecule medicine, it is tiny enough to move through the cancer cell membrane and stick to the damaging HER2 protein. Tykerb stops the cell from dividing and the cancer cell therefore dies.

“The independent data monitor asked us to stop one of our pivotal phase III Tykerb trials early, such was the evidence of its efficacy,” adds Paolo. “We filed for approval in the US in September and in Europe the following month.”

We have applied for an initial indication for Tykerb for treatment of advanced or metastatic HER2 positive breast cancer, in combination with capecitabine, in women whose breast cancer has progressed on other therapies. We expect further indications to follow as results from ongoing phase III trials emerge.

Cervical cancer is the second most common cancer in women worldwide, with almost 500,000 new cases each year. It is caused by the human papillomavirus (HPV), a sexually transmitted virus, and all sexually active women are potentially at risk. Screening can detect the early signs of cervical cell abnormalities, allowing early and prompt treatment. Without a significant improvement in prevention of cervical cancer, it is estimated there will be a million new cases a year by 2050 (source: International Agency for Research on Cancer).

Clinical trials carried out in 2006 suggest that Cervarix, our vaccine to prevent HPV, is highly effective and well-tolerated in women aged 10-55. In a recently published study, Cervarix offered up to 100 per cent protection against the two most common cancer-causing HPV types.

“Cervarix was filed in Europe and many of our International markets during 2006 and preparations are currently underway to file in the US,” says Philippe Monteyne, VP Global Vaccine Development. “The indications are that Cervarix could work for a wide age range and for a long period of time, with immune response time already stretching to more than four years.”

Growing our vaccines pipeline

Philippe Monteyne believes that ours is the richest vaccine pipeline in the industry. “We’re very proud of both the number of potential products and the fact that they are in all stages,” he says.

Currently in phase III development, Synflorix is designed as a dual pathogen vaccine developed to prevent meningitis, pneumonia and otitis. 2007 will be an important year for Synflorix and we expect that further progress with clinical studies will lead to filing for approval in Europe by the end of the year. We also have an extensive portfolio of meningitis vaccines currently in clinical development.

“We have a therapeutic vaccine for lung cancer, MAGE-A3, moving into phase III trials and our malaria vaccine continues to make good progress,” adds Philippe. “Towards the end of the year we also received data demonstrating that our new generation seasonal flu vaccine generated greater immune responses for those over 65, compared to a traditional seasonal flu vaccine.”

In addition, we will be filing Rotarix, the only two dose oral vaccine giving protection against severe rotavirus diarrhoea, for approval in the US during the first half of 2007. Rotarix is now registered in 78 countries worldwide and generated initial sales of £44 million in 2006.

Rising to the challenge of a flu pandemic

“An influenza pandemic isn’t inevitable, but experts remain deeply concerned about the likelihood of an outbreak,” says David Stout, President, Pharmaceutical Operations. "Where and when it will strike is the cause of debate. What is not open to question is the fact that GSK is developing a twin response to counter the threat of H5N1.”

Firstly, we have invested £100 million to increase production capacity for Relenza, our antiviral flu treatment, and the 10 millionth pack produced in 2006 left the production line in December. This performance is 20 times the original capacity of our manufacturing sites.

Secondly, the prospects for our H5N1 vaccine are excellent. Our proprietary adjuvant system allows us to produce an effective vaccine at much lower dosage levels than was at first thought possible. This means we can increase production approximately 10-fold so that more people worldwide can be inoculated against H5N1.

“Our H5N1 pandemic vaccine was filed in January 2007 and has already been pre-sold in some countries,” says David. “Switzerland, for example, has ordered 8 million doses for pre-pandemic use, one for each member of its population, and has also reserved capacity for 8 million doses in the event of an actual pandemic.”

Greater innovation for consumers

We are increasing the value of our pipeline of new Consumer Healthcare products by focusing on greater innovation. “We are looking for innovation wherever we can find it, inside or outside the company – something we call Open Innovation,” says Ken James, our head of R&D for Consumer Healthcare. “We have also increased alignment between R&D and our global brand teams so we understand consumers’ needs better and can deliver more innovative products that meet those needs.”

We expect to launch 10 new products in 2007, including alli, the first FDA-approved OTC weight-loss treatment in the US, Aquafresh White Trays to whiten teeth, Sensodyne Pronamel, the first toothpaste designed to protect teeth from acid erosion, and an extension to our range of Commit lozenges that help people stop smoking.