Human papillomavirus 9-valent vaccine, recombinant (Merck Sharp & Dohme)

RAHWAY, N.J.--( BUSINESS WIRE )--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive top-line results from its pivotal Phase 3 trial (V503-064) evaluating the company’s 9-valent Human Papillomavirus (HPV) vaccine, GARDASIL ® 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) in Japanese males ages 16 to 26 years. The trial met its primary and secondary endpoints demonstrating that administration of a 3-dose regimen of GARDASIL 9 reduced the combined incidence of anogenital persistent infection caused by 9 types of HPV compared with a placebo. “ A decade after the first approval of GARDASIL 9, Merck continues to evaluate this important vaccine in additional patient populations and remains committed to helping prevent certain HPV-related cancers through broad and equitable access globally,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “ These data build on the clinical efficacy of GARDASIL 9 for the prevention of persistent infection in males and can potentially make a significant impact in addressing the global burden of certain HPV-related cancers and diseases.” Merck plans to share these data with regulatory authorities in Japan and other countries around the world to support licensure for use in males. The full results also will be presented at an upcoming scientific congress. The clinical development program evaluating GARDASIL 9 in males also includes an ongoing confirmatory Phase 3 trial evaluating efficacy in preventing HPV oral persistent infection to support effectiveness against HPV-related oropharyngeal and other head and neck cancers ( NCT04199689 ). About V503-064 V503-064 is a Phase 3, double-blind, placebo-controlled clinical study ( NCT04635423 ) to evaluate the safety/tolerability and efficacy of GARDASIL 9 (V503) in preventing HPV-related anogenital persistent infection in Japanese males 16 to 26 years of age. GARDASIL 9 is commercialized in Japan under the name SILGARD 9. The primary efficacy objective was to demonstrate reduction in the incidence of HPV 6/11/16/18-related 6-month anogenital persistent infection. The secondary efficacy objective was to demonstrate reduction in the incidence of HPV 31/33/45/52/58-related 6-month anogenital persistent infection. The study enrolled 1,059 participants. About GARDASIL 9 in the U.S. GARDASIL 9 is a vaccine indicated in females 9 through 45 years of age for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by human papillomavirus (HPV) Types 16, 18, 31, 33, 45, 52, and 58; cervical, vulvar, vaginal, and anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11. GARDASIL 9 is indicated in males 9 through 45 years of age for the prevention of anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11. The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. GARDASIL 9 does not eliminate the necessity for vaccine recipients to undergo screening for cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers as recommended by a health care provider. GARDASIL 9 has not been demonstrated to provide protection against diseases caused by: HPV types not covered by the vaccine HPV types to which a person has previously been exposed through sexual activity Not all vulvar, vaginal, anal, oropharyngeal and other head and neck cancers are caused by HPV, and GARDASIL 9 protects only against those vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58. GARDASIL 9 is not a treatment for external genital lesions; cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers; or cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), or anal intraepithelial neoplasia (AIN). Vaccination with GARDASIL 9 may not result in protection in all vaccine recipients. Select Safety Information GARDASIL 9 is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]. Because vaccines may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following HPV vaccination. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion. Safety and effectiveness of GARDASIL 9 have not been established in pregnant women. The most common (≥10%) local and systemic adverse reactions in females were injection-site pain, swelling, erythema, and headache. The most common (≥10%) local and systemic reactions in males were injection-site pain, swelling, and erythema. The duration of immunity of a 2-dose schedule of GARDASIL 9 has not been established. Dosage and Administration GARDASIL 9 should be administered intramuscularly in the deltoid or anterolateral area of the thigh. For individuals 9 through 14 years of age, GARDASIL 9 can be administered using a 2-dose or 3-dose schedule. For the 2-dose schedule, the second dose should be administered 6–12 months after the first dose. If the second dose is administered less than 5 months after the first dose, a third dose should be given at least 4 months after the second dose. For the 3-dose schedule, GARDASIL 9 should be administered at 0, 2 months, and 6 months. For individuals 15 through 45 years of age, GARDASIL 9 is administered using a 3-dose schedule at 0, 2 months, and 6 months. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter) , Facebook , Instagram , YouTube and LinkedIn . Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site ( www.sec.gov ). Please see Prescribing Information for GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) at https://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_pi.pdf and Patient Information/Medication Guide for GARDASIL 9 at https://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_ppi.pdf

As major multinational corporations (MNC) report their financial results for the second quarter of 2024, pharmaceutical industry leaders such as Astrazeneca, Roche, Sanofi, Johnson & Johnson and Novartis have announced their financial results for the first half of 2024 (H1). As of August 6, according to the operating income data of the first half of the year, the ranking of the top ten enterprises in the global pharmaceutical industry has been settled, and the specific ranking is as follows: Quarterly and Half-Yearly Revenue and Year-Over-Year Growth Rate Chart for the Second Quarter and Full Year 2024 Rank Company 2024 Q2 Revenue (Billion USD) YoY Growth 2024 H1 Revenue (Billion USD) YoY Growth 1 Johnson & Johnson 224.5 4.3% 438 3.3% 2 Roche 178.19 13.9% 337.19 5.0% 3 Merck 161.12 7.2% 318.87 8.0% 4 Pfizer 132 2.0% 281.62 -11.0% 5 AbbVie 144.62 4.3% 267.72 3.7% 6 AstraZeneca 129.38 13.3% 256.17 18.0% 7 Novartis 125.1 11.0% 243 11.0% 8 Bristol-Myers Squibb 122.01 9.0% 240.66 7.0% 9 Sanofi 117.22 10.2% 230.20 8.4% 10 GlaxoSmithKline 100.38 13.0% 194.12 12.0%   With the gradual fading of the novel coronavirus epidemic in 2023, the revenue pattern of the global large pharmaceutical companies has ushered in a new round of change. Entering 2024, the impact of the epidemic on business operations has significantly weakened, and pharmaceutical companies have gradually returned to the normal development track. From the performance point of view, in the first half of 2024, in addition to Pfizer, the revenue of the remaining nine pharmaceutical companies generally showed an increase.   Against this backdrop, Johnson & Johnson has solidified its position as the top global pharmaceutical and medical device company in terms of revenue. According to the financial data for the first half of 2024, Johnson & Johnson's overall revenue reached $43.83 billion, an increase of 3.3%. From the perspective of treatment segment segmentation, the tumor segment is particularly strong, and its revenue has surpassed the autoimmune diseases segment to become the largest revenue contribution of Johnson & Johnson. Specifically, revenue from the oncology segment reached $5.09 billion in the second quarter, up 15.7% year over year; In the autoimmune diseases segment, revenue in the same period was $4.722 billion, a growth rate of only 5%.   In terms of product lines, Darzalex in oncology, with its $5.57 billion in sales, successfully surpassed Stelara in autoimmune diseases ($5.536 billion in sales) to become the top-selling product in the first half of 2024. In addition, two new oncology drugs, BCMA CAR-T therapy Carvykti and dual antibody product Tecvayli, also showed strong growth momentum, with sales reaching $343 million and $268 million, respectively, with year-on-year growth rates of 81.5% and 70.2%.   In order to further strengthen its competitiveness in the field of oncology and immunization, Johnson & Johnson continues to increase investment in innovative drugs. In the first half of 2024, J&J completed a number of important acquisitions. Among them, the $2 billion acquisition of AmbrxBiopharma brought several ADC pipelines to the company; The $850 million acquisition of Proteologix and the $1.25 billion acquisition of a subsidiary of NumabTherapeutics further strengthen the company's portfolio of dual antibody products in the field of autoimmune diseases.   Roche showed solid growth in the first half of 2024, with total revenues of CHF 29.848 billion (US $33.719 billion), up 5% year-on-year. Among them, the pharmaceutical business, as the core driver, contributed 22.637 billion Swiss francs (about $25.573 billion) in revenue, and China revenue achieved double-digit growth to reach 1.609 billion Swiss francs (about $1.818 billion).   In pharmaceuticals, the oncology segment continued to play a leading role, contributing 9.619 billion Swiss francs ($10.867 billion), or 42.5% of total revenue, to Roche, which remained at 4% despite a slight slowdown in year-on-year growth. In contrast, the ophthalmology business showed strong growth with revenues of CHF 1.891 billion, up 54% year on year, and although it currently accounts for only 8.4% of total revenues, its potential cannot be ignored.   Specific to the product level, the ophthalmological double antibody Vabysmo (Pharisimumab) performance is particularly outstanding, the first half of the sales revenue of up to 1.794 billion Swiss francs (about 2.027 billion US dollars), an increase of 93%, almost doubled, successfully ranked among Roche's top 5 best-selling drugs. In addition, Ocrevus (Orizumab), Hemlibra (Emetzizumab), Evrysdi (Rispran), Phesgo (Trastuzumab + pertuzumab), Polivy (Vipostuzumab), Xolair (Omazumab), Alecensa (Aletinib) and other drugs also remained strong Growth trend.   On the other hand, Merck also achieved impressive results in the first half of 2024. The company's total revenue reached $31.887 billion, an increase of 8%, and pharmaceutical revenue reached $28.415 billion, an increase of 9%. Revenue in the second quarter was $16.1 billion, up 7 percent from a year earlier. This increase was mainly due to the excellent performance of K-drug (Pabolizumab) and HPV vaccine.   As a star product of Merck, K drug sales reached 14.217 billion US dollars in the first half of this year, achieving a double-digit high growth of 18%, and is expected to break through the 30 billion US dollars mark for the whole year. At the same time, HPV vaccines also maintained a stable sales performance, Gardasil/Gardasil 9 sales reached $4.727 billion, an increase of 7%.   In addition, the company's oncology products such as Welireg (HIF-2α inhibitor) and Reblozyl (Rottsip), as well as the anti-cytomegalovirus infection drug Prevymis (Lytamovir) and 15-valent pneumococcal vaccine Vaxneuvance, also achieved double-digit or higher growth.   However, it is worth noting that Merck's main revenue is still highly dependent on K drugs and HPV vaccines. Among them, K drug sales accounted for nearly half of the company's total revenue. Although K-drug is still in a period of rapid growth, its patent will expire in 2028, when it will face the risk of declining sales. At the same time, the HPV vaccine market is increasingly competitive, and Merck's HPV vaccine sector revenue is not indestructible.   As a result, MSD is actively pursuing a second growth curve. Since the beginning of this year, the company has continuously introduced new potential products and pipelines through acquisitions, including pneumonia conjugate vaccine, the new drug Sotatercept for pulmonary hypertension, a new generation of RSV neutralizing antibodies, TL1A antibodies, and neoantigen mRNA vaccines, with a view to achieving more diversified revenue sources in the future.   Among the world's top 10 multinational pharmaceutical companies, Pfizer has been the most affected by the COVID-19 pandemic. In 2023, due to the sharp decline in sales of new coronavirus vaccine Comirnaty and anti-new coronavirus drug Paxlovid, the company failed to continue the brilliant performance of over 100 billion dollars in 2022, not only lost the top position in the industry, but also withdrew from the top three ranks. Entering 2024, although the first half of the revenue decline is still as high as 11%, showing that the company has not completely rid of the negative impact of the fading of the new coronavirus dividend, but the second quarter performance has shown signs of recovery. Financial data show that in the first half of 2024, the company's total revenue was 28.162 billion US dollars, down 11% year-on-year; In the second quarter, revenue reached $13.2 billion, up 2% from the same period last year and exceeding market analysts' expectations ($12.96 billion). If the contribution of COVID-19 vaccines and oral COVID-19 drugs is not included, the revenue growth in the second quarter was more significant, reaching 14%, which is the first time since the global coronavirus epidemic gradually eased in the fourth quarter of 2022, Pfizer achieved positive quarterly revenue growth, marking the company has adjusted to a good state and embarked on a new journey.   From the perspective of business structure, in the first half of 2024, the revenue of COVID-19 product Paxlovid was 2.286 billion US dollars, down 46% year-on-year; Comirnaty's revenue was $548 million, down 88% year over year. Despite the continued decline in revenue from COVID-19 products, the company's oncology business has achieved rapid growth, reaching $7.505 billion in revenue in the first half of the year, up 23% year-on-year. Among them, the breast cancer blockbuster CDK4/6 inhibitor Ibrance (Pipercilil), despite a slight decline in sales (-8%), still topped oncology drug sales with $2.184 billion in revenue. Androgen receptor signaling inhibitor Xtandi (Enzaluamide) and third-generation ALK inhibitor Lorbrena (Loratinib) also saw growth of 20% and 46%, respectively, with revenues of $913 million and $332 million, respectively.   In addition, ADCs such as Vyndaqel (chlorobenzolic acid), Eliquis (Apoxaban) and Nurtec ODT/Vydura, which were acquired through the Seagen acquisition, also began to contribute to the company's revenue. Abbvie also showed solid growth in the first half of 2024, with total revenue of $26.772 billion, up 3.7% year-on-year. In terms of therapeutic areas, autoimmune diseases, neuroscience, and oncology were the three pillars of the company's revenue, generating $12.342 billion (+0.6%), $4.127 billion (+15.6%), and $3.177 billion (+11%), respectively.   In the autoimmune diseases segment, although Humira (Adalimumab) has failed to reverse the downward trend in performance, with a decline of about 32% to $5.084 billion, full-year revenue is expected to fall below the $10 billion mark. However, the company's two star products in the field, Skyrizi (Lisencizumab) and Rinvoq (Upatinib), have maintained strong growth momentum, achieving revenue of $4.735 billion (+46.6%) and $2.523 billion (+60.4%), respectively, of which Skyrizi is expected to break the $10 billion revenue mark by the end of the year. In the oncology segment, Imbruvica continued to lose market share, with first-half revenue down 6.4% year-on-year to $1.671 billion; Venclexta, on the other hand, maintained steady growth, with first-half sales of $1.251 billion (+16%). In addition, the new blood cancer product CD3/CD20 dual antibody Epkinly since the FDA approved the market in May last year, sales have also doubled, from $31 million in the first half of 2023 to $63 million in the first half of this year. At the same time, the FRα ADC drug Elahere (Somituximab) acquired by the company in the acquisition of ImmunoGen late last year also contributed $192 million to the company's revenue in six months.   In the neuroscience segment, with the exception of Duodopa, a drug for Parkinson's disease, which showed negative growth, all products achieved steady growth. Although Qulipta's sales volume is not large ($281 million in revenue in the first half of the year), the growth rate is as high as 73.2%, becoming the fastest growing product in the field. Other products such as Ubrelvy, Botox Therapeutics and Vraylar also saw varying degrees of growth. Looking ahead, as AbbVie's pipeline in neuroscience continues to advance and its layout is optimized, the company is expected to continue to expand its market advantage in this field.   Novartis continues to deepen its commitment to nuclear medicine and invests in small nucleic acids and gene therapy. In the first half of 2024, Novartis achieved total revenue of $24.3 billion, an increase of 11%, of which sales in the China market reached $2.1 billion, an increase of 29%.   In the therapeutics segment, Novartis is showing strong growth. Oncology revenue reached $6.984 billion, up 14% year-over-year; Cardiovascular/renal metabolism revenue of $4.111 billion, up 37% year-over-year; Immunization revenue was $4.403 billion, up 21% year on year; Revenue in the neuroscience segment was $2.234 billion, up 39% from a year earlier.   Within these areas, several of Novartis's core products performed well, such as Entresto (sacubactril valsartan) revenue of $3.777 billion, up 30% year-over-year; Kesimpta (Oftolumab) revenue of $1.436 billion, an increase of 64%; Cosentyx revenue of $2.852 billion, up 21% year-over-year; Kisqali (Ribosili) revenue of $1.344 billion, an increase of 48%.   In addition, Novartis's layout in the field of nuclear drugs has also achieved significant results. In the first half of the year, Pluvicto and Lutathera generated revenue of $655 million (+45%) and $344 million (+16%), respectively, for a combined revenue of nearly $1 billion. Meanwhile, sales of Leqvio, a long-acting PCSK9 siRNA lipd-lowering drug, reached $333 million, up 135% year-over-year, making it Novartis' fastest growing new drug category. Gene therapy products also performed well, with Zolgensma, which treats spinal muscular atrophy (SMA), reporting first-half revenue of $644 million, up 6 percent year-on-year.   It is worth noting that Novartis has shown a unique vision in product development and M&A strategy. Unlike other multinational pharmaceutical companies (MNC), Novartis's products and research pipeline are less involved in ADC, PD-1, GLP-1 and other hot tracks. Instead, Novartis prefers to focus on the development of cutting-edge technologies and innovative therapies, such as nuclear drugs, small nucleic acids, cell and gene therapies (CGT). Although the combined revenue of these emerging areas is still less than 10% of total revenue, Novartis's future development prospects will be broader as the market matures in the future.   In addition, the top 10 MNCS such as Astrazeneca, Sanofi, GlaxoSmithKline, Bristol-Myers Squibb also achieved positive revenue growth in the first half of 2024. With the intensification of market competition, each MNC is actively adjusting its strategy, some grasp the hot spots of The Times to expand the advantages of the field, some choose to avoid homogenized competition, and some focus on the core business by cutting off non-core assets. All these efforts are in order to stand out in the fierce market competition, looking forward to the second half of the MNC can continue to bring wonderful performance.