[e-drug] Roche finally lowers price of nelfinavir

[mpalmedo@cptech.org]

E-DRUG: Roche finally lowers price of nelfinavir
-------------------------------------------------
[We reported earlier in E-drug that Roche had not yet lowered the price of
its nelfinavir. Finally, after 10 months, Roche has given in to pressures
from MSF and developing countries. Below 2 messages pasted together,
crossposted (with thanks) from IP-Health. WB]

http://www.accessmed-msf.org/prod/publications.asp?scntid=13220031435336&co
ntenttype=PARA&

Bowing to pressure, Roche cuts its price for AIDS drug nelfinavir
13 February, 2003
---------------------------------------------------------------

Geneva, 13th February, 2003 - Starting in April last year, Médecins Sans
Frontières (MSF) has been urging pharmaceutical company Roche to reduce
its price for nelfinavir (brand-name Viraceptâ), a crucial second-line
AIDS drug that was priced out of reach of most patients in developing
countries. Roche's announcement today that they will sell nelfinavir
with significant reductions in poor countries is a welcome result of
this long campaign.

"We are very pleased with this price reduction, and glad to see that
Roche acknowledges that their pricing policy was flawed," explains
Daniel Berman, from MSF's Campaign for Access to Essential Medicines.
"The long struggle to reduce the price of this Roche drug is proof of
the limitations of a fully voluntary system. For new drugs, there needs
to be an internationally-supported enforceable system that reduces
prices to affordable levels in developing countries."

Generic competition remains the most effective means to push prices
down. However, for newer drugs for which no generic equivalents are
available, a system of affordable prices from originator companies is
critical.

The case of nelfinavir

While other AIDS drug producers taking part in the UN Accelerating
Access Initiative had long ago set up a differential pricing system for
poor countries and were offering drugs at 87-92% off Swiss prices, Roche
was only offering a 40-50% discount. In fact, nelfinavir was
significantly more expensive in Guatemala (US$8,358 per patient per
year) and the Ukraine (US$7,110) than in Switzerland (US$6,169).

With this new discount, Roche will now charge approximately US$900 per
patient per year for least developed countries and sub-Saharan Africa,
down from US$3,171. At just over 85% off Swiss prices, this discount is
equivalent to those offered by other multinational pharmaceutical
companies. Roche has also established a price of just under US$3,000 per
patient per year for middle-income countries, unfortunately only 48% off
Swiss prices.

It is also important to note that Roche's published prices are
"ex-factory": additional fees for freight and insurance will be added to
the drug price, raising the price by around 20% for the customer.
Published prices by other pharmaceutical companies such as Merck and
Bristol-Myers Squibb already include these charges.


________________________


For many years, Médecins Sans Frontières (MSF) has been caring for
people living with HIV/AIDS in developing countries. Medical projects
include prevention efforts, voluntary counselling and testing,
psychosocial support, prophylaxis and treatment of opportunistic
infections. MSF started providing antiretroviral treatment to patients
with HIV/AIDS in 2001. MSF now treats 2,500 patients in Cambodia,
Cameroon, Guatemala, Honduras, Kenya, Laos, Malawi, Mozambique, South
Africa, Thailand, Uganda and Ukraine. This year, MSF will double its
intake of patients in existing projects, and will open new projects in
Burkina Faso, Burma, DRC, Ethiopia, Guinea, Indonesia, Nigeria, Peru,
Rwanda, Zambia, and Zimbabwe.


Related Press

Wall Street Journal: Roche to Sell Drug for AIDS At Cost in Poorer
Countries

Reuters: Roche Cuts AIDS Drug Price Following Protests






--
Mike Palmedo
Consumer Project on Technology
T-202-387-8030
F-202-234-5176
mpalmedo@cptech.org
_______________________________________________

The table with the actual new prices didn't cut-and-paste well.  The
price  per pack of 270 (250mg) tablets of Viracept will be 300 CHF in
"Low income countries and Lower middle income countries - as classified
by The World Bank," and it will be 90.90 CHF in "All countries in
sub-Saharan Africa and all UN defined Least Developed Countries."  The
price of 270 (200mg) tablets of Invirase will be 300 CHF in the low and
middle income countries and 95.40 CHF in sub-Saharan Africa & LDCs.

In US dollars:

- Viracept, Low/Middle Income countries - USD 221.47
- Viracept, Sub-S. Africa and LDCs - USD 67.10
- Invirase, Low/Middle Income countries - USD 221.47
- Invirase, Sub-S. Africa and LDCs - USD 70.43

QUESTION: Why 270 drugs?  How long would this quantity last before it
ran out?

http://www.roche.com/med-corp-detail-2003?id=937&media-language=e

Basel, 13 February 2003

Roche updates pricing policy for protease Inhibitor AIDS Drugs within
Accelerating Access Initiative
No profit prices for direct sales of Viracept and Invirase to Least
Developed Countries and sub- Saharan Africa


  Following ongoing discussions with partners, Pfizer Inc. and Japan
Tobacco Inc., holding the patents for Viracept (nelfinavir), Roche
announces an updated policy for its protease inhibitor (PI) drugs
Invirase (saquinavir) and Viracept to treat HIV/AIDS across Least
Developed Countries and sub- Saharan Africa. The policy aims to further
increase access to these WHO defined essential medicines in countries
hardest hit by the AIDS pandemic, with substantial price reductions for
Viracept.

Key elements of this updated policy include:

Further reduction in the price of the adult formulation of Viracept to
the same "no profit" level previously available for the paediatric
formulation and Invirase - now available for direct supplies from Roche
headquarters (HQ) in Switzerland to sub-Saharan Africa and UN defined
Least Developed Countries
Clear pricing for direct supplies from Roche HQ to low income and lower
middle income countries - as classified by the World Bank
Reiteration that Roche will not act against infringement of patents
Roche holds on HIV/AIDS drugs in sub-Saharan Africa and UN defined Least
Developed Countries, nor will Roche file patents on new or
investigational HIV/AIDS medications in these countries.
"Our revised policy demonstrates Roche's commitment to the fight against
HIV and to further accelerate access to care in these African and Least
Developed Countries" stated William M. Burns, Head of Roche Pharma. "The
"no profit" prices are designed to facilitate greatest possible access
to Invirase and Viracept in these hardest hit regions of the world and
we will request these governments to eliminate tax and duty mark ups for
these essential medicines. While our policy has significantly reduced
prices and removed patent issues as barriers to HIV therapy, it would be
wrong to suggest that we can solve the problem through these steps
alone. Affordability is only one of many barriers to care in developing
countries."

This news represents a significant expansion of Roche's policy since
2000 when Roche joined the Accelerating Access Initiative to increase
access to HIV healthcare. As part of that initiative, Roche provided
significant reductions on the price of its PIs - with Invirase and
Viracept paediatric powder available at no profit across sub-Saharan
Africa and the world's Least Developed Countries. In addition Roche is
supporting programmes in the region to develop local expertise and
provide therapy.

"We are very pleased that our business partners at Roche share our
commitment to improving access to HIV/AIDS medicines for patients facing
the most difficult economic and health circumstances," said Pfizer
Chairman and Chief Executive Officer Hank McKinnell. "This announcement
reconfirms our belief that access to medicines should not be limited by
a limited income."

Pricing policy - designed to increase access to essential Protease
Inhibitors in most needy countries
The "no profit" prices for all countries in sub-Saharan Africa and the
Least Developed Countries are ex-factory prices direct from Roche's
headquarters in Basel Switzerland and are available to Governments, Non
Profit Institutional Providers of HIV care and Non-Governmental
Organisations (NGOs) in these countries. While the full terms of
purchase are posted on www.Roche-hiv.com, the prices available for
direct supply from Roche HQ mean that additional costs for freight,
import, duty, taxes, distribution and inventory need to be added. The
retail prices within these countries will therefore be higher and may
vary substantially.

Summary of prices available for direct purchases from Roche Basel, valid
as of 1st March 2003*

Available to


 Viracept

Price per pack of 270 x 250mg tablets/ CHF
 Invirase

Price per pack of 270 x 200mg capsules/ CHF

Low income countries and Lower middle income countries - as classified
by The World Bank
300.00
 300.00

All countries in sub-Saharan Africa and all UN defined Least Developed
Countries. These are "no profit" prices.
 90.90 95.40

These prices are all quoted ex-factory from Roche Basel in Swiss Francs
and will be reassessed on an annual basis in line with costs as long as
Roche continues to market these particular products. The prices are
listed as direct sales from Roche Basel as only this way can clear and
equitable prices be quoted for all the qualifying countries, which would
not be possible for national retail prices.

Roche is currently looking into ways of differentiating the packaging of
these reduced priced essential medicines to ensure they are only used by
those for whom they were purchased and not sold on to other countries.

In low income and lower middle income countries where there is a local
Roche affiliate, the company is taking action to align Viracept prices
from these local affiliates to a maximum of CHF 420 per pack of 270 x
250mg tablets. The retail prices within these countries will be higher
and may vary significantly depending on nationally mandated distribution
and retail margins. Local supply conditions across upper middle and high
income countries remain unchanged.

The "no profit" prices direct from Roche Basel are the lowest prices at
which the products can be provided in a sustainable manner. They do not
reflect research or development costs, marketing costs, distribution
costs or company overheads. In order to achieve the lowest price level
for Viracept in line with this "no profit" price, Roche's licensing
partners Agouron/Pfizer and Japan Tobacco, who hold the patent rights of
Viracept, have agreed to waive all royalties on the sales of the product
in qualifying countries.

Roche in HIV
Roche is at the forefront of efforts to combat HIV infection and AIDS,
committed since 1986 to groundbreaking research and development of
innovative new drugs and diagnostic technology. Saquinavir was the first
Protease Inhibitor (PI) and was first introduced by Roche in 1995 in the
US.

As a consequence of Roche's continuous research and development, the
combination of boosted saquinavir with ritonavir (1000/100 mg twice
daily) has shown encouraging results in the MaxCmin 1 trial with high
efficacy and an excellent safety and tolerability profile. Saquinavir/r
was approved in the EU in August 2002. Viracept (nelfinavir), another PI
is supplied by Roche outside the US and Canada. In first-line HIV
therapy, Viracept delivers consistent long-term efficacy and safety.
When used first line, Viracept also allows the subsequent use of both
NNRTIs and other PIs for most patients due to its unique resistance
pattern.

About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading
research-oriented healthcare groups. The company's two core businesses
in pharmaceuticals and diagnostics provide innovative products and
services that address prevention, diagnosis and treatment of diseases,
thus enhancing people's health and quality of life. The two core
businesses achieved a turnover of 19.3 billion Swiss Francs in the first
three quarters of 2002 and employed about 57,000 people worldwide.

All trademarks used or mentioned in this release are legally protected.

Please see http://www.Roche-hiv.com for full terms and conditions.

Notes to editors
The following countries are designated by the United Nations as Least
Developed:
Afghanistan, Angola, Bangladesh, Benin, Bhutan, Burkina Faso, Burundi,
Cambodia, Cape Verde, Central African Republic, Chad, Comoros,
Democratic Republic of Congo, Djibouti, Equatorial Guinea, Eritrea,
Ethiopia, Gambia, Guinea, Guinea Bissau, Haiti, Kiribati, Lao People's
Democratic Republic, Lesotho, Liberia, Madagascar, Malawi, Maldives,
Mali, Mauritania, Mozambique, Myanmar, Nepal, Niger, Rwanda, Samoa,
Senegal, Sao Tome and Principe, Sierra Leone, Solomon Islands, Somalia,
Sudan, Togo, Tuvalu, Uganda, Tanzania, Vanuatu, Yemen and Zambia.

Additional countries in sub-Saharan Africa not covered by UN list of
Least Developed Countries for which the lowest level, no profit prices
apply:
Botswana, Cameroon, Congo, Gabon, Ghana, Ivory Coast, Kenya, Mauritius,
Namibia, Nigeria, South Africa, Swaziland and Zimbabwe.

Low-income economies - source World Bank classification of economies1

Armenia, Azerbaijan, Georgia, India, Indonesia, Korea Dem. Rep., Kyrgyz
Republic, Moldova, Mongolia, Nicaragua, Pakistan, Tajikistan, Ukraine,
Uzbekistan, Vietnam.

Lower-middle-income economies1,2
Albania, Algeria, Belarus, Belize, Bolivia, Bosnia and Herzegovina,
Bulgaria, China, Colombia, Cuba, Dominican Republic, Ecuador, Egypt, El
Salvador, Fiji, Guatemala, Guyana, Honduras, Iran, Iraq, Jamaica,
Jordan, Kazakhstan, Latvia, Lithuania, Macedonia FYR, Marshall Islands,
Micronesia Fed. Sts, Morocco, Papua New Guinea, Paraguay, Peru,
Philippines, Romania, Russian Federation, Sri Lanka, St. Vincent and the
Grenadines, Suriname, Syrian Arab Republic, Thailand, Tonga, Tunisia,
Turkmenistan, West Bank and Gaza, Yugoslavia Fed. Rep.

1 Those not otherwise classified as "Least Developed" by the United
Nations.
2 Other than those already listed above in the list of sub-Saharan
countries where no profit prices apply.

Further information on WHO defined essential medicines.



--
Mike Palmedo
Consumer Project on Technology
T-202-387-8030
F-202-234-5176
mpalmedo@cptech.org
_______________________________________________


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