By Siddharth Cavale and Richa Naidu
(Reuters) - Lonza Group AG <LONN.S> is in the “last step” of discussions with U.S. regulators for approval to claim that its formulation is effective in killing the novel Coronavirus on surfaces, an executive at the pharmaceutical and chemical giant told Reuters.
Earlier this week, Reckitt Benckiser Group Plc <RB.L> became the first company to win the U.S. Environmental Protection Agency’s approval to market two of its Lysol disinfectant sprays as household COVID-19 killers.
Reuters previously reported that Reckitt had procured a strain of the virus from an independent lab, for testing. The EPA’s approval allows Reckitt to claim that Lysol can kill the novel coronavirus, or the SARS-CoV-2, on surfaces.
Ernesto Lippert, Lonza’s vice president of strategic development and advocacy, told Reuters Thursday that it, too, obtained a strain of SARS-CoV-2 and had tested a range of its formulations in approved EPA labs. He said data shows that the products could indeed kill SARS-CoV-2 on surfaces.
“We are probably be going to be the second one after Reckitt Benckiser to have a range of our products with the actual claim against SARS-CoV-2,” Lippert said, adding that Lonza is in the “last step” of the process and that “EPA’s approval is going to be very soon.”
Reuters could not independently verify Lonza’s discussions with the EPA or the timing on a possible decision by the agency.
An EPA spokesperson said on Friday Lonza was one of several companies to have submitted laboratory data against SARS-CoV-2, but declined to elaborate on the approval timeline.
Lonza is one of a few big chemical companies, along with U.S.-based Stepan Co <SCL.N> and Pilot Chemicals, which own chemical formulations that go into many household products. The formulations typically have been pre-tested and EPA- approved for use against a variety of pathogens. Lonza’s current clients include 3M and the maker of Pine Glo kitchen and bathroom cleaner.
The EPA in March issued new guidelines, allowing hundreds of smaller companies to quickly gain regulatory approval without subjecting their products to time-consuming testing.
Applicants with data showing their products are effective against “non-enveloped” viruses won expedited approval to market their products as potentially effective against SARS-CoV-2. The EPA considers “non-enveloped” viruses to be harder-to-kill than even SARS-CoV-2, which is an “enveloped” virus.
That easing of the rules coupled with the licensing means companies can go through an accelerated EPA vetting process than the previous time frame of six months to one year for approval.
Alexandra Dapolito Dunn, assistant administrator of the EPA’s Office of Chemical Safety and Pollution Prevention, said in a statement late March that the move would allow the EPA to better protect public health by assuring the availability of surface disinfectants to use against the novel coronavirus.
“Supplemental registration is by far the easiest and quickest mechanism to get a product into the market," said regulatory consultant Kevin Kutcel. "You just send a notification to the EPA and you can immediately get into the marketplace very, very quickly.”
Lonza’s Lippert said the company had a more than 110% spike in supplemental registrations of its formulations in the second quarter compared to the first quarter of the year. It also is currently reviewing 62 applications to license its formulas, most of which already are EPA-approved as effective against “non-enveloped” viruses.
“Normally regulators are pretty dogmatic about these things - they insist on all the testing and are pretty rigid,” said Michael Reynen, the former research head of Procter & Gamble’s <PG.N> surface care business in parts of Europe, the Middle East and Africa. "But now the situation out there is pretty desperate.”
Consumer demand for cleaning and disinfecting products continues to soar.
“The Pope couldn’t have bought a bottle of Lysol last week if he wanted to, and now because of the EPA’s approval [of Lysol] it’ll be even harder,” said Josh Bloom, director of chemical and pharmaceutical sciences at consumer advocacy group American Council of Science and Health (ACSH).
Over the past five months, the EPA has approved nearly 750 products that license formulations as potentially effective against COVID, according to a list compiled by the American Chemistry Council trade group.
In late February, the list had only about 100 products, almost all from Lysol and Clorox. By June, the ACC list was comprised mostly of other brands licensing formulations from primary registrants Lonza, Pilot and Stepan, according to a Reuters analysis.
Stepan and Pilot were not immediately available to comment.
(Reporting by Siddharth Cavale in Bengaluru and Richa Naidu in Chicago; Editing by Vanessa O'Connell and Edward Tobin)