Tom Riga, Spectrum Pharmaceuticals CEO
Covid-19 has been a rough go for many drugmakers, but few more so than Spectrum Pharmaceuticals, which has seen inspection delays and unwanted CRLs haunt its chance at a first approval. Feeling the sting, Spectrum will now downsize to keep the lights on through the year.
Spectrum will cut 30% of its workforce and pivot its R&D efforts around its two furthest-along drugs as part of a restructuring effort that will pave the company’s cash runway out into next year, it announced Wednesday.
In August 2021, the FDA handed Spectrum a CRL for a neutropenia drug set to be marketed as Rolontis, citing manufacturing issues in the drug’s application. The FDA ordered a re-inspection at the drug’s manufacturing site in South Korea — this after Covid-19 related travel restrictions for FDA inspectors pushed off Rolontis’ early review date by the agency.
Spectrum said it would prioritize its R&D efforts around getting Rolontis across the finish line as well as driving ahead on poziotinib, a TKI inhibitor candidate for HER2 exon 20-mutant non-small cell lung cancer. Spectrum CEO Tom Riga had this to say in a statement:
The decision to restructure the organization is necessary to focus on our advanced clinical programs that will drive our future growth. I would like to express my appreciation to our colleagues who are affected by this decision and are leaving Spectrum. We are grateful for their dedication and their contributions to advancing our mission. The changes we are implementing are expected to result in a reduction in operating expenses and the extension of the company’s cash runway into 2023.
As Rolontis and poziotinib get the upvote, Spectrum said it will ‘deprioritize’ development of its early-stage pipeline, which includes its FIT Program (IGN 002) and IL-12. Meanwhile, the company plans to ‘significantly reduce’ its footprint at selected facilities this year amid the cost-cutting efforts.
In all, the cuts will reduce Spectrum’s burn rate by about 20-25%, which the company expects will save enough cash to get it into 2023.
Shares in $SPPI, already well in penny stock territory, were trading down around 4% on the news Wednesday.
Their Staying Power Lies in their Patient-Centricity
Decentralized clinical trials (DCTs) were traditionally utilized in an isolated fashion prior to the COVID-19 pandemic. To continue their research within the constraints of the pandemic, sponsors and clinical investigators pivoted to a decentralized model out of necessity. At the onset, regulatory agencies offered some guidance on the digital approaches that are acceptable to ensure DCT approaches are applied in a way that maintains patient safety, as well as data quality and integrity.
Patrick Collison, co-founder of Stripe, has become one of Silicon Valley’s biggest advocates for new forms of funding and conducting science (Matt Winkelmeyer/Getty Images for WIRED)
It’s big days for biology.
The pandemic has seen a series of very public scientific breakthroughs: mRNA vaccine, Covid antibodies, CRISPR as therapy. The minds behind these advancements have graced magazine covers and received prestigious awards.
But the last two years have also, far more quietly, seen a series of new experiments in how to fund the next generation of scientific breakthroughs.
Since March 2020, investors, academics, a significant number of Silicon Valley types, at least one Russian billionaire and two crypto billionaires and, most recently, a few West Coast universities have launched a series of grant programs, institutes, NGOs and companies hoping to change how life science research is done. Though unaffiliated and varying greatly in both size and form, they have broadly promised to evade bureaucracy and misaligned incentives and advance both basic and not-so-basic research in ways they say can’t be done in either conventional academia or profit-focused biotech.
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The FDA this week announced further changes to revamp its structure, this time with alterations to its Office of the Chief Scientist that were agreed to by HHS late last month.
The FDA’s OCS has decided to shift its technology transfer program from the Office of Regulatory Science and Innovation to the OCS Immediate Office to further enhance the effectiveness of the agency’s outside partnership programs.
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Joshua Liang, Clover Biopharmaceuticals CEO
Business in China is booming, with more than a thousand biotech and biopharma companies — including some big multinational players — flocking to Zhangjiang Pharma Valley to take advantage of a growing talent pool in Shanghai.
Clover Biopharmaceuticals is the latest, announcing on Wednesday that it has begun construction on a new R&D center in Zhangjiang Hi-Tech Park. The Chinese biotech (which also has a corporate office in Boston) promises a state-of-the-art facility with new preclinical research labs, manufacturing process development labs, and a GMP pilot manufacturing plant.
Jeff Albers and Kate Haviland (Brad Bahner Photography/PR Newswire)
After a busy 2021 brought Blueprint Medicines its fourth FDA approval, the company is kicking off the new year with plans to shake up its C-suite.
Jeff Albers, Blueprint’s CEO for the past eight years, will be stepping down April 4 and transitioning to the executive chairman position, the biotech announced Wednesday morning. He will be replaced by COO Kate Haviland, who moves into both the chief executive and president roles. Christina Rossi also nabs a promotion from chief commercial officer to COO.
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For anyone who’s been following how the US government has been allocating and shipping supplies of its Covid-19 treatments over the past year, the news has shifted so many times that it can be difficult to keep track of what’s still being shipped and where.
More change is coming this week too, as HHS has now decided to re-start shipments of both Eli Lilly (bamlanivimab plus etesevimab) and Regeneron (casirivimab plus imdevimab) monoclonal antibody products after a short pause because neither product works against the new variant Omicron. Lilly’s combo also was halted last June due to the presence of other variants.
Kicking off 2022, hundreds of pharmaceuticals, including some blockbusters, saw their list prices rise by about 5% on average. But overall, net drug prices (cost after rebates) declined for the fourth year in a row, potentially complicating already stalled drug price reform efforts.
Among the drugs seeing new increases as of Jan. 1 are Gilead’s bevy of blockbuster HIV drugs.
Biktarvy, which pulled in more than $7 billion in worldwide sales in 2020, saw a 4.8% price increase in 2021, and now, another 5.6% increase in 2022, according to a new report from the nonprofit 46brooklyn Research.
All the big R&D trends are on display in this new list of drug approvals for 2021. Plus one.
Add up everything OK’d from CDER and CBER, and you have 60 new drug approvals for last year, topping the 59 in 2020. That’s a close second to the 64 OKs that came out of the FDA in 2018. The dark days of the early 2000s are a distant memory now, with a host of hungry upstarts promising to make their own entries one day as Big Pharmas double down on innovation.
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Annexon has some disappointing news, and it is evident at the Nasdaq.
Annexon, which went public back in 2020, had its share price $ANNX tumble more than 30% down to $7.30 on Wednesday after several patients discontinued treatment in a Phase II clinical trial for Huntington’s disease.
The drug candidate, ANX005, is a C1q blocker that was being designed and tested to disrupt Huntington’s disease. And while Annexon claimed the drug had shown improvement in more than half of patients after six months, five patients withdrew from the treatment — three due to a drug-related adverse event, two of which were considered serious adverse events, including systemic lupus erythematosus and idiopathic pneumonitis. Annexon said that after post-study drug discontinuation, one patient had symptoms resolved and the other patient stabilized.
https://endpts.com/spectrum-hits-the-reset-button-slicing-away-30-of-its-workforce-in-pivot-around-2-lead-assets/
