PharmAsia News: Benda Anticipates 2008 Approval In India For Gene Therapy Product

SHANGHAI - China-Based Benda Pharmaceuticals anticipates 2008 approval from India’s Central Drugs Control Organization for its gene therapy product Gendicine for treatment of head and neck cancer. The company filed its application for the recombinant human Ad-p53 injection in November.

"For Benda, Gendicine getting approved by the Indian government will be an important step towards the international market," Xia Qian, an analyst from Beijing-based Orient Health Ecommerce Ltd., told PharmAsia News.

"We are confident that Gendicine will be approved and be available for sale in India in 2008," said Yiqing Wan, chairman and CEO of Benda. “The anticipated success in India would not only substantially add to Benda's top line and bottom line growth, but it could also pave the way for Gendicine's entry into other important foreign markets.”

“Obviously, each new market entrance requires adherence to that country's regulatory requirements and approval process, but prior countries' endorsements can have a positive impact during the application process,” added Wan.

Approved in China in 2003 to treat squamous cell cancers of the head and neck, Gendicine is the world’s first commercially licensed gene therapy product, according to Benda. Originator and Benda subsidiary SiBiono was granted the new drug license from China’s State Food and Drug Administration (SFDA), and received a Certificate of GMP for Pharmaceutical Products for Gendicine’s production facilities in April 2004, which allowed SiBiono to launch Gendicine worldwide.

Gendicine is a recombinant human adenovirus vector/gene p53 injection, which has been used to treat solid tumors alone or in combination with radiotherapy, chemotherapy or other therapies. It is mainly composed of human normal p53 tumor suppressor gene and modified adenovirus serotype 5. The former is the key structure that exerts the treatment function on the tumor, and the latter acts as a vector delivering the therapeutic p53 gene into target cells.

Chinese Trials Showed Three-Fold Therapeutic Effect

In Chinese clinical trials conducted in 2001 to 2003, which supported the Gendicine application, 64 percent of 135 patients with head and neck tumors had tumors eliminated after one month of Gendicine treatment, marking a 340 percent increase in efficacy compared to traditional treatments, the company said.

Of 107 patients with late-stage head and neck squamous cell tumors who underwent eight weeks of a joint treatment of radiotherapy and weekly gene therapy injections in 2001 to 2003, 68 experienced complete remission, while the remaining 39 experienced partial remission.

Gendicine is administered via direct intratumor injection, intravenous infusion, arterial infusion and intrathoracic or intraperitoneal infusion. Self-limited fever was the most common adverse event observed in clinical trials.

Indian Partner To Bear Cost, Get Factory Price, Indian Rights

Sibiono entered into a joint venture with an Indian pharmaceutical firm to launch Gendicine in the Indian market in May 2007. SiBiono declined to name the Indian partner.

According to the agreement, the Indian firm would complete clinical trials in India and file for approval from the Indian Central Drugs Control Organization. Under the deal, the Indian partner would bear associated costs and in return would get Gendicine at the factory price, with rights to sell it in the Indian market.

The market price of Gendicine is approximately $237 per vial and the typical treatment process requires 16 to 24 vials per patient.

The Indian domestic oncology drug market exceeded $204 million in 2006 and is expected to grow at 22 percent annually over the next 10 years, according to IRIS News Digest. There are 700,000 new cancer cases each year in India, according to the ICRA report on Indian Healthcare and TIFAC.

– Dai Jialing (pharmasia@elsevier.com)