Takeda Pharmaceutical has agreed to sell two of its non-core drugs in deals that could generate up to $5.7 billion for the pharma giant—and are intended to refocus its portfolio on five key business areas following its recently-completed $59.8 billion purchase of Shire.

Takeda said it will sell its dry eye disease treatment Xiidra® (lifitegrast ophthalmic solution) 5% product to Novartis for up to $5.3 billion. Takeda generated $388 million in adjusted net sales last year from Xiidra, the first and only FDA-approved prescription treatment indicated for both signs and symptoms of dry eye disease, with a mechanism of action that targets inflammation.

“Takeda determined that this transaction would create the most value for Takeda shareholders, and ensure the business will continue delivering innovative therapeutics to the patients and professionals who rely on them,” the company said yesterday in a statement.

Novartis agreed to buy Xiidra for $3.4 billion upfront and up to an additional $1.9 billion tied to achieving milestones. The acquisition is expected to close in the second half of this year, subject to satisfaction of customary closing conditions, receipt of required regulatory clearances and, where applicable, satisfaction of local works council requirements.

Upon the close of the deal, approximately 400 employees based primarily in the U.S. and Canada, will transition to Novartis, Takeda said.

Takeda has also agreed to sell its TachoSil® Fibrin Sealant Patch to Ethicon for $400 million cash upfront. The surgical patch is designed to achieve safe, fast, and reliable bleeding control, and generated adjusted net sales of approximately $155 million in the fiscal year that ended March 31, 2018, Takeda said.

Approximately 80 employees will transition to Ethicon upon the close of the deal, which is also expected during the second half of 2019. Ethicon will acquire the assets and licenses that support the manufacturing, licensing, and commercialization of TachoSil®, while Takeda will maintain ownership of the manufacturing facility in Linz, Austria. Takeda has entered into a long-term manufacturing services agreement, under which it will continue to manufacture TachoSil® products and supply them to Ethicon.

Takeda said it did not expect its sell-offs of Xiidra and TachoSil to have a material impact on its FY2019 consolidated earnings forecast, set to be announced on May 14. That forecast will be updated later to reflect the deals once a reliable estimate of their impact can be made, which according to Takeda will depend on the exact timing of transaction close.

“Important steps”

“These initial divestitures represent important steps in advancing the growth strategy Takeda outlined following our transformational acquisition of Shire earlier this year,” Takeda president and CEO Christophe Weber said yesterday in a statement. “We are working to strategically simplify and optimize our portfolio, while also rapidly deleveraging and continuing to invest in our growth drivers as a global, values-based, R&D-driven biopharmaceutical leader.”

The deals are part of Takeda’s ongoing effort to fine-tune its pipeline by focusing on five key therapeutic areas: rare diseases, plasma-derived therapies, neuroscience, gastroenterology (GI), and cancer.

Takeda further signaled its interest in boosting its oncology pipeline yesterday through a separate deal to in-license Curadev’s lead small-molecule candidate the Stimulator of Interferon Genes (STING) agonist CRD5500 and associated patents, indicated for solid tumors, for an undisclosed price.

At the 2019 Annual Meeting of the American Association for Cancer Research, Curadev reported that its STING agonist potently activated all major known human STING variants and activated the immune system to shrink distant tumors, in poster presentation LB-061, “CRD5500: a versatile small molecule STING agonist amenable to bioconjugation as an ADC.”

The presentation also noted that CRD5500 combined well with anti-PD-L1/anti-CTLA4/IDO-TDOi treatments when dosed intratumorally or systematically. The molecule has a long tumor residence time, good drug-like properties, can be dosed by multiple routes, and has been successfully conjugated with Roche’s cancer treatment Herceptin® (trastuzumab), according to Curadev.

“The ability of hSTING agonists to generate Type 1 IFN anti-tumor immune responses makes them a promising therapeutic option either as a single agent or in combination with other therapies,” Curadev concluded. “CRD5500 is a small molecule STING agonist that can be delivered in multiple formats making it well suited for further development as an anti-cancer agent.”

Takeda becomes Curadev’s latest collaboration partner since the company established its labs in 2011; other partners range from drug developers such as Endo International, Medivation (since acquired by Pfizer), and Roche, as well as research institutes such as The University of Texas (UT) Southwestern Medical Center in Dallas, and INSERM in Paris.

“Our drug discovery efforts have targeted fundamental host immune mechanisms to stimulate anti-tumor immunity,” added Curadev co-founder and CSO Arjun Surya, PhD. “With its commitment to pursuing novel immuno-oncology targets, Takeda is an ideal partner to collaborate on the further development of a STING agonist that is potential first-in-class small molecule.”

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