Partnering News: Shionogi, AbbVie & Otsuka

A roundup of bio/pharmaceutical partnering news from Shionogi & Co./F2G, AbbVie/Cugene, and Otsuka/Akebia. Highlights below.

* Shionogi, F2G in $480-M Pact for Antifungal Drug
* AbbVie, Cugene in Autoimmune Disease Pact
* Otsuka, Akebia Ends Pact for Renal Anemia Drug

Shionogi in $480-M Pact for Antifungal Drug
Shionogi & Co., an Osaka, Japan-headquartered bio pharmaceutical company, and F2G, a Manchester, UK-based bio/pharmaceutical company, have entered into a pact, worth up to $480 million, to develop and commercialize in Europe and Asia, olorofim, a new antifungal agent for invasive fungal infections

Olorofim is an oral antifungal therapy developed by F2G to treat invasive aspergillosis (IA), a rare disease occurring primarily in immunocompromised patients, and other rare mold infections.

Under the agreement, Shionogi will conduct the clinical trials and subsequent registration and commercialization of olorofim for IA in Europe and Asia. Shionogi will make an upfront payment to F2G of $100 million and share development costs in global studies. F2G will also be eligible to receive additional regulatory and commercial milestones of up to $380 million, as well as double-digit royalties on net sales.

Source: Shionogi

AbbVie, Cugene in Autoimmune Disease Pact
Abbvie and Cugene, a Waltham, Massachusetts-based clinical-stage bio/pharmaceutical company, have entered into an exclusive global license option agreement for potential treatments of autoimmune and inflammatory diseases.

Cugene’s lead candidate is CUG252, in Phase I for treating various autoimmune diseases. It is an engineered IL-2 mutein designed to selectively activate and expand immune-suppressive Treg cells while reducing undesired IL-2 activity on other IL-2 receptor expressing cells.

Under the agreement, Cugene will receive an upfront payment of $48.5 million, and will also be eligible to receive development and regulatory milestones and a license option exercise payment if AbbVie exercises the option. In addition, Cugene may also receive commercialization and sales-based milestones and tiered royalties. AbbVie will receive an option to obtain an exclusive license for certain IL-2 muteins, including CUG252. During the option period, Cugene will conduct a Phase Ib study in patients with autoimmune/inflammatory disease. Upon exercise of the option, AbbVie will conduct all future clinical development, manufacturing, and commercialization activities for CUG252.

Source: AbbVie and Cugene

Otsuka, Akebia Ends Pact for Renal Anemia Treatment
Otsuka Pharmaceutical has decided to terminate its global license agreements with Akebia Therapeutics, a Cambridge, Massachusetts-headquartered bio/pharmaceutical company, for vadadustat, a potential oral treatment for anemia associated with chronic kidney disease (renal anemia).

Otsuka and Akebia had been co-developing vadadustat for renal anemia. In March 2022, Akebia received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for its new drug application (NDA) for vadadustat. As a result, Otsuka has decided to terminate its co-development of vadadustat and has notified Akebia of the termination of its global license agreements.

Akebia says it plans to request an end of review meeting with the FDA and plans to evaluate and determine potential next steps for vadadustat in the US following the end of review meeting with the FDA. In the meantime, the company says it is focused on its path forward without a US approval for vadadustat.

Source: Akebia Therapeutics and Otsuka Pharmaceutical