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IVAX to Distribute Letter to Shareholders

Business Wire, Feb 2, 2005

MIAMI -- IVAX Corporation (AMEX:IVX) (LSE:IVX.L) will distribute a letter to shareholders, the text of which follows.

Dear Shareholder:

Recently, IVAX announced that we expect to meet or exceed analysts' consensus earnings expectations of $.19 per share for the fourth quarter 2004 and $.72 for the year 2004. IVAX ended a good year with a strong fourth quarter. Revenues for the year were at record levels and net income per share was about 50% higher than in 2003. We begin 2005 with great optimism and expect to provide earnings guidance for the year at about the time of the release of our 2004 financial data.

IVAX Pharmaceuticals, our U.S. generics company, had an outstanding 2004 during which three products with first-to-file status (metformin ER, glyburide/metformin and gabapentin tablets) were launched. Despite an environment of aggressive pricing and competition from authorized generic products for certain of our drugs which would have otherwise enjoyed a six month period of exclusivity, sales and profits for IVAX' generic unit were strong. IVAX now has 61 Abbreviated New Drug Applications (ANDAs) pending with the FDA, twelve of which are potential first-to-files with current U.S. brand sales of almost $13 billion.

In Latin America, revenues for the five quarters ending in the third quarter 2004 were 29%, 22%, 46%, 25% and 21% higher than revenues in previous year's respective quarters. This trend of significant revenue growth in Latin America continued in the fourth quarter 2004 and our managers there anticipate sustained aggressive growth in 2005.

Our sales and profits also continued to grow in Central and Eastern Europe. In Western Europe, our brand respiratory product sales increased, but our generics business was challenged by general pricing pressure. Our veterinary business, DVM Pharmaceuticals, Inc., had an excellent year, with strong sales and profits.

IVAX continues to make progress on its proprietary drug pipeline. On January 11, 2005, IVAX and our partner, Serono S.A., announced that a phase III study of Mylinax(R), an oral formulation of cladribine, will be initiated in the first quarter of 2005. Upon approval, Mylinax could be the first orally administrated disease-modifying treatment for multiple sclerosis patients.

On November 19, 2004, IVAX announced positive phase II results for TP-38 at the Society for Neuro-Oncology meeting in Toronto and we announced the initiation of another, larger phase II trial. TP-38 is a targeted toxin being developed to treat glioblastoma, a highly malignant form of brain cancer.

We continue major phase II development of Talampanel for epilepsy. Talampanel is also in a phase II trial for brain cancer that is sponsored by the National Cancer Institute.

We've made significant progress with two of our soft corticosteroids. We have begun a phase II trial of our soft corticosteroid, Respicort(TM) (BNP-166), in Airmax(TM), our patented, multi-dose dry powder inhaler, to treat asthma. We also plan to file in the first half of 2005 for an approval in the European Union of another of our soft corticosteroids for the treatment of allergic rhinitis.

We recently in-licensed citicoline, a drug in advanced development, to treat acute stroke patients; and HNM-214, a polo-like kinase inhibitor, for which we are planning phase II clinical trials to treat pancreatic and prostate cancer. After successful pre-clinical development, we are commencing clinical trials for several of our new asthma molecules.

IVAX' proprietary respiratory product business made significant advances in 2004. QVAR(R), our CFC-free aerosol corticosteroid for asthma, continued to gain U.S. market share. IVAX' QVAR sales in Europe are also growing and we expect that growth to accelerate now that IVAX has launched QVAR in Easi-Breathe(R), our patented breath-operated aerosol inhaler (BOI), in the United Kingdom.

An important event for IVAX in 2004 was the FDA approval of its New Drug Application (NDA) for its patented HFA (CFC-free) formulation of albuterol in a metered dose inhaler. Albuterol is used as a "rescue" medication for the relief of asthma symptoms. HFA's will replace the ozone depleting CFC propellants after the FDA requires the removal of CFC albuterol from the U.S. market. IVAX' HFA albuterol MDI, launched in December 2004, is one of three CFC-free albuterol products on the U.S. market, and the potential total market is significant. IVAX also has received an approvable letter from the FDA for its NDA for its HFA formulation of albuterol in its breath operated inhaler. Final approval of this product is possible during the first half of 2005. Our breath operated inhaler eliminates the need to coordinate the release of the medicine with its inhalation, an advantage that could permit IVAX to achieve a significant share of the 50-60 million albuterol inhalers sold each year in the U.S.

IVAX' strategy for long-term growth continues to stress the combination of a powerful generics business with the development and sales of proprietary drugs. Our strengthening worldwide marketing and sales network will help leverage the investments we are making to develop important new drug products.


 

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