Competition grows in the biopharming market

Thursday, May 5, 2005

By Nancy Cole

The bad news for Ventria Bioscience, the California based 
biopharmaceutical company that drew rice-industry opposition for plans 
to produce human proteins in Missouri Bootheel fields, may not be over yet.

A Houston-based biotechnology firm claims it already manufactures 
pharmaceutical-grade human lactoferrin at costs similar to those 
estimated by Ventria.
Rick Barsky, the chief executive officer of Agennix Inc., said the 
small, private company also holds dozens of patents worldwide for its 
lead product, talactoferrin alfa, which already is in human clinical 
trials for the treatment of cancer and diabetic ulcers.
"Our actual costs are comparable to [Ventria’s] best guess of their 
projected costs," Barsky said.
Ventria sought permits from the U.S. Department of Agriculture’s 
Biotechnology Regulatory Services to grow up to 200 acres this year in 
Missouri of rice genetically engineered with human lactoferrin and 
lysozyme, which it plans to use in an oral rehydration solution for 
treating children with acute diarrhea.
Ventria’s plans drew opposition from Missouri rice farmers, who say that 
pharmaceutical rice poses an economic threat to their $93 million 
industry. Anheuser-Busch Cos. also threatened to boycott the state’s 
rice because of contamination fears, until Ventria agreed to plant 120 
miles away from commercial fields.
Last week Ventria’s president and chief executive officer, Scott Deeter, 
said the company was shelving plans to grow genetically modified rice 
this year in Missouri because the USDA permits were unlikely to be 
approved in time for planting. Instead, Ventria has applied for two 
permits to grow rice in North Carolina — a state with no commercial rice 
production — where the company already has a permit to grow its rice on 
2.5 acres.
Deeter said Ventria still plans to plant pharmaceutical rice next year 
in Missouri and to follow through on plans to relocate the company from 
Sacramento to Northwest Missouri State University in Maryville.
Deeter did not return calls seeking a comment on Ventria’s production 
costs for human lactoferrin.
"Biopharming" proponents argue that food crops offer a low-cost way to 
produce large volumes of pharmaceuticals.
"It’s important to allow this work to go forward so that we can have new 
treatments for diseases," said Lisa Dry, a spokesman for the 
Biotechnology Industry Organization.

"The whole concept is that by using plants — instead of building a 
fermentation facility, which can cost from $500 [million] to $700 
million and take five to seven years to build — you can produce drugs 
that might be too expensive... to produce otherwise," Dry said.
Ventria’s vice president of research and development, Ning Huang, 
estimated his company’s cost of producing recombinant proteins using 
transgenic rice in a January 2004 article in the journal BioProcess 
International.
Agennix’s Barsky said he suspected that such estimates often fail to 
include the cost of "meeting the ‘current Good Manufacturing Practice’ 
requirements for a pharmaceutical drug" that is regulated by the Food 
and Drug Administration. Plant-made pharmaceutical companies might have 
to spend even more money than Agennix to "show the level of purity and 
consistency and all of the safeguards that we show in our closed 
system," he said.
Regardless of cost, Barsky said Ventria may have trouble selling human 
lactoferrin for a number of other reasons, including Agennix’s head start.
"We’ve been developing it as a drug and we’re in human clinical trials 
with our recombinant human lactoferrin, which is not produced by 
genetically modified crops," he said. "We produce it in a pharmaceutical 
manufacturing facility."
Since September 2002, Agennix has contracted the Dutch company DSM 
Pharma Products to manufacture more than 200 kilograms of human 
lactoferrin at DSM’s factory in Capua, Italy.
Barsky said Agennix holds "over 75 issued patents and more than 50 
pending patents" that give the company "broad protection on the 
composition of matter as well as on clinical applications," which could 
make it difficult for Ventria to sell human lactoferrin.



Arkansas Democrat-Gazette