Biotechnology is ninety-five percent devoted to human health problems, according to Fred Dorey, former president of the Bay Area Bioscience Center. Here are profiles of three East Bay biotech firms working on revolutionary ways to treat illnesses from the common cold to cancer.

BAYER

The head cold, that bane of civilization, may be slowed or stopped by a nasal spray produced by Bayer Biotechnology of Berkeley. Cold viruses try to enter the body only through “ports” in the nose. “All viruses modify their evolution to find the normal human port somewhere. These rhinoviruses find these nasal ports and go in, said Wolf-Dieter Busse, senior vice president and head of Bayer Biotechnology.

The medicine, called ICAM, short for intra-cellular adhesion molecules, is in clinical phase I human trials. The spray should mask cold-virus entry ports and lure the rhinovirus into false ports where it can be isolated. If a virus does infect a cell, it can be trapped as it tries to spread. “The infection is reduced in severity and in some cases can be prevented, so we think this will be probably the first true cold medicine on the market,” Busse said.

Bayer has about 1000 workers at its 20-acre campus in Berkeley. The Germany-based company came to the East Bay when it bought Cutter Labs, which had been based in Berkeley since 1907. In 1989, the parent corporation designated Berkeley as its world-wide center for biotechnology.

In 1991, the City of Berkeley and Bayer, with a huge amount of community participation, reached a development agreement, a contract between a landowner and a government. Bayer wanted assurances they would be able to build on their campus in the coming years, Berkeley wanted to safeguard its citizens and their quality of life. There were more than 100 community meetings and 16 commissions looked at the plan.

Now Bayer has a state-of-the-art campus, products on the market and has initiated an innovative program to train young people in Berkeley for the kinds of biotech jobs emerging in the area. One Of Bayer’s motivating factors to build was the need for a place to produce Kogenate, a clotting drug for hemophiliacs, which was nearing FDA approval.

Second-generation Kogenate II is now in phase three human clinical trials, the large well-controlled trials designed to establish whether a drug is effective and safe. These are the final phase of trials that normally precede a new drug application.

An example of how drugs are improved, Kogenate II needs no human albumen proteins as did the original Kogenate. Though human albumen used in these medicines is not thought to be able to transfer viruses, ” because of what happened with AIDS and unknown viruses, there is an assumption that human proteins have a certain risk,” said Busse.

“Everybody believes the more you reduce the load of human proteins, like human albumen, in such a product, the greater acceptance it has in the market,” he added.

In terms of mitigating suffering, Bayer cannot produce as much original Kogenate as needed because they cannot get enough albumen. The all-synthetic process should allow them to produce enough of the new version to expand to new markets and help more people.

Bayer has five other products in various phases of development and approval. The company will look at between 100 and 1000 new proteins in the next year and will be happy to get a half-dozen products to market out of that group, said Busse.

Looking five or ten years ahead, Bayer hopes to be able to inject DNA directly in the liver of hemophiliacs to give them a base supply of clotting agent. “Gene therapy is a significant technological challenge. We believe that if we can do these projects, we can do anything,” said Busse.

CHIRON

Chiron Corporation of Emeryville, formed in the early ‘eighties and one of the pioneer biotech companies in the world, is a biotech icon. The company that started with one lab in an old Shell Oil building now has 7000 employees and $1.2 billion in sales.

The company began as solely a research organization and now is a fully-integrated bio-pharmaceutical organization. “We do vaccines, diagnostics and therapeutics, I think were one of the few if not the only that does research into that broad spectrum, said Jim Knighton, who has been with Chiron for four years.

“We were just a thousand when I joined, and managing that growth has been our biggest challenge,” he said. The company was formed in 1981 by professors out of Berkeley and UCSF. Chiron’s first product was a genetically engineered, or “recombinant,” Hepatitis B vaccine.

The company settled in Emeryville and found the town suited its needs. Chiron was able to expand facilities with a minimum of trouble and had access to the top-notch resources of the Bay Area.

“The whole biotech industry was born here,” said Knighton. Schools like Stanford University and the University of California in San Francisco and Berkeley built great labs, attracted great students “and it became a great incubator for the whole industry,” said Knighton.

Chiron took off with a blast, but suffered during the recession of the late eighties and early nineties. The company is bouncing back and mergers and acquisitions fueled growth, said Knighton. Forty-five percent of Chiron is owned by Novartis, a Swiss company and founders Drs. Bill Rudder and Ed Pinhoet are running the company.

“Our stock has kind of struggled the last couple of years. but this year we’re up twenty-five percent. We have a search out for a new CEO, but the founders have taken it this far, which is a very rare story,” said Knighton, vice president of investor relations.

Now, Chiron has a couple of new products emerging They recently got approval for product to treat metastatic melanoma, and a rabies vaccine. In partnership with Ortho-McNeil, Chiron is producing PDGF, or platelet derived growth factor, the first recombinant wound-healing agent for foot sores common to diabetics

There are four components to Chiron’s research, recombinant protein, gene therapy, combinatorial chemistry and genomics. They have research activity on, and drugs in development for, infectious diseases, cancer, and cardio vascular diseases, said Knighton.

“The history of Chiron is an interesting microcosm of what’s gone on in the business,” said Knighton, adding that the industry is still in its infancy.

“We’re seeing growing expertise in the running of these businesses. The industry has grown in its own management (and) in getting drugs out. Expertise has grown, not just in the research area, but now in the development and commercial area, that’s a big change,” Knighton said.

“The business element is coming into the industry. Science itself has advanced. We’re understanding more about biotech than we ever have. It’s been meteoric,” said Knighton.

MATRIX

Matrix Pharmaceutical, Inc. is using biotechnology from a different angle. Rather than develop new drugs from genetic research, Matrix has focused on delivering cancer drugs more effectively.

Matrix is both helping effective drugs become more effective and is breaking new ground in getting the drug into the tumor.” Local drug therapy for cancer is quite a novel idea. We’re working with drugs we know are effective against cancer, but only to a limited extent, and one of the limitations is the delivery,” Dworkin said.

We have patented drug-delivery systems that allow us to inject low doses of chemotherapy drugs directly into solid tumors and retain them there for a long period of time, said Peter Dworkin, company spokesperson.

The huge plus is the rest of the body isn’t poisoned by the chemotherapy drug as happens with traditional systemic chemotherapy. “You’re putting the drug where you want it and not where you don’t want it, with the benefit of far fewer side effects (like) nausea, vomiting and potentially much more serious things like neurological changes and suppression of the immune system,” said Dworkin.

“We think we have the opportunity to be more effective than chemotherapy. While the doses are low, the concentrations of the drug we are able to put in the tumor are quite high, like 100 times or more drug in the tumor than you can get with systemic chemotherapy, so its potentially more effective and less toxic than traditional chemotherapy.

The delivery system is a special biodegradable protein gel mixed with a common chemotherapy drug. The mixture is injected with a syringe.

“Between the advanced imaging equipment that exists now, CAT scans, ultrasound, etcetera, we can see almost any tumor in the body. Those tumors we can’t reach directly we can use an endoscope or another minimally invasive procedure to actually get the needle to the tumor,” said Dworkin.

A critical component of treatment is to interrupt the cancer cell division. The Matrix system allows the dose to stay in the tumor for eight hours or more. “So you expose the tumor cells to high concentration of drug and you expose them for a long time. That’s important because not all cells are actively dividing at any one time(and) traditional chemotherapy may not arrive at the right time to interrupt cell division,” said Dworkin.

In the real world we see our drugs being used in combination with current treatments of cancer, with surgery or systemic chemotherapy. The system is now in phase III clinical trials and the company hopes to file the new drug application next year.