Naming your Company - Brand Institute, inc.



			Naming your Company 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 Allergan, Inamed enter $3.2 billion definitive merger agreement Allergan Inc. and Inamed Corp. entered into a definitive merger agreement, whereby Allergan will acquire Inamed in a cash-or-stock transaction worth more than $3.2 billion. Allergan originally proposed the acquisition last month, a move that exceeded the $2.8 billion merger agreement Inamed entered with Medicis Pharmaceuticals Corp. in March. Terms of the final agreement permit Inamed shareholders to receive either $84 cash or 0.8498 shares of Allergan common stock in exchange for each Inamed share owned. Specific provisions are structured such that 45 percent of the total Inamed shares tendered are exchanged for cash and the remaining 55 percent are exchanged for Allergan common stock. "The signing of the merger agreement by both parties marks a significant milestone in the process of combining the two companies and delivering on our vision to create a world-leading franchise in the high-growth medical aesthetics arena," said David Pyott, Allergan's chief executive officer. Nicholas Teti, Inamed's CEO, noted the firms "continue to work with the appropriate regulatory authorities as they review the transaction and do not anticipate that the regulatory process will lead to any material delay in the closing of this transaction." As part of its strategy to win regulatory approval from the Federal Trade Commission, Inamed terminated its distribution agreement and all associated obligations with Ipsen Ltd. for Reloxin (botulinum toxin type A) cosmetic therapy, The Wall Street Journal noted. Allergan shares closed at $107.31, up $0.71, or 0.7 percent, in moderate trading on the New York Stock Exchange, while Inamed shares closed at $87.02, up $1.26, or 1.5 percent, in heavy trading on the Nasdaq. Naming your Company Tamiflu prophylaxis indication expanded for use in children The Food and Drug Administration expanded the use of F. Hoffmann-La Roche Ltd.'s Tamiflu (oseltamivir phosphate) to include prevention of influenza in children aged 1 through 12 years. The drug was already approved to prevent influenza in adolescents and adults and to treat influenza in those aged 1 year or older. The dosing specified for the new indication is 30 mg to 60 mg (depending on weight) to be administered once daily for 10 days. Available in capsule and liquid suspension formulations, Tamiflu is the only antiviral indicated to treat influenza type A or type B infection in patients aged 1 year or older, Roche said. Production and stockpiling of Tamiflu has increased throughout the world as fears of avian bird flu infections have spread. The most recent supplemental New Drug Application was based on results from a subset of pediatric patients in a trial of more than 1,000 patients overall. Findings indicated that post-exposure prophylaxis effectively prevented the secondary spread of influenza infection and illness in households. Data also showed the protective efficacy of Tamiflu was comparable between children aged 1 through 12 years and patients in the entire trial group. As part of the newest approval, Roche will provide safety information to the FDA for 40 to 50 pediatric patients who used the approved preventive dosing regimen for up to six weeks. Naming your Company Pfizer's investigational smoking-cessation drug granted priority review by FDA Pfizer Inc.'s New Drug Application for varenicline tartrate received priority review from the Food and Drug Administration as a potential smoking-cessation therapy. The company plans to market the product under the brand name Champix. It is intended to activate the nicotinic receptor, thus reducing the severity of cravings and withdrawal symptoms. Pfizer noted that less than 7 percent of smokers who try to quit on their own reach more than a year of abstinence, with most relapsing within a few days of trying to quit. In November, results presented at the American Heart Association's Scientific Sessions 2005 showed varenicline was more effective than GlaxoSmithKline Plc's Zyban (bupropion), the only marketed oral prescription drug for smoking cessation. During two double-blind, placebo-controlled trials of approximately 2,000 smokers, a greater proportion of the subjects who received varenicline rather than Zyban or placebo quit smoking by the end of the 12-week treatment period (44 percent vs. 30 percent and 18 percent, respectively). Furthermore, varenicline-treated participants were twice as likely to stop smoking as Zyban-treated enrollees and four times as likely as placebo-treated subjects. Pfizer submitted an NDA for varenicline to the FDA in November. Naming your Company FDA approves orally disintegrating citalopram hydrobromide for depression Biovail Corp. received approval from the Food and Drug Administration for its New Drug Application regarding the use of citalopram hydrobromide in an orally disintegrating tablet formulation as a treatment for depression. As an active ingredient, citalopram hydrobromide was first marketed in 1998 as Celexa by Forest Laboratories Inc. Forest licensed Celexa from H. Lundbeck A/S and distributes it as an oral solution or tablet. Generic versions of citalopram hydrobromide tablets and the oral solution are now available as well. Biovail believes that its new formulation of immediate-release citalopram hydrobromide--available in orally disintegrating tablets of 10 mg, 20 mg and 40 mg--offers new dosing options and prescribing flexibility. "Patients may benefit from the convenience--particularly those who have difficulty swallowing tablets, or those who may not, or do not, always have access to water," title="branding company" the company explained. Biovail added that it is in the process of considering several commercialization options for the drug. Naming your Company Potential treatment for liver cancer receives orphan drug status Adherex Technologies Inc.'s eniluracil received an orphan drug designation from the Food and Drug Administration for its use with fluoropyrimidines to treat hepatocellular cancer. The designation was granted to encourage development of therapies for liver cancer, which affects less than 200,000 Americans each year and has treatments of limited effectiveness, the company noted. "Hepatocellular cancers have been shown to have very high levels of the enzyme dihydropyrimidine dehydrogenase (DPD), which may underlie the resistance of this cancer to 5-fluorouracil treatment," title="branding company" explained Dr. William Peters, chief executive officer of Adherex Technologies. Eniluracil is intended to be given in combination with 5-fluorouracil or other 5-fluorouracil prodrugs because it works to irreversibly block the activity of the DPD enzyme, thereby improving the therapeutic value and effectiveness of 5-fluorouracil chemotherapy. The drug was in-licensed from GlaxoSmithKline Plc in July 2005, and Adherex expects to have eniluracil in Phase III trials by the middle of 2007. "GlaxoSmithKline studied eniluracil and 5-fluorouracil in liver cancer in two Phase II studies, where despite using what we now realize was a sub-optimal dose and schedule, the results showed a high frequency and duration of stable disease. This gives us confidence that by using a more proper dose and schedule of eniluracil in combination with 5-fluorouracil, hepatocellular cancer may respond to treatment with 5-fluorouracil and this could provide an expedited route to approval for eniluracil in the United States," title="branding company" Peters said. Naming your Company FDA grants orphan drug designation for Osiris' Prochymal Osiris Therapeutics Inc. received an orphan drug designation from the Food and Drug Administration for its Prochymal adult stem cell product, which is being evaluated as a potential therapy for acute graft versus host disease (GVHD). The firm is currently engaged in two clinical trials of Prochymal for treating GVHD, a complication of bone marrow transplantation that affects approximately 50 percent of patients who receive such transplants. In January, the FDA granted Prochymal fast track status, the first ever received by a stem cell drug. "Having both orphan drug designation and fast track status clearly adds support to the development of Prochymal for patients suffering from life-threatening GVHD," said C. Randal Mills, Osiris' chief executive officer. "Our team is working with an excellent network of physicians to advance the program as safely and quickly as possible." The company noted the new treatment approach associated with Prochymal, which has the ability to modulate the immune system, may benefit patients with other immunological conditions, such as rheumatoid arthritis. Naming your Company Naming your Company Boehringer Ingelheim GmbH Boehringer Ingelheim GmbH and TransTech Pharma Inc. entered into a global research and license collaboration, whereby Boehringer Ingelheim will utilize TransTech's proprietary TTP Translational Technology to discover therapies against an undisclosed biologic target. The agreement could reach $54 million, including an up-front payment, research support and product milestones in development and commercialization. Naming your Company Naming your Company TAP Pharmaceutical Products Inc. TAP Pharmaceutical Products Inc. said it will license its Prevacid (lansoprazole) trademark and other intellectual property to Novartis AG for future development and marketing in the over-the-counter market. TAP will continue to commercialize and sell prescription Prevacid until at least 2009, when its patent expires. The treatment is indicated for short-term heartburn relief and other symptoms of gastroesophageal reflux disease. Naming your Company Naming your Company Genzyme Corp. Genzyme Corp. acquired from Avigen Inc. an extensive portfolio of assets focused on adeno-associated virus technology, a Phase I/II clinical development program in Parkinson's disease and a clinical hemophilia collaboration. Genzyme made an initial $12 million payment to Avigen and will make additional milestone and royalty payments based on future achievements of products associated with the agreement. Naming your Company Naming your Company LifeScan Inc. LifeScan Inc., a unit of Johnson & Johnson, received a letter from the Food and Drug Administration stating that the manufacture of OneTouch Ultra and OneTouch UltraSmart Blood Glucose Meters do not comply with Current Good Manufacturing Practices requirements. Specifically, the letter said LifeScan failed to investigate some consumer complaints, did not adequately analyze causes of quality problems, did not follow correct procedures for design changes, failed to ensure that a quality system was maintained and did not report product malfunctions within 30 days. The firm said it takes these issues "very seriously" and would work with the FDA to address them, Dow Jones Newswires reported. Naming your Company Naming your Company NicOx SA NicOx SA initiated the first Phase III trial to evaluate the efficacy of HCT 3012, a nitric oxide-donating derivative of naproxen, in relieving the signs and symptoms of osteoarthritis without having a detrimental effect on blood pressure. "[A] true medical need exists for a nonsteroidal anti-inflammatory drug with a neutral blood-pressure effect, especially among the 40 percent of OA patients which are estimated to be hypertensive," title="branding company" the firm said. The 13-week, double-blind, controlled trial is expected to enroll approximately 820 patients with knee OA into four treatment arms. Another trial with HCT 3012 is planned to begin in the first half of 2006. Naming your Company


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