[Ip-health] 1.5 billion AMC launched, no US support

[Benjamin Krohmal]

thanks to pharmalot.com for the link


Philadelphia Enquirer
Feb. 09, 2007
Plan to fund vaccines for third world
By Thomas Ginsberg
http://www.philly.com/mld/inquirer/news/local/16657320.htm

Pleading hasn't worked. Freebies ultimately fail. Outright pressure
can backfire.

So, global health officials will try a different tactic today to
enable drug companies - notably several in the Philadelphia area - to
help save millions of third-world children from preventable diseases:
a guarantee of profitable markets.

Canada, Britain, Italy and Norway are scheduled to introduce a unique
$1.5 billion program to fund development of vaccines exclusively for
diseases in developing countries. The Advance Market Commitments for
Vaccines Against Neglected Diseases program aims to create vaccine
markets in certain poor countries by pinpointing needed vaccines in
late-stage research, negotiating prices in advance, and reimbursing
countries for their eventual purchases - somewhat like a health
insurer may cover drug purchases by a patient.

GlaxoSmithKline P.L.C., Merck & Co. Inc., Wyeth and Sanofi Pasteur
Inc. stand to benefit directly from the program. At least one, the
Merck Vaccine Division in Montgomery County, said it could foresee
adding jobs if the program worked as envisioned.

The effort sprang from years of debate and frustration over the
industry's retreat from unprofitable emerging markets. Low and
unreliable returns had driven many companies to discontinue some
vaccines or leave the business entirely.

Today, the remaining vaccine-makers, ironically, are thriving in high-
profit markets such as the United States and Europe by charging
unprecedented prices for new vaccines. But those pricey products are
even less accessible to poorer countries.

The advance-market program is the second recent initiative by wealthy
donors and governments - not including the United States - to address
the vaccine crisis in the developing world. In November, Britain led
creation of a financing organization hoping to sell $5 billion in
bonds to support vaccine purchases and distribution.

Combined, the efforts could inject $6 billion or more in coming years
into vaccines for developing nations. Drug companies had lobbied
quietly for the programs to cover their risks and nurture profitable
markets for vaccines that their scientists were passionately pursuing.

"I cannot take shareholder money and put it on a product with no
return," said Jean St=E9phenne, president of GlaxoSmithKline's Belgium-
based vaccine division. "Can you do this without public partnerships?
No, it's impossible."

Pilot project plan set

The advance-market program's pilot project will target the
pneumococcal virus, which can cause pneumonia and meningitis and is
blamed for at least one million childhood deaths a year, according to
the World Health Organization. If that is successful, other targets
may be malaria, rotavirus, tuberculosis or HIV.

Currently, there are two pneumococcal vaccines: Prevnar for children,
made by Wyeth, of Collegeville, and Pneumovax 23 for adults, made by
Merck. While neither is considered entirely effective or appropriate
for children in the developing world, their track record gives the
financing plan a head start and a better chance at proving itself,
officials said.

Wyeth is in late-stage research on a next generation of Prevnar that
would block 11 types of pneumococcal infection. Although the company
was pursuing the vaccine anyway, it welcomed the program. "What it
does, this potential source of money, is allow us to think about
investing in additional manufacturing capacity" for wider markets,
said Jim Connolly, executive vice president of Wyeth's vaccine division.

Merck declined to say if it would pursue a new vaccine for the
developing world, but it called the advance-market guarantee
encouraging.

London-based GlaxoSmithKline, whose U.S. vaccine offices are in the
Philadelphia region, is in late-stage testing of a pneumococcal
vaccine, Synflorix, that will benefit from market guarantees.

'Win-win' for global health

"The A.M.C. funding commitment is the latest win-win in global
health," said Patricia Seif, a spokeswoman.

Sanofi Pasteur, the Swiftwater, Pa., vaccine subsidiary of Paris-
based Sanofi-Aventis, said it hoped to "work within the framework" of
the program in its early-stage research on an infant pneumococcal
vaccine, said a spokesman, Len Lavenda.

The advance-market program, requiring a long-term financial
commitment by donor countries, is being organized under the auspices
of the Group of Seven wealthy nations with the help of the GAVI
Alliance, a nonprofit group created by the Bill and Melinda Gates
Foundation.

The concept emerged in the 1990s and was heavily promoted by U.S.
Treasury officials under President Bill Clinton. The Bush
administration has backed the idea but has not committed funds.

"The United States welcomes the opportunity to work with others on
the development of critically needed medical treatments," said
Brookly McLaughlin, a Treasury Department spokeswoman. "However,
given the budgetary restrictions on making a long-term binding
commitment, we are not in a position to make a financial commitment
at this time."

Some advocates expressed dismay at the U.S. role.

"This administration likes to engage in things that it wholly owns,
rather than things that are part of a broader international effort,"
said Nils Daulaire, president of the Global Health Council, a
Washington-based research group.

Ruth Levine, program director of the Center for Global Development, a
Washington-based nonprofit organization, said the program should
appeal to the Bush administration's "values, such as being oriented
toward the market and in tune with making less-developed countries
viable for business."

She added, "I'm a perennial optimist. There's a strong chance the
U.S. will still come in."

For more information about the Advance Market Commitment for Vaccines
program, the GAVI Alliance and childhood

pneumococcal disease, see the Web sites listed at

http://go.philly.com/vaccines09


Benjamin Krohmal
Coordinator - Project on Medical Innovation
Knowledge Ecology International
Tel: +1-202-332-2670 ex. 14
Fax: +1-202-332-2673
ben.krohmal@keionline.org