Commercialization Deal: TerSera Therapeutics and AstraZeneca’s for Zoladex in US & Canada

AstraZeneca has entered into an agreement with TerSera Therapeutics LLC for the commercial rights to Zoladex (goserelin acetate implant) in the US and Canada. Zoladex is an injectable luteinising hormone-releasing hormone agonist, used to treat prostate cancer, breast cancer and certain benign gynaecological disorders.

About Goserelin

Goserelin (brand name Zoladex, by AstraZeneca), is a drug used to suppress production of the sex hormones (testosterone and estrogen), particularly in the treatment of breast and prostate cancer. It is an injectable gonadotropin releasing hormone superagonist (GnRH agonist), also known as a luteinizing hormone releasing hormone (LHRH) agonist.

Structurally, it is a decapeptide. It is the natural LHRH/GnRH decapeptide with two substitutions to inhibit rapid degradation.

Goserelin acetate stimulates the production of the sex hormones testosterone and estrogen in a non-pulsatile (non-physiological) manner. This causes the disruption of the endogenous hormonal feedback systems, resulting in the down-regulation of testosterone and estrogen production.

Zoladex was approved by the U.S. Food and Drug Administration in 1989 for treatment of prostate cancer.

About the Deal

• In 2016, product sales for Zoladex were $69 million in the US and Canada, and $816 million globally.
• AstraZeneca will continue to commercialise Zoladex in all markets outside the US and Canada.
• AstraZeneca will maintain a significant ongoing interest in Zoladex in the US and Canada through the sustainable and ongoing income from the upfront, milestone, quarterly sales-based and supply payments received from TerSera.
• TerSera will pay AstraZeneca $250 million upon completion.
• AstraZeneca will also receive sales-related income through milestones totalling up to $70 million, as well as recurring quarterly sales-based payments at mid-teen percent of Product Sales.
• The $250 million upfront, $70 million milestone payments and double-digit percentage quarterly sales-based payments received from TerSera will be reported as Externalisation Revenue in the company’s financial statements.
• AstraZeneca will also manufacture and supply Zoladex to TerSera, providing a further source of ongoing income from Zoladex in the US and Canada.
• The agreement does not include the transfer of any AstraZeneca employees or facilities and does not impact AstraZeneca’s financial guidance for 2017.

Mark Mallon, executive vice president, Global Product & Portfolio Strategy at AstraZeneca said: “This agreement allows us to retain a significant share of the value of Zoladex in the US and Canada, while concentrating our resources on our innovative New Oncology medicines. It also ensures patients have continued access to Zoladex, with TerSera’s dedicated focus helping to expand the potential of this important medicine.”

Ed Fiorentino, chairman and CEO of TerSera Therapeutics, said: “We are very pleased to be partnering with AstraZeneca, and investing in the future growth of Zoladex, which continues to be a mainstay of treatment for its indicated uses.”

The transaction is expected to complete in the first quarter of 2017, subject to customary closing conditions.

TerSera Therapeutics LLC acquires, develops and markets specialty pharmaceutical products with a focus on select therapeutic areas.

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas – oncology, cardiovascular & metabolic diseases and respiratory.