Zydus partners US-based IDRI for Kala-Azar vaccine

The vaccine is designed to prevent deadly parasitic disease more popularly known as Kala-Azar

Ahmedabad-based Cadila Healthcare (Zydus Cadila) has entered into a partnership with Seattle-based non-profit research and product development organisation Infectious Disease Research Institute (IDRI) for the production and clinical development of IDRI’s visceral leishmaniasis (VL) vaccine candidate, designed to prevent the deadly parasitic disease more popularly known as Kala-Azar. 

 

Kala-Azar or VL is transmitted by the bite of an infected sand fly. There are over 500,000 new VL  cases and 50,000 associated deaths each year.  VL is the most severe form of leishmaniasis, affecting vital organs, and, if left untreated, the disease can be fatal, a company statement here claimed.

 

Currently, leishmaniasis occurs in four continents and is considered to be endemic in 88 countries; 72 of those are developing countries, with the disease being most common in India, Nepal, Bangladesh, Sudan and Brazil. The statement further added, "While there are drugs to treat the disease, they are expensive and often toxic. To date, a safe and efficacious vaccine to prevent this disease does not exist." 

 

Zydus & IDRI will collaborate to conduct clinical development activities in India with the 'goal of developing, registering and marketing this vaccine candidate for the prevention of VL, which will achieve the objective of global access – that is, ensuring the vaccine is affordable to and accessible by all people in need.'

 

Conducting trials in India, where there are real-life situations of disease exposure, is critical to determining the effectiveness of IDRI’s VL vaccine candidate and ensuring it is approved and available within endemic countries.

 

IDRI’s VL vaccine candidate (LEISH-F3+GLA-SE) is the product of more than 20 years of research and development supported by the US National Institutes of Health (NIH) and the Bill & Melinda Gates Foundation. After completion of a Phase one clinical trial of 36 US adult volunteers to test safety and immunogenicity, the vaccine was shown to be safe and to induce potent immune responses in healthy volunteers, the release claimed. 

 

Pankaj R. Patel, chairman and managing director, Zydus group said, "Zydus has always been committed to working with partners and collaborating to bridge unmet healthcare needs. By partnering with IDRI on this very important  mission, we will be taking an all important step to eradicate visceral leishmaniasis which is a huge healthcare burden."

 

Steven G  Reed, IDRI founder and president added, "Zydus’ expertise and breadth of development and commercialisation experience will be instrumental in getting IDRI’s VL vaccine to the people who need it most. We are appreciative of Zydus’ commitment to this program. This is an excellent example of cooperating to help combat a devastating disease without consideration for a profit motive. IDRI could not ask for a better partner in this endeavor."

 

Zydus Cadila is India's fourth largest healthcare group and an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies.The group posted revenues of over Rs 6300 crore in 2012-13.  Vaccine Technology Centre (VTC) is the vaccine division of the Zydus Group. VTC has two research and development centers, one located in in Catania, Italy and the other in Ahmedabad, in Gujarat. 

 

Zydus vaccine division has indigenously developed, manufactured and launched India’s first vaccine against H1N1 (Vaxiflu-S). The current programmes under development include vaccine candidates designed to address infectious diseases like next-generation Influenza, Measles-Mumps-Rubella-Varicella, Typhoid, DPT-HiB, Hepatitis-B, Hepatitis-A, Hepatitis-E, Japanese Encephalitis, HPV and combination vaccines. Research is also focused on developing a Malaria vaccine.