BioLineRx has announced that it has received from the European Patent Office a notice of intention to grant a European patent claiming the salt of BL-1020, a first-in-class orally available treatment for schizophrenia.
In March 2012, the Company announced that a European patent was granted claiming BL-1020's composition and its use for the treatment of schizophrenia, which will be valid through September 2022.
The current patent, when granted, will be valid through June 2026, thereby effectively extending the patent protection term of the drug product in Europe by almost four years.
Member patents of this family are pending in the U.S., Japan, India, China, Korea, Mexico, Israel and Australia.
BL-1020's composition and its use for the treatment of schizophrenia are covered by issued patents or pending patent applications in the U.S., Europe, Japan, India, China, Korea, Mexico and Australia.
The issued patents and any patents to issue in the future based on pending patent applications in this family will expire, without taking into account any possible extension periods, in September 2022.
In addition, several other complementary patent applications are pending worldwide claiming the crystalline form of BL-1020 and the use of BL-1020 for improving cognitive function. These patents, if issued, would be valid through at least December 2030.
In June 2011, BioLineRx announced commencement of the Phase II/III CLARITY clinical trial of BL-1020. This 450-patient trial aims to determine the short-term (6 weeks) and the long-term (24 weeks) cognitive benefit and anti-psychotic efficacy, safety and tolerability of BL-1020 in schizophrenia patients, compared with Risperidone (one of the leading schizophrenia treatments). The CLARITY trial is proceeding at approximately 30 sites in Romania and India.
Dr. Kinneret Savitsky, CEO of BioLineRx, stated, "We are extremely pleased at receiving this notice of intention to grant an additional European Patent covering BL-1020, which joins the broad protection we have already received in other territories, securing a broad basis for our future commercial operations. We believe this represents significant further progress in the development and commercialization of BL-1020. Today, almost 1% of the world’s population suffers from schizophrenia, and in approximately 90% of the cases, it is accompanied by cognitive impairment that may severely affect daily functioning. Current therapies for schizophrenia do not address this need. BL-1020 has previously demonstrated improved cognitive function in schizophrenia patients, and we are currently conducting the CLARITY clinical trial, with validation of BL-1020’s cognition enhancement as its primary objective. We expect to obtain results in mid-2013.”