US

Chiesi Group Acquires Unikeris Limited and Adds Revcovi® (elapegademase-lvlr) Injection to Product Portfolio

24 November 2020
  • Addition of approved therapy for treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID)expands Chiesi commitment to addressing significant areas of unmet need in treatment of rare diseases
  • Under terms of the agreement Chiesi Group has acquired all rights to Revcovi, which will continue to be available to patients through Chiesi Global Rare Diseases, a business unit of Chiesi Group

 

Boston, MA 24/11/2020 – Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an internationalresearch-focused healthcare Group (Chiesi Group), today announced that Chiesi Group has acquired Unikeris Limited,global marketer for Revcovi for the treatment of adenosine deaminase deficiency severe combined immunedeficiency (ADA-SCID). Terms were not disclosed.

 

“Our mission at Chiesi Global Rare Diseases is to revolutionize the lives of people living with rare diseases by developingand marketing therapies that address significant areas of unmet need,” said Giacomo Chiesi, Head of Chiesi GlobalRare Diseases. “Through this acquisition, we add Revcovi, a therapy for patients with ADA-SCID, to our portfolio. Thisis another demonstration of our commitment to families affected by rare diseases around the world.”

 

Adenosine deaminase severe combined immune deficiency (ADA-SCID) is an ultra-rare inherited disorder caused by adeficiency in adenosine deaminase (ADA), an enzyme found throughout the body. It is estimated to occur inapproximately one in 200,000 to 1,000,000 newborns worldwide. It is associated with severely impaired immune functionand a range of metabolic abnormalities. Left untreated, many patients die before age two. Revcovi works to replace ADAvia intramuscular injection. It was approved in the U.S. in October 2018 and is available to patients in the EU through anamed-patient access program.

 

“Our focus on meeting the needs of patients living with ADA-SCID will build on our progress in research and productdevelopment in areas including lysosomal storage disorders, rare hematology and rare ophthalmology indications,” Mr.Chiesi added. “We look forward to working with leaders in patient advocacy and healthcare providers in efforts tosupport patients living with this challenging disease.”

 

INDICATION

Revcovi (elapegademase-lvlr) is indicated for the treatment of adenosine deaminase severe combined immunedeficiency (ADA-SCID) in pediatric and adult patients.

 

IMPORTANT SAFETY INFORMATION

Revcovi (elapegademase-lvlr) is indicated for the treatment of adenosine deaminase severe combined immunedeficiency (ADA-SCID) in pediatric and adult patients.

 

WARNINGS AND PRECAUTIONS:

  • Injection site bleeding in patients with thrombocytopenia: Increased risk of local bleeding in patients with thrombocytopenia; should not be used if thrombocytopenia is severe.
  • Delay in improvement of immune function: Protect immune deficient patients from infections until improvement in immune function.

 

ADVERSE REACTIONS

The most commonly reported adverse reactions were cough and vomiting.

In addition, the following post-marketing reports for the same class of enzyme replacement therapy used in thetreatment of ADA-SCID, may also be seen with Revcovi treatment:

  • Hematologic events: hemolytic anemia, autoimmune hemolytic anemia, thrombocythemia, thrombocytopeniaand autoimmune thrombocytopenia
  • Dermatological events: injection site erythema, urticaria
  • Lymphomas

 

IMPORTANT MONITORING INFORMATION:

Treatment with Revcovi should be monitored by measuring trough plasma ADA activity and trough dAXP levels formaintenance of therapeutic targets. If a persistent decline in plasma ADA activity occurs, immune function and clinicalstatus should be monitored closely, and precautions should be taken to minimize the risk of infection.

 

Please refer to Revcovi’s Full Prescribing Information.

 

About Chiesi Global Rare Diseases

Chiesi Global Rare Diseases is a business unit of the Chiesi Group established in February 2020 and focused onresearch and development of treatments for rare and ultra-rare disorders. The Global Rare Diseases unit works incollaboration with Chiesi Group to harness the full resources and capabilities of our global network to bring innovative newtreatment options to people living with rare diseases, many of whom have limited or no treatments available. The unit isalso a dedicated partner with global leaders in patient advocacy, research and patient care. 

 

About Chiesi Group

Based in Parma, Italy, Chiesi Farmaceutici is an international research-focused healthcare group with 85 years of experience in the pharmaceutical industry and a global presence in 29 countries. Chiesi researches, develops, andmarkets innovative drugs in the respiratory therapeutics, specialist medicine, and rare disease areas. Its R&Dorganization is headquartered in Parma (Italy), and is integrated with R&D groups in France, the USA, the UK, andSweden to advance Chiesi's pre-clinical, clinical, and registration programs. Chiesi employs nearly 6,000 people.Chiesi Group is a certified Benefit Corporation. For more information www.chiesi.com.

 

 

Media Contact

Jenna Urban

Berry & Company Public Relations 1-212-253-8881

jurban@berrypr.com

 

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