http://www.starmedical.co.uk/ The latest 10 news stories from STAR Medical Fri, 10 Oct 2008 11:57:20 GMT en-us http://www.starmedical.co.uk/star-news-story.php?news=318 http://www.starmedical.co.uk/star-news-story.php?news=318 Fri, 10 Oct 2008 11:57:20 GMT Top Line Clinical Results Expected in November 2008 BOTHELL, Wash., Oct. 9 /PRNewswire-FirstCall/ — SCOLR Pharma, Inc. (Amex: DDD - News) announced today the completion of patient enrollment and dosing for the third of its three pivotal trials to evaluate the safety and efficacy of its formulation of 12-hour extended-release (ER) ibuprofen for the over-the-counter (OTC) market. The Company expects to report top-line results from this pivotal trial in November 2008. Ibuprofen is an analgesic that is sold in immediate-dose products as Advil® and Motrin®, among others, as well as generically. The Company enrolled and treated approximately 240 patients at a single center in the United States. The randomized, placebo-controlled, double-blind, parallel group study was designed to evaluate the efficacy and safety of multiple doses of ibuprofen 600mg ER in dental pain following molar extraction. It is anticipated that the data from this trial will be used to support a submission to the U.S. Food and Drug Administration (FDA) for product approval in the United States. If approved, the Company believes its ibuprofen product would be the first and only OTC 12-hour, extended-release ibuprofen product on the market in the United States. Additional information about the clinical trial can be found at www.clinicaltrials.gov. As previously reported, the Company will also be required to complete a label comprehension and consumer use study for product approval prior to submission. Daniel O. Wilds, the Company’s Chief Executive Officer, commented, “We are very pleased with the efficiency in which over 300 potential subjects were recruited and screened to enable the successful and timely dosing of our targeted study population. The attainment of this clinical study milestone is an important measure of our success in advancing this exciting project and we look forward to announcing study results later this year.” Ibuprofen is an analgesic typically used for the treatment of pain, fever and inflammation. Total global OTC sales of the analgesic market in which the 12-hour ibuprofen product will compete are estimated at more than $8 billion, according to IMS Review Plus data. The Company estimates the annual U.S. sales of immediate-release OTC ibuprofen products exceeds $1 billion. About SCOLR Pharma: Based in Bothell, Washington, SCOLR Pharma, Inc. is a specialty pharmaceutical company. SCOLR Pharma’s corporate objective is to combine its formulation expertise and its patented CDT platform to develop novel pharmaceutical, over-the-counter (OTC), and nutritional products. Our CDT drug delivery platform is based on multiple issued and pending patents and other intellectual property for the programmed release or enhanced performance of active pharmaceutical ingredients and nutritional products. For more information on SCOLR Pharma, please call 425.373.0171 or visit http://www.scolr.com/. For further details on this press release, for disclaimer information and for the latest SCOLR Pharma updates, please visit www.scolr.com/news http://www.starmedical.co.uk/star-news-story.php?news=317 http://www.starmedical.co.uk/star-news-story.php?news=317 Thu, 09 Oct 2008 17:19:07 GMT Researchers at the Harvard School of Medicine are investigating a possible genetic link to pre-eclampsia. A study on mice has shown that those who have been genetically engineered to be deficient in the enzyme catechol-O-methyltransferase (COMT) will suffer from the condition. Pre-eclampsia affects the delivery of nutrients and oxygen from the placenta to the baby and can be life-threatening to both mother and child if undetected. It can cause convulsions, kidney failure and liver problems. It is not fully understood what causes the illness, but the only way to cure it is to deliver the baby early. The condition therefore accounts for 15% of all premature births in the UK. In its early stages, pre-eclampsia is symptomless and so is only detectable by regular antenatal check-ups. Professor Andrew Shennan, Consultant Obstetrician at St Thomas’s Hospital in London explained that all women undergo regular blood pressure and urine tests but that “if [there was] a very good test which said ‘you don’t have to see this woman but you need to monitor this woman’ it would be very useful.” In an effort to contribute toward the development of diagnostic tests and treatments for pre-eclampsia, the Harvard researchers have been looking at proteins which can affect the level of oxygen delivered to the placenta. COMT is an enzyme that deactivates epinephrine (often known as adrenaline) and norepinephrine - both neurotransmitters and hormones involved in the development of new blood vessels. The scientists found that mice without it are unable to produce 2-methoxyoestradiol (2-ME) a compound that usually increases in the last 3 months of human pregnancy. Low levels of COMT in women with pre-eclampsia have been noted. When given COMT, it was found that mice were cured of pre-eclampsia. In his report in the journal Nature, lead researcher Dr Raghu Kalluri commented; “If this is a gene responsible for pre-eclampsia in some families then it would be a nice genetic test. But also levels of 2-ME can be measured in pregnant women and they can be supplemented with a pill. We would be giving back what is missing in the mothers and babies.” The scientists will now carry out a large clinical trial in women to observe the effects of COMT. Along with a genetic test to identify women most at risk of the condition, 2-ME can also be measured in urine and blood samples. Some experts warned that the researchers could still be a long way from developing a definitive test, remarking that other markers for pre-eclampsia have been found in the past but have come to nothing. A spokesperson from the Royal College of Obstetricians and Gynaecologists said “there’s a lot of big studies at the moment looking at this area but the problem is that screening is very expensive for the small percentage who have the disease.” Pre-eclampsia is thought to be the cause of growth restriction in around 4 million babies worldwide. Up to 8 million women are affected, with around 150,000 suffering eclamptic convulsions. Some 40,000 women die from the condition every year and 12% of their babies then die in their first month. http://www.starmedical.co.uk/star-news-story.php?news=316 http://www.starmedical.co.uk/star-news-story.php?news=316 Tue, 07 Oct 2008 15:14:00 GMT New research by the Office of National Statistics (ONS) contradicts previous reports indicating a fall in alcohol consumption. Lead researcher Eileen Goddard explained that previous statistics from the alcohol industry based on Customs data suggested a fall of around 5% in consumption between 2004-2006. However, doubt was cast over the results in light of the fact that stronger beers and larger glasses of wines are now being consumed. In addition to this, results are likely to be skewed by people under-reporting or underestimating what they drink. Previous calculations suggested men drank an average of 14.8 units a week and women around 6.2. New results show people are drinking around 32% more than this – around 18.7 units for men and 9 units for women. Recommended limits are 21 units a week for men and 14 for women. The government suggests no more than 2 units per day for women and 3 for men are consumed, in order to avoid binge drinking. The ONS report indicated that around 40% of men and 30% of women exceed the daily limit at least once per week. Frank Soodeen from Alcohol Concern commented, “over the last 20 years middle-class families particularly have moved alcohol from the fringe of their lives to the centre of it. Because it’s so available they are drinking almost on a daily basis.” In addition to finding that the English drink more than the Scottish and the Welsh, the report also found that men in high-flying professions were more likely to consume more than the recommended units. They were found to use drinking as a mechanism for coping with stress, drinking around (or the equivalent of) 3 bottles of wine a week. On average, men in high positions were found to drink around 23 units per week – more than 11 medium glasses of wine. The report shows that across all social classes about 10 million people are drinking more than the recommended weekly units and usually at home – half of the population had drunk in their homes in the last week. However, 60% of people were classified as low or moderate drinkers and around 14% don’t drink at all. Chief Executive of the Wine and Spirit Trade Association, Jeremy Beadles, believes people are drinking more responsibly on the whole - “the message of responsible drinking is continuing to get out as the long-term trends continue to improve. It is also clear that the vast majority of people drink sensibly.” • a pint of ordinary lager or beer contains over 2 units of alcohol • a standard 175ml glass of wine around 2 units, a large glass • (250ml) 3 units and a bottle between 8-10.5 units depending on the proof • a bottle of alcopop is around 1.5 units • a 25ml shot of spirit is 1 unit http://www.starmedical.co.uk/star-news-story.php?news=315 http://www.starmedical.co.uk/star-news-story.php?news=315 Mon, 06 Oct 2008 09:26:15 GMT Some likely near-term movers on the FDA's decision date calendar for 70 different items include Cypress Bioscience (CYPB) + partner Forest Labs (FRX) with a pending decision on milnacipran in the treatment of fibromyalgia slated for the end of October in addition to results from a Phase 3 trial for the drug some time before year end. Also, Discovery Labs (DSCO) is not listed on the calendar, but expects to file a complete response to a May 1st FDA approvable letter for Surfaxin by the end of September and expects a Class I review by the agency with a potential decision in just two months. Another company not listed on the calendar is BioDelivery Sciences (BDSI), which expects approval for Onsolis [BEMA fentanyl] during the first half of 2009 after making modifications to the risk management program it previously submitted as required by the FDA for approval of the high-potency opioid pain medication. The current slide in shares of Eli Lilly (LLY) could prove to be a good entry point assuming the issues surrounding the delay are minor or just caused by the FDA being understaffed. Analysts are forecasting blockbuster sales for Effient, which could eventually reach $2 billion by some estimates; so approval for the drug is important to fuel the future growth of Eli Lilly in the face of looming generic competition for Zyprexa. Effient would represent new competition for the multi-billion dollar blood thinner Plavix, which is marketed by Bristol-Myers (BMY) and Sanofi-Aventis (SNY). Given the complexity of the regulatory filing for Effient and the previous three-month delay, it appears the FDA probably just needs more time to review the application rather than something more ominous such as requiring additional clinical trials. Also, many companies have faced similar delays by the agency, such as Cardiome's (CRME) wait of over six months for an approvable ruling on Kynapid. Momenta Pharma (MNTA) represents a pure-play on the future of complex bio-generic drugs with a major near-term opportunity to steal market share from Sanofi's (SNY) Lovenox, which posted blockbuster sales of $3.8 billion worldwide in 2007. The company's stock price tanked to below $5 per share last November as the FDA rejected the ANDA for Enoxaparin. The generic division of the FDA does not issue decision date deadlines, but the fact that no new clinical trials were required and the complete response has now been filed by the Sandoz generic drug division of Novartis (NVS) removes a degree of uncertainty and makes it a waiting game for Momenta investors. For further details and to comment of this article, please visit www.seekingalpha.com http://www.starmedical.co.uk/star-news-story.php?news=314 http://www.starmedical.co.uk/star-news-story.php?news=314 Fri, 03 Oct 2008 14:54:21 GMT PRINCETON, N.J., October 01, 2008 - Bristol-Myers Squibb Company (NYSE: BMY) announced today that the U.S. Food & Drug Administration (FDA) approved the use of REYATAZ® (atazanavir sulfate) 300 mg once-daily boosted with ritonavir 100 mg as part of combination therapy in previously untreated (treatment-naive) HIV-1 infected patients. REYATAZ boosted with ritonavir (REYATAZ/r) taken once daily with food is recognized by the U.S. Department of Health and Human Services (DHHS) as a preferred component of combination HIV therapy for treatment-naive patients1. For treatment-naive patients who are unable to tolerate ritonavir, REYATAZ 400 mg (without ritonavir), taken once daily with food, is recommended. This use of once-daily REYATAZ/r in HIV-1 infected treatment-naive adult patients is based on 48-week results from the CASTLE study, which demonstrated similar antiviral efficacy of REYATAZ/r to twice-daily lopinavir/ritonavir (lopinavir/r), each as part of HIV combination therapy, in treatment-naive HIV-1 infected adult patients. Within the CASTLE study, the REYATAZ/r arm was associated with low increases from baseline in total cholesterol (13 percent), LDL cholesterol (14 percent), HDL cholesterol (29 percent), and triglycerides (15 percent). The lopinavir/r arm was associated with 25 percent increase in total cholesterol, 19 percent increase in LDL cholesterol, 37 percent increase in HDL cholesterol, and 52 percent increase in triglycerides. Two percent of patients in the REYATAZ® (atazanavir sulfate)/r arm and eight percent of patients in the lopinavir/r arm required lipid-lowering therapy in the study, compared to 1 percent in each arm at baseline. Safety events in this study were consistent with prior experience. Grade 2-4 treatment-related adverse events that occurred in two percent or greater of patients in the CASTLE study included jaundice (4 percent and zero percent), nausea (4 percent and 8 percent), diarrhea (2 percent and 11 percent) and rash (3 percent and 2 percent) in the REYATAZ/r and lopinavir/r arms, respectively. Grade 3–4 increases in total bilirubin were seen in 34 percent of patients in the REYATAZ/r arm and in less than 1 percent of patients in the lopinavir/r arm. “Bristol-Myers Squibb is committed to developing medicines that enhance the care of people living with HIV and AIDS,” said Elliott Sigal, M.D., Ph.D., Executive Vice President, Chief Scientific Officer and President, Research and Development, Bristol-Myers Squibb. “Boosted REYATAZ provides health care professionals a newly approved, once-daily dosing option as part of combination therapy for patients naive to HIV therapy.” For more information on this subject, please visit newsroom.bms.com http://www.starmedical.co.uk/star-news-story.php?news=313 http://www.starmedical.co.uk/star-news-story.php?news=313 Wed, 01 Oct 2008 09:39:42 GMT Bayer and the National University of Singapore have set up a preclinical cancer research collaboration. Initially, the alliance will focus on three projects, and the German-based group will invest up to 10 million euro in R&D activities in Singapore over the next five to eight years. The partnership will involve Singapore-based universities, hospitals, research institutes and companies. These projects are going to profile oncology drugs in Asian populations, to identify novel biomarkers and to investigate novel tumour models. Andreas Busch, head of global drug discovery at Bayer Schering Pharma, said that the firm is looking forward to making use of Singapore’s “excellent translational research capabilities and world- class research infrastructure to develop and further advance new anti-cancer therapies”. He added that “we also see this agreement as the start of further research collaborations in Singapore that Bayer will continue to invest in”. John Wong, dean of the medical school of NUS said “we are hopeful that our joint efforts will translate into discoveries to innovation therapies that will benefit Singaporeans and patients around the world.” Bayer biopharmaceuticals pact in Kentucky The Singapore deal comes a day after Bayer said that it is collaborating with the USA’s Kentucky Bioprocessing to set up a facility at the latter’s Owensboro site to produce plant-made pharmaceutical proteins and other products on commercial scale. This will be based on Bayer's magnICON technology, which is being used to develop a vaccine for the therapy of non-Hodgkin-lymphoma. Bayer is also in the process of licensing out magnICON to other parties. By Kevin Grogan For further information on this story and accompanying forums, as well as more industry news, please visit pharmatimes.com http://www.starmedical.co.uk/star-news-story.php?news=312 http://www.starmedical.co.uk/star-news-story.php?news=312 Mon, 29 Sep 2008 09:18:37 GMT A Bristol University study has already demonstrated that people who sleep less than 5 hours a night are more likely to be hungrier during the day. Their research showed that adults who regularly slept fewer than 5 hours a night had 15% more ghrelin. This hormone increases our sense of hunger and consequently often leads to eating more food during the day, in particular more calorie-rich sweet and starchy food. A University of Chicago study concurred with Bristol University’s, adding that whilst ghrelin is increased leptin – the hormone that tells us that we’re full – decreases with a lack of sleep. The two combine to greatly increase the chances of obesity. Now, a University of Michigan Study, published in the Pediatrics journal says that inadequate sleep in childhood can lead to an increased risk of obesity in adult years. The researchers analysed the sleep patterns, weight and height of 785 children aged 8, observing them again at age 11. They took into account original body mass index and controlled the experiment accordingly. Lead researcher, Dr Julia Lumeng said “Many children aren’t getting enough sleep, and that lack of sleep may not only be making them moody or preventing them from being alert and ready to learn in school, it may also be leading to a higher risk of being overweight.” Of the children who slept between 10 and 12 hours, 12% were obese by 11; of those who slept fewer than 9 hours, 22% were obese by the same age. “Our findings provide additional support for policies that propose later school start-times” commented Dr Lumeng. “The very early school start-times for US adolescents have raised concerns in the paediatric community because of their apparent adverse impact on sleep duration and, consequently, children’s general academic and behavioural functioning.” Parents’ weight and behaviour were not taken into account in the study and therefore reasons for the significant increase in the changes of obesity are somewhat speculative. However, Dr Lumeng suggested that tiredness could make children less likely to go outside and play or exercise as well as more moody and therefore more likely to seek out comfort food. Sleep and obesity researcher, Dr Sharhad Taheri said “we are just starting to work out the mechanisms: hormones play a role, but a lack of physical activity, which tires you out, could well be a factor too. Parents need to realise the importance of sleep. Taking televisions and gadgets out of bedrooms could be a really good start.” Jodi Mindell of the Children’s Hospital of Philadelphia Sleep Centre reminded of the importance of other contributing factors to weight-gain; “I don’t want parents to think, ‘If I get her to sleep, she’s not going to be overweight.’ I think this is a small piece in the http://www.starmedical.co.uk/star-news-story.php?news=311 http://www.starmedical.co.uk/star-news-story.php?news=311 Fri, 26 Sep 2008 09:29:48 GMT Thai dermatologists have reported the results of an experiment with aloe vera in the British Journal of Dermatology. The team from the Srinagarind Hospital Medical School at Khon Kaen University treated 54 patients suffering from oral lichen planus. Lichen Planus affects more than 1% of people and usually affects skin and mucous membranes. It can also affect nails and hair. Oral lichen planus lasts longer than skin lichen planus and commonly affects the cheeks, gums and tongue. It typically appears as patches of fine white lines and dots. Most cases are mild and result in few or no symptoms but more severe cases can cause painful sores and ulcers, redness, blisters and a burning sensation. There is no known cure for the condition but medicines are available to ease the discomfort. Spicy foods, citrus juices, caffeinated drinks and crispy foods can all aggravate lichen planus and interfere with healing. The disease can lead to poor dental hygiene and gum disease and in severe cases, if the underside of the tongue is involved, there is an increased risk of developing oral cancer – about twice that of the general population. The cause of oral lichen planus is unknown. Most doctors think it is likely to be an autoimmune disease in which the inflammatory cells that usually fight germs begin to attack healthy parts of the skin and mucous membranes. It may also occur as a result of an allergic reaction to certain drugs or dental materials. The condition is not infectious, inherited or nutrition-related. Of the 54 patients involved in the Thai experiment, 27 were treated with a topically applied aloe vera, and 27 were given a placebo. After 8 weeks of treatment, 81% of the aloe vera group reported positively on the treatment compared with 4% of the placebo group. For around 30% of the aloe vera group, burning sensations completely disappeared (compared with 4% of the placebo group) and 63% of the group reported their symptoms had improved by more than 50% (compared with only 7% of the placebo group). Neither group suffered from any serious side effects. One of the authors of the report, Charoen Choonhakarn, said “We found that the effect of 70 per cent aloe vera gel on the disorder was significantly better than a placebo. The results showed decreases both in clinical signs and in pain scores. Mild, adverse effects were reversible and aloe vera was well tolerated.” Aloe vera is already used to treat cuts, burns and eczema, and sap and other derivatives are often included in cosmetics (such as make-up, tissues, moisturises) though the efficacy of this is unknown. The team of dermatologists involved in the study now think the anti-inflammatory, antibacterial, antiviral, antifungal substance can be used to tackle common mouth ulcers as well as its more common use in treating skin disorders. A British Association of Dermatologists spokesperson commented, “aloe vera has proven anti-inflammatory and wound-healing properties. This is an interesting development for the treatment of mouth ulcers.” http://www.starmedical.co.uk/star-news-story.php?news=310 http://www.starmedical.co.uk/star-news-story.php?news=310 Thu, 25 Sep 2008 09:17:24 GMT Switzerland-headquartered Nycomed has announced plans to cut over 250 jobs in a bid to improve the competitiveness of its manufacturing network in Europe. The firm said it will transfer production from two Danish and a Finnish plant to other sites which will help it reduce costs “and adapt to ever-changing requirements”. With this new strategy, Nycomed will focus technologies and capabilities at five “dedicated centres of competence” which are located in Oranienburg and Singen (Germany), Lyszkowice (Poland), Linz (Austria) and Asker (Norway). In total, 10 plants in Europe will ensure supply, the company added. The country which will be most affected by the change is Denmark. The plants in Grenaa and Helseholmen will be closed, while the Roskilde facility will be re-organised and capacity will be reduced. 190 positions in Denmark will go by the end of 2009. Nycomed also noted that it will discontinue manufacturing at its Ekenas plant in Finland, and production will be transferred to Germany and Poland. Negotiations to sell the facility, where some 66 jobs are expected to go, have already started. Barthold Piening, Nycomed’s executive vice president for operations, said the restructuring will allow the firm to remain competitive “in a tough market environment, where pressure on costs and fast market introduction has become critical”. He added that “regrettably this is not possible without a reduction of a number of positions” but “we all have to acknowledge that this change is an essential precondition to secure the long-term success of the company”. Earlier this year, Nycomed announced that it will move production of active pharmaceutical ingredients from Singen and Linz to the Zydus Nycomed joint venture set up in India with partner Cadila Healthcare. By Kevin Grogan For more information, to visit forums on this and other topics, or for related articles, please visit pharmatimes.com/WorldNews http://www.starmedical.co.uk/star-news-story.php?news=309 http://www.starmedical.co.uk/star-news-story.php?news=309 Wed, 24 Sep 2008 13:53:04 GMT Boehringer Ingelheim and Pfizer have rejected claims from a meta-analysis published in the Journal of the American Medical Association which argues that the inhaled anticholinergics Spiriva and Atrovent are associated with significantly increased risk of cardiovascular death, myocardial infarction or stroke. The study published in JAMA says that patients with chronic obstructive pulmonary disease who took Spiriva (tiotropium), or Boehringer’s older treatment Atrovent (ipratropium) for at least a month had a 58% higher risk of cardiac death, heart attacks or strokes than those on placebo or other treatments. The findings were based on an analysis of 17 controlled trials involving 14,783 patients carried out by a team of researchers led by Sonal Singh of the Wake Forest University School of Medicine in Winston-Salem. The meta-analysis follows a Veterans Affairs study published in the Annals of Internal Medicine found that patients with COPD who used ipratropium were 34% more likely to die of a heart attack or arrhythmia than those using only a similar product called albuterol, or those who did not take any drugs. Furthermore in March, US regulators said they were reviewing the risk of stroke from an analysis by Boehringer of safety data from 29 studies testing either the Spiriva HandiHaler or the European-Union approved version, Spiriva Respimat, in around 13,500 patients with COPD. However Boehringer and Pfizer have responded quickly to take the JAMA meta-analysis to task. Specifically, they have released a new analysis of 30 “rigorously-controlled” clinical trials confirming the long-term safety profile of Spiriva. That data, which is taken from 19,545 COPD patients, demonstrated that there is no increased risk of death or death due to cardiovascular events in patients treated with the drug. The new and expanded safety data, which includes findings from the four-year UPLIFT study, “contradicts the conclusions about tiotropium in an article by Singh et al”, said Boehringer. Head of the firm’s R&D operations and chief executive-designate, Andreas Barner, confirmed that “we strongly disagree with the conclusion reached by Singh et al” and “patients and physicians can be confident that Spiriva is a safe and effective medication”. Boehringer said that peer-reviewed meta-analyses “have their appropriate place in scientific research” but they have “well-recognised limitations, such as combining study summaries rather than analysing individual patient data, or not correcting for patients who dropped out of trials early”. The company added that the analysis by Dr Singh and colleagues is contributed by a single study, the Lung Health Study, involving ipratropium, in which most of the cardiovascular deaths occurred among patients who were not using their medication. Other limitations include “the inability to adjust for treatment duration and accounting for patients who discontinue the trial early, apparent double-counting of trials and combining placebo and active comparator drugs in the control group”. Dr Barner added that in clinical trials and since the introduction of Spiriva, “we have collected extensive safety data adding up to an exposure of more than 10 million patient years.” The complete findings from the UPLIFT study will be presented on October 5 during the European Respiratory Society 2008 Annual Congress in Berlin. By Kevin Grogan For further comment and the opportunity to visit forums debating this topic, please visit pharmatimes.com/WorldNews