Hustling on half-lives

OKLAHOMA CITY—Caisson Biotech LLC, a biopharmaceuticalcompany with a patented heparosan-based drug delivery technology, announced inearly May that it had entered into a development and license agreement withDanish company Novo Nordisk A/S. The agreement, which is the first licensetransaction between the two companies, gives Novo Nordisk the exclusive rightsto use Caisson's proprietary heparosan-based drug delivery technology toengineer and develop compounds within undisclosed therapeutic areas.

Under the terms of the agreement, Caisson will receive anundisclosed upfront payment in addition to contract research and manufacturingpayments. In addition, Caisson will be eligible to receive milestone paymentsupon achievement of certain predefined clinical, regulatory and commercialtargets plus royalties on the global sales of the therapeutic productsdeveloped under the agreement, representing a total deal value potentially inexcess of $100 million.

As noted by Dr. Paul DeAngelis, chief scientist at Caisson,his company recently completed feasibility studies with Novo Nordisk that seemto validate Caisson's heparosan-based drug delivery technology for productpharmacokinetics and enhanced half-life in relation to at least one undisclosedtherapy area, and Per Falk, senior vice president of Novo Nordisk'sBiopharmaceutical Research Unit, calls the heparosan technology "an interestingapproach for generating novel therapeutics with prolonged half-lives."

"Our technology utilizes a naturally occurring sugar polymerthat is stable and inert in the bloodstream, but is biodegradable inside cellsfor the purpose of cloaking, enlarging and/or protecting drug cargo," DeAngelissaid in the news release about the license deal. "We can customize heparosanwith respect to polymer size and conjugation chemistry, thus providingflexibility to enhance a variety of therapeutic proteins, peptides, deliveryplatforms (e.g., liposomes, viruses ornanoparticles) and small molecules."

"Novo Nordisk is continuously looking for externalinnovation which is complementary to our own technical capabilities and whichwill support our vision to develop superior protein and peptide therapies inthe area of diabetes, hemophilia, growth disorders and autoimmune/inflammatorydiseases," Jens Aakerso, licensing director for Novo Nordisk, tells ddn. "As part of our innovation sourcing initiatives, wecame across Dr. DeAngelis' highly interesting work on heparosan, and we areconvinced that this technology holds promise for fine-tuning the half-life andpharmacological properties of our compounds to even better match patients'needs for less frequent administration."

As for what the deal means strategically for Caisson, CEOThomas Harlan tells ddn, "The extensivediligence process undertaken by Novo Nordisk, a global healthcare company andleader in diabetes care, will provide important independent third partyvalidation and credibility to companies interested in evaluating Caisson'stechnology, thus setting the stage for future drug delivery partnerships.Revenue from these partnerships will provide sustainable internal capital tolaunch the development of Caisson's internal clinical pipeline, leveraging thelong-term value of its drug delivery technology."

The genesis of the deal goes back to May 2009, whenDeAngelis recalls that he met a Novo Nordisk scientist, Dr. Carsten Behrens, atthe Carbohydrate Bioengineering Meeting in Italy, where he was giving a talk onthe heparosan modification system.

"Carsten asked several questions at that time, and westarted a dialogue. Within about six months, we began collaborating onfeasibility projects. Over the next year, we obtained and delivered positivedata to Novo Nordisk," he recalls. "In 2011, Caisson CEO Thomas Harlan andManaging Director Dr. Breca Tracy and I met a team from Novo Nordisk at BIO inWashington, D.C., and began term sheet negotiations. Due diligence began inearly 2012, and negotiations continued until May, at which time the deal wasfinalized and signed."

Caisson Biotech is a wholly owned subsidiary of HeparinexLLC, also located in Oklahoma City, but is funded and managed by EmergentTechnologies Inc. a life-sciences technology investment and management firmheadquartered in Austin, Texas.

Novo Nordisk, of course, is known as an industry leader indiabetes care, with 89 years in that area, but also boasts prominent marketstatus in areas like hemophilia care, growth hormone therapy and hormonereplacement therapy. The global healthcare company employs approximately 32,700employees in 75 countries, and it markets products in more than 190 countries.