CEPTARIS RECEIVES US FDA APPROVAL FOR VALCHLOR - A SIGNIFICANT CLOSING CONDITION OF ACTELION'S ACQUISITION OF PRIVATELY-HELD CEPTARIS
Actelion Pharmaceuticals Ltd / CEPTARIS RECEIVES US FDA APPROVAL FOR VALCHLOR - A SIGNIFICANT CLOSING CONDITION OF ACTELION'S ACQUISITION OF PRIVATELY-HELD CEPTARIS . Processed and transmitted by Thomson Reuters ONE. 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:
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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.
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:
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
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.
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
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Actelion Pharmaceuticals Ltd
Gewerbestrasse 16 Allschwil Switzerland
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