BREAKING NEWS

ANI Pharmaceuticals Acquires Four NDAs from AstraZeneca for $46.5 Million

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. 

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