Analyst comment by Stephanie Maclean, research analyst at Frost and Sullivan, on novel methods of delivering cancer drugs that are being explored to increase compliance and competitive position
An area of growing importance and interest in cancer management is the quality of life of the patient.
Advanced stage cancer patients being treated with cytotoxic therapeutics are often subjected to debilitating side effects.
A product able to reduce the discomfort and inconvenience experienced by these patients should be well received and thus biotechnology and pharmaceutical companies are endeavouring to expand the choice of available therapeutics.
Stephanie Maclean, research analyst from Frost and Sullivan, talks about novel methods of delivering cancer drugs that are being explored to increase compliance and competitive position, and extend the product life cycle.
Liposomal Anti-Cancer Agents.
In Europe, there are very few marketed anti-cancer agents, which use an advanced form of injectable delivery technology.
The type of technology applied to the drug produces a different desired effect.
Caelyx and Myocet are liposomal formulations of doxorubicin.
Caelyx is officially approved for treating metastatic ovarian cancer, but much of its use is off label in advanced breast cancer.
Myocet was approved by the EMEA in 2000 for the treatment of metastatic breast cancer.
Conventional doxorubicin is a popular anti-cancer agent, however cardiotoxicity can be a problem and can result in the need to cut short or delay treatment.
Although, liposomal doxorubicin has been shown to reduce the level of cardiotoxicity, sales of Caelyx and Myocet have been poor, with European uptake under three percent.
The application of liposomal drug delivery technology has not given Schering Plough or Elan, a competitive advantage.
It is felt the high cost of the products has lead to restrictions on the target populations, with both products initially confined to patients at a high risk for cardiovascular complications.
Hycamtin Product Range.
GlaxoSmithKline (GSK) is developing an oral version of Hycamtin (topotecan) to complement its intravenous infusion product.
Hycamtin is currently the best selling second line treatment for metastatic ovarian cancer.
In 2001, GSK signed a deal with INEX Pharmaceuticals, a company specialising in targeted delivery of chemotherapeutics.
Part of the agreement includes the encapsulation of Hycamtin inside INEX's TCS delivery system (a second-generation liposomal delivery technology).
A liposomal formulation of Hycamtin is expected to improve patient comfort, as the dosing frequency is likely to be reduced.
The encapsulation should allow for higher doses of topotecan to be administered with a lower toxicity profile, improving efficacy and leading to improvements in survival time.
If approved, it is believed that a liposomal formulation will help to maintain GSK's leading position in the second line treatment of metastatic ovarian cancer.
However it is essential that the product be backed up with strong clinical evidence, so as to better the limited market success experienced by Elan and Schering Plough.
Product Line Extension. Due to more aggressive forms of cancer therapy, the percentage of patients experiencing severe anaemia is rising.
This can interrupt and delay treatment as well as reduce quality of life. Eprex and NeoRecommon are available in Europe to treat anaemia in these patients.
The patents are soon to expire and in order to gain a competitive position in the market, Amgen is launching Aranesp.
This higher priced, second generation product will build a competitive advantage for Amgen in Europe.
The first generation erythropoietin products require three times weekly dosing whereas Aranesp would be administered once per fortnight, at best.
This longer acting version is aimed at reducing patient inconvenience and physician time.
However, in a cost constrained European market, patients are taught to self medicate and this will reduce the dosing benefits.
Conclusion.
It is essential that if a product is to be brought to market at a premium price, then the clinical evidence should clearly demonstrate the benefits over alternative treatments.
In a cost constrained European market, strong supporting data is necessary, if maximum uptake is to be achieved.
Many physicians have expressed a sceptical attitude towards these products and believe that the high prices cannot be justified when compared to their current understanding of product benefits.
