Actelion closes acquisition of privately-held Ceptaris Therapeutics adding Valchlor to Actelion's product portfolio
(Thomson Reuters ONE) -
Actelion Pharmaceuticals Ltd /
Actelion closes acquisition of privately-held Ceptaris Therapeutics adding
Valchlor to Actelion's product portfolio
. Processed and transmitted by Thomson Reuters ONE.
The issuer is solely responsible for the content of this announcement.
* Valchlor(TM) is the only FDA-approved topical formulation of mechlorethamine
* US launch planned for Q4 2013
* US patient support and assistance programs will be available for Valchlor
ALLSCHWIL / BASEL, SWITZERLAND - 19 September 2013 - Actelion (SIX: ATLN)
announced today that it has concluded the acquisition of Ceptaris Therapeutics,
Inc. following US Food and Drug Administration (FDA) approval for Valchlor
(mechlorethamine) gel 0.016% and the satisfaction of additional closing
conditions. Ceptaris was a privately held, specialty pharmaceutical company
established to develop the proprietary gel formulation of mechlorethamine for
the treatment of early stage mycosis fungoides, a type of Cutaneous T-Cell
Lymphoma (CTCL).
Valchlor (mechlorethamine) gel 0.016% is indicated 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. Valchlor gel is applied
topically once-a-day and dries on the skin. The availability of Valchlor allows
US physicians to treat mycosis fungoides type CTCL with an FDA-approved
formulation of topical mechlorethamine. In addition to consistent, controlled
manufacturing processes, Valchlor will be provided with labeling that includes
data and instructions for correct use, to help achieve the best possible
clinical results.
Jean-Paul Clozel, M.D. and CEO at Actelion, commented: "Prior to the approval of
Valchlor, there were no approved topical mechlorethamine products available for
prescription. As a result, patients were dependent on formulations prepared
locally by compounding pharmacies in a non-standardized environment. Information
about pharmacy-compounded preparations is not required to be submitted to, or
reviewed by, the FDA prior to their use by patients. Therefore, such
preparations do not undergo the same rigorous FDA review as Valchlor has. This
new standardized product represents a clinically relevant improvement for
patients suffering from mycosis fungoides."
COMMERCIALIZATION OF VALCHLOR
Valchlor will be distributed in the US by Accredo Specialty Pharmacy with target
availability in the fourth quarter of 2013. Physicians will be able to prescribe
Valchlor by visiting www.valchlor.com. Patient support and assistance programs
will be available to patients. The program services offered will include
insurance verification and financial assistance for eligible patients, as well
as disease and product information.
Otto Schwarz, Chief Operating Officer at Actelion, commented: "Actelion is ready
to leverage our expertise in orphan and ultra-orphan indications to
appropriately commercialize Valchlor, a meaningfully differentiated medicine, to
specialists in the field of dermatology and oncology. We intend to make Valchlor
available in the US during the fourth quarter of this year, using a dedicated
sales force and will evaluate the opportunity outside the US, before filing for
registration in other regions."
ABOUT VALCHLOR (MECHLORETHAMINE) GEL
Valchlor (mechlorethamine) gel 0.016% is indicated 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. Valchlor gel is applied
topically once-a-day and dries on the skin. 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
is the first and only FDA-approved topical formulation of mechlorethamine.
IMPORTANT SAFETY INFORMATION FOR VALCHLOR
Valchlor is for topical dermatologic use only. Valchlor is a cytotoxic drug.
Avoid direct skin contact with Valchlor in individuals other than the patients
due to risk of dermatitis, mucosal injury and secondary cancers. The use of
Valchlor is contraindicated in patients with a history of severe or systemic
hypersensitivity to mechlorethamine or inactive ingredients. Contact with mucous
membranes, especially those of the eyes, must be avoided. Exposure of the eyes
to mechlorethamine may cause pain, burns, inflammation, photophobia, blurred
vision and in some cases severe and long-lasting injury to the eye. Patients
should be monitored for non-melanoma skin cancers during and after treatment
with Valchlor. The most common adverse reaction to Valchlor is dermatitis, which
in some cases may be severe and require dosing changes or discontinuation.
Elderly patients may be more susceptible to dermatitis. Women should avoid
becoming pregnant or nursing while using Valchlor due to potential hazard to the
fetus. Valchlor is an alcohol-based gel. Avoid fire, flame and smoking until the
gel has dried.
# # #
NOTES TO THE EDITOR
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.
RESULTS OF THE VALCHLOR PIVOTAL TRIAL
The approval of Valchlor was based on a randomized, observer-blinded, non-
inferiority pivotal trial comparing Valchlor to a pharmacy-compounded
mechlorethamine preparation in patients with stage IA-IIA CTCL. Patients had
received at least one prior skin-directed therapy. Qualifying prior therapies
included topical corticosteroids, phototherapy, bexarotene gel (retinoid
selectively activating the retinoid X receptors), and topical nitrogen mustard
(mechlorethamine). Patients were not required to be refractory to or intolerant
of prior therapies. In the thirteen cancer center study, 260 patients (the vast
majority of whom were IA and IB) were enrolled (1:1 randomization), making it
the largest randomized study ever conducted in mycosis fungoides-type CTCL.
Results of the study were published earlier this year in JAMA Dermatology [1].
In the study, 60% of patients treated with Valchlor had a confirmed response at
12 months, defined as reduction of at least 50% in the Composite Assessment of
Index Lesion Severity (CAILS) score, while 48% of those treated with the
compounded control achieved a confirmed response. CAILS responses were seen as
early as 1 month, with further responses observed through 11 months of
treatment.
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 THE ACQUISITION
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 was contingent
upon certain closing conditions, including the US FDA approval of Ceptaris'
product, Valchlor.
Actelion paid to Ceptaris USD 25 million upon signing, followed by a further
payment of 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.
References
1. Lessin SR, Duvic M, Guitart J, Pandya AG, Strober BE, Olsen EA, et al.
Topical chemotherapy in cutaneous T-cell lymphoma: Positive results of a
randomized, controlled, multicenter trial testing the efficacy and safety of
a novel mechlorethamine, 0.02%, gel in mycosis fungoides. JAMA Dermatol.
2013;149(1):25-32.
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/1729865/578000.pdf
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
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#1729865]
Unternehmensinformation / Kurzprofil:
Datum: 19.09.2013 - 07:00 Uhr
Sprache: Deutsch
News-ID 298118
Anzahl Zeichen: 13548
contact information:
Town:
Allschwil
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 243 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Actelion closes acquisition of privately-held Ceptaris Therapeutics adding Valchlor to Actelion's product portfolio"
steht unter der journalistisch-redaktionellen Verantwortung von
Actelion Pharmaceuticals Ltd (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
