By Matthew Willett
EpiGenesis Pharmaceuticals Inc. might tell you its asthma pipeline is as good at opening revenue channels as it is at opening bronchial passages.
Asian development and license rights for the company's flagship candidate, EPI-2010 - currently in Phase I testing in the U.S. and the UK - could bring in "just north of" $100 million for EpiGenesis through its deal with Taisho Pharmaceuticals Co. Ltd., of Tokyo.
Concurrent to the announcement of the Taisho agreement was the disclosure of a $15 million milestone payment from Chiesi Farmaceutici S.p.A., a payment associated with the European nonexclusive licensing deal EpiGenesis struck with Chiesi last year.
And the breath of fresh funding isn't fully drawn yet for EpiGenesis, since the Taisho deal calls for co-ownership of North American marketing, distribution and commercialization rights, allowing the pair to shop for a partner in North America.
EpiGenesis, of Cranbury, N.J., uses epigenomics, the study of abnormally expressed genes, in its efforts at discovery and commercialization of respiratory disease therapeutics. Its platforms include small-molecule competencies as well as work with respirable antisense oligonucleotides (RASON), a novel class of drugs company officials say take advantage of underutilized aspects of antisense technology.
EPI-2010, a RASON candidate, targets the adenosine A1 receptor, and is designed to prevent production of the asthma-associated mediator. EpiGenesis President James Mannion told BioWorld Today the compound is "doing very well" in terms of safety, according to internal interim data analysis from the Phase I trial currently under way.
"EPI 2010 is our flagship product targeted at asthma, and it has several key characteristics," Mannion said. "It's preventative, designed to prevent symptoms, and based on animal and laboratory studies it should have a long action, and be administrable once a week. It's a novel approach, and we believe this is a breakthrough compound, an entirely new class of compounds for the field. We think it offers a lot of potential for the asthma population, a population that's currently characterized as having an increase in incidence."
The deal with Taisho for access to EPI-2010 and EpiGenesis' respiratory discovery and development platform includes an equity stake in EpiGenesis for Taisho, research reimbursement for EpiGenesis, milestone considerations and support for EpiGenesis' target validation and screening efforts. Specific financial details were not disclosed.
"The forward-looking part of the deal is primarily focused on Taisho support for our target validation and library screening activities for drug discovery, and that's really an investment by Taisho in our drug discovery platform," Mannion said. "They have an opportunity to evaluate some future therapeutics as they emerge from that platform over the next few years."
The RASON library now at Taisho's fingertips is based on technology Mannion said is underutilized today.
"The RASON class leverages the concept of delivery of antisense therapeutics directly to the lung, which is the site of action and where the therapeutic is needed," he said. "A lot of the potential of antisense therapeutics as a class has been inhibited because of the poor ability to deliver it to the site where it's needed. Other types of delivery, oral delivery or by injection, we think, do not take advantage of some of the properties of the antisense class."
Antisense therapeutics for asthma stand a chance of entering what Mannion said is estimated to be, within several years, a $20 billion market. The RASONs might also be useful in other indications, he added.
"The market for asthma compounds is about $10 billion right now, and we'd anticipate seeing that double over the next seven our eight years. The market seems to be growing at a rate of 10 percent, so by 2007 or 2008 you might see the market right around $20 billion," Mannion said. "We also believe that the approach we're using has direct applicability to other large markets in the respiratory area, including chronic obstructive pulmonary disease and allergic rhinitis, and those three disease areas, our focus area, together make up 85 [percent] to 90 percent of the current respiratory market."
He said EpiGenesis hopes to seek regulatory approval for EPI-2010 in about 2005. Other products in the pipeline continue to progress toward clinical development, he said.
EPI-12323, an inhalable small-molecule compound targeted against asthma, is undergoing preclinical study, and Mannion said the company hopes it could replace the inhaled steroids that currently dominate the asthma market. It's slated to enter the clinic later this year.
Privately held EpiGenesis also is developing a pharmacogenomics-based test for asthma, Rainbow-ABC, which the company said might also predict a therapeutic response to EPI-2010 and EPI-12323.