endreon chairwoman figures Provenge growth, infrastructure can pave its way into CAR-T

About a year after taking in Dendreon from debt-laden Valeant for $820 million, Chinese conglomerate Sanpower is pushing for its expansion agenda. It's looking to maintain 10% annual revenue growth from its prostate cancer immunotherapy Provenge, to win approval for the therapy in China and beef up its portfolio with a buy in the cell therapy field.

Grace Xu, Sanpower’s SVP for biomedicine business and Dendreon’s chairwoman, recently laid out her company's plans to FiercePharma on the sidelines of the 9th Annual China Healthcare Investment Conference in Shanghai.

Provenge revenue growth

When Sanpower completed the Dendreon transaction last June, Valeant estimated revenue in the second half of 2017 would be around $170 million. Without giving the exact numbers, Xu told FiercePharma that it has achieved that target, with annual profit of over $100 million.

Combine that with the $161 million Valeant reported for the first six months, and Provenge has achieved about 10% annual sales growth compared with 2016’s $303 million. The company expects to maintain that momentum for some time, and it has a few reasons to back that up.

Calling Provenge "a good product [originally] not being handled commercially in the right way," Xu said the old Dendreon was like a group of scientists trying to sell drugs: a difficult task for any drug, let alone a novel treatment with a much more complex manufacturing and administration. The National Comprehensive Cancer Network "category 1" recommendation for Provenge wasn’t properly used, Xu said, and the time required to win reimbursement was daunting for doctors. All that hobbled Provenge’s efforts to gain traction, giving rivals in Johnson & Johnson’s Zytiga, and Astellas and Pfizer’s Xtandi, the opportunity to swoop in and gain firm footholds.

Although that window for first-to-market advantage has already closed, Dendreon recently breathed a long sigh of relief as a potential direct competitor, Bavarian Nordic’s cancer vaccine candidate Prostvac, failed a closely watched phase 3 as a monotherapy in advanced prostate cancer, also dimming its hopes in combination therapies. Even if Prostvac finally shows some worth alongside other immuno-oncology agents, without any head-to-head data, Xu expects the product won’t pose a threat to Provenge in at least the next five years.

What’s more, Valeant did its part straightening out Provenge’s commercial activities during its short two years in command. Xu said current bill-to-payment is kept within around a month. Meanwhile, the company recently revealed some positive real-world data to underscore effectiveness, and it's informing physicians and also looking to build new DTC campaigns to get more sign-ups. Parent Sanpower Group, which owns hospitals in China, might also be able to help out in that country.

"Provenge is a mature, long-lived asset with natural barriers to entry," said Xu. "It is significantly underpenetrated today, with only 8% penetration, allowing for substantial upside."

Xu said they’re also evaluating Provenge’s potential in the early stage of the disease—a market she said is four times the size of mCRPC—and hope to expand its indication around 2022 to 2023.

A plan for China

As a subsidiary of a Chinese company, going into China is the obvious next step for Dendreon. Earlier this year, the company consulted with China FDA’s Center for Drug Evaluation on a clinical plan to get Provenge approved there, and it is on track to initiate a study early next year, said Xu.

Because Provenge is already an established product in the U.S., not much additional data will be needed, Xu said. The plan is to launch Provenge on the Chinese mainland by the end of 2020. As for pricing, the company intends to wait until the expected Chinese approval of Bristol-Myers Squibb's immunotherapy Opdivo and use that price tag—as compared to the BMS product's U.S. price—as a reference.

Before a full China rollout, Hong Kong, S.A.R., China will first help Dendreon accumulate commercial operation experience with cell-based products—and gather real-world data—in Asian territories. As Hong Kong, S.A.R., China recognizes clinical data used to gain approval in the U.S., no additional clinical studies are required there, and after a local GMP permit and a few test production batches, Provenge will likely be available there next year, according to Xu.

The company has already acquired a 1,000-square-meter lab in Hong Kong, S.A.R., China to make Provenge and potentially other cell therapies, and expects to finish construction of a GMP-compliant facility in Shanghai’s biotech hub Zhangjiang in about two months to supply the mainland. If Sanpower can move some of Provenge’s manufacturing to China, that would cut the cost of supplying other markets, too.

What’s outside of Provenge?

When Sanpower reached out to analysts about a potential buy for Dendreon, many advised against it, and many were surprised at the $820 million price tag as compared to the $495 million Valeant paid to acquire it in 2015. But Xu disagreed. To her, Dendreon ticked all the boxes for Sanpower’s break into biopharma therapeutics.

"First, we can’t afford or handle a company like Kite or Juno," said Xu. "And Dendreon has the entire infrastructure available for purchase, from research to clinical development, to manufacturing sites along with their technology; it has a novel, long-acting drug, with commercial capability and experience, and it’s financially self-sustained."

Now all these assets will serve Dendreon’s growth ambition: a move into the hot oncology area of cell therapies of the CAR-T or TCR-T variety. With FDA-approved manufacturing sites familiar with products made by tweaking patients’ own cells, Dendreon could immediately get on with such products, said Xu. The company is actively looking to in-license or purchase a candidate in the field, and intends to explore further within uro-oncology, where it is currently more comfortable.

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