© AzurPharma Ltd.
Company Number 399192
DUBLIN, Ireland, 14th April, 2009 - Azur Pharma Limited ("Azur") today announced
it has commenced commercialisation of ElestrinTM. Azur licensed US rights to Elestrin
from BioSante Pharmaceuticals, Inc. ("BioSante") (Nasdaq: BPAX) in December 2008.
Elestrin was approved by the U.S. Food and Drug Administration in December 2006
and is patented through June 2022.
Azur is marketing Elestrin to estrogen prescribing physicians, comprised mostly
of gynaecologists. Azur recently increased its Women's Health and Urology sales
team to 65 people to support the launch. Mr. Seamus Mulligan, Chairman and CEO of
Azur, commented, "We are excited about the potential for Elestrin in the United
States market. Its low dose regimen and ease of administration provide dosing flexibility
and clinical benefit for physicians and patients. The product is an important addition
to our women's health product portfolio."
About Elestrin
Elestrin (estradiol gel 0.06%) is a clean, clear, fast-drying estrogen formulation
indicated for the treatment of vasomotor symptoms, such as hot flushes, associated
with menopause. It is supplied in a dose-metered pump with the flexibility of delivering
either a one-pump or a two-pump dose. One pump actuation delivers Elestrin in a
unit dose of 0.87 g, (0.52 mg of estradiol) and provides systemic delivery of 0.0125
mg of estradiol daily. The 1.7 g dose, two pump actuations, provides systemic delivery
of 0.0375 mg daily.
Estrogens should not be used in individuals with known or suspected pregnancy, undiagnosed
abnormal genital bleeding, breast cancer, estrogen-dependent neoplasia, active thrombophlebitis
or thromboembolic disorders, or a documented history of these conditions, or stroke.
Estrogens have been reported to increase the risk of endometrial carcinoma in postmenopausal
women.
Because of these risks, estrogens with or without progestins should be prescribed
at the lowest effective doses and for the shortest duration consistent with treatment
goals and risks for the individual woman.
For full prescribing information: http://www.azurpharma.com/pdf/ElestrinPI.pdf
About Azur Pharma
Azur is a privately held pharmaceutical company dedicated to enhancing patients'
lives by developing and marketing pharmaceutical products in specialist therapeutic
areas. Azur's strategy is to identify, evaluate, selectively acquire and enhance
the value of late stage development and approved pharmaceutical products. (Website:
www.azurpharma.com)
Azur Media Contact
Mr. Ray Gordon, MRPA Kinman Communications
Telephone: +353-1-7038619/+353-87-2417373
E-mail: ray@mrpakinman.ie