SK Chem Strikes Korea Sanofi Vaccine Deal
This article was originally published in PharmAsia News
Executive Summary
In an ongoing effort to boost its vaccine portfolio, SK Chemicals has reached a strategic alliance with Sanofi Pasteur, the vaccine division of Sanofi, to begin marketing in South Korea Sanofi's Menactra, a meningococcal conjugate vaccine, and a live-attenuated Japanese encephalitis vaccine.
By Jung-Won Shin
SEOUL - Under the contract, Sanofi Pasteur will provide the two vaccines to SK Chemicals Co. Ltd., while the South Korean firm will focus on marketing and sales activities in the adult sector.
Menactra, a quadrivalent meningococcal (A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine, received approval from the U.S. Food and Drug Administration as the first of its kind back in 2005, and over 70 million injections in 53 countries have been administered since. Clinical tests in the U.S. have shown immunogenicity of 98% in the four serogroups. [See Deal]
Sanofi Pasteur received approval from South Korea's Ministry of Food and Drug Safety (MFDS) for the domestic marketing of Menactra on November 21 last year. Currently, Novartis AG’s Menveo, which received approval from MFDS in 2012, is the only meningococcal conjugate vaccine sold in the country. Both Menveo and Menactra are not currently reimbursed by South Korea’s national health insurance scheme.
Meningococcal meningitis is an inflammation of the protective membrane around the brain caused by viruses, bacteria or fungi, and early symptoms are similar to those of common colds such as fever and headache. Severe cases may lead to death, hearing loss, amputation, brain damage, or paralysis in 24 hours, which necessitates preventive immunization.
According to the European Federation of Pharmaceutical Industries and Associations, at least 500,000 cases of meningococcal meningitis are estimated to occur world-wide every year and 50,000 of them are fatal.
Sanofi’s live-attenuated Japanese encephalitis vaccine (JEV) is still awaiting approval in South Korea. It was developed as a cell culture (Vero-cell) derived vaccine as recommended by the World Health Organization, reducing the risk of contamination and increasing safety.
The vaccine has shown 100% seroprotection 28 days after a single dose in clinical trial in South Korea.
SK Vaccine Interests
SK and Sanofi have already been collaborating in various areas including R&D and marketing. In March last year, the French firm inked a long-term strategic alliance with SK to jointly develop pneumococcal conjugate vaccines, and the latest tie-up further beefs up SK’s vaccine portfolio. [See Deal]
In various other partnerships with multinational pharmaceutical giants, SK has developed and launched 11 basic vaccines, including mandatory vaccines for hepatitis B, chickenpox, diphtheria, tetanus, and pertussis (DTP), polio, measles, mumps, and rubella (MMR), tetanus and diphtheria (Td), as well as the basic vaccines against meningitis and influenza.
Earlier this month, South Korea’s MFDS approved SKYCellflu, SK’s cell culture-based seasonal trivalent influenza vaccine, marking the first time a domestic vaccine manufacturer has used cell culture technology to produce an influenza vaccine.
According to a research report by HI Investment & Securities, SK is also expected to launch herpes zoster, flu (quadrivalent) and pneumococcal vaccines, which are currently undergoing Phase III clinical trials, this year and next year in the domestic market after receiving approvals from the MFDS.