Washington Editor

Diseases, such as cholera, dengue fever, leprosy and malaria, that largely have been eliminated in developed nations but persist in poorer populations - the so-called neglected diseases - affect more than a billion people worldwide, according to the World Health Organization (WHO).

Because most of the people afflicted with neglected diseases are from impoverished communities, there only has been modest interest, but little urgency, from wealthier nations and industry to invest in new therapies and delivery systems to combat the diseases.

The Biotechnology Industry Organization (BIO) wants to change that, Alan Eisenberg, executive vice president of business development and emerging companies, told BioWorld Today.

BIO is teaming with BIO Ventures for Global Health and the Bill and Melinda Gates Foundation to host a three-day forum in March to bring together leaders and experts from the biotech industry, government, global health foundations and the medical community to explore new innovations and potential collaborations to address neglected diseases.

Neglected diseases are very different from so-called orphan diseases defined by the Orphan Drug Act, which outlines what therapies can be given orphan drug designation by the FDA, Eisenberg noted.

An orphan disease, according to the FDA, is one that affects fewer than 200,000 people in the U.S.

Neglected diseases are generally infectious or parasitic diseases and typically thrive in places with unsafe water, poor sanitation and limited access to health care services and can affect hundreds of thousands, even millions, of a nation's population.

"They are much more location-specific," Eisenberg said.

BIO's March forum, he said, will offer three panel tracks focused on the latest trends in R&D, lessons learned from partnering and innovation and markets and incentives.

Panelists participating in three high-level roundtables will discuss how to contain malaria, what is expected of the biotech industry in confronting neglected diseases and addressing global health "from bench to bedside," Eisenberg explained.

In addition, at least 30 companies and organizations involved in discovery and development, including the Department of Defense, will be making presentations about vaccines, drugs and diagnostics.

BIO also is using its partnering software at the March forum to match biotech drugmakers with potential funders and other collaborators, such as innovators of new delivery and storage systems, Eisenberg said.

"This type of an event serves to really take some of our core competencies, which are to bring together various industry leaders representing different perspectives to spur development and innovation within the industry, for, in this case, really a broader purpose," he said. "I think the outcome is we will be seeing new collaborations between companies . . . some thoughtful conversation about direction and certain policy and business areas and, hopefully, some good business getting done as well."

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, is scheduled to take part in one of the forum's plenary roundtables, Eisenberg noted.

Other scheduled participants include Chris Hentschel, president of the Medicines for Malaria Initiative; Ruth Levine, vice president of programs and operations for the Center for Global Development; and Solomon Nwaka, manager of genomic and discovery for WHO's Special Program for Research and Training in Tropical Diseases.

Cheryl Scott, chief operating officer for the Gates Foundation, also is scheduled to participate, along with several biotech company CEOs.

BIO hosted a similar, but much smaller conference six years ago, Eisenberg noted. But, he added, "Since then, the global health field has really exploded. There are a dramatic amount of things that have changed."

The BIO Partnering for Global Health Forum 2008 is scheduled for March 10-12 in Reston, Va.

Orphan Drug Act Turns 25

The Orphan Drug Act, the landmark law that led to an increase in the number of therapies for rare and frequently untreated diseases, celebrated its 25th anniversary recently.

In the decade before the act was passed, only 10 new drugs were developed for rare diseases, according to the National Organization for Rare Disorders (NORD). But in the 25 years since then, more than 1,100 treatments for rare diseases have entered the research pipeline and more than 300 have been approved by the FDA, the group noted.

The National Institutes of Health along with NORD will be marking the anniversary of the act at an international scientific conference in May.

"The biotech industry has historically taken financial risks to develop therapies and cures to serve small patient populations suffering from rare, devastating diseases," said Jim Greenwood, CEO of BIO.

"The Orphan Drug Act established some necessary protection to attract the investment required to research and develop these breakthrough technologies," he said.

Greenwood noted that biotech and pharmaceutical manufacturers who receive orphan drug designation are granted seven years of market exclusivity for a drug approved to treat rare diseases.

Congress Probing Celebrity Drug Endorsements

Congress has opened an investigation about the use of celebrity endorsements of prescription medications in direct-to-consumer advertisements.

Lawmakers specifically are targeting Robert Jarvik, inventor of the Jarvik heart, who appears frequently in Pfizer's Lipitor commercials.

In a letter to Pfizer, Reps. John D. Dingell (D-Mich.), chairman of the Committee on Energy and Commerce, and Bart Stupak (D-Mich.), chairman of the Subcommittee on Oversight and Investigations, questioned Jarvik's medical qualifications, noting that he may not be a practicing physician with a valid license.

"We are concerned that consumers might be misled by Pfizer's television ads for Lipitor starring Dr. Jarvik," Dingell said.

"In the ads, Dr. Jarvik appears to be giving medical advice, but apparently, he has never obtained a license to practice or prescribe medicine," he noted.

Jarvik's appearance in the ads, Stupak added, could "influence consumers into taking the medical advice of someone who may not be licensed to practice medicine in the United States. Americans with heart disease should make medical decisions based on consultations with their doctors, not on paid advertisements during a commercial break."

The lawmakers requested records related to Jarvik's contract with Pfizer and his professional qualifications.

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