Genzyme says new plant approval is imminent
pharmafile | February 18, 2009 | News story | Research and Development, Sales and Marketing |Â Â GenzymeÂ
Genzyme has said it expects to get approval to make a Pompe disease treatment at a new US manufacturing unit by the end of the month, giving a lift to the drugs sales.
Myozyme (alglucosidase alfa) is already a $300 million product and is performing well for Genzyme in Europe. But a combination of insufficient production capacity globally – and regulatory obstacles in the US has held the product back.
Last month, for example, the European Medicines Agency's Committee for Medicinal Products (CHMP) recommended that infants, children and adolescents be given priority access to Myozyme during the current supply shortage in order to eke out available stocks.
Genzyme has built a new 2,000-litre production unit in Allston in the US, but in April 2008 the FDA ruled Genzyme must apply for approval before it can use it.
The agency's position was that bringing this production online represents such a major change to Myozyme's Biologics License Application that the product made at Allston should be classified as a different product because it has a different pattern of glycosylation (sugar side chains) on the protein.
That meant Genzyme needed to file a dossier to get approval to sell the Allston product under a different trade name, and upon approval will have two versions on the US market.
The company also makes some supplies of the drug at a smaller facility in Framingham which uses 160-litre reactors, and this product will continue to be branded as Myozyme. Product made at Allston will be sold as Lumizyme.
As a result, Genzyme had to draw up a Risk Evaluation and Mitigation Strategy (REMS) which is pending approval at the FDA. The company expects a decision to be made by 28 February, but estimates that the delay in bringing the drug to market cost it $45m in lost revenues in 2008.
Genzyme is also building up capacity on the other side of the Atlantic, with two 4,000-litre perfusion reactors in Belgium was submitted for approval in December and could come online in April.
Once the Allston capacity comes online Myozyme/Lumizyme could see revenues increase by 50% in 2009, said Genzyme's chief financial officer, Michael Wyzga, on the firm's fourth-quarter results call. Despite the hold-ups global sales of Myozyme advanced by $95 million in 2008 to reach $296 million.
In 2009 sales of the drug could reach more than $430 million, said Wyzga.
Related Content
Use of Genzyme’s MS drug Lemtrada restricted under ongoing EMA safety review
The EMA has launched a review into Genzyme’s multiple sclerosis drug Lemtrada (alemtuzumab) after reports …
Alnylam and Sanofi close research phase of 2014’s $700m RNAi rare disease partnership
Alnylam and Sanofi have announced their intention to bring to an end the research and …
Cancer drugs prices vary up to 388% between high-income countries
The price of new cancer drugs varies widely between high-income countries in Europe, Australia, and …
