Access & Lotus move to protect oral delivery tech IP

Access Pharmaceuticals and Lotus Pharmaceuticals have both moved to protect their oral delivery technologies with patents.

Firstly, En Ze Jia Shi Pharmaceuticals, a wholly owned subsidiary of Lotus, has been issued a patent by the Intellectual Property Office of the People's Republic of China for controlled-release oral gliclazide. Composition and preparation methods are covered by the patent through to 2030.

Zhongyi Liu, CEO of Lotus, said: “The drug release rate of conventional oral gliclazide is uncontrolled, which can lead to unpleasant side effects due to quick drug release. Our controlled-release formulation has the potential to provide a more stable and sustained drug delivery.”

Using the controlled release formulation results in fewer side effects, greater efficacy and an improved safety profile, said Liu. Furthermore, Liu said dosing frequency can be reduced, making the treatment more convenient for diabetics requiring long-term daily medication.

Lotus expects to begin clinical trials of its gliclazide formulation in 2010, following receipt of the Chinese State Food and Drug Administration, with a view to gaining regulatory approval in 2014.

Access oral drug delivery technology

Access has submitted additional patent applications covering its Cobalamin-mediated oral drug delivery technology formulations of a number of injectable drugs, including Avastin (bevacizumab) and Herceptin (trastuzumab).

Filing the patents is intended to strengthen intellectual property (IP) protection of the technology as Access advances its collaboration and partnering strategy. Furthermore, Access has rebranded its Cobalamin-mediated oral drug delivery technology as CobOral delivery technology.

"As we continue exploiting our CobOral and CobaCyte technology platforms to yield valuable oral formulations of top-selling injectables, we believe filing these additional patents is critical in maintaining our strong IP position”, said Jeffrey Davis, president and CEO of Access.