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IVAX Distributes Letter To Shareholders.


Business Editors & Health/Medical Writers

MIAMI--(BW HealthWire)--Aug. 14, 2001

IVAX Corporation (AMEX AMEX

See: American Stock Exchange
:IVX)(LSE LSE - Language Sensitive Editor :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 paclitaxel /pac·li·tax·el/ (pak?li-tak´sel) an antineoplastic that promotes and stabilizes polymerization of microtubules, isolated from the Pacific yew tree (Taxus brevifolia);

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 FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 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 lung cancer, cancer that originates in the tissues of the lungs. Lung cancer is the leading cause of cancer death in the United States in both men and women. Like other cancers, lung cancer occurs after repeated insults to the genetic material of the cell. . 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 Side effects

Effects of a proposed project on other parts of the firm.
. We plan to conduct a Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the  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 to be spoken of; to be mentioned, whether favorably or unfavorably.

See also: Report
 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 continuing operations

Parts of a business that are expected to be maintained as an ongoing segment of an overall business operation. Income and losses from continuing operations are reported separately if any segments have been discontinued during the
 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.

For the six months ended June 30, 2001, income from continuing operations rose by 116% to $128 million, or $.62 per diluted share, versus income from continuing operations of $59.1 million, or $.29 per diluted share, for the same period a year earlier. Net revenues for the first six months of 2001 advanced by 52.6% to $561.7 million compared to net revenues of $368.1 million in the prior year.

In the second quarter, our investment in research and development increased by 17% over the prior year. For the current year, we expect our R&D spending to be approximately $90 million, with about two-thirds dedicated to our proprietary pipeline of novel compounds to treat various forms of cancer, multiple sclerosis, epilepsy, Parkinson's disease Parkinson's disease or Parkinsonism, degenerative brain disorder first described by the English surgeon James Parkinson in 1817. When there is no known cause, the disease usually appears after age 40 and is referred to as Parkinson's disease. , asthma, non-malignant prostate enlargement, inflammatory bowel disease inflammatory bowel disease
n. Abbr. IBD
Any of several incurable and debilitating diseases of the gastrointestinal tract characterized by inflammation and obstruction of parts of the intestine.
 and cystic fibrosis cystic fibrosis (sĭs`tĭk fībrō`sĭs), inherited disorder of the exocrine glands (see gland), affecting children and young people; median survival is 25 years in females and 30 years in males. . These products are in various stages of research and development.

Our gross profit margin Gross profit margin

Gross profit divided by sales, which is equal to each sales dollar left over after paying for the cost of goods sold.


gross profit margin

A measure calculated by dividing gross profit by net sales.
 improved to 52.5% of net revenues for the second quarter of 2001 compared to 48.5% in the second quarter of 2000, primarily due to sales of IVAX' brand equivalent anti-cancer drug, paclitaxel. Excluding paclitaxel sales, second quarter net revenues from other worldwide sales increased by 22% over the year ago period. Net revenues in North America increased 103.7% while net revenues in Europe and Latin America increased 37.8%, but were decreased by a negative currency impact just under 5%. Our increase in income from continuing operations was achieved despite a higher tax rate for the current period compared to last year. We anticipate continued year-over-year increases in revenues and normal operating income Operating Income

The profit realized from a business' own operations.

Notes:
This would not include income from things such as investments in other firms. Also referred to as operating profit or recurring profit.
 for the remainder of this year.

Resumption Of Share Repurchase Share Repurchase

A program by which a company buys back its own shares from the marketplace, reducing the number of outstanding shares. This is usually an indication that the company's management thinks the shares are undervalued.
 Program

In response to the recent decline in stock price and our confidence in the company's prospects for continued growth of our overall business and, in particular, our brand equivalent paclitaxel anti-cancer product, we recently resumed the repurchase of shares under our current split-adjusted 12.5 million share repurchase program authorized by IVAX' Board of Directors in August 2000. During the past year, we repurchased approximately 4.2 million shares of our outstanding common stock on a split adjusted basis and sold 5.1 million put options under this program, of which 1.4 million options are currently outstanding. Since February 1998, we have repurchased 45.3 million shares of our outstanding common stock on a split-adjusted basis at an average price of $8.87 per share. IVAX IVAX Industrial Vax (Dec Computer)  currently has approximately 201 million common shares outstanding.

Recent FDA Approvals

On July 27, 2001, we received FDA approval for over-the-counter (OTC OTC

See: Over-the-counter.


OTC

See over-the-counter market (OTC).
) sales of our famotidine tablets USP USP - unique sales point  in 10 mg strength for the short-term prevention of heartburn heartburn, burning sensation beneath the breastbone, also called pyrosis. Heartburn does not indicate heart malfunction but results from nervous tension or overindulgence in food or drink.  and sour stomach. We immediately began marketing and shipping this product through our wholly owned subsidiary Wholly Owned Subsidiary

A subsidiary whose parent company owns 100% of its common stock.

Notes:
In other words, the parent company owns the company outright and there are no minority owners.
, IVAX Pharmaceuticals, Inc. We expect our OTC famotidine 10 mg tablets to be one of only two brand equivalent products with regulatory approval for immediate sale. With the addition of this product to the antacid antacid, any one of several basic substances that counteract stomach acidity (see stomach). Antacids are used by physicians to treat hyperchlorhydria, i.e., the excessive production of hydrochloric acid by the parietal cells lining the stomach.  category, IVAX is currently the only manufacturer and store-brand distributor of all three major H2 blocker products: Cimetidine cimetidine /ci·met·i·dine/ (si-met´i-den) a histamine H2 receptor antagonist, which inhibits gastric acid secretion; used as the base or the monohydrochloride salt in the treatment and prophylaxis of gastric or duodenal ulcers,  200 mg (generic equivalent of Tagamet(R)); Ranitidine ranitidine /ra·ni·ti·dine/ (rah-ni´ti-den) a histamine H2 receptor antagonist, used as the hydrochloride salt to inhibit gastric acid secretion in the treatment of gastric and duodenal ulcer, gastroesophageal reflux disease, and  75 mg (generic equivalent of ZANTAC(R)); and Famotidine 10 mg (generic equivalent of Pepcid AC(R)).

On August 8, 2001, we received FDA approval for our Abbreviated New Drug Application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar  (ANDA ANDA
abbr.
abbreviated new drug application
) for sales of isosorbide mononitrate isosorbide mononitrate (ī´sōsor´-bīd mon´ōnī´trāt),
n brand name: ISMO;
drug class: antianginal, organic nitrate;
action:
 extended-release tablets in 30 mg and 120 mg strengths. Previously, we received FDA approval for our isosorbide mononitrate extended-release 60 mg tablets. Isosorbide mononitrate is used to treat angina due to coronary artery disease coronary artery disease, condition that results when the coronary arteries are narrowed or occluded, most commonly by atherosclerotic deposits of fibrous and fatty tissue.  and is the generic equivalent of Schering Corporation's Imdur(R) tablets. We will sell this product through our wholly owned subsidiary, IVAX Pharmaceuticals, Inc.

We have received six generic drug generic drug, a drug sold or prescribed under the nonproprietary name of its active ingredients or under a generally descriptive name rather than under a brand or trade name.  approvals so far this year - with 33 ANDAs and tentative approvals currently pending at the FDA. We are continuing our aggressive filing schedule for new ANDA submissions.

Acquisition Of Laboratorio Chile S.A.

In July 2001, we successfully completed the acquisition of approximately 99.6% of the outstanding shares and the outstanding American Depository Shares ("ADSs") of Laboratorio Chile S.A. for approximately $394 million in cash. It is the largest Chilean pharmaceutical company in revenue terms and also among the major pharmaceutical companies in Argentina and Peru. Lab Chile manufactures, markets and sells a broad line of more than 900 branded and brand equivalent products in Chile, Argentina, Peru and Bolivia. Its main products focus on the treatment of respiratory and infectious diseases and the company has strong franchises in cardiovascular, neurological and gynecological gynecological /gy·ne·co·log·i·cal/ (-kah-loj´i-k'l) gynecologic.  products. This acquisition adds Chile to the growing IVAX Latin American family, which already includes companies in Mexico, Venezuela, Peru, Argentina and Uruguay. Our continued growth in this region is part of our previously announced strategy to increase our presence in rapidly growing markets such as Latin America, Central and Eastern Europe The term "Central and Eastern Europe" came into wide spread use, replacing "Eastern bloc", to describe former Communist countries in Europe, after the collapse of the Iron Curtain in 1989/90.  and Asia. On July 31, 2001, pursuant to the requirements of Chilean and U.S. law, we commenced simultaneous tender offers in the United States and Chile for the remaining .4% of the outstanding shares of Laboratorio Chile, S.A.

Update On Respiratory Research And Development

IVAX continues to expand the international marketing of asthma drugs in various European countries leveraging its patented Easi-Breathe(R) device, the top selling breath-activated device in the United Kingdom. The asthma medications, albuterol albuterol /al·bu·ter·ol/ (al-bu´ter-ol) a ß agonist used as the base or sulfate salt as a bronchodilator.

al·bu·ter·ol
n.
 and beclomethasone, are available in Easi-Breathe inhaler inhaler /in·hal·er/ (in-hal´er)
1. an apparatus for administering vapor or volatilized medications by inhalation.

2. ventilator (2).


in·hal·er
n.
 formats in both CFC CFC

See: Controlled foreign corporation
 and CFC-free formulations, while cromolyn sodium cro·mo·lyn sodium
n.
A drug usually administered by inhalation and used to prevent certain allergic attacks, especially those associated with asthma or hay fever.
 is as yet available only in a CFC formulation. In addition, our metered-dose dry powder inhaler The Dry Powder Inhaler is generally a proprietary device to deliver medications for the treatment or maintenance management of respiratory diseases and conditions. These conditions or diseases may include Asthma, Bronchitis, Emphysema, COPD and Diabetes.  in albuterol and budesonide formats is awaiting regulatory approval in Europe and will be marketed by a partner. Earlier this summer we also entered into an agreement with the Italian group Chiesi Farmaceutici to co-promote and distribute a CFC-free formulation of beclomethasone and other asthma inhalation products in the UK. Our Easi-Breathe inhaler and Chiesi's patented beclomethasone CFC-free Modulite(TM) will be marketed as Beclazone Modulite(TM) Easi-Breathe(R).

For the U.S. market, IVAX has completed initial Phase III clinical trials which will support FDA submissions for our CFC-free albuterol and beclomethasone in our Easi-Breathe and conventional metered-dose formats as well as for budesonide in our metered-dose dry powder inhaler. However, additional Phase III trials to support each of these products will be required and are either underway or in preparation. In that connection, we are currently in Phase III clinical trials for albuterol in CFC-free formats, and expect to start certain additional Phase III clinical trials for beclomethasone in CFC-free formats in the fourth quarter of this year. We also estimate commencing Phase III clinical trials for budesonide in our metered-dose dry powder inhaler in 2002. We have a high degree of confidence in these clinical programs for our various respiratory products as they successfully completed similar clinical testing overseas and are currently on the market in Europe or awaiting regulatory approval. We also believe our respiratory business will continue to achieve significant growth over the coming years.

In addition, we expect to start separate Phase III clinical trials for our fluticasone nasal spray (brand equivalent to Flonase(R)) in the third quarter of this year.

As a service to asthma patients worldwide and the physicians who treat them, we launched a Web site at www.asthma4all.com that provides comprehensive, up-to-date information on this condition. This Web site features state of the art graphics as well as a live news feed of developments relating to asthma, information about IVAX' products, links to other sources of information for asthma sufferers, and a powerful search engine to explore these resources.

Brain Tumor Brain Tumor Definition

A brain tumor is an abnormal growth of tissue in the brain. Unlike other tumors, brain tumors spread by local extension and rarely metastasize (spread) outside the brain.
 Compounds

Our lead brain cancer compound, TP38, is currently in Phase I/II clinical trials at the Duke University Medical Center and the University of California The University of California has a combined student body of more than 191,000 students, over 1,340,000 living alumni, and a combined systemwide and campus endowment of just over $7.3 billion (8th largest in the United States).  at San Francisco. These studies have yielded encouraging results that are expected to be reported in the coming months. TP-38 is a highly potent medication, which unlike most experimental cancer treatments of malignant brain tumors, is designed to kill cancer cells while leaving the normal brain cells unaffected.

In July 2001, our immunotoxin immunotoxin /im·mu·no·tox·in/ (im´u-no-tok?sin) any antitoxin.

im·mu·no·tox·in
n.
A hybrid molecule formed by binding a toxin to a monoclonal antibody, used to destroy tumor cells.
 program with Duke University Medical Center was expanded to develop and market specific toxins that bind to and destroy cells expressing the EGF EGF
abbr.
epidermal growth factor
 receptor variant III (EGFRvIII). EGFRvIII is found on the surface of a high percentage of cancers of the brain, breast, lung, and ovary ovary, ductless gland of the female in which the ova (female reproductive cells) are produced. In vertebrate animals the ovary also secretes the sex hormones estrogen and progesterone, which control the development of the sexual organs and the secondary sexual  and is not found on normal cells. The absence of this receptor on healthy cells makes EGFRvIII a very attractive potential target for directed toxin therapy of a wide range of tumors of the brain and other parts of the body.

Appointment of Director of Investor Relations Investor relations

The process by which the corporation communicates with its investors.
 and Corporate Communications

In July 2001, Howard A. Goldman joined the company as director of investor relations and corporate communications. Mr. Goldman will be responsible for communications with the global investment community, media and IVAX' employees. He has more than 17 years of comprehensive investor and communications experience - including the medical diagnostics, pharmaceutical and healthcare sectors - serving public and private companies from corporate and consulting situations. He also was in television news for four years as a broadcast journalist, producer and on-camera anchor. Mr. Goldman received his Master's of Science degree and Bachelor of Science Noun 1. Bachelor of Science - a bachelor's degree in science
BS, SB

bachelor's degree, baccalaureate - an academic degree conferred on someone who has successfully completed undergraduate studies
 degree in Communication from Illinois State University ISU is recognized in the prestigious US News rankings as a "National University", that is, a university which grants a variety of doctoral degrees and strongly emphasizes research. . In addition, he is the current president of the South Florida Chapter of NIRI NIRI National Investor Relations Institute
NIRI Nutrition Intervention Research Initiative (Mississippi)
NIRI Near Infrared Imager
NIRI National Institute on Recreation Inclusion
NIRI New Ideas Research Institute
 (National Investor Relations Institute The National Investor Relations Institute, known as "NIRI", is the professional association for investor relations professionals in the United States.

NIRI was founded in 1969 and has more than 4,500 members, both from the United States and other countries.
) and has been an officer and board member of this professional organization since 1998.

We plan to update you from time to time. IVAX has been enjoying excellent results in recent years and we expect our progress to continue.

Sincerely,





Phillip Frost, M.D.        Isaac Kaye              Neil Flanzraich
Chairman and               Deputy Chief            Vice Chairman and
Chief Executive Officer    Executive Officer       President


Except for the historical matters contained herein, statements in this press release are forward-looking, including statements regarding IVAX' belief in the growth prospects of its overall business and paclitaxel products in particular, the enhancement of its supply and production capacity for paclitaxel, the opportunities for penetration of the paclitaxel market, IVAX' expectation that the agreement with Novation The substitution of a new contract for an old one. The new agreement extinguishes the rights and obligations that were in effect under the old agreement.

A novation ordinarily arises when a new individual assumes an obligation to pay that was incurred by the original party
 will continue for multiple years, the anticipation that Novation patients and hospitals will experience significant savings and cost-effective care as a result of the agreement with IVAX, the proposed commencement date of shipments of paclitaxel to Novation, IVAX' expectations and beliefs regarding the timing and results of clinical trials for its products and the anticipated benefits to patients of its products, IVAX' expectations regarding R&D spending and for increases in revenue and operating income for the remainder of the year, anticipated research and development expenses, IVAX' plans to continue an aggressive schedule for new ANDA submissions, and IVAX' expectations regarding competition for its famotidine tablets, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. Investors are cautioned that forward looking statements reflect our current views regarding future events, our business and prospects which are subject to and may be affected by risks, uncertainties and assumptions, including that IVAX may not be able to obtain a consistent and cost-effective source of raw materials for paclitaxel; that the market share of IVAX' paclitaxel may not increase despite the availability of additional supplies; that the recently approved paclitaxel products may diminish the growth prospects and demand for IVAX' paclitaxel; that additional brand-equivalent forms of Taxol(R) may be launched; that demand for IVAX' paclitaxel will not remain strong or that additional sources of supply will not permit IVAX to serve that demand; that there may be delays in the production of paclitaxel or the shipment of paclitaxel to Novation and other customers; that production capacity for paclitaxel may diminish; that IVAX may not succeed in developing an oral paclitaxel product; that IVAX' patents pertaining to this product may be invalidated or may otherwise not succeed in preventing other oral paclitaxel products; that others may develop oral paclitaxel formulations that are superior to the IVAX formulation; that Phase III clinical trials for IVAX' oral paclitaxel may not be commenced, may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that IVAX' oral paclitaxel, by itself, may not have effectiveness comparable to other treatments of lung cancer, and may not have greater convenience and less side effects; that IVAX' acquisitions will not provide earnings power and additional distribution capabilities for IVAX' products; that IVAX may not pursue or succeed in its strategy to increase its presence in Latin America, Central and Eastern Europe and Asia; that IVAX will not experience continued year-over-year increases in revenues and normal operating income for the remainder of this year; that IVAX' R&D spending will be less than anticipated and/or will not be allocated as anticipated; that IVAX' famotidine 10 mg tablets will not be one of only two brand equivalent products with regulatory approval for immediate sale; that IVAX will not be the only manufacturer and store-brand distributor of all three major H2 blocker products; that products in development will not be successfully developed, or if developed will not receive regulatory approval, or if developed and approved will not be successfully marketed; that IVAX may not receive approval of its pending ANDAs; that IVAX may not file additional ANDAs or NDAs; that IVAX may not be able to integrate the operations of Laboratorio Chile without significant capital expenditures or other costs; that IVAX may not realize the anticipated benefits of the acquisition of Laboratorio Chile; that economic instability, political instability, and/or currency fluctuation, and other risks associated with operations in emerging markets may reduce the profitability of the pharmaceutical markets in which IVAX operates; that the clinical trials for asthma and other respiratory products, TP38 and other products under development may not be commenced, may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications. In addition, with respect to the expectation that the Novation agreement will be multi-year, this expectation could be adversely affected by the fact that either party may earlier terminate the contract. In addition to the risk factors set forth above, investors should consider the economic, competitive, governmental, technological and other factors discussed in the Company's Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Taxol(R) is a registered trademark of the Bristol-Myers Squibb Company. Tagamet(R) is a registered trademark of SmithKline Beecham Pharmaceutical Co. ZANTAC(R) is a registered trademark of Glaxo Group Limited Company. Flonase(R) is a registered trademark of Glaxo Group Limited Corporation. Pepcid AC(R) is a registered trademark of Merck & Co., Inc.

IVAX Corporation, headquartered in Miami, Florida, is engaged in the research, development, manufacturing, and marketing of branded and brand equivalent pharmaceuticals and veterinary and diagnostic products in the U.S. and international markets.
COPYRIGHT 2001 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2001, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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