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Period Ending January 25, 2008
PREGNANCY: STUDY STRENGTHENS LINK BETWEEN CAFFEINE AND MISCARRIAGES
High doses of daily caffeine during pregnancy—whether from coffee, tea, caffeinated soda, or hot chocolate—cause an increased risk of miscarriage, according a study by the Kaiser Permanente Division of Research. The study controlled for, for the first time, pregnancy-related symptoms of nausea, vomiting, and caffeine aversion that tended to interfere with the determination of caffeine’s true effect on miscarriage risk. The research appears in the current online issue of the American Journal of Obstetrics and Gynecology. While previous research showed a link between caffeine consumption and miscarriage, this is the first study to thoroughly control for morning sickness, which typically causes many women to avoid caffeine. Women who consumed 200 mg or more of caffeine per day (two or more cups of regular coffee or five 12-ounce cans of caffeinated soda) had twice the miscarriage risk as women who consumed no caffeine. Women who consumed less than 200 mg of caffeine daily had more than 40 percent increased risk of miscarriage. The increased risk of miscarriage appeared to be due to the caffeine itself, rather than other possible chemicals in coffee because caffeine intake from non-coffee sources such as caffeinated soda, tea, and hot chocolate showed a similar increased risk of miscarriage.
High doses of daily caffeine during pregnancy—whether from coffee, tea, caffeinated soda, or hot chocolate—cause an increased risk of miscarriage, according a study by the Kaiser Permanente Division of Research. The study controlled for, for the first time, pregnancy-related symptoms of nausea, vomiting, and caffeine aversion that tended to interfere with the determination of caffeine’s true effect on miscarriage risk. The research appears in the current online issue of the American Journal of Obstetrics and Gynecology. While previous research showed a link between caffeine consumption and miscarriage, this is the first study to thoroughly control for morning sickness, which typically causes many women to avoid caffeine. Women who consumed 200 mg or more of caffeine per day (two or more cups of regular coffee or five 12-ounce cans of caffeinated soda) had twice the miscarriage risk as women who consumed no caffeine. Women who consumed less than 200 mg of caffeine daily had more than 40 percent increased risk of miscarriage. The increased risk of miscarriage appeared to be due to the caffeine itself, rather than other possible chemicals in coffee because caffeine intake from non-coffee sources such as caffeinated soda, tea, and hot chocolate showed a similar increased risk of miscarriage.
PERSONALIZED MEDICINE: STATINS ELIMINATE INCREASED RISK OF HEART DISEASE FROM PEOPLE WITH GENETIC VARIANT
Alameda, California-based Celera said three publications report that a variant of the gene encoding kinesin-like protein 6 (KIF6) is associated with up to a 55 percent increased risk of primary and recurrent coronary heart disease events. These research studies included a total of more than 30,000 individuals, among whom about 60 percent are carriers of this risk variant. These research studies also showed that the excess risk associated with the KIF6 variant was virtually eliminated by pravastatin (Pravachol) therapy and that high-dose atorvastatin (Lipitor) therapy reduced risk in carriers of the KIF6 risk variant more effectively than moderate-dose pravastatin therapy in acute coronary syndrome patients. These papers are published in the online edition of the Journal of the American College of Cardiology. The increased risk of clinical events observed in KIF6 carriers and its reduction by statin therapy was independent of other well-known CHD risk factors, including smoking, hypertension, cholesterol level, age, and sex, further supporting the conclusion that a KIF6 gene variant is a new, independent predictor of risk for CHD and clinical benefit from statin therapy.
Alameda, California-based Celera said three publications report that a variant of the gene encoding kinesin-like protein 6 (KIF6) is associated with up to a 55 percent increased risk of primary and recurrent coronary heart disease events. These research studies included a total of more than 30,000 individuals, among whom about 60 percent are carriers of this risk variant. These research studies also showed that the excess risk associated with the KIF6 variant was virtually eliminated by pravastatin (Pravachol) therapy and that high-dose atorvastatin (Lipitor) therapy reduced risk in carriers of the KIF6 risk variant more effectively than moderate-dose pravastatin therapy in acute coronary syndrome patients. These papers are published in the online edition of the Journal of the American College of Cardiology. The increased risk of clinical events observed in KIF6 carriers and its reduction by statin therapy was independent of other well-known CHD risk factors, including smoking, hypertension, cholesterol level, age, and sex, further supporting the conclusion that a KIF6 gene variant is a new, independent predictor of risk for CHD and clinical benefit from statin therapy.
CANCER: EXELIXIS AND BMS TO CO-DEVELOP HEDGEHOG PATHWAY INHIBITOR
South San Francisco, California-based Exelixis said that Bristol-Myers Squibb has exercised its option to develop and commercialize Exelixis' compound XL139, a small-molecule inhibitor of the hedgehog pathway. Hedgehog signaling is deregulated in a variety of cancers, and the pathway is a promising target for novel cancer therapies. Under the terms of the collaboration agreement between the two companies, the selection of XL139 by BMS entitles Exelixis to a milestone payment of $20 million. In addition, Exelixis has exercised its option under the collaboration agreement to co-develop and co-commercialize XL139 in the United States. Following the transfer of the XL139 development program, which is expected to occur promptly, BMS will lead all global activities. The parties will co-develop and co-commercialize XL139 in the U.S. and share those profits 50/50. Exelixis will be entitled to receive double-digit royalties on product sales outside of the U.S.
South San Francisco, California-based Exelixis said that Bristol-Myers Squibb has exercised its option to develop and commercialize Exelixis' compound XL139, a small-molecule inhibitor of the hedgehog pathway. Hedgehog signaling is deregulated in a variety of cancers, and the pathway is a promising target for novel cancer therapies. Under the terms of the collaboration agreement between the two companies, the selection of XL139 by BMS entitles Exelixis to a milestone payment of $20 million. In addition, Exelixis has exercised its option under the collaboration agreement to co-develop and co-commercialize XL139 in the United States. Following the transfer of the XL139 development program, which is expected to occur promptly, BMS will lead all global activities. The parties will co-develop and co-commercialize XL139 in the U.S. and share those profits 50/50. Exelixis will be entitled to receive double-digit royalties on product sales outside of the U.S.
BREAST CANCER: ABRAXIS WINS EU COMMISSION APPROVAL TO MARKET DRUG FOR METASTATIC DISEASE
Los Angeles-based Abraxis BioScience said that the European Commission has granted marketing approval for Abraxane powder for suspension for infusion (an albumin-bound nanoparticle formulation of paclitaxel) for the treatment of metastatic breast cancer in patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline-containing therapy is not indicated. The late-stage clinical trial results on which the approval was based demonstrated that Abraxane doubled the response rate and significantly prolonged progression-free survival and overall survival versus Taxol in the approved indication. Abraxane is now approved in 33 countries including the U.S. and Canada. In Europe, there are approximately 300,000 cases of metastatic breast cancer. The product is currently under active review in Australia, Russia, South Korea, and China by their respective regulatory agencies.
PERSONALIZED MEDICINE: 23ANDME MARKETS SERVICE IN CANADA AND EUROPE
Mountain View, California-based 23andMe said it has begun making its services available to consumers in Canada and 49 European countries. The company, which officially launched in the U.S. on November 16, 2007, helps individuals understand their own genetic information through the latest advances in DNA analysis technologies and web-based interactive tools. 23andMe sends individuals a saliva kit containing a bar-coded tube for saliva collection. Customers then use the enclosed mailing materials to send their samples to 23andMe’s contracted laboratory. The DNA is then extracted and exposed to a microchip-like device that reads more than half a million points in the individual's genome, including a proprietary set of over 30,000 markers, chosen by
23andMe scientists, to produce a detailed genetic profile.
Menlo Park, California-based Geron said it entered into a licensing agreement with Sienna Cancer Diagnostics that gives the Melbourne, Australia company access to critical granted patents and know-how related to the detection or measurement of telomerase activity. Telomerase has great potential as a cancer biomarker, being present in about 95 percent of all epithelial cancers. Sienna’s lead product in development is a non-invasive assay that utilizes Sienna’s proprietary Telomerase Biosensor Technology to detect telomerase activity in urine for the diagnosis of bladder cancer. The assay could supplement or replace invasive cystoscopy procedures. In the U.S. alone, approximately $700 million is spent annually on cystoscopic procedures to monitor and diagnose the occurrence or recurrence of bladder cancer. Under the terms of the license, Sienna gains worldwide exclusive rights within a defined field to Geron-controlled intellectual property to detect telomerase activity for the cancer in in-vitro diagnostics market. In consideration for the license, Geron received a significant equity interest in Sienna and is entitled to receive royalties on future product sales.
Palo Alto, California-based StemCells said that it has entered into a research collaboration with the Oregon Health & Science University Casey Eye Institute to evaluate the company’s proprietary purified human neural stem cells as a potential treatment for retinal degeneration, a leading cause of blindness. Published studies have shown that in a well-established animal model of retinal degeneration, known as the Royal College of Surgeons Rat Model, human neural stem cells protect retinal function and thereby preserve vision. Under the collaboration, the parties will evaluate engraftment and function of StemCells’ human neural stem cells in the same rat model as part of preparation for planned clinical trials The research is expected to be concluded by year end. In the United States, age-related macular degeneration affects over 1.5 million people in the over-65 population and is the leading cause of blindness in that group. The macula, one of the most critical parts of the retina, is responsible for processing detailed vision. Retinitis pigmentosa is a class of hereditary diseases that also leads to progressive degeneration of retinal cells. In the United States, the most common types of retinitis pigmentosa affect approximately 65,000 people. For both conditions, preventative measures are generally not available and current treatments have only limited effects.
Irvine, California-based Allergan said it has entered into a strategic collaboration with Clinique Laboratories that combines the cosmetic maker’s expertise in product development and formulation with Allergan’s leadership in the medical aesthetics market. The new skin care line, which will incorporate the Clinique brand name, will offer clinically proven skin care products to complement in-office aesthetic procedures. It will be sold exclusively in physicians’ offices in the United States and is expected to launch in the fall of 2008. Over the past ten years, non-surgical aesthetic procedures have increased nearly 750 percent, with consumers in the United States spending more than $12 billion on cosmetic procedures in 2006.
San Diego-based Cypress Bioscience and Forest Laboratories said they have submitted a New Drug Application to the U.S. Food and Drug Administration for milnacipran, a unique dual-reuptake inhibitor being developed for the treatment of fibromyalgia syndrome. Fibromyalgia syndrome is defined by widespread chronic pain, as well as a broad spectrum of related symptoms including fatigue, cognitive dysfunction, and reduced physical function. Milnacipran is a unique dual-reuptake inhibitor, which preferentially blocks the reuptake of norepinephrine with higher potency than serotonin, two neurotransmitters known to play an essential role in regulating pain and mood. It has been approved for a non-pain condition in over 50 countries, with real-world commercial experience outside the United States for 10 years. Milnacipran is jointly being developed for fibromyalgia syndrome in the United States market by Forest and its licensor, Cypress Bioscience.
URINARY TRACT: NOVABAY GETS CLEARANCE TO START HUMAN TRIALS OF ANTI-INFECTIVE TO PREVENT CATHETER INFECTIONS
Emeryville, California-based NovaBay Pharmaceuticals said it has received clearance from the U.S. Food and Drug Administration to begin human clinical trials of its lead Aganocide compound, NVC-422, for the prevention of catheter-associated urinary tract infections, or CAUTI. NVC-422 is a novel topical, non-antibiotic anti-infective compound that, in vitro, has been shown to destroy pathogens rapidly. CAUTI is the major source of hospital acquired (nosocomial) infections, accounting for more than 40 percent of all hospital infections, according to the Centers for Disease Control. These 800,000 infections result in prolonged hospitalization, urosepsis, septicemia, and, in a small proportion of cases, death. The cost of treating a case of CAUTI has been reported to vary from $2,000 to $30,000 depending upon severity. The company expects to move NVC-422 into clinical trials for additional indications during 2008.
Emeryville, California-based NovaBay Pharmaceuticals said it has received clearance from the U.S. Food and Drug Administration to begin human clinical trials of its lead Aganocide compound, NVC-422, for the prevention of catheter-associated urinary tract infections, or CAUTI. NVC-422 is a novel topical, non-antibiotic anti-infective compound that, in vitro, has been shown to destroy pathogens rapidly. CAUTI is the major source of hospital acquired (nosocomial) infections, accounting for more than 40 percent of all hospital infections, according to the Centers for Disease Control. These 800,000 infections result in prolonged hospitalization, urosepsis, septicemia, and, in a small proportion of cases, death. The cost of treating a case of CAUTI has been reported to vary from $2,000 to $30,000 depending upon severity. The company expects to move NVC-422 into clinical trials for additional indications during 2008.
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