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Panacos' PA-457 significantly reduces HIV viral load in Phase IIa study; shares rise

Shares of Panacos Pharmaceuticals Inc. jumped 46.1 percent after preliminary Phase IIa trial results showed the firm's PA-457 drug candidate significantly reduced HIV viral load when compared with placebo and demonstrated no evidence of patient resistance to the drug.

The randomized, double-blind study included 32 patients infected with HIV who were not receiving other antiretroviral therapy. Eight patients received placebo, while 24 patients received 25 mg, 50 mg, 100 mg or 200 mg of PA-457 once daily for 10 days.

Viral load reduction on day 11 constituted the primary endpoint. On day 11, both the 100-mg and 200-mg doses of PA-457 led to statistically significant reductions in viral load (up to -1.7 log 10) when compared with placebo.

Specifically, viral loads showed a median 0.03 log10 increase with placebo, a 0.05 log10 increase with 25 mg of PA-457, a 0.17 log10 decrease with 50 mg of PA-457, a 0.48 log 10 decrease with 100 mg of PA-457 and a 1.03 log10 decrease with 200 mg of PA-457.

"The 1.5 log10 viral load reduction seen in patients at the 200-mg dose with less than 100,000 viral copies/mL [at baseline] may potentially reflect the potency of the drug when used in combination therapy in normal clinical practice," said Graham Allaway, Panacos' chief operating officer.

Further, genetic analyses available for 21 patients showed no development of resistance to the drug.

"We believe that PA-457 is a potential breakthrough drug which could play a role throughout the HIV treatment spectrum, including both naove and treatment-experienced patients, based on once-a-day oral dosing, potent activity observed against [a] drug-resistant virus and a promising safety profile," said Dr. Samuel Ackerman, chief executive officer of Panacos. "We now plan to move forward aggressively to initiate a Phase IIb study of the drug in the first half of 2006."

Panacos said PA-457 is the first in a new class of HIV drugs known as maturation inhibitors and is designed to work against HIV, including resistant strains, in a broad spectrum.

Panacos shares closed at $10.30, up $3.25, in heavy trading on the Nasdaq.

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Endo reports positive results from Phase III trial of Oxymorphone

Endo Pharmaceuticals Inc. released positive results from a Phase III clinical trial of oxymorphone extended-release tablets, a semi-synthetic u-opioid agonist and a potential treatment for patients with moderate to severe chronic low back pain.

In the randomized, double-blind study, researchers compared the safety and efficacy of oxymorphone ER with placebo in 205 opioid-naove patients with moderate to severe chronic low back pain. Endo conducted the trial in response to the Food and Drug Administration's request for additional clinical data to support the company's New Drug Application.

The results demonstrated a statistically significant difference in pain scores between oxymorphone ER and placebo during the trial's 12-week treatment period.

The results of this study will supplement previously submitted data from a Phase III trial, which "the company believes the FDA already has accepted as demonstrating efficacy in the intended patient population."

The FDA issued an approvable letter in October of 2003 for the oxymorphone ER NDA in which it requested that Endo conduct an additional Phase III study to confirm the drug's safety and efficacy.

Endo expects to submit a complete response to the FDA's approvable letter early next year.

Oxymorphone ER's delivery system uses Penwest Pharmaceuticals Co.'s TimeRx time-release technology. Penwest and Endo are partners in the development and commercialization of the drug.

Endo shares closed at $28.55, up $1.19, or 4.4 percent, while Penwest shares closed at $14.19, up $3.00, or 26.8 percent, both in heavy trading on the Nasdaq.

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Progenics reports additional positive data from Phase III trial on MNTX

Progenics Pharmaceuticals Inc. released additional positive results from a Phase III trial of methylnaltrexone (MNTX), its investigational treatment for opioid-induced constipation in patients with advanced medical illness.

In March, the company presented initial results from the randomized, 154-patient study, MNTX 301, which showed both the 0.15 mg/kg of body weight dose and the 0.30 mg/kg dose of MNTX to be statistically significant as compared with placebo regarding the primary efficacy endpoint of laxation within four hours. Specifically, 62 percent and 58 percent of patients who took MNTX 0.15 mg/kg or MNTX 0.30 mg/kg, respectively, achieved laxation within four hours compared with 13 percent of placebo-treated patients. Further, statistically significant results were reported for both doses for the secondary endpoints of laxation within 24 hours and median time to laxation, according to Progenics.

A final analysis released Monday showed significant improvement among the additional secondary endpoints of constipation distress, bowel movement difficulty and consistency, and global impressions of clinical change.

Four hours after receiving treatment, 64 percent of patients who received MNTX 0.15 mg/kg, 63 percent of patients who received MNTX 0.30mg/kg and 34 percent of patients who received placebo had improvement in constipation distress. At 24 hours, the percentages were 64 percent, 57 percent and 29 percent, respectively.

Thirty-eight percent and 35 percent of the MTNX 0.15 mg/kg and 0.30 mg/kg groups, respectively, experienced an improvement in bowel movement consistency after 24 hours compared with 19 percent of placebo-treated patients. An improvement in bowel movement difficulty after 24 hours was experienced by 34 percent, 42 percent and 21 percent of patients treated with MNTX 0.15 mg/kg, MNTX 0.30 mg/kg and placebo, respectively.

As rated by clinicians, improvement in global impression of change after 24 hours was 60 percent, 58 percent and 20 percent in the 0.15 mg/kg group, the 0.30 mg/kg group and the placebo group, respectively; patient ratings for this same scale were 59 percent in both MTNX groups and 22 percent in the placebo group.

No significant changes were observed in terms of opioid withdrawal symptoms or pain levels in any of the treatment groups.

These data were slated for presentation Monday at the International Association for the Study of Pain, 11th World Congress on Pain in Sydney, Australia.

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Paxil associated with higher risk of suicide attempts in adults, new meta-analysis shows

GlaxoSmithKline Plc's Paxil (paroxetine), a selective serotonin reuptake inhibitor (SSRI), appears to be linked to a higher risk of suicide attempts in adults than does placebo, according to a new meta-analysis published online in the journal BMC Medicine.

Four investigators at the University of Oslo, in Norway, evaluated unpublished data from 16 studies during which adults were randomized to Paxil (n=916) or placebo (n=550). In total, the researchers arrived at 190.7 patient-years for Paxil and 73.3 patient-years for placebo. After registering the number of suicides, suicide attempts and ideations and then correcting for the duration of therapy and placebo treatment, the research team conducted their statistical analyses.

No suicides occurred in any of the 16 trials. However, seven patients treated with Paxil attempted suicide as compared with only one patient the placebo groups.

"Although we report a small data set, by taking various priors into account, the data strongly suggest that the use of SSRIs is connected with an increased intensity of suicide attempts per year. The two [previous] meta-analyses and our contribution, taken together, make a strong case for the conclusion, at least with a short time perspective, that adults taking antidepressants have an increased risk of suicide attempts," the investigators concluded.

They added that recent recommendations to limit the use of Paxil in children and adolescents should be extended to include the drug's use by adults.

GSK said in a press release that it disagrees with the researchers' conclusion, adding that "it serves only to cause confusion and unnecessary concern" for patients who are taking an SSRI such as Paxil to treat their depression.

"The subanalysis is misleading, as it focuses on incorrectly selected data, collected 15 years ago, which formed part of the successful regulatory submission in 1989 for use of [Paxil] to treat depression in adults. The subanalysis also fails to acknowledge the current body of data, which is significantly more extensive and which has been recently reviewed by the [European Union] authorities," the firm added.

In June, the Food and Drug Administration issued a public health advisory reiterating that health care professionals need to monitor patients taking antidepressants due to potential suicide risks among these patients.

Specifically, the FDA recommended that adults being treated with antidepressants, especially those being treated for depression, should be "watched closely for worsening of depression and for increased suicidal thinking or behavior."

According to the advisory statement, the FDA is conducting a review of available data to "determine whether there is an increased risk of suicidality (suicidal thinking or behavior) in adults being treated with antidepressant medications." The review is expected to take a year or longer to complete and the results will be made available to the public, the FDA said.

Earlier this year, the European Medicines Agency's Committee for Medicinal Products for Human Use recommended that stronger warnings be included in the labels of SSRIs. GSK pointed out, however, that the committee examined the existing safety and efficacy data for Paxil and "re-affirmed the positive benefit-risk for [Paxil]'s use in the treatment of depression and anxiety disorders in adults."

Additionally, the company said Paxil's label already states that depression is associated with an increased risk of suicidal thoughts, self-harm and suicide and that clinical experience with all antidepressants has shown the risk of suicide may increase in the early stages of recovery.

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No link found between short-term use of Actos for diabetes, higher hospitalization for congestive heart failure, evidence finds

Short-term use of Takeda Pharmaceuticals North America Inc. and Eli Lilly and Co.'s thiazolidinedione, Actos (pioglitazone hydrochloride), may not lead to an increased risk of hospitalization for congestive heart failure among patients with diabetes, according to new research.

Investigators evaluated patients from the Kaiser Permanente Medical Care Program who initiated therapy for type 2 diabetes between October 1999 and November 2001. All patients were free of congestive heart failure at the beginning of the study. Patients who initiated sulphonylureas (25.3 percent) served as the reference group.

Slightly more than 50 percent of patients initiated metformin, 15.2 percent initiated Actos and another 8.6 percent began treatment with insulin; these treatments were initiated alone or as additions to pre-existing or maintained therapies.

During a mean follow-up of 10.2 months, 320 admissions were made for congestive heart failure. Compared with patients initiating sulphonylureas, first-time users of Actos had no significant increase in hospitalizations for congestive heart failure.

However, the incidence of hospitalization for congestive heart failure was more than 50 percent higher among those initiating insulin relative to patients initiating sulphonylureas. New metformin users had a lower incidence of hospitalization than did those in the reference group.

The findings were published in the August issue of the journal Diabetic Medicine.

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J&J's Cypher associated with significantly lower risk of restenosis, target vessel revascularization compared with Boston Scientific's Taxus, meta-analysis shows

Patients treated with Johnson & Johnson's sirolimus-eluting stent, Cypher, have a significantly lower risk of restenosis and target vessel revascularization compared with those treated with Boston Scientific Corp.'s paclitaxel-eluting stent, Taxus, according to findings from a meta-analysis published in the Aug. 17 issue of JAMA.

Using PubMed, the Cochrane Central Register of Controlled Trials, conference proceedings and other online sources of clinical trial information, investigators identified six randomized trials involving 3,669 patients that compared Cypher to Taxus in patients with coronary artery disease (CAD).

The primary outcome of interest to researchers was target lesion revascularization; secondary outcomes included stent thrombosis, myocardial infarction, death and the composite of death or MI. Researchers also identified binary restenosis as the angiographic outcome of interest.

Results indicated that target lesion revascularization was performed less often in patients who received a Cypher stent compared with those who received a Taxus stent (5.1 percent vs. 7.8 percent). Also, angiographic restenosis was less frequently observed in those treated with Cypher than with Taxus (9.3 percent vs. 13.1 percent).

In addition, researchers said event rates for Cypher compared with Taxus were 0.9 percent and 1.1 percent, respectively, for stent thrombosis; 1.4 percent and 1.6 percent, respectively, for death; and 4.9 percent and 5.8 percent, respectively, for the composite of death or MI.

"[T]he results of our meta-analysis show that in patients with CAD presenting with various clinical and angiographic risk profiles, [Cypher] stents are better than [Taxus] stents in reducing the risk of restenosis," the study authors concluded. "Although the risk of death and MI was not significantly different between these two drug-eluting stents, our finding needs to be confirmed by longer follow-up studies."

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Alpharma Inc.

Alpharma Inc.'s shares rose 24.5 percent after the company said it is still "actively considering various strategic alternatives to maximize shareholder value." The generic drug company said it has not entered into any material definitive agreements and did not disclose any additional information, noting that its policy is to "not comment on potential transactions." Alpharma shares closed at $24.92, up $4.91, in heavy trading on the New York Stock Exchange.

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Salix Pharmaceuticals Ltd.

Salix Pharmaceuticals Ltd. and Altana Pharma U.S. agreed to terminate their co-promotion agreement for Xifaxan (rifaximin) 200 mg tablets, a treatment for travelers' diarrhea, ahead of schedule. Salix said the decision to end the agreement, which began in March, was made so that Altana can focus on respiratory therapeutics. The companies are working together "to ensure that physicians writing Xifaxan have an appropriate level of support" during the transition out of the current arrangement. Salix reaffirmed its guidance for 2005, anticipating revenue of $150 million to $155 million and earnings of at least $0.60 per share, noting that these projections do not include any potential effects from the company's proposed acquisition of InKine Pharmaceutical Co. Inc. later this year. Xifaxan is licensed from Alfa Wassermann SpA.

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HaptoGuard Inc.

HaptoGuard Inc. filed an Investigational New Drug application with the Food and Drug Administration for BXT-51072, an oral organoselenium compound that "exhibits potent anti-inflammatory features by mimicking glutathione peroxidase," according to the company. As Oxis International Inc. has already conducted Phase I studies for the compound under an IND for a gastrointestinal indication, HaptoGuard hopes to proceed immediately into Phase II clinical trials for its proposed cardiovascular indications. HaptoGuard said that BXT-51072 may protect against excessive oxidation of lipids, thereby limiting inflammation. Therefore, the company believes the drug may be of benefit to patients with diabetes, whose cardiovascular disease may be caused in part by high levels of circulating oxidized lipids. In 2004, Oxis granted HaptoGuard a worldwide exclusive license for BXT-51072 for cardiovascular indications.

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Third Wave Technologies Inc.

Third Wave Technologies Inc.'s Invader UGT1A1 Molecular Assay received approval from the Food and Drug Administration for use in identifying patients who could be at an increased risk of adverse reactions to Camptosar (irinotecan hydrochloride). Camptosar is a colorectal cancer therapy distributed by Pfizer Inc. under a license from Yakult Honsha Co. Ltd. and Daiichi Pharmaceutical Co. Ltd. The blood test detects and identifies mutations in UGT1A1, a gene that affects how drugs are broken down and cleared from the body. The results will help physicians determine the most appropriate Camptosar dosage for their patients and minimize harmful drug reactions.

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