Does Therapeutic Repurposing in Cancer Meet the Expectations of Having Drugs at a Lower Price?

Therapeutic repurposing emerged as an alternative to the traditional drug discovery and development model (DDD) of new molecular entities (NMEs). It was anticipated that by being faster, safer, and cheaper, the development would result in lower-cost drugs. As defined in this work, a repurposed cancer drug is one approved by a health regulatory authority against a non-cancer indication that then gains new approval for cancer. With this definition, only three drugs are repurposed for cancer: Bacillus Calmette-Guerin (BCG) vaccine (superficial bladder cancer, thalidomide [multiple myeloma], and propranolol [infantile hemangioma]). Each of these has a different history regarding price and affordability, and it is not yet possible to generalize the impact of drug repurposing on the final price to the patient. However, the development, including the price, does not differ significantly from an NME. For the end consumer, the product's price is unrelated to whether it followed the classical development or repurposing. Economic constraints for clinical development, and drug prescription biases for repurposing drugs, are barriers yet to be overcome. The affordability of cancer drugs is a complex issue that varies from country to country. Many alternatives for having affordable drugs have been put forward, however these measures have thus far failed and are, at best, palliative. There are no immediate solutions to the problem of access to cancer drugs. It is necessary to critically analyze the impact of the current drug development model and be creative in implementing new models that genuinely benefit society.

Barriers for Pharmaceutical Innovation With Focus in Cancer Drugs, the Case of Mexico.

Drug innovation does not only generate economic growth but also portrays a country's efforts toward innovation. The article reviews the current status on the innovation of the Mexican pharmaceutical industry with a focus on cancer drugs. The authors examined the scientific and nonscientific literature in search of the origin of innovative cancer drugs, as well as the regulatory frames by which these drugs are approved in Mexico. The article presents a narrative analysis of the author's experiences on the barriers that impede pharmaceutical innovation in Mexico. To the best of the authors' knowledge, there was only 1 domestic approval by COFEPRIS, the Mexican health regulatory agency, of an anticancer product developed under a repositioning approach. Among the barriers impeding drug innovation in Mexico are, but not be limited to, insufficient funds for the discovery phase; unaffordable or limited capacity for performing preclinical studies under good laboratory practices (GLP); lengthy clinical trial approval; unfavorable conditions for clinical trials for both academic and domestic pharmaceutical industry-sponsored studies; unclear policies for drug approvals and marketing. The authors state specific proposals for overcoming these barriers to generate a climate for increasing participation of academic and existing domestic pharmaceutical industry as well as to increase venture capital and favor start-up and early-stage companies. In conclusion, Mexico has the human resources and material infrastructure to innovate. The implementation of these and any other constructive proposals are just a matter of political will.

The prince and the pauper. A tale of anticancer targeted agents.

Cancer rates are set to increase at an alarming rate, from 10 million new cases globally in 2000 to 15 million in 2020. Regarding the pharmacological treatment of cancer, we currently are in the interphase of two treatment eras. The so-called pregenomic therapy which names the traditional cancer drugs, mainly cytotoxic drug types, and post-genomic era-type drugs referring to rationally-based designed. Although there are successful examples of this newer drug discovery approach, most target-specific agents only provide small gains in symptom control and/or survival, whereas others have consistently failed in the clinical testing. There is however, a characteristic shared by these agents: -their high cost-. This is expected as drug discovery and development is generally carried out within the commercial rather than the academic realm. Given the extraordinarily high therapeutic drug discovery-associated costs and risks, it is highly unlikely that any single public-sector research group will see a novel chemical "probe" become a "drug". An alternative drug development strategy is the exploitation of established drugs that have already been approved for treatment of non-cancerous diseases and whose cancer target has already been discovered. This strategy is also denominated drug repositioning, drug repurposing, or indication switch. Although traditionally development of these drugs was unlikely to be pursued by Big Pharma due to their limited commercial value, biopharmaceutical companies attempting to increase productivity at present are pursuing drug repositioning. More and more companies are scanning the existing pharmacopoeia for repositioning candidates, and the number of repositioning success stories is increasing. Here we provide noteworthy examples of known drugs whose potential anticancer activities have been highlighted, to encourage further research on these known drugs as a means to foster their translation into clinical trials utilizing the more limited public-sector resources. If these drug types eventually result in being effective, it follows that they could be much more affordable for patients with cancer; therefore, their contribution in terms of reducing cancer mortality at the global level would be greater.