Naming your Business - Brand Institute, inc.



			Naming your Business 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 Amgen to buy Abgenix for approximately $2.2 billion Amgen Inc. will acquire Abgenix Inc. for approximately $2.2 billion in cash plus the assumption of debt. Specifically, Abgenix shareholders will receive $22.50 cash for each common share. Abgenix shares closed at $14.65, up $0.46, or 3.2 percent, in moderate trading on the Nasdaq Wednesday. The announcement was made after the stock market closed. The companies have already worked together to co-develop and commercialize panitumumab, a potential first-line adjunct therapy for metastatic colorectal cancer. It is the first epidermal growth factor receptor inhibitor to show a statistically significant improvement in progression-free survival for patients with metastatic colorectal cancer who have failed usual chemotherapy, the companies said. If it proves successful in trials of colorectal cancer and head and neck cancer, Amgen believes the treatment could achieve $2 billion or more in global sales. "We believe this transaction will allow us to advance panitumumab to its full potential for patients and to maximize the value of both Abgenix's growing portfolio of antibody product candidates and our exceptional scientific platform," title="branding company" said Bill Ringo, chief executive officer of Abgenix. The companies plan to begin a Biologics License Application for panitumumab later this week. The acquisition will eliminate a royalty that Amgen was set to pay Abgenix on future sales of denosumab. The product uses Abgenix's XenoMouse antibody technology and is being assessed for its therapeutic potential in bone loss conditions. Amgen will take over Abgenix's manufacturing plant in Fremont, Calif., and anticipates retaining most of Abgenix's manufacturing employees. Amgen will also obtain Abgenix's scientific knowledge and assets. Both firms' boards of directors have unanimously approved the merger, but the transaction is still subject to approvals by Abgenix shareholders and regulatory authorities as well as customary closing conditions. It is expected to close by the end of the first quarter of 2006. Amgen predicted that its adjusted earnings per share will be diluted by between $0.05 and $0.10 in 2006 and 2007, but that the impact to such earnings will be accretive thereafter if panitumumab is commercially successful. Naming your Business Arena's APD356 achieves primary efficacy endpoint in Phase IIb trial; shares rise Shares of Arena Pharmaceuticals Inc. jumped 18.1 percent after the company released positive Phase IIb results for APD356, its investigational treatment for obesity. The double-blind, dose-ranging trial included 469 patients who were obese, with an average weight of 220 lbs and an average body mass index of 36.4 kg/m2 at baseline. Subjects were required to abstain from alcohol use and were randomized to placebo or APD356 at dosages of 10 mg, 15 mg or 20 mg daily. They received no diet or exercise advice during the study. At day 85, there was a statistically significant higher average weight loss in the patients who received APD356 as compared with placebo: patients' weight dropped by an average 0.7 lbs with placebo versus 4 lbs with APD356 10 mg, 5.7 lbs with APD356 15 mg and 7.9 lbs with APD356 20 mg. Echocardiograms taken at baseline and at treatment end showed APD356 had no effect on heart valves or pulmonary artery pressures, Arena said. "This trial demonstrated excellent weight loss, particularly considering there was no diet or exercise component in this trial, and the emerging safety and tolerability profile compares favorably with other weight loss drugs," title="branding company" said Dr. Steven Smith, the principal investigator. APD356, which is designed to selectively stimulate the 5-HT2C serotonin receptor, is expected to enter Phase III trials next year. Jack Lief, chief executive officer of Arena, told Reuters that he anticipates the firm will apply for approval from the Food and Drug Administration in 2009. If approved, he suspects the drug will be launched in 2010. Reuters added that Adam Noah, a Merriman Curhan Ford & Co. analyst, forecasts the drug could achieve $1 billion in sales per year. Arena shares closed at $13.48, up $2.07, in heavy trading on the Nasdaq. Naming your Business Zadaxin fails to meet primary endpoints in Phase III HCV trial; SciClone shares plunge Shares of SciClone Pharmaceuticals Inc. fell 40 percent after the company reported that results of a Phase III hepatitis C trial of Zadaxin (thymalfasin) failed to meet its primary endpoints. The drug was being tested in combination with F. Hoffmann-La Roche Ltd.'s Pegasys (peginterferon alpha-2a) to treat patients with hepatitis C virus who had failed previous interferon-based therapy. The participants received a 48-week course of therapy with either Zadaxin 1.6 mg twice weekly and Pegasys 180 mcg once weekly or placebo and Pegasys. The treatment phase was followed by a 24-week observation period. The results showed that among 269 patients who received treatment with Zadaxin and Pegasys, 10 (4 percent) achieved a sustained viral response. This response rate was not statistically significantly better than that seen with placebo plus Pegasys, which resulted in a sustained viral response in five of 265 patients (2 percent). Additionally, no significant difference in histological improvement was observed between the treatment groups as assessed by liver biopsy at week 72. "While all of us at SciClone are disappointed that this trial did not achieve statistical significance, there are several other important trials ongoing for Zadaxin, including the ongoing triple therapy HCV clinical trial as well as a Phase II malignant melanoma trial, both trials being conducted in Europe," said Dr. Ira Lawrence, chief executive officer of SciClone. In fact, the company reported promising interim results from a large Phase II trial of Zadaxin in combination with dacarbazine chemotherapy with and without low-dose interferon alpha to treat patients with stage IV malignant melanoma. SciClone said the data demonstrated a "distinct" title="branding company" Zadaxin dose-dependent tumor response. SciClone's European partner is Sigma-Tau S.p.A. SciClone shares closed at $2.31, down $1.54, in heavy trading on the Nasdaq. Naming your Business Human Genome Sciences to spin off early-stage product unit Human Genome Sciences Inc. will spin off its CoGenesys division into a separate company, contingent upon CoGenesys' successful completion of funding by May 31, 2006. The spinoff is expected to reduce HGS' operating costs by more than $35 million during the next three years. Originally created as a division of HGS in the first quarter of this year, CoGenesys began with 60 employees and "demonstrated its ability to generate value through the early development of promising HGS assets." title="branding company" As its own firm, CoGenesys will focus on monetization of HGS' intellectual property and proprietary technology assets as well as early development of selected gene-based product opportunities. "We believe that the decision announced today will enable HGS to realize value from certain intellectual property assets and early-stage product opportunities, while maintaining our primary focus on the commercialization of our later-stage products in clinical development," title="branding company" said H. Thomas Watkins, chief executive officer of HGS. HGS will provide CoGenesys with more independence so it can secure funding from sources outside of HGS. Along with a $10 million start-up loan, HGS granted CoGenesys exclusive rights to develop and commercialize biological products based on certain HGS-discovered human genes and a license to use HGS' albumin-fusion technology to develop and commercialize certain albumin-fusion proteins as therapies. In exchange, HGS will be entitled to retain an equity investment in CoGenesys and the right to first refusal before CoGenesys outlicenses certain developed products. HGS will also receive an up-front payment for products licensed to CoGenesys as well as a portion of CoGenesys' revenue from outlicensure or sales of resulting therapeutic and diagnostic products. Furthermore, HGS may require CoGenesys to perform preclinical development work for up to two HGS products each year, but CoGenesys would receive potential milestone payments and reimbursement for certain related expenses. Effective Dec. 31, Steven Mayer will resign from his position at HGS as executive vice president to become the chief executive officer of CoGenesys. HGS currently has several product candidates in Phase I and II development. Naming your Business ActivBiotics, Metaphore Pharmaceuticals to merge Biopharmaceutical firm ActivBiotics Inc. entered into a definitive merger agreement with privately held Metaphore Pharmaceuticals Inc. for an undisclosed amount. The combined company will focus on the infectious disease and inflammation markets. The transaction, which is expected to close by early January, will make Metaphore a wholly owned subsidiary of privately held ActivBiotics. "With our combined financial resources, a recently initiated Phase III antibacterial program for treating peripheral arterial disease and a rich pipeline of earlier stage product opportunities, we believe the combined company is well positioned to assume a leadership role as an emerging pharmaceutical company focused on significant infectious disease and inflammation markets," said Steve Gilman, ActivBiotics' chief executive officer. ActivBiotics' lead product candidate is rifalazil, which is being tested in a pivotal study in patients with intermittent claudication, a manifestation of peripheral arterial disease, the company said. Metaphore's clinical development efforts currently focus on pain, arthritis and inflammatory disorders. The companies said details of the merger agreement will be announced at closing. Naming your Business FDA panel to vote on Merck's Zostavax vaccine; supports RotaTeq data The Vaccines and Related Biological Products Advisory Committee of the Food and Drug Administration will meet Thursday to determine its view on Merck & Co. Inc.'s investigational Zostavax (zoster vaccine live). Merck is proposing that the vaccine be approved as an immunization in adults aged 50 years or older to prevent herpes zoster and postherpetic neuralgia and to reduce acute and chronic zoster-associated pain. Briefing documents from both the regulatory agency and Merck were posted on the agency's Web site on Wednesday. In the 004 study, the FDA found that during the first approximate three years after vaccination, Zostavax reduced the incidence of herpes zoster by 51.3 percent, the incidence of postherpetic neuralgia by 66.5 percent and the burden-of-illness score (composite measure of herpes zoster pain) by 61.1 percent compared with placebo in healthy patients aged 60 years or older. However, there was a trend that the efficacy in all three endpoints decreased during this three-year period. Zostavax induced no statistically significant effects on the rates of mortality, hospitalizations, serious morbidity, use of pain drugs or interference with activities of daily living. "FDA analysis of the data further reveals a consistent trend toward progressive loss of vaccine efficacy in prevention of herpes zoster with increasing age, although the numbers of subjects and cases of herpes zoster occurring at the oldest ages are relatively small," title="branding company" the agency's documents said. Indeed, age appeared "to be an important factor in some study measures of vaccine efficacy," title="branding company" as the incidence of herpes zoster and burden-of-illness score showed a greater reduction in the patients aged 60 to 69 years than in the patients aged 70 years or older. Also, both the regulatory agency and Merck stated that when interpreting the study's safety data, caution should be used as the result of "the passive and inconsistent nature of safety data collection in the Routine Safety Monitoring Cohort for adverse experiences occurring from day 43 post-vaccination through study-end . . . ." title="branding company" Separately, the same FDA committee unanimously voted Wednesday to support Merck's RotaTeq (rotavirus vaccine, oral, pentavalent) as a safe and effective preventive of rotavirus, a leading cause of diarrhea in children. Merck agreed to the panel's request for long-term, post-approval studies that would monitor for cases of intussusception, or bowel obstruction, and other possible side effects. Naming your Business Naming your Business Pfizer Inc. Pfizer Inc. will fund the PRECISION trial, which will be conducted by The Cleveland Clinic as "the first large-scale trial . . . to exclusively study" title="branding company" the safety of ibuprofen, naproxen and Pfizer's Celebrex (celecoxib) in patients who have or are at high risk for heart disease. Approximately 20,000 patients with osteoarthritis or rheumatoid arthritis will be enrolled beginning in 2006 and will be followed for an average of two years for the occurrence of serious cardiovascular events. None of the executive committee members will accept honoraria or other compensation from the makers of any drugs in this class, the clinic said. Naming your Business Naming your Business Guidant Corp. Guidant Corp. informed the Food and Drug Administration of three additional deaths associated with its recently recalled heart devices, The New York Times reported. The number of deaths related to short-circuiting of the devices is now seven, according to The Times. The electrical failures involve different models and are related to Guidant's method of using an insulating material that appears to make it vulnerable to deterioration, the report indicated. The Justice Department is looking into the company's use of the insulating material as well as its handling of safety issues. Naming your Business Naming your Business Depomed Inc. Depomed Inc. and Biovail Corp. reached an agreement to revise the terms of their partnership agreement regarding Glumetza (metformin hydrochloride), an extended-release treatment for type 2 diabetes. Depomed will receive marketing and distribution rights to the 500 mg and 1,000 mg formulations in the United States as well as the New Drug Application that led to the drug's Food and Drug Administration approval in June. Biovail has rights to Glumetza in Canada but has relinquished its option on metformin combination products that use Depomed technology. Naming your Business Naming your Business Pharmaxis Ltd. Pharmaxis Ltd. said the first patients have enrolled in the Phase III trial of its Aridol (mannitol) lung function test. The study is designed to compare Aridol with known methods of diagnosing airway responsiveness in patients who are suspected of having asthma. Pharmaxis noted that people without airway inflammation do not respond to an Aridol challenge test. The company added that the Aridol lung function test may help physicians more accurately determine the severity of a patient's disease and allow prescription of the right amount of medication. Full patient recruitment is expected to take approximately six months. Pharmaxis said it plans to file for marketing approval from the Food and Drug Administration in 2006 after the completion of the trial. Naming your Business


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