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NIPRISAN IN THE NEWS

The road to commercialization in Africa:
Lessons from developing the sickle-cell drug Niprisan

One of the few low-toxicity drugs available anywhere to treat sickle-cell anemia -- a debilitating chronic blood disorder -- is derived from medicinal plants in Nigeria. Authors Kumar Perampaladas, Hassan Masum, Andrew Kapoor, Ronak Shah, Abdallah S. Daar and Peter A. Singer looked at barriers faced by Nigeria's National Institute for Pharmaceutical Research and Development (NIPRD) while bringing this important product to market. They also chronicle many significant achievements in this drug's development process, even though it ultimately failed.

Nigeria alone has more than 4 million sickle-cell anemia patients, and every year an estimated 150,000 children are born with the condition, which also afflicts many North Americans and Europeans of African descent.

NIPRD developed the herbal medicine Niprisan from a combination of certain seeds, stems, fruit and leaves. Formal agreements entitled the traditional practitioners whose knowledge was used in the development program to product sale royalties.

The drug developers won regulatory approval in Nigeria, partnered with US-based firm XeChem, demonstrated clinical efficacy and safety, and were awarded valuable "orphan" drug status by the US Food and Drug Administration.

Niprisan failed to achieve mainstream success, however, due to a number of problems, such as insufficient manufacturing capacity, quality control issues, pricing and distribution, and lack of financing. Today, NIPRD is considering options for another commercial partner to take the drug forward.

The paper cites five key lessons learned for policy-makers and entrepreneurs:

* Make benefit-sharing agreements with traditional medical healers whose knowledge is used.

* Seek partners to fill gaps in knowledge and technical expertise.

* Subsidize clinically-proven new drugs derived from traditional medicines, where the disease is endemic to a region and good alternative treatments are lacking.

* Institute standardization and quality control measures in drug manufacturing, especially for traditional medicines, the potency and effectiveness of which can be influenced by the raw materials involved (i.e. plant material quality, age, time of harvest, location, soil quality, preparation, handling, etc.).

* Train skilled entrepreneurial leaders to manage partnerships, recruit talented professionals, approach government for funding, and handle the missteps and breakthroughs that go along with early stage drug development.

Venture funding for science-based African health innovation

Authors Hassan Masum, Justin Chakma, Ken Simiyu, Wesley Ronoh, Abdallah S Daar and Peter A. Singer describe case studies of five health venture funds based in the developing world, and suggest lessons.

The five funds included publicly-owned organizations, corporations, social enterprises, and subsidiaries of foreign venture firms. Three funds aimed primarily for financial returns, one for social and health returns, and one had mixed aims. (One of the funds, Bioventures, is discussed above.)

Lessons learned include

* The importance of measuring and supporting both social and financial returns;

* The need to engage both upstream capital such as government funding and downstream capital from the private sector; and

* The existence of many challenges including difficulty of raising capital, low human resource capacity, regulatory barriers, and risky business environments.

The authors suggest that those looking to design venture funding for African science-based health innovation with significant impact should structure funds for long-term sustainability and attract for-profit private sector funds.

The proposed venture approach can complement existing initiatives to encourage local scientific and economic development while tapping new funding sources.

The authors conclude that there is a case for venture funding as one support mechanism for science-based African health innovation, with opportunities for risk-tolerant investors to make financial as well as social returns.

http://www.chem.info/News/Feeds/2010/12/topics-material-handling-studies-detail-triumphs-troubles-of-african-innov/


African health research has solutions but no support

AFP - African health laboratories are bubbling with innovation to combat the continent's diseases but these home-grown solutions are stagnating due to a lack of support, studies published Sunday said.

The studies published by the Science journal and BioMed Central identified 25 "stagnant technologies" that never got off the drawing board.

"Driven largely by entrepreneurs, innovative and affordable technologies to improve health in Africa are under development throughout the continent," said Ken Simiyu, who co-authored the study for Canada's McLaughlin-Rotman Center for Global Health (MRC).

"Clearly, many Africans have the needed talent and know-how," he told AFP.

After touring laboratories in sub-Saharan Africa, the Kenyan scientist discovered a plethora of dormant innovations:

-- A low-cost dipstick technology developed in Ghana for quick village diagnosis of schistosoma, a parasitic disease that affects more than 50 percent of people in some areas of Africa.

-- An easy-to-use and inexpensive portable medical-waste incinerator developed in Uganda that could solve the problem of hospital waste management in rural areas, especially during mass immunisation programmes.

-- A herbal, anti-malarial medicine called Nibima developed in Ghana.

There are many other such African inventions that have not hit the market.

"It is not entirely financial. It is a more general innovation problem, which involves politics and finance," Simiyu said.

African countries dedicate an average of 0.2 to 0.3 percent of GDP to research and development, 10 times less than developed countries.

But while the scientists behind those innovations have not always received adequate funding, they have also lacked the required contacts and skills to move their products to the stages of licensing, manufacturing and marketing.

The Kenya Medical Research Institute (KEMRI), for example, built a facility to produce AIDS and hepatitis B diagnostic kits but the factory has remained idle due to a regulatory change from the government, its main purchaser.

One of the study's papers relates how the commercialisation of a drug developed by Nigeria's National Institute for Pharmaceutical Research and Development to treat sickle-cell anaemia never got off the ground.

The product is one of the few low-toxicity drugs to treat the disease, a chronic blood disorder that affects four million people in Nigeria alone and afflicts many people of African descent in the West.

However, the treatment, called Niprisan, never achieved success due to a raft of problems "such as insufficient manufacturing capacity, quality control issues, pricing and distribution, and lack of financing," the study said.

The study did identify some success stories, such as the Tanzanian company A to Z Textiles, which managed to overcome regulatory and procurement hurdles to become one of the world's largest producers of insecticide-treated bed nets.

In a preface to the work, Harvard professor Calestous Juma noted that concern over access to medecines had dominated the health policy debate for years, wrongly assuming that Africa would continue to rely on imports.

"This collection of original papers provides a different prognosis. They reveal an emergent 'health innovation system' in Africa," he said.

McLaughlin-Rotman Center director Peter Singer stressed that African know-how -- 16 of the 25 innovations studied involved traditional plant products -- needed to be urgently supported.

"Required are creative institutions and coherent policies that reduce risk, build on local strengths, and promote the effective use of local health research," he said.

"Many people will die if we wait for scientists from elsewhere to invent and market the health products Africa needs," Singer said.

http://www.france24.com/en/20101212-african-health-research-has-solutions-but-no-support


Lack of support keeps African discoveries languishing in labs

Institutional frameworks must be improved to save stagnant technologies

Linda Nordling

A laboratory technician in Amuria, Uganda examines a patient's blood for signs of malaria.More funding for neglected disease research in Africa has yet to lead to more cures.Jake Lyell / Alamy

Africa is struggling to turn local discoveries into drugs and other health-care inventions, according to a slew of papers published today on open-access publisher BioMed Central1,2,3.

The papers identify 25 'stagnant technologies' languishing in African health-research institutions. These include a portable medical-waste incinerator, a dipstick test for the parasitic disease schistosomiasis and several drug candidates extracted from African plants1.

A host of factors thwart the take-up of these technologies, the papers' authors say. Scientists in Africa have no incentive to commercialize results, and there is scant institutional support for knowledge transfer. In addition, venture capital is scarce, existing regulatory frameworks inhibit innovation and intellectual property protection remains weak.

"What we found in Africa is that there is funding for basic research, but there is nobody taking these findings forward," says Ken Simiyu, a technology commercialization researcher at the University of Toronto, Canada, and co-author of the stagnant-technologies paper.
Stalled drugs

The papers were produced by the McLaughlin-Rotman Center for Global Health (MRC) in Toronto and draw on the experiences of authorities, researchers and entrepreneurs in Ghana, Kenya, Madagascar, Nigeria, Rwanda, South Africa, Tanzania and Uganda.

One paper2 mentions Nicosan, a drug candidate for sickle-cell anaemia that was developed at Nigeria's National Institute for Pharmaceutical Research and Development in Abuja. The institute is dogged by funding problems (see 'Funding woes afflict African herbal therapy institute')

Other stalled drug candidates include a Ghanaian herbal anti-malarial therapy called Nibima, extracted from the local shrub Cryptolepis sanguinolenta, and Sunguprot, an extract from the Tylosema fassoglensis plant. Sungoprot's Kenyan developers say that it can help to manage HIV symptoms.

However, the papers also identify products that have succeeded against tough odds. Tanzania's A to Z Textiles company based in Arusha, Tanzania has become one of the world's largest producers of insecticide-treated nets to prevent malaria3. The company overcame local barriers of procurement and regulatory issues. Donor funding played a critical role, showing that aid has a role to play in fuelling African innovation, the researchers say.

"These studies demonstrate that, with the right partners and incentives along with support from governments at home and abroad, Africans have the scientific creativity and entrepreneurial talent to improve local health and prosper at the same time," said MRC director Peter Singer in a statement.
Funding boost

Research and development spending for 'neglected diseases' including HIV, malaria and tuberculosis grew to more than US$2.5 billion in 2007 (see graph), according to a 2009 report by The George Institute for International Health, a not-for-profit medical-research body with operations in Australia, China and India. Most of the funding comes from philanthropic funders and the governments of developed countries (see pie chart).

The lion's share of the money ends up in developed countries, but African researchers have also benefited from the increase. In Uganda, for instance, health-research spending more than tripled from US$18 million in 2005–06 to US$56m in 2008–09, according a status report published in June this year by the Uganda National Council for Science and Technology.

To capitalize on this investment, African governments, international donors and the private sector need to join forces, say the MRC authors. They propose the creation of regional or national venture-capital funds and the setting up of national life-sciences innovation centres to bring science, business and capital under one roof. Rwanda already has such a centre, and Uganda, Tanzania and Kenya are in the process of establishing them.

Government support will be crucial, says Simiyu. "Because of the inherent risk in health innovation, especially in Africa, it is unlikely that the private sector would get involved initially," he says.
Persistent problem

Marcel Tanner, director of the Swiss Tropical and Public Health Institute in Basel, agrees that home-grown African discoveries can't be validated without support. But one of the biggest challenges — that of up-scaling technologies into production and universal use — requires more thought than it is given in the MRC papers, he says.

"The science of going to scale is not sufficiently covered. That's a scientific issue, not just a marketing issue. You need to look at public acceptance of new technologies and manufacturing capacity," says Tanner.

African ministers, health researchers and pharmaceutical-industry representatives met in Pretoria, South Africa, in February this year to discuss how to support home-grown drug development. But progress has been slow on a planned US$600-million endowment fund to support an African Network for Drugs and Diagnostic Innovations, proposed by African scientists in 2008. Some African governments have pledged money to the fund, but none have paid up.

Africa's innovation problems will persist, warns Umar Bindir, director general of Nigeria's National Office for Technology Acquisition and Promotion. The continent's poor education standards, lack of transparency at all institutional levels and a lack of respect for regulations will keep bogging down innovative products, he says. "We are going to keep seeing this for quite some time, in my opinion," he says.

http://www.nature.com/news/2010/101212/full/news.2010.666.html