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RebrandBrand 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 PFIZER PLANT BEGINS PRODUCTION OF NOVEL CHOLESTEROL DRUG ------------------------------------------------------------------------------- Pfizer Inc. began production of torcetrapib, which the company plans to combine with its blockbuster cholesterol-lowering drug, Lipitor (atorvastatin calcium), at a $90 million plant expansion in Ireland.The firm believes that combining torcetrapib's ability to increase HDL cholesterol levels with Lipitor's proven efficacy in lowering LDL cholesterol levels "could provide an even greater reduction in the risk of cardiovascular disease." The torcetrapib/atorvastatin global clinical program will include 25,000 patients and cost approximately $800 million, making it the largest and most comprehensive clinical trial development program ever, according to Pfizer. "If we prove our hypothesis, torcetrapib/atorvastatin has the potential to benefit millions of lives around the world," said Dr. John LaMattina, president of global research and development for Pfizer. "Nothing is certain except our huge investment. Even if this fails as a new medicine, we will have advanced scientific understanding in this area." "Having the operation up and running before our regulatory filings should facilitate the review process," said Nat Ricciardi, president of global manufacturing for Pfizer. In a study published last year in The New England Journal of Medicine, torcetrapib increased HDL cholesterol levels and decreased LDL cholesterol levels when used as monotherapy or in combination with Lipitor. -=- NOVARTIS' EXJADE NDA RECEIVES PRIORITY REVIEW ------------------------------------------------------------------------------- The Food and Drug Administration granted priority review to Novartis AG's New Drug Application for Exjade (deferasirox), an oral iron chelator intended to treat chronic iron overload caused by blood transfusions. Novartis said Exjade is much easier to administer than the standard of care in iron chelation, deferoxamine mesylate. Novartis markets deferoxamine as Desferal; it usually requires an eight- to 12-hour-long subcutaneous infusion each day, for five to seven days a week for as long as the patient receives blood transfusions. Exjade is taken just once daily after it is dispersed in a glass of water or orange juice. The NDA filing was based on data from a clinical trials program that enrolled more than 1,000 patients. In a Phase III trial that compared Exjade with deferoxamine, 20- and 30-mg/kg of body weight/day of Exjade significantly reduced liver iron concentration (LIC)--considered to be an indicator of body iron content--in adult and pediatric patients who were receiving blood transfusions. At these doses, Exjade was not inferior to deferoxamine, but at the 5 mg/kg/d and 10 mg/kg/d doses, Exjade did not achieve non-inferiority. However, studies also showed that Exjade resulted in the maintenance or reduction of absolute LIC in patients with different diseases who were receiving transfusions regularly. "We hope that once Exjade becomes available as a treatment option, it will not only improve the quality of life of those patients who for years have endured the discomfort of deferoxamine, but will also provide a new and acceptable treatment option for those who have been risking their lives by avoiding chelation therapy altogether because of the burdensome nature of the current standard of care," said Dr. Diane Young, global head of clinical development at Novartis Oncology. Exjade has already received orphan drug status, and David Epstein, head of Novartis Oncology, told Dow Jones Newswires the drug could be on the market within a few weeks of the FDA's decision. According to Dow Jones, analysts expect the drug could generate revenue of between $200 million and $700 million in its best year. If Exjade receives expanded indications, some analysts believe the drug could achieve more than $1 billion in sales annually. -=- BOSTON SCIENTIFIC INFRINGED ON J&J STENT PATENTS, JURY SAYS ------------------------------------------------------------------------------- A U.S. District Court jury in Delaware ruled that Boston Scientific Corp.'s Taxus Express and Liberte drug-eluting stents infringed on stent patents held by Johnson & Johnson, The Wall Street Journal reported. Analysts were not surprised by the verdict as J&J had successfully enforced its key stent patent in previous legal proceedings against Boston Scientific and Medtronic Inc. Paul LaViolette, Boston Scientific's chief operating officer, said the firm has yet to decide whether to appeal the jury's decision, The Journal said. "The Taxus Express is still for sale and it will be for sale," he said. In addition, LaViolette said the Liberte's U.S. launch is still slated for August or September of this year. According to The Journal, J&J said it will seek damages of more than $1 billion from Boston Scientific in a damages trial that is expected to begin in August. In a second patent trial that started this week, Boston Scientific is seeking an infringement finding against J&J's Cypher stent, The Journal said, adding that Cypher and Taxus Express are thought to hold approximately 30 percent and 60 percent of the drug-eluting stent market, respectively. -=- RETAIL PHARMACY SALES FOR 12-MONTH PERIOD ENDED APRIL 2005 RISE 6 PERCENT IN KEY GLOBAL MARKETS ------------------------------------------------------------------------------- Drug sales through retail pharmacies in 13 key markets rose 6 percent at a constant exchange rate to $356.29 billion from May 2004 to April 2005, according to IMS Health's Retail Drug Monitor. For the 12-month period ended April 2004, retail pharmacy drug sales totaled $328.84 billion. U.S. retail drug sales grew 7 percent to $177.77 billion during the 12 months ended April 2005, led by $41.13 billion in sales of central nervous system drugs. In the United States and Canada, cardiovascular drugs experienced a growth of 12 percent at constant exchange, reaching $35.44 billion. Sales growth rates in the top five European markets, the top three Latin American markets and Japan were 4 percent, 13 percent and 2 percent, respectively. Once again, Pfizer Inc.'s cholesterol-lowering drug, Lipitor (atorvastatin calcium), was the best-selling drug, with global sales totaling more than $10.9 billion. Bristol-Myers Squibb Co. and sanofi-aventis Group's thrombosis treatment, Plavix (clopidogrel bisulfate), again experienced the highest rate of growth, at 26.1 percent. -=- MYOBLOC, BOTOX COMPARABLE IN TREATMENT OF CERVICAL DYSTONIA, STUDY SHOWS ------------------------------------------------------------------------------- New trial findings indicate Solstice Neurosciences Inc.'s Myobloc (botulinum toxin type B) injectable solution is clinically equivalent to Allergan Inc.'s Botox (botulinum toxin type A) for the treatment of cervical dystonia. A total of 111 toxin-naïve patients with cervical dystonia entered the double-blind trial. Cervical dystonia, also known as spasmodic torticollis, is a condition of involuntary contractions in the neck muscles that leads to abnormal head and neck movements and posture. The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) is used to assess the character and severity of the condition. During the first phase, the patients were randomized to receive 10,000 U of Myobloc or 150 U of Botox. When they returned to baseline TWSTRS total scores, they received higher doses of their previous therapy: 15,000 U of Myobloc or 200 U of Botox. Both therapies led to substantial improvements in TWSTRS that appeared by week four and lasted through week 12. A statistical analysis demonstrated a clinical non-inferiority endpoint. Both treatments groups also had similar adverse events. These data were presented as a poster presentation in Denver, Colo., at the International Conference 2005–Basic and Therapeutic Aspects of Botulinum and Tetanus Toxins. Solstice Neurosciences purchased the manufacturing and marketing rights for Myobloc from Elan Biopharmaceuticals Inc. last year. The product is indicated for reducing the severity of abnormal head position and pain associated with cervical dystonia. -=- NUVIGIL EFFECTIVE, WELL TOLERATED FOR TREATING RESIDUAL EXCESSIVE SLEEPINESS IN PATIENTS WITH OBSTRUCTIVE SLEEP APNEA/HYPOPNEA SYNDROME WHO ADHERE TO NASAL CPAP, STUDY FINDS ------------------------------------------------------------------------------- New data suggest that Cephalon Inc.'s Nuvigil (armodafinil) is an effective treatment for residual excessive sleepiness in patients with obstructive sleep apnea/hypopnea syndrome (OSA/HS) who adhere to nasal continuous positive airway pressure (nCPAP). In the 12-week, double-blind study, 392 patients were randomized to receive Nuvigil 150 mg, Nuvigil 250 mg or placebo once daily. Study subjects were OSA/HS patients with an Epworth Sleepiness Scale (ESS) score of at least 10 on adequate nCPAP therapy. Researchers performed assessments at baseline and at weeks four, eight and 12. The Maintenance of Wakefulness Test (MWT) was performed at two-hour intervals. In addition, Clinical Global Impression of Change (CGI-C), ESS, Brief Fatigue Inventory (BFI) and tests of cognitive function from the Cognitive Drug Research System (CDR) were performed. Overall, 344 patients completed the study. Data revealed that when used as an adjunct to therapeutic nCPAP, once-daily Nuvigil significantly improved wakefulness throughout the day and improved overall clinical condition. Nuvigil increased mean sleep latency by 1.9 minutes, a significant improvement compared with the 1.7-minute decrease in mean sleep latency observed for placebo. Moreover, both the 150 mg and 250 mg doses of Nuvigil significantly improved clinical condition on the CGI-C as compared with placebo at all weeks and at the final visit. The researchers added that both doses of Nuvigil significantly improved self-reported wakefulness on the ESS as compared with placebo at all weeks and the final visit. While Nuvigil 150 mg and 250 mg significantly reduced BFI global fatigue as compared with placebo at week 12 and the final visit, no improvement was reported in the BFI scale measuring worst fatigue in the past 24 hours. Overall, Nuvigil treatment resulted in improved aspects of memory and attention on the CDR measurement. For example, significant improvement in CDR quality of episodic secondary memory across the first four sessions (daytime) was noted for both doses of Nuvigil at week four and for the 250 mg dose of Nuvigil at week eight. Moreover, significant improvement across the three sessions (later afternoon) was seen with the 250 mg dose of Nuvigil at week eight. This study was presented at the 19th annual meeting of the Associated Professional Sleep Societies in Denver. Cephalon filed a New Drug Application for Nuvigil, a single-isomer formulation of the company's Provigil (modafinil), in May. The company seeks approval of Nuvigil as a treatment to improve wakefulness in patients with excessive sleepiness resulting from narcolepsy, OSA/HS or shift work sleep disorder. -=- Rebrand BRISTOL-MYERS SQUIBB CO. ------------------------------------------------------------------------------- Bristol-Myers Squibb Co. completed an agreement with South Korea's Celltrion Inc. for Celltrion to manufacture biologic products that BMS is developing. Celltrion said it can manufacture multiple products according to U.S. current Good Manufacturing Practices, including BMS' abatacept, an investigational treatment for rheumatoid arthritis, and belatacept, an investigational treatment for patients receiving solid organ transplants. "Although commercial terms of the agreement were not disclosed, the agreement is believed to represent the largest biologics manufacturing contract for an Asian biopharmaceutical contract manufacturer," Celltrion said, adding that it expects technology transfer activities to begin immediately. -=- Rebrand PROTEIN DESIGN LABS INC. ------------------------------------------------------------------------------- Protein Design Labs Inc. (PDL) sublicensed development and commercialization rights for antibody-drug conjugates directed against the PR1 antigen to Genentech Inc. PDL will receive an undisclosed up-front licensing fee plus milestone payments and royalties on future sales under certain conditions. PDL said its collaboration agreement with Seattle Genetics Inc. gives it the right to develop antibody-drug conjugates to certain targets, including PR1, which is often differentially expressed in prostate cancer. -=- Rebrand XOMA LTD. ------------------------------------------------------------------------------- Xoma Ltd. and Lexicon Genetics Inc. will collaborate to accelerate the development and commercialization of antibody therapeutics. During the first three years, Lexicon will select at least three targets to submit to the collaboration; Xoma will then generate or engineer antibodies that modulate these targets. The firms will share responsibilities and costs, with costs and profits allocated in a 35 percent to 65 percent ratio to Xoma and Lexicon, respectively. -=- Rebrand VALENTIS INC. ------------------------------------------------------------------------------- Valentis Inc. granted biolitec AG--through its associate, Biolitec Pharma Marketing Ltd.--an exclusive worldwide license to develop and commercialize new drug formulations that use Valentis' pegylated liposome technology. Biolitec said the technology, when used with its own photoactive drugs, could increase drug infiltration into tumor and inflammatory tissues, thus reducing the treatment time for cancer and inflammation. Valentis will receive an up-front payment and possible milestone payments and royalties on product sales. -=- Rebrand
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