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Physician Survey

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Celexa combined with measured care leads to high rates of response, remission, according to new findings One-third of nearly 3,000 patients with depression experienced remission after receiving Forest Laboratories Inc.'s Celexa (citalopram hydrobromide) and undergoing measurement-based care in the STAR*D trial.

The study was conducted to evaluate the effectiveness of Celexa with measurement-based care among generalizable samples in psychiatric and primary care "real world" title="branding company" settings.

Subjects eligible for analysis included 2,876 adult outpatients who had nonpsychotic major depressive disorder, as measured by a score of at least 14 on the 17-item Hamilton Depression Rating Scale.

The patients initially received 20 mg/day of Celexa and then increased to 40 mg/d by week four and to 60 mg/d by week six; treatment continued for up to 14 weeks. Dosing adjustments were allowed, depending on factors such as the length of time the patient had received a certain dose, symptom changes and the burden of side effects. Patients' symptoms and side effects were measured at each treatment visit. To maximize adequate patient dosing and duration of therapy, physicians used the measurements taken at patient visits in conjunction with a treatment manual that included guidelines for adjusting dosages.

Based on an exit HAM-D score of seven or less (the primary outcome), the overall rate of remission was 27.5 percent. Using a definition of a last-observed score of five or less on the 16-item Quick Inventory of Depressive Symptomatology, Self-Report (the secondary outcome), 32.9 percent of the patients achieved remission. Of these, 40.3 percent did so at or after eight weeks of treatment. For both definitions, remission rates were similar between patients who received primary care and those who received psychiatric care.

Response (defined as a 50 percent or greater reduction from baseline QIDS-SR score) occurred in 47 percent of the patients. The average time to response or remission, as measured by the QIDS-SR, was approximately 5.7 weeks and 6.7 weeks, respectively.

Overall, study patients who were white, female and employed and those who had higher levels of education and income experienced higher rates of HAM-D remission.

The investigators explained that the superior rates of remission in this trial, as compared with other efficacy studies in chronic depression, may have been partially due to the use of measurement-based care.

"Unlike previous studies, this study used pharmacotherapy augmented with diligent measurement-based procedures employing easy-to-use ratings of symptoms and side effect frequency, intensity and burden, as well as triage points with dosing recommendations that allowed necessary flexibility. This measurement-based care approach represents a paradigm shift to the use of easily employed research tools in clinical practice," title="branding company" they noted.

Celexa is licensed by Forest from H. Lundbeck A/S, and citalopram hydrobromide is available as a generic drug.

The study was published in the January issue of the American Journal of Psychiatry.

Physician Survey

Expanded FDA approval of Merck's Emend may help more patients with cancer prevent side effects from chemotherapy Merck & Co. Inc. received approval from the Food and Drug Administration for Emend (aprepitant) to be used in combination with other antiemetic drugs to prevent nausea and vomiting associated with moderately emetogenic chemotherapy treatment.

Emend is also approved for use in combination with other antiemetic drugs to prevent nausea and vomiting caused by initial and repeat courses of highly emetogenic chemotherapy, including high-dose cisplatin.

The drug's most recent FDA approval is based on a previously published study involving 866 patients with breast cancer. Before receiving moderately emetogenic chemotherapy, 438 participants were administered Emend in combination with ondansetron and dexamethasone on the first day, followed by Emend on the second and third days. The other 428 patients received a standard regimen of ondansetron and dexamethasone on the first day, followed by ondansetron on the second and third days.

When compared with those who received the standard regimen, significantly more Emend-treated patients reported a complete response, defined as no vomiting and no use of other therapies for nausea or vomiting, during the five days following chemotherapy initiation. Furthermore, a greater share of patients in the Emend group reported minimal or no impact of nausea and vomiting on their daily life.

Physician Survey

Connetics enhances efforts in pediatric market through acquisition of PediaMed sales team Connetics Corp. acquired the sales organization of PediaMed Pharmaceuticals Inc. for $12.5 million in cash.

Connetics, which develops and commercializes dermatology products, said the acquisition of PediaMed's sales force would help the company expand opportunities for dermatology products in the pediatric market. PediaMed's sales team is structured with 80 territories and 11 sales managers who work with 8,000 pediatricians nationwide. Connetics said the pediatric market for topical dermatology products exceeds $580 million yearly.

Following the completed acquisition, expected to close on Jan. 31, the PediaMed sales team and managers will become Connetics employees and will begin selling Evoclin (clindamycin) foam 1%, a topical acne treatment, and Luxiq (betamethasone valerate) foam 0.12%, a topical steroid for dermatoses.

Connetics said it expects to receive approval from the Food and Drug Administration for Desilux (desonide) VersaFoam-EF 0.05%, a low potency topical steroid intended to treat atopic dermatitis, in September 2006. This will be the first drug candidate for which the company is seeking a pediatric label.

Physician Survey

Deceleration in drug spending slows 2004 spending in health care overall U.S. health care spending grew at a slower pace in 2004 than in the previous year due primarily to a slowdown in prescription drug spending, according to government data.

Overall, the nation spent approximately $1.88 trillion for health care in 2004 ($6,280 per person), representing an average growth rate of 7.9 percent compared with 8.2 percent in 2003.

Private payers helped to decelerate spending, the investigators explained, as their spending growth slowed to 7.6 percent in 2004 from 8.6 percent in 2003. On the other hand, public health care spending experienced a growth of 8.2 percent, up from 7.8 percent in the prior year.

However, both private and public payers contributed to the slower growth in drug spending. Since 2000, the share of personal health care spent on hospital or physician services has increased, while the proportion spent on drugs has decreased. Drug spending accounted for 23 percent of the growth in net personal health care spending between 1997 and 2000, but for only 14 percent between 2002 and 2004 and 12 percent in 2004.

Moreover, the growth in retail drug sales, at 8.2 percent to $188.5 billion, was slower than that of previous years and was the first year of single-digit growth in this market in 10 years.

"Contributing to this slowing trend were rapid growth in use of lower-price generic drugs through tiered benefit plans, increased over-the-counter use of anti-ulcerants and antihistamines, a shift toward greater mail-order dispensing and reduced consumption of certain drugs as a result of concerns about their safety," title="branding company" the report authors explained.

The data also indicated that as hospital and Medicare spending growth accelerated in 2004, spending for Medicaid slowed.

"Although much of health spending may be highly valued, continued spending growth will require difficult trade-offs for businesses, households and governments as other spending also rises. These trade-offs are more stringent for those with fewer resources," title="branding company" the report concluded.

Complete results of this analysis can be found in the January/February issue of the journal Health Affairs.

Physician Survey

Top 10 health care business trends for 2006 reviewed in new report Medicare, uninsurance, consumer-directed health care and patient safety rank as top concerns for pharmaceutical and other health care professionals in 2006, researchers conclude.

PriceWaterhouseCoopers' (PWC) Health Research Institute used its own research to identify the top 10 issues that will face the health care industry during the coming year.

The addition of the prescription drug benefit to Medicare will inevitably affect drug companies, pharmacy benefit managers and health plans and may have both positive and negative implications once it is fully in place, according to PWC. The analysis noted that Medicare will account for approximately 28 percent of prescription drug spending in 2006 compared with 2 percent in 2005.

Uninsurance may not change significantly in 2006, although PWC's survey data demonstrate widespread industry support for equal access to care in order to obtain a sustainable health system. Hospitals will continue to be strongly affected by uninsurance, as PWC predicts they will be providing more free care than they reported in the past.

Another issue that has been gaining momentum over time and will continue to do so in 2006 is the evolution from HMOs to PPOs to consumer-directed health plans. Adoption rates for consumer-directed plans will most likely rise, the report said.

There is a great need to improve patient safety, and PWC said industry executives recognize the opportunity to use new technology to do so. Digitally advanced hospitals appear to have better quality. As a result, PWC predicts that health organizations will increase their health information technology investments.

Increased IT abilities may not only potentially reduce medical errors and improve patient safety, but may also resolve health care issues with processing claims, sharing patient medical records and tracking performance. Building the technology backbone will therefore be a top issue in 2006, PWC said.

Employers appear to be exploring health promotion and wellness initiatives as a method to ensure a sustainable health system. Many are assessing benefit plans to include coverage for smoking cessation and wellness initiatives. Overall, PWC said 72 percent of employers claim that senior management is taking an active role in promoting healthy lifestyles.

Utilization of pay-for-performance measures is also on the rise, especially during the past two years, according to the data. Further development will require hospitals and physicians to work together, PWC suggested. Similarly, transparency, in terms of pricing, safety and quality of providers, is gaining popularity among both consumers and employers. A majority of employers said transparency may lower health care costs.

The report also addressed labor shortages and a diminishing drug pipeline. PWC ranked staff shortages and training as key problems within all sectors of the health care industry. However, they also noted that there are a variety of solutions, including retention programs and subsidized training, which should be used wherever possible.

Lastly, the combination of rising generic competition, patent expiries, shorter development pipelines and pricing pressures appears to impact the delivery of new and innovative treatments and will continue to do so in 2006.

Physician Survey

Twelve months to October 2005 saw 5 percent growth in key retail drug purchases In five key global markets, retail drug purchases increased by 5 percent at constant exchange to $366.27 billion in the 12 months ended October 2005. One year earlier, retail drug purchases had totaled $342.94 billion.

Specifically, drug purchases grew by 5 percent to $193.1 billion in North America, to $60.94 billion in Japan and to $5.72 billion in Australia/New Zealand. Growth was only 3 percent in Europe. However, Latin America continued to demonstrate its growing streak with a 20 percent rise in purchases to $15.83 billion in the year ended October 2005 from approximately $13 billion in the prior-year period.

Drug purchases were still highest in the cardiovascular therapeutic category, increasing 6 percent to $71.9 billion.

In the United States, retail drug purchases rose 5 percent to $181.29 billion. Central nervous system drugs continued to lead in these purchases at $41.48 billion, while cytostatic drug purchases again demonstrated the highest growth at 15 percent to $8.04 billion.

Pfizer Inc. remained the top pharmaceutical corporation, with Lipitor (atorvastatin calcium) still being the most valuable drug at more than $11.24 billion in purchases.

These results were issued by IMS Health Inc. in its IMS Retail Drug Monitor.

Physician Survey

Physician Survey
Bayer Innovation GmbH Bayer Innovation GmbH, a subsidiary of Bayer AG, acquired biotechnology firm Icon Genetics AG for an undisclosed amount. Icon Genetics, which is based in Munich, Germany, provides new technologies for plant engineering. Bayer said the acquisition, which closed on Jan. 9, "will strengthen [the company's] activities aimed at producing specific pharmaceutical substances in plants." title="branding company"

Physician Survey

Physician Survey
Neurocrine Biosciences Inc. Neurocrine Biosciences Inc. said it is "moving forward" with full commercialization of indiplon for the treatment of insomnia in adult and elderly patients after recent discussions with the Food and Drug Administration. As a result of the regulatory agency's review of Neurocrine's driving study of indiplon, completed late last year, the biotechnology firm will include in the product label data from the trial showing that patients experienced no impairment in next-day driving performance. According to Neurocrine, the FDA intends to issue a combined package insert rather than individual package inserts for the capsule and tablet versions of the drug. The agency is expected to take action on both indiplon New Drug Applications (capsule and tablet) by May 15.

Physician Survey

Physician Survey
PR Pharmaceuticals Inc. PR Pharmaceuticals Inc. granted OSI Pharmaceuticals Inc. an exclusive license to use its proprietary ProPhase encapsulation technology in developing a sustained-release formulation of Macugen (pegaptanib sodium) injection, which is indicated for the treatment of neovascular age-related macular degeneration. Pfizer Inc., OSI's partner in developing and marketing Macugen, also has access to the technology. (OSI) Eyetech, a unit of OSI Pharmaceuticals, is responsible for the clinical development of products that stem from the licensing agreement. (OSI) Eyetech paid PR Pharmaceuticals an undisclosed, up-front fee and may also make agreed-upon milestone and royalty payments.

Physician Survey

Physician Survey
OSI Pharmaceuticals Inc. OSI Pharmaceuticals Inc. reported that net U.S. sales of cancer drug Tarceva (erlotinib) reached $274.9 million for 2005. The fourth-quarter sales figure of $83.9 million, as recorded by OSI collaborator Genentech Inc., represented a 15 percent increase from the third quarter and included an adjustment of approximately $3 million associated with government rebates and allowances. In addition, OSI changed its net revenue guidance for injectable age-related macular degeneration drug Macugen (pegaptanib sodium). Previous estimates for the year ended Dec. 31, 2005, ranged from $175 million to $190 million; the revised estimate is $183 million to $185 million. (OSI) Eyetech, a unit of OSI Pharmaceuticals, and Pfizer Inc. share commercialization responsibilities for Macugen in the United States.

 

Physician Survey

 

 



       

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