News

Accelis Pharma enters into an agreement to promote PANDEL® and VEREGEN® products in the United States

East Windsor, New Jersey, September 18, 2015 – Accelis Pharma, a specialty pharmaceutical company based in East Windsor, New Jersey, announced today the signing of an agreement with Fougera Pharmaceuticals Inc., a wholly owned subsidiary of Sandoz Inc., to promote PANDEL® (hydrocortisone probutate) Cream, 0.1% and VEREGEN® (sinecatechins) Ointment, 15% to primary care practitioners.

PANDEL® is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 18 years of age or older.

VEREGEN® is indicated for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older.

The agreement enables PANDEL® and VEREGEN® promotional efforts within the primary care arena through the use of Accelis Pharma’s dedicated sales force to substantially augment both the number of physicians reached and the frequency of calls. Under the agreement, Accelis Pharma’s sales force is expected to begin its promotional efforts in October 2015 to its existing primary care practitioners.

About Accelis Pharma

Accelis Pharma is a specialty pharmaceutical company focusing on acquiring, developing and marketing prescription products in Dermatology, Cough and Cold, Wound Care, and Pain Management. Accelis Pharma markets several FDA approved products in the United States, including, OBREDON® Oral Solution. The Company promotes its branded products to physicians and practitioners through its Accelis Pharma sales force.

Additional information about Accelis Pharma is available on the Company’s website, visit www.accelispharma.com.

PANDEL® Important Safety Information

Pandel® is contraindicated in those patients who are hypersensitive to any of the components of the preparation. If irritation develops, Pandel® should be discontinued and appropriate therapy instituted. This medication is for external use only. Avoid contact with the eyes. The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive, unless directed by the physician. Therapy should be discontinued when control is achieved. If no improvement is seen within two weeks, contact your physician.

VEREGEN® Important Safety Information

Do not use VEREGEN® Ointment, 15% if you are allergic to any ingredient in this product. Do not use VEREGEN® Ointment, 15% for warts in the vagina, cervix, or inside the anus. Avoid contact with your eyes, nostrils and mouth while ointment is on your finger(s).

Avoid use of VEREGEN® on open wounds. Do not expose skin that has been treated with VEREGEN® to the sunlight, sunlamps or tanning beds. Tell your doctor if you are using any other type of skin product on the area to be treated. Avoid sexual contact (genital, anal or oral) when VEREGEN® Ointment, 15% is on your genital or perianal skin. If you do choose to have sexual contact, you must wash off the ointment carefully before having protected sexual contact as the ointment may weaken condoms and vaginal diaphragms.

Be sure to tell the doctor if you have a weak immune system, if you are pregnant or nursing a baby, or if you have used VEREGEN® before. Avoid using this product in patients younger than 18 years of age or for longer than 16 weeks. If your warts do not go away or come back after treatment contact your doctor.

The most common side effects with VEREGEN® Ointment, 15% are local skin and application site reactions including: redness, swelling, sores, rash with blisters, burning, itching, pain, hard spots.

For more information, consult your healthcare professional.

You are encouraged to report negative side effects of prescription drugs to the Food and Drug Administration (FDA). Please visit www.fda.gov/medwatch or call 1-800-FDA-1088.

VEREGEN is a registered trademark of MediGene AG, D-82152 Planegg/Martinsried, Germany.