Pharma cos. bet on African market for their anti-AIDS drugs

By Ramnath Subbu

MUMBAI, MAY 13. Indian pharmaceutical companies have trained their sights on the African continent where acquired immuno- deficiency syndrome (AIDS) has spread at an alarming rate.

There is a huge opportunity in Africa following the withdrawal of the patent suit filed by 39 global pharma companies against the South African Government which allowed the sale of cheaper branded generic drugs.

India itself presents a daunting scene with possibly the second highest HIV positive infections after South Africa.

The anti-AIDS retroviral drugs market in India is dominated by Cipla which in many ways has been the most aggressive player in this segment and also enjoys the `first mover' advantage over others as far as venturing into the African market is concerned.

The company had created a furore in global pharma circles when it offered to sell its `triple AIDS cocktail' to a doctor's group Medicines Sans Frontiers (MSF), which is working in Africa and Southeast Asia for the treatment of AIDS at $350 per patient per year three months ago.

This was when global pharma companies were charging between $10,000-15,000 per patient per annum for the same regimen.

The number of HIV positive cases in Sub-Saharan Africa alone is estimated to exceed 25 million while in India, it is in the region of 3.5-4 million cases, according to the National AIDS Control Organization (NACO).

Other players to have announced a foray in the anti-AIDS segment are Zydus Cadila, Aurobindo Pharma, Ranbaxy, Hetero Drugs and Kopran.

A company seeking to export drugs from India requires a compulsory licence from the importing country. Under compulsory licensing, a manufacturer is allowed to produce a patented drug in exchange for a licence fee to the inventor. The fees vary from deal to deal.

Cipla was the first to take the lead in exporting to the African markets. The company supplied MSF a cocktail consisting of Lamivudine, Stavudine and Nevirapine. Its first lot was supplied to Cambodia and it recently signed an agreement with the Nigerian government.

Nigeria is buying the drug to treat 10,000 patients per annum and at $350 per patient, the order is worth $3.5 million. Execution of the order is to commence soon.

Cipla is in talks with the governments in Zimbabwe, Cameroon, Ivory Coast and Algeria and is also in discussions with Anglo- American, a South African private sector firm, for treatment of 20,000 patients at $350-500 per annum.

Zydus Cadila has put up applications to export its cocktails to Kenya, Uganda and South Africa. According to the company, the application has been registered in these countries and clinical trials are on. There are also some negotiations taking place on the pricing.

Hetero Drugs is in talks to supply its drugs to Kenya and Congo and its registration is being processed in Colombia and West Asia. The company offered to supply its triple drug cocktail to MSF at $347 per patient per annum.

It is also in talks with the Nigerian and Zimbabwean governments and expects a more definite picture to emerge in the next few months. Aurobindo Pharma has stated that it is in discussions with MSF.

Today, the triple drug `cocktail' regimen typically consists of two nucleoside reverse transcriptase inhibitors (NRTIs) in combination with either a protease inhibitor (PI) or a non- nucleoside transcriptase inhibitor (NNRTI).

The compounds Zidovudine, Lamivudine and Stavudine are NRTIs which form the backbone of triple therapy. Either Zidovudine or Stavudine is used in combination with Lamivudine.

Now with the introduction of Didanosine, the options have widened and patients who do not respond to the earlier mentioned combinations can switch to a Stavudine-Didanosine or Zidovudine- Didanosine combination.

Nevirapine belongs to the NNRTI class of anti-retroviral drugs. These act by inhibiting reverse transcriptase, which is essential for the multiplication of the human immunodeficiency virus. NNRTIs inhibit HIV-1 strain but are not active against HIV-2 strain. Indinavir, Nelfinavir, Abacavir are protease inhibitors (PI).

Regarding the domestic market, Mr. Srinivas Lanka, director, Aurobindo Pharma, said, ``There is no clear evidence on the size of the domestic market for the anti-AIDS drugs but on the basis of sales at the retail level, it appears to be around Rs. 120 crores in size.

Owing to the stigma attached to AIDS, numbers can be gleaned only from indirect sources. But with the increasing incidence of the infection, this market is now growing at 200 per cent per annum.''

``Most of the drugs in use today have pre-1995 patents. The fact of the matter is that there is no product to kill the virus as yet and all medication is only to retard or prevent the progress of HIV positive patients to full-blown AIDS.

Unfortunately in India, the government is working only on prevention of HIV infection and not on its treatment,'' said Mr. Lanka.

Cipla last week announced a cut in the domestic prices of its drugs. The company's price cuts are in the region of 15-17 per cent for the basket of products including Zidovir, Lamivir, Duovir, Stavir, Nevirapine and Dinex 100.

Consequently, the price of its triple drug cocktail, of Stavudine-Nevirapine-Lamivudine, per patient will go down to Rs. 3,495 per month against the earlier price of Rs. 4,320 per patient per month.

Ranbaxy Laboratories last week launched Lamivudine, Nevirapine and Zidovudine products in the Indian market. Virocomb, a combination of Lamivudine and Zidovudine, has been priced at Rs. 500 per strip of 10 tablets. Its Zidovudine tablets have been priced at Rs. 260 per 10 strip. The drugs are to be marketed through its division - Crosslands.

Aurobindo Pharma has set up a new division - Imunus to offer HIV/AIDS drugs. Imunus last week launched five options for the treatment of HIV and plans to offer seven more options in this financial year.

The five options include Zidovex, Lamivox, Nevirex, Stavex and Zixovex-L. The seven options to be introduced by the end of the financial year include Didanosine, Efavirenz, Delavirdine, Indinavir, Ritonavir, Saquinavir and Nelfinavir.

Aurobindo has eight bulk drugs and two formulation plants and has earmarked a Rs. 20 crore fund for Imunus.

The medicines are to be distributed free through NGOs and government organisations besides Aurobindo's own centres.

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