Uni-Bio Science Group's NDA for Osteoporosis Drug Uni-PTH Accepted for Review by CFDA

Apr 08, 2015 21:18 JST

Source: Uni-Bio Science Group Limited

HONG KONG, Apr 08, 2015 - (ACN Newswire) - Uni-Bio Science Group Limited ("Uni-Bio" or the "Group";HKEx code: 690) today announced that its New Drug Application ("NDA") for Uni-PTH, the Group's proprietary parathyroid hormone 1-34 analogue, has been accepted for review by the China Food and Drug Administration ("CFDA"). The application for Uni-PTH is currently under review for the treatment of post-menopausal women with osteoporosis, a disease affecting an estimated of 70-100 million patients in China according to industry reports. China's osteoporosis market is expected to reach RMB 15.5 billion in 2015, accounting for approximately one-fifth of the global market.

The filing follows the announcement of Uni-PTH's successful Phase III clinical trial results in June 2014 in which Uni-PTH was shown to be an effective anabolic (bone growing) agent for the treatment of osteoporosis. Uni-PTH showed a significant difference versus positive control at increasing lumbar spine bone mass density after 12 months of treatment. Based on other biologic drug applications, the CFDA normally takes 24 months to deliver the outcome of its review. Once approved, Uni-Bio will be permitted to market Uni-PTH in China.

In China, currently available treatments used for osteoporosis patients are anti-resorptives - they restore bone density by decreasing bone remodeling. Uni-PTH is part of the only class of drugs which have the ability to stimulate new bone formation, thereby improving bone quality in addition to restoring bone density and bone strength. Physicians believe that Uni-PTH is also more effective in managing ostealgia (bone pain) when compared to current treatments; in clinical studies patients reported that they felt better after treatment with Uni-PTH.

Mr. Kingsley Leung, Executive Director of Uni-Bio Science Group, said: "The filing of the NDA marks a significant achievement for the Group and reflects continued progress in our ambition to deliver novel treatments to patients in China. We look forward to working with the CFDA during the review process."

"Uni-PTH has the potential to be the first approved product in China to provide access to patients to a novel and cost effective alternative in improving the quality of their bones, especially benefiting those who have a high risk of bone fracture, significantly improving their quality-of-life. We hope to deliver the same results for the other innovative programmes in our proprietary development pipeline and partnered programmes", he concluded.

The Group is also in the process of developing innovative formulations and drug delivery devices for Uni-PTH. Such modifications should further expand the value of the product offering by increasing the compliance and convenience to users.

About Osteoporosis
Osteoporosis is a silent bone disease characterized by reduced bone mass and disruption of bone architecture, leading to high risk of fragility fractures. Clinical manifestations include severe pain, spinal deformation and fragility fracture. More than 200 million females are affected by osteoporosis globally. World treatment market rose from US$7.3B to US$11.4B from 2010-2015; an estimated annual CAGR of 9.2%. The Chinese market increased by an annual average of 13.5% in the same period, reaching a value of US$2.5B and representing approximately one fifth of the global market. The fast growth in China is expected to continue due to increasing prevalence of osteoporosis among the female population, as well as growing elderly population, rising standards of living and increase awareness of bone health. According to a recent research, osteoporosis-related fractures will double in China by 2035, leading to a significant future economic burden.

About Uni-PTH
Uni-PTH is a 34 amino acid analogue of parathyroid hormone (PTH), a protein hormone released by the parathyroid gland to control the level of calcium and phosphorus in blood and vitamin D in kidney. Intermittent exposure to PTH will activate osteoblasts more than osteoclast; osteoblast are cells used to build bone in bone remodeling. Therefore, by mimicking the effects of PTH, a once-daily injection of Uni-PTH increases bone density and bone strength by stimulating new bone formation.

Contact:

Strategic Financial Relations Limited
Veron Ng     Phone: +852 2864 4831   Email: veron.ng@sprg.com.hk
Angelus Lau  Phone: +852 2864 4805   Email: angelus.lau@sprg.com.hk
Winkie Wong  Phone: +852 2114 4319   Email: winkie.wong@sprg.com.hk
Fax:   +852 2527 1196

Source: Uni-Bio Science Group Limited
Sectors: Daily Finance, BioTech