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.

 

Source: Organon & Co.