Lung Cancer Drug To Be Developed
CARLSBAD , A local biotechnology firm landed what one analyst described as a “landmark deal” in terms of financial commitment and drug development of “antisense” technology.
Pharmaceutical giant Eli Lilly & Co. said Aug. 22 it would invest more than $200 million in Carlsbad-based Isis Pharmaceuticals Inc. and co-develop a promising treatment for non-small cell lung cancer.
Under the agreement, Lilly, which is based in Indianapolis, will spend $75 million to buy a 9 percent stake in Isis for $18 a share.
Lilly will also pay a $25 million license fee for the rights of Isis’ lung cancer drug, Isis 3521, fund its development, and provide a loan of $100 million to be paid back in four years.
Lilly has also agreed to make additional payments of $200 million or more provided Isis meets certain milestones.
Sushant Kumar, an analyst for Mehta Partners in New York City, said the deal is exceptional in many ways: “Isis gets $100 million , which is a huge amount of cash to identify and develop new drugs in other disease areas.”
It also is confirmation that antisense is a viable concept and could lead to new drugs for multiple diseases, including cancer and diabetes, he added.
The idea behind antisense is to make a mirror image of the target gene sequence, which is delivered to the diseased cell to prevent it from producing proteins that are involved in disease.
Non-small cell lung cancer ranks among the deadliest types of cancers.
Patients receiving standard chemotherapy typically survive eight to nine months, he said.
The combination of chemotherapy and Isis’ drug, Isis 3521, has shown promise in extending lives.
In an ongoing study during which patients received a combination of two chemotherapy drugs and Isis 3521, patients’ lives were extended to 15.9 months, Isis reported.
Isis is conducting two studies to evaluate the safety of combining its lung cancer drug with two chemotherapies , one of which is Lilly’s own lung cancer therapy Gemzar.
Lilly said it plans to initiate its own large study to see if the combined treatment of Isis 3521 and Gemzar works better than Gemzar alone, Kumar said.
The market opportunity for non-small lung cancer drugs is substantial , between $300 million and $500 million, Kumar estimated.
He said given the relatively short life expectancy with current treatment, lung cancer patients are likely to put up with the inconvenience of long-term infusion to live longer.
Dr. Jon Holmlund, Isis’ executive director of drug development, describes how the drugs are administered.
Isis 3521 is infused continuously over a two-week period via a portable pump that is hooked up to the patient’s chest wall.
Patients wear the pump on their bodies while going about their daily activities.
Thus far, patients seemed to tolerate the drug well and had only minor side effects, including fatigue, he said.
After two weeks, patients take a seven-day break before going back on treatment.
During the third week, however, patients undergo chemotherapy in a hospital setting.
Kumar expects Lilly to begin its Phase III trial, the latest of three required studies by the Food and Drug Administration before a drug can be approved, in the first quarter of 2002.
He anticipates Isis will release data of an on-going 600-patient Phase III trial in the second half of 2002.
A company spokeswoman didn’t want to give a date since the study’s end-point is measured on patient’s life expectancy.
When asked if Lilly is searching for new opportunities now that its blockbuster anti-depressant Prozac has gone generic, Kumar downplayed the importance.
“Lilly is a very big concern,” he said. “Even though Prozac has gone generic, they still have a lot going on.”
He sees Isis’ deal as a good platform to boost Lilly’s cancer franchise.
Isis shares soared nearly 50 percent on Aug. 22, the day the collaboration was announced, closing at $14.89.
