Healthcare Names

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FDA approves Aczone gel acne treatment

The Food and Drug Administration approved QLT Inc.'s Aczone (dapsone) gel 5% for the topical treatment of mild to moderate acne vulgaris.

The firm said Aczone gel--the only topical formulation of dapsone--achieved a statistically significant reduction in the number of acne lesions and a better success rate on the Global Acne Assessment Score in two randomized, double-blind, vehicle-controlled studies involving 3,000 patients with acne. No significant differences in adverse event rates were observed between the Aczone-treated patients and those in the control group.

QLT said patients will need to be screened to assess their predisposition to hemolytic anemia resulting from a deficiency of the enzyme glucose 6-phosphate dehydrogenase (G6PD); those found to have this disorder will require regular blood tests while being treated with Aczone. The firm said 1.4 percent of the patients in the Aczone clinical trial program had this deficiency, reflecting the rate of incidence in the general North American population. Specific populations, however, such as males of black descent, can have an incidence rate of 10 to 14 percent.

QLT noted that it will conduct a six-month, post-approval Phase IV study involving 50 acne patients with G6PD deficiency. When this study has been completed, the company plans to file an application with the FDA to re-evaluate the product's labeling.

After ending a partnership with Astellas U.S. LLC last week, QLT acquired the worldwide rights to Aczone, which was developed by subsidiary QLT USA Inc. Reuters reported that QLT may consider establishing its own sales force to launch Aczone.

Aczone is also being investigated as a treatment for rosacea.

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FDA revises erectile dysfunction drug labels to include vision loss risk

The Food and Drug Administration approved updated labeling for Lilly ICOS LLC's Cialis (tadalafil), Bayer AG's Levitra (vardenafil hydrochloride) and Pfizer Inc.'s Viagra (sildenafil citrate) due to a small number of post-marketing reports of sudden vision loss related to non-arteritic ischemic optic neuropathy (NAION), a condition where blood flow to the optic nerve is blocked.

The agency advises patients who experience decreased vision or sudden vision loss in one or both eyes to cease taking these erectile dysfunction drugs and immediately contact a physician or health care provider. In addition, patients taking or thinking of taking any of these drugs should tell their health care professionals of any prior severe vision loss, which could be a sign of a previous episode of NAION; such patients are at an increased risk of developing the condition again, the agency said.

"At this time, it is not possible to determine whether these oral medicines for [ED] were the cause of the loss of eyesight or whether the problem is related to other factors such as high blood pressure or diabetes, or to a combination of these problems," the FDA said.

In an alert, the agency said other risk factors for NAION include being more than 50 years of age, having heart disease, having high cholesterol, being a smoker and having certain eye problems.

According to The Wall Street Journal, the FDA said it has received 38 reports of NAION among Viagra users, four reports of the blindness among Cialis users and one case involving a patient who was taking Levitra.

In May, CBS News reported that the FDA was examining reports that certain ED drugs have been linked to blindness. At the time, Daniel Watts, a Pfizer spokesman, said the firm was talking with the agency about revising Viagra's label to reflect such a risk, although he said there was no proof the drug caused the blindness.

Pfizer said in June that a review of post-marketing ocular events found no evidence of an increased risk of blindness among patients taking Viagra, adding that the FDA also found no evidence of a causal relationship between the drug and blindness.

Lilly ICOS updated Cialis' label in May disclosing information about reports of "serious visual impairments," although a spokesman for the firm said there had never been one case of sudden blindness in "exhaustive studies involving 60,000 patients," The Journal reported.

Levitra is manufactured, marketed and distributed by Bayer AG, Schering-Plough Corp. and GlaxoSmithKline Plc.

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Actos linked with anti-inflammatory, potential anti-atherogenic effects among patients with type 2 diabetes, analysis demonstrates

Takeda Pharmaceuticals North America Inc. and Eli Lilly and Co.'s Actos (pioglitazone hydrochloride) may have an effect on inflammatory biomarkers of arteriosclerosis that is independent of blood glucose control, according to new evidence.

In a prospective study of patients with type 2 diabetes who had not previously taken thiazolidinediones and who had hemoglobin (Hb) A1C levels between 6.6 and 9.9 percent, participants were randomized to receive Actos 45 mg/day or sanofi-aventis Group's Amaryl (glimepiride) in a dose of 1 to 6 mg/d, titrated for optimal glycemic control. Of the 192 patients who enrolled, 173 were included in the intent-to-treat population.

At six months, a comparable significant improvement in HbA1C was observed for the Actos (-0.8) and Amaryl (-0.6) groups.

Compared with Amaryl, Actos achieved reductions for a number of metabolic and cardiovascular risk parameters, including fasting glucose, LDL/HDL cholesterol ratio, high-sensitivity C-reactive protein, matrix metalloproteinase-9 and monocyte chemoattractant protein.

Results also demonstrated a significant regression of carotid intima-media thickness for the Actos treatment arm. Changes achieved in the Amaryl arm did not reach statistical significance.

Researchers determined that the observed beneficial effects of Actos on cardiovascular risk markers were independent from overall metabolic improvement and may be the direct effects of peroxisome proliferator-activated receptor gamma activation.

Complete data can be found in the June 21 issue of the Journal of the American College of Cardiology.

They also noted that Actos is currently being evaluated in a separate study of 5,238 patients with type 2 diabetes to establish whether these findings can be translated into substantial clinical outcome improvements.

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Aldara may provide long-term clinical benefit in patients with actinic keratosis, new study shows

Most patients treated with 3M Pharmaceuticals' Aldara (imiquimod) who experienced complete clearance of their actinic keratosis (AK) lesions showed a long-term clinical benefit from the cream approximately one and a half years after treatment, according to Phase III data.

During four Phase III trials, patients were randomized to apply Aldara 5% cream or vehicle cream to AK lesions on their face or balding scalp. Subjects applied the cream either twice a week or three times per week for 16 weeks.

Led by the University of Minnesota's Dr. Peter Lee, a research team decided to study long-term follow-up data from these studies and estimate AK recurrence among those patients whose AK lesions had completely cleared by the eight-week post-treatment visit. A total of 146 patients were evaluated for clinical evidence of AK.

After a 12- to 18-month follow-up period, 75 percent of the patients who applied Aldara three times per week and nearly 60 percent of those who applied Aldara twice each week continued to show complete clearance of AK.

Specifically, 24.7 percent of the patients who applied Aldara three times weekly and 42.6 percent of the patients who applied Aldara semiweekly experienced a recurrence of at least one AK lesion in the treatment area.

Compared with a median of six AK lesions at baseline in the Aldara-treated patients, there was a median of only one AK lesion in the previously treated area among this group at follow-up.

Additionally, the skin quality observed in the active treatment group at the end of the Phase III studies continued to be evident at follow-up.

"This study confirms my belief in Aldara cream and its potential to proactively treat certain types of AK and, more importantly, decrease the possibility for recurrence," Dr. Lee said.

He added that Aldara therapy for both clinical and subclinical AK lesions could decrease the number of treatments and physician visits, as well as the possibility of developing squamous cell carcinoma.

The study results are published in the June issue of the journal Dermatologic Surgery.

Healthcare Names

Several interferon beta drugs similarly effective in relapsing remitting multiple sclerosis, study shows

New data from the Global QUASIMS study, the largest retrospective, observational study in multiple sclerosis, show comparable efficacy between four interferon beta preparations in patients with relapsing MS throughout the world.

The original open-label, observational study began in Germany, Austria and Switzerland, but later expanded to other countries. Investigators studied 7,156 patients with relapsing remitting MS who received uninterrupted, two-year therapy with either 30 mcg of Biogen Idec Inc.'s Avonex (interferon beta-1a) once each week, 250 mcg of Betaferon (interferon beta 1b) every other day or 22 or 44 mcg of Serono Inc. and Pfizer Inc.'s Rebif (interferon beta-1a) three times per week. In the United States, Betaferon is marketed by Berlex Inc. under the brand name Betaseron.

The follow-up group included patients who had received at least one disease-modifying treatment for less than two years and then subsequently received uninterrupted treatment with one of four interferon betas for two years.

Patients were evaluated with the Expanded Disability Status Scale (EDSS), which measures clinical status of patients with MS based on their daily activity/function levels (0=normal neurological exam, 10=death from MS).

After two years of treatment, average EDSS scores changed 0.13 from 2.52 at baseline for Avonex, 0.26 from 2.90 for Betaferon, 0.16 from 2.44 for 22 mcg Rebif and 0.22 from 2.65 for 44 mcg Rebif.

The rates of relapse-free patients after two years were 48 percent with Avonex, 47 percent with Betaferon, 44 percent with 22 mcg Rebif and 39 percent with 44 mcg Rebif.

In the follow-up group, 36.4 percent of those receiving Avonex, 42.1 percent of those receiving Betaferon, 36.9 percent of those who received 22 mcg of Rebif and 33.8 percent of those who received 44 mcg of Rebif were relapse-free at two years.

"These results suggest that higher doses and frequencies of interferon beta may not necessarily be better when you take into account the comparable disease progression as assessed by the [EDSS] and the fact that patients treated with Avonex could have significant advantages in the long term due to this treatment's low incidence of neutralizing antibodies and its once-weekly dosing, which encourages better long-term adherence to therapy," said Volker Limmroth, a neurologist at the University of Essen in Germany and the primary study investigator.

Collection of data is ongoing in the Greece, Portugal, Spain and Argentina settings.

These results from Slovakia, Greece, Brazil and Australia were presented in Vienna at the annual meeting of the European Neurological Society.

Healthcare Names

Drugs companies reformulating cold medicines following pressure from regulatory agencies

Pharmaceutical companies are beginning to reformulate their cold medicines in an attempt to prevent people from extracting pseudoephedrine, an active ingredient found in many over-the-counter cold and allergy medicines, and converting it into methamphetamine, Dow Jones Newswires reported.

Law enforcement agencies and state governments have put pressure on the companies to change their formulations, while more than 12 states have restricted access to over-the-counter drugs such as Pfizer Inc.'s Sudafed (pseudoephedrine hydrochloride) and Sinutab (acetaminophen/pseudoephedrine hydrochloride).

In late April, Kmart Holding Corp., Target Corp., Wal-Mart Stores Inc., CVS Corp., Rite Aid Corp., Walgreen Corp., Longs Drug Stores Corp. and Albertson's Inc. said they would move cold and allergy drugs containing pseudoephedrine behind pharmacists' counters. According to Dow Jones, a report in May from the Office of National Drug Control Policy showed the number of methamphetamine labs dropped 50 percent in Oklahoma and Oregon, two of the first states to implement restricted sales procedures.

But Elizabeth Assey, a spokeswoman for the Consumer Healthcare Products Association, said drug companies are moving cautiously as they work to produce effective substitutes and await legislation that could affect their reformulations. In addition, reformulating therapies that contain a combination of pseudoephedrine and another active ingredient, such as ibuprofen, would require approval by the Food and Drug Administration, a process that could take as long as three to five years.

By January, Pfizer plans to reformulate up to one-half of its products containing pseudoephedrine with phenylephrine. Boehringer Ingelheim GmbH, the largest producer of phenylephrine, said it could sufficiently increase production of the drug to enable the replacement of the entire U.S. supply of pseudoephedrine by 2006.

Johnson & Johnson's McNeil Consumer & Specialty Pharmaceuticals division, Wyeth and Schering-Plough Corp. are also considering reformulations. Leiner Health Products, a supplier of generic cold and allergy drugs, began shipping replacement products to various retail chains in June.

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Able Laboratories Inc.

Able Laboratories Inc. said recent regulatory and financial issues may lead the company to declare bankruptcy. The company will also evaluate strategic alternatives. On Friday, Able received a list of inspectional observations from the Food and Drug Administration related to the company's suspension of manufacturing operations and the FDA's formal recall in May of all Able products. Also on Friday, Able disclosed that Robert Mauro had resigned as the company's president, director and interim chief executive officer. The company added that the ongoing disruption caused by the recall and the suspension of its manufacturing operations "has had, and will continue to have, a material adverse effect" on the company's financial status. Able also said it could not determine if or when manufacturing operations would resume.

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New River Pharmaceuticals Inc.

New River Pharmaceuticals Inc. signed a licensing agreement with the Ernest Gallo Clinic and Research Center and the regents of the University of California to explore a potential new method of using opioid analgesics to treat pain. The method, which has been studied in preclinical tests, uses a combination of methadone and morphine to reduce the risk of opioid tolerance and dependence. New River will pay a licensing fee, along with possible milestone and royalty payments, in exchange for the exclusive license to pursue commercial development of the technology.

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VioQuest Pharmaceuticals Inc.

VioQuest Pharmaceuticals Inc. entered into a merger agreement to acquire Greenwich Therapeutics, a company that owns the licensing rights to cancer agents sodium stibogluconate and triciribine. The agreement states that Greenwich Therapeutics stockholders will receive approximately 47 percent of VioQuest's outstanding common stock on a fully diluted, post-merger basis. VioQuest said half of the stock will be held in escrow, to be released in increments as certain milestones relating to Phase I and Phase II trials are achieved.

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Biophan Technologies Inc.

Biophan Technologies Inc., a developer of biomedical technology, provided additional details regarding its licensing and equity agreements with Boston Scientific Corp. in a Form 8-K/A the company filed with the Securities and Exchange Commission Friday. Boston Scientific will pay Biophan a $750,000 license fee up front, plus yearly license maintenance fees. For licensed technologies specified in the agreement, Boston Scientific will make milestone payments to Biophan upon the release of commercial products derived from the technologies, and Biophan will receive royalties from the sale of such products. In addition, Boston Scientific will receive $5 million in Biophan common stock, priced at a 10 percent premium over the average closing price for the 30-day period preceding the closing of the agreements.

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