Actelion launches VALCHLOR (mechlorethamine) gel 0.016% in the US

Date: Nov-20-2013Actelion (SIX: ATLN) has announced that VALCHLOR™ (mechlorethamine), the first and only FDA-approved topical formulation of mechlorethamine, is now available for patients in the United States (US). VALCHLOR, a gel which is applied topically once a day, is an alkylating drug indicated to treat patients with stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL) who have received prior skin-directed therapy. VALCHLOR is an orphan drug that was acquired by Actelion US Holding Company, a subsidiary of Actelion Ltd., on September 18, 2013 as part of a merger with Ceptaris Therapeutics, Inc. VALCHLOR is distributed in the US by Accredo Specialty Pharmacy.

"The availability of VALCHLOR is exciting news for patients and the treatment community.
Physicians now have the option to treat appropriate MF-CTCL patients with the first formulation of topical mechlorethamine that is FDA-approved based on rigorous clinical evidence to support its use," said Youn H. Kim, M.D., Joanne and Peter Haas Jr. professor for cutaneous lymphoma research, professor of dermatology, and director, Multidisciplinary Cutaneous Lymphoma Clinic, Stanford University School of Medicine.

"The use of topical mechlorethamine has been documented over several decades," said Stuart Lessin, M.D. former director of dermatology at the Fox Chase Cancer Center, president of the Board of Directors of the Cutaneous Lymphoma Foundation and lead investigator in the VALCHLOR pivotal trial. "With the launch of VALCHLOR, physicians can prescribe with confidence knowing that an FDA-approved formulation is now available, along with support and financial-assistance programs for eligible patients to help facilitate education and access."

Mycosis fungoides is the most common type of cutaneous T-cell lymphoma, a rare form of
non-Hodgkin's lymphoma. In the US, approximately 20,000 patients are currently diagnosed
with stage IA-IB MF-CTCL, qualifying it as a rare or orphan disease.

"We look forward to partnering with dermatology and oncology specialists to bring this
treatment to appropriate patients with MF-CTCL," said Bill Fairey, president of Actelion
Pharmaceuticals US Inc. "Actelion has deep expertise in rare, orphan diseases which we are
utilizing to help ensure VALCHLOR is accessible to patients who may benefit from this
important therapy."

Commitment to Access and Patient Support

Actelion has established VALCHLOR Support™, an assistance program to help eligible
patients successfully start and remain on VALCHLOR therapy. The program, administered by
Accredo Specialty Pharmacy, includes reimbursement and financial
support for eligible patients, as well as disease and product information.







"MF-CTCL can have a significant impact on the appearance and daily lives of patients
affected by the disease," said Susan Thornton, chief executive officer of the Cutaneous
Lymphoma Foundation. "We are thrilled to have a new treatment option in VALCHLOR,
supported by an assistance program for eligible patients to help ensure access."
For more information on the VALCHLOR Support program, patients can call
1-855-4-VALCHLOR (1-855-482-5245) between 9:00am - 11:00pm Eastern Time, or visit
www.valchlor.com.

About VALCHLOR

VALCHLOR (mechlorethamine) gel 0.016% is an alkylating drug indicated for the topical
treatment of stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL)
in patients who have received prior skin-directed therapy. VALCHLOR is a gel which is
applied topically once a day. Mechlorethamine, commonly known as nitrogen mustard, is a
chemotherapeutic agent previously approved for intravenous treatment of mycosis fungoides,
the most common type of cutaneous T-Cell lymphoma. Mechlorethamine is one of the
suggested skin-directed treatment regimens for early-stage MF-CTCL according to the latest
National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in
Oncology (NCCN Guidelines®)1. VALCHLOR is the first and only FDA-approved topical
formulation of mechlorethamine.

For more information and full prescribing information visit www.valchlor.com

Important Safety Information for VALCHLOR

Caregivers must wear disposable nitrile gloves during application and avoid direct skin
contact. 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.

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
malignant T-cells. The malignant T-cells in the body initially migrate to the skin, causing 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.  

Courtesy: Medical News Today Note: Any medical information available in this news section is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional.