After months of working damage control for Avandia, GlaxoSmithKline has released some positive news on the oncology front. The company announced last Monday that it plans to release five new cancer medicines over the next three years, a huge leap for a company whose name is not synonymous with that space. The newcomers, three direct-acting oncologics that treat cancer and two supportive cancer medications, are:
Tykerb, an oral breast cancer treatment released in the United States in March. This drug has been used to treat nearly 3,000 patients.
MAGE-A3 ASCI, a new vaccine entering Phase III trials in late 2007. The therapeutic vaccine has shown positive effects when used to treat non-small-cell lung cancer. GSK claims that with more than 2,200 patients already signed up, the Phase III trial will be one of the largest ever conducted for the treatment of cancer. "Non-small-cell cancer is very unresponsive to any type of treatment. So if you have a successful compound in that space that is likely to generate very significant sales, it could become a blockbuster," says Graham Lewis, vice president of global pharma strategy at IMS Health.
Pazopanib, an oral multi-kinase inhibitor that prevents the development of new blood vessels, thereby slowing tumor progression. In clinical trials, the drug has seen positive effects in treating renal cell carcinoma, soft tissue sarcoma, and aggressive ovarian cancers, according to GSK.
Ofatumumab, a fully human high-affinity antibody for the treatment of follicular non-Hodgkin's Disease and chronic lymphocytic leukemia.
Promacta, an oral novel compound used to treat thrombocytopenic sufferers that are at risk for uncontrollable bleeding. In a controlled study, patients treated with the medication saw a drop in bleeding as opposed to those taking the placebo. The drug also is being investigated for people afflicted by idiopathic thrombocytopenic purpura, hepatitis C-associated thrombocytopenia, and chemotherapy-induced thrombocytopenia.
Rezonic, an enti-emetic medicine that in combination with Zofran can be used to curb nausea and vomiting in cancer patients.
"The science has been moving faster in oncology than in other scientific areas, and we understand so much more now that we are in the phase of translating the knowledge to application," said Paolo Paoletti, senior vice president at GSK. "On the other hand, cancer is still a huge unmet need, and while we are taking a huge step forward, we have not completely cured the disease."
According to Paoletti, the drug manufacturer began researching cancer drugs just before the merger of Glaxo and SmithKline, more than 10 years ago. After the unification, the new company formed small drug-development divisions called Centers of Excellence in areas such as cardiology and oncology, so that researchers could focus solely on individual drug treatments.
"From discovery through development, we are creating a unique group that is working only on oncology," Paoletti said. "We don't have five drugs in discovery, we have five drugs in late-stage development that will be submitted in three years and, hopefully, we will have new drugs for cancer patients."
Oncology is one of the fastest-growing sectors of the pharmaceutical industry and is expected to double in size by 2011 and be worth $75 to $80 billion, according to IMS Health. "This is a vibrant and growing market on a global basis, and we think it is going to continue," Lewis says. IMS expects that 50 new chemical entities will be launched in direct oncology in the next five years. "GSK is not currently a top 10 player in oncology, but it is likely to become a serious player in the space," Lewis said. "It is unlikely that any other major players will launch more than three novel compounds over this period."
One of the challenges in the cancer drug arena is competition. "Once upon a time, you developed a novel compound in oncology and essentially there was no competition," Lewis said. "Quite a number of the compounds that will be launched in the next five years will be competing with drugs that are already on the market." In addition, a number of drugs on the market will be exposed to generic competition, which could well affect some of the new products.