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TURF Analysis

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FDA says Abbotts Xinlay not approvable Abbott's prostate cancer drug Xinlay (atrasentan) was deemed not approvable by the Food and Drug Administration, Abbott said in a Securities and Exchange Commission filing on Friday.

Abbott was seeking approval for Xinlay as a treatment for metastatic, hormone-refractory prostate cancer in men with bone metastases.

In September, the FDA's Oncologic Drugs Advisory Committee voted unanimously against approving the drug.

Documents posted on the FDA's Web site prior to the panel's meeting said the agency was concerned about the drug's failure to meet the primary endpoint of time to disease progression in Phase II and Phase III studies. The FDA was also concerned with the use of nonbioequivalent drug formulations, protocol violations, cardiovascular risks associated with Xinlay and the use of pooled data.

After the committee's decision, Abbott's Chief Executive Officer, Miles White, said Abbott planned to continue studying Xinlay in a late-stage trial of approximately 1,000 men with cancer that has not yet spread.

Abbott said this ongoing trial will not be affected by the FDA's decision.



TURF Analysis

Remicade significantly improves psoriasis symptoms, according to recent study Treatment with Centocor Inc.'s rheumatoid arthritis drug, Remicade (infliximab), can "quickly and significantly improve psoriasis symptoms," according to recent findings from the EXPRESS trial published in the Oct. 15 issue of The Lancet.

The double-blind, placebo-controlled study included 378 patients with moderate to severe psoriasis. Patients were allocated to receive Remicade 5 mg/kg of body weight or placebo to determine the efficacy and safety of Remicade.

The results showed that Remicade was effective in both induction and maintenance regimens; during one year of treatment, a high percentage of patients achieved at least a 75-percent or 90-percent sustained improvement in psoriasis symptoms, as measured with the Psoriasis Area and Severity Index (PASI 75 and PASI 90, respectively).

At week 10, 80 percent of Remicade-treated patients achieved PASI 75 compared with 3 percent of patients in the placebo group. Additionally, 57 percent of the Remicade-treated patients achieved PASI 90 compared with 1 percent of the placebo group.

At week 50, 61 percent of the active treatment group achieved PASI 75 and 45 percent achieved PASI 90.

"These results indicate that [Remicade] is a very effective therapy among the newer biological treatments for psoriasis," said Christopher Griffiths, lead investigator of the study. "As a dermatologist, I am very encouraged by the data, which show that patients with moderate to severe psoriasis can rapidly achieve skin clearance and that these results can be maintained."

Griffiths also confirmed that physicians' assessments of patient improvement supported the study findings, "with 83 percent of those receiving the drug assessed as having minimal or cleared symptoms by week 10 of the trial as opposed to just 4 percent of those receiving the placebo."

TURF Analysis

Lilly's Zyprexa may improve schizophrenia symptoms better than Pfizer's Geodon, new data suggest Treatment with Eli Lilly and Co.'s Zyprexa (olanzapine) appears to improve psychopathology associated with schizophrenia better than Pfizer Inc.'s Geodon (ziprasidone hydrochloride), according to a recent study published in the October issue of The American Journal of Psychiatry.

The double-blind, parallel-group trial evaluated 548 patients with schizophrenia. Participants were randomized to receive 10 mg/day to 20 mg/d of Zyprexa or 80mg/d to 160 mg/d of Geodon for 28 weeks. The primary efficacy measure was the Positive and Negative Syndrome Scale (PNSS) total score.

Patients treated with Zyprexa showed significantly more improvement than patients treated with Geodon when assessed with the PNSS (total score) as well as with all subscales, and with the Clinical Global Impression ratings for severity of illness and improvement.

Additionally, significantly more patients treated with Zyprexa completed the study (165 of 277) than did patients treated with Geodon (115 of 271). The Zyprexa group also had a higher responder rate.

However, researchers observed more weight gain with Zyprexa as compared with Geodon. Moreover, Geodon-treated patients had significantly superior fasting lipid profiles as compared with Zyprexa-treated patients, although there was no significant difference in fasting glucose level between the groups.

TURF Analysis

Educational intervention increases prescribing of appropriate hypertension therapy, study finds Physicians may be more likely to utilize ACE inhibitors and angiotensin receptor blockers after receiving materials highlighting hypertension management guidelines from the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC-VII), according to a new study.

Researchers mailed educational information on JNC-VII guidelines to 21,105 primary care physicians in a managed care organization with members in Arizona, California, Colorado, Oklahoma, Oregon, Nevada, Washington and Texas.

The researchers analyzed pharmacy claims from the six-month pre-intervention period and the six-month post-intervention period and found that, after the educational intervention, utilization rates for ACE inhibitors and ARBs increased by 45.6 percent and 47.6 percent, respectively.

In the six-month period after the intervention, utilization of both drug classes increased approximately 1.5-fold, the researchers noted.

Researchers also identified a subset of 2,621 PCPs who had at least 10 patients with diabetes who were not taking ACE inhibitors or ARBs.

Approximately 80 percent of these PCPs were randomized to receive additional educational information, including treatment recommendations by the American Diabetes Association. The other 20 percent of these PCPs did not receive the additional information and served as the control group.

In this subset of PCPs, 17.5 percent of those who received the additional diabetes-specific information began therapy with ACE inhibitors or ARBs compared with 16.2 percent in the control group, a statistically significant difference.

"A large number of patients with diabetes remain untreated with ACE inhibitor or ARB therapy, and continued clinical interventions in this area are needed to further optimize the use of ACE inhibitor or ARB therapy among this population," the researchers concluded.

This study appeared as a poster at the Academy of Managed Care Pharmacy's 2005 Educational Conference in Nashville, Tenn.

TURF Analysis

Boston Scientific reports third-quarter loss Boston Scientific Corp. reported a net loss for the third quarter, due in part to legal fees related to the settlement agreement with Israeli stent maker Medinol Ltd.

The company posted a net loss of $269 million, or $0.33 per diluted share, compared with net income of $258 million, or $0.30 per diluted share, in the same quarter of last year. Boston Scientific's income for the quarter, excluding special charges, was $347 million, or $0.42 per diluted share, compared with $404 million, or $0.47 per diluted share, a year ago.

Net sales for the third quarter were $1.51 billion compared with $1.48 billion for the third quarter of 2004, a 2 percent increase.

During the third quarter, the company recorded special charges of $616 million, net of tax. The quarter's after-tax special charges are comprised primarily of the $598 million related to the settlement agreement with Medinol.

Last month, Boston Scientific agreed to pay Medinol $750 million to settle a lingering legal dispute. This is the largest payment Boston Scientific has ever made in a legal dispute with another company, according to The Wall Street Journal.

For the fourth quarter, the company expects worldwide sales to be between $1.55 billion and $1.59 billion and earnings per share, excluding net special charges, to be between $0.40 and $0.44.

The company anticipates full-year worldwide sales to be between $6.29 billion and $6.33 billion and earnings per share for 2005, excluding net special charges, to be between $1.81 and $1.85.

Boston Scientific shares closed at $23.86, down $0.44, or 1.8 percent, in heavy trading on the New York Stock Exchange.

TURF Analysis

UnitedHealth reports record growth in Q3 UnitedHealth Group Inc.'s third-quarter net earnings increased 21 percent compared with last year's third-quarter earnings on "strong and diverse growth," according to chief executive officer Dr. William McGuire.

The company earned $842 million, or $0.64 per diluted share, in the current quarter compared with $698 million, or $0.52 per diluted share, in the third quarter of 2004.

Analysts had expected the company to earn $0.63 per share, according to Reuters Estimates.

Revenue in the third quarter increased from $9.86 billion in 2004 to $11.32 billion in 2005, an increase of 15 percent.

"We now expect full-year earnings of $2.48 per share in 2005, a 26-percent advance, and foresee further earnings per share growth in 2006 of 15 percent or more, prior to considering any per share contributions from the launch of our new prescription drug plans for seniors or the pending PacifiCare merger," the company said.

In July, UnitedHealth signed a definitive agreement to acquire PacifiCare Health Systems Inc. for approximately $8.1 billion in cash and stock.

UnitedHealth shares closed at $56.43, up $2.23, or 4.1 percent, in moderate trading on the New York Stock Exchange.

TURF Analysis

TURF Analysis
GE Healthcare GE Healthcare and ThermoGenesis Corp. entered into a global distribution agreement and research and development partnership. Under terms of the agreement, GE Healthcare will receive exclusive global distribution rights for the AXP AutoXpress Platform, "a closed and automated system for harvesting mononuclear cells from cord blood," and the BioArchive System, "a computer-controlled cryopreservation and storage system for cord blood," in North America, Europe, Africa and the Middle East and Gulf regions. The companies plan to jointly present the AXP System at the AABB Annual Meeting in Seattle in October. The AXP System will be available commercially in the first quarter of 2006.

TURF Analysis

TURF Analysis
Fresenius AG Fresenius AG agreed to acquire Helios Kliniken GmbH, a private clinic operator, for approximately $1.93 billion, which includes $120.9 million for the net cash position. Fresenius will acquire 94 percent of Helios shares and current Helios management will continue to hold the remaining 6 percent. The agreement will expand Fresenius' hospital-management arm, adding a third major business to the German health care group's renal products and renal clinics operations. The acquisition will make Fresenius one of the largest hospital companies, according to The Wall Street Journal.

TURF Analysis

TURF Analysis
Speedel Pharmaceuticals Inc. Speedel Pharmaceuticals Inc. began a Phase I study of SPP635, one of its renin inhibitors intended to treat hypertension. The safety and tolerability trial will test single and multiple oral doses of the drug in healthy volunteers and is expected to be complete in the second half of 2006. Speedel's SPP100 renin inhibitor is currently in Phase III trials with the company's development partner, Novartis AG. Speedel anticipates that Novartis will file a New Drug Application for SPP100 as a treatment for hypertension in the beginning of 2006.

TURF Analysis

TURF Analysis
Point Therapeutics Inc. Point Therapeutics Inc. initiated its Phase III program for talabostat in the treatment of metastatic non-small cell lung cancer. The program will evaluate talabostat in patients with stage IIIB/IV NSCLC after a platinum-based chemotherapy has failed. The program will involve two double-blind, randomized, placebo-controlled trials enrolling up to 800 patients. The first trial will evaluate talabostat in combination with sanofi-aventis Group's Taxotere (docetaxel), and the second trial will evaluate talabostat in combination with Eli Lilly and Co.'s Alimta (pemetrexed). Progression-free survival will be the primary endpoint.

 

TURF Analysis

 

  



       

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