| GSK's product pipeline is maturing rapidly and is one of the largest in the industry |
195 projects
in development, of which 140 are in the clinic |
Nearly
80% increase
in New Chemical Entities in the pipeline since the merger |
|
"My son Mario was 14 weeks old when he received his first dose of Rotarix. I am happy I was able to give the vaccine to Mario and to protect him against rotavirus diarrhoea"
Yolanda Cervantes and Mario, now six months old |
 |
GSK's pipeline shows considerable strength. At the end of February 2005, there were 140 projects in clinical development, including 88 New Chemical Entities (NCEs), 32 Product Line Extensions (PLEs) and 20 vaccines.
Since the merger, the number of NCEs in clinical development has increased by nearly 80% and our pipeline has matured. In 2001, more than half our NCEs were in Phase I; by the end of February 2005, almost two-thirds of our NCEs were in Phases II and III.
We expect to see a significant increase in the number of major new compounds entering Phase III trials in the next three years.
Number of projects in clinical trials in each therapeutic area (end February 2005)
| |
Phase I |
Phase II |
Phase III |
Total |
| Cardiovascular & Metabolic |
|
|
|
|
Infectious diseases
|
|
|
|
|
Musculoskeletal,
Inflammation, GI & Urology |
|
|
|
|
| Neurosciences |
|
|
|
|
| Oncology |
|
|
|
|
| Respiratory |
|
|
|
|
| Vaccines |
|
|
|
|
| Total |
|
|
|
|
| Phase I |
Evaluation of clinical pharmacology, usually conducted in volunteers. |
| Phase II |
Determination of dose and initial evaluation of efficacy, conducted in a small number of patients. |
| Phase III |
Large comparative studies (compound versus placebo and/or established treatment) in patients to determine clinical benefit and safety. |
|
New product extensions in 2004
In 2004, PLEs - new indications and dosage forms for existing products - continued to contribute to turnover and mitigate competition from generic medicines. New indications for Seretide/Advair made this important asthma medicine available for use by children aged 4 to 11 years. Kivexa/ Epizicom, a single tablet combining two successful HIV treatments, was introduced, simplifying the medication regime for patients.
Clinical Trial Register
During 2004, GSK established a website called the GSK Clinical Trial Register to publish clinical trial data relating to marketed medicines. Although prescribing information approved by regulatory authorities will continue to guide appropriate use of GSK medicines, the Register serves as another resource for researchers, medical professionals and the public. Along with publications in medical journals and presentations at medical congresses, the Register demonstrates GSK's commitment to ensuring the clear communication of data concerning its products. |
|
|
Best news in 2004
The best news in 2004 was the results from our clinical programme for Cervarix, a vaccine candidate against cervical cancer, which turned out to be even better than we had hoped for. Cervarix showed a 100% efficacy in Phase II trials against the most common strains of the human papilloma virus (HPV), which cause more than 70% of cervical cancers. Major resources are being allocated to this project in 2005 in order to complete Phase III trials and to apply for a licence in early 2006.
New product launches in 2005
GSK plans to launch six new products in 2005. Two of these, Rotarix and Vesicare, have already been launched.
Rotarix, our two-dose oral vaccine against rotavirus, which causes severe diarrhoea and vomiting in infants, was launched in Mexico in January 2005. This disease kills more than half a million children each year or one child every minute, mainly in developing countries. With Rotarix, GSK pioneered its 'South First' launch strategy, which focuses first on countries where there is most need. The Mexican government will pay for a vaccination campaign in order to eliminate the infection. |
Vesicare, a treatment for overactive bladder, was launched in the US in January 2005. The four other new products expected to be launched in 2005 are: Boniva a once-monthly treatment for osteoporosis, Avandaryl for type 2 diabetes, Entereg for post-operative
bowel problems and Requip for restless legs
syndrome.
Meeting unmet medical needs
GSK is making significant progress with
potential new medicines to treat depression, schizophrenia, multiple sclerosis, Alzheimer's
disease and migraine.
In 2004, we announced the establishment of a
pre-clinical research facility in Singapore, which
will employ a team of 30 to 35 scientists. This
will focus on new therapies to treat neurodegenerative
diseases such as Alzheimer's disease, Parkinson's disease and schizophrenia.
Diseases of the developing world
GSK is the only company that is developing medicines and vaccines to treat all three of the World Health Organization's top priority diseases: malaria, tuberculosis and HIV/AIDS.
In 2004, GSK's pyridone project was awarded the Medicines for Malaria Venture 'Project of the Year'. This potential medicine has since moved into pre-clinical development.
GSK is the industry leader in HIV R&D and, for many years, our products have formed the core of HIV/AIDS treatment guidelines around the world.
The number of New Chemical Entities (NCEs) in the pipeline has increased by nearly 80% since 2001
| |
Oct
2001 |
Dec
2003 |
Feb
2005 |
| Phase III |
8 |
12 |
11 |
| Phase II |
15 |
32 |
43 |
| Phase I |
27 |
38 |
34 |
| Total |
50 |
82 |
88 |
|
 |
 |
|
 |
Cervarix: Our vaccine candidate against cervical cancer showed 100% efficacy in Phase II trials against HPV 16 and 18. Cervical cancer is the second most common cancer in women - 510,000 are diagnosed and 288,000 die from the disease each year. GSK believes that Cervarix will save many lives and has the potential to be our best-selling vaccine yet.
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| Lapatinib: GSK's new anti-cancer compound is designed to destroy cancer cells while causing less toxic side-effects than conventional chemotherapy. Having shown promise in women with advanced breast cancer who had not responded to existing therapy, it is being evaluated in an expanded clinical programme. |
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Planned GSK pipeline filings, 2005-07
| New Chemical Entities |
Allermist
steroid – rhinitis |
'115
TPO antagonist - low platelets |
Cervarix
HPV vac - cervical cancer |
'140
CCR5 antagonist - HIV |
Rotarix
vaccine - rotavirus |
Radafaxine
NDRI - depression |
Lapatinib
dual kinase inhibitor - cancer |
'381*
COX-2 inhibitor - pain |
| Product Line Extensions |
Arixtra
acute coronary syndrome |
Lamictal XR
once a day |
Avandamet XR
once a day |
Requip CR
once a day |
Coreg CR
once a day |
Trexima
migraine |
Avandia
Alzheimer's disease |
Wellbutrin XL
EU filing |
*381 filing date to be confirmed |
|
GSK Corporate Website
