[e-drug] BMS Stalls on Offer

[Mike Palmedo <mpalmedo@essential.org>]

E-drug: BMS Stalls on Offer
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[Cross posted from Pharm-policy mailing list. Thanks. HH]

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.

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

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