PARIS--(BUSINESS WIRE)--Regulatory News:
Ipsen (Euronext: IPN; ADR: IPSEY) today announced that Lonza has successfully re-manufactured the active ingredient of Increlex® (mecasermin [rDNA origin] Injection). The European Medicines Agency (EMA) has been informed that Ipsen is preparing for the resupply of Increlex® in the European Union (EU).
Consultations with the EU Member States’ national competent authorities are now in process to allow immediate resupply. Resupply in the US is still pending. Ipsen continues to actively address the management of the shortage period in the US to reduce its impact on patients and their families.
Christel Bories, Deputy CEO of Ipsen stated: “We are very pleased that resupply of Increlex® to patients in Europe is imminent. We are still working closely with other national competent authorities to solve the outstanding issues in those countries.”
About Increlex® (mecasermin [rDNA origin] injection)
Increlex® is an important drug used to treat patients with Severe Primary IGF-1 Deficiency (Primary IGFD) and is considered to be a drug of medical necessity. Increlex®’s active principle (IGF-1) for the treatment of Severe Primary IGF-1 Deficiency (Primary IGFD) is manufactured by Lonza Biologics Inc. at its Hopkinton, MA facility.
The active substance in Increlex® is a recombinant insulin-like growth factor of human origin (IGF-1). IGF-1 is the direct hormonal mediator of stature and bone growth and must be present for normal growth of bones and cartilage in children. In severe primary IGF-1 deficiency, children’s serum IGF-1 levels are low despite the presence of normal or elevated GH levels. If the IGF-1 is not present in sufficient quantities, the child will not reach a normal stature. In October 2006, Tercica Inc. granted Ipsen the rights to develop and market Increlex® worldwide, with the exception of the United States, Japan, Canada, the Middle East and Taiwan. Ipsen’s acquisition of Tercica in 2008 gave it full access to this molecule (IGF-1). The only indication filed for Increlex® is the treatment of severe primary IGF-1 deficiency in children and adolescents. Increlex® has been marketed in the United States since the beginning of 2006. It was granted orphan drug status by the EMA on 5 April 2006 and marketing authorization in the European Union on 3 August 2007. Increlex® is currently marketed by Ipsen in most European countries. On 25 April 2013, Ipsen announced that the supplier of Increlex®’s (mecasermin [rDNA origin] Injection) active ingredient, Lonza, was facing manufacturing issues with Increlex® at its Hopkinton site (MA, USA). Lonza has been working closely with the Food and Drug Administration (FDA) to address these issues. Ipsen has been diligently addressing management of the shortage period to reduce its impact on the patients and their families. The supply interruption occurred in mid-June 2013 in the US and in Q3 2013 in Europe and the rest of the world.
Ipsen is a global specialty-driven pharmaceutical company with total sales exceeding €1.2 billion in 2012. Ipsen’s ambition is to become a leader in specialty healthcare solutions for targeted debilitating diseases. Its development strategy is supported by 3 franchises: neurology, endocrinology and uro-oncology. Moreover, the Group has an active policy of partnerships. Ipsen's R&D is focused on its innovative and differentiated technological platforms, peptides and toxins. In 2012, R&D expenditure totalled close to €250 million, representing more than 20% of Group sales. The Group has close to 4,900 employees worldwide. Ipsen’s shares are traded on segment A of Euronext Paris (stock code: IPN, ISIN code: FR0010259150) and eligible to the “Service de Règlement Différé” (“SRD”). The Group is part of the SBF 120 index. Ipsen has implemented a Sponsored Level I American Depositary Receipt (ADR) program, which trade on the over-the-counter market in the United States under the symbol IPSEY. For more information on Ipsen, visit www.ipsen.com.
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