Catalyst for Change

There are other benefits that derive from the special organizational characteristics of a PDP. Due to the multiple parties involved, a PDP facilitates capacity building, especially across geographies and demographics. Specifically, it encourages the Big Pharma partner to consider a wider range of options in distributing medicines in unfamiliar but high-opportunity emerging markets. This leads to a better understanding of the consumer; for an industry that lags in even defining where its customer base begins and ends, such basic awareness can increase levels of access and adherence to drug therapy. Likewise, many Big Pharma companies—ranging from GlaxoSmithKline and Lilly to Japan's Otsuka—believe that investment in a PDP creates synergies with other, more profitable business segments through the technology transfers that seed the growth of a permanent local science and manufacturing infrastructure in markets where they want to expand their footprint. Many PDPs now have direct experience in emerging and developing countries, helping Big Pharma avoid the pitfalls of operating in these unfamiliar markets.

The scalable, focused approach of a PDP can also have a powerful, positive impact on employee motivation, since the ground rules for engagement around an unmet medical need are fairly clear. Finally, as noted in a Feb. 16 commentary by FDA officials in The New England Journal of Medicine, PDPs are able to facilitate codevelopment around novel combination drugs—an under-represented intervention that is critical to building efficacy in treatments for complex big diseases such as TB and malaria. PDPs are particularly helpful in bringing private companies together so that their best compound assets can be tested, regardless of sponsor.

Founded in 1900, Fiocruz is today the largest biomedical research institute in Latin America, with a reputation as a skilled negotiator in leveraging the power of partnership to become the dominant player in generics and vaccines geared to low-income patients. Its market clout is such that it has local manufacturing rights to eight of the 16 drugs commonly used in "cocktail" combinations by HIV patients. "The lower prices obtained through this route from the foreign drug makers allow us to subsidize access to these life-extending medicines to the entire HIV+ population in Brazil, securing a key public health policy objective," Fiocruz representative Carlos Morel tells Pharm Exec.

More important, Fiocruz has a set of partnerships with Big Pharma linked to the transfer of technologies to develop new medicines for commercial sale, both inside Brazil and globally. "Fiocruz has as its key objective the capacity to patent, develop, license, manufacture, or sell new medicines to treat priority diseases worldwide," Morel says. "In that sense, we are decidedly not a philanthropic enterprise."

One example is the PDP that Fiocruz has inked with GSK for the production and development of vaccines. Here, the UK drug maker is distributing pneumococcal vaccine to an estimated 3 million to 5 million Brazilian children a year, while Fiocruz concentrates on improving and then sharing the science around infectious diseases. "One goal of the partnership is to develop and commercialize a global vaccine for dengue fever, which is a huge public health problem in Brazil," says Morel. "We are creating the science and GSK is contributing its production know-how." Such synergies have allowed the PDP to fill some resource gaps, with Fiocruz recently purchasing from GSK a local manufacturing plant that now makes some 70 essential medicines—ranging from anti-hypertensives to patented ARVs for AIDS—supplied by the Brazilian Ministry of Health for low-income patients.