Lonza expects EPA approval coming "very soon" to make COVID-killing claims for disinfectants on surfaces

Stepan

10/07/2020 16:16

By Siddharth Cavale and Richa Naidu
    July 10 (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.  urn:newsml:reuters.com:*:nL1N2B638F 
    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. 

    <^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^
FOCUS-Cleaning product makers race to labs to bolster
coronavirus claims     urn:newsml:reuters.com:*:nL1N2B638F 
    ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^>
 (Reporting by Siddharth Cavale in Bengaluru and Richa Naidu in
Chicago; Editing by Vanessa O'Connell and Edward Tobin)
 ((siddharth.cavale@thomsonreuters.com; within U.S.
+1-646-223-8780; outside U.S. +91 80 6749 1130; Reuters
Messaging: siddharth.cavale.thomsonreuters.com@reuters.net))