AstraZeneca makes $575M deal for Takeda's respiratory business

LONDON—AstraZeneca has announced the establishment of a definitive agreement under which it will acquire Takeda Pharmaceutical Co. Ltd.’s core respiratory business. This deal includes an expansion of rights to roflumilast, which is marketed as Daliresp in the United States and Daxas elsewhere, the only approved oral PDE4 inhibitor for the treatment of chronic obstructive pulmonary disease (COPD). AstraZeneca has been marketing the drug in the United States since the first quarter of the year, when it acquired the rights from Actavis. This agreement also nets AstraZeneca access to several other marketed respiratory medicines and early pipeline products.

Per the terms of the deal, AstraZeneca will pay Takeda $575 million for its respiratory business. In addition, roughly 200 staff will transfer to AstraZeneca once the transaction is complete. AstraZeneca expects the deal to close in the first quarter of 2016, and for it to be immediately accretive to earnings from 2016. Annual global sales for the three medicines included in this deal, excluding AstraZeneca sales of Daliresp in the United States, totaled $198 million for the period ending March 2015.

“The agreement with Takeda complements our respiratory business, one of our three main therapy areas, supports our return to growth and will be immediately accretive to earnings from 2016. Daxas in particular adds to our portfolio of treatments for patients with severe COPD,” Luke Miels, executive vice president of Global Portfolio and Product Strategy at AstraZeneca, said in a press release.

In addition to the Takeda deal, AstraZeneca, along with MedImmune, simultaneously announced a series of strategic initiatives in China. Among those initiatives is a strategic alliance with WuXi AppTec to produce innovative biologics locally in China. The agreement grants AstraZeneca the option to acquire WuXi AppTec’s biologics manufacturing capacity in Wuxi City in the next few years through an overall investment of roughly $100 million. Prior to that, Wuxi AppTec will be AstraZeneca's exclusive partner for R&D manufacturing for innovative biologics in China. This builds on MedImmune and WuXi AppTec's existing joint venture to develop and commercialize MEDI5117 in China.

Bahija Jallal, executive vice president of MedImmune, remarked: “We are delighted to broaden our collaboration with WuXi AppTec, a company with strong leadership in the Chinese biopharmaceutical sector, to address the healthcare needs of local patients. This strategic alliance, alongside our accelerated investments, will create a sustainable and strategic innovation platform in China and strengthen our leadership in developing next-generation biologics for both local needs and patients around the world.”

In other recent news of AstraZeneca, the company confirmed in early December that it was exploring a deal with Acerta Pharma BV that would give it Acerta’s investigational drug acalabrutinib, which is being positioned as a rival to Imbruvica. The medicine has shown potential both in leukemia and auto-immune diseases. The news was followed by mid-December with AstraZeneca announcing it had agreed to pay $4 billion to acquire a 55-percent stake in Acerta, a deal under which Acerta gets an upfront payment of $2.5 billion and additional $1.5 billion either before the end of 2018 or following FDA approval of acalabrutinib. AstraZeneca also has the option to purchase the remaining stake in Acerta for $3 billion, contingent on the achievement of specific milestones related to the approval and marketing of acalabrutinib.

Mid-December also saw the completion of AstraZeneca's purchase of ZS Pharma for $2.7 billion, a deal that enhances AstraZeneca's metabolic and cardiovascular disease product pipeline and gives it access to ZS Pharma's potential hyperkalemia drug, ZS-9 (sodium zirconium cyclosilicate).

In addition, around the same time, Regulus Therapeutics announced it had received a $10-million milestone payment from AstraZeneca for the clinical development of RG-125 (AZD4076), a GalNAc-conjugated anti-miR targeting microRNA-103/107 (miR-103/107) for the treatment of non-alcoholic steatohepatitis (NASH) in patients with type 2 diabetes/pre-diabetes. NASH is a serious condition that can cause scarring of the liver, and there is no approved treatment. RG-125 is the third microRNA therapeutic program in Regulus’ portfolio that has advanced into clinical development. RG-125 has showed effects on a pathway profile that mirrors that seen in people with NASH. Moreover, RG-125’s inhibition of miR-103/107 with anti-miRs has been shown to lead to a sustained reduction in fasting glucose and fasting insulin levels.