Monday, February 28, 2005

CANADIAN STUDY SHOWS CLASS EFFECT OF ACE INHIBITORS ON CONGESTIVE HEART FAILURE PATIENTS

Results of a Canadian study showed that ACE inhibitors are interchangeable in terms of their impact on the mortality or hospital readmission of congestive heart failure (CHF) patients, suggesting a class effect.

Researchers conducted a retrospective study using an administrative database to identify CHF patients discharged from the hospital between April 1, 1997, and March 31, 2000. The patient analysis was limited to those surviving more than 30 days after discharge and those initiated on ACE inhibitors.

There were 6,753 patients in the database who were initiated on ACE inhibitors, and their average age was 79.2 years. Patients using enalapril (n=2,976 patients) were the reference group for the study, and patients were divided into those initiated on enalapril, lisinopril (n=1,192), King Pharmaceuticals Inc.'s Altace (ramipril) (n=1,138) or other ACE inhibitors (n=1,447), such as benazepril hydrochloride, captopril, cilazapril, fosinopril sodium, Solvay SA's Aceon (perindopril erbumine), quinapril hydrochloride and Abbott Laboratories' Mavik (trandolapril). The CHF patients were followed for two years.

The primary outcome measured was the combined endpoint of readmission for CHF as a primary diagnosis or mortality. Secondary outcomes were CHF readmission alone and mortality alone.

Analysis of the data showed no significant difference in the combined endpoint of readmission for CHF or mortality for those patients initiated on Altace, lisinopril, or any other ACE inhibitors as compared with enalapril users. There was also no significant difference in CHF readmission alone or mortality alone between the groups.

The results suggest that regardless of differences in pharmacological properties of ACE inhibitors, there is a class effect of ACE inhibitors on CHF patients.

"[The implication] is that physicians can prescribe ACE inhibitors for heart failure based on factors such as cost and convenience rather than on perceived superior or inferior effectiveness of one ACE inhibitor over another," study co-author Dr. Karen Tu told Reuters.

The study appeared in the Jan. 15 issue of the American Journal of Cardiology.

Monday, July 26, 2004

MYLAN LABS TO ACQUIRE KING PHARMACEUTICALS IN $4 BILLION AGREEMENT

Generic drug manufacturer Mylan Laboratories Inc. entered into a definitive agreement with King Pharmaceuticals Inc. whereby Mylan will acquire the branded specialty pharmaceutical company in a stock-for-stock transaction valued at nearly $4 billion.

The agreement will tie Mylan's manufacturing, science, compliance and intellectual property management capabilities together with King's developed sales and marketing infrastructure and expertise in business development for acquiring pharmaceutical brand products and companies, according to a joint press release.

For the 12 months ended March 31, the combined company would have had $3 billion in revenue, $650 million in operating cash flow and nearly 6,000 employees, including a sales force of approximately 1,400.

King currently markets Altace (ramipril), an ACE inhibitor indicated for hypertension management and cardiovascular protection. For the 12-month period ended March 31, Altace generated approximately $450 million in sales.

The companies' combined sales forces will help Mylan's intended launch and marketing of the hypertension therapy nebivolol, if approved by the Food and Drug Administration. In May, Bertek Pharmaceuticals Inc., the branded drugs division of Mylan, submitted a New Drug Application to the FDA for nebivolol.

"This transaction combines the number one domestic generic pharmaceutical company and a leading pharmaceutical branding company with highly complementary platforms and creates the second largest pharmaceutical company based on the number of U.S. prescriptions dispensed," said Robert Coury, Mylan's chief executive.

"The significant expansion of our branded business advances our long-term strategy, and we are confident that combining the fundamental strengths and assets of our two companies will result in the potential for greater growth for all shareholders," he added.

Terms of the transaction provide that King shareholders will receive 0.9 Mylan common shares for each outstanding King share owned. Based on Mylan's closing stock price on Friday, the value of the transaction is estimated to be approximately $4.0 billion, or approximately $16.66 per King share.

The transaction is expected to close by the end of the 2004 calendar year.

Shares of King were at $13.23, up $2.86, or 27.6 percent, in midday trading on the New York Stock Exchange. Mylan shares were at $15.86, down $2.65, or 14.3 percent, also in midday Wall Street trading.

Monday, June 28, 2004

DATA INDICATE ALTACE BENEFITS LEFT VENTRICULAR STRUCTURE, FUNCTION IN PATIENTS WITH CONTROLLED BLOOD PRESSURE, PRESERVED LEFT VENTRICULAR EJECTION FRACTION

New data suggest Wyeth and King Pharmaceuticals Inc.'s Altace (ramipril) has beneficial effects on left ventricular (LV) structure and function among vascular patients with controlled blood pressure and preserved LV ejection fraction (LVEF).

In the trial, 506 patients with vascular disease on echocardiographic measures of LV mass (LVM) and LV function were randomized to receive Altace 10 mg daily, Altace 2.5 mg daily or placebo. Baseline blood pressure and LVEF were similar in all treatment groups (131/76 mm Hg and 58 percent, respectively).

Data showed after four years that LVM index increased by 3.98 g/m2 in the placebo group and by 4.16 g/m2 among Altace 2.5 mg-treated patients, but decreased by 2.02 g/m2 in patients administered Altace 10 mg.

Furthermore, the changes in end-diastolic and end-systolic volumes were 4.16 mL and 5.31 mL for placebo-treated patients; -0.43 mL and 2.90 mL in the Altace 2.5 mg group; and -5.90 mL and -1.90 mL in Altace 10 mg recipients.

"In summary, our study shows a significant dose-dependent, but, at least in part, BP-independent beneficial effect of ACE inhibitor therapy on LV structure and function," the researchers said. "These data provide further evidence supporting the use of long-term ACE inhibitor therapy in a wide range of patients with cardiovascular disease."

This study can be viewed in the June 16 issue of the Journal of the American College of Cardiology.

Wednesday, July 30, 2003

GROWTH IN KING'S BRANDED DRUG SALES BOOSTS REVENUE, BUT ONE-TIME CHARGES LEAD TO Q2 LOSS

King Pharmaceuticals Inc. shares fell 7.4 percent after the drug maker posted a net loss in the second quarter of 2003.

The Bristol, Tenn.-based firm said it incurred a net loss of $35 million, or $0.15 per diluted share, compared with net earnings of $58.4 million, or $0.24 per share, in the same period of 2002.

Special items in the quarter included charges related to King's acquisition of Elan Corp. Plc's primary care business, which includes the insomnia drug Sonata (zaleplon) and the muscle relaxant Skelaxin (metaxolone), and costs related to an ongoing investigation of company's pricing practices by the Securities and Exchange Commission.

Excluding special items, net earnings reached $84.1 million, or $0.35 per share, compared with $77.1 million, or $0.31 per share, during the year-ago quarter. King said it expects to earn between $1.50 per share and $1.60 per share in the full year.

Quarterly revenue totaled $370.7 million, a 31 percent increase from $282.5 million in 2002. Net revenue from pharmaceutical brand drugs rose 21 percent to $328.8 million.

King said that growth in sales of Altace (ramipril) for heart failure and Thrombin-JMI, which is used to control blood loss during surgery, contributed significantly to the revenue growth. Altace net sales grew 27 percent from the prior-year period to $140.1 million while net sales of Thrombin-JMI increased 87 percent to $35 million.

Shares of King closed at $14.80, down $1.19, in heavy trading on the New York Stock Exchange.