Upsher-Smith Launches Kymbee^™ (deflazacort) Tablets for the Treatment of Duchenne Muscular Dystrophy

Company Reinforces Commitment to Rare Disease Community through its Promise of Support^® Program

Maple Grove, MN – December 1, 2025 – Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced the launch of KYMBEE™ (deflazacort) Tablets, indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older. Manufactured by Upsher-Smith in Minnesota, KYMBEE™ is the only deflazacort backed by Upsher-Smith’s Promise of Support^® Program. Available in 6 mg, 18 mg, 30 mg, and 36 mg strengths, KYMBEE™ Tablets are dispensed through Orsini Specialty Pharmacy, a leader in rare disease and complex therapy solutions.

“At Upsher-Smith, we recognize the challenges associated with accessing certain medications for DMD and the stress this can create for families,” said Michelle Zachman, PharmD, BCPS, BCMAS, Medical Affairs Director, Upsher-Smith. “Through the availability of KYMBEE™ and our Promise of Support^® Program, we’re proud to offer a U.S.-manufactured product, backed by our comprehensive support program designed to help ease some of the challenges associated with prescribing and accessing deflazacort.”

Upsher-Smith’s Promise of Support^® Program for KYMBEE™

KYMBEE™ is backed by the Upsher-Smith Promise of Support^® Program, designed to assist families throughout their treatment journey. The comprehensive program provides:

• Copay assistance*
• Help navigating insurance coverage
• Pathways to access therapy, even when insurance challenges arise
• A dedicated support team

*Limitations apply

For Families and Prescribers

Families are encouraged to ask your doctor about KYMBEE™ (deflazacort) Tablets. If you or your doctor have questions about KYMBEE™, reach out to Upsher-Smith at 1-888-650-3789.

IMPORTANT SAFETY INFORMATION for KYMBEE™ (deflazacort) Tablets

Who should not take KYMBEE?

Do not take if you have had hypersensitivity, including allergic reactions, to deflazacort (the active ingredient in KYMBEE) or to any of the inactive ingredients in KYMBEE.

What is the most important information I should know about KYMBEE?

• KYMBEE can cause changes in endocrine (hormone) function. Do not stop taking KYMBEE, or change the amount being taken, without first checking with a healthcare provider, as there may be a need for gradual dose reduction to decrease the risk of adrenal insufficiency and steroid “withdrawal syndrome.” Acute adrenal insufficiency can occur if corticosteroids, including KYMBEE, are withdrawn abruptly, and can be life threatening. A steroid “withdrawal syndrome” may also occur following abrupt discontinuance of corticosteroids. For patients already taking corticosteroids during times of stress, the amount of KYMBEE prescribed may need to be increased.
• There is an increased risk of infection when taking KYMBEE. Tell a healthcare provider if the patient has had recent or ongoing infections or if they have recently received a vaccine. Seek medical advice immediately if the patient develops fever or other signs of infection. Some infections can potentially be severe and life threatening. Patients should avoid exposure to chickenpox or measles and alert their healthcare provider immediately if they are exposed.
• KYMBEE can cause an increase in blood pressure and water retention. If this occurs, dietary salt restriction and potassium therapy may be needed.
• There is an increased risk of developing a hole in the stomach or intestines in patients with certain gastrointestinal disorders when taking corticosteroids like KYMBEE.
• KYMBEE can cause behavior and mood changes that can be severe. Seek medical attention if any behavioral or mood changes develop.
• There is a risk of osteoporosis with prolonged use of KYMBEE, which can lead to fractures in the spine and in long bones.
• KYMBEE may cause cataracts or glaucoma. A healthcare provider should monitor for these conditions if therapy is continued for more than 6 weeks.
• Immunizations should be up-to-date according to immunization guidelines prior to starting therapy with KYMBEE. Live attenuated or live vaccines should be administered at least 4 to 6 weeks prior to starting KYMBEE. Live attenuated or live vaccines should not be used in patients taking KYMBEE.
• KYMBEE can cause serious skin rashes. Seek medical attention at the first sign of a rash.
• Rare instances of anaphylaxis, a severe allergic reaction, have occurred in patients receiving corticosteroid therapy, including KYMBEE.

Before taking KYMBEE, tell a healthcare provider about all medical conditions, including if the patient:

• is pregnant or planning to become pregnant. KYMBEE can harm an unborn baby.
• is breastfeeding or planning to breastfeed. KYMBEE may appear in breastmilk and could affect a nursing child.

Certain medications can cause an interaction with KYMBEE. Tell a healthcare provider about all the medicines you are taking, including over-the-counter medicines (such as insulin, aspirin or other non-steroidal anti-inflammatory drugs), dietary supplements, and herbal products. Alternate treatment, dosage adjustment, and/or special test(s) may be needed during the treatment.

What are the side effects of KYMBEE?

The most common side effects include: facial puffiness or Cushingoid appearance, weight increased, increased appetite, upper respiratory tract infection, cough, frequent daytime urination, unwanted hair growth, abdominal obesity, and colds. These are not all of the possible side effects. Call a healthcare provider for medical advice about side effects.

This safety information is not comprehensive. Please see the full Prescribing Information for more information on KYMBEE. You can also visit www.upshersmith.com or call 1-888-650-3789.

You are encouraged to report suspected adverse reactions to the FDA by visiting www.fda.gov/medwatch or by calling 1-800-FDA-1088.

What is KYMBEE?

KYMBEE (deflazacort) Tablets are a prescription medicine used to treat Duchenne muscular dystrophy (DMD) in patients 5 years of age and older.

About Duchenne Muscular Dystrophy

Duchenne muscular dystrophy (DMD) is a rare genetic condition that causes progressive muscle weakness due to a change in the gene that encodes for dystrophin, a protein needed for normal muscle function. It impacts around 15,000 individuals in the United States, and over 300,000 globally. It primarily affects boys, who are diagnosed around 4 years of age, and can impact mobility, breathing, and heart function over time. While there is currently no cure, early diagnosis and comprehensive care—including physical therapy, medication, and monitoring of cardiac and respiratory health—can help slow progression.

About Upsher-Smith Laboratories, LLC

Upsher-Smith Laboratories, LLC, now a member of Bora Group, is a trusted U.S. pharmaceutical company that strives to improve the health and lives of patients through an unwavering commitment to high-quality products and sustainable growth. We bring generics and brands to a wide array of customers, always backed by our attentive level of service, strong industry relationships, and dedication to uninterrupted supply. For more information, visit www.upsher-smith.com.

About Bora Group

Founded in 2007, Bora Pharmaceuticals (“Bora” or “the Company”, 6472.TW) is a leading pharmaceutical services company with a vision and goal of “Contributing to Better Health All Over the World”. Operating under a “Dual Engine” model that integrates CDMO and commercial expertise, we empower pharmaceutical and biotech partners to optimize product development, accelerate launches, and scale supply to meet global patient needs. At the same time, we actively broaden R&D and sales infrastructure, focusing on niche and rare disease markets to improve patients’ quality of life. By investing in talent, infrastructure, and biologics expansion, Bora continues to transform operations and achieve sustainable growth. For more information, visit www.bora-corp.com.

KYMBEE and Promise of Support are trademarks of Upsher-Smith Laboratories, LLC.