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FDA unleashes 16 generics of VasotecMerck gets good news on VasotecENALAPRIL.(Vasotec from Merck)(Company Business and Marketing)(Brief Article)Biovail Corp. (Active Pharmaceutical Ingredient Watch).(purchase of Vasotec,…Biovail Acquires Vasotec-R/Vaseretic-R From Merck And Co., Inc.

Aventis, the firm’s contract manufacturer, will produce the drug for Watson in Cincinnati. Eight other generic manufacturers, including ESI Lederle, Teva and Apothecon hold tentative approvals for generic formulations of Vasotec.
COPYRIGHT 2000 Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
COPYRIGHT 2008 Gale, Cengage Learning

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FDA unleashes 16 generics of VasotecMerck gets good news on VasotecWatson’s generic Vasotec gets OKENALAPRIL.(Vasotec from Merck)(Company Business and Marketing)(Brief Article)Biovail Corp. (Active Pharmaceutical Ingredient Watch).(purchase of Vasotec,…

Teva received tentative approval for 20 and 40 mg famotidine tablets in October 1998. Pepcid’s patent expires this month.
COPYRIGHT 2001 Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
COPYRIGHT 2008 Gale, Cengage Learning

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FDA unleashes 16 generics of VasotecMerck gets good news on VasotecWatson’s generic Vasotec gets OKENALAPRIL.(Vasotec from Merck)(Company Business and Marketing)(Brief Article)Biovail Corp. (Active Pharmaceutical Ingredient Watch).(purchase of Vasotec,…

In contrast to other plant closings, at least four pharmaceutical firms are pumping money into their Puerto Rico operations. Eli Lilly a week earlier said it would invest US$250 …

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FDA unleashes 16 generics of VasotecWatson’s generic Vasotec gets OKENALAPRIL.(Vasotec from Merck)(Company Business and Marketing)(Brief Article)Biovail Corp. (Active Pharmaceutical Ingredient Watch).(purchase of Vasotec,…Biovail Acquires Vasotec-R/Vaseretic-R From Merck And Co., Inc.

“Our study shows that, for moderate and mild heart failure, there is clear benefit,” says Salim Yusuf, project officer for the study at the National Heart, Lung and Blood Institute. “Until now we didn’t have a treatment that improved survival.”
Vasotec, a drug already prescribed for approximately 400,000 Americans, yields an estimated $600,000 in annual sales, according to Wedbush Morgan Securities.
A Merck spokesman notes that the average retail cost of a 5 mg. dosage of Vasotec is $1.34, or approximately $488 annually. It is currently approved for severe congestive heart failure in conjunction with other medications. The company is now considering labeling changes to include the new findings.
COPYRIGHT 1991 Racher Press, Inc.
COPYRIGHT 2008 Gale, Cengage Learning

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FDA unleashes 16 generics of VasotecMerck gets good news on VasotecWatson’s generic Vasotec gets OKENALAPRIL.(Vasotec from Merck)(Company Business and Marketing)(Brief Article)Biovail Corp. (Active Pharmaceutical Ingredient Watch).(purchase of Vasotec,…

COPYRIGHT 2000 Racher Press, Inc.
COPYRIGHT 2008 Gale, Cengage Learning

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FDA unleashes 16 generics of VasotecMerck gets good news on VasotecWatson’s generic Vasotec gets OKENALAPRIL.(Vasotec from Merck)(Company Business and Marketing)(Brief Article)Biovail Corp. (Active Pharmaceutical Ingredient Watch).(purchase of Vasotec,…

Vanlev is a vasopeptidase inhibitor, unlike Vasotec, an angiotensin-converting enzyme (ACE) inhibitor. Analysts are slashing earnings per share estimates on BMS for 2003 and beyond, while maintaining 2002 EPS projections.
Deutsche Banc Alex. Brown analyst Barbara Ryan lowered her …

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WHAT: In his presentation, “Evaluating Sales Force Performance:
Quantity vs. Quality,” Luby will use case studies and personal
experiences working with major pharmaceutical companies to
evaluate the industry’s method of measuring sales force
effectiveness, which has traditionally focused almost entirely
on quantity metrics, as the area of quality was not entirely
understood. Luby will outline how sales force quality metrics
can more accurately reveal how well a sales force is
executing, based on the major drivers of physician
prescribing.

At WBR PharmaForce, leaders from the pharmaceutical,
biopharmaceutical and health care industries will gather to
discuss a range of topics, including sales force optimization,
physician access, incentive compensation, sales training and
leadership, data analysis and sales force technology. With
keynote presenters from top pharmaceutical companies,
including Pfizer and Eli Lilly, the event provides attendees
with insight into how to implement successful training models
to maximize market share, overcome the difficulties in
accessing customers, design and administer optimal incentive
compensation plans, and employ best practices for augmenting
sales force strategies using the latest technologies.

WHEN: The WBR PharmaForce Conference will be held September 19-21,
2006.

Luby’s presentation is scheduled for Wednesday, September 20,
at 9:55 a.m.

WHERE: Doral Forrestal Conference Center & Spa, Princeton, NJ

About Mike Luby
Michael J. Luby is a co-founder of TargetRx. Luby brings more than 15 years of pharmaceutical marketing and sales experience from a variety of therapeutic areas to his role as President, CEO and Board Member of the Company. As the CEO since the Company’s inception in 1999, Luby has succeeded in raising over $50 million in capital, expanding the TargetRx team to more than 100 employees, and securing clients in the majority of the top 30 pharmaceutical companies worldwide. Luby is also the lead author on TargetRx’s patented method of analyzing the effectiveness of marketing and sales strategies. Luby has been honored with the Philadelphia Business Journal’s “40 Under 40″ award and selected by PharmaVOICE as one of the 100 most inspiring people in life sciences. TargetRx has also received the Eastern Technology Council’s Enterprise Award for Life Sciences Growth Company of the Year.
Prior to starting TargetRx, Luby spent 10 years at Merck & Co., Inc., where he created and executed marketing strategies for both the specialty and mass markets. The concept for TargetRx was born from his dissatisfaction with the lack of insightful, predictive and actionable marketing information from external sources during his tenure at Merck. As senior director of marketing, worldwide for new products at Merck, Luby spearheaded global pre-launch strategy and planning activities for two late-stage development products. He also served as director of new product marketing, managing the marketing strategy of early-stage drug development candidates and evaluating the potential of in-licensing opportunities from biotech companies. Luby’s previous roles included marketing management and research analyst positions for successful drugs such as Fosamax, now a multi-billion dollar brand, Vasotec and Prilosec, as well as positions focusing on marketing to managed care customers, including an assignment at Merck-Medco Managed Care.
Luby holds a B.A. in economics from Dartmouth College and an M.B.A. from the Wharton School of the University of Pennsylvania.
About TargetRx
TargetRx is a pharmaceutical sales and marketing effectiveness company that provides actionable insight to pharmaceutical companies to help them effectively sell and market their products and improve their financial performance. TargetRx has developed a highly predictive, database of physician attitudes that it uses in combination with its patented analytic methods to provide pharmaceutical companies with powerful “leading indicators” of how their sales and marketing initiatives will affect physician prescribing. TargetRx benchmarks performance, identifies immediate improvement opportunities and predicts future performance for its clients. TargetRx works with the majority of the top 30 pharmaceutical companies in the U.S. For further information, visit www.targetrx.com.
COPYRIGHT 2006 Business Wire
COPYRIGHT 2008 Gale, Cengage Learning

WHITEHOUSE STATION, N.J.–(BUSINESS WIRE)–Dec 4, 2008 - Merck & Co., Inc. today reaffirmed its financial guidance for 2008 and 2010, and provided guidance for 2009. Merck’s senior management will host a conference call to discuss the details of the Company’s financial guidance today at 8:00 a.m. EST.
“In 2009, we expect strong product volume growth from key products such as JANUVIA/JANUMET, ISENTRESS and ZOSTAVAX,” said Richard T. Clark, chairman, president and chief executive officer. “However, we anticipate that top-line growth will be offset by the effects of a volatile global economy, fluctuations in the foreign exchange markets, as well as continued challenges for certain key products.
“This will be an important execution year for Merck as we continue the transformation of our company into a more lean and flexible business, and further reduce our cost structure, while strongly supporting our key products and growth opportunities,” said Clark.
“During 2009, we expect to file NDAs for two promising candidates in Phase IIl that address patient needs in the treatment of migraines and acute heart failure, and will continue to fully fund our R&D opportunities including outcomes studies for key products such as JANUVIA and VYTORIN as well as promising candidates including MK-0524A and MK-0822.
“The investments we’re making to promote our products, develop our best-in-class R&D capabilities and bring more efficiency to our business operations will position Merck for future growth,” he said.
2008 Guidance
Merck today reaffirmed its full-year 2008 non-GAAP (generally accepted accounting principles) earnings per share (EPS) guidance range of $3.28 to $3.32 that adjusts for certain items and a 2008 GAAP EPS range of $3.45 to $3.55. The Company has included in its full-year 2008 GAAP guidance:

A pretax charge of approximately $1.3 billion to $1.5 billion associated with the Company’s global restructuring programs.
The $2.2 billion pretax gain from a distribution from the AstraZeneca limited partnership.

A reconciliation of anticipated 2008 EPS as reported in accordance with GAAP to non-GAAP EPS that adjusts for certain items is provided in the table that follows:

Full-Year 2008

GAAP EPS

$3.45 to $3.55

EPS impact of items*

$(0.17) to $(0.23)

Non-GAAP EPS, which adjusts for items listed below 1

$3.28 to $3.32

* Amount calculated as follows (In millions except per share amount):

Full-Year 2008

Costs related to the global restructuring programs

$1,500 to $1,300

Gain on distribution from AstraZeneca

(2,223)

Net (increase) decrease before income taxes

(723) to (923)

Income tax expense (benefit) on above items

367 to 427

(Increase) decrease in net income

$(356) to $(496)

EPS impact of items

$(0.17) to $(0.23)

Details on Merck’s full-year 2008 financial guidance can be found on page 5 of this news release.
1 Merck is providing information on earnings per share in 2008 and 2009, adjusted for certain items, because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing this information enhances investors’ understanding of the Company’s performance. This information should be considered in addition to, but not in lieu of, earnings per share prepared in accordance with GAAP.
2009 Guidance
For the full-year 2009, the Company expects a non-GAAP EPS range of $3.15 to $3.30, excluding certain items and a 2009 GAAP EPS range of $2.95 to $3.17. The 2009 GAAP guidance includes a pretax charge of approximately $400 million to $600 million associated with the Company’s global restructuring programs.
A reconciliation of 2009 EPS as reported in accordance with GAAP to non-GAAP EPS, which adjusts for certain items, is provided in the table that follows.

Full-Year 2009

GAAP EPS

$2.95 to $3.17

EPS impact of items*

$(0.20) to $(0.13)

Non-GAAP EPS, which adjusts for items listed below

$3.15 to $3.30

* Amount calculated as follows (In millions except per share amount):

Full-Year 2009

Costs related to the global restructuring program

$600 to $400

Income tax expense (benefit) on above items

(180) to (120)

(Increase) decrease in net earnings

420 to 280

EPS impact of items

$(0.20) to $(0.13)

In 2009, the Company expects both GAAP and non-GAAP EPS in the first quarter to be less than one-fourth of the full-year EPS. In addition, the Company anticipates marketing and administrative spend and R&D expenses to be more equally distributed across the four quarters than in previous years.
Details on the 2009 guidance can be found on page 6 of this release.
Peter N. Kellogg, executive vice president and chief financial officer, said “Merck’s anticipated 2009 performance and the resulting cash flow, coupled with our strong balance sheet, will enable the Company to maintain our dividend at current levels, pursue share repurchases and take advantage of strategic opportunities.”
Elements of Long-Term Guidance
The Company had previously provided guidance on the 2005 to 2010 time period. Merck anticipates non-GAAP revenues, including 50 percent of the revenues from our joint ventures, will have a compound annual growth rate of 2 to 4 percent from 2005 to 2010. Merck’s GAAP reported sales, excluding 50 percent of the revenues from our joint ventures, are expected to have a compound annual growth rate of 1 to 3 percent from 2005 to 2010.
Non-GAAP EPS compound annual growth rate from 2005 to 2010 is expected to be in the mid-to-high single-digits, excluding certain items. Merck anticipates EPS compound annual growth rate on a GAAP basis to increase by double-digits over the same period. The non-GAAP EPS guidance excludes restructuring charges and net tax charges of $0.43 per share in 2005 and anticipated charges related to the 2008 restructuring program of $100 million to $400 million in 2010. For the purpose of the 2010 guidance, the Company is excluding any one-time gains that may result from AstraZeneca exercising its option with respect to AstraZeneca LP.
Merck anticipates capital expenditures of approximately $1.4 billion in 2008. Capital expenditures for 2009 are expected to be approximately $1.6 billion.
Conference Call
The Company will host a conference call to discuss the Company’s financial guidance. Investors are invited to a live Web cast of Merck’s conference call today at 8:00 a.m. EST by visiting the Newsroom section of the Merck Web site (www.merck.com/newsroom/webcast/). Institutional investors and analysts can participate in the call by dialing (706) 758-9927. Journalists are invited to listen by calling (706) 758-9928. A replay of the conference call will be available starting at 11 a.m. EST today through 5 p.m. EST on Dec. 11. To listen to the replay, dial (706) 645-9291 or (800) 642-1687 and enter ID # 73736995.
Merck Financial Guidance for 2008
Sales forecasts for Merck & Co., Inc. and major products for 2008 are as follows:

Worldwide 2008 Sales

Total Sales* (as recorded by Merck & Co., Inc.)

$23.7 to $24.0 billion

Product

SINGULAIR (Respiratory)

$4.3 to $4.5 billion

COZAAR/HYZAAR (Hypertension)

$3.5 to $3.7 billion

FOSAMAX (Osteoporosis)

$1.4 to $1.7 billion

GARDASIL (as recorded by Merck & Co., Inc.)

$1.4 to $1.6 billion

Other Vaccines (as recorded by Merck & Co., Inc.)

$2.6 to $2.8 billion

Other reported products**

$7.8 to $8.2 billion

* Total sales equals sales from products listed above plus supply sales to our partners (primarily AstraZeneca) and other non-promoted products.
** Other reported products comprise: ARCOXIA, CANCIDAS, COSOPT, CRIXIVAN, EMEND, INVANZ, ISENTRESS, JANUVIA, JANUMET, MAXALT, PRIMAXIN, PROPECIA, PROSCAR, STOCRIN, TIMOPTIC/TIMOPTIC XE, TRUSOPT, VASOTEC/VASERETIC, ZOCOR and ZOLINZA.

Under an agreement with AstraZeneca (AZN), Merck receives revenue at predetermined percentages of the U.S. sales of certain products by AZN, most notably NEXIUM. In 2008, Merck anticipates that these revenues will be approximately $1.5 billion to $1.7 billion.
Equity income from affiliates includes the results of the Merck and Schering-Plough collaboration and Sanofi-Pasteur MSD combined with the results of Merck’s other joint venture relationships. Equity income from affiliates is expected to be approximately $2.3 billion to $2.5 billion for 2008.
Product gross margin (PGM) percentage is estimated to be approximately 77 percent to 78 percent for the full-year 2008. This guidance excludes the portion of the restructuring costs that will be included in product costs and will affect reported PGM in 2008.
Marketing and administrative expense is anticipated to be approximately $7.4 billion to $7.6 billion.
Research and development expense (which excludes joint ventures) is anticipated to be approximately $4.7 billion to $4.9 billion. This guidance excludes the portion of the restructuring costs that will be included in research and development expense in 2008.
As part of the Company’s restructuring of its operations, additional costs related to site closings, position eliminations and related costs will be incurred in 2008. The aggregate 2008 pretax expense related to these activities is estimated to be in the range of $1.3 billion to $1.5 billion.
The consolidated 2008 tax rate is estimated to be approximately 18 percent to 21 percent. This guidance does not reflect the tax rate impact of the gain on distribution from AstraZeneca or restructuring costs. The effective tax rate to be applied to the AstraZeneca gain and the Company’s restructuring costs is at a higher level than the underlying effective tax rate guidance.
Merck plans to continue its stock buyback program in 2008. As of November 30, 2008, $2.4 billion remains under the current buyback authorizations approved by Merck’s Board of Directors.

Given these guidance elements, Merck anticipates full-year 2008 non-GAAP EPS of $3.28 to $3.32, excluding certain items, and 2008 GAAP EPS in the range of $3.45 to $3.55.
Merck Financial Guidance for 2009
This guidance is based on recent exchange rates. Sales forecasts for Merck & Co., Inc. and major products for 2009 are as follows:

Worldwide 2009 Sales

Total Sales* (as recorded by Merck & Co., Inc.)

$23.7 to $24.2 billion

Product

SINGULAIR (Respiratory)

$4.4 to $4.7 billion

COZAAR/HYZAAR (Hypertension)

$3.4 to $3.7 billion

JANUVIA/JANUMET (Diabetes)

$2.4 to $2.7 billion

GARDASIL (as recorded by Merck & Co., Inc.)

$1.4 to $1.6 billion

Other Vaccines (as recorded by Merck & Co., Inc.)

$2.8 to $3.1 billion

Other reported products**

$6.6 to $7.0 billion

* Total sales equals sales from products listed above plus supply sales to our partners (primarily AstraZeneca) and other non-promoted products.
** Other reported products comprise: ARCOXIA, CANCIDAS, COSOPT, CRIXIVAN, EMEND, FOSAMAX, INVANZ, ISENTRESS, MAXALT, PRIMAXIN, PROPECIA, PROSCAR, STOCRIN, TIMOPTIC/TIMOPTIC XE, TRUSOPT, VASOTEC/VASERETIC, ZOCOR and ZOLINZA.

Under an agreement with AstraZeneca (AZN), Merck receives revenue at predetermined percentages of the U.S. sales of certain products by AZN, most notably NEXIUM. In 2009, Merck anticipates that these revenues will be approximately $1.2 billion to $1.4 billion.
Equity income from affiliates includes the results of the Merck and Schering-Plough collaboration and Sanofi-Pasteur MSD combined with the results of Merck’s other joint venture relationships. Equity income from affiliates is expected to be approximately $2.2 billion to $2.5 billion for 2009.
Product gross margin (PGM) percentage is estimated to be approximately 77 percent to 78 percent for the full-year 2009. This guidance excludes the portion of the restructuring costs that will be included in product costs and will affect reported PGM in 2009.
Marketing and administrative expense is anticipated to be approximately $7.0 billion to $7.3 billion.
Research and development expense (which excludes joint ventures) is anticipated to be approximately $4.8 billion to $5.1 billion. This guidance excludes the portion of the restructuring costs that will be included in research and development expense in 2009.
As part of the Company’s restructuring of its operations, additional costs related to site closings, position eliminations and related costs will be incurred in 2009. The aggregate 2009 pretax expense related to these activities is estimated to be in the range of $0.4 billion to $0.6 billion.
The consolidated 2009 tax rate is estimated to be approximately 22 percent to 25 percent.
Merck plans to continue its stock buyback program in 2009. As of November 30, 2008, $2.4 billion remains under the current buyback authorizations approved by Merck’s Board of Directors.

Given these guidance elements, Merck anticipates full-year 2009 non-GAAP EPS of $3.15 to $3.30, excluding certain items, and 2009 GAAP EPS in the range of $2.95 to $3.17.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.
Forward-Looking Statement
This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck’s business, particularly those mentioned in the risk factors and cautionary statements set forth in Item 1A of Merck’s Form 10-K for the year ended Dec. 31, 2007, and in its periodic reports on Form 10-Q and Form 8-K, which the Company incorporates by reference.

Contact: Merck & Co., Inc.
Media:
Amy Rose, 908-423-6537
David Caouette, 908-423-3461
or
Investor:
Eva Boratto, 908-423-5185

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That’s why recent studies of apolipoprotein A-1 (ApoA-1) Milano are important. This cholesterol-carrying protein is found only in a small number of Italian villagers who have very little atherosclerosis despite low levels of HDL. Researchers combined ApoA-1 Milano with a natural phospholipid–a major component of biological membranes–to create a substance that works like a supercharged HDL molecule to quickly escort cholesterol from the body.
In a landmark study conducted at Cleveland Clinic, five weekly doses of ApoA-1 Milano complex were given to patients with unstable angina or heart attack brought on by extensive blockages in the coronary arteries. After only five treatments, the amount of cholesterol-laden plaque in their arteries was measured by intravascular ultrasound (IVUS) and found to have decreased by 4.2 percent.
Unfortunately, this HDL-mimicking compound is not available as a drug. However, the study demonstrated the potential value of a drug that significantly raises HDL levels.
“We need to find a way to raise HDL with an oral drug,” says lead investigator investigator Steven E. Nissen, M.D., Chairman of the Department of Cardiology at Cleveland Clinic.
Manipulating cholesterol
Studies lowering LDL (”bad”) cholesterol far beyond current recommendations have proven that very low LDL can slow the progression of atherosclerosis. It appears that lowering LDL while simultaneously raising HDL may reverse the disease. The theory was first illustrated in a 2001 study that documented plaque regression with simvastatin (Zocor) combined with niacin. Niacin is one of the few drugs that raises HDL. However, unpleasant side effects such as liver dysfunction, flushing or redness of the skin, rash, and headache often prevent niacin from being taken in large enough doses to affect HDL.
Now it appears a single statin may accomplish both goals. In a 2006 clinical trial called A Study to Evaluate the Effect of Rosuvastatin on Intravascular Ultrasound (ASTEROID), researchers gave large doses of rosuvastatin (Crestor) to patients for two years. Over this period, LDL dropped to an average of 60.8 mg/dL, and the average HDL increased by 14.7 mg/dL. Measurements taken with IVUS showed the total amount of arterial plaque was reduced nearly 9 percent.
“This was a small pilot study. We are now looking at a larger, placebo-controlled additional study that will track the effects of this drug on heart attack and cardiac deaths,” says Dr. Nissen.
Lowering blood pressure
High blood pressure is a risk factor for the development of CAD. Now it appears that lowering blood pressure may actually help reverse CAD.
In the Comparison of Amlodipine versus Enalapril to Limit Occurrences of Thrombosis (CAMELOT) trial, patients were randomized to receive one of these two blood pressure medications–amlodipine (Norvasc) or enalapril (Vasotec)–or placebo for two years. The goal was to determine the effect of these medications on heart attack and cardiac death.
But the study did not end there. More than 430 CAMELOT participants signed up to be included in a sub-study in which the amount of atherosclerosis in their coronary arteries was measured using IVUS. After 24 months of treatment, the inside measurement of the coronary arteries (lumen) was wider in patients who had taken amlodipine than in those who had taken enalapril or placebo. In addition, fewer heart attacks occurred in the amlodipine group than in the other patients. However, heart attacks had no correlation with lumen size, raising questions that need to be answered in another clinical trial.
With so many blood pressure medications on the market, Dr. Nissen thinks more than one might reverse atherosclerosis. However, he is pinning his hopes on a drug that raises HDL. “I think it’s our best bet,” he says.
WHAT YOU CAN DO
To reduce your risk of CAD:
* Eat a low-cholesterol diet.
* Use statins to lower LDL cholesterol and talk with your doctor about raising HDL.
* Keep your blood pressure at or below 120/80 mmHg.
* Don’t smoke. Smoking increases your heart attack risk even if your cholesterol and blood pressure are normal.
COPYRIGHT 2007 Belvoir Media Group, LLC
COPYRIGHT 2008 Gale, Cengage Learning

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The tentative approval comes nearly one year before the patent and pediatric exclusivity on Vaseretic(R) expire on March 18, 2002. Taro currently expects to begin selling the product in the U.S. market at that time.
Growing Cardiovascular Line
“Taro has a growing number of cardiovascular products in the U.S. market,” stated Barrie Levitt, M.D., FACC, Chairman of the Company. “Taro is committed to cardiology, and we expect to continue building our cardiovascular product line.” The Company currently markets Warfarin Sodium Tablets and Acetazolamide Tablets, in addition to the more recent approvals for Amiodarone Hydrochloride Tablets, Enalapril Maleate Tablets and Enalapril/HCTZ.
Since 1996, Taro has introduced an increasing number of oral dosage form products in the U.S. market. Today, Taro has ANDA approvals for 14 oral dosage form products in 33 varying strengths. Taro plans to continue expanding its oral dosage form offering in the U.S.
In January 2001, Taro received approval from the FDA on its ANDA for Enalapril Maleate Tablets in strengths of 2.5 mg, 5 mg, 10 mg and 20 mg, bioequivalent to Merck’s Vasotec(R) Tablets. In March 2001, the Company received approval from the FDA on its ANDA for Amiodarone Hydrochloride Tablets 200 mg, bioequivalent to Wyeth-Ayerst Laboratories’ Cordarone(R) Tablets.
Taro currently has 9 ANDAs submitted to the FDA (including the tentative approval for Enalapril Maleate/HCTZ), and multiple international filings with regulatory agencies around the world.
Taro is a multinational, science-based pharmaceutical company dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products.
For further information on Taro Pharmaceutical Industries Ltd., visit the Company’s website at www.taropharma.com.
To receive additional information on Taro Pharmaceutical Industries Ltd., at no charge, dial 1-800-PRO-INFO and enter company code 104 or ticker symbol TARO.
Certain statements in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Although Taro Pharmaceutical Industries Ltd. believes the expectations reflected in such forward-looking statements to be based on reasonable assumptions, it can give no assurance that its expectations will be attained. Factors that could cause actual results to differ include industry and market conditions, slower than anticipated penetration of new markets, changes in the Company’s financial position, regulatory actions, and other risks detailed from time to time in the Company’s SEC reports, including its Annual Report on Form 20-F for the last fiscal year ended December 31, 1999.
COPYRIGHT 2001 Business Wire
COPYRIGHT 2001 Gale Group