Alexion to Acquire Enobia Pharma Corp. and First Potential Treatment for Patients with Hypophosphatasia (HPP)
- Late-Stage Investigational Enzyme Replacement Therapy for
Ultra-Rare Life-Threatening Genetic Metabolic Disease -
- Conference Call Scheduled for Tomorrow Morning -
CHESHIRE, Conn. & MONTREAL, CANADA--(BUSINESS WIRE)--
Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) and Enobia Pharma Corp.
today announced that the companies have signed a definitive agreement
under which Alexion will acquire 100% of the capital stock of Enobia.
Enobia is a private biopharmaceutical company based in Montreal, Canada
and Cambridge, Massachusetts, which is focused on the development of
therapies to treat patients with ultra-rare and life-threatening genetic
Enobia's lead product candidate ENB-0040 (asfotase alfa), is a human
recombinant targeted alkaline phosphatase enzyme-replacement therapy for
patients suffering with hypophosphatasia (HPP), an ultra-rare,
life-threatening, genetic metabolic disease for which there are no
approved treatment options. Alexion will acquire full worldwide
development and commercial rights to asfotase alfa. Asfotase alfa was
awarded orphan drug designation in the U.S. and EU in 2008 and Fast
Track status in the U.S. in 2009, and is currently in Phase II clinical
"Hypophosphatasia is an ultra-rare and life-threatening disease, and
those patients who survive live with debilitating morbidities including
skeletal deformity, severe muscle weakness, and progressive damage to
vital organs," said Leonard Bell, M.D., Chief Executive Officer of
Alexion. "Asfotase alfa has shown very compelling Phase II clinical data
in infants and juveniles with hypophosphatasia. The acquisition of
Enobia is very well aligned with Alexion's objective to develop and
deliver life-transforming therapies for patients suffering with
ultra-rare, severe, and life-threatening disorders."
"Alexion has proven expertise in developing and commercializing
therapies to transform the lives of patients with severe and ultra-rare
disorders, making them the ideal partner to advance the work of the
Enobia team and bring asfotase alfa to HPP patients around the world,"
said Jonathan Silverstein, General Partner of OrbiMed and Enobia
Chairman. OrbiMed is a controlling shareholder in Enobia.
"Enobia and our scientific collaborators have developed an elegant
compound showing very promising clinical results to date," said Dr.
Robert Heft, President and Chief Executive Officer of Enobia. "Together
with Alexion, we share a sharp focus on transforming the lives of
patients with severe and ultra-rare disorders. The hypophosphatasia
patient community will be well served by the experience and
international scope of Alexion."
Alexion will acquire Enobia in an all-cash transaction. Under the terms
of the agreement, Alexion has agreed to pay $610 million in cash upon
consummation of the transaction, and up to $470 million in cash to be
paid upon achievement of various regulatory and sales milestones.
Alexion is not issuing equity in connection with the acquisition. The
transaction is subject to customary conditions, including the expiration
or termination of the waiting period under the Hart-Scott-Rodino
Antitrust Improvements Act. The Boards of both companies have approved
the transaction and the companies currently anticipate that the
transaction will be completed in the first quarter of 2012.
Alexion intends to finance the acquisition through cash on hand and $300
million of committed bank debt.
Goldman, Sachs & Co. is acting as financial advisor to Alexion. Ropes
and Gray LLP is acting as legal counsel to Alexion. Bank of America
Merrill Lynch is acting as financial advisor to Enobia. WilmerHale is
acting as legal advisor to Enobia.
About Hypophosphatasia (HPP)
HPP is an ultra-rare, genetic, and life-threatening metabolic disease
characterized by defective bone mineralization and impaired phosphate
and calcium regulation leading to progressive damage to multiple vital
organs including destruction and deformity of bones, profound muscle
weakness, seizures, impaired renal function, and respiratory failure.1,2,3,4
The severe manifestations of the genetic deficiency in HPP affect people
of all ages, and approximately 50 percent of infants with the disease do
not survive past one year of age.1
HPP is caused by a genetic deficiency of an enzyme known as tissue
non-specific alkaline phosphatase (TNSALP), which causes life-long
abnormalities in metabolism of the two vital minerals calcium and
phosphate, leading directly to the debilitating morbidities and
premature mortality of the disease.1 There are currently no
therapies approved for HPP.1
About Asfotase Alfa
Asfotase alfa is an investigational, highly innovative, first-in-class
recombinant protein that addresses the underlying cause of HPP by
targeting replacement of the missing enzyme to the necessary body
tissues. Asfotase alfa is designed to normalize the genetically
defective metabolic process and prevent or reverse the severe and
life-threatening complications of life-long dysregulated mineral
metabolism in patients with HPP.
2012 Initial Financial Outlook
Alexion will provide 2012 financial guidance in February, including
one-time expenses related to the Enobia acquisition. 2012 non-GAAP
research and development expenses are expected to transiently rise to
approximately 20 to 21% of sales, due to activities associated with
Enobia's programs, and then to return to the Company's target of
approximately 17% to 18% of sales in 2013. Non-GAAP selling, general and
administrative expenses associated with the proposed acquisition are
expected to have limited impact in 2012.
Alexion is reiterating all areas of 2011 guidance provided in its third
quarter 2011 earnings announcement in October.
Conference Call Information
Alexion will host a conference call tomorrow, December 29 at 9:00AM
Eastern Time, to discuss the proposed acquisition. To access the live
call, please dial 1-888-297-0356 (U.S.) or 1-719-325-2109
(international). The conference passcode number is 5470489. Telephone
replay will be available for a limited period following the call,
beginning at 12:00PM Eastern Time. The replay number is 888-203-1112
(USA) or 719-457-0820 (International), confirmation code 5470489. The
audio webcast can be accessed at www.alexionpharma.com.
About Enobia Pharma Corp.
Enobia Pharma Corp., based in Montreal, Canada, and Cambridge,
Massachusetts, is a privately held clinical stage biotech company
focused on developing novel therapeutics for serious metabolic bone
disorders. The Company's largest investors include OrbiMed, Fonds de
Solidarité des Travailleurs du Québec (F.T.Q.), Capital Régional et
Coopératif Desjardins, CTI Life Sciences Fund, L.P., and Lothian
Partners 27 (Sarl) SICAR. For more information, please visit
Alexion Pharmaceuticals, Inc. is a biopharmaceutical company focused on
serving patients with severe and ultra-rare disorders through the
innovation, development and commercialization of life-transforming
therapeutic products. Alexion is the global leader in complement
inhibition, and has developed and markets Soliris®
(eculizumab) as a treatment for patients with PNH and aHUS, two
debilitating, ultra-rare and life-threatening disorders caused by
chronic uncontrolled complement activation. Soliris is currently
approved in more than 35 countries for the treatment of PNH, and in the
United States and the European Union for the treatment of aHUS. Alexion
is evaluating other potential indications for Soliris and is pursuing
development of other innovative biotechnology product candidates in
early stages of development. This press release and further information
about Alexion Pharmaceuticals, Inc. can be found at: www.alexionpharma.com.
Safe Harbor Statement
This news release contains forward-looking statements, including
statements related to potential benefits from the acquisition of Enobia,
and its employees, technology and product candidate; statements related
to guidance regarding anticipated financial results for 2011 and 2012,
potential medical benefits for asfotase alfa for hypophosphotasia, and
assessment of the Company's financial position and commercialization
efforts. Forward-looking statements are subject to factors that may
cause Alexion's results and plans to differ from those expected,
including for example, decisions of regulatory authorities regarding
marketing approval or material limitations on the marketing of Soliris
for its current or potential new indications, and a variety of other
risks set forth from time to time in Alexion's filings with the
Securities and Exchange Commission, including but not limited to the
risks discussed in Alexion's Quarterly Report on Form 10-Q for the
period ended September 30, 2011, and in Alexion's other filings with the
Securities and Exchange Commission. Alexion does not intend to update
any of these forward-looking statements to reflect events or
circumstances after the date hereof, except when a duty arises under law.
Mornet E. Review of Hypophosphatasia. Orphanet Journal of Rare
Diseases. 2007:2:40 doi:10.1186/1750-1172-2-40. Available at:
Seshia SS, Derbyshire G, Haworth JC, Hoogstraten J. Myopathy with
Hypophosphatasia. Arch Dis Child. 1990. 65(1):130-1.
Whyte MP. Hypophosphatasia: Nature's Window on Alkaline Phosphatase
Function in Humans, in Principles of Bone Biology, 3rd Ed. Part II:
Molecular Mechanisms of Metabolic Bone Disease, Chapter 73:
1573-1598. Academic Press. 2008.
Silver MM, Vilos GA, Milne KJ. Pulmonary Hypoplasia in Neonatal
Hypophosphatasia. Pediatr Pathol. 1998. 8:483-493.
Irving Adler, 203-271-8210
Alexion Media Contact:
Kristie Kuhl, 212-508-9642
Anne Smith, 617-674-5751
VP and Chief Commercial Officer
Media Contact (United States):
Feinstein Kean Healthcare
Source: Alexion Pharmaceuticals, Inc.
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