The deal, worth up to $63 million(€52.7 million), highlights the progress inhaled therapeutics has made and represents a viable alternative to injectable forms of the drug. The recent FDA approval of the inhaled insulin product Exubera now paves the way for similar products to be developed.
Under the terms of the agreement, Syntonix will receive an upfront fee and research support. Boehringer Ingelheim has the option to develop and commercialise the peptide candidates.
Additonal terms will see Syntonix receive milestone and royalty payments on any products developed and commercialised under the agreement.
"We are pleased with this collaboration because it is our first in the area of therapeutic peptides," said Alan Bitonti, vice president, Research and Development of Syntonix.
March 2005 saw the first collaboration involving this technology. Geneva-based company, Serono entered into a licensed worldwide exclusive rights agreement to use the Transceptor and SynFusion technologies for the development and commercialisation of interferon-beta:Fc products.
Interferon-beta therapy, inhaled by inhalation, may be possible to treat multiple sclerosis (MS). It has been demonstrated that certain Fc constructs can facilitate transport of therapeutic proteins across the lung epithelium through neonatal Fc receptor-mediated uptake.
The agreement focused on the development of a next-generation inhaled version of Rebif, a frequent dose drug that relies on subcutaneous injection of interferon beta-1a therapy for certain forms of MS.
Rebif was approved in Europe in 1998 and in the US in 2002. It had sales of $1.1 billion in 2004. Terms of that deal were not disclosed.
The Synfusion technology has been proven to reduce the frequency of injections normally required for such therapies. Novel drug delivery approaches of this sort represent significant advantages in terms of patient compliance, absorption and effectiveness, and ease of administration.
"Our technologies, Transceptor and SynFusion, also enable both efficient transport through the lung epithelium and an increase in the circulating half- life of protein and peptide drugs," added Bitonti.
Drugs produced using the SynFusion technology link the Fc region of an antibody to a drug in a novel manner, providing longer-acting therapeutic proteins or peptides.
Furthermore, the Transceptor technology uses the FcRn transport pathway to enable the pulmonary delivery of SynFusion drugs with high systemic bioavailability.
Transceptor allows patients to breathe normally using existing marketed inhaler devices.
Syntonix is currently working on using its Synfusion technology to develop longer-acting clotting factors to treat haemophilia, and to develop an inhaled version of EPO (erythropoietin) for anaemia.
The company is in discussions to partner the haemophilia program, and the anaemia program recently completed a proof-of-principle study in humans.