FDA Approval - Brand Institute, inc.



			FDA Approval 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 MEDTRONIC TO PAY KARLIN TECHNOLOGIES, DR. GARY MICHELSON $1.35 BILLION TO ACQUIRE SPINE-RELATED INTELLECTUAL PROPERTY, SETTLE LITIGATION ------------------------------------------------------------------------------- Medtronic Inc. agreed to purchase spine-related intellectual property from Karlin Technologies Inc. and Dr. Gary Michelson as part of a $1.35 billion transaction. Under the agreement--which settles all outstanding litigation between the parties--Medtronic will gain ownership of more than 100 issued U.S. patents, more than 110 pending U.S. applications and approximately 500 foreign patents, valued at approximately $800 million. According to Medtronic, the patents pertain to novel spinal technology and techniques that are currently being utilized and could be part of future products. Medtronic will also take ownership of all inventions related to the diagnosis and treatment of the spine conceived or acquired by Karlin or Michelson in the 15 years following the agreement's closing. The additional $550 million of the total cost relates to the litigation settlement and includes court-ordered royalties and damages, Reuters said. According to the Associated Press, a federal jury ordered Medtronic to pay $510 million in punitive and compensatory damages to Michelson last fall for breaching patent agreements Michelson made with spinal-implant maker Sofamor Danek a decade prior to that company's 1999 acquisition by Medtronic. Medtronic expects that between $75 million and $175 million of the $800 million fee will be expensed as in-process research and development when the transaction closes, which is forecast to occur by July 30, the end of the company's fiscal 2006 first quarter. The $550 million fee will be recorded as an expense in the fourth quarter of 2005. Additionally, Medtronic will no longer make royalty payments to Karlin and Michelson under existing license agreements. Michelson originally sought $1.7 billion in damages, the AP stated. Medtronic noted that this acquisition could lift earnings over the long term, though not immediately, Reuters reported. -=- TODAY SPONGE FEMALE CONTRACEPTIVE RETURNS TO MARKET AFTER 11-YEAR ABSENCE ------------------------------------------------------------------------------- The Food and Drug Administration re-approved the Today Sponge, a hormone-free, female contraceptive, to be sold over the counter in the U.S. market. The sponge sold more than 250 million units in the United States from 1983 to 1994, before it was withdrawn from the market. Wyeth, then known as American Home Products, previously manufactured the product and said it stopped manufacturing the sponge for economic reasons, not because of safety issues. New Jersey-based Allendale Pharmaceuticals Inc. bought the rights to the sponge in 1998 and has been seeking FDA approval since that time. Allendale said the previous company stopped making the sponge due to complications with the production facilities. Allendale has sold its polyurethane contraceptive in Canada and through the Internet since March of 2003, reporting sales of more than 400,000 units, even without advertising. Having received the green light, Allendale plans to begin shipping the sponge immediately to U.S. residents through its Web site and intends to make the product available in the near future through retail drug stores, supermarkets and mass marketers such as Wal-Mart. Gene Detroyer, Allendale's chief executive officer, said he expects sales of 10 million to 15 million sponges in the first year of the product's return to the U.S. market. Although the sponge has been shown to be less effective at preventing pregnancy than alternative methods requiring a prescription, such as oral contraceptives or intrauterine devices, it does provide another option for those who cannot tolerate or prefer not to use such methods. The FDA-approved packaging information reports that 13 percent to 16 percent of women who use the sponge may become pregnant within a year of typical use. Additionally, research published last year showed the sponge to be less effective in women who have already had at least one child, although the manufacturer claims there is no difference in effectiveness among this group. "As a practitioner, I can tell you that many women are looking forward to the return of the sponge," said Dr. Anne Davis, assistant professor of clinical obstetrics and gynecology at Columbia University. "Women need different contraceptive methods at different points in their lives. Women who have used the Today Sponge describe it as easy to use, convenient and safe. It's important to have a variety of contraceptive options available to all women." The sponge, which uses a reservoir of spermicide to kill sperm and acts as a physical barrier to the cervix, can be used for 24 hours and through multiple acts of intercourse. It does not protect against sexually transmitted diseases. -=- SCHERING-PLOUGH REPORTS Q1 2005 PROFIT HIGHER THAN EXPECTED ------------------------------------------------------------------------------- Schering-Plough Corp. reported higher-than-expected first-quarter profit in 2005, fueled by sales of its antibiotics and cholesterol drugs. The company reported net income of $105 million, or $0.07 per diluted share, for the first quarter of 2005 compared with a loss of $73 million, or $0.05 per diluted share, in the same period a year ago. First-quarter earnings were affected by special charges of $27 million, or approximately $0.02 per share, mainly in employee termination costs. However, excluding special items, the company posted earnings of $0.09 per share, which was more than the $0.02 per share forecast by analysts polled by Reuters Estimates. Schering-Plough credits the higher earnings to increased sales and higher equity income from its cholesterol joint venture with Merck & Co. Inc. Net sales increased 21 percent to $2.4 billion from $1.96 billion in the same period of 2004. The sales figures do not include sales of cholesterol products marketed under Schering-Plough's partnership with Merck, as those products use a separate equity calculation. At least 6 percent of the sales increase was due to U.S. sales of the antibiotics Avelox (moxifloxacin hydrochloride) and Cipro (ciprofloxacin hydrochloride), both of which Schering-Plough markets in an agreement with Bayer AG. Global cholesterol joint venture net sales, including Vytorin (ezetimibe/simvastatin) and Zetia (ezetimibe) cholesterol drugs, totaled approximately $505 million for the first quarter, a jump from net sales of $188 million in the same quarter of 2004. U.S. joint venture sales also increased sharply from $169 million in last year's first quarter to $426 million for the first quarter of 2005. The company said combined sales of the two drugs make up 10 percent of the market share, according to Dow Jones Newswires. Sales of the company's allergy drug Claritin (loratadine) remained flat in the first quarter of 2005 after loss of patent protection last year. "In defining our anticipated turnaround, we think that the beginning of our turnaround phase will be marked by two or three quarters of solid performance, as demonstrated by growth in sales and earnings per share versus prior-year quarters, excluding special items," said Schering-Plough's Chief Executive Officer Fred Hassan. Hassan added that he expects research costs may surge as a result of some investigational drugs entering clinical trials. Schering-Plough shares closed at $20.75, up $0.05, or 0.2 percent, in moderate trading on the New York Stock Exchange. -=- SERONO TAKES $725 MILLION CHARGE, POSTS SIGNIFICANT Q1 LOSS ------------------------------------------------------------------------------- Serono SA reported a first-quarter net loss greater than its projected full-year profit after taking a $725 million charge related to an investigation into U.S. sales of its AIDS drug, Serostim (somatropin recombinant). Specifically, the biotechnology company posted a first-quarter net loss of $567.7 million, or $0.97 per American depository share. Serono said it received a subpoena requesting documents related to Serostim from the U.S. Attorney's office in Boston in 2001. Based on discussions with this office, Serono decided to take a provision that its management felt would likely cover resolution of the investigation. Analysts cited by Reuters "were surprised at the extent of the charge, raising questions as to what it was intended to cover." By greatly reducing the company's $1.3 billion cash reserve, the charge limits the company's ability to purchase drugs for its pipeline, analysts added. Recently, four former Serono sales and marketing executives were indicted by the U.S. Attorney's office in Boston in connection with an alleged conspiracy to offer and pay kickbacks to physicians as an incentive for prescribing Serostim, Reuters reported. Excluding charges, net income fell 11.7 percent to $92.7 million, or $0.16 per American depository share, from $105 million in the first quarter of 2004. Analysts polled by Reuters had predicted a 14 percent increase in net profit to $120.6 million. Total revenue rose 8 percent to $601.4 million from $557.1 million in the previous-year period. Worldwide sales of Serono's multiple sclerosis drug, Rebif (interferon beta-1a), grew 12.8 percent to $292.8 million, compared with $259.6 million in the same period a year ago. After a slow start to the quarter, Rebif sales rebounded after Biogen Idec Inc. and Elan Corp. Plc's Tysabri (natalizumab) was withdrawn from the market, Reuters stated. Nonetheless, analysts polled by Reuters expected Rebif sales of $311.9 million. Serono and Pfizer Inc. co-market Rebif. Psoriasis drug, Raptiva (efalizumab), achieved worldwide sales of $4.5 million, up dramatically from $0.1 million in the fourth quarter of 2004. Serono still expects full-year net profit in the range of $520 million to $540 million, with a 10 percent to 15 percent increase in product sales from $2.2 billion in 2004, Dow Jones Newswires stated. Separately, CancerVax Corp. said in a Securities and Exchange Commission filing that it expected Serono to announce that CancerVax would continue to be entitled to receive up to $230 million in potential milestone payments under their development agreement for Canvaxin, a vaccine that the companies had been developing as a treatment for Stage IV melanoma. Of that sum, $80 million is related to the receipt of U.S. and European marketing authorizations for Canvaxin as a treatment for Stage III melanoma. After announcing the discontinuation of Phase III trials of Canvaxin earlier this month based upon the recommendation of an independent data and safety monitoring board, CancerVax believed, at the time, that it would no longer be entitled to receive the entire $253 million in potential milestone payments under its agreement from Serono. Serono shares closed at $16.53, down $1.23, or 6.9 percent, in heavy trading on the New York Stock Exchange. -=- NEW FDA OVERSIGHT BOARD MAY MEAN MORE ADVISORY COMMITTEE MEETINGS ------------------------------------------------------------------------------- As drug safety issues have sparked the forming of the Food and Drug Administration's Drug Safety Oversight Board, the number of advisory committee meetings may increase in response, according to an FDAAdvisoryCommittee.com report. "Nothing that we're doing here in setting up the board is meant to diminish the role of our advisory committees," said Steven Galson, acting director of the Center for Drug Evaluation and Research at a recent meeting of the FDA's Science Board. In the past few years, the FDA has gradually scheduled fewer advisory committee meetings but began scheduling them more often in 2005 as drug safety issues have emerged. Galson said that committee chairs and members will be involved in the drug safety board activities and will act as consultants. Galson said their duties might include writing position papers and giving presentations to the drug safety panel. Galson added the drug safety board would include members from some CDER offices, the Center for Biologics Evaluation and Research and the Center for Devices and Radiological Health. It will be chaired by the CDER deputy director and will include three voting members, each from the Office of New Drugs and the Office of Drug Safety. -=- PFIZER'S ZITHROMAX, BMS' TEQUIN DO NOT PREVENT CARDIOVASCULAR HEART DISEASE, ACCORDING TO TWO TRIALS ------------------------------------------------------------------------------- Two double-blind studies found Pfizer Inc.'s antibiotic Zithromax (azithromycin) and Bristol-Myers Squibb Co.'s antibiotic Tequin (gatifloxacin) do not work for the secondary prevention of cardiovascular heart disease in patients with coronary artery disease or acute coronary syndrome. In the Azithromycin and Coronary Events Study (ACES), 4,012 patients with stable coronary heart disease were randomized to receive 600 mg of Zithromax or placebo once weekly for one year. The primary endpoint was a composite of the first occurrence of nonfatal myocardial infarction, coronary revascularization, hospitalization for unstable angina or death due to coronary heart disease. The primary endpoint occurred in 22.3 percent of the Zithromax-treated patients and 22.4 percent of the patients who received placebo, representing a 1 percent reduction in the risk of the primary endpoint in the Zithromax arm. With regard to any of the components of the primary endpoint, death from any cause, or stroke, the treatment group showed no significant risk reductions. The results also did not change when the patients were stratified by sex, age, smoking status, diabetes mellitus status or baseline Chlamydia pneumoniae serologic status. Assuming the treatment was adequate, the researchers said these results "suggest that neither C. pneumoniae nor another organism susceptible to [Zithromax] plays an important role in events associated with late-stage coronary heart disease. However, since ACES was not designed to study the role of C. pneumoniae in the pathogenesis of atherosclerosis, the results of the trial do not tell us anything about a possible pathogenic role of C. pneumoniae in the early development or acceleration of atherosclerosis." Meanwhile, the Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction (PROVE IT-TIMI) study enrolled 4,162 patients who had been hospitalized for an acute coronary syndrome during the previous 10 days. The patients received standard treatment for acute coronary syndromes and were randomized to receive either BMS' Pravachol (pravastatin sodium) or Pfizer's Lipitor (atorvastatin calcium). In addition, they received either 400 mg of Tequin or placebo daily for two weeks. This step was followed by a 10-day course of Tequin or placebo every month for a mean duration of two years. The primary endpoint was a composite of the first occurrence of myocardial infarction, documented unstable angina requiring rehospitalization, revascularization (if performed 30 days after randomization), stroke and death from all causes. Based on the Kaplan-Meier analysis, primary endpoint events occurred in 23.7 percent of the Tequin arm and 25.1 percent of the placebo group at two years. Furthermore, no benefit was evident in the secondary endpoints or subgroups, including those patients whose titers were elevated to C. pneumoniae or C-reactive protein. In an accompanying editorial, Dr. Jeffrey Anderson said the hypothesis that infection plays a role in atherosclerosis "does not easily lend itself to proof or disproof according to Koch's classic postulates." He said that another reason for the negative results could be that an advanced, unmodifiable stage of disease was used for study. Additionally, "whereas ACES and PROVE IT-TIMI, together with other studies, appear conclusively to eliminate [Zithromax, Tequin] and related agents as useful preventive therapies for secondary cardiovascular events, they leave open the possibility that novel antibiotics with more potent bactericidal activity against intracellular microbes could lead to a different outcome." While standard antibiotics do not work for secondary prevention of cardiovascular heart disease, Anderson concluded, positive observations indicating infection can be a stimulus for atherothrombosis "suggest that we should rethink, revise, and reformulate hypotheses and research strategies. . . " The studies and editorial were published in the April 21 issue of The New England Journal of Medicine. -=- FDA Approval ASTRAZENECA PLC ------------------------------------------------------------------------------- AstraZeneca Plc's cholesterol-lowering drug, Crestor (rosuvastatin calcium), has a favorable benefit-risk ratio for most patients at starting doses of 5 mg or 10 mg, according to the European Medicines Agency. The committee began reviewing the recommended starting dose of Crestor in November because of "public health concerns." The EMEA said while most patients can begin treatment at 5 mg or 10 mg, those who are predisposed to myopathy, those of Chinese and Japanese ancestry and those aged more than 70 years should begin therapy at the lower dose of 5 mg. -=- FDA Approval PAR PHARMACEUTICAL COS. INC. ------------------------------------------------------------------------------- Par Pharmaceutical Cos. Inc.'s subsidiary Kali Laboratories Inc. received final approval from the Food and Drug Administration for its Abbreviated New Drug Application for tramadol hydrochloride/acetaminophen tablets, giving Kali 180 days of marketing exclusivity. The drug is indicated for the short-term management of pain. Ortho-McNeil Pharmaceutical Inc., a subsidiary of Johnson & Johnson, markets Ultracet, the branded version of the drug, and is currently in litigation against Kali for patent violations. Shipments of the generic formulation have commenced, according to Par. -=- FDA Approval ALLERGAN INC. ------------------------------------------------------------------------------- Allergan Inc. will restructure its European operations, cutting approximately 160 positions and taking pre-tax charges between $40 million and $53 million beginning in the first quarter of 2005 and ending in the second quarter of 2006. The company expects to spend between $9 million to $11 million to fund the plan and save between $6 million to $9 million annually once it is completed. Allergan does not expect the restructuring to affect its 2005 guidance. -=- FDA Approval RITE AID CORP. ------------------------------------------------------------------------------- Rite Aid Corp. will provide pharmacy benefit management (PBM) services to employers, health plans and insurance companies and will offer 90-day prescriptions as an alternative to mail-order prescriptions. Mark de Bruin, Rite Aid's senior vice president of pharmacy services, said the company will also offer mail-order capabilities for clients who require them. Rite Aid contracted with ProCare Rx to provide back-office services for the new PBM. -=- FDA Approval


	- advertising slogan - b2b branding - best company names - brand architecture - brand association - brand awareness - brand building - brand communication - brand communications - brand creation - brand essence - brand evaluation - brand experience - brand extension - brand extensions - brand id - brand identification - brand image - brand management - brand marketing - brand name generator - brand name product - brand name search - brand personality - brand planning - brand position - brand positioning - brand products - brand profile - brand repositioning - brand revitalization - brand strategist - brand valuation - brand value - brand values - brand vision - branded media - branding a product - branding advertising - branding campaign - branding consultancy - branding consultant - branding consulting - branding design - branding expert - branding experts - branding firm - branding firms - branding guidelines - branding ideas - branding identity - branding logos - branding process - branding products - branding research - branding strategies - branding strategy - branding tools - brandname - brandnames - business branding - business naming - business slogan - catchy slogan - change company name - changing company name - co branding - cobranding - companies name - companies names - company logo - company logos - company name change - company name creator - company name finder - company name generator - company name ideas - company name registration - company name suggestions - company taglines - company titles - conjoint analysis - consumer market research - consumer panels - consumer research - consumer survey - cool company names - corporate identity - corporate identity design - corporate internet branding - corporate logo - corporate name change - corporate name generator - corporation name - corporation names - create a company name - create company name - creating a company name - creative company names - design branding - design company names - digital branding - drug safety - fda approval - fda regulations - find company name - food package design - global branding - global market research - global panel - global survey - good company name - good company names - great company names - healthcare market research - how to choose a company name - how to name a product - how to name your company - ideas for company names - identity branding - image branding - internal branding - international market research - internet branding - internet market research - internet panel - internet poll - internet surveys - law firm names - line extension - logo branding - logo companies - logo company - logo creation - logo design - logo designer - logo designers - logo research - market research panels - market research tools - marketing branding - marketing slogan - name a company - name company - name creation - name development - name generation - name research - names for companies - naming a business - naming a company - naming a product - naming business - naming consultants - naming products - naming service - naming services - naming software - naming standards - naming strategy - naming tools - naming your business - naming your company - new company name - new company names - online market research - package designs - pharmaceutical consultants - physician survey - product brand - product launches - qualitative research - real branding - rebrand - rebranding - register a company name - register company name - registered company names - registering company name - registering company names - research panel - research panels - slogan - slogans - strategic branding - strategic name development - survey panel - survey tool - survey tools - tagline - tagline generator - trade name search - trademark - trademark search - trademark searches - trademark searching - trademarks - unique company names - visual branding - your company name


			Austin / Chicago / Geneva / London / Los Angeles / Miami / New York / Ottawa / Raleigh Durham / Rockville / San francisco / Tokyo