Sickle cell anaemia

U.S. NHLBI

A long chapter in an internationally-watched experiment in the commercialisation of an indigenous medicine has drawn to a close after the company charged with producing the drug had its licence revoked.

Nicosan — based on a traditional remedy for sickle cell anaemia — has been manufactured by the company Xechem, in Nigeria, since 2003.

But the Nigerian government's National Institute for Pharmaceutical Research Development (NIPRD) has withdrawn the company's licence, according to documents seen by SciDev.Net.

The move follows the apparent collapse in production of the drug, which has left many Nigerian sickle cell sufferers without a medicine with which to alleviate their symptoms.

It brings to an end a six-year saga in which Xechem International and its subsidiary Xechem Nigeria were dogged by allegations that funds and loans had disappeared. In November 2008 Xechem International filed for bankruptcy protection in the United States and Xechem Nigeria is up for auction today (16 March).

Nicosan (formerly Niprisan) is based on extracts from West African plants that had been known to generations of a Nigerian family as an effective treatment for sickle cell anaemia.

Around 12 million people suffer from the painful genetic illness. It has been labelled "probably the most neglected serious public health disorder in Africa" by Charles Wambebe, chief executive officer of the International Biomedical Research Institute in Abuja, Nigeria.

The family who owned the recipe initially drew up a Memorandum of Understanding for its development with Nigeria's National Institute for Pharmaceutical Research and Development. This pioneering agreement has been widely cited as a case study in "benefit sharing" — allowing vulnerable groups to have a stake in the profits from commercialising indigenous products.

In 2003, in a controversial move, Xechem bought the rights to develop Nicosan. By February last year its subsidiary, Xechem Nigeria, said it was producing some 50,000 capsules a year (see Sickle cell drug mired in controversy).

But the following month (March) a fraud complaint was brought before Nigeria's Economic and Financial Crime Commission against Xechem Nigeria. The complainant alleged that US$3.5 million of public funding from the Nigerian government, which was supposed to have been spent on drug manufacture, had been misused.

Xechem had also borrowed nearly US$4 million from a Nigerian bank and US$4 million from a US bank. The destination of these loans has also been questioned.

Rumours that the NIPRD was considering revoking Xechem's licence have been around for some months. A source told SciDev.Net that the company had not kept up with its quarterly reports and royalties.

But, when asked about this two weeks ago, Ireti Oniyide, managing director of Xechem Nigeria, said rumours of a licence reassignment were "not true".

"We are producing the drug and it is on the market. You can go to Lawcas or Cutteman pharmacy in Abuja or JKK or Medcloth in Lagos and get it. You cannot get it everywhere because we need to make sure that they have the correct storage facilities.''

He said that that the parent company, Xechem International, filed for bankruptcy protection (see Bankruptcy leaves indigenous sickle cell treatment in jeopardy) specifically to "to protect the Nigerian company. It has not affected us".

A SciDev.Net survey has, in recent weeks, failed to find the drug in major pharmacies in Nigeria.

And a senior government official told SciDev.Net, on condition of anonymity, that Xechem had stopped production activities for over two months after operating on a skeletal basis for 16 months.

Wambebe, formerly director general of the NIPRD, said last month that he wanted to see the product available for people at an affordable rate. "It is an area of great concern for me, being the chief investigator who initiated the research and development on Nicosan."

Dorothy Ogundu, a Nigerian physician and scientist who worked in the United States on the commercialisation of Nicosan five years ago, said: "I don't know whether to be sad or angry at the events that keep unfolding."

She said in an email that she had worked on the drug "because I believed in the necessity of finding a reprieve in the sickle cell affected community, one that has caused havoc amongst Nigerians".

"I see this as a misadventure on all sides, the murder of the golden bird, while those who should and ought to know better did nothing," she added.