The Power of Product Development Partnership - Pharmaceutical Executive


The Power of Product Development Partnership

Pharmaceutical Executive

Bigger Health Impact?

Meeting rising public expectations of the R&D-based industry is vital to preserving that basic "license to operate," the absence of which could break the entire cycle of medicines innovation. This suggests in turn that one of the unheralded merits of the PDP model is its potential to address the very biggest challenges in health, strengthening the industry's association with innovations that require no metrics—because they save lives. "The reputational impact when pharma engages in this space far outweighs any costs," says former Merck CEO P. Roy Vagelos, who pioneered the basic concept of the disease-based partnership back in the 1980s, with Merck's Mectizan program to eliminate the parasite that causes the debilitating condition known as river blindness. "It's become an open-door asset for doing business globally. It is surprising that it has taken the industry as long as it has to recognize that."

TB: If You Can Make it Here

A strong example—rich with promising precedents—is evident in the work of the PDPs now under way to address the lag in new pharmaceutical and vaccine interventions to combat tuberculosis (TB). The script is very simple: the cupboard of new therapies is bare despite a rising incidence of infection and resistance to the existing arsenal of multidrug therapies, which risks leaving the public defenseless against a killer that can easily be transmitted through casual contacts.

In fact, when you examine the profile of TB, all the elements of a "grand challenge" for the innovative drug industry are there:

Unmet medical need. TB is deadly and highly contagious, responsible for nearly 2 million deaths a year, second only to HIV, to which it also contributes as a key factor in mortality. About one-third of all HIV+ patients also have TB. There are few boundaries against infection and the incidence of TB is rising, with an estimated 9.4 million new cases reported in 2009. There is no doubt that TB is a formidable threat to public health, due to its unique link to other chronic infectious diseases and its role in suppressing the immune system. Even with the science and technological breakthroughs since the gene code was broken a decade ago, it is astounding that today there are more active cases of TB than at any time in history.

Significant indirect economic costs. TB scores among the highest in the global burden of disease, with an estimated cost of $12 billion annually, distributed among all countries—rich and poor. Every year a TB victim goes undiagnosed, he or she will infect another 12 people. In the US, hospitalization charges for a patient with multidrug resistant (MDR) TB can average around $600,000; in developing countries, the cost to administer the standard DOTS drug package is often higher than the annual income of the recipient patient. Failure to treat also carries a spinoff effect by accentuating the adverse public health impact from other communicable diseases that are easier for TB patients to contract. This means there are also fewer resources to address the increasing toll from non-communicable ailments.

Medicines are the vital defense against TB. While preventive public health measures, infrastructure improvements, and overall economic development are critical to eliminating TB, planning for that is complex and long-term. Drugs provide the stopgap solution in regulating the disease and slowing the pace of new infections, yet basic individual therapy guidelines—requiring four or more drugs administered rigorously to ensure patient compliance over six to 30 months—have not changed. The last new drug for TB was introduced over 40 years ago. Yet the sanitariums that once confined TB victims in a cocoon of protection—to benefit the healthy—have been closed. Can a larger pandemic just be waiting to happen?

TB is a test case for new medical innovation. A key barrier to controlling TB is simplifying the treatment regimen, by reducing the number of drugs taken through high-value combination therapies; shortening the length of treatment; and better targeting of the bacillus to control resistance or latent infection. In the latter case, there is an urgent need for drugs to fight MDR TB, which accounts for nearly 5 percent of new cases and is now found in every region, including the US and Europe. At present, however, given the length of treatment, required use of injectables for the first six months, and the cost and complexity of administration and monitoring, global scale-up of MDR treatment is—from a practical point of view—not an option. Drugs that can be designed to combat co-infection with HIV are needed. A new TB vaccine should also be part of the mix.


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