Afrezza® (insulin human) Inhalation Powder Approved in Brazil
2019年6月3日 - 9:00PM
MannKind Corporation (Nasdaq:MNKD) and BIOMM SA (BVMF:BIOM3) today
announced that Afrezza® (insulin human) Inhalation Powder, an ultra
rapid-acting mealtime insulin to improve glycemic control in adult
patients with diabetes mellitus, has been registered by the
Brazilian Health Regulatory Agency (ANVISA). The
commercialization of Afrezza in Brazil is expected to begin in the
fourth quarter this year, subject to the pricing registration
process by Câmara de Regulação do Mercado de Medicamentos (CMED).
“The regulatory approval of Afrezza in Brazil is
an important milestone for MannKind and our partner Biomm. It not
only represents our first international approval of Afrezza, but
more importantly, we now have the opportunity to bring a novel
mealtime insulin therapy to patients in a country with one of the
highest prevalence of diabetes in the world, according to the
International Diabetes Federation,” said Michael Castagna, Chief
Executive Officer of MannKind Corporation.
Afrezza is an ultra rapid-acting orally inhaled
insulin therapy indicated to improve glycemic control in adult
patients with diabetes mellitus. Afrezza consists of a dry powder
formulation of human insulin delivered using a small, discreet and
easy-to-use inhaler. Administered at the start of a meal, Afrezza
dissolves rapidly upon inhalation to the deep lung and passes
quickly into the bloodstream (in less than one minute).
Glucose-lowering effects are achieved within minutes of
administration, and clinical data with Afrezza demonstrates proven
efficacy and safety in the treatment of both type 1 and type 2
diabetes.
“Insulin was first isolated and purified for
clinical use in 1923 and now, almost 100 years later, we are
excited that patients in Brazil are expected to soon have access to
Afrezza, the only non-injectable oral insulin available in the
market,” said Heraldo Marchezini, President Director/CEO of Biomm
SA. “We believe that Afrezza, with its distinct time-action profile
and route of administration, will address many of the unmet needs
for mealtime insulin therapy and has the potential to change the
way that diabetes is treated. As a pioneering biotechnology
company, we are proud to leverage our portfolio of diabetes
products and offer another option to treat the significant and
growing numbers of patients with diabetes in Brazil.”
Currently, diabetes mellitus affects 425 million
adults worldwide, including more than 12 million in Brazil,
according to the International Diabetes Federation. Diabetes
mellitus is characterized by the body's inability to regulate
levels of blood glucose properly. Insulin, a hormone produced by
the pancreas, normally regulates the body's glucose levels, but in
people with diabetes mellitus insufficient levels of insulin are
produced or the body fails to respond adequately to the insulin it
produces.
ABOUT MANNKIND
CORPORATIONMannKind Corporation (NASDAQ: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 orally inhaled ultra
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
and research 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's mission
is to develop, produce and market global competitive biomedicines
with quality and accessibility. The company's focus is developing
biological products, aiming to guarantee national self-sufficiency.
Due to its innovator DNA, the company is pioneer in
biotechnological drugs in Brazil. Founded in 2002, Biomm’s
headquarters and factory are in Nova Lima (MG), with capacity to
produce 20 million vials of insulin per year, based on advanced and
innovative technologies that guarantee the medicines quality. The
company is listed on the Brazilian stock exchange (BVMF: BIOM3).
For further information access www.biomm.com.
FORWARD-LOOKING STATEMENTS This
press release contains forward-looking statements that involve
risks and uncertainties. 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
MannKind’s and Biomm’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 risks
detailed in MannKind’s filings with the Securities and Exchange
Commission. 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 neither MannKind
nor Biomm undertakes any obligation to revise or update any
forward-looking statements to reflect events or circumstances after
the date of this press release.
MannKind CorporationRose AlinayaInvestor
Relations818-661-5000ir@mannkindcorp.com
Biomm S/A Bruna Sales - +55 11 3147 7423 | c:
+55 11 94836 6956bruna.sales@maquinacohnwolfe.com
Raquel Tomacelli - +55 11 3147-7906 | +55 11
98048-8022 raquel.tomacelli@maquinacohnwolfe.com
Nancy Campos - + 55 (11) 3147-7900| + 55 11
97574-9149nancy.campos@maquinacohnwolfe.com
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