CEPTARIS RECEIVES US FDA APPROVAL FOR VALCHLOR - A SIGNIFICANT CLOSING CONDITION OF ACTELION'S ACQUISITION OF PRIVATELY-HELD CEPTARIS
(Thomson Reuters ONE) -
Actelion Pharmaceuticals Ltd /
CEPTARIS RECEIVES US FDA APPROVAL FOR VALCHLOR - A SIGNIFICANT CLOSING CONDITION
OF ACTELION'S ACQUISITION OF PRIVATELY-HELD CEPTARIS
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The issuer is solely responsible for the content of this announcement.
ALLSCHWIL / BASEL, SWITZERLAND - 26 August 2013 - Actelion (SIX: ATLN) today
highlighted the announcement from Ceptaris Therapeutics, Inc., which stated that
the US Food and Drug Administration (FDA) has granted marketing approval for
VALCHLOR(TM) (mechlorethamine) Gel 0.016% for the topical treatment of stage IA
and IB mycosis fungoides-type cutaneous T-cell lymphoma (CTCL) in patients who
have received prior skin directed therapy.
On July 30, 2013 Actelion US Holding Company, a subsidiary of Actelion Ltd, and
Ceptaris Therapeutics, Inc. entered into an agreement whereby Actelion would
acquire Ceptaris. Under the terms of the agreement, the merger is contingent
upon certain closing conditions, including the announced US FDA approval of
Ceptaris' product, VALCHLOR.
The companies are now completing further closing conditions before the
acquisition is concluded. Actelion will provide a further update upon closing.
The full Ceptaris statement can be found on the corporate website of Ceptaris:
http://www.ceptaris.com/news/
# # #
NOTES TO THE EDITOR
ABOUT THE MERGER AGREEMENT
Actelion US Holding Company, a subsidiary of Actelion Ltd, and Ceptaris
Therapeutics, Inc. have entered into an agreement whereby Actelion acquire
Ceptaris. Under the terms of the agreement, the merger is contingent upon
certain closing conditions, including the announced US FDA approval of Ceptaris'
product, VALCHLOR.
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.
ABOUT MYCOSIS FUNGOIDES AND CUTANEOUS T-CELL LYMPHOMA
Mycosis fungoides is the most common type of Cutaneous T-Cell Lymphoma (CTCL), 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 Cutaneous T-Cell
Lymphoma (CTCL). Topical mechlorethamine preparations are currently recommended
for the treatment of early stage CTCL by the National Comprehensive Cancer
Network (NCCN). VALCHLOR Gel is the first and only FDA-approved topical
formulation of mechlorethamine.
The most common side effects associated with VALCHLOR in the pivotal trial were
local skin reactions, including dermatitis (56%), pruritus (20%), bacterial skin
infections (11%), skin ulceration or blistering (6%) and skin hyperpigmentation
(5%). The most common of these skin reactions, dermatitis, ranged from mild to
severe. No systemic absorption of mechlorethamine was detected with VALCHLOR
treatment.
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. Ceptaris' drug is 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® (bosentan), 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. Actelion, founded in late 1997, 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 2,300 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
The above information contains certain "forward-looking statements", relating to
the company's business, which can be identified by the use of forward-looking
terminology such as "estimates", "believes", "expects", "may", "are expected
to", "will", "will continue", "should", "would be", "seeks", "pending" or
"anticipates" or similar expressions, or by discussions of strategy, plans or
intentions. Such statements include descriptions of the company's investment
and research and development programs and anticipated expenditures in connection
therewith, descriptions of new products expected to be introduced by the company
and anticipated customer demand for such products and products in the company's
existing portfolio. Such statements reflect the current views of the company
with respect to future events and are subject to certain risks, uncertainties
and assumptions. Many factors could cause the actual results, performance or
achievements of the company to be materially different from any future results,
performances or achievements that may be expressed or implied by such forward-
looking statements. Should one or more of these risks or uncertainties
materialize, or should underlying assumptions prove incorrect, actual results
may vary materially from those described herein as anticipated, believed,
estimated or expected.
Press Release PDF:
http://hugin.info/131801/R/1724720/574960.pdf
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Thomson Reuters clients. The owner of this announcement warrants that:
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other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Actelion Pharmaceuticals Ltd via Thomson Reuters ONE
[HUG#1724720]
Unternehmensinformation / Kurzprofil:
Datum: 26.08.2013 - 07:05 Uhr
Sprache: Deutsch
News-ID 290698
Anzahl Zeichen: 8417
contact information:
Town:
Allschwil
Kategorie:
Business News
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