Medical Recruiting

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Pfizer Q2 net income up 21 percent; Lipitor sales strong

Strong sales of cholesterol drug Lipitor (atorvastatin calcium) led Pfizer Inc. to report a 21 percent increase in second-quarter 2005 net income.

Net income for the quarter was $3.46 billion, or $0.47 per diluted share, compared with $2.86 billion, or $0.38 per diluted share, in the second quarter of 2004. The results surpassed analysts' expectations of $0.44 per share, The Associated Press reported.

Excluding charges, adjusted income was $3.42 billion, or $0.46 per share, compared with adjusted earnings of $3.61 billion, or $0.47 per share, in the year-ago period.

Revenue for the quarter rose 1 percent to $12.43 billion compared with $12.27 billion in the same quarter last year.

Worldwide Lipitor revenue reached $2.86 billion for the quarter, an increase of 21 percent based on 2004 second-quarter revenue of $2.36 billion.

In addition, cancer drugs Camptosar (irinotecan hydrochloride) and Aromasin (exemestane) experienced 58 percent and 86 percent revenue increases, respectively. However, revenue of anti-inflammatory drug Celebrex (celecoxib) fell 45 percent to $401 million during the quarter, based on cardiovascular safety concerns associated with COX-2 inhibitors, the AP noted. The company said it expects 2005 adjusted diluted earnings per share of approximately $1.98.

Pfizer shares closed at $27.06, down $0.32, or 1.2 percent, in heavy trading on the New York Stock Exchange.

Medical Recruiting

Genentech revises warning label for Raptiva

Genentech Inc. issued a letter advising health care providers of changes to the label for its psoriasis drug, Raptiva (efalizumab).

Specifically, Genentech added the following warning to the drug's prescribing information: "Reports of hemolytic anemia, some serious, diagnosed four to six months after the start of Raptiva treatment have been received. Raptiva should be discontinued if hemolytic anemia occurs."

Although no causal relationship between Raptiva and hemolytic anemia has been established, two cases were observed in clinical trials of the drug and two additional cases were reported in the postmarketing setting, the company said in its letter.

In addition, Genentech updated the warnings section of the label to include "rare postmarketing reports of necrotizing fasciitis, tuberculous pneumonia, bacterial sepsis with seeding of distant sites, severe pneumonia with neutropenia and worsening of infection (e.g., cellulitis pneumonia) despite antimicrobial treatment."

Raptiva was approved by the Food and Drug Administration in October 2003 and is indicated for the treatment of adult patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Medical Recruiting

Amgen, Wyeth report increased 2005 Q2 profit fueled by strong drug sales

Amgen Inc. and Wyeth both posted increased 2005 second-quarter net earnings and revenue as a result of strength in core drug sales growth

For the three months ended June 30, 2005, Amgen reported net income of $1.03 billion, or $0.82 per diluted share, compared with $748 million, or $0.57 per diluted share, in the year-ago period.

Quarterly income adjusted for costs associated with Amgen's acquisition of Tularik Inc. and Immunex Corp. and other one-time items totaled $1.1 billion, or $0.88 per diluted share, in 2005 versus $809 million, or $0.62 per diluted share, in 2004. Thomson First Call said average analyst expectations were $0.72 per share, according to The Wall Street Journal.

Amgen's total revenue reached $3.17 billion in the second quarter of 2005, up 23 percent from $2.59 billion achieved in the year-earlier quarter.

Overall, U.S. drug sales rose from $2.01 billion in 2004's second quarter to $2.53 billion in the second quarter of 2005. In particular, U.S. sales of anemia treatment Aranesp (darbepoetin alfa) grew from $380 million in 2004's second quarter to $536 million in 2005's second quarter.

Rheumatoid arthritis and psoriasis treatment Enbrel (etanercept), which the company co-promotes with Wyeth in North America, also demonstrated strong growth with U.S. sales reaching $614 million in the second quarter of 2005 compared with $423 million in the prior year's same period.

Second-quarter growth has prompted the firm to adjust its full-year guidance. Amgen now expects total revenue to grow to a range of mid-to-high teens instead of the low double-digit to mid-teens growth last projected. Furthermore, earnings per share will range between $3.10 and $3.20, up from a previous range between $2.80 and $2.90.

Amgen shares closed at $81.17, up $10.65, or 15.1 percent, in heavy trading on the Nasdaq.

Wyeth reported net income of $976.6 million, or $0.72 per diluted share, in the second quarter compared with $827.3 million, or $0.61 per share, last year in the same period. The firm beat analysts' expectations of $0.70 per share reported by Thomson Financial, The Associated Press said.

Revenue for the quarter grew 12 percent to $4.71 billion in 2005 versus $4.22 billion in 2004.

Besides strong sales associated with Enbrel, Wyeth said its antidepressant, Effexor (venlafaxine hydrochloride), recorded a 7 percent increase in quarterly worldwide sales to $889 million.

Wyeth reaffirmed full-year earnings guidance in the range of $2.80 and $2.90 per diluted share.

"Although we are not revising our guidance range at this time, if the current strong business trends continue, full-year earnings are more likely to approach or even exceed the upper end of this range," said Wyeth Chief Financial Officer Ken Martin.

Wyeth shares closed at $46.28, up $1.28, or 2.8 percent, in moderate trading on the New York Stock Exchange.

Medical Recruiting

Lunesta safe, effective for treating insomnia in perimenopausal, menopausal women, preliminary data indicate

Sepracor Inc.'s Lunesta (eszopiclone) may be linked with sleep improvement for perimenopausal and menopausal women with insomnia, preliminary Phase IIIB/IV study results reveal.

A total of 410 perimenopausal and menopausal women experiencing insomnia were randomized to receive 3 mg of Lunesta or placebo at night for four weeks.

Lunesta-treated patients reported statistically significant improvements in onset of sleep, wake time after sleep onset and total sleep time for each week compared with the group who received placebo.

Moreover, compared with baseline values and averaged throughout the double-blind period, the Lunesta group reported fewer nocturnal awakenings due to hot flashes. A physician global assessment, which measured overall change in menopausal symptoms, revealed a statistically significant improvement for the Lunesta versus placebo group.

Results also indicated that Lunesta, which is indicated to treat insomnia in patients who have difficulty falling asleep and for those with sleep maintenance difficulty, was well tolerated.

Complete results will be presented in San Diego at The North American Menopause Society's annual meeting in September.

Medical Recruiting

Phase III trial indicates preseasonal treatment with PreHistin reduces allergy symptoms

Preliminary analyses from a Phase III clinical trial for Cobalis Corp.'s allergy drug, PreHistin (cyanocobalamin), show that preseasonal treatment with the drug appears to reduce allergy symptoms.

The double-blind, parallel group trial included 641 patients with a multi-year history of sensitivity to Mountain Cedar pollen. Participants received either placebo or the active drug over a six-week period. Three-weeks of treatment were administered before the allergy season began, and patients were studied for another three weeks following the start of the season. Patients in two of the study arms received the active drug prior to the onset of the allergy season, and patients in the other two arms received only placebo.

Patients who received preseasonal treatment with PreHistin showed reductions in mean AM and PM scores for the sum of four primary reflective symptoms: sneezing, runny nose, nasal congestion and nasal itch, Cobalis said in a press release.

Symptom scores for sneezing and nasal itch revealed that the study arm that received PreHistin for the entire six-week period had the least increase in allergy symptoms and performed best when compared with the other groups.

"Based on the analyses that take into account differences in symptom severity at week one, it appears there are statistically reliable differences among treatment arms," said GCP MP's Mark Bradshaw, Ph.D., who conducted the preliminary analysis. "From a scientific standpoint, the evidence for differences among the treatment arms is very strong."

Cobalis said it will release the final detailed results of the study after independent statistical analysts and biostatisticians complete the full detailed analysis of all data points. The company expects to release these results within four to six weeks.

Medical Recruiting

Full coverage of ACE inhibitors for Medicare enrollees with diabetes may lead to extended life expectancy, reduced costs, data show

Providing older patients who have diabetes with a free supply of ACE inhibitors through the Medicare program may incur financial savings by preventing more serious health problems, researchers suggested.

Researchers developed a Markov model based on published literature and Medicare claims data to predict the lifetime costs for a cohort of beneficiaries aged 65 years or older with diabetes whose disease progression would be modified through the use of ACE inhibitors. The model assumed that ACE inhibitors were available for free to any enrollee with diabetes through "first-dollar coverage," or no cost sharing.

The total discounted lifetime cost per beneficiary by current Medicare practices (no drug coverage) was $117,549 and resulted in a discounted quality-adjusted life expectancy of 8.13 life years, according to the study results. Comparatively, Medicare first-dollar coverage decreased discounted lifetime costs to $115,943 and increased quality-adjusted life years to 8.36.

Medicare adoption of first-dollar coverage of ACE inhibitors saved both lives (0.23 quality-adjusted life years) and money ($1,606 per beneficiary) by preventing certain medical events (i.e., myocardial infarctions, strokes and heart failure), making it the dominant strategy.

Compared with the new Medicare drug plan to be implemented in 2006, which will cover approximately 35 percent of prescription drug costs, first-dollar coverage remained a dominant strategy and resulted in 0.15 additional quality-adjusted life years and $922 in savings.

Sensitivity analyses revealed that results changed based on how much the Medicare drug benefit and decreased copayments would affect ACE inhibitor use. In the base-case assumption, free availability of the drugs would increase utilization from 40 percent to 60 percent of patients, while the 2006 Medicare benefit would increase usage from 40 percent to 47 percent.

"A reduction in program costs from a cost-saving intervention may mean more money to spend on other health care needs of the elderly in a time when Medicare solvency is a national health policy concern," the study investigators wrote.

The analysis appeared in the July 19 edition of Annals of Internal Medicine.

Medical Recruiting

Medical Recruiting
Novartis AG

Novartis AG's plan to acquire Eon Labs Inc. was approved by the U.S. Federal Trade Commission on the basis that Novartis divest three of its products to a competitor. Novartis said it will divest antidepressant desipramine hydrochloride, pain reliever orphenadrine citrate extended release and rifampin, a treatment for certain bacterial infections, to Amide Pharmaceutical Inc. In an effort to create the world's largest generic drug company, Novartis announced in February that it would purchase generic drugmakers Eon Labs and Germany's Hexal AG for $8.3 billion.

Medical Recruiting

Medical Recruiting
F. Hoffman La-Roche Ltd.

F. Hoffman La-Roche Ltd. signed an agreement to acquire Swiss biotech company GlycArt Biotechnology AG, a privately owned antibody developer. Roche will pay approximately $180 million in cash for all of GlycArt's outstanding capital stock. Roche expects the transaction, which is expected to close in the third quarter of 2005, to strengthen its expertise in therapeutic antibody research and development.

Medical Recruiting

Medical Recruiting
Epix Pharmaceuticals Inc.

Epix Pharmaceuticals Inc. announced changes in its ongoing Phase II trial for EP-2104R, an imaging agent designed to detect blood clots with magnetic resonance imaging. Based on a Food and Drug Administration review of the firm's 14-day, repeat dose preclinical toxicology study, Epix said it would amend the trial to include additional patient safety monitoring. The amended protocol may delay the timeline for completion and incur additional development costs, although the extent of the delay and costs could not be determined. Epix shares closed at $9.81, down $0.57, or 5.5 percent, in heavy trading on the Nasdaq.

Medical Recruiting

Medical Recruiting
Neose Technologies Inc.

Neose Technologies Inc. said the Food and Drug Administration placed the company's proposed Phase I trial of NE-180 on hold. The FDA is requiring additional manufacturing and preclinical information to complete its review of the Investigational New Drug application for NE-180, which was submitted on June 23. NE-180 is a GlycoPEGylated erythropoietin designed to treat chemotherapy-induced anemia. Neose now expects the trial to begin in the fourth quarter of 2005 rather than the third quarter. Neose shares closed at $3.35, down $0.81, or 19.5 percent, in heavy trading on the Nasdaq.

Medical Recruiting

Medical Recruiting