ITF Therapeutics LLC Announces Opening of New U.S. Headquarters in Concord, Massachusetts

10,000-square-foot facility to house corporate offices and serve as a center for meetings and events with members of the Duchenne muscular dystrophy and other rare disease communities

CONCORD, Mass., March 5, 2025 /PRNewswire/ -- ITF Therapeutics LLC, the U.S. affiliate of Italfarmaco, today announced the opening of the company's new U.S. headquarters in Concord, Massachusetts. The 10,000-square-foot facility located at 575 Virginia Road, Unit 201, will include corporate offices as well as meeting spaces where ITF will welcome members of the Duchenne muscular dystrophy (DMD) and other rare disease communities.

"ITF Therapeutics was founded only one year ago, and in that short time we have rapidly expanded our team to include specialists who are working to make a positive difference for people living with rare diseases and we announced the FDA approval and commercial launch of our first product, DUVYZAT™ (givinostat)," said Matt Trudeau, president, ITF Therapeutics. "Our new U.S. headquarters in Concord will help us continue the momentum, bringing together more of our team members to plan for many exciting new opportunities for our company. The office will also be a welcoming space where members of the communities we serve can share their insights with us to keep their voices front and center in our work."

The headquarters will accommodate up to 40 members of the ITF Therapeutics team. In planning the design of the headquarters, ITF worked closely with leaders from the patient advocacy community to understand and incorporate features that support accessibility and comfort for guests.

"As we planned for our new office, members of our team at every level stressed the importance of making this a space that reflects our focus on honoring the experiences of people living with DMD and their families," Trudeau added. "We are very much looking forward to hosting community members and creating many new opportunities for them to engage with ITF Therapeutics in meaningful ways."

Please see the Indication and Important Safety Information for DUVYZAT below.

About DUVYZAT™ (givinostat)

DUVYZAT is a U.S. FDA-approved histone deacetylase (HDAC) inhibitor indicated for the treatment of patients six years of age and older with Duchenne muscular dystrophy (DMD) that was discovered through the research and development efforts of Italfarmaco in collaboration with Telethon and Duchenne Parent Project (Italy). HDACs are enzymes located in the body's cells that play a key role in maintaining and repairing muscles. In DMD, the HDAC enzymes become overactive, leading to chronic muscle inflammation, decreased muscle repair, and replacement of muscle with fat and scar tissue. DUVYZAT inhibits HDAC overactivity and is thought to help reduce inflammation, increase the body's ability to repair muscles, and slow muscle loss. For more information visit www.DUVYZAT.com.

About ITF Therapeutics LLC

ITF Therapeutics was launched in January 2024 as the U.S. affiliate of Italfarmaco focused on the development and commercialization of products to treat rare diseases. Building on a legacy grounded in collaboration and innovation, ITF Therapeutics strives to partner with leaders from the patient advocacy and treatment communities to ensure that our programs reflect and support their unique needs and goals. The establishment of ITF Therapeutics reflects Italfarmaco's goal to build a world-class team of experts who share a passion to make a positive impact for rare disease communities. For more information visit www.itftherapeutics.com.

About Italfarmaco

Founded in 1938 in Milan, Italy, Italfarmaco is a private global pharmaceutical company that has led the successful development and approval of many pharmaceutical products around the world. The Italfarmaco group has operations in more than 90 countries through directly controlled or affiliated companies. The company is a leader in pharmaceutical research, product development, production, and commercialization with proven success in many therapeutic areas including immuno-oncology, gynecology, neurology, cardiovascular disease, and rare diseases. Italfarmaco's rare disease unit includes programs in Duchenne muscular dystrophy, Becker muscular dystrophy, amyotrophic lateral sclerosis, and polycythemia vera. For more information visit www.italfarmaco.com.

Indication and Important Safety Information

What is DUVYZAT?

DUVYZAT is a prescription medicine that is used for the treatment of Duchenne muscular dystrophy (DMD) in people 6 years of age and older.

It is not known if DUVYZAT is safe and effective in children under 6 years of age.

Important Safety Information

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

• Low platelet counts in your blood (thrombocytopenia). Platelets are important for blood clotting, and a decrease in their numbers can lead to an increased risk of bleeding or bruising. Your healthcare provider will check your blood count before you start DUVYZAT and regularly during treatment for any signs of thrombocytopenia. Call your healthcare provider right away if you notice any unusual bleeding or small red or purple spots on the skin called petechiae. Your healthcare provider may change your dose of DUVYZAT if your blood platelet counts continue to be low or may stop your treatment with DUVYZAT.
  
  
• Increased levels of fat (triglycerides) in your blood. You may not have any symptoms, so your healthcare provider will do blood tests before you start DUVYZAT and regularly during treatment to check your triglyceride levels. Your healthcare provider may change your dose of DUVYZAT if your triglyceride levels continue to be high or may stop your treatment with DUVYZAT.
  
  
• Frequent watery loose stools (diarrhea) and vomiting. DUVYZAT can cause vomiting and moderate to severe diarrhea. If diarrhea occurs, you should keep track of the frequency and severity of your diarrhea symptoms, drink plenty of fluids, and contact your healthcare provider. Your healthcare provider may change your dose of DUVYZAT if the diarrhea cannot be managed or does not go away. Your healthcare provider may also stop your treatment with DUVYZAT.

Before taking DUVYZAT, tell your healthcare provider about all of your medical conditions, including if you:

• have any heart problems or if you take any medicines that could increase your chance for irregular heart rhythms.
  
  
• have any bleeding problems.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking DUVYZAT with certain other medicines may affect each other. Taking DUVYZAT with other medicines can cause serious side effects. Do not start or stop other medicines without talking to your healthcare provider.

DUVYZAT can cause serious side effects, including:

• See "What is the most important information I should know about DUVYZAT?"
• Changes in the electrical activity of your heart called QT Prolongation. QT Prolongation can increase the risk of developing a type of irregular heart rhythm known as Torsades de Pointes. Call your healthcare provider right away if you feel faint, have an irregular heartbeat, feel dizzy, or lose consciousness.

The most common side effects of DUVYZAT included diarrhea, nausea, vomiting, stomach pain, low platelet counts in the blood, increased fat level in the blood, and fever.

These are not all of the possible side effects of DUVYZAT. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information and Medication Guide.

DUVYZAT is a registered trademark of Italfarmaco S.p.A.

U.S.A.

Media inquiries: Brian Connor | +1 212 253 8881 | [email protected]

Other inquiries: Patient Advocacy and Communications Lead U.S.A. | [email protected]

Global

Media inquiries: Charlotte Spitz or Jacob Verghese | +49 (0)151 7441 6179 | [email protected]

Other inquiries: Patient Advocacy and Communications Lead | [email protected]

C-DUV-US-0318 02/2025

SOURCE ITF Therapeutics LLC