Biotech firms focus on developing drugs for cancer treatment

Five area biotechnology companies are doing their parts to give the world a fighting chance against cancer.

NaPro BioTherapeutics, Roche Colorado, OSI Pharmaceuticals, Array BioPharma and Amgen each focus on researching, developing or manufacturing pharmaceuticals that give cancer patients a needed edge.

With the American Cancer Society estimating that more than 1.33 million new cancer cases will be diagnosed in 2003, the biotech firms are racing against time.

Since 1991 NaPro has focused on the development, production and licensing of complex natural product pharmaceuticals as well as on genetic technologies. ?The only product we have and sell is Paclitaxel,? said Robert Cohen, vice president. ?And we’re planning to sell that business to redirect our focus into oncology and gene editing.?

NaPro’s Paclitaxel business generated $34.2 million in product sales and $10.2 million in gross profit in 2002. The company announced the imminent sale in April and expects to complete the transaction by the end of the fourth quarter.

Paclitaxel plays a vital role in the process of destroying proliferating tumor cells. Since 1991, NaPro has focused on the development and manufacturing of Paclitaxel after pioneering its extraction from the needles of yew trees.

Now the company is ready to hand the task over and refocus its efforts on new research and development. ?We’re working on two programs now — targeted oncology and gene editing,? Cohen said.

The two candidate drugs in NaPro’s targeted oncology research are directed toward head and neck cancers and small-cell lung and pancreatic cancers. ?When they enter the body, they won’t affect other cells so the side effects will be limited,? Cohen explained. ?Since they will go directly to the tumors, it may not be necessary to use as much.?

NaPro’s gene-editing research focuses on two areas. One aims to address and correct the underlying genetic basis of sickle cell disease. ?It can get into the mutation, affect it, make the mutation chance itself — and then it disappears,? Cohen said. ?We are showing that it can change hemoglobin from sick to normal.?

The focus of NaPro’s other gene therapy shows that it has the ability to break up plaque in the brain and is a potential therapy for Huntington’s disease — currently an untreatable malady.

?We hope to be in the clinical stage with one of the targeted oncology products by the first half of next year,? Cohen said.

On April 28, Roche Colorado announced that the positive results of Phase III studies of its drug Fuzeon have led the FDA to grant accelerated approval. The drug is targeted to reduce HIV levels when used in combination with other anti-HIV drugs.

?This is the most complex drug produced,? said John Tayer, Roche community relations manager. ?Typically, there are seven to 10 steps to making a drug, but this one calls for 106 process steps to make it.

?We actually had to design a new series of equipment to produce it.?

Fuzeon is targeted to patients who are showing resistance to all other AIDS drugs. Tayer refers to it as a last-hope drug and the first in a new class of drugs called fusion inhibitors

In mid-March, OSI Pharmaceuticals entered into an agreement with Serano S.A. to market and promote Novantrone, a chemotherapy drug used to treat multiple sclerosis, leukemia and prostate cancer. Total sales of the drug in 2002 were $80 million. OSI paid Serono initial fees that totaled $55 million.

?We expect it to pay for itself within five years and for us to be profitable in 18 to 20 months after Tarceva hits the market,? said Kathy Galante, OSI director of investor and public relations.

Tarceva, OSI’s advanced drug candidate, is in Phase III clinical trials for non-small cell lung cancer and pancreatic cancer. ?There are about 178,000 cases of non-small cell lung cancer in the U.S. alone,? Galante said.

Amgen holds its place in the cancer pharmaceuticals line as a bulk production facility operating in Longmont and Boulder. The plant produces three drug formulas — Aranesp, Epogen and Kineret.

Aranesp treats chemotherapy-induced anemia and anemia associated with renal failure. Epogen also works with renal-failure-related anemia. Kineret is used in the treatment of rheumatoid arthritis.

?Kineret is our newest drug — it just received FDA approval within this past year,? said Jessica Graziano, Amgen community relations specialist.

One of Array BioPharma’s research and development projects is around a drug program that can turn off targets in the body that affect progression of diseases. The program, referred to as a MEK program, focuses on creating an oral version of a drug that requires cancer patients to receive in hospitals as injections.

?Advantages are that an oral version will be easier to manufacture so development costs will be less complicated,? said Tricia Haugeto, Array communications manager. ?The main advantage is that it will be easier for patients to take.?

Array continues to work on developing two other drugs that will affect inflammation and cancer. ?By the end of the year we hope to identify a lead candidate for one of these two,? Haugeto said. ?Then we can submit an application to the FDA and ask to do clinical trials.?