Organon’s HADLIMA™ (adalimumab-bwwd) and NuvaRing® (etonogestrel/ethinyl estradiol vaginal ring) Added to Mark Cuban’s Cost Plus Drugs

April 15, 2024 12:00 am EDT Collaboration expands patient access to two products through costplusdrugs.com online pharmacy Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, today announced that the Mark Cuban Cost Plus Drug Company, PBC (Cost Plus Drugs), has added HADLIMA, an FDA-approved biosimilar to HUMIRA (adalimumab), and NuvaRing to its online pharmacy.  At Cost Plus Drugs, HADLIMA is now listed at $1027.62.* This is 85% less than the standard list price of HUMIRA. HADLIMA is available in both citrate-free high concentration (40 mg/0.4 mL), the most-utilized formulation of the originator, and citrate-containing low concentration (40 mg/0.8 mL) formulations to provide patients with continuity of care. All eligible HADLIMA patients, including those who receive HADLIMA through Cost Plus Drugs, may enroll in the “HADLIMA For You” patient support program. HADLIMA was developed, and is manufactured, and supplied by Samsung Bioepis. “Providing patients affordable access to their everyday medicines is core to Organon’s vision of a healthier every day,” said Meghan Rivera, US Managing Director. “Cost Plus Drugs’ innovative distribution channel enables us to reach patients who may rely on our medications but have concerns about cost or access.” “At Cost Plus Drugs, our mission is to sell every drug we are legally able to sell at transparent, affordable prices,” said Mark Cuban, Co-founder of Cost Plus Drugs. “We’re so excited to make HADLIMA and NuvaRing available to our patients. Organon adding these products to costplusdrugs.com demonstrates their commitment to accessibility and transparency, and we look forward to continuing to work together to help our patients.” NuvaRing is listed on Cost Plus Drugs at $45.* The availability of NuvaRing on Cost Plus Drugs helps to broaden access to family planning options for women. When considering family planning options, women should speak to a trusted healthcare provider so they can make informed decisions about the option that is best for them.  *This is the manufacturer price and does not include service fees. About HADLIMA™ (adalimumab-bwwd) Injection, 40 mg/0.4 mL and 40 mg/0.8mL HADLIMA is a tumor necrosis factor (TNF) blocker indicated for: Rheumatoid Arthritis: HADLIMA is indicated, alone or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (DMARDs), for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. Juvenile Idiopathic Arthritis: HADLIMA is indicated, alone or in combination with methotrexate, for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Psoriatic Arthritis: HADLIMA is indicated, alone or in combination with non-biologic DMARDs, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. Ankylosing Spondylitis: HADLIMA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. Crohn’s Disease: HADLIMA is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. Ulcerative Colitis: HADLIMA is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients.  Limitations of Use: The effectiveness of HADLIMA has not been established in patients who have lost response to or were intolerant to tumor necrosis factor (TNF) blockers. Plaque Psoriasis: HADLIMA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HADLIMA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician. Hidradenitis Suppurativa: HADLIMA is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. Uveitis: HADLIMA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. SELECTED SAFETY INFORMATION FOR HADLIMA SERIOUS INFECTIONS Patients treated with adalimumab products, including HADLIMA, are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue HADLIMA if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before HADLIMA use and during therapy. Initiate treatment for latent TB prior to HADLIMA use. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria. Carefully consider the risks and benefits of treatment with HADLIMA prior to initiating therapy in patients:  with chronic or recurrent infection who have been exposed to TB with a history of opportunistic infection who resided in or traveled in regions where mycoses are endemic with underlying conditions that may predispose them to infection Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HADLIMA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy. Do not start HADLIMA during an active infection, including localized infections. Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection. If an infection develops, monitor carefully and initiate appropriate therapy. Drug interactions with biologic products: A higher rate of serious infections has been observed in rheumatoid arthritis (RA) patients treated with rituximab who received subsequent treatment with a TNF blocker. An increased risk of serious infections has been seen with the combination of TNF blockers with anakinra or abatacept, with no demonstrated added benefit in patients with RA. Concomitant administration of HADLIMA with other biologic DMARDs (eg, anakinra or abatacept) or other TNF blockers is not recommended based on the possible increased risk for infections and other potential pharmacological interactions. MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including adalimumab products. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants. Consider the risks and benefits of HADLIMA treatment prior to initiating or continuing therapy in a patient with known malignancy. In clinical trials, more cases of malignancies were observed among adalimumab-treated patients compared to control patients. Non-melanoma skin cancer (NMSC) was reported during clinical trials for adalimumab-treated patients. Examine all patients, particularly those with a history of prolonged immunosuppressant or psoralen and ultraviolet A (PUVA) therapy, for the presence of NMSC prior to and during treatment with HADLIMA. In adalimumab clinical trials, there was an approximate 3-fold higher rate of lymphoma than expected in the general U.S. population. Patients with chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk of lymphoma than the general population, even in the absence of TNF blockers. Postmarketing cases of acute and chronic leukemia were reported with TNF blocker use. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving TNF blockers were lymphomas; other cases included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents. HYPERSENSITIVITY Anaphylaxis and angioneurotic edema have been reported following adalimumab administration. If a serious allergic reaction occurs, stop HADLIMA and institute appropriate therapy. HEPATITIS B VIRUS REACTIVATION Use of TNF blockers, including HADLIMA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal. Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy. Exercise caution in patients who are carriers of HBV and monitor them during and after HADLIMA treatment. Discontinue HADLIMA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming HADLIMA after HBV treatment. NEUROLOGIC REACTIONS TNF blockers, including adalimumab products, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, optic neuritis, and Guillain-Barré syndrome. Exercise caution when considering HADLIMA for patients with these disorders; discontinuation of HADLIMA should be considered if any of these disorders develop. HEMATOLOGIC REACTIONS Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with adalimumab products. Consider stopping HADLIMA if significant hematologic abnormalities occur. CONGESTIVE HEART FAILURE Worsening and new onset congestive heart failure (CHF) has been reported with TNF blockers. Cases of worsening CHF have been observed with adalimumab products; exercise caution and monitor carefully. AUTOIMMUNITY Treatment with adalimumab products may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop. IMMUNIZATIONS Patients on HADLIMA should not receive live vaccines. Pediatric patients, if possible, should be brought up to date with all immunizations before initiating HADLIMA therapy. Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero-exposed infant. The safety of administering live or live-attenuated vaccines in infants exposed to adalimumab products in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants. ADVERSE REACTIONS The most common adverse reactions in adalimumab clinical trials (>10%) were: infections (eg, upper respiratory, sinusitis), injection site reactions, headache, and rash. Before prescribing HADLIMA, please read the accompanying Prescribing Information, including the Boxed Warning about serious infections and malignancies. The Medication Guide and Instructions for Use also are available. ABOUT NuvaRing® (etonogestrel/ethinyl estradiol vaginal ring) INDICATION AND USAGE NuvaRing is an estrogen/progestin vaginal ring for use by females of reproductive age to prevent pregnancy. SELECTED SAFETY INFORMATION FOR NUVARING WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive (CHC) use. The risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs, including NuvaRing, should not be used by women who are over 35 years of age and smoke. Patients Who Should Not Use NuvaRing NuvaRing is contraindicated in women who are known to have a high risk of arterial or venous thrombotic diseases, women who have liver tumors or liver disease, undiagnosed abnormal uterine bleeding, current diagnosis of, or history of, breast cancer which may be hormone-sensitive, or hypersensitivity reactions, including anaphylaxis and angioedema, to any of the components of NuvaRing, women who are pregnant, or women who use Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations. Serious Risks With NuvaRing Thromboembolic and Other Vascular Events: The use of a CHC, like NuvaRing, is associated with increased risks of several serious side effects, including blood clots, stroke, or heart attack, especially in women with other risk factors for these events. Some studies suggest that the risk is increased by combination oral contraceptives containing desogestrel (etonogestrel is the biologically active metabolite of desogestrel); other studies do not support this finding. Stop NuvaRing if an arterial thrombotic or venous thromboembolic event (VTE) occurs. The risk of VTE is highest during the first year of CHC use and after restarting a CHC following a break of at least 4 weeks. Stop NuvaRing at least 4 weeks before and for 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism, and during and following prolonged immobilization. Start NuvaRing no earlier than 4 weeks after delivery, in women who are not breastfeeding. Toxic Shock Syndrome (TSS): If signs and symptoms of TSS are present, initiate appropriate medical evaluation and treatment. Liver Disease: Disturbances of liver function may require CHC discontinuation until liver function markers return to normal and CHC causation has been excluded. Discontinue NuvaRing if jaundice develops. Risk of Liver Enzyme Elevations With Concomitant Hepatitis C Treatment: Due to potential for ALT elevations, discontinue NuvaRing prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. NuvaRing can be restarted approximately 2 weeks following completion of treatment with the Hepatitis C combination drug regimen. High Blood Pressure: For women with well-controlled hypertension, monitor blood pressure and stop NuvaRing if blood pressure rises significantly. An increase in blood pressure is more likely in older women and with extended duration of use. Hypersensitivity Reactions: Hypersensitivity reactions of anaphylaxis and angioedema have been reported during use of NuvaRing. If anaphylaxis and/or angioedema is suspected, NuvaRing should be discontinued and appropriate treatment administered. Carbohydrate and Lipid Metabolic Effects: Monitor prediabetic and diabetic women using NuvaRing and consider alternative contraception for women with uncontrolled dyslipidemia. Headache: Consider discontinuation of NuvaRing in women who develop new onset of headaches that are recurrent, persistent, or severe, or in the case of increased frequency or severity of migraine. Bleeding Irregularities: Evaluate irregular bleeding or amenorrhea for causes such as pregnancy or malignancy. Most Common Adverse Reactions The most common adverse reactions reported by ≥2% of women (n=2,501) using NuvaRing in clinical trials were: vaginitis (13.8%), headache (including migraine) (11.2%), mood changes (eg, depression, mood swings, mood altered, depressed mood, affect lability) (6.4%), device-related events (eg, expulsion/discomfort/foreign-body sensation) (6.3%), nausea/ vomiting (5.9%), vaginal discharge (5.7%), increased weight (4.9%), vaginal discomfort (4.0%), breast pain/discomfort/tenderness (3.8%), dysmenorrhea (3.5%), abdominal pain (3.2%), acne (2.4%), and decreased libido (2.0%). Counsel patients that NuvaRing does not protect against HIV infection (AIDS) and other sexually transmitted infections. Before prescribing NuvaRing, please read the accompanying Prescribing Information including Boxed Warning regarding the increased risk of serious cardiovascular events, especially in women who smoke. The Patient Information is also available.  About Cost Plus Mark Cuban Cost Plus Drug Company (more commonly known as Cost Plus Drugs) offers FDA-approved medicines with complete transparency so that patients know they are getting a fair price. As a public-benefit corporation, they prioritize their social mission of improving public health. To learn more about the mission, check out costplusdrugs.com/mission. About Organon Organon is a global healthcare company formed to focus on improving the health of women throughout their lives. Organon offers more than 60 medicines and products in women’s health in addition to a growing biosimilars business and a large franchise of established medicines across a range of therapeutic areas. Organon’s existing products produce strong cash flows that support investments in innovation and future growth opportunities in women’s health and biosimilars. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical innovators looking to commercialize their products by leveraging its scale and presence in fast growing international markets. Organon has a global footprint with significant scale and geographic reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey. For more information, visit http://www.organon.com and connect with us on LinkedIn, Instagram, X (formally known as Twitter) and Facebook. Cautionary Note Regarding Forward-Looking Statements Some statements and disclosures in this press release are “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about the addition of Organon’s HADLIMA and NuvaRing to the Cost Plus Drugs online pharmacy and the potential benefits thereof. Forward-looking statements include all statements that do not relate solely to historical or current facts and can be identified by the use of words such as “aims,” “may,” “expects,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “will,” or words of similar meaning. These forward-looking statements are based on Organon’s current plans and expectations and are subject to a number of risks and uncertainties that could cause Organon’s plans and expectations, including actual results, to differ materially from the forward-looking statements. Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the Securities and Exchange Commission (“SEC”), including Organon’s most recent Annual Report on Form 10-K and subsequent SEC filings, available at the SEC’s Internet site (www.sec.gov). Brands mentioned are the trademarks of their respective owners.   Organon Media Contacts: Karissa Peer (614) 314-8094 Kate Vossen (732) 675-8448 Organon Investor Contacts: Jennifer Halchak (201) 275-2711 Source: Organon & Co. 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