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By Cynthia Robbins-Roth

BioWorld Today Columnist

Just when things seem very dour, what with threats of Democrats tinkering with drug pricing, biogeneric competition and scientific founders imprisoned for nasty behavior, events remind us of why it's so entertaining to be in biotech.

As we head toward April Fool's day, here are my favorite news bites:

Persistence pays off for BioCryst Pharmaceuticals of Birmingham, Ala. The firm was founded in 1986 to use rational drug design to create small-molecule antiviral drugs and immune regulators.

BioCryst thrashed through clinical failures and recalcitrant collaborators for almost 20 years, instituting the dreaded "restructuring" in 2002 after its lead flu drug failed in Phase III.

Clearly, that restructuring and CEO (now chairman) Charles E. Bugg's persistence paid off. Four years later, BioCryst has a drug aimed at immune cell cancers in Phase III and a partnership with Mundipharma; a new version of its flu blocker in Phase II that has attracted lucrative partnerships with Shionogi Green Cross, of Korea, and the U.S. government; and a treatment for graft rejection and autoimmune disease in the clinic with Roche.

Take note, prospective biotech entrepreneurs: You are in this for the long haul. Better eat your Wheaties.

Malaysia's Forest Research Institute has been collaborating with the Massachusetts Institute of Technology for the past five years to identify the active agents in tongkat ali, an herbal aphrodisiac. Scientific studies (the mind boggles) showed the herb makes rats and mice friskier, but has widely varying effects on people.

The $4 billion global market for aphrodisiacs has prodded the Malaysian scientists and their collaborators to identify and patent the key components in the mix. Some of the molecules may treat cancer and malaria. Clinical trials are under way, and the government opened a $7 million research center to work on biotech-based manufacturing.

Talk about generating multiple blockbuster product opportunities from a single platform!

It was a tough quarter for biopharma PR. Congress opened hearings into FDA's handling of drug safety with testimony from a former employee of contract research group PPD Inc. that Sanofi-Aventis and PPD knew of problems with clinical studies of the antibiotic Ketek before regulators reported fraud at one of the sites.

Ketek became the focus of concern last year when the FDA ordered stronger label warnings after 12 cases of acute liver failure (four fatal) and 23 cases of acute liver injury were reported.

Meanwhile, the BBC ran a program based on internal memos from GlaxoSmithKline suggesting the firm deliberately misled doctors about the safety and efficacy of its Seroxat antidepressant for children. The drug was banned by British authorities in 2003 for children younger than 18 after finding Glaxo's studies in fact showed the drug trebles the risk of suicidal thoughts and behavior in depressed kids. Meanwhile, the firm's sales reps were being told that the drug "demonstrates remarkable efficacy and safety." Glaxo released a statement voicing concern that patients would be misled into not using their medication, and stating that the problems were revealed as clinically significant only when all nine pediatric studies were pooled and, besides, none of the participants actually killed themselves.

And finally, Genentech was portrayed as Scrooge when The Wall Street Journal reported the company refused to provide drugs for the NIH head-to-head study of its Avastin (approved for cancer, $100/dose for off-label eye use) and Lucentis ($1,950/dose) in macular degeneration. Those related molecules with similar mechanisms of action are in the eye of a drug-pricing storm, as docs try to cut costs for their elderly patients. With Medicare anticipating over $1 billion annually in taxpayers' money potentially going for Lucentis, you can see why the potential to save significantly would be a motivating force. Aggressive pricing may overshadow Lucentis' scientific qualities.

Ganeden Biotech Inc. wins top prize for the most disconcerting marketing campaign and the silliest sounding location. The firm, based in the BioHio ag biotech research park in Ohio, manufactures and sells probiotic products for gastro-intestinal function, arthritis and topical fungal infections. Ganeden launched the "Get Uncorked and go to Cork!" contest, in which contestants are encouraged to "create an imaginary fun story centered on constipation" that preferably takes place in County Cork, Ireland - and the winner gets a trip for two to that lovely location. The deadline is April 20, with online voting for the winning story.

Richard Branson and his Virgin Group have entered the stem cell arena. He has launched an umbilical cord stem cell bank that will split each sample in two. One part will be stored for future use by that individual, the other will go into a national bank that can be accessed by anyone in need.

Maybe he can connect up with Advanced Cell Therapeutics, which was reported earlier as conducting stem cell treatments on the overnight Cork-to-Swansea ferry to avoid Irish bans. (See BioWorld Today, July 31, 2006.) (Hey, I wonder if this will be included in that Ganeden prize trip to Cork?)

Ethical concerns were raised last year because UK footballers were storing their newborns' stem cells as potential treatments for their own cartilage and ligament injuries. Could that explain Posh Spice's three children with soccer great David Beckham?

Controversial South Korean cloning pioneer Hwang Woo-suk is suing to be reinstated at Seoul National University after being fired for falsified research. According to the Associated Press, Hwang claims that although some results were faked, his cloning work was real.

And the whole mammoth cloning thing involving bribes of the Russian mafia? Just a side project.

Cynical investors discredit claims by biotech execs that external forces are acting against company stock price. Vindication came when Duros hedge fund manager Scott Sacane was sentenced to a big fine and federal prison for manipulating stock prices of Aksys Ltd. and Esperion Therapeutics by concealing acquisition of 77 percent of Aksys and more than $100 million of Esperion. He continued to purchase shares even after signing nonpurchase agreements with management. Other companies in his portfolio included Allos Therapeutics and Novoste.

Tune in April 9 for more Biopharma Fun! Send your favorite industry news to me at info@bioventureconsultants.com.

Robbins-Roth, PhD, founding partner of BioVenture Consultants, can be reached at info@bioventureconsultants.com. Her opinions do not necessarily reflect those of BioWorld Today.



BioWorld Today  March 26, 2007