Small Companies With Promising Drugs Could Benefit From Program to Encourage Development of Drugs to Fight Tropical Diseases
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 drugsfor tropical diseases could increase and accelerate the financial returnsfor small companies with the most promising technologies.
Joel L. Bellenson, Chief Executive Officer of Upstream, said that thepriority review voucher program expected to be implemented in the thirdquarter of 2008 is anticipated to motivate large companies to compete foraccess to tropical disease drug candidates by partnering with or byacquiring small companies.
"The Duke University economists who originated the priority review voucherconcept believe these transferable vouchers will accelerate thecommercialization of drugs and could therefore be worth $300 million ormore to large pharmaceutical companies," said Bellenson. "Small companies,such as Upstream, with viable tropical disease compounds in research anddevelopment, are anticipated to become targets of large companies forpartnerships and acquisitions."
"Some big pharma executives said at the Bioventures Global Healthconference held in Washington, D.C. in March -- and others have told usdirectly -- that they would explore collaborations or acquisitions of smallcompanies with promising tropical disease pipelines," Bellenson said.
"The priority review voucher program, when implemented, could make aconsiderable difference in enabling us to accelerate our development andcommercialization efforts for these drug candidates. We look forward tolearning more details as the program is launched in the coming months,"Bellenson said.
Upstream's advanced computational drug discovery platform has the potentialto identify and optimize multiple drug candidates quickly and efficiently,and its library of compounds has produced a number of candidates with thepotential to treat major tropical diseases. Upstream recently announcedits third set of positive preclinical toxicity results for its candidatesfor malaria, trypanosomiasis and leishmaniasis. The good safety profile inanimals and encouraging in vitro anti-parasitic activity seen to date withthese compounds have been encouraging for Upstream and its network ofinternational 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 2007authorizes the FDA to award a priority review voucher to any company thatobtains approval for a treatment for a neglected tropical disease. Draftregulations were circulated for comment late last year and it is expectedthe program will be implemented by the FDA during the third quarter of2008. The voucher, which is anticipated to be transferable and marketable,would entitle the bearer to a priority six-month review for anotherproduct, not necessarily a tropical disease drug. Normally, the FDA reviewprocess 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 sixmonths could be worth more than $300 million to a company with atop-selling drug with a net present value close to $3 billion(1).
