VALCHLOR(TM) gel under FDA Review for Early-Stage Mycosis Fungoides-Type CTCL
ALLSCHWIL/BASEL, Swzerland and MALVERN, PA, USA I July 31, 2013 IActelion 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.
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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®).
SOURCE: Actelion Pharmaceuticals
Post Views: 199
VALCHLOR(TM) gel under FDA Review for Early-Stage Mycosis Fungoides-Type CTCL
ALLSCHWIL/BASEL, Swzerland and MALVERN, PA, USA I July 31, 2013 IActelion 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®).
SOURCE: Actelion Pharmaceuticals
Post Views: 199
