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Product NameBrand 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 Berlex's Yaz oral contraceptive approved by FDA Berlex Inc.'s Yaz (ethinyl estradiol 20 mcg/drospirenone 3 mg) was approved by the Food and Drug Administration for use as a monophasic oral contraceptive. It is the first pill to offer the progestin drospirenone in a 24-day active hormone pill regimen.The approval was based on a clinical trial that included 1,027 women. The study demonstrated the safety and 99 percent contraceptive efficacy of Yaz. Participants in the trial also experienced predictable monthly withdrawal bleeding, with breakthrough bleeding rates comparable to other low-dose oral contraceptives. Drospirenone, a spironolactone analogue with antimineralocorticoid properties, has a 30-hour half-life that, when combined with the 24-day active hormone pill regimen, results in less hormonal fluctuation between cycles as compared with traditional oral contraceptives with 21 days of active pills and seven days of placebo. Yaz will be available by prescription in the United States in April. "Yaz represents a clear advancement in oral contraception, and underscores the Berlex commitment to provide novel and innovative options in birth control to allow for individual choice," said Reinhard Franzen, chief executive officer of Berlex Laboratories. In addition, the company recently received an approvable letter from the FDA for use of the drug to treat premenstrual dysphoric disorder. "We are continuing our dialogue with the FDA in order to take Yaz even further by bringing women the first oral contraceptive for the treatment of the emotional and physical symptoms of premenstrual dysphoric disorder," Franzen added. Berlex Inc. is a U.S. affiliate of Schering AG. Product Name FDA issues Public Health Advisory for Danco's medical abortion drug The Food and Drug Administration issued a Public Health Advisory for Danco Laboratories LLC's Mifeprex (mifepristone), which is indicated for the medical termination of intrauterine pregnancy. The advisory was issued after the agency was informed of two additional deaths following medical abortion with the drug. The FDA issued a previous advisory in July 2005, which it updated in November, to disclose four confirmed deaths from sepsis between September 2003 and June 2005 in U.S. women who had a medical abortion with Mifeprex and misoprostol. All four of these fatal infections tested positive for Clostridium sordellii and involved an off-label dosing regimen of oral Mifeprex followed by intravaginal misoprostol. The FDA said it is investigating the circumstances associated with the two new deaths, the cause of which they cannot yet confirm. The agency noted that all medical abortion providers and patients should be aware of the specific directions and circumstances for the use of Mifeprex and of all possible risks, including sepsis. "In particular, physicians and their patients should fully discuss early potential signs and symptoms that may warrant immediate medical evaluation," the FDA said. The agency outlined the drug's approved dosing regimen and said health care professionals and patients should investigate the possibility of sepsis in patients who show symptoms such as vomiting, nausea or diarrhea. Patients with these symptoms should be treated with antibiotics, the agency said, noting that prophylactic antibiotics are not recommended since the cases of sepsis are so rare in these patients. Product Name Actavis offers to acquire Pliva for $1.6 billion Iceland's Actavis Group submitted a preliminary, nonbinding proposal to acquire Pliva d.d., a Croatian-based generic drug company, for $1.6 billion in cash. Pliva stated that its management board "does not believe that the proposal adequately reflects the fundamental value and future prospects of the company." Pliva recently divested its loss-making proprietary businesses and is working toward its manufacturing consolidation program through the divestment of its production plant in Germany. According to Pliva, both actions materially improve the company's profitability prospects. Robert Wessman, Actavis' chief executive officer, said his company hopes to "enter into a positive and constructive dialogue with Pliva's management and supervisory board in the coming days" to work toward an agreement. If successful, the purchase of Pliva would be the latest in a flurry of acquisitions in recent years by Actavis that has thrust the company into the top five generics companies in the world, according to Actavis. The combination of the two companies would form the world's third largest generic pharmaceuticals company. Product Name Salix's colon cleansing tablets approved by FDA Salix Pharmaceuticals Ltd.'s OsmoPrep (sodium phosphate monobasic monohydrate/sodium phosphate dibasic anhydrous) tablets were granted marketing approval by the Food and Drug Administration. The tablets are indicated for cleansing of the colon prior to colonoscopy in patients aged 18 years or older. "OsmoPrep is the most advanced tablet formulation product approved for bowel cleansing prior to a colonoscopy," said Carolyn Logan, chief executive officer of Salix. "We consider OsmoPrep to be a key addition to our portfolio designed to provide important and effective products to gastroenterologists and their patients." Logan added that the tablets are highly tolerable for patients. Bill Forbes, the firm's chief development officer, said that many patients would prefer the tablet-form cleansing agent to liquid cleansing agents, which are difficult to tolerate. According to Salix, more than 10 million uses of bowel cleansing agents were prescribed last year, and most colonoscopies in the United States are performed to screen for colorectal cancer. The firm noted that colonoscopy is extremely effective in detecting the cancer, but that less than half of U.S. adults aged 50 years or older undergo the recommended procedure. OsmoPrep is under patent protection until 2013, and Salix is seeking protection through 2024. Product Name Addition of Actos to insulin may have positive impact on glycemic control, lipid profile in patients with diabetes, according to new study A combined regimen of Takeda Pharmaceutical Co. Ltd. and Eli Lilly and Co.'s Actos (pioglitazone hydrochloride) and insulin may improve glycemic control and lipid metabolism among patients with type 2 diabetes, new research reveals. A total of 690 patients who had poorly controlled diabetes and who were taking a stable insulin dose (more than 30 U/day for 30 days or more) were randomized to receive a 30 mg or 45 mg dose of Actos once daily for 24 weeks. Approximately 70 percent of patients in each group completed the study. The 30 mg group experienced a 1.2 percent reduction in hemoglobin A1C levels from baseline, and the 45 mg group experienced a 1.5 percent reduction. Furthermore, fasting plasma glucose decreased an average of 31.9 mg/dL for the 30 mg group and 45.8 mg/dL for the 45 mg group. For both groups, insulin dosage decreased significantly from baseline (4.5 U for the 30 mg group and 7.3 U for the 45 mg group). The researchers also observed decreases from baseline in triglyceride levels, very low-density lipoprotein cholesterol and free fatty acids along with increases from baseline in HDL cholesterol for both groups. Small but significant increases from baseline were observed in total and LDL cholesterol. The study also showed that Actos was generally well tolerated, as the authors said the incidence of edema, weight gain and heart failure was no higher among study patients than what is expected for this population. Complete data were published in the March/April 2006 issue of the journal Diabetes, Obesity and Metabolism. Product Name Eight drug companies agree to share data on laboratory tests The Food and Drug Administration said The Critical Path Institute (C-Path), a nonprofit organization, and eight large pharmaceutical companies joined together to form the Predictive Safety Testing Consortium in an effort to determine the safety of new products before human testing begins. The companies, which include Pfizer Inc. and GlaxoSmithKline Plc, will share details of their laboratory methods, and C-Path will collect and summarize the data to present it to the FDA. "This unprecedented sharing of potential early indicators of clinical safety may streamline the cost and time of preclinical drug safety evaluation and better inform the use of 'personalized medicine,'" the FDA said. The agency noted that the current predictive safety tests used by individual firms are not very valuable to the FDA because the tests' methods have not been validated by an unbiased party. Under the consortium, however, member companies will be able to have their tests validated by other members and C-Path's external experts. The FDA will have an advisory role in this process. The other members of the consortium are Bristol-Myers Squibb Co., Johnson & Johnson Pharmaceutical Research & Development LLC, Merck and Co. Inc., Novartis Pharmaceutical Corp., Roche Palo Alto LLC and Schering-Plough Research Institute. "The Predictive Safety Testing Consortium is a prime example of a collaborative culture that must exist to modernize the development process," said Mike Leavitt, secretary of the Department of Health and Human Services. "The collective sharing of scientific information and research across the entire health care community is crucial to igniting the medical innovation required to keep pace with biomedical research." Product Name Product Name Genentech Inc. Genentech Inc. said at its annual investment meeting that it expects approximately 40 to 50 percent growth in adjusted earnings per share for 2006. The firm also aims to bring at least 15 new major indications or products to the market and to begin development on at least 20 new molecules by 2010. Genentech shares closed at $88.14, up $5.55, or 6.7 percent, in heavy trading on the New York Stock Exchange. Product Name Product Name Barr Pharmaceuticals Inc. Barr Pharmaceuticals Inc. received notice from the Food and Drug Administration that additional clinical data will not be required to support the approval of Duramed Pharmaceuticals Inc.'s New Drug Application for Seasonique (levonorgestrel/ethinyl estradiol 0.15 mg/0.03 mg and ethinyl estradiol 0.01 mg) extended-cycle oral contraceptive tablets. The FDA previously issued an approvable letter for the drug that requested additional data to support its regimen of 84 days of combination therapy, followed by seven days of unopposed estrogen for the hormonal prevention of pregnancy. Product Name Product Name MediSpectra Inc. MediSpectra Inc.'s Luma cervical imaging system was approved by the Food and Drug Administration as the first optical imaging device to aid clinicians in the examination of women with abnormal Pap tests. When used as an adjunct to colposcopy, the noncontact optical imaging device is expected to reduce the number of high-grade cervical cancer precursors that can be missed when a woman is evaluated for an abnormal Pap test with colposcopy alone. The system, which scans tissue with a combination of fluorescence spectroscopy, white light diffuse reflectance spectroscopy and video imaging, was evaluated in clinical trials involving more than 3,500 women at 15 clinical practice centers in the United States. Product Name Product Name Hana Biosciences Inc. Hana Biosciences Inc. signed an agreement to obtain worldwide licenses to three targeted chemotherapy candidates from Inex Pharmaceuticals Corp. The candidates, Marqibo (sphingosomal vincristine), sphingosomal vinorelbine and sphingosomal topotecan, are intended to treat solid and hematological cancers. In exchange for the rights, Hana will pay Inex $11.5 million in cash and stock. Contingent on the achievement of certain milestones, Hana will pay Inex up to an additional $30.5 million in cash and stock. If approved, Inex will also be eligible for royalties on product sales. The transaction is dependent on the execution of definitive agreements and subject to customary closing conditions. Product Name
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