Collaboration is easy on the eyes

Jerini Ophthalmic and PR Pharmaceuticals to develop sustained-release formulations for eye diseases

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BERLIN—German pharma Jerini AG announced last month that its wholly owned subsidiary, Jerini Ophthalmic Inc. (JOI), will work with Fort Collins, Colo.-based pharmaceutical company PR Pharmaceuticals (PRP) to develop sustained-release formulations (SRFs) for the treatment of eye diseases.

The collaboration agreement between JOI and PRP will focus on the development of SRFs for a range of ophthalmic indications, including age-related macular degeneration (AMD), the leading cause of blindness in people over the age of 55. The agreement leverages JOI's ophthalmic drug development expertise with PRP's proven drug delivery platform and formulation resources, enhancing JOI's ability to move several lead drug compounds from feasibility to commercial products, says JOI CEO Dr. Anthony P. Adamis.

"Developing new agents and treatment paradigms for AMD is essential, and our ophthalmic compounds offer novel therapeutic potential to address this debilitating disease," Adamis says.

The collaboration will permit JOI and PRP to develop an SRF for several of JOI's lead drug compounds, including JSM 6427, an integrin antagonist, and JPE 1375, an inhibitor of the complement cascade.

JSM-6427, a potent and specific small molecule, is designed to prevent the conversion of dry AMD to wet AMD by inhibiting three key processes in the development of wet AMD: ocular angiogenesis, inflammation and fibrosis. Phase I clinical trial results for JSM-6427 are due in the second half of 2008.

JPE-1375 is a small molecule peptidomimetic antagonist targeting the complement pathway, a highly validated target for dry AMD. It targets C5aR, the receptor for complement factor C5a, which is a key component involved in the activation of inflammatory cells. JPE-1375 has shown significant efficacy in multiple preclinical models.

One of PRP's core strengths is the development of bioactive compounds in its injectable sustained-release technologies. This made PRP an ideal match for JOI, even after conducting multiple proof-of-concept feasibility studies with other SRF platforms, Shina says.
"JOI is interested in developing SRFs that are compatible with multiple classes of drugs and ocular use. We are targeting four- to six-month dosing, reducing the patient treatment burden to two to four times annually. We found that PRP offered the most flexible and feasible technology to meet JOI's target SFR product profile," Adamis says.

PRP's ProPhase technology is specifically designed for controlled release of frequently injected and often unstable therapeutic proteins and peptides. ProPhase technology improves current therapies by reducing injection frequency and combines FDA-approved, biodegradable polymers to form controlled release microparticles with an FDA-approved protective shield for the protein (PEGylation). This results in a very low burst, smooth drug release and dramatically increased protein content in the final product, says PRP President Dr. Patrick Bols.

"These are elements that actually put us on the map in the ophthalmic field," Bols says. "The opportunity to work closely with Jerini Ophthalmic on developing a sustained-release formulation for each of its new drug candidates is very exciting for us and represents yet another endorsement of our unique technology platforms by an important pharmaceutical partner."

Under the terms of the agreement, JOI will pay an undisclosed upfront payment along with milestone payments for the achievement of preclinical and clinical goals and royalties on eventual product sales. In return, PRP agrees to cooperate exclusively with JOI on specified ophthalmic targets and to provide the company with all sustained-release formulations developed through the collaboration agreement.

The SRFs the team will develop will not only effectively manage retinal disease, but also reduce the treatment burden for patients—which sets this research effort apart from other sustained-release eye disease formulations currently in development, Adamis says.

"Having drugs that need to be dosed only twice yearly will greatly enhance their commercialization," he says. "The reduced treatment burden will permit us to pursue a prevention strategy for dry and wet AMD with JPE1375 and JSM6427, respectively. These are large, unmet medical needs."

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