Press Release
Friday, September 05, 2008

FOR IMMEDIATE RELEASE
April 23, 2008
Contact: Ruth Hoffman
Candlelighters Childhood Cancer Foundation

In Commemoration of Cancer Control Month, Over 4,000 Americans Urge Congress to Preserve Incentives for Life-Saving Therapies

Rep. Inslee’s Leadership Praised; Biosimilar Proposal Should Protect Development of Tomorrow’s Cures, say Signers

KENSINGTON, MD (April 23, 2008) In commemoration of Cancer Control Month, members of the Candlelighters Childhood Cancer Foundation today met with U.S. Representative Jay Inslee to commend his leadership on preserving incentives for life-saving therapies and presented him with a petition of over 4,000 Americans urging Congress to put the concerns of patients waiting for a cure, like children with cancer, first.

Declaring biotech drugs, “The Pipeline of Hope,” the petition addresses current legislation being considered that would create a pathway for making “follow-on” biologics, or lower-cost versions of biotech medicines. The petition notes that because only one new drug has received marketing approval by the FDA for childhood cancer in the last decade, now is not the time to pass legislation that jeopardizes the development of new breakthrough therapies.

“While saving costs is a laudable goal, for child cancer patients and their families, we must put the search for new cures first,” said Ruth Hoffman, Executive Director of the Candlelighters Childhood Cancer Foundation.  “We commend Representative Inslee for his leadership on this issue – he is a true advocate for patients.”

Representative Inslee is the lead sponsor of H.R. 1956, the “Patient Protection and Innovative Biologic Medicines Act of 2007, legislation that creates a pathway for biosimilars (also referred to as “follow-on biologics”) but establishes an appropriate balance between reducing cost, ensuring safety and providing incentives for innovation.

Biologic drugs are made from living cell lines and are more complex than traditional chemical drugs. Current debates in the U.S. Congress have centered on the ownership of research conducted by innovators who discover and develop a new biologic therapy. The 1984 “Hatch-Waxman Act,” which created standards for chemical generic drugs, provided up to fourteen years of protected time for the original versions. Unlike chemical drugs, a biologic drug costs far more to manufacture-- on average over $ 1.2 billion.

According to Hoffman, “The community of children with cancer in their families knows what is at stake here. Along with our supporters, we are relying on our Senators and Members of Congress to pass legislation that offers at least fourteen years of data exclusivity to protect the scientists and innovators who take on the high-risk challenges of pursuing these medical miracles.”

PETITION

• Because the survival rate of childhood cancer has not changed in the last decade.
• Because treatment for children with cancer has not changed significantly in recent years and we are eagerly awaiting a major breakthrough.
• Because current toxic therapies are not a solution for children with cancer as they cause lifelong health problems including second cancers.
• Because biologic products are among the most promising and effective medicines for the treatment of serious and life-threatening diseases, like childhood cancer.
• Because it is vital that we spur innovation for pharmaceutical companies to invest in the development of these life-saving drugs.
• We, the undersigned, petition Congress to support H.R. 1956, the “Patient Protection and Innovative Biologic Medicines Act of 2007,” legislation that creates a pathway for “follow-on” biologics but establishes an appropriate balance between reducing cost, ensuring safety and providing incentives for innovation.

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