Renewed Hope for the Success of Biologics
(PRWEB) July 12, 2003
Novel biologics appear to be going from strength to strength. New indication approvals and positive clinical trial results are being published at an alarming rate, which is certainly good news for pharma/biotech companies and patients alike.
After a string of clinical development failures and approval problems, it seems that novel biologics are now beginning to show their true therapeutic potential. This is an exciting time for drug developers and can bring hope to a significant number of patients who have found that traditional therapies just do not do the job for their specific needs.
The recent approval of Humira (Abbott) was heralded as a major advance in the treatment of rheumatoid arthritis (RA). The company believes that their drug has ‘blockbuster’ potential and anticipates it to be one of their major revenue generators. And it certainly appears to be on the right course. In the first three months of being on the US market, the drug generated $24 million in revenues, exceeding company expectations and threatening competing products, such as Enbrel and Remicade.
Abbott now believes that sales of the drug in 2003 may reach $250 million, a substantial achievement in the initial launch year. Furthermore, new clinical data has shown that Humira is not only effective in late stage RA, but is also effective in the early stages of the disease, and can inhibit the progression of structural damage associated with rheumatoid arthritis.
Such data could not only increase product uptake, will also widen the target population that may benefit from such treatment. Good news for Abbott.
Roche Pharma is another major global corporation experiencing positive results with their MAb pipeline. Roche, in conjunction with IDEC Pharmaceuticals are experiencing positive clinical results with MabThera. This MAb, originally developed for the treatment of B cell lymphoma has begun pivotal phase IIb and III studies in RA after encouraging phase IIa results were released in June 2003.
The 161 patient trial revealed that a short induction regimen of MabThera, either alone or in combination with methotrexate resulted in a better disease response than with methotrexate alone. The side effect profile was also positive.
The company is forging on with late stage trials, incorporating patients who have shown limited response to anti-TNF therapies and those with inadequate responses to disease modifying anti rheumatic drugs (DMARD).
MabThera, currently RocheÂ’s major revenue generator could prove to be a strong competitor in the RA field. ItÂ’s different mechanism of action to tumour necrosis factor (TNF) inhibitors, that is the depletion of B cells, may prove advantages and offer an alternative and possibly more effective therapy option.
Amgen is also experiencing a strong start to 2003. Enbrel, the companyÂ’s TNF antagonist continues to generate significant revenues, and this trend is predicted to continue in the future. Enbrel is now indicated for rheumatoid arthritis, psoriatic arthritis and has recently been approval in the US for ankylosing spondylitis, the first biological agent to gain this indication. This, in combination with the likelihood of further license expansion, will result in continued revenue growth from Enbrel.
And finally, Genentech also has something to celebrate, with the long awaited approval of Xolair, for the treatment of moderate to severe asthma. This has been an uphill struggle for Genentech, and for Novartis, itÂ’s partner for this project, with regulatory bodies demanding extensive additional clinical data.
However, the hard work and investment seems to have paid off, with US launch this year, and approval in the EU expected in 2005. In fact 2003 looks to be going well for Genentech, with strong phase III data for Avastin being reported and a flurry of new product launches, including Raptiva for psoriasis expected in the second half of this year.
In summary, it can be concluded that, following the lengthy and significant investor negativity that has surrounded the biotech industry recently, investor interest in biotech is beginning to be re-ignited. If current marketed products can mirror the strong growth seen in the first quarter of this year, and successful launches occur, the future certainly is looking much more promising.
By Jennifer Cassels
For further information please contact:
Katja Feick
Public Relations Manager
Healthcare Group
Phone: 0049 69 7703312
Fax: 0049 69 234566
Katja. feick@frost. com
