AstraZeneca Sells North American Zoladex Rights

21.02.2017 -

AstraZeneca has agreed to sell the commercial rights for its cancer treatment Zoladex in the US and Canada for $250 million upfront to private equity-backed TerSera Therapeutics –  a US company specialized in acquiring and developing pharmaceutical products dedicated to select therapeutic areas. It will, however, continue to commercialize the drug in all markets outside of the US and Canada.

The Anglo-Swedish drugmaker has recently focused its recent R&D efforts on new areas such as immuno-oncology in an effort to offset expiring patents on some of its older drugs.

As part of the deal, AstraZeneca will also receive sales-related income through milestones worth up to $70 million, as well as recurring quarterly sales-based payments at what it said is a “mid-teen percent” of product sales. It will continue manufacturing the drug for TerSera.

First approved in the US and Canada in 1989, the injectable luteinizing hormone-releasing hormone agonist Zoladex is used to treat prostate cancer, breast cancer and certain benign gynecological disorders. In 2016, its sales totaled some $69 million in the US and Canada, and $816 million worldwide.

Mark Mallon, AstraZeneca’s executive vice president, global product & portfolio strategy, said the agreement will allow the company to retain a significant share of the value of Zoladex in the US and Canada, while concentrating its resources on innovative “new  oncology” medicines. He said it will also ensure that patients have continued access to the treatment.

The transaction, which does not include the transfer of any AstraZeneca employees or facilities and – the company stressed – does not impact its financial guidance for 2017, is expected to be wrapped up during this year’s first quarter, subject to customary closing conditions.  

AstraZeneca’s shares made gains last week when it reported positive results from clinical trials with Lynparza, a treatment for BRCA-mutated metastatic breast cancer. Some analysts view the drug as a potential blockbuster. The company’ largest shareholder, Woodford Investment Management, reportedly increased its holdings in the pharmaceutical manufacturer on the news.

Lynparza, AstraZeneca said, met its primary endpoint in the phase 3 trials, as initial findings from a study indicated that the drug’s safety profile was consistent with previous studies. Patients treated with Lynparza are said to have shown a “statistically significant and clinically meaningful improvement” in progression-free survival for metastatic breast cancer sufferers compared to those treated with chemotherapy.

Sean Bohen, AstraZeneca’s executive vice-president for global medicines development and chief medical officer, said the results were the first positive Phase 3 data for a PARP inhibitor beyond ovarian cancer. “This,” he said, “is highly encouraging for the development of our broad portfolio which aims to treat multiple cancers by targeting DNA damage response pathways."

In December 2016, the drugmaker’s application for sale of its new bladder cancer treatment durvalumab was been accepted by the US Food and Drug Administration. AstraZeneca previously said it saw durvalumab as a potential breakthrough treatment for several forms of cancer.