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USAN NamesBrand 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 FDA WILL REQUIRE ADDITIONAL CLINICAL STUDY OF HEREDITARY ANGIOEDEMA DRUG, DYAX REVEALSDyax Corp. said Friday that it will be required to conduct an additional clinical trial of its experimental drug for hereditary angioedema, DX-88, prior to receiving Food and Drug Administration approval. Shares of the company dropped nearly 25 percent on the news. Dyax has received fast track and orphan drug designations from the FDA for DX-88, and was hopeful it could gain FDA approval based on data from Phase II studies it has already initiated. The company said Friday, however, that it is involved in discussions with the FDA to plan additional clinical work that will be required to file a Biologics License Application. Dyax added that it has received a positive response from the agency on the clinical data presented to date. Dyax now expects to file a BLA for DX-88 "after 2005." It was expected that Dyax would file for approval of DX-88 in 2005, ahead of the filing for a similar drug being developed by privately held German firm Jerini AG, according to CBS MarketWatch. Jerini's drug is now entering Phase III studies and could be ready for submission to the FDA in early 2006. Jerini's drug has also been granted orphan drug status, but differs enough from Dyax's drug that the two could each receive approval, said Hibernia Southcoast Capital analyst Bennett Weintraub, according to CBS MarketWatch. Hereditary angioedema is a potentially life-threatening condition characterized by episodes of acute swelling and inflammation that can affect the extremities, abdominal tract, genitalia and larynx. Dyax also reported its third-quarter financial results Friday, noting an increase in net loss and a decrease in revenue. Net loss from continuing operations totaled $8.0 million, or $0.25 per share, compared with a loss of $6.0 million, or $0.25 per share, in the same period of last year. Overall revenue fell from $5.9 million to $3.3 million. Dyax shares closed at $6.08, down $1.99, in heavy Nasdaq trading. GILEAD REPORTS THIRD-QUARTER RESULTS, DISCONTINUES CLINICAL DEVELOPMENT OF TWO HIV DRUGS Gilead Sciences Inc. reported its third-quarter net income increased 55 percent in 2004, but Gilead shares dropped 9.4 percent after the firm said it will discontinue development of two HIV drugs involved in clinical trials. Gilead said it recently completed a Phase I/II viral dynamics study of its GS 9005, data from which failed to demonstrate a sufficient antiviral response to the drug. Gilead said these results are consistent with the low oral bioavailability of GS 9005 observed in an earlier Phase I study. Separately, Gilead decided the profile of GS 7340 does not differentiate it from Gilead's current HIV products enough to support its continued development. GS 7340 was also in Phase I/II development. The company, however, said it will continue to focus its research efforts on treatments for HIV as well as for hepatitis C virus and diseases of the lymphatic system. In the third quarter of this year, Gilead's HIV drugs generated $228.1 million in sales, including $139.4 million in the United States. During last year's third quarter, the firm's global HIV drug sales totaled $121.4 million, 88 percent less than this year. U.S. sales in 2004 included $108.5 million in Viread (tenofovir disoproxil fumarate) sales, $18.2 million in sales of Truvada (tenofovir disoproxil fumarate/emtricitabine) and $12.8 million for Emtriva (emtricitabine). Overall product sales totaled $310.7 million, up 60 percent year-over-year, while total revenue reached $326.2 million, reflecting a 63 percent increase. The firm's net income totaled $113.2 million, or $0.25 per diluted share, compared with $73.1 million, or $0.17 per share, in the third quarter of 2003. Analysts polled by Thomson First Call had been expecting earnings of $0.21 per share, according to CBS MarketWatch. Shares of Gilead closed at $33.25, down $3.43, in heavy Nasdaq trading. MCKESSON POSTS MIXED RESULTS FOR FY 2006 SECOND QUARTER Although McKesson Corp. posted a drop in net income for the second fiscal quarter of 2005 and lowered its full fiscal-year guidance, the firm reported revenue growth. During the quarter ended Sept. 30, 2004, the firm's net income dropped 45 percent to $86.1 million, or $0.29 earnings per diluted share, from $156.5 million, or $0.53 per share, one year ago. This beat the average $0.24 earnings per share predicted by analysts polled by Thompson First Call. Overall revenue increased 19 percent from $16.81 billion during the second quarter of fiscal 2004 to $19.93 billion this past quarter. Revenue in McKesson's Pharmaceuticals Solutions division rose 20 percent from one year ago to approximately $18.92 billion. But a previously announced decline in volume-weighted priced increases for U.S. drug products reduced segment operating profit during the quarter, the firm said. John Hammergren, chief executive officer of McKesson, attributed the pharmaceutical division's revenue growth to the first full quarter of their new agreement with the Department of Veterans Affairs, the August implementation by its Caremark customer of the Advance PCS business and growth in Canada. "We can now affirm that the business is larger and more profitable than we anticipated," he commented. With the anniversary dates for the VA and AdvancePCS businesses in the third quarter of fiscal year 2006, Hammergren said, "our pharmaceutical distribution revenue growth rate is expected to return to market growth adjusted for our mix of business." Since August 2003, the company has focused on "securing more predictable compensation from manufacturers." Many agreements have already been signed with pharmaceutical manufacturers, McKesson said, but "the earnings in our Pharmaceutical Solutions segment will likely continue to be highly dependent on the level and timing of price increases through the end of fiscal 2005." The drug wholesaler thus reduced its guidance to a range of $2.00 to $2.20 earnings per share for the full fiscal year from previous earnings guidance of between $2.20 to $2.35 per share. It noted that achievement of the revised guidance is based on the assumption that volume-weighted U.S. pharmaceutical price increases during the third and fourth quarters are comparable to the recent past. Shares of McKesson closed at $24.98, up $2.00, or 8.7 percent, in heavy Wall Street trading. IRIDEX LASER THERAPY FOR WET AMD FAILS IN CLINICAL STUDY Iridex Corp.'s experimental laser treatment for occult neovascular (wet) age-related macular degeneration (AMD) failed to show significant benefit in a trial presented in New Orleans at the annual meeting of the American Academy of Ophthalmology, pushing Iridex shares down nearly 37 percent. The study enrolled 303 patients who were randomly assigned to receive Transpupillary Thermotherapy (TTT) or a sham treatment. TTT-treated subjects had laser energy applied for 60 seconds. One retreatment was permitted three months later at the physician's discretion. Two-year data showed 47 percent of eyes treated with TTT avoided modest or severe vision loss, compared with 43 percent of eyes given the sham treatment. This difference was not statistically significant. Iridex said 18- and 24-month data showed an advantage of approximately four letters in the TTT group, which was also not significant. However, 11 percent of TTT-treated subjects showed improvement (defined as a two-line or greater increase) at one year compared with 3 percent of those in the sham treatment group. This outcome was significant. Safety results showed 5 percent of TTT-treated eyes had severe vision loss during the first month of follow-up, compared with 1 percent of eyes that received sham treatment, a non-significant difference. Study Chairman Dr. Elias Reichel said analyses of these data remain to be conducted. "Specifically, careful inspection of baseline characteristics between groups and a per protocol analysis that evaluates the subset of enrolled patients who met all key eligibility criteria needs to be done." Shares of Iridex closed at $4.50, down $2.64, in heavy trading on the Nasdaq. REBIF REDUCES CONVERSION TO MS, SLOWS LOSS OF BRAIN TISSUE, STUDY SHOWS New data published in the Oct. 23 issue of The Lancet indicates that early treatment with Rebif (interferon beta-1a) effectively reduced conversion to clinically definite multiple sclerosis and slowed progressive loss of brain tissue among patients with isolated syndromes. Rebif is co-marketed by Serono SA and Pfizer Inc. The enrolled patients had a first neurological episode suggestive of multiple sclerosis, abnormalities on a neurological examination and a positive brain MRI scan. They were randomized to receive 22 mcg of Rebif or placebo subcutaneously once each week. Of the treated patients, MRI data for brain volume measurements were available for 131, 111 and 112 patients at baseline, month 12 and month 24, respectively. For patients receiving placebo, 132, 98 and 99 had available measurements at the same time points. A fully automated segmentation technique was used to measure normalized brain parenchymal volume at baseline and percentage brain volume changes. Overall, 31 percent of patients treated with Rebif converted to clinically definite multiple sclerosis as compared with 47 percent of patients who received placebo. A significant treatment effect was detected for month 24 versus baseline percentage brain volume change. Patients receiving placebo showed a mean percentage brain volume change of -0.83 percent, -0.67 percent and -1.68 percent during the first year, second year and the entire study period, respectively. The corresponding changes were -0.62 percent, -0.61 percent and -1.18 percent in the Rebif arm. At all time points, these changes in brain volume were significant in both treatment groups. Moreover, the number of new T2 lesions that formed during the first year showed a weak correlation with percentage brain volume change during the second year. "The weak correlation between new lesion formation and brain volume reduction suggests that, even at the earliest clinical phase of the disease, inflammatory demyelination is not enough to fully account for irreversible tissue loss in multiple sclerosis," the investigators said. TYPE 2 DIABETES PATIENTS ON INSULIN THERAPY APPEAR TO HAVE AN INCREASED RISK OF COLORECTAL CANCER Chronic insulin therapy significantly increases the risk of colorectal cancer among subjects with type 2 diabetes, according to new data published in the October issue of Gastroenterology. The researchers noted that endogenous hyperinsulinemia in the context of type 2 diabetes is potentially associated with an increased risk of colorectal cancer. To further investigate this issue, they conducted a retrospective cohort study among patients with type 2 diabetes -- some who used insulin and others who did not. Patients in both of these categories were followed for the occurrence of colorectal cancer. Among the 3,160 insulin users, the incidence of colorectal cancer was 197 per 100,000 person-years compared with 124 per 100,000 person-years among the 21,758 type 2 diabetes patients who were not receiving insulin. After taking age and sex into account, the researchers found that patients using insulin for at least one year were more than twice as likely to develop colorectal cancer as compared with non-insulin users. The colorectal cancer risk also significantly increased with each incremental year of insulin therapy. "This study provides direct epidemiologic support for the hypothesis that long-term insulin therapy is associated with an increased risk of colorectal cancer among type 2 diabetes mellitus patients," the investigators concluded. They added that these results highlight the need for adherence to existing colorectal screening guidelines in insulin-treated type 2 diabetes patients. The American Gastroenterological Association (AGA) said in a statement that patients should not discontinue insulin therapy as a result of this study, but should ask their physicians about the colorectal cancer screening methods currently available. "If confirmed in additional studies, practicing physicians should consider long-term insulin therapy as a marker of elevated colorectal cancer risk," the AGA added. USAN Names CELGENE CORP. Celgene Corp. received an approvable letter from the Food and Drug Administration regarding the firm's supplemental New Drug Application for Thalomid (thalidomide). The letter stated that sufficient support for accelerated approval may be provided by the results of a completed study comparing thalidomide plus dexamethasone with dexamethasone alone in multiple myeloma patients who have not received prior treatment. Celgene said it believes it could receive accelerated approval of the sNDA in six to nine months. USAN Names ALPHARMA INC. Alpharma Inc. received Food and Drug Administration approval to market gabapentin tablets in 600 mg and 800 mg strengths. The firm also received first-to-file status and is therefore entitled to 180 days of market exclusivity for the products. Alpharma did not comment on its launch plans. Earlier this year, Alpharma launched gabapentin 100 mg, 300 mg and 400 mg capsules, and Ivax Corp. launched gabapentin 100 mg, 300 mg and 400 mg tablets. Gabapentin is the generic equivalent to Pfizer Inc.'s epilepsy treatment Neurontin. USAN Names VISX INC. Visx Inc.'s net income totaled $11.3 million in the third quarter of 2004, up from $4.9 million in the same period of last year. Revenue fell from $39.3 million in last year's third quarter to $38.7 million this year. Shares of the ophthalmic device company fell $2.62, or 13.6 percent, to close at $16.60 in heavy trading on the New York Stock Exchange. USAN Names OMNICELL INC. Omnicell Inc. reported third-quarter net income of $3.3 million, or $0.12 per diluted share, up from $2.3 million, or $0.09 per share, in the same period of last year. Revenue reached $32.7 million compared with $26.4 million in the year-ago period. The company, however, lowered its 2005 earnings outlook to a range of $0.55 to $0.60 per share from previous guidance of $0.75 per share, CBS MarketWatch reported. Omnicell is a provider of patient safety solutions preferred by nurses, according to a press release. Shares closed at $9.55, down $4.36, or 31.3 percent, in heavy Nasdaq trading. USAN Names
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