Healthcare Naming

Brand Institute is the premier full-service branding agency dedicated to strategic and innovative brand naming and identity solutions. We strive to exceed the expectations of every client by combining leading-edge market research with the highest levels of client service, integrity and brand management

Novartis seeks additional indication for breast cancer drug, Femara

Novartis AG submitted marketing authorization applications in the United States and Europe for the use of Femara (letrozole) in the adjuvant treatment of hormone receptor-positive early breast cancer in postmenopausal women.

The applications are based on data from the Breast International Group (BIG) 1-98 study, a Phase III, double-blind study in which more than 8,000 postmenopausal women with hormone receptor-positive early breast cancer were randomized to receive either tamoxifen for five years, Femara for five years, tamoxifen for two years followed by Femara for three years, or Femara for two years followed by tamoxifen for three years.

At a median follow-up of 26 months, Femara extended disease-free survival by reducing the risk of recurrence at a rate that was 19 percent higher than that of tamoxifen. Moreover, Femara-treated patients had a 27 percent reduction in the risk of distant metastases compared with those receiving tamoxifen. Femara also offered a 14 percent reduction in the risk of death.

In addition, two separate, preplanned subset analyses showed Femara reduced the risk of cancer returning by 29 percent among patients with node-positive breast cancer at the time of diagnosis and by 30 percent in those who had previously received chemotherapy. The risk of distant metastases in node-positive patients and in patients who received adjuvant chemotherapy was lowered by more than 30 percent with Femara compared with tamoxifen, Novartis said.

Femara and tamoxifen were generally well tolerated and had a similar safety profile. Osteoporosis, bone fractures and arthralgia/arthritis were significantly more common among Femara-treated patients.

"BIG 1-98 is the only clinical trial designed to incorporate both a head-to-head comparison of Femara with tamoxifen during the first five years following breast cancer surgery and a sequencing of both agents to determine the most effective approach to minimizing the risk of recurrence," Novartis stated.

Novartis said results from ongoing arms of the study, which are expected to demonstrate whether monotherapy or sequential therapy is more effective, are expected in 2008.

If approved, Femara would be "the only breast cancer treatment available to significantly reduce the risk of recurrence in the adjuvant setting as well as in extended adjuvant treatment following tamoxifen," Novartis said.

Approvals for the extended indication are expected in late 2005 and in 2006, the firm stated, and could increase the drug's annual sales to between $1 billion and $2 billion, up from $386 million last year, according to analysts cited by Reuters.

In June of 2004, Novartis' supplemental New Drug Application for Femara received a priority review designation from the Food and Drug Administration for the extended adjuvant treatment of early breast cancer among postmenopausal women who have completed standard adjuvant tamoxifen therapy.

Femara is indicated for the extended adjuvant treatment of early breast cancer in postmenopausal women who have received five years of adjuvant tamoxifen therapy; the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown, locally advanced or metastatic breast cancer; and the treatment of advanced breast cancer in postmenopausal women with disease progression following anti-estrogen therapy.

Healthcare Naming

Janssen adds safety information to Duragesic label

Janssen Pharmaceutica Products LP added new safety information to the label of its pain patch, Duragesic transdermal system, CII.

The label explains that Duragesic has a high concentration of fentanyl, a strong Schedule II opioid agonist. Fentanyl and other Schedule II opioid substances have the highest potential for abuse and an associated risk of fatal overdose resulting from respiratory depression.

The new information specifies that because serious or life-threatening hypoventilation may occur, Duragesic is contraindicated in patients who are not opioid-tolerant.

The label also advises that patients who are concomitantly using Duragesic and potent CYP3A4 inhibitors be carefully monitored, as an increase in fentanyl plasma concentrations could cause potentially fatal respiratory depression. The drug should also be used with extreme caution in patients with significant chronic obstructive pulmonary disease or cor pulmonale and in patients who have a substantially decreased respiratory reserve, hypoxia (insufficient levels of oxygen reaching the blood or tissues), hypercapnia (an unusually high concentration of carbon dioxide in the blood due to hypoventilation) or pre-existing respiratory depression.

Moreover, the label warns that using damaged or cut Duragesic patches could lead to the absorption of potentially fatal doses of fentanyl.

The patch is manufactured by Alza Corp.

Healthcare Naming

NDA for Preos accepted for FDA review

The Food and Drug Administration has accepted for review NPS Pharmaceuticals Inc.'s New Drug Application for Preos (parathyroid hormone), an injectable treatment for osteoporosis in postmenopausal women.

The NDA was submitted on May 10, and the FDA has determined the information contained therein is sufficient for a substantive review. In addition to manufacturing and preclinical data, the filing is based on results from 13 studies, including Phase I, Phase II and Phase III trials, open-label extension studies and studies of Preos combined with other drugs.

Results from a subgroup analysis of a randomized, Phase III trial with Preos were presented last October at the annual meeting of the American College of Rheumatology. Of the 1,870 postmenopausal women who took at least 75 percent of their prescribed doses (100 mcg of Preos or placebo), Preos provided a 66 percent reduced risk of vertebral fracture overall. There was also a 69 percent reduced risk of fracture with Preos among patients who had previously experienced a fracture.

However, a higher proportion of Preos-treated patients than placebo-treated patients had serum calcium measures exceeding 10.7 mg/dL.

Reuters noted that Bennett Weintraub, an analyst with Hibernia Southcoast Capital Inc., said this finding could indicate that Preos' tolerability may not be as high as that of Eli Lilly and Co.'s Forteo (teriparatide [rDNA origin]) osteoporosis treatment.

Healthcare Naming

Genentech reports higher Q2 earnings, revenue than year-ago period

Spurred by higher sales of the company's cancer drugs, Genentech Inc.'s net income rose 73 percent in the second quarter of 2005 compared with the same period a year ago.

Genentech's net income reached $296.2 million compared with $170.8 million reported in the prior-year period. Earnings per diluted share rose from $0.16 to $0.27.

On a non-GAAP basis, earnings rose from $0.19 to $0.30 per share, higher than the average $0.26 per share estimated by analysts polled by Thomson First Call, Dow Jones Newswires reported.

"We are currently expecting year-over-year non-GAAP earnings per share for 2005 to increase by greater than 35 percent, relative to 2004," said David Ebersman, chief financial officer at Genentech.

Total operating revenue during the second quarter of 2005 rose to $1.53 billion from $1.13 billion in the second quarter ended June 30, 2004, reflecting a 35 percent increase. This included a 39 percent growth in total product sales to $1.27 billion.

In the United States, product sales for the quarter were led by Rituxan (rituximab), a B-cell non-Hodgkin's lymphoma treatment, at $450.3 million. Avastin (bevacizumab), a metastatic colorectal cancer therapy whose sales rose 85 percent to $245.7 million, ranked second. With sales of $70.2 million, Tarceva (erlotinib hydrochloride), a non-small cell lung cancer drug introduced last November, showed a growth rate of 47 percent from the previous quarter.

Dr. Susan Hellmann, president of product development, said the company anticipates filing Herceptin (trastuzumab), currently approved to treat metastatic breast cancer, for an indication in adjuvant breast cancer during the first quarter of 2006. Other filings are being prepared for Avastin, Herceptin and Rituxan.

Genentech distributes Tarceva, but the product is manufactured for OSI Pharmaceuticals Inc. by Schwarz Pharma AG. Tarceva is a registered trademark of OSI Pharmaceuticals.

Genentech shares closed at $83.50, up $0.33, or 0.4 percent, in moderate trading on the Nasdaq.

Healthcare Naming

Omnicare to buy excelleRX for $268.8 million; McKesson to buy D&K Healthcare Resources for approximately $205.6 million

Omnicare Inc., a provider of pharmacy and pharmacy-related services to long-term care facilities, will acquire privately held excelleRX Inc., a pharmaceutical care services firm primarily serving hospice patients, for $268.8 million.

ExcelleRX, which operates three call centers and two mail service pharmacies, serves approximately 400 hospice agencies with approximately 48,000 patients in 46 states and has annual revenue of approximately $130 million, Omnicare said.

"The expertise and talent in hospice pharmacy services that excelleRX brings to Omnicare makes this a highly attractive addition to Omnicare's business," said Joel Gemunder, Omnicare's chief executive officer. "Equally important, we share the same vision that the future direction of pharmacy services will be based on the effective management of drug therapies to produce optimal outcomes cost effectively."

Omnicare expects the acquisition to add "modestly" to its 2005 earnings per share and to a greater extent in 2006. The transaction is expected to close in the third quarter of 2005.

Last week, Omnicare said it would also acquire institutional pharmacy provider NeighborCare Inc. for approximately $1.8 billion.

Omnicare shares closed at $48.36, up $1.00, or 2.1 percent, in heavy trading on the New York Stock Exchange.

In separate news, McKesson Corp., a pharmaceutical distributor and health care services company, signed a definitive agreement to acquire D&K Healthcare Resources Inc., a pharmaceutical distributor, for $14.50 in cash per share. McKesson will also assume D&K's undisclosed outstanding debt.

The share transaction is valued at approximately $205.6 million based on 14.2 million outstanding shares of D&K as of the end of March, Dow Jones Newswires reported.

D&K, which reported sales of $2.54 billion in fiscal year 2004, serves independent and regional pharmacies located primarily in the Midwest and the South, McKesson said.

Upon the closing of the transaction, which is expected to occur in the third calendar quarter of 2005, D&K will become part of McKesson's U.S. pharmaceutical business.

McKesson does not expect the acquisition to have a material impact on its fiscal 2006 financial results. The acquisition is expected to add slightly to the firm's earnings per fully diluted share in fiscal 2007.

McKesson shares closed at $45.21, up $0.66, or 1.5 percent, in moderate trading on the New York Stock Exchange. D&K shares closed at $14.30, up $5.80, or 68.2 percent, in heavy trading on the Nasdaq.

Healthcare Naming

Study evaluates prescribing, dispensing, abuse trends for controlled prescription drugs

Nearly half of physicians surveyed said patients regularly try to pressure them into prescribing a controlled prescription drug, according to a report by The National Center on Addiction and Substance Abuse at Columbia University.

Researchers conducted an "intensive," three-year study of prescription opioids, central nervous system (CNS) depressants, CNS stimulants and steroids. Approximately 2,000 physicians and pharmacists were surveyed to obtain the data included in the report.

Forty-three percent of the physicians in the survey said they do not ask whether their patients have a history of prescription drug abuse, and one-third do not habitually obtain treatment records from previous or other treating physicians before prescribing controlled substances for an extended period of time, the report stated.

Nearly 60 percent of the physicians said that patients are at the root of most drug diversion, with "doctor shopping," patient deception or manipulation of physicians and forged or altered prescriptions seen as the main mechanisms for diversion (96.4 percent, 87.8 percent and 69.4 percent, respectively). Approximately three-quarters of physicians have stopped prescribing a controlled drug to a patient during the last 12 months as a result of addiction concerns.

Regarding medical school training, researchers found that only 19.1 percent of physicians were taught how to identify drug diversion, and only 39.6 percent learned how to spot prescription drug abuse and addiction.

Furthermore, the survey results showed that 28.4 percent of pharmacists do not regularly check a prescribing physician's Drug Enforcement Agency number when dispensing controlled drugs. Sixty-one percent said they do not routinely ask patients if they are taking other controlled substances when dispensing another such drug. Slightly less than half of the pharmacists said they had received training to help prevent drug diversion or identify abuse and addiction since attending pharmacy school.

From 1992 to 2003, the controlled-drug abuse rate among 12- to 17-year-olds and adults rose 212 percent and 81 percent, respectively, the report added. From 1992 to 2002, prescription opioid abuse by 12- to 17-year-olds jumped by 542 percent, more than four times the rate of increase among adults.

Healthcare Naming

Healthcare Naming
AstraZeneca Plc

AstraZeneca Plc entered into a global licensing agreement and research collaboration with Avanir Pharmaceuticals to develop and commercialize reverse cholesterol transport (RCT)-enhancing compounds to treat cardiovascular disease. RCT-enhancing compounds increase the flow of lipids from blood vessel walls through a process referred to as reverse cholesterol transport and may reverse cholesterol buildup inside blood vessels. The companies said that existing therapies have only demonstrated the capacity to prevent disease progression, whereas RCT-enhancing compounds may actually reverse vascular disease. In addition to an up-front payment of $10 million, Avanir is eligible to receive milestone payments of $330 million and royalties. AstraZeneca will pay all product discovery and development costs.

Healthcare Naming

Healthcare Naming
Bayer Pharmaceuticals Corp.

Bayer Pharmaceuticals Corp. and Onyx Pharmaceuticals Inc. have finished the submission of a New Drug Application for sorafenib, also known as BAY 43-9006. Sorafenib is intended to treat patients with advanced renal cell carcinoma (RCC), or kidney cancer. The Food and Drug Administration accepted sorafenib into the Pilot 1 Program for continuous marketing applications. Under the program, which was designed for drugs given fast track status that may provide significant benefit compared with existing therapies, the FDA must review each "reviewable unit" of the submission within six months. The NDA for sorafenib is based on an ongoing Phase III trial.

Healthcare Naming

Healthcare Naming
Mylan Laboratories Inc.

Mylan Laboratories Inc. expects first-quarter fiscal 2006 earnings of $0.14 to $0.16 per diluted share, with adjusted earnings per diluted share of $0.24 to $0.26. These figures include $0.03 per share for a contingent legal liability regarding lorazepam and clorazepate litigation. The company also reaffirmed its fiscal 2006 and 2007 guidance. For 2006, the company expects adjusted earnings per diluted share to be between $0.92 and $1.15 while for 2007, the company expects $1.20 to 1.74 per diluted share.

Healthcare Naming

Healthcare Naming
Esprit Pharma Inc.

Esprit Pharma Inc. acquired the U.S. marketing rights to Sanctura (trospium chloride), a drug used to treat overactive bladder. Esprit, a private specialty pharmaceutical company focused on the urology market, will co-promote Sanctura with Indevus Pharmaceuticals Inc. John Spitznagel, Esprit's chief executive officer, said acquisition of the rights to Sanctura blends well with the company's business model for growth.

Healthcare Naming

Healthcare Naming