Actelion enters into an agreement to acquire privately-held Ceptaris Therapeutics
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Actelion Pharmaceuticals Ltd /
Actelion enters into an agreement to acquire privately-held Ceptaris
Therapeutics
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VALCHLOR(TM) gel under FDA Review for Early-Stage Mycosis Fungoides-Type CTCL
ALLSCHWIL/BASEL, SWITZERLAND and MALVERN, PA - 31 July 2013 - Actelion US
Holdings Company, a subsidiary of Actelion Ltd (SIX: ATLN), and Ceptaris
Therapeutics, Inc. announced today that they have entered into an Agreement for
Actelion to acquire Ceptaris. Under the terms of the Agreement, the merger is
contingent upon certain closing conditions, including U.S. Food and Drug
Administration (FDA) approval of Ceptaris' product, VALCHLOR(TM).
If approved, VALCHLOR would be the first and only FDA-approved topical
formulation of mechlorethamine for the treatment of early-stage mycosis
fungoides-type cutaneous T-cell lymphoma. VALCHLOR has a PDUFA date of 27
August 2013.
Under the terms of the Merger Agreement, Actelion paid to Ceptaris USD 25
million upon signing and will pay to Ceptaris' shareholders USD 225 million upon
closing of the transaction. Ceptaris' shareholders are also eligible to receive
additional payments based on net sales of VALCHLOR and/or the achievement of
certain commercial milestones.
Jean-Paul Clozel, M.D. and Chief Executive of Actelion, commented: "Should the
FDA approve VALCHLOR and Actelion acquire Ceptaris, we would be able to offer
this meaningfully differentiated medicine to patients who today are dependent on
formulations prepared locally by compounding pharmacies in a non-standardized
environment. At the same time, we would leverage our existing knowhow and
infrastructure in the fields of orphan and ultra-orphan indications when
appropriately commercializing VALCHLOR to specialists in the field of
dermatology and oncology."
Nicholas Franco, Chief Business Development Officer at Actelion commented: "If
this transaction is consummated, we can build a product portfolio beyond our PAH
franchise. We expect the transaction to become cash-accretive before the end of
2014."
"We believe that Actelion's expertise in rare diseases make it an ideal partner
to deliver VALCHLOR to patients globally," said Stephen Tullman, President and
CEO, Ceptaris Therapeutics, Inc. "We look forward to advancing VALCHLOR
together to meet the needs of patients. We appreciate the ongoing support of
our investors, led by Vivo Ventures (represented by Albert Cha), who have
enabled us to develop VALCHLOR."
Aquilo Partners, L.P. acted as the financial advisor to Ceptaris on the
transaction.
###
NOTES TO EDITOR:
About Mycosis Fungoides and Cutaneous T-Cell Lymphoma
Mycosis fungoides is the most common type of Cutaneous T-Cell Lymphoma, a rare
form of non-Hodgkin's lymphoma. The cause of mycosis fungoides remains unknown
and there is no known cure. Unlike most non-Hodgkin's lymphomas, mycosis
fungoides is caused by a mutation of T-cells. The malignant T-cells in the body
initially migrate to the skin, causing various lesions to appear.
These lesions typically begin as what appears to be a rash and may progress to
form plaques and disfiguring tumors. Early stage cases may be confused with
other skin conditions until a definitive diagnosis is made based upon skin
biopsy. Most cases of mycosis fungoides are early-stage and are diagnosed in
patients over the age of 50.
About Mechlorethamine Gel
Mechlorethamine is a chemotherapeutic agent previously approved for intravenous
treatment of mycosis fungoides, the most common type of CTCL. Topical
mechlorethamine preparations are currently recommended for the treatment of
early stage CTCL by the National Comprehensive Cancer Network (NCCN). However,
there are no FDA-approved topical mechlorethamine products, limiting
availability to non-standardized, pharmacy-compounded preparations.
ABOUT CEPTARIS
Ceptaris Therapeutics Inc. is a privately held, specialty pharmaceutical company
that was established to develop a proprietary gel formulation of mechlorethamine
for the treatment of early stage (stages I-IIA) mycosis fungoides, a type of
CTCL. If approved, Ceptaris' investigational drug would be the first FDA-
approved topical mechlorethamine product available to treat the signs and
symptoms of this rare cancer. Please visit http://www.ceptaris.com for more
information. Ceptaris is a NeXeption portfolio company.
ABOUT ACTELION LTD
Actelion Ltd is a biopharmaceutical company with its corporate headquarters in
Allschwil/Basel, Switzerland. Actelion's first drug Tracleer(®), an orally
available dual endothelin receptor antagonist, has been approved as a therapy
for pulmonary arterial hypertension. Actelion markets Tracleer® through its own
subsidiaries in key markets worldwide, including the United States (based in
South San Francisco), the European Union, Japan, Canada, Australia and
Switzerland.
Founded in late 1997 Actelion is a leading player in innovative science related
to the endothelium - the single layer of cells separating every blood vessel
from the blood stream. Actelion's over 2,350 employees focus on the discovery,
development and marketing of innovative drugs for significant unmet medical
needs. Actelion shares are traded on the SIX Swiss Exchange (ticker symbol:
ATLN) as part of the Swiss blue-chip index SMI (Swiss Market Index SMI(®)).
For further information please contact:
Roland Haefeli
Senior Vice President, Head of Investor Relations & Public Affairs
Actelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123 Allschwil
+41 61 565 62 62
+1 650 624 69 36
www.actelion.com
Media for Ceptaris:
Mariesa Kemble
Sam Brown Inc.
mariesak(at)sambrown.com
(608) 850-4745
Press Release PDF:
http://hugin.info/131801/R/1719734/572384.pdf
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Source: Actelion Pharmaceuticals Ltd via Thomson Reuters ONE
[HUG#1719734]
Unternehmensinformation / Kurzprofil:
Datum: 31.07.2013 - 17:35 Uhr
Sprache: Deutsch
News-ID 283562
Anzahl Zeichen: 7426
contact information:
Town:
Allschwil
Kategorie:
Business News
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