Shire ( ) recently entered into an agreement with arGEN-X, a Netherlands-based privately-held biopharmaceutical company, to create novel treatments for rare genetic diseases.

As per the terms of the deal, Shire retains an option to license the candidates for exclusive development (preclinical and clinical) and commercialization worldwide. In exchange of this option, arGEN-X will be eligible to receive an upfront technology access fee, research funding, preclinical success payments, milestones and royalties from Shire. Financial terms of the agreement were not made public.

This deal is in line with Shire’s strategy of targeting specialist markets with strong patent protection and global rights.

Generic Threats

Shire is facing generic threats for several of its key marketed products. The company is already facing generic competition for Adderall XR, one of its top revenue-generating products. Teva Pharmaceutical Industries, Ltd. ( TEVA - Analyst Report ) and Impax Laboratories, Inc. ( IPXL - Snapshot Report ) had launched generic versions of Adderall XR in April 2009 and October 2009, respectively.

Vyvanse, currently the top revenue grosser at Shire, is also facing patent challenges. Six companies, including Sandoz, Inc., Amneal Pharmaceuticals LLC, Watson Laboratories ( ) , Roxane Laboratories, Inc., Mylan Pharmaceuticals, Inc. ( MYL - Analyst Report ) and Actavis Elizabeth LLC and Actavis Inc. (both together) have filed Abbreviated New Drug Applications (ANDA) for their generic versions of Vyvanse. Shire has filed patent infringement lawsuits against all these companies.

Shire is currently fighting patent infringement lawsuits for several of its other products such as Intuniv, Fosrenol and Lialda.

Our Recommendation

We currently have a Neutral recommendation on Shire. The stock carries a Zacks #2 Rank (Buy rating) in the short run.

Shire’s recent collaborations and acquisitions (including Movetis and Advanced BioHealing Inc.) have added immense potential to its pipeline. With several of its products already facing or likely to face generic competition, the company’s pipeline needs to deliver.