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Lilly drug to treat complications of diabetes shows mixed results

Eli Lilly and Co. said its investigational drug, ruboxistaurin mesylate (proposed brand name Arxxant), reduced vision loss in patients with diabetic retinopathy, but did not show statistically significant results in treating sensory symptoms in patients with diabetic peripheral neuropathy.

As a result, Lilly will submit a New Drug Application to the Food and Drug Administration for ruboxistaurin for the treatment of diabetic retinopathy, but will not submit an NDA for the drug as a treatment of diabetic peripheral neuropathy.

In a Phase III trial of 685 patients with diabetic retinopathy, a condition that leads to progressive damage to the small blood vessels of the eye and can result in vision loss and possible blindness, ruboxistaurin met the primary endpoint. The study showed a statistically significant reduction in this endpoint, which was to reduce the occurrence of sustained moderate vision loss in these patients.

Separately, the drug was studied in two Phase III trials of more than 500 patients combined for the treatment of diabetic peripheral neuropathy, a progressive disorder that results in the deterioration of nerve function. Study results showed that ruboxistaurin-treated patients did not demonstrate a statistically significant change in sensory symptom scores, the primary endpoint, as compared with placebo-treated patients.

Lilly said it plans to submit the NDA for ruboxistaurin for the treatment of diabetic retinopathy at the end of 2005 and will continue an ongoing Phase III trial of the drug for the treatment of nerve dysfunction of diabetic peripheral neuropathy; the trial is scheduled to end in 2007. If the drug is approved to treat diabetic retinopathy, it will be the first orally administered drug approved for this indication, Lilly added.

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Herceptin combined with Taxotere improves outcomes compared with Taxotere alone, researchers report

Genentech Inc.'s Herceptin (trastuzumab) combined with sanofi-aventis Group's Taxotere (docetaxel) provides superior overall survival (OS), response rate, response duration (DR), time to progression (TTP) and time to treatment failure (TTF) with little added toxicity, compared with Taxotere alone as first-line treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer, according to data published in the July issue of the Journal of Clinical Oncology.

The open-label, randomized trial, which included a total of 186 patients with HER2-positive metastatic breast cancer, compared six cycles of Taxotere 100 mg/m2 every three weeks (n=94) with the same regimen plus Herceptin 4 mg/kg of body weight loading dose followed by 2 mg/kg weekly (n=92) until disease progression.

In the intent-to-treat analysis, the overall response ratio (ORR) in the combination arm was 61 percent, with six (7 percent) complete responses (CR) and 50 (54 percent) partial responses (PR) compared with an ORR of 34 percent in the Taxotere-alone arm, two (2 percent) CRs and 30 (32 percent) PRs. According to the study authors, the response rate in the combination arm was superior to that of the Taxotere-alone arm in all subgroups analyzed.

Additionally, 27 percent of patients in the combination arm had stable disease compared with 44 percent of patients in the Taxotere-alone arm. Patients in the combination arm had a median OS of 31.2 months compared with 22.7 months for patients in the Taxotere-alone arm. The combination arm was also superior in all other time-to-event analyses, with median DR of 11.7 months versus 5.7 months, median TTP of 11.7 months versus 6.1 months and median TTF of 9.8 months versus 5.3 months for the combination and Taxotere-alone arms, respectively.

A total of 53 patients (57 percent) in the Taxotere-alone arm crossed over to the combination arm, usually at disease progression, the authors noted. Median OS in patients who remained in the Taxotere-alone arm was 16.6 months compared with 30.3 months for patients who crossed over to Herceptin at any point after withdrawal from this trial.

There was a higher incidence of grade 3 (67 percent vs. 55 percent) and grade 4 (34 percent vs. 23 percent) adverse events in the combination arm compared with the Taxotere-alone arm, though most of the imbalances noted were due to a higher incidence of grade 1 and grade 2 toxicities, the authors noted.

"Importantly, the improvement in survival was seen even though approximately 50 percent of patients in the [Taxotere]-alone arm crossed over to receive [Herceptin], which could be expected to dilute any survival benefit conferred by [Herceptin] administered as first-line therapy," the authors wrote.

They also noted that the data from this trial are in line with data from a previous trial that compared paclitaxel plus Herceptin with paclitaxel alone. Together, the results from these trials "provide strong evidence that the combination of [Herceptin] with a taxane is efficacious and well tolerated as first-line therapy for women with HER2-positive [metastatic breast cancer], offering a significant survival benefit as well as a higher rate and longer duration of responses, compared with a taxane alone," the authors concluded.

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Vioxx associated with increased risk of clinically relevant upper GI events among patients with history of colorectal adenomas, data reveal

Compared with placebo, Merck & Co. Inc.'s Vioxx (rofecoxib) is associated with an increased risk of clinically relevant upper gastrointestinal (GI) events among patients with a history of colorectal adenomas, according to study results published in the July issue of Gastroenterology.

Noting that COX-2 inhibitors such as Vioxx were designed as a safer alternative to conventional nonsteroidal anti-inflammatory drugs with respect to GI toxicity, researchers conducted a double-blind trial in order to determine the effect of three years of treatment with Vioxx on the risk of recurrent neoplastic polyps of the colon in patients with a history of colorectal adenomas.

More than 2,500 patients were randomized to 25 mg of Vioxx daily or placebo. At baseline, 16 percent of patients were taking low-dose aspirin (no more than 100 mg/day).

Results showed that the patient-years (PY) rate of perforations, ulcers or bleeds (PUBs) and the PY rate of PUB complications was 0.88 and 0.23 among the Vioxx group and 0.18 and 0.06 among the placebo group, respectively. Furthermore, the PY rate of PUBs for patients who took aspirin at baseline was 1.43 for patients in the Vioxx group and 0 for patients in the placebo group.

There was no statistically significant difference in investigator-reported dyspepsia between the two groups (7.1 percent vs. 7.4 percent).

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Drug purchasing pools offer more savings than Medicare prescription discount plans, other purchasing systems, analysis shows

Drug purchasing pools that negotiate directly with pharmaceutical companies for reduced prices on prescription drugs may offer more savings than Internet pharmacies and Medicare-approved prescription drug discount programs, new data show.

Researchers examined the cost of two equipotent evidence-based drug regimens, one brand name and one generic, that are commonly prescribed to patients with cardiovascular disease.

First, researchers found the prices for the regimens at the Web site, www.drugstore.com. Then, they accessed the Medicare Web site, which allows patients to view their potential prescription costs under the discount card plans.

Researchers selected the least expensive Medicare card plan in a specific zone denoted on the Medicare Web site. This plan was chosen to assess the total annual costs for a non-dual-eligible, unmarried person at or above 150 percent of the poverty level income threshold for 2004.

Researchers also obtained the Denver Veterans Affairs Medical Center (VAMC) acquisition and dispensing costs for the same regimens. The VAMC negotiates drug prices directly with the pharmaceutical companies.

Results indicate that for the brand-name regimen, the annual savings was 10.6 percent with the Medicare prescription discount card program compared with drugstore.com. However, the Denver VAMC could offer the same regimen for 60.5 percent less than drugstore.com and 55.8 percent less than the Medicare discount card plan.

The Medicare prescription discount card program offered 39.9 percent in annual savings compared with drugstore.com for the generic regimen, although, the Denver VAMC could supply the same regimen for 77 percent less than drugstore.com and 61.8 percent less than the Medicare discount card plan.

The study was published as a research letter in the July 27 issue of JAMA.

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United Therapeutics' Q2 2005 profits nearly triple; shares soar

United Therapeutics Corp. shares rose 26.3 percent on news of the company's 2005 second-quarter results, which showed net income for the quarter increased 194 percent, based largely on improved sales of its hypertension drug, Remodulin (treprostinil sodium).

For the second quarter of 2005, net income rose to $12.2 million, or $0.49 per diluted share, up from $4.1 million, or $0.18 per diluted share, in the same period a year ago.

According to The Associated Press, these results surpassed the average estimate of $0.33 per share from analysts polled by Thomson Financial.

Total revenue increased to $30.1 million in the second quarter, up from $18.3 million in the second quarter of 2004. The AP reported that this figure surpassed analysts' estimates of revenue of $25.4 million.

United Therapeutics also released interim results from a 21-patient Phase IV post-marketing study of Remodulin, which was conducted to satisfy a Food and Drug Administration condition for the drug's approval in 2002. In the study, 13 of 14 patients who received Remodulin were able to successfully transition from GlaxoSmithKline Plc's Flolan (epoprostenol sodium), another hypertension drug, and complete the study without the need to begin rescue therapy. Only one of seven patients in the placebo group was able to make this transition. The company said it has submitted the results to the FDA and has asked for permission to end the study.

United Therapeutics shares closed at $68.27, up $14.22, in heavy trading on the Nasdaq.

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Cephalon posts significant 2005 Q2 loss but higher revenue; firm beats earnings expectations

Affected by significant acquisition-related charges, Cephalon Inc. reported a net loss of $249 million, or $4.29 per diluted share, during the second quarter ended June 30, 2005, compared with an $8.4 million loss, or $0.15 per diluted share, in the same period a year ago.

However, excluding expenses and charges, second-quarter income per diluted share was $0.69, up from $0.45 in the previous-year period and $0.11 more than the average forecast of analysts polled by Reuters Estimates.

The firm's revenue grew 19 percent to $286 million. Cephalon's narcolepsy drug, Provigil (modafinil), achieved quarterly sales of $129.9 million, a 26 percent increase from the second quarter of 2004.

The company reiterated its annual sales guidance of $1.2 billion to $1.25 billion and reduced its 2005 guidance for adjusted income per diluted share by $0.10 to $2.70 to $2.85.

For the third quarter of 2005, the company expects to report sales of $310 million to $320 million and adjusted earnings per diluted share of $0.65 to $0.70.

Cephalon shares closed at $$43.84, up $1.04, or 2.4 percent, heavy trading on the Nasdaq.

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Merck & Co. Inc.

Merck & Co. Inc. was sent a warning letter from the Food and Drug Administration stating that the company did not notify health officials about changes in the manufacturing process for Elspar (asparaginase), a biologic drug for the treatment of leukemia. The FDA letter said that Merck prepared production cell culture from an existing production cell culture instead of preparing it from a master cell culture, which requires the submission of a prior approval supplement. In addition, the letter said the company began a re-isolation procedure for selecting cells for use in the production of Elspar, which "amounts to recloning and requires the submission of a prior approval supplement." The agency said Merck's response to an earlier letter was not adequate. In the letter, the FDA said if Merck fails to correct these deviations, it may be subject to "further regulatory action, such as license suspension, license revocation, seizure and/or injunction, without further notice."

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The Pharmaceutical Research and Manufacturers of America

The Pharmaceutical Research and Manufacturers of America (PhRMA) unveiled new "Guiding Principles" on direct-to-consumer advertising. The principles state that drug firms should submit all new DTC television advertisements to the FDA prior to their broadcast; any advertisement that identifies a product by name should clearly state what the drug is approved for and the major risks associated with the drug. Also, DTC advertisements should present a drug's benefits and risks in a balanced and clear fashion that does not distract from the content and supports dialogue between patients and health care professionals. In addition, the principles call on companies to spend "an appropriate amount of time" educating health professionals about new drugs or indications before starting the first DTC advertising campaign. PhRMA said it will establish an "Office of Accountability," which will collect comments from the general public and health care professionals about DTC advertising by firms that adopt the principles; this office will issue periodic public reports about the comments. After the principles are in effect for one year, the office "will select an independent panel to review the reports for that year, track the overall trends as they relate to the principles and make recommendations in accordance with the principles."

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The Centers for Medicare & Medicaid Services

The Centers for Medicare & Medicaid Services proposed a 4.3 percent reduction in Medicare payment rates to physicians for 2006. The reduction is mandated by a statutory formula that takes into account "substantial growth in overall Medicare spending in 2004," the agency said. "The payment reduction shows the need for more effective ways to pay physicians that help them improve quality and avoid unnecessary costs," said Dr. Mark McClellan, CMS administrator. CMS said it expects to pay approximately $56.5 billion to 875,000 physicians and other health care professionals in 2006. Other proposed rule changes include expanding the screening for glaucoma to include Hispanic-Americans aged 65 years or older, providing supplemental payments to federally qualified health centers that contract with Medicare Advantage plans and revising payments for separately billable drugs and biologics dispensed by end-stage renal disease facilities.

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European Medicines Agency

The European Medicines Agency's Committee on Medicinal Products for Human Use (CHMP) said that it does not recommend changing its advice to patients and prescribers regarding the use of nonselective nonsteroidal anti-inflammatory drugs (NSAIDs). In completing its assessment of available data on the thrombotic risk of nonselective NSAIDs, CHMP emphasized that these drugs are widely used, effective medicines for the treatment of arthritis; prescribing should be based on overall safety profiles of these drugs; and patients should take the lowest effective dose for the shortest time possible. The committee said it is reviewing data on the gastrointestinal risks and serious skin reactions for nonselective NSAIDs and expects to share its findings in September of this year.

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