Marking the latest Alzheimer’s disease (AD) disappointment, Eli Lilly and Co.’s solanezumab failed in a phase III trial to slow progression of cognitive decline in patients at the preclinical stage of the disease – those with amyloid plaque but no clinical symptoms – prompting the company to terminate development. The Indianapolis-based company is turning its attention instead to phase III AD products donanemab and remternetug.
U.S. Sen. Bernie Sanders (I-Vt.) sent letters to Sanofi SA and Novo Nordisk A/S executives on March 1, urging them to follow Eli Lilly and Co.’s example in cutting prices for their insulin products, offering more affordable access for Americans with diabetes. Industry leaders, however, have long argued that the problem goes far beyond list price, as pharmacy benefit managers and health plans have simply not passed their rebates onto consumers.
As several key revenue-driving products fall off patent in coming years, pharmaceutical companies are increasingly focused on mechanisms by which they can draw innovation to them. What launched as the Partner of Choice organization, for example, has now become the newly named Pfizer Ignite model – an end-to-end engine designed to bring innovation to the pharmaceutical company in return for services.
With a $200 million oversubscribed and upsized series A round completed, Cargo Therapeutics Inc. will advance its autologous CD22 chimeric antigen receptor (CAR) T-cell therapy, CRG-022, which has breakthrough therapy designation in the U.S. “The proceeds are critical for us,” said Gina Chapman, CEO of San Mateo, Calif.-based Cargo. “We will demonstrate manufacturability this year and kick off the pivotal phase II.”
As broader markets struggled throughout 2022, the biopharma industry’s largest and most lucrative companies ended the year in a strong position, according to BioWorld’s Biopharmaceutical Index (BBI), which showed the 22 component stocks climbed by 17.3% throughout the year. Neither the Nasdaq Biotechnology Index (NBI) nor the Dow Jones Industrial Average (DJIA) demonstrated such gains. They were down by 10.9% and 8.8%, respectively. All three indices, however, are following the same path in 2023, shooting up throughout the month of January and back down in recent weeks.
San Diego-based Travere Therapeutics Inc. gained U.S. FDA accelerated approval for its dual endothelin angiotensin receptor antagonist, Filspari (sparsentan), to reduce proteinuria in adults with primary IgA nephropathy, or Berger’s disease.
The Biotechnology Innovation Organization (BIO) found in a new study that 77% of clinical programs focused on pain therapeutics five years ago are no longer active and that financings of companies working in the space are lackluster at best. Meanwhile, oncology companies, targeting an overall smaller market, have raised huge sums of venture capital money, $9.7 billion in 2021 vs. pain and addiction companies’ $228 million.
With the passage of the Inflation Reduction Act in the U.S. in August 2022, biopharma company leaders have re-evaluated pipelines, sought legal advice, and discussed ways to mitigate the potential impacts the legislation will have on pricing therapies and extending their reach to new indications.
The market downturn has left many biopharma companies searching for new ways to raise funds, with some eyeing the strong venture capital market as a potential resource. But having a disruptive technology and solid data may be the best way to stand out in a sea of companies, say financial executives that participated Feb. 6 in a panel discussion during the first full day of the BIO CEO 2023 conference in New York.
Starting out the year slow, biopharma financings are about 22% below where they were at the end of January last year, and they are well behind the first month of the previous two years as well, suggesting company executives may need to continue to prioritize costly programs as resources are depleted – at least for the near future.
