PharmaEssentia Expands North American Commercial Footprint with Acquisition of Canadian Partner FORUS Therapeutics
Acquisition deepens
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By acquiring 100% of FORUS,
"This acquisition is the culmination of a strong and proven partnership with the FORUS team," said Dr.
The FORUS team brings more than 25 years of hematology and oncology commercialization experience, with backgrounds at Celgene, Roche, Pfizer, and other leading global pharmaceutical companies. Collectively, the team has launched more than 10 products, generating over
"Joining PharmaEssentia marks an exciting new chapter and opportunity for the FORUS team," said
About
For more information about
About BESREMi® (ropeginterferon alfa-2b-njft)
Ropeginterferon alfa-2b-njft is currently FDA-approved and marketed as BESREMi® for the treatment of adults with polycythemia vera (PV). The Company plans to seek a ropeginterferon alfa-2b-njft label expansion to include ET and has submitted a sBLA with the U.S. FDA.
BESREMi® holds orphan drug designation in the United States for the treatment of polycythemia vera (PV) in adults. It has received regulatory approval in over 40 countries, including from the European Medicines Agency (2019), the U.S. Food and Drug Administration (2021), and the Pharmaceuticals and Medical Devices Agency in Japan (2023). The product was developed by PharmaEssentia. PharmaEssentia retains full global intellectual property rights across all indications.
INDICATION
BESREMi® is indicated for the treatment of adults with polycythemia vera.
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF SERIOUS DISORDERS
Interferon alfa products may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping therapy.
CONTRAINDICATIONS
Existence of or history of severe depression, suicidal ideation, or suicide attempt
Hypersensitivity to interferons or any inactive ingredients
Moderate or severe hepatic impairment
History or presence of active serious or untreated autoimmune disease
History of transplantation and receiving immunosuppressant agents
WARNINGS AND PRECAUTIONS
Patients exhibiting the following events should be closely monitored and may require dose reduction or discontinuation of therapy:
- Depression and Suicide: Monitor closely for symptoms and need for treatment.
- Endocrine Toxicity: Discontinue if endocrine disorders occur that cannot be medically managed.
- Cardiovascular Toxicity: Avoid use in patients with severe, acute or unstable cardiovascular disease. Monitor patients with history of cardiovascular disorders more frequently.
- Decreased Peripheral Blood Counts: Perform blood counts at baseline, every 2 weeks during titration, and at least every 3-6 months during maintenance treatment.
- Hypersensitivity Reactions: Stop treatment and immediately manage reaction.
- Pancreatitis: Consider discontinuation if confirmed pancreatitis
- Colitis: Discontinue if signs or symptoms of colitis
- Pulmonary Toxicity: Discontinue if pulmonary infiltrates or pulmonary function impairment
- Ophthalmologic Toxicity: Advise patients to have eye examinations before and during treatment. Evaluate eye symptoms promptly and discontinue if new or worsening eye disorders.
- Hyperlipidemia: Monitor serum triglycerides before BESREMi® treatment and intermittently during therapy and manage when elevated.
- Hepatotoxicity: Monitor liver enzymes and hepatic function at baseline and during treatment. Reduce dose or discontinue depending on severity.
- Renal Toxicity: Monitor serum creatinine at baseline and during therapy. Discontinue if severe renal impairment develops.
- Dental and Periodontal Toxicity: Advise patients on good oral hygiene and to have regular dental examinations.
- Dermatologic Toxicity: Consider discontinuing if clinically significant dermatologic toxicity.
- Driving and Operating Machinery: Advise patients to avoid driving or using machinery if they experience dizziness, somnolence, or hallucination.
Please see full Prescribing Information, including Boxed Warning.
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Media
Muriel Huang
Director, Investor Relations and Corporate Communication
muriel_huang@pharmaessentia.com
Source: PharmaEssentia Corporation