Amgen may see $3B+ in additional taxes; EQRx, AbCellera ink antibody development deal
Alongside the release of its Q2 results late Tuesday, Amgen also signaled that it’s defending what could be a sizeable chunk of cash that it owes the IRS.
Last month, the company said it filed a petition in the US Tax Court to contest notices of deficiencies received from the IRS over three years in the early 2010s.
“These notices seek to increase our U.S. taxable income by an amount that would result in additional federal tax of approximately $3.6 billion, plus interest. Any additional tax that could be imposed would be reduced by up to approximately $900 million of repatriation tax previously accrued on our foreign earnings,” the company said, adding, “We firmly believe that the IRS’s positions in the notices are without merit and we will vigorously contest the notices through the judicial process.”
SVB Leerink analyst Geoffrey Porges did not mention that potential tax bill in a note on the earnings Wednesday, but called it a “lackluster quarter” for the California-based company. He also explained how Amgen is in rebuilding mode, as it’s restocking its early-stage pipeline with a string of acquisitions. “The company could be well positioned by 2023 or 2024 when the fruits of those acquisitions and collaborations, and of their long standing investment in bispecifics and novel immunological medicines, approaches fruition,” he wrote.
Shares of BeyondSpring skyrocket on new, positive cancer drug trial results
About five years since it filed for an IPO, pharma company BeyondSpring is hitting the big time. The New York-based company saw shares of its stock spike by more than 320% at one point on Wednesday morning as it reported positive Phase III results for its first-in-class selective immunomodulating microtubule-binding agent plinabulin in combination with docetaxel to treat 2nd and 3rd line NSCLC (EGFR wild type) compared to docetaxel alone.
The company said that in a trial of 559 patients, the drug combination met the primary endpoint of increasing overall survival (p = 0.03) and met key secondary endpoints, including significantly improving ORR, PFS and 24- and 36-month OS rates, and significant reduction in the incidence of Grade 4 neutropenia.
Josh Schimmer at Evercore ISI noted that the positive data was very unexpected and moved his peak sales projection on the drug up to $2 billion.
Trevor Feinstein of the Piedmont Cancer Institute and a principal investigator of the trial said in a statement: “The treatment of 2nd and 3rd line NSCLC, especially with EGFR wild type where tyrosine kinase inhibitors do not work, is an area of severe unmet medical needs. Now that checkpoint inhibitor immunotherapy has moved into first line, there is a vacuum in this indication, where treatment is heavily centered around docetaxel.”
EQRx and AbCellera ink antibody development deal
Drug pricing disruptor EQRx, which has made clear its mission to aggressively discount markets dominated by expensive drugs, on Wednesday announced another AI-powered partnership, this time with therapeutic antibody developer AbCellera.
As part of an effort to expand EQRx’s early-stage pipeline, the new partnership will seek to identify novel antibody drug candidates, beginning in the fields of oncology and immunology. Financial details of the partnership were not disclosed.
The deal includes the option for additional investment from AbCellera at progressive stages of preclinical development, clinical development, and commercialization in exchange for an increased share of product sales.
Previously in June, EQRx launched a partnership with UK-based AI specialist Exscientia in search of other discovery opportunities. Meanwhile, EQRx’s first target is PD-1, which despite seven drugs on the market hasn’t seen pricing discounts. In May, EQRx and partner CStone read out late-stage data showing their PD-1 drug sugemalimab hit its primary endpoint of progression-free survival as a consolidation therapy for patients with stage III non-small cell lung cancer whose disease hasn’t progressed after concurrent or sequential chemoradiotherapy.
Kyowa Kirin and Synaffix sign ADC agreement
While financial details were not disclosed, Synaffix will initially provide target-specific rights to its proprietary ADC technologies in exchange for a license signature fee, enabling Kyowa Kirin to evaluate two of its antibodies as potential therapeutic candidates. The deal builds off an earlier research agreement between the two companies.
Kyowa Kirin said it may expand the deal with additional ADC targets, and if it does, Synaffix is eligible to receive a license issuance fee for each additional target and milestone payments plus royalties on potential future commercial sales of ADCs developed against each licensed target.
Peter van de Sande, CEO of Synaffix, said in a statement, “This collaboration is our sixth announced out-licensing deal, expanding the geographic footprint of and validation of our ADC technologies. At the same time, this brings the number of ADCs in development based on Synaffix’ technologies beyond 10, with three of those partnered programs already in clinical trials.”
Sarepta adds new gene therapy to treat genetic neuromuscular disease
Building on its work related to Duchenne muscular dystrophy, Sarepta Therapeutics on Wednesday executed an exclusive license agreement for an investigational gene therapy, known as calpain 3, to treat a genetic neuromuscular disease known as Limb-girdle muscular dystrophy type 2A.
The gene therapy was initially developed by the Abigail Wexner Research Institute at Nationwide Children’s Hospital, and the partnership between Sarepta and Children’s dates back to 2019.
LGMD2A is caused by mutations in the CAPN-3 gene and is the most common type of LGMD, accounting for almost a third of cases. Sarepta did not disclose any plans for how it will take calpain 3 into the clinic.