Healthcare Branding

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Purdue Pharma to lay off nearly 40 percent of work force

Purdue Pharma LP is laying off 825 employees, or approximately 38 percent of its work force, in the wake of an appeals court ruling that allows sales of generic versions of its painkiller OxyContin (oxycodone hydrochloride, controlled-release), The Associated Press reported.

"This is the most painful decision I have had to make in my 20 years at Purdue," said Michael Friedman, Purdue's chief executive officer. "But we are left with no other options, given the drop in revenues that we are projecting."

The firm, which will now have approximately 1,300 employees, said it is laying off 290 of the 720 employees at its Stamford, Conn., headquarters, trimming 300 sales positions nationwide and cutting additional jobs at facilities in New York and New Jersey.

In June, the U.S. Court of Appeals for the Federal Circuit in Washington, D.C., dismissed claims that Endo Pharmaceuticals Holdings Inc.'s oxycodone extended-release tablets, in 10 mg, 20 mg, 40 mg and 80 mg doses, infringed upon certain Purdue patents and permanently enjoined Purdue from enforcing these patents.

Purdue is appealing that ruling by a three-judge panel by asking that all 12 of the federal circuit judges review the case, the AP stated, adding that OxyContin accounted for more than three-quarters of Purdue's revenue.

Purdue, which is developing new pain drugs and will sell its own generic version of OxyContin, said last year that it would dismiss 300 employees after federal regulators opened the door to OxyContin generics, the AP added.

OxyContin and generic versions of 80 mg oxycodone had combined U.S. sales of approximately $2 billion in 2004, Endo said.

Oxycodone tablets are indicated to manage moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time.

Healthcare Branding

J&J infringed on Boston Scientific stent patents, jury says

A U.S. District Court jury in Delaware ruled that Johnson & Johnson's Cypher drug-eluting stent infringes on a Boston Scientific Corp. patent covering technology that allows drug coatings to be placed on stents, Dow Jones Newswires reported.

In addition, the jury found that J&J's Cypher, Bx Velocity, Bx Sonic and Genesis stents infringe on one of Boston Scientific's design patents.

Paul LaViolette, Boston Scientific's chief operating officer, said the ruling "confirms our belief that we have fundamental intellectual property covering drug-eluting stent technology and stent design."

Cordis Corp., a J&J subsidiary, said it will ask a judge to overturn the jury's decision. If unsuccessful, the firm said it will appeal to the Court of Appeals for the Federal Circuit in Washington, D.C.

In June, a U.S. District Court jury in Delaware ruled that Boston Scientific's Taxus Express and Liberte drug-eluting stents infringed on stent patents held by J&J, The Wall Street Journal reported.

Based on two successful stent-patent trials, J&J will seek more than $1 billion from Boston Scientific in a damages trial that is expected to start in August, Dow Jones Newswires said.

However, analyst Mike Weinstein of JPMorgan Chase & Co. said the latest ruling was "a huge victory" that "significantly enhances [Boston Scientific's] negotiating position versus J&J." Weinstein added that the ruling "may have just saved [Boston Scientific] $750 million to $1 billion--put another way, $0.90 to $1.20 a share."

Boston Scientific shares closed at $28.60, up $1.71, or 6.4 percent, in heavy trading on the New York Stock Exchange.

Healthcare Branding

Ligand's Targretin improves survival in select group of NSCLC patients, subgroup analysis shows

Ligand Pharmaceuticals Inc. said its Targretin (bexarotene) therapy for the treatment of non-small cell lung cancer improved overall survival in patients who show high sensitivity to the drug. The findings were presented at the 11th annual World Conference on Lung Cancer in Barcelona, Spain.

As had been reported at the American Society of Clinical Oncology meeting in Orlando, Fla., the intent-to-treat analysis of both SPIRIT I (Targretin plus cisplatin/vinorelbine tartrate vs. cisplatin/vinorelbine alone) and SPIRIT II (Targretin plus carboplatin/paclitaxel vs. carboplatin/paclitaxel alone) trials demonstrated that the addition of Targretin capsules did not improve overall survival or progression free survival in NSCLC patients.

However, further subset analysis of the two Phase III trials showed that a large proportion of patients developed high-grade hypertriglyceridemia within three weeks of initiating treatment. These patients were considered to have a high sensitivity to Targretin. In the SPIRIT I trial, 32 percent of Targretin-treated patients fit this parameter, while in the SPIRIT II trial, 40 percent showed a high sensitivity to the drug.

Patients in this subgroup had significantly higher overall survival (12.4 months for high sensitivity patients compared with 9.2 months for control patients in SPIRIT II and 12.3 months compared with 9.9 months in SPIRIT I). Of the 595 Targretin-treated patients in both studies, 215 patients in the high sensitivity group (36 percent) had an overall survival of 12.3 months versus 9.5 months in the control groups.

"The extensive analysis of the SPIRIT I and SPIRIT II data, including the subanalysis of survival in a biomarker-selected population of Targretin-treated patients conducted prior to and during ASCO 2005 and ongoing at the 11th World Conference on Lung Cancer in Barcelona, has further clarified the concept of the remaining potential of Targretin to benefit an important segment (30 percent to 40 percent) of first-line NSCLC patients," said Dr. Andres Negro-Vilar, Ligand's chief scientific officer.

Targretin, a selective retinoid X receptor modulator, was approved by the Food and Drug Administration in December 1999 for the treatment of cutaneous manifestations of cutaneous t-cell lymphoma in patients who are refractory to at least one prior systemic therapy. It was granted European Commission marketing authorization in March 2001.

Healthcare Branding

Atacand reduces risk of diabetes in heart failure patients, study finds

Treatment with AstraZeneca Plc's Atacand (candesartan cilexetil) may reduce the risk of developing diabetes mellitus in heart failure patients, according to a study published in the July 5 issue of the journal Circulation.

In the randomized, double-blind CHARM study of 5,436 patients with heart failure who did not have a diagnosis of diabetes, patients received either Atacand (target of 32 mg once daily) or placebo for two to four years.

In the Atacand group, 163 (6 percent) developed diabetes compared with 202 (7.4 percent) in the placebo group. In addition, the composite endpoint of death or diabetes was observed in 692 (25.2 percent) of Atacand-treated patients and 779 (28.6 percent) of placebo-treated patients.

Although the results were not statistically heterogeneous in the different subgroups studied, the apparent magnitude of benefit appeared to be smaller among patients who also received ACE inhibitors.

The authors noted that Atacand, an angiotensin receptor blocker, has previously been shown to reduce cardiovascular mortality and heart failure hospitalization in heart failure patients.

"These benefits of [Atacand] in preventing multiple adverse outcomes in this high-risk population provide persuasive evidence of the clinical benefits of ARBs in patients with heart failure," the authors concluded.

Healthcare Branding

Lilly's Alimta confers survival advantage in patients with MPM, updated results show

Patients with malignant pleural mesothelioma (MPM) who are treated with a combination of Eli Lilly and Co.'s Alimta (pemetrexed) and cisplatin live longer than previously reported, according to data presented at the 11th annual World Conference on Lung Cancer in Barcelona, Spain.

The data are from updated trial results of a randomized Phase III trial of 448 patients with MPM, a cancer of the lining of the lungs often associated with asbestos exposure. The investigators found that patients in the combination group had a median survival of 12.8 months after diagnosis, which was 3.8 months (42 percent) longer than patients who received cisplatin alone.

For patients treated with Alimta and cisplatin, 33 percent survived 18 months compared with 23 percent treated with cisplatin alone. In addition, 22 percent of the combination therapy-treated patients survived 24 months compared with 17 percent of patients who received single-agent cisplatin.

Lilly said the drug is the only approved therapy to show a statistically significant survival advantage in patients with MPM. It is also approved in the United States and the European Union as a monotherapy for second-line non-small cell lung cancer.

"Before Alimta was available, patients suffering from [MPM] had no hope--rarely living a year after diagnosis," said Dr. Nicholas Vogelzang, director of the Nevada Cancer Institute. "At 18 months, there is still a statistically significant difference in survival, which demonstrates patients are living longer when treated with this Alimta combination."

Healthcare Branding

Upward dose adjustment of Remicade common in one patient group, linked to increase in RA-related costs

In one rheumatoid arthritis cohort, data show upward dose adjustment with Centocor Inc.'s Remicade (infliximab) was frequent, occurred earlier in drug therapy in 2002 than in 2000 and was associated with significant increases in drug costs.

By using the PharMetrics Patient-Centric Database, a group of researchers obtained medical and pharmaceutical claims data from 75 U.S. health plans. They identified all the patients with RA who were newly treated with Remicade between June 2000 and June 2002; 1,236 of these patients received at least three infusions and were included in the analyses.

Patient data were reviewed for the six months prior to the first Remicade infusion (pretreatment period) and for at least six months after the first infusion. Maintenance treatment with Remicade was determined according to the second infusion, so that an upward dose adjustment was considered to be a subsequent increase in vials used or at least two infusions that occurred during an interval of less than 49 days.

Overall, 61.7 percent of patients had at least one upward dose adjustment during the average follow-up of approximately 15 months. Most often, these patients' claims showed an increase in the number of vials. However, more than 25 percent of patients had upward dose adjustments of both types (dose and frequency).

The overall median time to upward adjustment was 254 days; time to adjustment, however, declined steadily from 330 days among patients who initiated Remicade treatment in 2000 to 224 days in 2002.

Based on the Cox proportional hazards model, pretreatment use of sanofi-aventis Group's Arava (leflunomide) was associated with a nearly six-fold increase in the likelihood of upward dose adjustment.

However, there was a 40 percent lower likelihood of upward dose adjustment with comorbid Crohn's disease or receipt of Remicade in a community pharmacy.

The researchers also found that the average annualized total RA-related costs were 54 percent higher in the patients who had received an upward dose adjustment ($22,283 vs. $14,425). The nearly two-fold higher cost of Remicade ($16,336 vs. $9,573) accounted for 86 percent of the total cost difference between the two groups.

"While medical chart information was not available for this study, any clinical benefits derived from upward dose adjustment did not appear to translate into cost savings in our study, except for the small but statistically significant lower non-RA-related cost in the upward dose adjustment group," the study authors noted. "[T]herefore, payers and providers should consider the impact of current dosing trends when monitoring the use of biologics for autoimmune diseases."

This study was published in the June issue of The Journal of Managed Care Pharmacy.

Healthcare Branding

Healthcare Branding
AstraZeneca Plc

AstraZeneca Plc will initiate Phase III studies to evaluate the anti-tumor activity of its oncology compound ZD6474 in patients with non-small cell lung cancer. The product, which now carries the brand name Zactima, is a novel once-daily drug that selectively targets key signaling pathways in cancer, including vascular endothelial growth factor receptor and epidermal growth factor receptor, and also inhibits RET kinase. Enrollment in the trials will begin in the next few months, AstraZeneca said.

Healthcare Branding

Healthcare Branding
Barr Laboratories Inc.

Barr Laboratories Inc. said the Food and Drug Administration approved its Abbreviated New Drug Application for 0.1 mg and 0.2 mg desmopressin acetate tablets, a generic version of sanofi-aventis Group's DDAVP tablets. Barr is entitled to 180 days of marketing exclusivity for this product and plans to launch it immediately. Barr said that IMS Health Inc. data indicate that DDAVP tablets had sales of approximately $191 million during the 12 months ended April 2005. Demopressin acetate tablets are indicated as antidiuretic replacement therapy for managing central diabetes insipidus and for managing the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. The drug is also approved to manage primary nocturnal enuresis.

Healthcare Branding

Healthcare Branding
Able Laboratories Inc.

Able Laboratories Inc. is canceling its annual shareholders' meeting, which was to take place July 8. In canceling the meeting for the second time, the company cited the need to focus on the recall of all of its products and the suspension of all manufacturing operations since May. Able said it could "give no assurance as to if or when it will be able to resume manufacturing operations," adding that the recall and suspension of manufacturing "has had, and will continue to have, a material adverse effect on the company's results of operations and financial position." The Food and Drug Administration issued a formal recall of all Able products on May 27, days after the company said it was suspending shipments of all products. Able shares closed at $3.05, down $0.47, or 13.4 percent, in moderate trading on the Nasdaq.

Healthcare Branding

Healthcare Branding
GPC Biotech AG

GPC Biotech AG said a Phase I trial evaluating satraplatin in combination with sanofi-aventis Group's Taxotere (docetaxel) in patients with advanced solid tumors has begun accruing patients. The primary objectives of the open-label trial are "to assess toxicity, determine maximum tolerated doses and recommend Phase II dosage for this combination." The study, which will enroll up to 48 patients, will also assess the objective response in patients with measurable diseases. GPC Biotech said the drug is also in a Phase III registrational trial as a second-line chemotherapy treatment for patients with hormone-refractory prostate cancer.

Healthcare Branding

Healthcare Branding