Since its founding in 1997, German company Noxxon Pharma AG has flown low, working to develop products based on its Spiegelmer technology.
But a three-part deal with New York-based Pfizer Inc. has Noxxon on the radar. Not only has Pfizer agreed to make an equity investment in the company, but it is licensing on an exclusive worldwide basis a preclinical, lead Spiegelmer compound for obesity. It also has entered a multiyear global collaboration with Noxxon to discover and develop other Spiegelmer products.
"We had previous agreements with some German pharmaceutical companies," said Steffen Helmling, Noxxon’s vice president of business development, "but we didn’t have any agreement like this with a pharmaceutical giant like Pfizer."
Berlin-based Noxxon expects to receive up-front cash payments, as well as research and development milestone payments, and royalties. None of those figures, or the amount of the equity investment, was disclosed.
"We’re very pleased with the deal terms, and it’s definitely going to move Noxxon a big step forward," Helmling told BioWorld Today.
In the discovery part of the agreement, Noxxon plans to use its Spiegelmer technology to create product candidates to disease-associated targets identified by Pfizer, which will have the option to select up to three targets per year to focus on in collaboration with Noxxon. The targets can be "in all possible therapeutic areas," Helmling said, adding that Pfizer is particularly interested in one undisclosed area for now, but he expects "others to come, as well."
The Spiegelmer technology was an outgrowth of work done at the Free University in Berlin. Spiegelmers are next-generation aptamers, mirror-image RNA molecules not found in nature that exhibit high specificity and affinity and are not broken down by nucleases. The name of the technology comes from the German word "spiegel," which means "mirror" in English.
Noxxon identifies Spiegelmers that bind to a target molecule in a manner similar to antibodies. The first approved aptamer is the ophthalmic drug Macugen, developed by Eyetech Pharmaceuticals Inc. (now part of New York-based OSI Pharmaceuticals Inc.) and Pfizer.
The difficulty with RNA technologies, Helmling said, is that they are degraded very quickly. Spiegelmers, on the other hand, are free from that setback because the human body does not recognize them.
"It doesn’t have the enzymatic makeup to degrade this type of molecule," Helmling said.
The Spiegelmer candidate being licensed by Pfizer is NOX-B11, a ghrelin-binding agent shown to curb ghrelin-mediated appetite and to cause weight loss in preclinical animal studies. Ghrelin is a "hunger hormone" that causes humans to overeat, Helmling said.
Noxxon is not the only company working with ghrelin as a target. Other companies, such as Research Triangle Park, N.C.-based Tranzyme Pharma; Rejuvenon Corp, of The Woodlands, Texas; and Cambridge, Mass.-based Elixir Pharmaceuticals Inc., have ghrelin drugs in early development for postoperative ileus and cancer cachexia. Dor BioPharma Inc., of Miami, is acquiring a product based on ghrelin, GTP 200, through its buyout of Danish firm Gastrotech Pharma A/S, of Copenhagen. The product has completed a Phase I/II trial in cancer cachexia. (See BioWorld Today, Nov. 3, 2005.)
Pfizer now will be responsible for worldwide development and commercialization of the Noxxon’s drug candidate, as well as any other future products developed under the collaboration.
Noxxon has two other preclinical-stage Spiegelmer products that might beat NOX-B11 to the clinic. All three are expected to start human trials in 2007, but the company is advancing on its own NOX-E36 and NOX-A12, for inflammation and pathological angiogenesis, respectively. Its strategy is to take certain products forward internally through Phase II trials before partnering.
Since inception, Noxxon has raised €$40 million (US$47.9 million), but expects to return to investors to help advance NOX-E36 and NOX-A12.
"We’ll be looking for a Series C round financing in the fall," Helmling said, "to fund our clinical projects next year."
In addition to its Berlin headquarters, Noxxon has an office in Cambridge, Mass., established last September.