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The Readout Damian Garde

Soon-Shiong’s ‘moonshot’ may not have left the atmosphere

Four years ago, Dr. Patrick Soon-Shiong promised to “develop an effective vaccine-based immunotherapy to combat cancer by 2020.” Cut to the present and the billionaire’s initiative has been largely silent, with all signs pointing to marginal progress at best.

As STAT’s Rebecca Robbins reports, Soon-Shiong had promised to enroll 20,000 cancer patients in trials testing novel approaches to the disease. According to public records, his initiative has recruited about a quarter of that at most. And the resulting data come from small, uncontrolled trials, leaving outside experts dubious of the effort.

In the meantime, Soon-Shiong’s major bets in biotech have languished. NantHealth, which sells software and diagnostic tests, and NantKwest, an immunotherapy company, have each lost more than 90% of their market value since going public.

Read more.

Boring news is bad news in biotech

Spare a thought for Dan Faga and Ben Hickey, the latest additions to the C-suite at Mirati Therapeutics. The Monday press release announcing their hiring called them “accomplished executives with proven expertise,” and then it sent Mirati’s share price down about 10%.

That’s not a referendum on each person’s talents but rather a market inference: If Mirati is hiring leaders for the long term, it’s probably not in the midst of a buyout negotiation. And if there’s no imminent takeout, then the company can’t be worth its previously rosy valuation.

As STAT’s Adam Feuerstein points out, the Mirati mini-story is illustrative for the state of biotech in 2020. The sector’s late-year surge was driven in part by an expectation of high-dollar M&A, which means a lot of companies have buyouts priced into their valuations. And thus when companies do quotidian company stuff, like hiring executives or attending conferences, their stock prices can only go in one direction.

Read more.

How worried should Alexion be?

Yesterday, a company called Apellis Pharmaceuticals said its late-stage rare disease drug outperformed Alexion Pharmaceuticals blockbuster Soliris in treating a rare blood disease. Just what that means for Alexion’s future remains a matter of debate.

The news, as STAT’s Kate Sheridan reports, is that Apellis ran a trial testing its drug, pegcetacoplan, head to head against Soliris for patients with paroxysmal nocturnal hemoglobinuria, or PNH. In the end, patients on Apellis’s drug saw a significant improvement in hemoglobin levels, a key metric for treating the disease.

According to Baird analyst Madhu Kumar, that means Apellis will likely claim about one-third of the PNH market within three years of its launch, which would mean hundreds of millions in revenue. SVB Leerink’s Dae Gon Ha was more cautious, however, pointing to the fact that Apellis’s drug had higher rates of injection site reactions and diarrhea, safety issues that might slow its commercial uptake.

Read more.

Here’s something 215 biotech leaders signed

It’s called “A new biotechnology and pharmaceutical industry commitment to patients and the public,” and it contains a promise to price drugs in line with their value, take only “reasonable” price increases, and more broadly “develop medicines with patients as our primary concern.”

Unlike Allergan’s old “social contract,” which promised to limit annual price increases to 9.9%, this document doesn’t include any numerals. And it arrives with plenty of linguistic wiggle room. Launch prices, for example, “will reflect innovation and value to patients,” and the undersigned promise to support the use of biosimilars “after legitimate patent and regulatory protections expire.” One can imagine a kaleidoscope of definitions for “innovation” and “legitimate.”

One thing does stand out: In the final bullet point, the signatories promise to “speak out about and not tolerate companies and other stakeholders who abuse this commitment to patients, and who abuse policies aimed at fairly rewarding innovation.” With a few hoodie-clad exceptions, biotech executives have long been happy to speak in general about so-called bad actors but rarely willing to name names. If any of the 215 leaders above are planning to change that, things could get interesting.

More reads

  • Conservative group with pharma ties makes clear there are drug pricing reforms they can support. (STAT)
  • Fred Hutch names Thomas Lynch new president. (GeekWire)
  • Pear Therapeutics licenses voice biomarkers for dementia and psychiatric disorders. (STAT Plus)
  • A Q&A with FDA’s Amy Abernethy on how the agency is grappling with digital health regulation. (STAT Plus)

Thanks for reading! Until tomorrow,

Wednesday, January 8, 2020

STAT

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