|
NOVARTIS
BUILDS ON ITS LEADING PRESENCE IN WOMEN'S HEALTH; |
BackNovartis
Builds On Its Leading Presence in Women's Health;
State-of-the-Art Transdermal Hormone Replacement Therapy Licensed From
Noven
- - - - - - - - - - - - - - - - - - - - - -
BASEL, Switzerland and MIAMI - Nov. 6, 2000 - Novartis Pharma AG (NYSE:NVS) and Noven Pharmaceuticals, Inc. (Nasdaq:NOVN) today announced a marketing agreement under which Novartis has acquired the exclusive rights to market Estradot™ (transdermal 17-beta estradiol) in all countries outside the US, Canada, and Japan. Estradot™ is a state-of-the-art transdermal estrogen patch for the treatment of post and peri menopausal symptoms and for the prevention of postmenopausal osteoporosis. Novartis and Noven already jointly market Estradot™ as Vivelle-Dot™ in the US through their jointly owned company, Vivelle Ventures LLC (also known as Novogyne Pharmaceuticals).
As part of the license, Noven will receive an up-front payment of $20 million (USD), which Noven will recognize as revenue over a period of years, and an additional milestone payment upon receipt of certain European regulatory approvals. Noven will manufacture and supply Novartis with the product. Other financial terms of the transaction were not disclosed.
"Estradot™ further consolidates our strong position in women's health," said Thomas Ebeling, Chief Executive Officer, Novartis Pharma AG. "We have high aspirations for the product in European markets, where hormone replacement therapy brings significant benefits to a large number of patients. Based on the excellent acceptance of the product in the less developed US patch market to date, we expect good sales growth for our women's health franchise from this asset."
"Novartis is a trusted business partner, both in the US and in Europe, with a demonstrated commitment to women's health and advanced HRT products," said Robert C. Strauss, Noven's President, Chief Executive Officer and Co-Chairman. "We expect that, in Novartis' capable hands, Estradot™ will reach its full potential across Europe and the other licensed territories."
Estradot™, developed by Noven, provides a convenient, well-tolerated, and cosmetically attractive means of administering hormone replacement therapy. At one-third the size of competing products, with excellent adhesion, its advance over earlier transdermal product generations is expected to make patch delivery of hormone replacement more accessible to women patients.
The parties are currently
seeking regulatory approval to market Estradot™ in the first European
market, the Netherlands. Under the terms of the license, Novartis will
then pursue the registration of Estradot™ in the licensed territory.
About Hormone Replacement
Therapy
Novartis pioneered
the transdermal hormone replacement therapy market in the 1980s, meeting
the needs of peri and post menopausal women requiring relief from menopausal
symptoms and long term protection against osteoporosis. By the year 2005,
it is conservatively estimated that 36% of women worldwide will be aged
over 50 with a potential need for alleviation of distressing menopausal
symptoms that compromise quality of life. Such symptoms include hot flushes
and night sweats, disturbed sleep, memory loss, and skin atrophy, as well
as the potential long-term consequence of osteoporosis.
About Novartis
Novartis (NYSE:NVS) is a world leader in healthcare with core businesses
in pharmaceuticals, consumer health, generics, eye-care, and animal health.
In 1999, the Group (including Agribusiness) achieved sales of CHF 32.5
billion (USD 21.6 billion) and invested more than CHF 4.2 billion (USD
2.8 billion) in R&D. Headquartered in Basel, Switzerland, Novartis employs
about 82,500 people and operates in over 140 countries around the world.
The Group plans to spin off its Crop Protection and Seeds sectors and
to merge them with the agrochemicals business of AstraZeneca in the fourth
quarter of 2000.
About Noven
Noven Pharmaceuticals,
Inc., headquartered in Miami, Florida, is a leader in the development
of transdermal and transmucosal drug delivery systems and technologies.
Noven has developed and presently manufactures a series of leading-edge
products, including the world's smallest estrogen transdermal delivery
system, the United States' only combination estrogen/progestin transdermal
delivery system, and the first transmucosal patch approved for marketing
by the U.S. Food and Drug Administration. With a wide range of additional
products in development, Noven is committed to becoming the world's premier
developer, manufacturer, and marketer of transdermal and transmucosal
drug delivery systems. For more information, see www.noven.com.
This release contains forward looking statements that involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. These statements can be identified by, among other things, terminology such as "aspirations", "expect", "estimated" or similar expressions. Many factors may cause the actual results, performance or achievements to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Some of these are uncertainties relating to product development, unexpected regulatory delays, government regulation generally, the ability to successfully commercialize the product, or the ability to obtain or maintain patent or other proprietary intellectual property protection as well as factors discussed in the Form 20-F filed by Novartis AG, and the Form 10-K and Form 10-Qs filed by Noven, with the Securities and Exchange Commission. Any of these or other factors can cause the actual results to vary materially from those described herein.
Contact:
James B. Messiry
Chief Financial Officer
(305) 253-1916
Copyright © 2000 Noven Pharmaceuticals, Inc. All rights reserved.