Pneumococcal 15-valent Conjugate Vaccine(Merck & Co.)

CAPVAXIVE is the sixth FDA-approved product to utilize the Pfenex Expression Technology® platform Ligand is entitled to a royalty on worldwide net sales of CAPVAXIVE JUPITER, Fla.--(BUSINESS WIRE)-- Ligand Pharmaceuticals Inc. (Nasdaq: LGND) today announced that its collaborator Merck & Co., known as MSD outside the United States and Canada, has received approval from the U.S. Food and Drug Administration (FDA) for CAPVAXIVE™, previously known as V116, a 21-valent pneumococcal conjugate vaccine for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in the adult population. The indication for pneumococcal pneumonia is under accelerated approval. The FDA approval of CAPVAXIVE triggers a $2 million milestone payment to Ligand and the company is entitled to a royalty on worldwide net sales. “We are excited to see our longstanding collaborator Merck receive regulatory approval for CAPVAXIVE,” said Todd Davis, CEO of Ligand. “We believe this asset will be an important contributor to our portfolio, which includes more than 25 commercial products including two marketed by Merck.” CAPVAXIVE utilizes the PeliCRM197® carrier protein which helps enhance antigen immunogenicity in conjugate vaccines. PeliCRM197 is produced using the Pfenex Expression Technology® platform which Ligand initially acquired in 2020 and ultimately spun out to Primrose Bio in September 2023. As part of the Primrose Bio transaction, Ligand retained the existing commercial royalties related to the Pfenex Expression Technology including CAPVAXIVE. Ligand will now collect commercial royalties on six products developed with the Pfenex Expression Technology, including Merck’s CAPVAXIVE and VAXNEUVANCE®, Jazz Pharmaceuticals’ RYLAZE®, Alvogen’s Teriparatide Injection, and Serum Institute of India’s Pneumosil® and MenFive® vaccines. About Ligand Pharmaceuticals Ligand is a biopharmaceutical company enabling scientific advancement through supporting the clinical development of high-value medicines. Ligand does this by providing financing, licensing our technologies or both. Its business model seeks to generate value for stockholders by creating a diversified portfolio of biopharmaceutical product revenue streams that are supported by an efficient and low corporate cost structure. Ligand’s goal is to offer investors an opportunity to participate in the promise of the biotech industry in a profitable and diversified manner. Its business model focuses on funding programs in mid- to late-stage drug development in return for economic rights, purchasing royalty rights in development stage or commercial biopharmaceutical products and licensing its technology to help partners discover and develop medicines. Ligand partners with other pharmaceutical companies to leverage what they do best (late-stage development, regulatory management and commercialization) in order to generate its revenue. Ligand’s Captisol® platform technology is a chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Ligand has established multiple alliances, licenses and other business relationships with the world’s leading biopharmaceutical companies including Amgen, Merck, Pfizer, Jazz, Takeda, Gilead Sciences and Baxter International. For more information, please visit Follow Ligand on X @Ligand_LGND. 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These forward-looking statements include: the timing and amount of milestone payments Ligand expects; the potential royalties to be paid on sales of CAPVAXIVE by Merck; the submission of any CAPVAXIVE supplemental regulatory licensure application with the FDA; and the intellectual property protections with respect to Primrose Bio’s Pfenex Expression Technology® platform. Actual events or results may differ from Ligand’s or its partner’s expectations due to risks and uncertainties inherent in Ligand’s and its partner’s business, including, without limitation: Merck may not be able to successfully commercialize CAPVAXIVE which will depend on a number of factors including coverage and reimbursement levels from governmental authorities and health insurers as well as market acceptance by healthcare providers; the market size for CAPVAXIVE may be smaller than estimated; Ligand is dependent on Merck for the commercialization of CAPVAXIVE; and other risks described in Ligand’s prior press releases and filings with the Securities and Exchange Commission available at . Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Merck has gained FDA approval for the first pneumococcal vaccine geared to the elderly, Capvaxive (V116). The FDA has approved the world’s first pneumococcal disease vaccine designed for adults, signing off on Merck’s Capvaxive (formerly V116) and positioning it to become the primary shot used by seniors to protect against the bacterial infection. While the nod applies to people at least 18 years of age, Capvaxive is specifically adapted for patients age 50 and older as the 21 serotypes it covers account for 84% of the pneumococcal disease of people in the age group, according to epidemiologic data from the CDC. This compares to a 52% figure in the same population for the 20 serotypes covered by the world’s dominant pneumococcal disease vaccine, Pfizer’s Prevnar 20, which is allowed both in children and adults. There have not been any studies conducted to compare the efficacy of Capvaxive and Prevnar 20. The approval of Capvaxive is backed by four phase 3 trials, including one that pitted it against Prevnar 20 on immune responses. The study showed V116’s non-inferiority in the 10 serotypes common to both vaccines and superiority in 10 of its 11 unique serotypes.  “We have eight serotypes in V116 that are not in any currently licensed vaccine. Those eight serotypes are responsible for 30% of invasive pneumococcal disease in adults 65 years of age and older,” Heather Platt, M.D., Merck’s pneumococcal vaccine lead, said in an interview with Fierce Pharma ahead of the approval. The accelerated nod for Capvaxive remains contingent upon verification of clinical benefit in a confirmatory study. On June 27, the CDC will assemble the Advisory Committee on Immunization Practices (ACIP) to discuss recommendations for the use of Capvaxive. Merck took the lead in developing a pneumococcal vaccine for adults and now stands to benefit as other companies developing shots for adults in the indication lag behind. The most serious challenger is likely California biotech Vaxcyte, which is developing a 24-valent shot which covers all the serotypes in Prevnar 20, plus four unique strains, and has fared well in a phase 2 trial against the Pfizer powerhouse. The company also has a 31-valent pneumococcal vaccine in its pipeline. The development of a pneumococcal shot adapted for adults has been a long time coming. The first vaccine for the infection, a polysaccharide type, hit the market in 1977. When the first conjugate vaccine, Prevnar 7 (PCV7), arrived in 2000, it significantly reduced the disease burden in both children and adults. But while subsequent conjugate vaccines with added serotypes were increasingly effective in protecting children, the same was not true for their efficacy in adults and it’s taken researchers a while to figure out why. “What’s happened over time, because we have the ability to look at good surveillance data, what we’ve seen is that the serotypes causing disease in children are actually different than the ones causing disease in adults,” Platt said.   There are more than 150,000 adults each year in the United States who are hospitalized with pneumococcal disease. With serious complications including bacteremia and pneumococcal meningitis, the case death rate for those hospitalized is 14%. Since the development of pneumococcal disease vaccines began, protecting children has been the paramount concern. But in recent years, that has begun to change, according to Platt. “As we meet with the CDC work group and listen to the discussions at ACIP, there is a growing understanding of the value of adult vaccination,” Platt said. Merck will target a variety of individuals with Capvaxive. In the U.S., approximately 34% of adults age 65 and older have never received a pneumococcal shot. But even those who have been vaccinated can benefit from Capvaxive and the new serotype protection that it provides, Platt said. There also is a significant population of adults of all ages who have chronic medical conditions—such as lung disease, liver disease, heart disease—who are at increased risk if they contract pneumococcal disease. Of this group, only 22% have been vaccinated for pneumococcal disease. “We have to understand, what’s the best way to create opportunities for protection,” Platt said. “Do people have access? Is it because they can’t get to the pharmacy? Or do they not understand that this is an important vaccine that can help prevent disease?” Merck now has a chance to grab a larger share of the pneumococcal vaccine market. In 2023, the company scored $665 million in sales of its 15-valent pneumococcal shot Vaxneuvance (formerly V114), which was approved in 2021. While the Prevnar franchise still is the market dominator with sales last year of $6.4 billion, Merck’s shot has contributed to a slowdown in the Pfizer product’s sales growth from 20% in 2022 (PDF) to 2% last year. “V116 is an adult-specific vaccine. It’s intended to complement those pediatric vaccines which are critical to protection,” Platt said. “We’re looking forward to the ACIP vote with the intent of improving public health.”