Published:
Shire to add New Orphan Drug to its HGT Portfolio - EU Launch Imminent
BASINGSTOKE, England andCAMBRIDGE Massachusetts, July 3
/PRNewswire-FirstCall/ --
- Shire proposes acquisition of biotechnology company, Jerini AG for an
equity purchase price of EUR328 million adding hereditary angioedema
(HAE) product, FIRAZYR(R), to its Human Genetic Therapies (HGT) portfolio
- FIRAZYR peak annual global sales expected to be around $350-400
million, based on current expectation of the competitive environment
- Expected to be accretive for Non GAAP earnings by the second half of
2010
- Acquisition to bring worldwide rights to FIRAZYR (Icatibant), a peptide
based therapeutic for HAE which has received a positive opinion from the
Committee for Medicinal Products for Human Use (CHMP); European
Commission approval expected in Q3 2008
- FIRAZYR launch anticipated in EU in 2H 2008 generating revenues this
year
- Shire will work with Jerini and the FDA to pursue the approval of
FIRAZYR in the US and seek to obtain approvals in the rest of the world
- Orphan designation in the EU and US: approximately 10,000 HAE diagnosed
patients; estimated prevalence is one in 50,000 individuals
- First-in-class HAE therapy that provides rapid access in a convenient,
pre-filled syringe formulation to be administered subcutaneously
- Highly complementary fit with Shire's portfolio of specialist products;
FIRAZYR expected to benefit significantly from Shire's global
infrastructure and expertise
- Jerini's other assets include Jerini Ophthalmic, Inc. and JPT Peptide
Technologies GmbH
- Unanimous support from Jerini's Supervisory and Management boards
Analysts/Investors Conference call at 11am BST/6am EDT - details below
Shire Limited (LSE: SHP, NASDAQ: SHPGY), the global specialty
biopharmaceutical company, announced today that Maia Elfte
Vermogensverwaltungs-GmbH, to be renamed "Shire Deutschland Investments
GmbH", a German indirect subsidiary of Shire Limited, will launch a voluntary
public takeover offer for shares in Jerini AG (FSE: JI4, ISIN: DE0006787476),
the publicly listed German biotechnology company. Jerini's Supervisory and
Management Boards unanimously support the transaction and will recommend
acceptance of the offer to its shareholders.
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 inEurope, which may begin
prior to completion of the transaction.
Once the offer document is published and circulated to Jerini's
shareholders, details will be available on http://www.Shire.com as well as on
http://www.Jerini.com.
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 inEurope 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(R)
(idursulfase) and REPLAGAL(R) (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.
Shire Chief Executive, Angus Russell comments:
"The proposed acquisition of Jerini would bring to Shire a new drug that
is highly complementary to our HGT portfolio, which we have been developing
since 2005 as part of our clear, overall focus on specialist drugs.
Consistent with our strategy, FIRAZYR is a product which satisfies a high
unmet medical need and treats a morbidly symptomatic disorder. With orphan
designation in bothEurope and the US, and a launch inEurope in the second
half of this year, the acquisition will bring near term revenues as well as
contribute to Shire's longer term growth."
Sylvie Gregoire, President of Shire Human Genetic Therapies, adds:
"HAE is a rare, serious orphan disease with a high unmet need. Very
little alternative treatment is available today to patients suffering with
this debilitating and sometimes life threatening disease. FIRAZYR is the
first quickly accessible product to treat HAE patients offered in a
convenient pre-filled syringe for subcutaneous administration. FIRAZYR not
only fits our HGT portfolio but also leverages our capabilities of building
successful global products for rare diseases."
Prof. Dr. Jens Schneider-Mergener, chairman of Jerini AG's Management
Board, said:
"We are delighted to have found with Shire the right partner. Firazyr(R)
will soon be available to HAE patients inEurope, and we are confident that
Shire's commercial expertise will ensure its successful market introduction
in all 27 EU countries."
About FIRAZYR
In development since 2001, FIRAZYR is a first-in-class compound, which
works by blocking the B2 receptor as an antagonist to the peptide-hormone
bradykinin. Bradykinin has been shown to be elevated in HAE patients and
responsible for edema formation during HAE attacks. FIRAZYR has been granted
orphan drug status for the symptomatic treatment of acute attacks of
angioedema by the European Medicines Agency (EMEA) and the US FDA,
potentially securing, upon approval, market exclusivity for ten and seven
years, respectively. Among the key benefits of FIRAZYR for patients, are its
safety and efficacy profile demonstrated in clinical studies to date,
subcutaneous administration, and room temperature stability. FIRAZYR will be
packaged in a pre-filled syringe.
About Hereditary Angioedema (HAE)
HAE is a debilitating and potentially life-threatening genetic disease
characterized by unpredictable recurring swelling attacks in the hands, feet,
face, larynx, and abdomen. It is estimated that approximately 10,000 patients
in the US andEurope have been diagnosed with HAE. HAE attacks affecting the
face, hands, and feet can be disfiguring, while attacks in the
gastrointestinal tract result in severe pain caused by swelling in the
intestinal wall. Attacks that affect the larynx are life-threatening because
swelling of the larynx constricts the upper airways and can lead to death by
suffocation. Patients frequently experience such episodes (up to 20 in a
year).
The prevalence of HAE is estimated as one in 50,000 people with
approximately 10,000 HAE patients in the European Union region, 7,000 in the
US/Canada and 8,000 patients inLatin America and ROW. As awareness of the
condition is low, it is estimated that only 50% of HAE patients in the world
are correctly diagnosed and managed today.
About Shire (LSE: SHP, NASDAQ: SHPGY)
Shire's strategic goal is to become the leading specialty
biopharmaceutical company that focuses on meeting the needs of the specialist
physician. Shire focuses its business on attention deficit and hyperactivity
disorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) and
renal diseases. The structure is sufficiently flexible to allow Shire to
target new therapeutic areas to the extent opportunities arise through
acquisitions. Shire's in-licensing, merger and acquisition efforts are
focused on products in niche markets with strong intellectual property
protection either in the US orEurope. Shire believes that a carefully
selected portfolio of products with strategically aligned and relatively
small-scale sales forces will deliver strong results.
For further information on Shire, please visit the Company's website:
http://www.shire.com.
About Jerini AG (FSE: JI4)
Jerini is a pharmaceutical company based inBerlin, Germany, focusing on
the discovery, development, and commercialization of novel peptide-based
drugs. As of 31st March 2008 Jerini had gross assets of EUR36.1 million and
in the year ended 31 December 2007 made a net loss of EUR29m. The company
pursues disease indications that have limited or no treatment options and has
built a drug pipeline composed of its own programs, as well as others in
collaboration with established partners. Jerini's lead compound, FIRAZYR, is
a first-in-class compound developed for the treatment of HAE and European
product launch is planned in the second half of 2008. Jerini has also
established several in-house development programs, which address indications
within the therapeutic areas of ophthalmology, oncology, and inflammatory
disease. For more information, please see http://www.Jerini.com.
DISCLAIMER
This press release is neither an offer to purchase nor a solicitation of
an offer to sell shares in Jerini AG, nor an offer to purchase or sell any
other securities. The terms and conditions of the voluntary public takeover
offer will be published in the offer document only after the permission of
the German Federal Financial Supervisory Authority (Bundesanstalt fur
Finanzdienstleistungsaufsicht, BaFin) has been obtained. Investors and
holders of shares in Jerini AG are strongly advised to read the relevant
documents regarding the takeover offer when they become available because
they will contain important information.
Advisers
Deutsche Bank are acting as advisers to Shire Limited and Credit Suisse
are acting as advisers to Jerini AG.
"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM
ACT OF 1995
Statements included herein that are not historical facts are
forward-looking statements. Such forward-looking statements involve a number
of risks and uncertainties and are subject to change at any time. In the
event such risks or uncertainties materialize, Shire's results could be
materially affected. The risks and uncertainties include, but are not limited
to, risks associated with: the inherent uncertainty of pharmaceutical
research, product development including, but not limited to the successful
development of JUVISTA(R) (Human TGF (Beta) 3) and veleglucerase alfa
(GA-GCB); manufacturing and commercialization including, but not limited to,
the establishment in the market of VYVANSE(TM) (lisdexamfetamine dimesylate)
(Attention Deficit and Hyperactivity Disorder ("ADHD")); the impact of
competitive products, including, but not limited to, the impact of those on
Shire's ADHD franchise; patents, including but not limited to, legal
challenges relating to Shire's ADHD franchise; government regulation and
approval, including but not limited to the expected product approval date of
INTUNIV(TM) (guanfacine extended release) (ADHD); Shire's ability to secure
new products for commercialization and/or development; and other risks and
uncertainties detailed from time to time in Shire's filings with the
Securities and Exchange Commission, including Shire Limited's Annual Report
on Form 10-K for the year ended December 31, 2007.
There will be a conference call for investors and analysts hosted by
Angus Russell, Shire Chief Executive and Sylvie Gregoire, President of Shire
Human Genetic Therapies at 11am BST/6am EDT
Live conference call for investors:
UK - +44(0)20-3023-4496
USA - +1-866-966-5335
Password - Shire
Live Webcast:
The call will also be available live over the Internet via audio webcast,
accessible through http://www.shire.com in the investors section. A slide
presentation to accompany the call will also be available on the Shire
website.
Replay:
A replay of the presentation will be available for two weeks. Details are
as follows:
UK and International dial in - +44(0)208-196-1998
US dial in - +1-866-583-1035
Pin code - 3008632#
Webcast replay http://www.shire.com, in the Investors section
For further information please contact:
Investor Relations
Clea Rosenfeld (Rest of the World)
+44-1256-894-160
Eric Rojas (North America)
+1-484-595-8252
Media
Jessica Mann (Global)
+44-1256-894-280
Jessica Cotrone (North America, HGT)
+1-617-613-4640
SOURCE Shire Ltd
Copyright © 2008, PRNewswire
Copyright © 2008, NewsBlaze,
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