By Karen Pihl-Carey
In another deal to use its drug delivery technology to develop the oral version of a drug, Emisphere Technologies Inc. will work with Regeneron Pharmaceuticals Inc. on Axokine, a potential treatment for obesity and its complications.
The collaboration could mean up to $31 million for Emisphere in fees, research funding and milestone payments if the oral version of the drug is successfully commercialized. Emisphere also will receive a royalty on sales of any oral products resulting from the collaboration, and Regeneron will receive exclusive worldwide marketing rights to the oral products. No further terms of the deal were disclosed.
¿What¿s interesting about this collaboration is this is a company with a very exciting product,¿ said Lewis Bender, Emisphere¿s senior vice president of business development. ¿It¿s a biotech product. So what we¿re able to do is establish a way to share risks with the biotech companies. We now have a template for being able to work with them to use our technology to develop oral formulations.¿
Axokine, a second-generation ciliary neurotrophic factor (CNTF), is just moving into a Phase II study this month in 175 obese patients. That study will use the injectable form. Emisphere¿s oral delivery technology achieved significant blood levels of Axokine in Regeneron¿s preclinical models, the companies said.
CNTF was originally evaluated as a potential treatment for patients with amyotrophic lateral sclerosis (ALS). In the clinical program, researchers discovered that reduced appetite and weight loss were among adverse events in the patients tested. Axokine tested in animal models of obesity confirmed the drug¿s ability to induce weight loss of fat.
Now, Regeneron is developing the product for the treatment of obesity and its complications, such as non-insulin dependent diabetes mellitus. The company entered into a 10-year collaboration with Procter & Gamble Co., of Cincinnati, in May 1997 for the discovery, development and commercialization of products that later included Axokine. P&G gave up the rights to Axokine in September after examining interim data from a Phase I study, but is continuing with the collaboration. (See BioWorld Today, Sept. 3, 1999, p. 1.)
While the Phase I interim data included the possibility that the market for Axokine might be limited to HSV-negative patients, the final data demonstrated that doses of up to 2 mcg/kg/day in both HSV-positive and HSV-negative patients resulted in no reports of herpes cold sore outbreaks.
Bender said the collaboration with Regeneron is similar to one Emisphere started in December 1997 with Novartis Pharma AG, of Basel, Switzerland. That deal related to development of an oral formulation of two compounds.
¿This is now at the stage that we were at with Novartis a few years ago,¿ he told BioWorld Today.
Last month, Novartis acquired an exclusive license to develop and commercialize an oral formulation of the osteoporosis drug calcitonin, which is currently marketed in the nasal and injectable form. The oral form was developed using Emisphere technologies. (See BioWorld Today, Feb. 18, 2000, p. 4.)
Bender said an oral form of Axokine will have a greater market potential than the injectable form.
¿The standard advantage is nobody likes to inject,¿ he said. ¿They prefer to take an oral product. And people who are obese have a much more difficult time injecting because the drug goes into the fat.¿
In February, Emisphere filed for a public offering of 2.5 million shares, hoping to fund the Phase III program for liquid oral heparin. The company is seeking a marketing partner for the product, Bender said.
Earlier this week, Regeneron filed to sell 4 million shares in a public offering to fund development of its pipeline, which includes products for cancer indications, ALS and constipation disorders. The company also is studying angiopoietins for promoting and blocking blood vessel growth, fixing leaky blood vessels and promoting the growth and mobilization of certain cells.
Regeneron was in an SEC-imposed quiet period and could not comment Thursday.
Regeneron¿s stock (NASDAQ:REGN) closed Thursday at $41.06, down 68.75 cents. Emisphere¿s stock (NASDAQ:EMIS) closed at $78.50, up $1.50.