Daiichi Sankyo Inks USD 200M Licensing Deal With Ultragenyx To Boost Gene Therapy Manufacturing

Daiichi Sankyo is in the midst of a companywide shift to oncology as part of its 2025 business plan, a transition that has scored at least one major approval so far. But Daiichi is also looking to life after 2025, and gene therapy could provide a lucrative roadmap moving forward.

Daiichi on Tuesday inked a non-exclusive licensing deal worth $200 million for Ultragenyx’s HeLa producer cell line platform to help boost its gene therapy product manufacturing, Ultragenyx said in a release.

The Japanese drugmaker intends to use Ultragenyx’s platform, which includes a proprietary system for adeno-associated viral vector manufacturing, to help boost capacity in the event one of its gene therapies reaches approval in the future.

“We are currently doing discovery research for gene therapy drugs using AAV vectors as one of our focused modalities toward sustained growth beyond achievement of our 2025 vision,” said Masayuki Yabuta, Daiichi’s head of biologics, in a release. “In order to provide these drugs to patients in the future, manufacturing technology must be established early. Ultragenyx’s proprietary technology is particularly excellent in terms of stable quality, high production efficiency, and ability to accommodate mass production.”

As part of the agreement, Daiichi will pay $175 million in cash upfront and $75 million in stock. In return, Ultragenyx will hold the exclusive rights to license its platform as well as an option to co-develop and commercialize rare disease products at the investigational stage, the company said.

Daiichi’s investment in its gene therapy capacity comes as the drugmaker looks for signs of growth after it reaches its 2025 business plan objectives, which includes an erstwhile investment pivot to oncology.

In December, Daiichi scored its first win in that oncology push after the FDA approved AstraZeneca-partnered antibody drug conjugate Enhertu as a treatment for patients with inoperable or metastatic HER2-positive breast cancer who have already failed on at least two other treatments.

AstraZeneca and Daiichi jointly develop and sell the drug outside of Japan, where Daiichi holds exclusive rights.

Enhertu was scheduled to launch in January at a per-patient cost of around $13,300 per month, SVB Leerink analyst Andrew Berens said in a note to investors Monday. At that price, Enhertu could reach $68 million in sales in 2020, with a peak sales estimate of $2.5 billion, Berens said.

Daiichi in August also nabbed an FDA green light—its first U.S. cancer nod since 2011—for Turalio for adults with a rare joint cancer known as tenosynovial giant cell tumor.

Those approvals have Daiichi well positioned to grow its antibody-drug conjugate portfolio as it moves away from its over-the-counter and pain businesses.

In November, Daiichi gave up opioid-induced constipation treatment Movantik to AstraZeneca and a month earlier opted to cancel its licensing agreement with Inspirion covering opioid drugs MorphaBond and RoxyBond.

As part of its reorganization and innovation plan for 2025, Daiichi in February 2018 said it would reorganize its U.S. commercial organization in preparation for upcoming oncology launches. At that time, the company planned to reduce headcount by about 280 employees.

On the manufacturing side, the company said it plans to invest $920 million or more “to be prepared for the increase in demand of ADC franchise’s investigational drugs and products.”-Fierce Pharma

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