Production & Manufacturing

ANI Pharmaceuticals buys four AstraZeneca NDAs

PBR Staff Writer Published 02 January 2018

ANI Pharmaceuticals has acquired the new drug applications (NDAs) and US marketing rights for AstraZeneca’s Atacand, Atacand HCT, Arimidex, and Casodex for $46.5m.

Atacand is an angiotensin II receptor blocker (ARB) indicated for the treatment of hypertension in adults and children 1 to <17 years of age, to lower blood pressure. The drug is also intended for the treatment of heart failure.

Atacand HCT is a combination of an angiotensin II receptor (type AT1) antagonist and a diuretic, hydrochlorothiazide. The drug has been indicated for the treatment of hypertension, to lower blood pressure.

Arimidex is a breast cancer drug which inhibits the aromatase enzyme. The drug is indicated for the adjuvant treatment of hormone receptor-positive early breast cancer in postmenopausal women.

It is also indicated for hormone-positive or hormone receptor unknown locally advanced or metastatic breast cancer in postmenopausal women as a first-line treatment option.

In addition to other indications, Arimidex is also indicated for treating advanced breast cancer in postmenopausal women whose disease had progressed after tamoxifen therapy.

Casodex, on the other hand is an androgen receptor inhibitor. The drug in combination with luteinizing hormone-releasing hormone (LHRH) analog is indicated for the treatment of Stage D2 metastatic carcinoma of the prostate.

ANI president and CEO Arthur Przybyl said: “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.”

According to IMS Health, Atacand, Atacand HCT, Arimidex, and Casodex had generated about $19m in US market sales through the trailing twelve months through October 2017.

Outside of the US, AstraZeneca will retain the rights to market and supply the four drugs. The transaction amount is inclusive of royalties, and sales-based milestones.

ANI Pharmaceuticals also owns a license to the trademarks of the drugs.

Image: ANI acquired NDAs for Atacand, Atacand HCT, Arimidex, and Casodex. Photo: courtesy of adamr/