Cut costs by US$1 billion and plan to launch 10 products | Wilnesh News

modern The company said Thursday it plans to cut spending by about $1.1 billion in 2027 and win approval for several new products as it charts a path forward after a rapid decline in business due to the coronavirus pandemic.

The biotech company said it expects to have 10 new products approved by 2027. “Pace yourself” in terms of R&D spending.

The company aims to cut R&D spending to $3.6 billion to $3.8 billion by 2027, down from $4.8 billion expected by the end of this year, according to a press release.

“You’re going to start to see things go down because there are studies that we’re basically going to end and not start,” Moderna CEO Stefanne Bancel told CNBC, adding that the company was moving its potential product portfolio into use. This refers to a class of viruses that can linger in a patient’s body for long periods of time without causing any symptoms, but can reactivate later in a patient’s life and cause serious health complications.

Also on Thursday, Moderna announced positive late-stage trial results for its vaccine targeting the high-risk respiratory syncytial virus Adults ages 18 to 59, plan to apply for approval for that age group this year. It also released positive data on an experimental stand-alone flu vaccine for adults 65 and older.

The company announced the updates Thursday at its annual R&D Day investor event in New York, which focused on its product pipeline and long-term business updates. About four months ago, U.S. regulators approved Moderna’s RSV vaccine for older adults, the second commercial product after a Covid vaccine.

The company said it currently has five respiratory shots with positive Phase 3 results and expects to submit three of them for approval this year. These include Moderna’s combination vaccine against COVID-19 and influenza, which is expected to apply for approval in the United States this year, as well as a more effective version of the COVID-19 vaccine.

Moderna also has five non-respiratory products involving cancer, latent viruses and rare diseases that could be approved in 2027, according to a company release.

The company expects revenue to reach $2.5 billion to $3.5 billion in 2025. From 2026 to 2028, Moderna expects a compound annual growth rate of more than 25% as new products are launched.

Bancel said the company’s success rate in developing drugs from Phase I to Phase III is “six times higher” than other companies in the biotech and pharmaceutical industries.

“This is really a fantastic achievement by the team and leaves us with a lot of effective drugs, which is why we need to pace ourselves in terms of R&D investment,” he told CNBC.

Moderna presented new data on its RSV vaccine, mRESVIA, which has been approved in the U.S. and EU for use in adults 60 years and older.

The company said the vaccine met all key efficacy goals in an ongoing Phase 3 study of adults ages 18 to 59 who are at higher risk of severe illness from the virus. Moderna added that no safety concerns were observed.

Currently, there are no RSV shots approved globally for use in younger, high-risk adults, such as those with weakened immune systems or chronic conditions such as asthma and diabetes. Moderna’s main competitor in the RSV field, Pfizer and GSKis also seeking to expand approval to that age group.

Bancel said the company plans to use “priority review vouchers” when seeking approval for people ages 18 to 59, which will reduce the time it takes the Food and Drug Administration to review the product. Six months instead of ten. Moderna hopes the agency will approve mRESVIA in this age group in time for the 2025 RSV season.

“Millions of people could benefit… We also do this to be competitive in the marketplace because if you’re a large retail pharmacy you want your product to be available to every customer that shows up. ,” Bancel said.

But the company also stopped developing an RSV vaccine for infants under 2 years old based on “emerging clinical data.”

Moderna said its experimental standalone flu vaccine, mRNA-1010, produced a higher immune response to the virus in a recent Phase 3 trial than existing flu shots. The company added that the vaccine also demonstrated “consistently acceptable safety and tolerability” in three late-stage trials.

Meanwhile, Moderna said it plans to “immediately” move a vaccine against norovirus, a highly contagious stomach bug that causes vomiting and diarrhea, into Phase 3 trials. Bancel said he believed the company could complete the study within a year and submit an application for approval immediately if the data were positive.

“This is probably a product that’s two years away from being on the market, which is good because there are currently no drugs to treat norovirus,” he said. “A lot of health care workers have been infected by patients.”

Moderna is also working with Merck on a personalized cancer vaccine that is being studied in combination with Keytruda in patients with different forms of the disease.

The companies are conducting a Phase 3 trial in patients with the fatal skin cancer and are discussing approval with regulators based on interim study data for the vaccine.

But Moderna said the FDA “does not support” so-called accelerated approval of the vaccine based on available data. This refers to a designation by the FDA that allows a drug to be approved more quickly if it meets an unmet medical need for a serious disease.

“We will continue to have discussions with regulators,” Bancel said, and “we will also generate additional data.”