Business Services Industry
IVAX Distributes Letter To Shareholders
Business Wire, August 14, 2001
Business Editors & Health/Medical Writers
MIAMI--(BW HealthWire)--Aug. 14, 2001
IVAX Corporation (AMEX:IVX)(LSE:IVX.L) will distribute a letter to shareholders relating to recent corporate events. The text of the letter to shareholders follows.
August 14, 2001
Dear Fellow Shareholders:
We are pleased to update you on recent items we consider to be of importance.
Brand Equivalent Paclitaxel
Sales of IVAX' injectable Onxol(TM) brand equivalent paclitaxel anti-cancer drug exceeded $77 million in the second quarter of this year following more than $50 million in revenues in the first quarter of 2001. IVAX' injectable paclitaxel is the brand equivalent to Bristol-Myers Squibb Company's Taxol(R), the largest selling anti-cancer drug in the world with U.S. sales well in excess of $1.0 billion in 2000.
We continue to believe in the strong growth prospects of our brand equivalent paclitaxel, even though the FDA recently approved two other generic paclitaxel products. These regulatory approvals had been expected for some time. Our confidence is based, in part, on IVAX' considerable experience in this marketplace, extensive clinical testing, and enhanced supply and production capacity. It is also important to point out that the branded product currently holds approximately 70% market share, representing opportunity to further expand our market penetration while providing space for other generic products.
- On August 13, 2001, we entered into a multi-year agreement to supply our injectable Onxol brand equivalent paclitaxel anti-cancer drug to Novation, the largest hospital supply chain management company in the United States providing purchasing solutions for more than 2,300 health care organizations, including some of the most prestigious hospitals across the country. This agreement to provide our lower-cost, brand equivalent paclitaxel represents significant savings to hospitals and brings cost-effective care to their patients. We expect to start shipments during September. We have a long-standing relationship with Novation and have been supplying its hospital members with an extensive line of products for a variety of indications across multiple therapeutic categories. - IVAX has been marketing its injectable paclitaxel product since October 2000, and has sold more than $160 million of this product. Since gaining regulatory approval more than 10 months ago, over 5,000 people in the U.S. have been treated with our paclitaxel product. This product has also received approval for various indications in Canada (May 2000), Poland (March 2000), the 15-member states of the European Union (July 1999), and the Czech Republic (March 1999). - We believe our paclitaxel product to be the only brand equivalent product to have undergone extensive pre-clinical, pharmacological and clinical studies. At over 100 sites in North America, Europe and Australia, more than 700 patients with non-small cell lung, breast and ovarian cancer or AIDS-related Kaposi's Sarcoma participated in our clinical trials. - In May 2001, production capacity for IVAX' paclitaxel was enhanced when the FDA approved an additional supplier of the paclitaxel active ingredient and contract manufacturer of the finished product. Demand for our product continues to be very strong and these additional sources of supply will permit us to serve an even larger market segment.
As previously reported, we are developing a patented, oral dosage form of paclitaxel which is anticipated to be of substantial benefit to patients as all presently marketed paclitaxel products, including IVAX' brand equivalent paclitaxel and the branded Taxol product, are administered only by injection. Recently completed Phase II clinical trials for our oral form of paclitaxel have shown anti-cancer activity in patients with advanced lung cancer. The results of these trials suggest that our oral paclitaxel, by itself, may be as effective as various combinations of intravenous drugs currently used to treat lung cancer, but with greater convenience and fewer side effects. We plan to conduct a Phase III clinical trial in which oral paclitaxel will be compared with standard intravenous chemotherapy as an initial treatment of advanced lung cancer. Anti-cancer effects have also been seen in ongoing Phase II studies for advanced breast cancer and advanced stomach cancer, and are expected to be reported when the full results are available.
Second Quarter Earnings
IVAX Corporation achieved substantially better financial results for the second quarter of 2001 than in 2000. Net revenues increased 63% to $301.8 million and earnings per share more than doubled to $.33 per share. Our continued growth over the last few years has resulted from new product introductions as well as strategic acquisitions that provide earnings power and additional distribution capabilities for our products.
For the second quarter of 2001, income from continuing operations was $67.9 million, or $.33 per diluted share, representing an increase of 109% over the $32.5 million, or $.16 per diluted share, reported in the second quarter of 2000. Net revenues for the second quarter of 2001 increased by 63.3% to $301.8 million as compared to net revenues of $184.8 million in the second quarter of last year.
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