Dec. 5, 2013
- ADAMA obtains regulatory approval for flagship NIMITZ® in Brazil
- Adama secured regulatory approval for its novel nematicide Nimitz® in Japan, South Korea and Taiwan
- Adama gained Israeli regulatory approval to market nematicide NIMITZ
- Australia to approve Adama's nematicide Nimitz
- MANA to launch Nimitz non-fumigant nematicide in US
Obtaining the approval for the registration file advancement by regulatory authorities in the U.S., Canada and Australia, who are conducting a Global Joint Review (GJR) process, represents a major step in MAI’s efforts to launch the product. The review is proceeding according to the authorities’ work-plan, and the Company has not identified major roadblocks for registration to date.
NimitzTM is a broad-spectrum, non-fumigant nematicide, which is highly effective in controlling plant-parasitic nematodes. Experts estimate the annual global losses caused by nematodes on agricultural crops to be over $120 billion. The product belongs to a new class of chemistry and offers a novel mode of action with very favorable toxicological and eco-toxicological profiles. NimitzTM fills a critical need for nematode control as other organizations in the industry are phasing out older, more toxic and environmentally hazardous fumigant and non-fumigant nematicides.
More than 1,000 successful field trials and hundreds of regulatory studies have been completed, which demonstrate the product’s effectiveness plus handling and application benefits of this innovative mode of action.
MAI submitted the complete OECD Dossier for the new product to the GJR committee in April 2012, and the Company expects a recommendation decision shortly. Based on the anticipated regulatory approval schedule, the Company intends to launch marketing activities and sales of NimitzTM in North America in 2014.
“I am proud of MAI’s research, development and registration teams whose sustained initiatives and commitment to excellence developed NimitzTM as part of our growing portfolio,” said Danny Karmon, global project leader, MAI.” “These teams are working diligently with the regulatory authorities to ensure its approval and launch.”
“The development of an innovative nematicide with favorable toxicological and environmental profiles is a major accomplishment for MAI,” said Dr. Tali Ehrlich, Head of global regulatory affairs, MAI. “Following the receipt of the required registration approvals, it will provide MAI with a new vehicle for growth.”