Ludhiana-based King Multitech Global Pvt. Ltd., part of the King Group, has inked a joint venture agreement with Japan Bioproducts Ind. Co. Ltd., to market human placenta extract injection 'Laennec' approved for liver dysfunction. It is currently awaiting approval from the DCGI for marketing in India.
The approval for test licence is expected to come through in a fortnight, after which we will work towards getting an import license, Karan Goel, CEO, King Multi Tech Global Pvt. Ltd. told Pharmabiz.
Laennec is a human placenta extract injectible manufactured by the 70 year-old Japan Bioproducts (JBP) located at Tomigaya, Shibuyaku, Tokyo for the last three decades. It is a mixture of water soluble biological active materials derived from human placenta. The product consists of many biological active materials like cell growth factors, cytokines, active peptides, amino acids, nucleobases, carbohydrates, vitamins and minerals.
The drug is recommended for liver cirrhosis, hepatitis viral attack, fatty liver or Steatosis and liver cancer. The hepato-cellular growth factor (HGF) derived from a human placenta helps revive the liver cells.
The product holds a 'specialized biological designated drug' status. It holds a license for ethical promotion from the ministry of health & welfare, Japan in 1974. Clinical trials have shown improvement in liver function and its safety standards. The drug is manufactured under the supervision of Pharmaceutical Affairs Law of Japan according to GMP guidelines. It is also exported to Russia, Korea, among other markets.
The drug improves tissue respiration and activates cell function. It improves fatty degeneration of liver tissues. The injection also encourages stem cells to mature into cells with individual functions, helps to increase the number of liver cells and repairs liver tissue that becomes necrotic due to virus or alcohol.
JBP has its own Placenta Research Institute at Kurume, Fukuoka, Japan. The placenta, which protects and nurtures a baby in a mother's womb, should no longer be discarded going by the efficacy of a drug like Laennec, explained Goel.
The company has a designed a method of placenta collection and extraction adhering to stringent safety norms. Around 5,000 human placentas are sourced from a leading hospital in Japan from normal deliveries by women with consent. They are tested for infections like HIV, HBV, HCV. Further investigations are carried out for the raw material during the production process to ensure that it sans viral contamination.
As there is no treatment for liver cirrhosis in India, except liver transplant, the drug will benefit scores of patients. Although cost of the injection is not disclosed, Goel stated that liver transplant is costly and painful compared to Laennec which has proved effective.
The King Group is ISO 9001:2000 certified by TUV and is recognized Two Star Export House in India. The company has team of medical representatives who are already engaged in marketing herbal products and supplements. It also has the expertise to provide supply chain management for the cellular-based products. It is also on the look out for partners to bring in drugs or technology related products in regenerative medicine. Efforts are on to form a National Society with cellular-based institutions to offer advisory services to the nascent stem cell industry.