Global Insight Perspective | |
Significance | The presentation of key new cancer drugs, including clinical data updates, and ambitious launch timeframes demonstrate GSK’s efforts in developing a strong cancer portfolio. |
Implications | The strength of GSK’s portfolio has been particularly showcased by promising oral breast cancer drug Tykerb, which has had a good sales start since its U.S. launch in March. |
Outlook | Despite significant investment in cancer, including the mega-deal with Danish biotech Genmab, GSK faces heated competition from the likes of Roche/Genentech, a cancer research powerhouse. |
GSK has revealed plans to launch five new cancer drugs from 2007 until 2010 during an overview of its oncology offerings in London, which included clinical updates on several key new drugs. Talking to investors and analysts, Moncef Slaoui, Chairman of R&D, said that GSK is actively developing late-stage drugs in “over twelve different types of cancer”, ranging from groundbreaking breast cancer pill Tykerb (lapatinib) to vaccines that can treat and prevent cancer.
A Good Start
Paolo Paoletti from GSK’s SVP Oncology Development Centre said that the promise of Tykerb, which is a rival to Roche (Switzerland) and Genentech (U.S.)’s injectable Herceptin, has already been witnessed in the United States. Since its launch in March, Tykerb has already treated about 3,000 U.S. advanced or metastatic breast cancer patients who have received previous therapy. A European roll-out of the drug under the brand-name Tyverb is expected in the second half of this year. GSK showcased data in which the drug showed significant efficacy in the treatment of HER-2 positive breast cancer in relapsed and first-line metastatic settings, which included a new analysis in combination with Roche’s Xeloda. Meanwhile, a large-scale study has commenced for the use of Tykerb in the adjuvant setting, with rapid enrolment occurring for the TEACH trial.
The Fab Five
The five experimental cancer drugs highlighted for launch included:
- Pazopanib for renal cell carcinoma: Registration studies have been fully enrolled for a late-stage trial of the anti-angiogenesis drug, which is similar to Roche/Genentech’s Avastin, for renal cell carcinoma. Pazopanib has also shown promise in treating aggressive ovarian cancer and soft tissue carcinoma;
- Promacta (eltrombopag) for thrombocytopenia: Phase III data shows that Promacta increased platelet count and significantly slashed incidence of patient bleeding in those with idiopathic thrombocytopenic purpura (ITP). GSK has earmarked the filing of Promacta to treat short-term ITP by the end of 2007 or early 2008;
- Rezonic (casopitant) for emesis: New Phase III data demonstrates the anti-emetic’s superiority when used in combination with Zofran, compared to Zofran alone, for the treatment of post-operative nausea and vomiting (PONV). GSK plans to file Rezonic for both PONV and chemotherapy-induced nausea and vomiting (CINV) in the first half of 2008;
- Cervarix for cervical cancer prevention: GSK hopes to roll-out the vaccine, recently approved in Australia, in Europe later this year. However, Cervarix is unlikely to debut in the U.S. market before 2008. It is a rival to Merck (U.S.)’s Gardasil, which has just been approved in Switzerland.
- Ofatumumab (HuMax-CD20) for NHL/CLL: GSK revealed plans for a head-to-head study of the monoclonal antibody, currently in trials for forms of leukaemia and lymphoma, with Roche/Genentech’s Rituxan/MabThera, which has a similar mechanism of action. Meanwhile, GSK’s co-development partner, Danish biotech Genmab, revealed that Ofatumumab could be launched in 2008.
Besides Cervarix, GSK also showcased research in the emerging field of therapeutic cancer vaccines. The British drug-maker plans to start recruitment for Phase III trials of its MAGE-A3 jab for non-small-cell lung cancer (NSCLC) in September.
Outlook and Implications
The overview showcases GSK’s significant progress in expanding and developing its cancer portfolio in a major push towards entering the oncology market. GSK values the oncology market at greater than £20 million (US$40 million), with annual growth of 20%. These six new products include pioneering treatments in cervical cancer and for blood disorder ITP, and cater for a significant unmet medical need. A significant number of compounds in early stages of development are expected to help sustain GSK’s productivity in oncology. With some 30 new oncology specialists recently recruited for research in this area, the British firm continues to strengthen its cancer capabilities. However, the most significant investment has seen GSK inking a mega deal with Genmab over Ofatumumab, which has been hailed as the biggest licensing deal in the biotech sector.
Despite expecting its oncology pipeline to be a key success for many years to come, GSK faces stiff competition from the likes of Roche/Genentech, a cancer powerhouse.