Unigene JV launches calcitonin in China

A joint venture between US-based Unigene Laboratories and China's Shijiazhuang Pharmaceutical Group will begin selling injectable calcitonin in China for the treatment of osteoporosis as of 1 April.

Unigene said it would profit doubly from the venture: it will generate sales of bulk calcitonin selling to the venture, as well as taking 45 per cent of any profits achieved by the joint venture itself.

The company has launched its injectable calcitonin product in the European Union and is developing nasal and oral formulations of calcitonin, as well as oral formulations of other peptides including parathyroid hormone (PTH) for osteoporosis.

Unigene said that the approval of its injectable calcitonin in Switzerland would enable the joint venture to promote and market the product for the treatment of osteoporosis in China in advance of the Chinese New Drug Application and that it might also facilitate the NDA approval process.

"The recent admission of China to the World Trade Organisation and the government's current emphasis on expanding the introduction of Western medicines creates a unique opportunity, for which we are well positioned,"​ commented Dr Warren P. Levy, president of Unigene.

Osteoporosis is a debilitating bone-thinning disorder that is a natural consequence of ageing. The disease leads to bone fragility, an increased susceptibility to fractures and chronic bone pain. The disease is most prevalent in women due to hormonal changes that take place at or after menopause. By age 65, the average woman has lost 30 per cent of her bone mass. Caucasian and Asian women are most affected, although 20 per cent of sufferers are men. Osteoporosis can lead to hip fractures, for which the mortality rate approaches 20 per cent, Unigene said.

China is the single largest osteoporosis market with an estimated 90 million sufferers and more than 15 million fractures per year, the company claimed. According to the Shanghai Medical Journal​ and Chinese medical experts, 90 per cent of Chinese citizens over 60, and virtually all of those over 70, have the disease. The Chinese government has identified osteoporosis as one of the top three health priorities in China.