Earlier this year, GlaxoSmithKline
Do we really have to talk about worms?
NTDs are ugly things, both in characterization and impact. We should first look at what they are. Don't read on if you're eating.
NTDs are bacterial and parasitic diseases that can be deadly but are more often disabling. They're typically associated with poverty and poor sanitation. Worms are the vehicle for many NTDs, transmitted by fecal contamination of drinking water or soil. Mosquitos and other insects carry some of the others and can enable a pandemic spread. Long-term consequences include heart and digestive problems, seizures, malnutrition, limb debility, growth deficiencies, psychiatric disorders, and sometimes death. Nearly one in six people suffers from one NTD or another.
Here's a sample of some of the drugs and vaccines aimed at treating or preventing some of these diseases.
Current FDA Phase
|GSK||Drug||Lymphatic filariasis (LF)||Albendazole (LF)||Approved|
|GSK||Drug||Soil-transmitted helminths (intestinal worms)||Albendazole (Asca/Trich)||Approved|
|GSK||Vaccine||Dengue fever (Break-bone fever)||DENV-1 PIV||Phase 1|
|GSK||Vaccine||Dengue fever||T-DEN||On Hold|
||Drug||Dengue fever||Novartis dengue drug discovery program||Discovery|
||Drug||Onchocerciasis (river blindness)||Moxidectin||Phase 3|
Source: BIO Ventures for Global Health.
In addition, Abbott Laboratories
Beyond those mentioned earlier, the other targeted NTDs are Guinea worm disease, blinding trachoma, sleeping sickness, leprosy, schistosomiasis, fascioliasis, and Chagas disease. Another disease may be listed as well, thanks to the viral (no pun intended) "Kony 2012" video and the attention it directed toward Uganda. Nodding disease is a terrible childhood affliction that leads to diminished cognitive ability, stunted growth, and eventually death. It appears to be spreading in east Africa and is strongly associated with river blindness.
The World Health Organization estimates that NTDs affect more than 1.5 billion people each year and cause about 570,000 deaths annually. NTDs are typically ignored because they have a relatively low mortality rate and largely affect the poorest of the poor, given their frequent origin in poor sanitation. The rest of the world should care about this. If the simple ethical argument doesn't appeal to you, consider a few additional factors:
- These diseases drag people out of the labor force in developing economies, thereby compromising potential low-cost manufacturing locations and nascent markets for consumer goods.
- These diseases could be headed your way. Insects transmit many NTDs, and they're traveling further to the north and south as habitats that used to be inhospitable to them warm up. Leishmaniasis is pushing north further into the United States. The non-insect-borne diseases are spreading, too. Liver rot used to be confined to isolated areas of the world and is now rearing its ugly head all over Europe, Oceania, and further reaches of the Americas.
Kill a worm, save a kid
Despite these factors, the financial incentives really haven't been there for Big Pharma to throw its weight behind these problems. In ride the Bill and Melinda Gates Foundation, a new federal program, and loads of public money, all in shining armor. Add in substantive commitments from the world's 13 leading pharmaceutical companies, and you have yourself a global initiative. The idea is to eliminate or control NTDs by 2020, and there will be $785 million in donations to help back that up.
The pharma companies are pooling efforts by opening up relevant elements of their research libraries through the Drugs for Neglected Diseases Initiative. This should stoke innovation and hopefully lead to new or improved treatments.
Kill a worm, make a profit?
Great, but we need to know what's in it for the companies. Sure, they build their brands, but there has to be something more.
Well, there is. Remember that federal program I mentioned? It's the FDA's Priority Review Voucher, or PRV, program. It awards a PRV to any sponsor of a newly approved drug or vaccine that targets an NTD.
This is powerful stuff, because not only does the voucher have the potential to speed a blockbuster drug through the approval process -- wait times can be reduced by as much as four to 12 months -- but it is also transferrable and therefore can be sold. Expert estimates value PRVs at $50 million to $500 million. Imagine having that little beauty sitting on your balance sheet!
The PRV program has been criticized for its susceptibility to manipulation, and for the risk it introduces of rushing approval on a drug that isn't ready for prime time. Still, it looks as though the program is here to stay.
Greatest worm slayer of them all
In this broad field, GlaxoSmithKline stands out. The company is No. 1 on the most recent Access to Medicine Index, which ranks global pharma companies on their efforts to increase access to medicine for societies in need. This sophisticated index takes into account such elements as R&D, licensing and patenting, and capability advancement, all attributes that contribute to the performance of a company. By comparison, Novartis, J&J, Abbott, and Pfizer rank third, ninth, 10th, and 11th, respectively.
Glaxo has made a clear strategy of pursuing access to medicine and sees this development as integral to its business model. Emerging markets have been a bright spot in comparison with revenue declines in the U.S. and Europe, and Glaxo has weathered recent patent expirations fairly well. While being at the forefront of this initiative may not make the big British pharma a buy right now, GlaxoSmithKline has certainly grabbed my attention.
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