West Coast Editor

Details of progress in Syntonix Pharmaceuticals Inc.'s first deal with Serono SA have not been made public, but signals suggest the multiple sclerosis alliance is going well - the overseas firm has signed another pact, this one worth up to $54 million plus eventual royalties for Syntonix if Serono exercises its option.

"We expect the [option] decision will be made by mid-2007," John Ripple, CEO of Syntonix, told BioWorld Today.

The latest agreement takes aim at an inhaled drug for infertility, an indication where Geneva-based Serono's footprint is strong. Serono markets injected Gonal-f (follitropin alfa), recombinant human follicle-stimulating hormone (FSH) to boost ovulation, in more than 90 countries including Europe and the U.S. Gonal-f, the most widely prescribed gonadotropin in the world, chalked up $547 million in sales last year.

Serono paid an undisclosed fee for an option to exclusive worldwide rights to Waltham, Mass.-based Syntonix's FSH:Fc SynFusion drugs, and will evaluate candidates before deciding whether to go further.

SynFusion links the Fc region of an antibody to a drug, resulting in a longer-acting protein or peptide that can be dosed less often. Syntonix's complementary technology, called Transceptor, provides a gain in bioavailability by using the FcRn transport pathway for pulmonary delivery of SynFusion drugs.

The earlier deal with Serono also involved a disease in which the pharma giant maintains a strong presence. Injected Rebif (interferon beta-1a) for MS sold about $1.3 billion last year, and the company hopes to come up with an inhaled version through the Syntonix arrangement. (See BioWorld Today, April 1, 2005.)

Others have similar hopes in other areas. Syntonix licensed overseas rights to FIX:Fc, its preclinical recombinant Factor IX product for hemophilia B, in January to Biovitrum AB, of Stockholm, Sweden. Ripple expects clinical work to start next year. (See BioWorld Today, Jan. 24, 2006.)

Last October, Ingelheim, Germany-based Boehringer Ingelheim GmbH entered a collaboration with Syntonix worth up to $63 million for inhaled peptides. (See BioWorld Today, Oct. 24, 2005.)

"That's a two-year research collaboration," Ripple said. "We've been progressing well, and both sides are excited about progress, but more research has to be done" before Boehringer decides whether to go forward with development of a drug.

Meanwhile, Syntonix keeps busy with internal programs focused on longer-acting intravenous drugs for hemophilia - a $5 billion market in which small trials can be done relatively quickly.

"We talked to thought leaders, and they all felt the first product we developed in this area should be a long-acting I.V.," Ripple said. A once-per-week dose would let hemophiliacs bleeding from trauma to get the drug quickly, while allowing users of the drug for prophylaxis to get it less often.

In hemophilia, Syntonix has the Biovitrum-partnered program, plus a longer-acting Factor VIII effort and a program known as Syntagonist. In the Biovitrum deal, Syntonix has kept North American rights, and will be "looking to do the same" with Factor VIII and Syntagonist, Ripple said.

The only recombinant Factor IX on the market for hemophilia is Madison, N.J.-based Wyeth's short-acting BeneFIX, injected several times per week. BeneFIX took less than two years from the start of trials to the new drug application filing. Syntonix expects to start pivotal trials with a hemophilia product in 2008, and market the compound with a North American sales force of about 25 people, Ripple said.

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