Unigene and Shijiazhuang Pharmaceutical Group to Expand Chinese Joint Venture
23 April 2008 15:40
Unigene Laboratories announced plans to broaden the activities of its joint venture with the Shijiazhuang Pharmaceutical Group ("SPG") and to expand the potential product line to be developed and marketed by the joint venture.
Unigene and SPG plan to establish the SPG-Unigene Biotechnology Research Institute in China. The Institute will continue ongoing registration activities for Unigene's calcitonin products, develop biopharmaceutical manufacturing facilities compliant with US current Good Manufacturing Practice guidelines, and establish and supervise the creation of a new pharmaceutical distribution network for joint venture products in China, all to take advantage of the world's largest osteoporosis market.
Unigene Laboratories reports that a comparative analysis of various osteoporosis therapies has been published, concluding that there is insufficient evidence to support claims of superior effectiveness among the drugs reviewed.
The study, commissioned by the Agency for Healthcare Research and Quality, Department of Health and Human Services, is entitled The Comparative Effectiveness of Treatments to Prevent Fractures in Men and Women with Low Bone Density or Osteoporosis. The study was performed by the Southern California/RAND Evidence-based Practice Center to assist physicians, patients, private- and public-sector organizations in making informed decisions about pharmaceutical alternatives for osteoporosis and reviewed data for bisphosphonates, calcitonin, parathyroid hormone, estrogen, selective estrogen receptor modulators and testosterone.
The leading category of osteoporosis drugs is the bisphosphonates, with established efficacy in reducing fractures in osteoporosis patients. However, according to the report, not enough scientific evidence exists to establish whether bisphosphonates are better at preventing fractures than calcitonin, estrogen or raloxifene. Additionally, certain bisphosphonates have been associated with osteonecrosis. Separately, the FDA is currently conducting a safety review of all bisphosphonate products and their possible link to atrial fibrillation, an established risk factor for stroke.
Findings in the report cite evidence that calcitonin has also demonstrated a reduction in fracture risk among post-menopausal women as well as men. The global history of calcitonin products demonstrates an impressive safety profile, with products being administered to patients for more than 35 years with virtually no significant side effects.
Calcitonin is the active ingredient in Fortical®, a nasal calcitonin product developed by Unigene and marketed by Upsher-Smith laboratories.
"The study suggests that many of the available products are effective in treating osteoporosis sufferers, yet there is little evidence to support differentiation of the products based on effectiveness," commented Dr. Warren Levy, President and CEO of Unigene. "The study also indicates that adherence to the therapy is an important factor in patient outcome. We hope that this study will encourage physicians and patients to recognize that, if there are acceptable alternatives for patients with osteoporosis or low bone density, and long-term therapy is desirable, then the side effect/safety profile of each drug should be considered carefully before treatment decisions are made."
Unigene will maintain its 45% ownership position in the joint venture. The combined capital investment commitment for the joint venture will remain at $15 million. Unigene's initial cash contribution to the joint venture will remain at US$900,000, which will be paid by Unigene upon the satisfaction of certain conditions, while the majority, or possibly all, of its remaining contribution will be in the form of technology.
"The creation of the Institute should allow for the addition of potential new revenue-generating products and programs to our joint venture distinct from calcitonin, thereby expanding our commercial opportunities in China," commented Dr Warren Levy, President and CEO of Unigene.
"The formation of the Institute will allow us to take advantage of the rapidly growing market potential for biotechnology products in China, to apply for government funds to support joint venture programs and to more fully utilize the additional resources available as a result of the acquisition of SPG by a private equity fund led by Legend Holdings and Goldman Sachs, which occurred in August of 2007."
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