Jerini sells onself to british Shire
Jerini AG for an equity purchase price of EUR 328 million
Jerini's lead compound, FIRAZYR is a first-in-class orphan drug developed for the symptomatic treatment of acute attacks of hereditary angioedema (HAE). HAE is a debilitating and potentially life-threatening genetic orphan disease characterized by unpredictable recurring swelling attacks in the hands, feet, face, larynx, and abdomen. The European launch of the product is anticipated for the second half of 2008.
Terms of the offer
Shire will offer EUR6.25 per share in cash for all issued Jerini shares valuing the company at EUR328 million. The acquisition will be funded out of Shire's current cash resources and is expected to be accretive for Non GAAP earnings by the second half of 2010.
It is anticipated that the offer to Jerini's shareholders will be open for acceptance until the end of Q3 2008 and is contingent upon the fulfilment of certain customary terms and conditions, including approval by relevant merger control authorities.
In addition, Shire has entered into purchase agreements with members of the Management and Supervisory Boards along with a number of the major institutional shareholders, committing 53% of Jerini's existing share capital (prior to the capital increase), and in addition is investing EUR21 million in return for the subscription for newly-issued shares which correspond to 9% of Jerini's increased share capital. This will provide Jerini with sufficient cash to initiate the imminent launch of FIRAZYR in Europe, which may begin prior to completion of the transaction.
Strategic rationale for the transaction
The acquisition brings a new addition to Shire's portfolio of treatments for rare disorders, prescribed by specialist physicians. The development of FIRAZYR will benefit significantly from Shire HGT's global infrastructure, specialist sales, medical and regulatory teams, orphan drug know-how and financial support.
In addition to the bridging finance, Shire will provide support from its established HGT commercial team in Europe to raise awareness of HAE, build Centers of Excellence and facilitate patient identification and treatment, similar to its successful strategy with its current orphan drugs ELAPRASE® (idursulfase) and REPLAGAL® (agalsidase alfa). Shire will also use its growing global infrastructure to support the launch of FIRAZYR as it gains approval elsewhere in the world.
On completion of the acquisition, Shire will conduct a strategic review of Jerini's other assets including Jerini Ophthalmic, Inc., a US subsidiary which is developing a treatment for Wet Age-related Macular Degeneration (AMD) and JPT Peptide Technologies GmbH, a peptide manufacturing operation which produces complex synthetic peptides.
Global development of FIRAZYR
Using its expertise in the US drug approval process, and experience of rare disease treatments, Shire will assist Jerini in pursuing US Food and Drug Administration (FDA) approval for the FIRAZYR new drug application (NDA), following Jerini's receipt of a 'not approvable' letter in April 2008. Shire is confident that FIRAZYR could obtain US approval after the issues raised in this 'not approvable' letter have been addressed. These issues were connected with efficacy data and not drug safety. A complete response will be submitted to the FDA within the next three to four months, and a path forward will be agreed with the agency for future registrations.
In addition, Shire will seek to support Jerini in its launch of this product in other markets, consistent with Shire's globally expanding footprint. Shire estimates that FIRAZYR could reach global peak sales of around $350-400 million during the next decade with over half of these sales coming from the EU.