Arrowhead R&D lead steps down, biotech vets step in

hepatitis B virus
Hepatitis B virus (Institute for Molecular Virology - University of Wisconsin–Madison)

Californian RNA biotech Arrowhead will lose its chief operating officer and R&D head from next year but is hiring a new chief medical officer and a new chief scientific officer to help steady its research exec team.

Bruce Given, M.D., says he will retire May 1, 2020, after more than 30 years in the biopharma world and eight years at Arrowhead.

As he prepares to leave, the biotech is hiring Javier San Martin, M.D., as its new CMO and Curt Bradshaw, Ph.D., as CSO. They both start work Monday. Before hitting the exit, Given “will work closely with Dr. San Martin and Dr. Bradshaw to ensure a smooth transition and will also be retained in an advisory capacity for a period of at least one year following his retirement,” Arrowhead said in a statement.

San Martin previously served as senior vice president and head of global clinical development at Ultragenyx since 2013, where he led the development of burosumab, a drug later approved for the treatment of X-linked hypophosphatemia.

He also served a stint at Alder Biopharmaceuticals, where he was responsible for managing the medical, regulatory and clinical operations group focused on early clinical programs; and, from 2006 to 2011, he was a global development leader at Amgen, coming to the biopharma from Eli Lilly.

Bradshaw, meanwhile, was president, CSO and board member for Tollnine, a company he co-founded to develop antibody conjugates for immuno-oncology. He’s also served at Solstice Biologics, working on siRNA tech, along with a host of other biotech companies.

Arrowhead has endured a tough few years: The day before the last U.S. election in November 2016 (and the timing could only have been deliberate to minimize its impact), Arrowhead quietly posted the miserable news that its hepatitis B candidate, ARC-520, was placed under a clinical hold by the FDA after a number of nonhuman primate deaths in testing.

Then things got worse: A few weeks later, at the end of November of the same year, this candidate, along with a host of others and 30% of its staff, were put under the ax as the biotech sought desperately to refocus.

Much of its work had revolved around its EX1 delivery vehicle, but the drugs created under this system—hep B meds ARC-520 and ARC-521 as well as ARC-AAT for alpha-1 antitrypsin deficiency—were canned. ARC-520 had once been touted as a potential cure for hep B, with the entire company and its platform once said to be a trillion-dollar opportunity.

Cue its market cap falling hard, dipping under $90 million on the news. It ended the year at around $1.55 a share; at its 2016 peak back in August, it had been valued at more than $8 a share.

But it’s had a resurgence over the past two years, and in 2018 was back on the up when Johnson & Johnson paid $175 million and committed to $1.6 billion in milestones for Arrowhead’s second-attempt hep B drug ARO-HBV.

Since being in the doldrums in 2016, the company now has a market cap of more than $4.6 billion, although it shares were slightly off on the news this morning in premarket trading.

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Chris Anzalone, Ph.D., president and chief at Arrowhead, said: “On behalf of the whole Arrowhead team, I would like to thank Bruce for all of his contributions since he joined Arrowhead in 2011, and I look forward to his continued valuable input in the future. Bruce has been a strong contributor to the success of our R&D organization. His lasting legacy is a culture in R&D that rewards innovation and speed. In addition, he has helped to develop a strong team of leaders that enable Arrowhead to continue down that same path.

“I’m also happy to welcome Javier and Curt to the Arrowhead team. Both are highly accomplished and proven leaders who can provide strategic and operational guidance to both our research and development teams as we advance our growing pipeline of RNAi therapeutics that leverage our TRiM™ platform to target liver, lung, tumor, muscle, and additional extra-hepatic tissues.”

Given added: “I am very proud of what we’ve been able to build together at Arrowhead and I look forward to helping the team during the next six months and beyond, as needed, during my retirement. It has been particularly gratifying to see Arrowhead’s unwavering commitment to innovation during the good times and also the resilience needed to overcome challenging times, which biotechnology companies invariably experience. Javier and Curt share these same traits and I’m confident that they will be great additions to the Arrowhead team.”