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PRESS RELEASE - JUNE 10th, 2008
UPSTREAM BIOSCIENCES EXPECTS INCREASED INTEREST FROM BIG PHARMA
AS FDA’S PROPOSED PRIORITY REVIEW VOUCHER PROGRAM IS IMPLEMENTED
• Small Companies With Promising Drugs Could Benefit from Program
to Encourage Development of Drugs to Fight Tropical Diseases
Vancouver, British Columbia– June 10th, 2008 –Upstream Biosciences Inc. (OTCBB: UPBS) announced today that the United States Food and Drug Administration’s (FDA) proposed priority review voucher program to stimulate development of drugs for tropical diseases could increase and accelerate the financial returns for small companies with the most promising technologies.
Joel L. Bellenson, Chief Executive Officer of Upstream, said that the priority review voucher program expected to be implemented in the third quarter of 2008, is anticipated to motivate large companies to compete for access to tropical disease drug candidates by partnering with or by acquiring small companies.
“The Duke University economists who originated the priority review voucher concept believe these transferable vouchers will accelerate the commercialization of drugs and could therefore be worth $300 million or more to large pharmaceutical companies,” said Bellenson. “Small companies, such as Upstream, with viable tropical disease compounds in research and development, are anticipated to become targets of large companies for partnerships and acquisitions.”
“Some big pharma executives said at the Bioventures Global Health conference held in Washington, D.C. in March — and others have told us directly — that they would explore collaborations or acquisitions of small companies with promising tropical disease pipelines,” Bellenson said.
“The priority review voucher program, when implemented, could make a considerable difference in enabling us to accelerate our development and commercialization efforts for these drug candidates. We look forward to learning more details as the program is launched in the coming months,” Bellenson said.
Upstream’s advanced computational drug discovery platform has the potential to identify and optimize multiple drug candidates quickly and efficiently, and its library of compounds has produced a number of candidates with the potential to treat major tropical diseases. Upstream recently announced its third set of positive preclinical toxicity results for its candidates for malaria, trypanosomiasis and leishmaniasis. The good safety profile in animals and encouraging in vitro anti-parasitic activity seen to date with these compounds have been encouraging for Upstream and its network of international collaborators. Malaria, leishmaniasis and trypanosomiasis, which are caused by related parasites, are leading sources of disability, death and economic hardship in Africa.
About priority review vouchers
The Food and Drug Administration Amendments Act of September 2007 authorizes the FDA to award a priority review voucher to any company that obtains approval for a treatment for a neglected tropical disease. Draft regulations were circulated for comment late last year and it is expected the program will be implemented by the FDA during the third quarter of 2008. The voucher, which is anticipated to be transferable and marketable, would entitle the bearer to a priority six-month review for another product, not necessarily a tropical disease drug. Normally, the FDA review process can take from 10 to 18 months.
Economists at Duke University, who proposed the voucher concept in 2006, have calculated that reduction of the FDA approval time from 18 to six months could be worth more than $300 million to a company with a top-selling drug with a net present value close to $3 billion(1). At this level, the voucher would be expected to offset the substantial investment and risk required for discovery and development of a new treatment for a neglected tropical disease.
About Malaria
Malaria is transmitted by mosquitoes in more than 100 countries worldwide. According to the World Health Organization (WHO), an estimated 500 million people become severely ill with malaria each year, many of them children. Malaria attacks the blood and internal organs of infected people and is a leading cause of disability and death in affected countries. An estimated one million people die each year of malaria, with 90% of cases occurring in Africa. Early diagnosis and treatment can shorten the duration of the disease and prevent death or complications. However, the malaria-causing parasite’s resistance to current medicines is undermining control efforts. Malaria infections are estimated to cost the economies of sub-Saharan Africa at least $12 billion annually from the direct costs of prevention and treatment as well as indirect economic costs associated with this debilitating disease.
About African Sleeping Sickness
An estimated 60 million people and 50 million cattle in sub-Saharan Africa are at risk of contracting African sleeping sickness, or trypanosomiasis infections. The trypanosome parasite, transmitted by the tsetse fly in more than 35 countries, attacks the blood and nervous systems of infected humans and animals. Without treatment, the disease is fatal. Available treatments for humans are costly, complex and toxic, requiring intravenous infusions and hospitalization. Current treatments for the animal form of the disease are toxic and are increasingly ineffective as a result of rising levels of drug resistance. Trypanosomiasis infections are estimated to cost the economies of sub-Saharan Africa at least $4.5 billion annually from lost farm income and increased malnutrition, with an estimated $600 million to $1.2 billion expended each year in control efforts and in losses in meat and milk production.
About Leishmaniasis
Leishmaniasis is a severe, geographically widespread parasitic disease caused by a protozoan flagellate and spread by the bite of infected sand flies. There are several different forms. The cutaneous type causes skin sores, the mucocutaneous form causes disfiguring lesions of the oral cavity area and the visceral type affects internal organs. Visceral leishmaniasis can be lethal if untreated. Leishmaniasis is increasing in incidence with an estimated two million cases per year, and 350 million people in 88 countries are estimated to be at risk. More than 90% of the world's cases of visceral leishmaniasis are in India, Bangladesh, Nepal, Sudan, and Brazil. Leishmaniasis is also found in Mexico, Central America, and South America.
About Upstream Biosciences, Inc.
Founded in 2004, Upstream Biosciences is a pioneer in the discovery and development of novel compounds for tropical parasitic diseases and in the development of genetic diagnostics for cancer susceptibility and drug response. Upstream’s innovative approach to drug discovery and its proprietary data mining pipeline enable it to apply advanced computational approaches to generating novel drug candidates and to locating and analyzing the genetic variations important to disease progression and drug response.
Investor contact:
Samantha Haynes
1-800-539-0289 or
info@upstreambio.com
Media contact:
Nancy McHarg
James Hoggan & Associates
Tel: 604-739-7500
nmcharg@hoggan.com
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