Staff Writer

Nobex Corp. entered an agreement valued at up to $283 million with GlaxoSmithKline plc to develop a modified oral insulin for controlling post-meal blood glucose levels.

"Right now we are on cloud nine," President and CEO Christopher Price told BioWorld Today. "This is clearly one of those value-changing events for a company."

Nobex, of Research Triangle Park, N.C., developed the oral insulin up to Phase I/II trials, with some of the studies conducted with healthy patients and some with diabetic patients. It has completed 10 Phase II studies in patients with Type I and Type II diabetes. From this point, GSK will take over the development funding.

GSK also will fund manufacturing and marketing. The London-based company, which also has facilities in Research Triangle Park, will make an undisclosed up-front payment to Nobex; milestone payments related to development progress, regulatory submissions and approvals; and the achievement of certain sales levels. Nobex also would receive royalties, if the product is approved.

Price would not disclose the development timeline for the drug, saying only that "a series of other studies" will be conducted.

"We are looking very much forward to working with GSK," Price said. "In my career, I have not seen a more collaborative culture."

Price also said it is a "stellar example" of how a small company and a large pharma can co-structure a deal. For its part, GlaxoSmithKline sees hope for diabetics in the compound.

"They have what appears to us to be a very promising compound - an oral insulin product that would be a real advance in the treatment of diabetes - and that's what has led us to this point," GSK director of communications Mary Anne Ryne told BioWorld Today.

Nobex's technology is designed to create new physical and chemical characteristics of drug molecules to allow for oral administration.

This is the biggest deal Nobex and its 55 employees have entered, Price said. Nobex was founded in 1993 and is a privately held company. The company's vice president of chemistry innovation, Nnochiri Ekwuribe, developed its technology platform. Originally named Protein Delivery Inc. until it changed its name in 2000 to reflect a broadened strategy, Nobex also has a joint venture with Elan Corp. plc, of Dublin, Ireland, and an agreement with Pharmacia Corp., of Peapack, N.J.

"It's the largest we've ever done both in terms of financial arrangements and the depth and extent of the collaboration," he said. "First and foremost, we wanted a top-10 global company; secondly, we wanted a company in diabetes; and third, we wanted a company that had the ability to rapidly launch and ramp up a product on a global basis. Because this is a global disease, we thought that was very important."

Nobex focuses its oral insulin program on Type II diabetic patients. One focus was related to first-phase insulin replacement by taking the product orally before a meal for control of post-meal blood glucose levels. It also has focused on a bedtime dose to address overnight and early morning fasting hyperglycemia, the company said.

"GSK will be funding a program to explore additional modified insulin compounds aimed at other aspects of the disease," Price said, explaining that the development program is confidential, but that the research will continue at Nobex, and Nobex will be very involved in the collaboration.

"We brought a lot to the table, and we didn't just want to throw it over the wall," Price said.

The deal with GSK "relieves the burden" on Nobex's expenditures, and will allow the company to redirect money to its preclinical program to both broaden and advance it, Price said.

Nobex has a program for Oratonin, or oral calcitonin, for osteoporosis, which is the subject of its joint venture with Elan. Oratonin is in Phase I trials.

A second existing collaboration is with Pharmacia. That program is focused on an "unnamed protein" that is being developed in oral form; it is now in preclinical studies.

Nobex's Apaza will "receive a great deal of attention" in the redirection of funding, Price said. It is in development for inflammatory bowel disease, and the company plans to enter the clinic by the fourth quarter, he said.

In addition, the company has other peptides being developed in the cardiovascular area, Price said. In this area, Nobex will be converting drugs - some marketed and some not - that are available only in injectable form and developing them into an oral form. It also has the product NET 001/002 in development for cancer.

"We also have some small-molecule drugs, and we will be able to focus a bit more attention on those," Price said.