According to a report by Datamonitor (September 2006), the top 50 pharmaceutical manufacturers who launched new products between 2002 and 2005, changed the pharmaceutical form at least two times out of three.
Cardiovascular, nervous system, diabetes and women's health are the most popular areas, and companies are already gearing up to redesign medicines in the nutritional and metabolic sectors. Nothing strange given that these are therapeutic areas to which the most represented pathologies in the population pertain and, therefore, the return on investment is practically guaranteed.
But the reasons aren't purely profitable, according to Tim Atkinson, director of research and analysis at Spectra Intelligence, and author of an independent "Global business inside" report on pharmaceutical reformulation. Atkinson suggests that the re-engineering of historical, blockbuster or less successful molecules leads to an increase in efficacy, compliance and, ultimately, clinical outcome. In support of his thesis, he cites Procardia XL, the prolonged-release formulation of Pfizer's nifedipine, which from '90 to '98 increased the sales budget by 8 billion dollars. A very similar experience is that of Johnson & Johnson which has derived the most active metabolite from its risperidone-based antipsychotic (Risperdal) and inserted it in a slow-release formulation (Invega).
Datamonitor confirms that, following the recent approval of Invega, J&J will attempt to switch as many patients to the new drug before the risperidone patent expires (2008). And it will probably succeed, given that it already has a precedent with the new formulation (Concerta) of methylphenidate.
Less successful, however, was Lilly's business, which associated two phenomena: olanzapine (the antipsychotic Zyprexa) and fluoxetine (the antidepressant Prozac), to create a drug – Symbyax – for bipolar disorder. Symbiax has not repeated the sales success of its progenitors, remaining a niche product, perhaps also due to the presence of strong generic versions of the two original molecules.
Another phenomenon that is collecting successes is that of the application of nanotechnologies to pharmaceutical technology. According to Atkinson, there are at least 35 anticancer drugs in the developing world that could be improved with these methods. An already successful case would be that of the injectable particulate paclitaxel from Abraxis BioScience, with a higher therapeutic index than the first patent of the molecule.
Another strategy that could prove successful concerns polymerosomes, biodegradable nanoparticles. Tennis Discher, a researcher at the University of Pennsylvania, has shown that polymerosomes behave like "Trojan horses" by carrying paclitaxel and doxorubicin into breast cancer cells.
At Altairnano, however, Rochelle Wagner is studying nano-encapsulation, to limit the toxicity of new chemotherapy. Spherical nanoparticles of Renalan (phosphate binders based on lanthanum) have been successfully tested in end-stage renal cell carcinoma. In fact, the increase in surface area in relation to volume has allowed to drastically reduce the required dose, minimizing toxicity.
Nanotechnology, explains Rochelle, can also be applied to reformulation, making it possible to obtain more selective drugs (if linked to organic nanoparticles) for certain tissues and therefore less toxic, or drugs (if linked to inorganic nanoparticles) with a longer duration of action thanks to the lower vulnerability to catabolic action.
Source "pharmamarketing.it"
Cardiovascular, nervous system, diabetes and women's health are the most popular areas, and companies are already gearing up to redesign medicines in the nutritional and metabolic sectors. Nothing strange given that these are therapeutic areas to which the most represented pathologies in the population pertain and, therefore, the return on investment is practically guaranteed.
But the reasons aren't purely profitable, according to Tim Atkinson, director of research and analysis at Spectra Intelligence, and author of an independent "Global business inside" report on pharmaceutical reformulation. Atkinson suggests that the re-engineering of historical, blockbuster or less successful molecules leads to an increase in efficacy, compliance and, ultimately, clinical outcome. In support of his thesis, he cites Procardia XL, the prolonged-release formulation of Pfizer's nifedipine, which from '90 to '98 increased the sales budget by 8 billion dollars. A very similar experience is that of Johnson & Johnson which has derived the most active metabolite from its risperidone-based antipsychotic (Risperdal) and inserted it in a slow-release formulation (Invega).
Datamonitor confirms that, following the recent approval of Invega, J&J will attempt to switch as many patients to the new drug before the risperidone patent expires (2008). And it will probably succeed, given that it already has a precedent with the new formulation (Concerta) of methylphenidate.
Less successful, however, was Lilly's business, which associated two phenomena: olanzapine (the antipsychotic Zyprexa) and fluoxetine (the antidepressant Prozac), to create a drug – Symbyax – for bipolar disorder. Symbiax has not repeated the sales success of its progenitors, remaining a niche product, perhaps also due to the presence of strong generic versions of the two original molecules.
Another phenomenon that is collecting successes is that of the application of nanotechnologies to pharmaceutical technology. According to Atkinson, there are at least 35 anticancer drugs in the developing world that could be improved with these methods. An already successful case would be that of the injectable particulate paclitaxel from Abraxis BioScience, with a higher therapeutic index than the first patent of the molecule.
Another strategy that could prove successful concerns polymerosomes, biodegradable nanoparticles. Tennis Discher, a researcher at the University of Pennsylvania, has shown that polymerosomes behave like "Trojan horses" by carrying paclitaxel and doxorubicin into breast cancer cells.
At Altairnano, however, Rochelle Wagner is studying nano-encapsulation, to limit the toxicity of new chemotherapy. Spherical nanoparticles of Renalan (phosphate binders based on lanthanum) have been successfully tested in end-stage renal cell carcinoma. In fact, the increase in surface area in relation to volume has allowed to drastically reduce the required dose, minimizing toxicity.
Nanotechnology, explains Rochelle, can also be applied to reformulation, making it possible to obtain more selective drugs (if linked to organic nanoparticles) for certain tissues and therefore less toxic, or drugs (if linked to inorganic nanoparticles) with a longer duration of action thanks to the lower vulnerability to catabolic action.
Source "pharmamarketing.it"
