Must Read News. See Also: A New Immunotherapy Combination by Incyte and AstraZeneca

Amgen (AMGN) and Kirin Holdings (Kirin) announced an agreement upon, which Kirin-Amgen, a joint venture between the two companies, will redeem Kirin’s shares in the joint venture and as a result, Kirin-Amgen will become a wholly-owned subsidiary of Amgen.

The Kirin-Amgen joint venture was established in 1984 as a 50-50 joint venture between Amgen and Kirin to fund the global development of Epogen® (epoetin alfa). The scope of this collaboration was expanded over time to include funding Neupogen® (filgrastim), Neulasta® (pegfilgrastim), Aranesp® (darbepoetin alfa), Nplate®(romiplostim) and brodalumab. Kirin-Amgen holds the intellectual property for each of these products and, in exchange for royalty rights, licensed the associated marketing rights in certain Asian countries to Kyowa Hakko Kirin (KHK), Kirin’s pharmaceutical subsidiary, and in other territories to Amgen.

Under the Terms of the Agreement

– The Kirin-Amgen joint venture will pay $780 million to Kirin.

– Amgen will make additional payments to Kirin upon the occurrence of certain sales (valued by Amgen at approximately $30 million).

– As sole shareholder of Kirin-Amgen, Amgen will own the product rights and remaining cash held by Kirin-Amgen.

– License agreements between Kirin-Amgen and KHK in certain Asian territories will remain in place. The transaction will be effective upon the fulfillment or waiver of certain conditions contained in the agreement, including the receipt of all necessary approvals from governmental authorities.

The transaction is expected to close during either the fourth quarter of 2017 or the first quarter of 2018.

Goldman Sachs & Co. LLC is acting as the exclusive financial advisor to Amgen in connection with this transaction.

Prohost Observation

We believe that the decision by Amgen and Kirin Holdings to dissolve the Kirin- Amgen joint venture to become a wholly-owned subsidiary of Amgen is a fair move that came on time. Now, Amgen will own the product rights and any remaining cash held by Kirin-Amgen. The Asian territory marketing rights held between Kirin-Amgen and KHK will stay the same.

Robert A. Bradway, chairman and chief executive officer at Amgen commented, “Our historic partnership with Kirin played a pivotal role in the growth of Amgen from a small, venture-backed start-up to one of the world’s largest biotechnology companies. I would like to thank Kirin for more than three decades of partnership, which has enabled us to reach patients suffering from

serious illness around the world with meaningful therapies. We look forward to continuing what has been Amgen’s longest-running collaboration through our ongoing relationship with KHK.”

This is a fair good move by both parties 

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Incyte and AstraZeneca

A New Collaboration  

Incyte (INCY) and MedImmune’s AstraZeneca’s (AZN) global biologics research and development decided to expand their clinical collaboration. As part of the new agreement, the firms will evaluate the efficacy and safety of Incyte’s product epacadostat – an IDO1 enzyme inhibitor, in combination with AstraZeneca’s Imfinzi® (durvalumab), a checkpoint inhibitor directed against PD-L1, compared to Imfinzi alone. A Phase 3 trial will be conducted in patients with locally advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemotherapy concurrent with radiation therapy (CRT).

Incyte is trying to seek to position IDO1 enzyme inhibition as a key component of combination immunotherapy, while AstraZeneca aims at exploring how its product Imfinzi, in combination with Incyte’s IDO1 enzyme inhibitor could provide additional benefit to patients with locally advanced lung cancer.

The Phase 3 trial will be co-funded by the two companies and will be conducted by AstraZeneca. Enrolling patients is expected to begin in the first-half of 2018. This agreement builds on an existing clinical collaboration since 2014.

Prohost Observation

The durability of the agreement between AstraZeneca and Incyte points to an agreeable and fruitful scientific partnership between the two firms. The new agreement brings into the clinical trials a combination of two immunotherapy products for the treatment of stage III unresectable non-small cell lung cancer (NSCLC) estimated to affect around one-third of NSCLC patients.

The current standard of care of NSCLC, which is chemotherapy and radiation, is slowly, but surely giving in to immunotherapy, especially, to checkpoint inhibitors. The efficacy of immuno-oncology treatments, including the checkpoint inhibitors Keytruda (pembrolizumab) from Merck, Obdivo (nivolumab) from Bristol-Myers Squibb and Imfinzi® (durvalumab) from AstraZeneca have proven to improve when the immunotherapy products are used in combination with other drugs, including immunotherapy drugs, targeted small molecule drugs and other approaches.

AstraZeneca selected Incyte’s Epacadostat, which is an oral inhibitor of indoleamine 2,3-dioxygenase 1 (IDO1) enzyme known to help cancer cells evade the immune system surveillance, enabling it to grow and metastasize. The combination of epacadostat and immune checkpoint inhibitors have previously demonstrated proof-of-concept on patients with unresectable or metastatic melanoma, non-small cell lung cancer, renal cell carcinoma, squamous cell carcinoma of the head and neck and bladder cancer. The addition of Incyte’s product epacadostat to checkpoint inhibitors has indeed contributed to the improvement of the response rates compared with using the checkpoint inhibitors alone.

The new approaches to immunotherapy, including checkpoint inhibitors, CAR T, IDO1 inhibitors is a game changer in the treatment of cancers.

See Also:  Nektar, Exelixis, Array and Celldex drugs’ combination with immunotherapy trials for various cancers.

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