MannKind and BIOMM Submit Registration Dossier to Brazilian Health Regulatory Agency (ANVISA)
October 23 2017 - 6:00AM
MannKind Corporation (Nasdaq:MNKD) (TASE:MNKD) and BIOMM SA
(B3:BIOM3) announced the submission of a registration dossier to
ANVISA, seeking the approval of Afrezza® (insulin human) inhalation
powder in Brazil.
The registration dossier includes recently
updated prescribing information for Afrezza, incorporating new
clinical data describing the rapid time-action profile of
Afrezza.
"We are excited to file our first international
application for approval of Afrezza in Brazil, which is in the top
ten countries with the highest diabetes rates in the world
according to the World Health Organization," said Michael Castagna,
Chief Executive Officer of MannKind Corporation. “BIOMM’s expertise
in the diabetes market allowed the dossier to be updated quickly
with the revised prescribing information, thereby providing
physicians and patients, if and when Afrezza is approved in Brazil,
with accurate information to achieve better glycemic control at
mealtime.”
BIOMM, the first Brazilian biopharmaceutical
company, is responsible for registering the product with ANVISA.
After approval, the drug will be submitted to CMED (the Brazilian
drug price control agency) for release, after which MannKind will
supply Afrezza to BIOMM, who will be responsible for the promotion,
distribution and sales of Afrezza in Brazil.
"We intend to offer Brazilian patients an
important technological innovation. Like all chronic diseases,
diabetes needs prolonged adherence to treatment. Therefore, more
comfortable and effective options may be a differentiating
attribute that has the potential to contribute to the quality of
life of the patient," said Heraldo Marchezini, Chief Executive
Officer of BIOMM SA.
ABOUT MANNKIND
CORPORATIONMannKind Corporation (NASDAQ:MNKD) (TASE:MNKD)
focuses on the development and commercialization of inhaled
therapeutic products for patients with diseases such as diabetes
and pulmonary arterial hypertension. MannKind is currently
commercializing Afrezza® (insulin human) inhalation powder, the
Company's first FDA-approved product and the only inhaled
rapid-acting mealtime insulin in the United States, where it is
available by prescription from pharmacies nationwide. MannKind is
headquartered in Westlake Village, California, and has a
state-of-the art manufacturing facility in Danbury, Connecticut.
The Company also employs field sales and medical representatives
across the U.S. For further information, visit
www.mannkindcorp.com.
ABOUT BIOMM SABiomm SA
(BOVESPA:BIOM3) is the first Brazilian biopharmaceutical company
and the only human biotech company listed on the Brazilian BOVESPA
Stock Exchange. The company is committed to making
difficult-to-treat chronic diseases more cost-effective, thereby
improving the quality of life for patients. With innovation in its
DNA, Biomm is pioneer in biotechnology and in the production of
insulin in Brazil. For further information, please visit the
web page: www.biomm.com.
Forward-Looking StatementsThis
press release contains forward-looking statements that involve
risks and uncertainties, including statements regarding MannKind's
and its partner’s ability to directly commercialize pharmaceutical
products. Words such as "believes", "anticipates", "plans",
"expects", "intend", "will", "goal", "potential" and similar
expressions are intended to identify forward-looking statements.
These forward-looking statements are based upon the MannKind's
current expectations. Actual results and the timing of events
could differ materially from those anticipated in such
forward-looking statements as a result of these risks and
uncertainties, which include, without limitation, the ability to
obtain regulatory approvals, the ability to get satisfactory
pricing terms from regulators and other risks detailed in
MannKind's filings with the Securities and Exchange Commission,
including the Annual Report on Form 10-K for the year ended
December 31, 2016 and subsequent periodic reports on Form 10-Q and
current reports on Form 8-K. You are cautioned not to place
undue reliance on these forward-looking statements, which speak
only as of the date of this press release. All
forward-looking statements are
qualified in their entirety by
this cautionary statement, and MannKind
undertakes no obligation to revise or update any forward-looking
statements to reflect events or circumstances after the date of
this press release.
_______________MannKind Contact:Rose AlinayaSVP,
Investor Relations818-661-5000ir@mannkindcorp.com
Biomm SA Contact:c/o RMA
Comunicação Alethéia Rocha - + 55 (11) 2244-5972| 96443
-7638 aletheia.rocha@rmacomunicacao.com.br
Monica Permagnani - + 55 (11) 2244 – 5985| 94187 -
6025 monica.permagnani@rmacomunicacao.com.br
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