WEP Clinical, the specialist pharmaceutical services company, has announced that it has launched Nitisinone MDK®, in the UK, France, Germany, Italy & Poland. WEP Clinical will make this medicine available on behalf of the drug manufacturer, MendeliKABS Inc. (“MDK”), a Canadian pharmaceutical company dedicated to the treatment of rare diseases.
WEP Clinical has an exclusive distribution agreement with MDK to supply Nitisinone MDK® across several EU territories. The product was granted a marketing authorisation by the EMA in August 2017.
Nitisinone MDK® is approved for use in adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (“HT-1”) in combination with dietary restriction of tyrosine and phenylalanine. HT-1 is a rare genetic metabolic disorder in which the body is unable to completely break down the amino acid tyrosine and harmful substances are formed, causing serious liver problems and liver cancer. It is classified as an orphan disease and affects 1 person out of 200,000 worldwide.
Jas Khera, Managing Director of WEP Clinical, said:
“This exclusive commercialisation, marketing and distribution agreement adds another important treatment to our portfolio of life-saving medicines which we are making available to hospitals and patients across Europe. Our team has worked hard to gain the necessary approvals and negotiate reimbursement mechanisms at the local level, in order to ensure this medicine is provided where and when it is needed most.
MDK is a valued partner of WEP Clinical and we are in full support of their mission to provide a safe and effective treatment option for hereditary tyrosinemia type 1 patients.”
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For further information, please contact:
Tel: 1-888 959-9987
About Nitisinone MDK
Nitisinone (2-nitro-4-trifluoromethylbenzoyl)-1,3-cyclohexanedione, or NTBC) is an inhibitor of the 4- hydroxyphenyl-pyruvate dioxygenase (HDDP), an enzyme involved in tyrosine degradation. Nitisinone MDK® is indicated for treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT 1) in combination with dietary restriction of tyrosine and phenylalanine. The product is presented as hard capsules containing 2 mg, 5 mg, or 10 mg of nitisinone as the active substance. Nitisinone MDK® is a ‘generic medicine’, meaning it contains the same active substance and works in the same way as the ‘reference medicine’ already authorised in the European Union (EU) called Orfadin®.
About WEP Clinical
WEP Clinical is a specialist pharmaceutical services company that partners with drug developers to make much-needed medicines available around the world. It supports its partner companies with all elements involved in product approval and commercialization across the EU, including negotiating reimbursement, marketing, tender participation, storing and handling product and ultimately delivering to hospitals and patients across the region. WEP Clinical has offices in the US, UK, Ireland and Portugal and has comprehensive regulatory and shipping knowledge, resulting in true global project management and distribution capabilities for customers.
Check out our company video for more information: www.wepclinical.com/company-video/
MendeliKABS is a Canadian pharmaceutical company based in Québec and dedicated to the treatment of rare diseases. Its vision is to provide safe and effective drug solutions that are affordable and universally accessible. The company integrates high-level expertise to offer health products and provide drugs manufacturing facilities in full compliance with international regulations and standards. MendeliKABS is the manufacturer of the generic drug, Nitisinone MDK®.