Healthcare Industry News: Biovail
News Release - May 2, 2006
Biovail to Promote AstraZeneca's Zoladex(R) 3.6mg (Goserelin Acetate Implant) for Endometriosis in the United States and Puerto RicoBiovail Pharmaceuticals, Inc. to Promote Zoladex(R) 3.6mg to Obstetricians/Gynecologists for Endometriosis Indication
TORONTO--(HSMN NewsFeed)--May 2, 2006--Biovail Corporation (NYSE:BVF ; TSX:BVF ) today announced that Biovail Pharmaceuticals, Inc. (BPI), the Company's wholly owned U.S. subsidiary, and AstraZeneca Pharmaceuticals LP have entered into an agreement for which BPI's specialty sales force will promote Zoladex® 3.6mg (goserelin acetate implant) to obstetricians and gynecologists for the treatment of endometriosis in the United States and Puerto Rico.
AstraZeneca will continue to manufacture and supply all quantities of Zoladex®
Biovail Chief Executive Officer Dr. Douglas Squires said the opportunity to promote the 3.6mg formulation of Zoladex® to OB/GYNs will further enable the Company to build its portfolio of products to promote to the women's health-care market.
"Biovail will leverage its expertise and relationships with women's health-care practitioners in the United States to proactively position the therapeutic benefits of Zoladex® 3.6mg as an important treatment to females who suffer from endometriosis," said Dr. Squires. "This strategic alliance with AstraZeneca for Zoladex® is a reaffirmation of Biovail's ability to enter into, and provide value to, Tier 1 pharmaceutical companies."
Lisa Schoenberg, Vice-President, Specialty Care, at AstraZeneca Pharmaceuticals LP, says that the company is excited about this partnership with Biovail.
"After giving careful consideration to several women's health companies, we feel that a strategic partnership with Biovail will provide an opportunity to bring significant benefits to women who suffer from endometriosis," says Ms. Schoenberg. "Biovail's sales organization has a proven track record, and has built a solid reputation with OB/GYNs, and women's health-care practitioners."
Biovail's 85-member specialty sales force currently promotes Zovirax® Cream and Zovirax® Ointment, leading topical anti-viral treatments for genital herpes and cold sores, to specialists and selected primary-care physicians in the U.S. More recently, Biovail entered into an agreement to provide promotion services for extended-release and immediate-release formulations of tramadol - Ultram® ER and Ultram® ODT respectively - to women's health-care practitioners. Ultram® ER was launched in February; Biovail and OMI anticipate the launch of Ultram® ODT later in mid-2006.
Zoladex 3.6mg is indicated for the management of endometriosis, including pain relief and reduction of endometriatic lesions for the duration of therapy. Experience for the management of endometriosis has been limited to women 18 years of age and older treated for six months.
Zoladex 3.6mg competes in the $934.8-million GnRH (gonadotropin releasing hormone) agonist analogs market. Statistics from IMS Health for the 12 months ended December 31, 2005, show that almost 338,000 prescriptions were written for GnRH analogs.
Endometriosis is a painful, chronic disease that affects over 5.5 million women in the United States and Canada, and millions more worldwide, according to the U.S.-based Endometriosis Association. It occurs when tissue similar to that which lines the uterus (tissue called the endometrium) is found outside the uterus - usually in the abdomen on the ovaries, fallopian tubes, and ligaments that support the uterus; the area between the vagina and rectum; the outer surface of the uterus; and the lining of the pelvic cavity.
This misplaced tissue develops into growths or lesions that respond to the menstrual cycle in the same way that the tissue of the uterine lining does: each month the tissue builds up, breaks down, and sheds. Menstrual blood flows from the uterus and out of the body through the vagina, but the blood and tissue shed from endometrial growths has no way of leaving the body. This results in internal bleeding, breakdown of the blood and tissue from the lesions, and inflammation - and can cause pain, infertility, scar-tissue formation, adhesions, and bowel problems.
"Safe Harbor" Statement Under the Private Securities Litigation Reform Act of 1995
To the extent any statements made in this press release contain information that is not historical, these statements are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and within the meaning of the "safe harbor" provisions of applicable Canadian securities legislation. These forward-looking statements relate to, among other things, our objectives, goals, strategies, intentions, plans estimates and outlook, and can generally be identified by the use of words such as "believe", "anticipate", "expect", "intend", "plan", "will", "may" and other similar expressions. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements.
Although Biovail believes that the expectations reflected in such forward-looking statements are reasonable, such statements involve risks and uncertainties, and undue reliance should not be placed on such statements. Certain material factors or assumptions are applied in making forward-looking statements, and actual results may differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from these expectations include, among other things: acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, regulatory matters including compliance with pharmaceutical regulations, availability of raw materials and finished products, the regulatory environment, the outcome of legal proceedings, consolidated tax-rate assumptions, fluctuations in operating results and other risks detailed from time to time in the Company's filings with the U.S. Securities and Exchange Commission ("SEC"), the Ontario Securities Commission ("OSC"), and other securities regulatory authorities in Canada. Additional information about these factors and about the material factors or assumptions underlying any such forward-looking statements may be found in our current Annual Report on Form 20-F, and in particular under the heading "Risk Factors" under Item 3, Sub-Part D. Biovail cautions that the foregoing list of important factors that may affect future results is not exhaustive. When relying on our forward-looking statements to make decisions with respect to the Company, investors and others should carefully consider the foregoing factors and other uncertainties and potential events. We undertake no obligation to update or revise any forward-looking statement.
About Biovail Corporation
Biovail Corporation is a specialty pharmaceutical company, engaged in the formulation, clinical testing, registration, manufacture, and commercialization of pharmaceutical products utilizing advanced drug-delivery technologies. For more information about Biovail, visit the Company's Web site at www.Biovail.com.
For further information, please contact Ken Howling at 905-286-3000 or send inquiries to ir@Biovail.com.
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