BAUDETTE, Minn., Dec. 29, 2017 /PRNewswire/ -- ANI
Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced that
it has acquired the NDAs and U.S. rights to market ATACAND®,
ATACAND HCT®, ARIMIDEX®, and CASODEX® from AstraZeneca for
$46.5 million in cash, royalties, and
sales-based milestones. AstraZeneca will continue to market
and supply ATACAND®, ATACAND HCT®, ARIMIDEX®, and CASODEX® outside
of the U.S. The acquired assets include the NDAs for all four
products and a license to their trademarks. The acquisitions
were funded through a combination of cash and debt.
Collectively, these products generated approximately
$19 million in U.S. market sales
during the trailing twelve months through October 2017, according to IMS Health.
Arthur S. Przybyl, ANI's
President and CEO stated, "This acquisition complements our brand
and generic strategies and further expands and diversifies our
commercial portfolio. Importantly, ANI has the capability to
manufacture and package all of the products at our containment
facility in Baudette, MN.
The addition of these assets will be material to our revenue and
EBITDA in 2018, and we plan to provide financial guidance for 2018
at the time of our next regularly scheduled earnings
announcement."
About ATACAND® tablets
ATACAND is an angiotensin II receptor blocker (ARB) indicated
for:
- Treatment of hypertension in adults and children 1 to <17
years of age, to lower blood pressure.
- Treatment of heart failure (NYHA class II-IV).
About ATACAND HCT® tablets
ATACAND HCT combines an angiotensin II receptor (type
AT1) antagonist and a diuretic, hydrochlorothiazide.
ATACAND HCT is indicated for:
- Treatment of hypertension, to lower blood pressure.
About ARIMIDEX® tablets
ARIMIDEX is an aromatase inhibitor indicated for:
- Adjuvant treatment of postmenopausal women with hormone
receptor-positive early breast cancer.
- First-line treatment of postmenopausal women with
hormone-positive or hormone receptor unknown locally advanced or
metastatic breast cancer.
- Treatment of advanced breast cancer in postmenopausal women
with disease progression following tamoxifen therapy.
- ARIMIDEX is approved for adjuvant treatment (treatment
following surgery with or without radiation) of postmenopausal
women with hormone receptor-positive early breast cancer.
- ARIMIDEX is approved for the initial [ARI uses first] treatment
of postmenopausal women with hormone receptor-positive or hormone
receptor-unknown locally advanced or metastatic breast cancer and
for the treatment of postmenopausal women with advanced breast
cancer that has progressed following treatment with tamoxifen.
Patients with hormone receptor-negative disease and patients who
did not previously respond to tamoxifen therapy rarely responded to
ARIMIDEX.
About CASODEX® tablets
CASODEX is an androgen receptor inhibitor indicated for:
- Use in combination therapy with a luteinizing hormone-releasing
hormone (LHRH) analog for the treatment of Stage D2 metastatic
carcinoma of the prostate.
- CASODEX 50 mg daily is indicated for use in combination
therapy with a luteinizing hormone-releasing hormone (LHRH) analog
for the treatment of Stage D2 metastatic carcinoma of the
prostate.
- CASODEX 150 mg daily is not approved for use alone or
with other treatments [see Clinical Studies (14.2)].
About ANI
ANI Pharmaceuticals, Inc. (the "Company" or "ANI") is an
integrated specialty pharmaceutical company developing,
manufacturing, and marketing branded and generic prescription
pharmaceuticals. The Company's targeted areas of product
development currently include narcotics, oncolytics (anti-cancers),
hormones and steroids, and complex formulations involving extended
release and combination products. For more information, please
visit our website www.anipharmaceuticals.com.
Forward-Looking Statements
To the extent any statements made in this release deal with
information that is not historical, these are forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Such statements include, but are not limited
to, statements about price increases, the Company's future
operations, products financial position, operating results and
prospects, the Company's pipeline or potential markets therefor,
and other statements that are not historical in nature,
particularly those that utilize terminology such as "anticipates,"
"will," "expects," "plans," "potential," "future," "believes,"
"intends," "continue," other words of similar meaning, derivations
of such words and the use of future dates.
Uncertainties and risks may cause the Company's actual results
to be materially different than those expressed in or implied by
such forward-looking statements. Uncertainties and risks include,
but are not limited to, the risk that the Company may face with
respect to importing raw materials; increased competition;
acquisitions; contract manufacturing arrangements; delays or
failure in obtaining product approval from the U.S. Food and Drug
Administration; general business and economic conditions; market
trends; products development; regulatory and other approvals and
marketing.
More detailed information on these and additional factors that
could affect the Company's actual results are described in the
Company's filings with the Securities and Exchange Commission,
including its most recent annual report on Form 10-K and quarterly
reports on Form 10-Q, as well as its proxy statement. All
forward-looking statements in this news release speak only as of
the date of this news release and are based on the Company's
current beliefs, assumptions, and expectations. The Company
undertakes no obligation to update or revise any forward-looking
statement, whether as a result of new information, future events or
otherwise.
For more information about ANI, please contact:
Investor Relations
IR@anipharmaceuticals.com
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SOURCE ANI Pharmaceuticals, Inc.