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Incyte shares fall despite data revealing potent antiviral activity of Reverset 200 mg in certain patients with HIV

Even though interim results from a Phase IIb trial showed that Incyte Corp. and Pharmasset Inc.'s Reverset, at a daily dosage of 200 mg, has potent antiviral activity in patients with HIV who are not responding to other treatment regimens, shares of Incyte fell 15.3 percent.

The six-month study included 199 patients with an average baseline viral load of 4.5 log10 who were not responding to their current treatment regimen. The patients were randomized to receive 50 mg, 100 mg or 200 mg of Reverset or placebo each day.

During the first 14 days (stage 1), Reverset was added to the patients' existing regimens. At the end of this period, approximately 30 percent of the patients continued to receive their original regimen plus the study drug. Physicians optimized the background regimen for the remaining approximately 70 percent of the patients, based on the patients' prior treatment history and the results of a viral genotype obtained during screening. At week 16, or the third study stage, all patients who had been receiving placebo were randomized to receive either 100 mg or 200 mg of Reverset; physicians were again able to re-optimize patients' background therapy.

During the first two weeks of the study, those who were not responding to their current treatment and received 200 mg of Reverset as add-on therapy showed a 0.7 log drop in viral load compared with the placebo-treated patients, who demonstrated no change in viral load.

Overall, those receiving the higher dose of Reverset at 16 weeks achieved a 1.2 log drop in viral load compared with a 0.8 log drop observed in the placebo group.

However, according to The Associated Press, Wells Fargo analyst Eun Yang said investors were hoping the difference between Reverset and placebo would be a 0.5 log reduction rather than the observed 0.4 difference in log reduction.

When response was defined as more than a 1 log drop in viral load, the rates of response were 54 percent in the 200 mg Reverset arm and 40 percent in the placebo arm.

Among those whose background regimen was not optimized, there was a 0.6 log drop in viral load at 16 weeks in patients receiving 200 mg of Reverset versus a 0.1 log drop evident in the nonoptimized, placebo-treated patients.

"The 200 mg dose of Reverset demonstrated potent, clinically meaningful antiviral effects in highly treatment-experienced patients, including patients carrying many of the common resistant viruses that we as physicians struggle to combat," said Dr. Calvin Cohen, the investigator who presented the study results at the Third International AIDS Society Conference on HIV Pathogenesis and Treatment in Rio de Janeiro.

"When Reverset was used without other cytidine analogs, 3TC and FTC, it was a very powerful drug against resistant virus," Cohen added.

Incyte noted that the lower doses of Reverset were less effective than the 200 mg dose, with viral load decreases of 0.3 to 0.4 log during the first two weeks and 0.8 to 0.9 log at week 16.

In the AP report, the company said that approximately half of the patients taking the 200 mg dose of Reverset along with Bristol-Myers Squibb Co.'s Videx (didanosine) experienced elevated levels of an enzyme linked with pancreatic disease, prompting Incyte to recommend that Reverset not be taken with Videx. Additionally, of the 151 patients who received Reverset, two taking the 100 mg dose developed pancreatitis. Incyte said factors other than the study drug may have caused the disease in these patients.

The study ended at week 24; however, only data from the first two stages were presented at the conference.

FTC, or Emtriva (emtricitabine), is marketed by Gilead Sciences Inc.; 3TC, or Epivir (lamivudine), is manufactured by GlaxoSmithKline Plc under an agreement with Shire Pharmaceuticals Group Plc.

Incyte shares closed at $7.42, down $1.34, in heavy trading on the Nasdaq.

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Forest receives non-approvable letter for Namenda for mild Alzheimer's disease

Forest Laboratories Inc. received a non-approvable letter for its supplemental New Drug Application seeking to expand the indication of Namenda (memantine hydrochloride) to include mild Alzheimer's disease.

After reviewing the application, which the Food and Drug Administration accepted in November 2004, the agency acknowledged it had previously told Forest that one positive study involving patients with mild to moderate AD would sufficiently support the requested expansion, according to Forest. The company further noted that the FDA said a six-month trial of patients with mild to moderate AD that reached statistical significance at the primary endpoints--the same study that was included in the sNDA--was an acceptable study to meet this requirement.

However, the agency chose not approve Namenda for the new indication because of two other studies of Namenda that were also included in the sNDA.

Although these other two studies showed Namenda to be numerically better than placebo, Forest said they did not reach statistical significance at the primary endpoints.

Forest said it intends to meet with the FDA to further discuss the decision, adding that the non-approvable letter is not expected to affect the company's current guidance of $2.30 per share for the fiscal year ending March 31, 2006.

Namenda was approved by the Food and Drug Administration in October 2003 as a treatment for moderate to severe AD.

Forest markets Namenda in the United States under license from Germany's Merz Pharma GmbH & Co.

Forest shares closed at $39.70, down $0.70, or 1.7 percent, in moderate trading on the New York Stock Exchange.

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Lilly's Zyprexa associated with better QOL, more weight gain than first-generation antipsychotics, new data suggest

Eli Lilly and Co.'s Zyprexa (olanzapine) appears to promote a better of quality of life for patients with schizophrenia than do first-generation antipsychotics (FGAs), according to a study appearing in the July issue of the Journal of Clinical Psychiatry.

Researchers randomized 197 patients aged 18 to 55 years with schizophrenia (diagnosed according to the DSM-IV) to receive Zyprexa (n=104; mean dose, 10.5 mg/day) or one of the following FGAs: haloperidol (n=74; mean dose, 15.8 mg/d), chlorpromazine hydrochloride (n=13; mean dose, 346.2 mg/d) or trifluoperazine hydrochloride (n=1; 15 mg/d).

Zyprexa-treated patients demonstrated greater improvement in negative symptoms and general psychopathology, as measured by the Positive and Negative Syndrome Scale. The Zyprexa group also had fewer incidences of tardive dyskinesia.

As measured by the Medical Outcomes Study 36-item Short-Form Health Survey, Zyprexa was associated with greater improvements in quality of life variables such as physical functioning, physical role limitations and emotional role limitations.

However, patients in the Zyprexa group gained significantly more weight than did patients taking an FGA. At baseline, the mean body mass index was 25.5 kg/m2 for Zyprexa-treated patients and 23.4 kg/m2 for FGA-treated patients. After nine months of treatment, the mean BMI was 28.7 kg/m2 for the Zyprexa group and 25.3 kg/m2 for the FGA group.

Zyprexa was better tolerated than were the FGAs, the researchers said, noting the lower rates of extrapyramidal symptoms observed in the Zyprexa group.

"The significant findings in differential quality-of-life improvements in patients taking [Zyprexa] versus patients taking FGAs were related to the physical components such as physical functioning and physical role limitations," the authors noted.

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ADEPT trial reveals inhibition of structural damage with Humira in patients with psoriatic arthritis

New results from the ADEPT trial suggest that Abbott's Humira (adalimumab) inhibits radiographic disease progression for up to one year in patients with psoriatic arthritis (PsA).

The first part of the trial was a 24-week, double-blind phase that included patients with moderate to severely active PsA (minimum of 3 swollen and 3 tender joints). After stratification based on methotrexate use and degree of psoriasis, the 313 patients were randomized to receive either 40 mg of subcutaneous Humira or placebo every other week.

Those who completed this study were then eligible to enroll in an open-label extension study during which all 285 participants received 40 mg of Humira every other week. After 12 weeks, patients failing to meet pre-specified criteria could receive 40 mg of Humira every week.

Evaluable radiographs were available for 296 patients at week 24 and 262 patients at week 48.

According to American College of Rheumatology criteria and Psoriasis Area and Severity Index scores, patients who received Humira demonstrated significantly better responses at week 24 than did patients who received placebo.

Humira-treated patients also showed significantly less progression in the modified total Sharp score (mTSS; a measure of radiographic progression of joint disease) than did patients who received placebo, as demonstrated by an average change of -0.2 in mTSS by the Humira arm and a mean change of 1.0 in the placebo group.

Approximately three times as many placebo-treated patients showed more than a 0.5 unit increase in mTSS at 24 weeks compared with those in the Humira arm.

Additionally, the inhibition of radiographic progression evident at 24 weeks was maintained at 48 weeks; mTSS changed an average of 1.0 for placebo as compared with 0.1 for Humira.

These findings were presented recently at the summer meeting of the American Academy of Dermatology in Chicago.

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Protopic shows continuous efficacy in atopic dermatitis in new study

In a study of nearly 8,000 pediatric and adult patients, Astellas Pharma Inc.'s Protopic (tacrolimus) provided continuous improvement in atopic dermatitis and no change from the safety profile reported in previous studies.

Of the 7,923 patients evaluated, 95.5 percent had severe or moderate atopic dermatitis at baseline. During the study, the participants applied Protopic 0.03% or 0.1% ointment twice daily on all affected areas.

Throughout the mean 239-day study duration, patients rarely discontinued treatment because of an adverse event (6.1 percent) or a lack of efficacy (4.9 percent).

While the average body surface area affected at baseline was 33.2 percent, the amount of area affected by the condition decreased by 52 percent at month one, by 71 percent at month 12 and by 91 percent at month 18.

The reduction in affected body surface area was generally similar for the two Protopic concentrations but was slightly higher for pediatric patients than for adult patients.

Most of the patients who applied Protopic 0.03% showed at least moderate improvement on the Physician's Global Evaluation of Clinical Response at all evaluation times and were more likely to clear or progress to excellent improvement with continued application of this concentration.

"This large population study did not reveal any safety concerns and no previously unreported adverse events were observed," the study authors commented.

The severity and frequency of common adverse events (flu-like symptoms and headache) were within the range of expected rates in the general U.S. population, and there were no reports of skin atrophy at the application site.

The complete study can be found in the supplemental August issue of the Journal of the American Academy of Dermatology.

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Patients taking Invirase boosted with Norvir show no significant protease inhibitor resistance, study shows

Patients who began treatment with F. Hoffmann-La Roche Ltd.'s Invirase (saquinavir mesylate) in combination with a small dose of Abbott's Norvir (ritonavir) showed no significant protease inhibitor resistance, according to a study presented at the Third International AIDS Society Conference on HIV Pathogenesis and Treatment in Rio de Janeiro.

In the study, 258 antiretroviral (ART)-naive patients received once-daily doses of 1,600 mg Invirase/100 mg Norvir plus two nucleoside reverse transcriptase inhibitors (NRTIs) for six months. At baseline, patients had a CD4 count of 200 to 350 cells/mm3.

Ten of 258 patients (4 percent) experienced viral failure (defined as two consecutive viral loads of more than 500 copies/mL) following a median 29.6 weeks of treatment, according to Roche, and none of the patients acquired major protease inhibitor resistance mutations. At viral failure, seven patients experienced minor protease mutations or natural polymorphisms; in four of the seven cases, the mutations or polymorphisms were observed at baseline.

Data from an earlier study showed that 91 percent of patients who received Invirase boosted with Norvir plus two NRTIs at an early stage achieved undetectable levels of HIV in the blood at 24 weeks.

"These data are important to physicians and patients because resistance to treatment is one of the major challenges in trying to control HIV/AIDS," Roche said.

Invirase, an HIV protease inhibitor, is currently approved to be dosed at 1,000 mg boosted with 100 mg of Norvir twice daily. The drug is available in 200 mg capsules and 500 mg tablets.

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GlaxoSmithKline Plc

GlaxoSmithKline Plc initiated Phase III studies of GSK 873140, or aplaviroc, in patients with HIV who have undergone previous therapy. The agent, a CCR5 inhibitor, is designed to prevent HIV-1 from entering and infecting cells. GSK in-licensed the product from Ono Pharmaceutical Co. Ltd. A Reuters report noted that this class of drugs could have fewer toxic side effects than existing treatments; analysts estimate that a successful CCR5 drug is likely to reach the market by 2007 or 2008 and could generate annual sales of $500 million to $700 million.

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Exelixis Inc.

Exelixis Inc. initiated a Phase I trial of XL820 to evaluate the tolerability, safety and pharmacokinetic profile of the orally administered, small molecule cancer drug candidate. The compound has shown dose-dependent growth inhibition in models of breast carcinoma, gliomas and leukemia, according to Exelixis. The open-label, dose-escalation trial will involve patients with solid tumors who have no other available options for prolonging their survival.

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Tapestry Pharmaceuticals Inc.

Tapestry Pharmaceuticals Inc. is downsizing to "reduce its cash burn" and will focus on developing its lead cancer compound, TPI 287. By cutting 14 positions, or approximately 30 percent of its workforce, and taking other cost-saving steps, the company said it should save approximately $7.4 million through the end of next year. Tapestry will incur a one-time cost of approximately $270,000 in conjunction with the downsizing. Before year-end, the company expects to begin a second Phase I trial for TPI 287, which has shown the ability to inhibit tumor cell growth in preclinical trials.

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Celltrion Inc.

Celltrion Inc., a joint venture between Aphton Corp. and VaxGen Inc., entered into a licensing and commercialization agreement and a product development and manufacturing agreement with Igeneon, a wholly owned subsidiary of Aphton. The agreements pertain to Igeneon's product candidate, IGN311, a humanized, monoclonal antibody being developed to treat certain epithelial tumors. Igeneon will receive milestone payments of $6 million from Celltrion, as well as royalties on product sales in Asia if the product is approved. Celltrion will provide various development and manufacturing services for IGN311 and will produce material to be used in future clinical development of the compound.

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