FDA Approves Shire's New Facility - Analyst Blog


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Shire plc ( SHPG ) recently received positive news when the U.S. Food & Drug Administration (FDA) approved a third manufacturing facility at Mass. U.S. for the production of active pharmaceutical ingredient (API) in type I Gaucher disease drug, Vpriv.

The news should relieve Shire as it had received a complete response letter (CRL) for the production of Vpriv's API at the Lexington, Mass. manufacturing facility.

We note that Shire intends to add a manufacturing capacity in the Lexington facility to support the rapid growth of Vpriv and Replagal. The facility was initially approved for the purification of Replagal API.

Subsequently, Shire submitted regulatory filings with both the European Medicines Agency (EMA) and the FDA for the production of Vpriv API at the new facility in Nov 2011. The EMA's Committee for Medicinal Products for Human Use approved the production of Vpriv in this facility in Feb 2012, which was later adopted by the European Commission in Mar 2012. Shire has submitted its response to the matters raised by the FDA in Oct 2012.

Vpriv generated sales of $342.7 million in 2013. Hence, we are encouraged by the recent approval which should ensure a smooth supply of  Vpriv .

Last week, Shire reported strong fourth quarter results. Shire is well placed in the attention deficit and hyperactivity disorder (ADHD) market driven by key drug Vyvanse and is working on a label expansion of the drug.

ViroPharma's lead drug Cinryze is approved in the U.S. for routine prophylaxis against angioedema attacks in adolescent and adults with hereditary hereditary angioedema (HAE). Cinryze complements Shire's Firazyr which is indicated for the on-demand treatment of acute HAE attacks. 

We are positive on Shire's acquisition of ViroPharma which will strengthen its HAE franchise as Cinryze and Firazyr are two complementary therapies for the treatment of HAE. Meanwhile, Shire's efforts to realign its business structure to drive growth and innovation are noteworthy.

Shire currently carries a Zacks Rank #2 (Buy). Other pharma stocks that look attractive at current levels include Endocyte Inc. ( ECYT ), Forest Laboratories ( FRX ) and Auxilium Pharmaceuticals Ltd . ( AUXL ). All the three stocks carry a Zacks Rank #1 (Strong Buy).

AUXILIUM PHARMA (AUXL): Free Stock Analysis Report

ENDOCYTE INC (ECYT): Free Stock Analysis Report

FOREST LABS A (FRX): Free Stock Analysis Report

SHIRE PLC-ADR (SHPG): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

This article appears in: Investing , Business , Stocks
More Headlines for: API , CRL , ADHD , HAE , AUXL

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