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Thursday, Oct 6, 2022

Dendreon Plots Reinvention as Contract Manufacturer

Dendreon Pharmaceuticals LLC is looking to leverage its expertise in cellular immunotherapy to bring in new business.

The Seal Beach-based cancer drugmaker unveiled a contract manufacturing and patient services division this month.

“Innovative cell therapies have the potential to change how we treat serious diseases, but there is currently insufficient capacity to meet anticipated industry demand,” Chief Executive Jason O’Neill said.

O’Neill joined Dendreon in mid-2020, tasked with improving commercial operations and building a second revenue stream. He was previously chief executive of breast cancer drugmaker Iridium Therapeutics and led Sanofi’s oncology portfolio for about six years, among other roles.

O’Neill said it quickly became apparent that Dendreon’s manufacturing division was a “hidden asset that was widely underutilized.”

The new division makes Dendreon one of four companies offering cell therapy manufacturing for commercial use in the U.S. Furthermore, it is the only contract manufacturer that has four successfully approved products and three manufacturing facilities, O’Neill said.

Market dynamics are also in Dendreon’s favor; there are over 220 cell therapies in Phase 2 and 3 trials moving through the regulatory approval process, he said.

Numerous Sales

The new line of business marks the latest chapter for Dendreon, which has seen numerous corporate changes over the past decade.

In 2010, Dendreon received FDA approval for its lead candidate, Provenge. The then Seattle-based company, which previously traded on the Nasdaq, saw its value soar to $6.7 billion. Provenge was thought to be the next big blockbuster: a personalized treatment for prostate cancer made with patient’s own white blood cells.

In mid-2011, the company opened a Seal Beach plant to manufacture Provenge after signing a long-term lease valued at $13.6 million and putting nearly $65 million worth of capital improvements into the area building.

Then it ran into manufacturing and reimbursement challenges, among other issues. The company cut 500 jobs as part of a 2011 restructuring plan and sold off its New Jersey plant in 2012.  

It ultimately filed for bankruptcy in 2014, and its market cap fell to $24 million.

Dendreon’s assets were sold for $495 million to Valeant Pharmaceuticals in 2015. Two years later, it traded hands for $820 million to China’s Sanpower Group. Less than a year after that, it sold once more, for $868 million to Nanjing Cenbest.

Proven Process   

Dendreon believes its experience dealing with manufacturing challenges, which included maintaining production of Provenge throughout the pandemic, makes it an ideal partner for late-stage cell therapy firms.  

“With more than a decade of proven expertise in cell therapy manufacturing and an established supply chain and logistics infrastructure, we have invested in an offering that fills an immediate market need in this rapidly expanding field,” O’Neill said.

The company’s headquarters—which runs about 180,000 square feet—will be the contract manufacturing services hub. Meanwhile, its Seattle facility will serve as the process development and manufacturing services center.

Dendreon’s recent pivot is similar to that of Tustin’s Avid Bioservices Inc. (Nasdaq: CDMO), which made the decision to focus on contract manufacturing in 2018. Avid’s shares have skyrocketed the past year, to a value approaching $1.5 billion.

“We are looking to establish partnerships with biopharmaceutical companies developing CAR-Ts, autologous, or allogeneic cell therapies,” Vice President of Business Development and Corporate Strategy Maria Cho said. “Looking ahead, we plan to continue to leverage our core capabilities as a growth engine for our strategic partners and the industry as a whole.” 

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