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BY OUR PHARMA CORRESPONDENT
4 August, 2005: IVAX Corporation received final approval from the US FDA for its Abbreviated New Drug Application (ANDA) for hydrochlorothiazide capsules 12.5 mg. This product will be sold through Ivax' wholly owned subsidiary, Ivax Pharmaceuticals, Inc.
Hydrochlorothiazide capsules 12.5 mg is the generic equivalent of Microzide Capsules 12.5 mg, which is marketed by Watson Pharmaceuticals, Inc. and is indicated for the management of hypertension.
According to IMS data, annual US sales of Microzide capsules 12.5 mg and hydrochlorothiazide capsules 12.5 mg were $41.7 million for the 12 months ended March 31, 2005.
Meanwhile, IVAX Pharmaceuticals, the US generic subsidiary of IVAXCorporation, will distribute, in the United States, morphine sulfate controlled-release tablets C-II in 15, 30, 60, 100 and 200 mg dosage strengths supplied by Purdue Pharma LP of Stamford, Connecticut, a company release said.
Morphine sulfate controlled-release tablets C-II are the generic equivalent of MS Contin (morphine sulfate controlled-release) tablets, a narcotic analgesic indicated for the relief of moderate to severe pain in patients who require repeated dosing over periods of more than a few days.
According to IMS data, US sales of MS Contin Tablets and morphine sulfate controlled-release tablets were approximately $200 million during the twelve months ending March 31, 2005. Purdue will receive a share of profits from the sale of this product.
IVAX Corporation (AMEX: IVX, LSE: IVX.L, WSE: IVX) reported second quarter 2005 net revenues of $577.3 million, a 24% increase over net revenues of $464.0 million in the second quarter 2004. Net income in the second quarter 2005 was $45.6 million. Earnings per share was $0.17 for the second quarter 2005. Net income in the second quarter 2004 was $48.1 million and earnings per share $0.18.
Neil Flanzraich, vice chairman and president of IVAX Corporation, said the company's income before income taxes for the second quarter of this year was $65.1 million compared to $58.2 million in the second quarter of 2004. Our net income for this quarter was impacted by a significantly higher income tax rate of approximately 30% as compared to a 17% tax rate for the comparable quarter in 2004.
He expressed his belief that second half of 2005 would be significantly stronger and confirm the company's earnings guidance of $0.76 - $0.86 per share.
Ivax said it did not include profit from the sale of the generic version of Zocor, which is expect to be launched in the middle of 2006 in the guidance.
"We continue to believe that we should be granted a six month period of exclusivity for our generic version of Zocor, which would provide very considerable upside to our guidance. Of course, our guidance for 2005 and 2006 must be qualified by any impact of our recently (July 25, 2005) announced agreement with Teva Pharmaceuticals Industries Ltd (Nasdaq:TEVA) providing for the acquisition of IVAX by Teva. We are currently preparing the proxy material to be filed with the SEC in order to obtain shareholder approval for this agreement,'' the statement said.
IVAX achieved substantial revenue growth in all its major business regions in the second quarter of 2005 over the same period last year. North American revenues increased 14% from $228.3 million to $261.0 million. European revenues increased 15% from $171.6 million to $197.0 million and Latin American revenues increased 29% from $76.0 million to $98.4 million.
Its US generics business was the major contributor to the 14% North American growth during the second quarter. The company had 6 generic product approvals and launches, one tentative approval and became the authorized distributor of generic equivalents of two important products, OMJ Pharmaceuticals, Inc.’s Ultracet and Purdue Pharma’s OxyContin.
IVAX’ branded respiratory product, albuterol sulfate HFA (CFC-free) in a standard metered dose inhaler, launched in the fourth quarter of 2004, is presently vying for the number one market share position among HFA albuterol products.
The company's animal health business has recently been expanded with the May 11, 2005 completion of the acquisition of Phoenix Scientific, Inc., the largest generic veterinary pharmaceutical company in the United States.
IVAX’ European revenues 15% growth came from the continued success of many of the company's Central and Eastern European operations, contributions from the Polish pharmaceutical company, Polfa Kutno, acquired in the fourth quarter 2004, continued growth of QVAR sales and IVAX’ first-to-market launch of Nasofan, the generic equivalent of Flonase, in the United Kingdom, where it has established a 44% market share.
IVAX' Latin American revenues grew 29%. This is the ninth consecutive quarter IVAX’ Latin American operations have achieved year-over-year, quarterly revenue growth. Its units in Venezuela, Chile, Argentina and Peru and the recently acquired (second quarter 2004) Peruvian pharmacy chain, BTL, made significant contributions to that growth.
During the second quarter 2005, IVAX spent 25% more on marketing and sales and 7% more on general and administrative expenses than the second quarter 2004. These expense increases were primarily related to recently acquired businesses: Medco and BTL in the second quarter 2004, Polfa Kutno in the fourth quarter 2004 and Phoenix Scientific on May 11, 2005. R&D expenditures in the second quarter 2005 were 7% lower than in the second quarter 2004, the release added.
IVAX Corporation, headquartered in Miami, Florida, discovers, develops, manufactures, and markets branded and brand equivalent (generic) pharmaceuticals and veterinary products in the US and internationally.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) and IVAX Corporation (AMEX: IVX) jointly signed a definitive agreement last week providing for the acquisition of IVAX by Teva.
Under the terms of the agreement, shares of IVAX common stock will, at the election of the shareholder, be converted into either $26 in cash or 0.8471 Teva ADRs, subject to proration such that no more than one-half of such elections are for cash and no more than half are for Teva ADRs. Based upon the NASDAQ average closing price of Teva's ADRs in the 5 days up to and including July 22, 2005, the transaction has a total indicated purchase price of approximately $ 7.4 billion. As a result of the transaction, it is expected that IVAX shareholders will own approximately 15% of TEVA on a fully-diluted basis. The cash portion of the consideration will be funded using a combination of Teva’s cash on hand and committed credit facilities. The boards of directors of both companies have unanimously approved the transaction. BY OUR PHARMA CORRESPONDENT
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