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Over a mean follow-up of 4.5 years, 102 subjects in the ramipril group (3.6%) developed diabetes, compared with 155 (5.4%) in the placebo group. The proportion of patients who required an oral glucose-lowering agent or insulin and the proportion who had a glycated hemoglobin of 110% or more above normal were significantly lower in the ramipril group, they said (JAMA 286[15]:1882-85, 2001).
These findings require confirmation because of their “enormous clinical and public health potential,” so the researchers are now conducting a large prospective trial with patients who have impaired glucose tolerance.
COPYRIGHT 2002 International Medical News Group
COPYRIGHT 2008 Gale, Cengage Learning

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ABIX via COMTEX) -- The landmark HOPE trial shows that normotensive patients on ramipril 10mg have reduced risks of stroke, heart attacks and deaths. An analysis of the European study also shows that the reduction in risk of the cardiovascular events were three times more than expected from the drug’s blood pressure-lowering effects on the overall trial participants. The manufacturer of ramipril, Aventis Pharma, says the research suggests that ramipril 10mg might have additional, but unknown, properties, which prevent cardiovascular events in victims …

Read the rest of this article with a Free Trial at HighBeam Research.

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ClinicalTrials.gov Identifier: NCT00273533
COPYRIGHT 2006 Journal of Drugs in Dermatology, Inc.
COPYRIGHT 2008 Gale, Cengage Learning

There are lots of medications used to treat high blood pressure. While many people dealing with hypertension will possibly be prescribed a combination of a variety of these medications, the amount of medication needed depends greatly on the type and the level of severity of the illness.
While antihypertensive medicines are used to lower blood pressure to normal levels, medications should always be used in combination with a healthy lifestyle change. The main objectives of high blood pressure medications are to not only lower blood pressure but to minimize the side effects caused by some of the medicines.

The Common Antihypertensive Medication Are:
Diuretics
Beta Receptor Antagonists (Beta Blockers)
Alpha I Receptor Blockers
Angiotensin Converting Enzyme Inhibitors (Ace-Is)
Angiotensin Ii Antagonists
Calcium Channel Blockers
Direct Vasodilators
Centrally Acting Agents
Combination Therapies.

DIURETICS
The types of diuretics used in clinical practice today are:

Thiazide diuretics
Loop diuretics
Potassium sparing diuretics
Aldosterone receptor blockers.
•Diuretics (also known as “water pills”) act by increasing the kidneys’ excretion of salt and water thus reducing blood volume with a consequent decrease in the pressure in the arteries.
Two of the commoner diuretics in use today are:
Hydrochlorothiazide (Microzide,Hydrodiuril), and Furosemide (Lasix)
Others are:
Acetazolamide (Diamox)
Amiloride (Midamor)
Chlorothiazide (Diuril)
Indapamide (Lozol)
Torsemide (Demadex)
Metolazone (Zaroxolyn)
Spironolactone (Aldactone)
Triamterene (Dyrenium)
Metolazone (Zaroxolyn).
Potential side effects of diuretic usage include increased frequency of urination, increased urinary excretion of potassium, impaired glucose tolerance and increased blood urate levels.

BETA(β)RECEPTOR ANTAGONISTS (beta blockers):
Beta blockers decrease the force of contraction of the heart thus decreasing the force of blood needed to pump blood into the arteries.
Commonly used beta blockers include:
Atenolol (Tenormin)
Bisprolol (Zebeta)
Metoprolol (Lopressor)
Propranolol (Inderal)
Timolol (Blocadren)
Potential side effects of beta blocker usage include decrease in heart rate, constriction (narrowing) of the bronchioles (avoid in asthma), hair loss, depression (rarely), fatigue, and impotence (rarely).

ALPHA 1 RECEPTOR BLOCKERS
Cause relaxation of the smooth muscles in the blood vessels by blockade of the alpha 1 receptors thus allowing blood to pass in these vessels more freely.
Commonly used alpha blockers include:
. Doxaxosin (Cadura)
. Prazosin (Minipress)
. Terazosin (Hytrin)
The major potential side effect of alpha I receptor blocker usage is a sudden decrease in the blood pressure on standing (postural hypotension).

NOTE: Labetalol (Normodyne,Trandate) has both alpha 1 selective and beta-blocking effects. It is particularly useful in treating hypertensive emergencies and hypertension in pregnancy (where first line agents are ineffective or poorly tolerated.

ANGIOTENSIN CONVERTING ENZYME (ACE)INHIBITORS.
Prevent the production of Angiotensin II by inhibiting the enzyme, Angiotensin Converting Enzyme (ACE). Angiotensin II causes the blood vessels to narrow.
Help dilate the arteries, thereby decreasing resistance to blood flow and consequently decreasing blood pressure.
Include Benazepril (Lotensin),Captopril (Capoten),Enalapril (Vasotec),Fosinopril (Monopril), Lisinopril (Zestril,Prinivil), Ramipril (Altace), and Trandolapril (Mavik).
Potential side effects include cough,increased in blood potassium levels, and rarely, swelling of the lips, cheeks and face (angioneurotic edema).

ANGIOTENSIN II ANTAGONISTS
Protect against the arteriolar narrowing effect of angiotensin II.
Help dilate arteries thus lowering blood pressure.
Tend to improve congestive cardiac failure symptoms, decrease the risk of further heart attacks and decreases the risk of death from heart failure.
Include Candesartan (Atacand),Eprosartan (Teveten) Irbesartan (Avapro), Losartan (Cozaar), Olmesartan (Benicar), Telmisartan (Micardis), and Valsartan (Diovan).
Are generally well tolerated.

CALCIUM CHANNEL BLOCKERS (Also known as calcium antagonists)
Divided into 2 broad categories:
. 1,4-dihydropyridines: include Amlodipine (Norvasc),Felodipine (Plendil),Isradipine (DynaCirc),Nifedipine (Procardia,Adalat) and Nisoldipine (Sular).
. Nondihydropyridines: include Diltiazem (Cardizem,Dilacor) and Verapamil (Calan,Veralan,Covera).
Reduce blood pressure by preventing the entry of calcium, needed for muscle contraction and blood vessel narrowing (constriction), into cells.
The overall effect is a decrease in force of contraction of the heart, opening up (dilating) the arteries, decrease in resistance to blood flow, decrease in the pressure in the arteries with a consequent decrease in blood pressure.
Potential side effects include swelling of the hands and feet, swelling of the gums, flushing, nausea and headaches.

DIRECT-ACTING VASODILATORS
Dilate the arteries in the body by direct relaxation of the arteriolar smooth muscles.
Are useful in the treatment of heart failure, specific types of hypertension or in combination with other medication, to achieve blood pressure goals.
Include Hydralazine (Apresoline), Fenoldapam, Sodium Nitroprusside and Minoxidil.
Potential side effects vary with the agent used and include hypotension, nausea, headaches and flushing.

CENTRALLY ACTING AGENTS
Are the oldest class of antihypertensive agents.
Act on the central nervous system and exerts control over nerve impulses that cause arteries to narrow (constrict).
Include Clonidine (Catapres), Methyldopa (Aldomet) and Reserpine.
Potential side effects include drowsiness, nausea, vomiting and depression.

COMBINATION THERAPIES
In the majority of hypertensive patients it is unlikely that a single drug will control blood pressure to target levels.
Clinical trials demonstrate that combination therapy is required in approximately two-thirds of hypertensive individuals.
Potential reasons why single-drug therapies fail include the presence of coexisting conditions such as obesity, diabetes mellitus and kidney disease, non-adherence to therapy, isolated systolic hypertension and unpredictability of the blood pressure response.
The common combination antihypertensives include:
. ACE inhibitor and Calcium channel antagonist e.g Lotrel, Tarka. Triapin
. ACE inhibitors and Diuretic e.g Vaseretic, Zestoretic.
. Angiotensin II receptor blockers and Diuretics e.g Diovan, Hyzaar.
. Beta blockers and Diuretic e.g, Lopressor, Tenoretic. . Diuretic and Diuretic e.g Moduretic, Maxzide.
Centrally acting agent and Diuretic e.g Regroton, Aldoril

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For the nine-month period ended September 30, 2006, total revenues were $1.48 billion compared to $1.35 billion for the nine-month period ended September 30, 2005. Including special items, net income equaled $252 million and diluted earnings per share equaled $1.04 during the nine-month period ended September 30, 2006, compared to net income of $212 million and diluted earnings per share of $0.88 during the same period of the prior year. Excluding special items, net earnings equaled $324 million and diluted earnings per share equaled $1.33 for the nine-month period ended September 30, 2006, compared to net earnings of $308 million and diluted earnings per share of $1.27 in the same period of 2005.
Brian A. Markison, President and Chief Executive Officer of King, stated, “We are pleased with our continued solid financial performance and our accomplishments during the third quarter. Importantly, we strengthened our portfolio with the launch of Glumetza[TM], a new generation metformin product for patients with Type II diabetes, and our agreement to acquire the rights to Avinza([R]), a true once-a-day morphine product.”
Mr. Markison emphasized, “Glumetza[TM] is an excellent complement to our cardiovascular/metabolics franchise and Avinza([R]) significantly strengthens our growing pain portfolio, positioning us to become a leader in pain management. We expect to close the Avinza([R]) acquisition on or about December 31, 2006. In the interim, our sales force is promoting the product pursuant to a separate copromotion agreement which terminates in January 2007.”
Mr. Markison added, “We are continuing to focus on business development opportunities in our key therapeutic areas to further improve our development pipeline, which includes four products in Phase III and two products in Phase II. Additionally, we expect T-62, our investigational drug for the treatment of neuropathic pain, to enter Phase II in the first half of 2007. As our pipeline continues to build momentum, we expect to report results from several key clinical programs next year.”
Net revenue from branded pharmaceuticals totaled $433 million for the third quarter of 2006, a 5% decrease from $455 million during the third quarter of 2005. This difference was primarily due to previously disclosed changes in reserve estimates and increases in wholesale inventory levels of the Company’s products in the third quarter of 2005 that each positively benefited net revenues during that quarter.
Altace([R]) (ramipril) net sales totaled $159 million during the third quarter of 2006 compared to $174 million during the third quarter of 2005.
Net sales of Skelaxin([R]) (metaxalone) totaled $106 million during the third quarter of 2006 compared to $116 million during the same period of the prior year.
Thrombin-JMI([R]) (thrombin, topical, bovine, USP) net sales totaled $70 million during the third quarter of 2006 compared to $54 million during the third quarter of 2005. Net sales of this product during the third quarter of 2006 benefited from an increase in wholesale inventory levels which remain within a normalized range.
Net sales of Sonata([R]) (zaleplon) totaled $19 million during the third quarter of 2006 compared to $20 million during the third quarter of the prior year.
Levoxyl([R]) (levothyroxine sodium tablets, USP) net sales totaled $25 million during the third quarter ended September 30, 2006 compared to $36 million during the third quarter of 2005.
King’s Meridian Medical Technologies business contributed revenue totaling $37 million during the third quarter of 2006 compared to $38 million during the same period of the prior year.
Royalty revenues, derived primarily from Adenoscan([R]) (adenosine), totaled $19 million during the third quarter ended September 30, 2006, compared to $22 million during the third quarter of 2005. During the third quarter ended September 30, 2006, net revenue from contract manufacturing equaled $3 million.
As of September 30, 2006, the Company’s cash and cash equivalents and investments in debt securities totaled approximately $918 million. During the third quarter of 2006, the Company generated cash flow from operations of approximately $127 million. King expects to use cash to consummate its planned acquisition of Avinza([R]). Additionally, King plans to utilize its cash position to fuel its business development initiatives and aggressively invest in the further development of products in its pipeline. Accordingly, the Company continues to believe that its total investment in research and development for the full year of 2006 could exceed $150 million.

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Our Bull of the Day recommendation is for 51job (Nasdaq: JOBS). 51job’s revenue growth rate rebounded to 18.2% in the fourth quarter of 2006 in spite of increasing competition in the China’s recruiting market. We think this is a sustainable growth rate for the company, and its gross margin continues to improve due to economies of scale. 51job continues to have the highest brand recognition both in the online and offline recruiting market in China. Moreover, China’s prosperous economy will continue to boost the recruiting market. Overall, we believe 51job is well positioned to leverage this market opportunity in China. Therefore, we are maintaining the Buy rating for the stock.
Bear of the Day:
Our Bear of the Day recommendation is for Hewitt Associates (NYSE: HEW). While Hewitt is the clear leader in the emerging human resources BPO (business process outsourcing) market, near term results continue to be negatively impacted by the up-front costs as the company develops this business niche. In addition, revenue declined in fiscal 2006, primarily due to the loss of the Bank of America contract. Lastly, the acquisition of Exult has compressed the company’s overall margin. The stock appears overvalued on depressed earnings from business development upfront costs; hence, the stock is rated a Sell.
Analyst Blog:
Most of King Pharmaceuticals’ (NYSE: KG) key products are either facing increased competition or generic threat. Additionally, we are concerned about declining prescription trends for most of these products. We believe that generic threat and mounting competition will continue to hinder both top- and bottom-line growth going forward. As such, we are maintaining our Sell rating with a $14 target. More than 70% of the company’s present revenue base is in danger of losing out to generic competition by 2009. Key products like Altace and Skelaxin are likely to face generic competition within the next 1-3 years.
Pride International’s (NYSE: PDE) fourth quarter results came in modestly lower that expected, reflecting higher costs from the Brazilian joint venture [JV] that was acquired during the quarter. While the U.S. Gulf of Mexico jack-up market is experiencing near-term softness, our medium to long-term outlook for the market remains favorable. We have lowered our 2007 EPS [earnings per share] estimate to $3.45 from $3.88, to reflect increased maintenance-related downtime for the fleet, and introduced our 2008 estimate at $4.82. The expected divestiture of its non-core Latin American assets is expected to be positive catalyst.
Get the full analysis of all four stocks by going to http://at.zacks.com/?id=2649.
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–General practitioners (GPs) in Europe favor the use of lifestyle modifications in the treatment of metabolic syndrome. One survey found that 88% of GPs in the United Kingdom and 69% in France identified physical exercise or diet as a preferred treatment for this disorder. More than 70% of GPs in the United Kingdom also favored treatment of cholesterol or triglycerides, hypertension, overweight, or all factors, and 60% favored the use of oral antidiabetics in the management of metabolic syndrome. French GPs were markedly less inclined to use these therapeutic options. Moreover, GPs in the United Kingdom described an average of 4.7 of these options as preferred courses of action, compared with an average of just 2.0 for French GPs.
–Physicians in the United States identify controlling hypertension and elevated low-density lipoprotein (LDL) cholesterol as top clinical priorities owing to the well-characterized cardiovascular risk associated with these abnormalities and the availability of effective agents that can regulate them. Common first-line therapy includes oral antidiabetic agents, antihypertensive agents, and statins to control each of these components. Physicians attach less importance to elevated triglycerides, low high-density lipoprotein (HDL) cholesterol, and obesity, likely because the connection between these disorders and elevated cardiovascular risk is less clear and because therapeutic options are limited.
–Achieving a consensus definition of metabolic syndrome would increase detection rates, stimulate the development of drugs targeted at metabolic syndrome, and improve the reimbursement climate for drugs prescribed for this indication. Recent convergence in definitions suggests that a consensus may be within reach, but two very influential associations have challenged the validity of the concept of metabolic syndrome. If other organizations support this view, and the medical profession responds to such advice, the concept of metabolic syndrome as a distinct disease could fall out of favor.
–Some of the most widely prescribed drugs for constituents of the metabolic syndrome (e.g., metformin, glibenclamide, simvastatin, lovastatin, pravastatin, ramipril, amlodipine) are off-patent in Europe, and many other agents will lose patent protection in the next five to ten years. As a result, the European market for metabolic syndrome therapies is becoming increasingly genericized. With one or more oral antidiabetics, statins, and antihypertensives available in generic form in most of Europe, physicians can manag most of the symptoms of metabolic syndrome without prescribing branded medicines.
We forecast that the market for metabolic syndrome therapies will increase from $9.7 billion in 2003 to $12.8 billion in 2013. This market has enormous untapped potential, especially in Europe, but several major barriers (e.g., a lack of consensus on the definition of the disease, underdiagnosis, poor management, difficulties in the licensing of new therapies, reimbursement restrictions) have constrained growth.
In this Decision Resources report, we consider the problems resulting from the lack of a consensus definition of metabolic syndrome. We then examine how limited knowledge and inadequate screening have contributed to underdiagnosis of the disease. We review therapeutic options and assess the reimbursement environment for metabolic syndrome therapeutics. Further, we analyze the challenges that face drugs in development for this disorder and the consequences of a renewed debate over the validity of metabolic syndrome as a distinct disease. We conclude with an assessment of the outlook and implications for the pharmaceutical industry.
Topics Covered
–Overview
–Lack of Consensus on Disease Definition
–Underdiagnosis
–Therapeutic Options
–Reimbursement Environment
–Drugs in Development
–Validity of Metabolic Syndrome As a Distinct Disease
–Outlook and Implications for the Pharmaceutical Industry

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At the end of the study, 6,786 patients agreed to enter a continuation phase, in which all patients received ramipril, and 3,994 patients were randomly assigned to receive 400 IU/day of vitamin E or placebo for an additional 2.6 years, producing a total study duration of 7.1 years. At the end of the first part of the study, the incidences of heart failure events and hospitalizations for heart failure were higher in the vitamin E group than in the placebo group, but the differences were of only borderline statistical significance. The results from the continuation phase, when combined with the original results, did achieve statistical significance: heart failure events occurred in 14.7% of those using vitamin, compared with 12.6% of those using placebo (16.7% increase) and hospitalizations for heart failure occurred in 5.8% and 4.2% of patients, respectively (38.1% increase).
Comment: Vitamin E has a long and controversial history as a potential treatment for heart disease. While some large-scale clinical trials have found vitamin E to be beneficial, the majority of studies have found little or no effect of vitamin E. The HOPE trial is the first to suggest that vitamin E actually increases the risk of certain types of heart disease.
All of the studies of vitamin E supplementation for heart-disease prevention have used alpha-tocopherol, whereas the vitamin E in food contains four different isomers: alpha-, beta-, gamma-, and delta-tocopherol. An increasing body of evidence indicates that gamma-tocopherol has a strong cardioprotective effect. Moreover, supplementing with large doses of alpha-tocopherol results in a decline in serum concentrations of gamma-tocopherol. It is possible, therefore, that the positive effects of alpha-tocopherol are negated by a reduction in gamma-tocopherol levels. That possibility is supported by epidemiological studies indicating that vitamin E from food protects against heart disease, whereas vitamin E from supplements (e.g., alpha-tocopherol alone) does not. Future vitamin E studies should use “mixed tocopherols” that contain the four vitamin E isomers in proportions that are similar to those found in the diet.
Zoler ML. Supplemental vitamin E linked to heart failure. Fam Pract News 2003(October 1):28.
COPYRIGHT 2004 The Townsend Letter Group
COPYRIGHT 2004 Gale Group

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Brian A. Markison, President and Chief Executive Officer of King, stated, “We are very pleased with our many accomplishments during the first quarter of 2007, including record high quarterly revenues and earnings and the expansion of our portfolio of marketed products with the acquisition of AVINZA([R]) (morphine sulfate extended release), a true once-a-day oral formulation of morphine.”
Mr. Markison continued, “Importantly, we made significant progress with our development pipeline in the first quarter of 2007 as evidenced by the FDA approval of our ALTACE([R]) (ramipril) tablet formulation. We are also pleased with the positive results from our Phase III clinical trial evaluating the efficacy and safety of our ALTACE([R]) diuretic combination product.” Mr. Markison concluded, “These accomplishments are indicative of the continued execution of our strategy for long-term growth.”
As of March 31, 2007, the Company’s cash and cash equivalents and investments in debt securities totaled approximately $818 million. During the first quarter of 2007, the Company generated cash flow from operations of approximately $108 million.
Joseph Squicciarino, King’s Chief Financial Officer, stated, “We expect to continue utilizing our strong cash position and cash flow to maximize our current product portfolio, advance projects in our research and development pipeline, and fuel our business development initiatives to invest in late stage development opportunities and strategically acquire marketed products.” Mr. Squicciarino continued, “Our robust cash flow from operations has enabled us to increase our R&D investment in a disciplined manner and we continue to expect our R&D investment in 2007 to exceed the 2006 level.”
Net revenue from branded pharmaceuticals totaled $449 million for the first quarter of 2007, an 8% increase from $418 million during the first quarter of 2006.
ALTACE([R]) net sales totaled $157 million during the first quarter of 2007, compared to $159 million during the first quarter of 2006.
Net sales of SKELAXIN([R]) (metaxalone) totaled $112 million during the first quarter of 2007, an increase of 14% compared to $99 million during the same period of the prior year.
THROMBIN-JMI([R]) (thrombin, topical, bovine, USP) net sales totaled $64 million during the first quarter of 2007, a 10% increase from $58 million during the first quarter of 2006.
Net sales of AVINZA([R]) totaled $9 million during the first quarter of 2007. The Company began recognizing revenue for AVINZA([R]) following the completion of its acquisition of the product on February 26, 2007.
Net sales of SONATA([R]) (zaleplon) totaled $24 million during the first quarter of 2007, an increase of 12% compared to $21 million during the first quarter of the prior year.
LEVOXYL([R]) (levothyroxine sodium tablets, USP) net sales decreased to $22 million during the first quarter ended March 31, 2007 from $31 million during the first quarter of 2006.
King’s Meridian Medical Technologies business contributed revenue totaling $43 million during the first quarter of 2007, compared to $41 million during the same period of the prior year.
Royalty revenues, derived primarily from ADENOSCAN([R]) (adenosine), totaled $20 million during the first quarter ended March 31, 2007. For the first quarter ended March 31, 2007, net revenue from contract manufacturing equaled $3 million.
Webcast Information
King will conduct a webcast today which may include discussion of the Company’s marketed products, pipeline, strategy for growth, financial results and expectations, and other matters relating to its business. Interested persons may listen to the webcast on Thursday, May 10, 2007, at 11:00 a.m., E.D.T. by clicking the following link to register and then joining the live event with the same URL:
http://www.kingpharm.com/web_casts.asp
If you are unable to participate during the live event, the webcast will be archived on King’s web site at the same link for not less than 14 days after the webcast.
About AVINZA([R])
AVINZA([R]) is an extended-release opioid agent for patients requiring continuous, around-the-clock analgesia for an extended period of time. AVINZA([R]) is appropriate for chronic, moderate-to-severe pain associated with malignant and non-malignant pain conditions. AVINZA([R]) is an extended release form of morphine allowing for once-daily dosing.