[Pharm-policy] Business Day: BMS Stalls on Offer

[Mike Palmedo]

http://www.bday.co.za/bday/content/direct/1,3523,890041-6099-0,00.html

BristolMyers-Squibb stalls on offer

Aspen may get only watered-down version of offer to copy two
antiretrovirals

MULTINATIONAL pharmaceutical manufacturer BristolMyersSquibb, which
effectively offered a voluntary license to generic drug makers to copy
its two antiretroviral drugs which treat HIV/AIDS, has not yet delivered
on its offer, despite requests for copying rights.

It appears as if the manufacturer will offer a much watereddown version
of its initial offer to Aspen Pharmacare, one of SA's largest generic
manufacturers, which has asked for permission to make the medicines and
sell them in Africa, including SA, at low prices.

This follows a drive by multinational firms to drop prices in poorer
nations, while at the same time generic manufacturers have been pushing
to secure permission to copy original drugs and drive prices down even
further.

In a letter to Aspen Pharmacare, which has not yet been received, the
company has said it will not challenge Aspen if it makes the drug,
according to Ian Strachan, BristolMyers-Squibb's regional CEO.

Meantime, Indian-based generics maker Cipla, known in SA as Cipla
Medpro, is going ahead with an application to the patents commissioner
for a compulsory license to make copies of a cocktail of antiretroviral
drugs and supply them in SA.

This step will challenge GlaxoSmithKline's patent for Combivir, a
combination of two of its antiretroviral drugs. It will also challenge
Boehringer Ingelheim on its patent for Nevirapine used to treat adults
with HIV/AIDS.

The application will also set a precedent in SA and deliver a signal
worldwide on how patent holders in poorer nations will respond to
challenges from generics manufacturers.

Jerome Smith, Cipla Medpro's local CEO, says the process, requiring a
court decision, should be completed within six weeks. He anticipates
getting the license and registration for its combination drug from the
Medicines Control Council at the same time.

The council has to register the drug after checking its safety and
efficacy before it can be made available to the public.

Cipla has asked for voluntary licenses from the companies a necessary
procedure before applying for a compulsory license and has either been
brushed off or, as Smith sees it, "suffered delay tactics" in the form
of "unnecessary questions".

GlaxoSmithKline's medical director, Peter Moore, said yesterday his firm
had had a request several months ago and had written for more
information on its lawyers' advice. If Combivir's patent was challenged,
he said, the firm would look to protect its intellectual property
rights.

Linda Philip, Aspen CEO, said this week her company had not yet received
a letter from BristolMyers-Squibb. Informed about what the letter said,
Philip said her company would need legal advice. An offer not to
challenge Aspen or prosecute it, would not deal with whether and where
the drug could be sold, made, and for how long, she said. Both firms are
likely, however, to sell these drugs only to the private healthcare
market, dominated largely by medical schemes.

This is because government has repeatedly said it will not be supplying
antiretroviral drugs to users of public health-care services, despite
the drugs' known effects to prolong the useful life of those infected
with HIV/AIDS.

Yet generics makers based in India seem optimistic they will be able to
sell to a larger market. If Cipla is successful, it will open the way at
a hefty cost as the application will cost about R1m for other generics
makers.

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