Johnson & Johnson said today it has ended development of the rheumatoid arthritis candidate sirukumab, and halted a Phase II/III trial of the acute myeloid leukemia (AML) candidate talacotuzumab—both of which the pharma giant had touted as potential blockbusters just five months ago.
Sirukumab had been under development by J&J’s Janssen Biotech for moderate-to-severely active rheumatoid arthritis, but was rejected on September 22 by the FDA, which instead issued a complete response letter requesting additional clinical data to further evaluate the drug’s safety.
“We maintain our belief in the efficacy and safety of sirukumab,” Janssen said in a statement. “However, the need for additional clinical data would result in significant delays to patient access in parts of the world. Given this, as well as the availability of other treatments targeting the IL-6 pathway, Janssen has made a strategic decision to prioritize other assets in our portfolio.
“We are disappointed that we were not able to meet the needs of rheumatoid arthritis patients with sirukumab, yet remain deeply committed to research and development of transformational medicines for people around the world,” Janssen added.
The decision to scrap sirukumab came more than a month after the FDA’s Arthritis Advisory Committee voted 12-1 against recommending approval based on its safety data. The data showed that of the 35 patient deaths reported in sirukumab clinical trials, all but one (34) occurred in patients treated with sirukumab. However, the panel acknowledged that the drug’s efficacy was sufficient for authorization.
The FDA panel vote occurred a week after GlaxoSmithKline (GSK) said it would end its collaboration with J&J to develop sirukumab—one of more than 30 clinical and preclinical programs GSK terminated because the company deemed them “unlikely to generate sufficient returns,” adding: “The Group is making a number of choices to prioritize the strongest assets and markets in its portfolio and move capital and resources away from those that offer more limited opportunities.”
J&J had developed sirukumab through a partnership with GlaxoSmithKline (GSK) launched in 2011. GSK gained exclusive rights to commercialize sirukumab in North, Central, and South America, while Janssen retained commercialization rights in the rest of the world, including Europe.
Janssen submitted the Biologics License Application for sirukumab in September 2016, based on data from the five Phase III trials comprising the SIRROUND clinical development program—SIRROUND-D, SIRROUND-T, SIRROUND-H, SIRROUND-M, and SIRROUND-LTE.
On May 17, J&J included sirukumab among pipeline drugs that it anticipated “will be approved and launched later this year.” Sirukumab was one of more than 10 drugs “with blockbuster potential” that J&J had planned to either launch or file for regulatory approval between 2017 and 2021, the company said.
A consensus of analyst data analyzed by Thomson Reuters had projected sirukumab average global sales to reach about $450 million by 2020, though peak-year projections stretched as high as $5.5 billion.
Sirukumab—which J&J had planned to market under the name Plivensia™—was an anti-interleukin (IL)-6 human monoclonal antibody indicated for moderately to severely active RA in adults who have had an inadequate response or are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).
2013 License Agreement
Talacotuzumab, also known as JNJ-56022473 (and formerly CSL-362) is a humanized IgG1 monoclonal antibody designed to bind to and neutralize CD123 (Interleukin-3 receptor alpha chain or IL3RA) with potential antineoplastic activity.
J&J’s Janssen Biotech has been developing talacotuzumab snice 2013 under an exclusive worldwide license from CSL. Janssen agreed to pay CSL a license fee and payments tied to achieving development, regulatory and sales milestones, all undisclosed, plus royalties on sales.
As of September 14, Janssen had not recruited patients for a Phase II/III trial (NCT02472145) whose first part was designed to assess the safety of talacotuzumab monotherapy and confirming a recommended Phase II dose (RP2D) in participants with AML for whom experimental therapy is appropriate. The trial’s second part was intended to assess complete response rate and overall survival in participants with AML who were not eligible for intense induction chemotherapy and who were randomly assigned to receive decitabine plus talacotuzumab at the RP2D or decitabine alone.
Enrollment for the trial had been projected to reach 326, with an estimated primary completion date of January 25, 2018.
J&J first announced its decisions in a single paragraph tucked into its announcement of third-quarter results. J&J finished the third quarter with net earnings of $3.8 billion, down 12% from $4.27 billion in Q3 2016—though adjusted net earnings, excluding after-tax intangible amortization expense and special items, rose 11% year-over-year to $5.2 billion. Q3 sales rose 10% from a year ago to $19.7 billion, above analyst expectations.
J&J raised its investor guidance for 2017, with the company raising its sales forecast to between $76.1 billion and $76.5 billion, up from between $75.8 billion to $76.1 billion. Also raised was J&J’s guidance on 2017 adjusted earnings, to between $7.25-$7.30 per share from between $7.12-$7.22 per share.