�Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company
(NYSE: LLY) in a conference call today provided context and additional
information regarding the August 18, 2008 U.S. Food and Drug Administration
(FDA) update to a prior qui vive for BYETTA(R) (exenatide) injection referencing
pancreatitis. The companies were aware of the pancreatitis cases referenced
in the alarm, as good as others, and antecedently reported these cases to the
FDA. The complete conference call replay will be usable through Amylin's
and Lilly's corporate websites after the call.
Since 2006, the U.S. prescribing information for exenatide has included
information about pancreatitis. A recent study has also shown that patients
with type 2 diabetes were at nearly trey times the risk of developing
pancreatitis than those without diabetes.(1) While a definite causal
relationship between exenatide and pancreatitis has non been proven, to
better understand the suspected human relationship, Amylin and Lilly proceed to
engage a comprehensive drug safe program that includes extended internal
and external review of single cases, and clinical and epidemiologic
studies.
"At Amylin and Lilly, patient safety is our foremost care. We are
committed to continuing to work closely with the FDA to ensure that
physicians and patients ar provided with accurate entropy about any
potential risks associated with the use of our products," said Orville G.
Kolterman, Senior Vice President, Research and Development at Amylin. "It is
crucial to read that pancreatitis, an rabble-rousing condition of the
pancreas, is a rare event. Further, the characteristics and complications of
the pancreatitis cases in patients on exenatide ar consistent with
pancreatitis in the general population. We believe exenatide continues to
have a positive benefit-risk profile for patients with type 2 diabetes."
About BYETTA(R) (exenatide) Injection
Exenatide is the first base and only approved incretin mimetic, a class of
drugs for the discourse of type 2 diabetes. Exenatide exhibits many of the
same effects as the human incretin endocrine glucagon-like peptide-1 (GLP-1).
GLP-1, secreted in response to food intake, has multiple effects on the
bowel, liver, pancreas and head that work in concert to regularize blood
refined sugar.(2) Exenatide is approved in the European Union as adjunctive therapy
to improve blood sugar control in patients with type 2 diabetes who have not
achieved adequate glycaemic control on maximally tolerated doses of metformin
and/or a sulphonylurea, two unwashed oral diabetes medications. Since the U.S.
market instauration in June 2005, close to one billion patients
worldwide have been treated with exenatide.
About Diabetes
Diabetes affects an estimated 246 zillion adults general and more than
48 million in Europe.(3,4) Approximately 90 to 95 percentage of those are
affected by type 2 diabetes, a condition characterized by failure of the
pancreatic beta-cell to adequately respond to the increased demands for
insulin that occur as a result of obesity-related insulin resistance.(5) In
westerly countries, around 90 per centum of type 2 diabetes cases are
attributable to weight attain.(6)
Type 2 diabetes usually occurs in adults over the age of 40, just is
increasingly common in younger people.(7) In virtually every developed
society, diabetes is ranked among the preeminent causes of blindness, nephritic
failure and lower limb amputation, as well as death through its effects on
cardiovascular disease (70-80 percent of people with diabetes die of
cardiovascular disease).(8) The total cost of caring for people with diabetes
in Europe is estimated 'tween 28 1000000000 and 53 billion Euros per year. The
deliberate estimates of the costs of diabetes care in Europe measure to 42.8
zillion International Dollars per year.(9)
Important Safety Information for exenatide
In clinical studies, the most common side personal effects were hypoglycaemia (low
blood sugar) when taken with a sulphonylurea, nausea (feeling sick), vomit
and looseness of the bowels. For the full list of all side personal effects reported with exenatide,
see the Package Leaflet. Exenatide should non be used in people who may be
hypersensitized (allergic) to exenatide or any of the other ingredients.
About Incretin Mimetics
Incretin mimetics are a distinct grade of agents used to treat type 2
diabetes. An incretin mimetic workings to mimic the antidiabetic drug or glucose
lowering actions of the naturally occurring human incretin hormone GLP-1.
These actions include stimulating the body's ability to produce insulin in
response to elevated levels of blood refined sugar, inhibiting the release of a
internal secretion called glucagon following meals, slowing the rate at which nutrients
are engrossed into the bloodstream and reducing food intake.
About Amylin and Lilly
Amylin Pharmaceuticals is a biopharmaceutical company committed to
improving lives through the discovery, development and commercialization of
innovative medicines. Amylin's research and development activities leverage
the company's expertness in metabolic process to educate potential therapies to treat
diabetes and obesity. Amylin is headquartered in San Diego, California with
over 2,000 employees in the United States.
Through a longstanding commitment to diabetes caution, Lilly provides
patients with breakthrough treatments that enable them to live yearner,
healthier and fuller lives. Since 1923, Lilly has been the industry drawing card in
pioneering therapies to help health care professionals ameliorate the lives of
citizenry with diabetes, and research continues on innovative medicines to
speak the unmet needs of patients.
Lilly, a leading innovation-driven corporation, is development a maturation
portfolio of first-in-class and best-in-class pharmaceutical products by
applying the latest research from its own general laboratories and from
collaborations with high scientific organizations. Headquartered in
Indianapolis, Indiana, Lilly provides answers - through medicines and
data - for some of the world's most urgent medical inevitably.
This campaign release contains forward-looking statements about Amylin and
Lilly. Actual results could disagree materially from those discussed or implied
in this press discharge due to a number of risks and uncertainties, including
the risk that exenatide and the revenues generated from exenatide may be
affected by contender; unexpected new data; guard and technical issues;
clinical trials not confirming premature results; presymptomatic trials not
predicting future results; new drug applications and label expansion requests
not being submitted in a timely manner or receiving regulative approval; or
manufacturing and supply issues. The potential for exenatide may besides be
unnatural by government and commercial reimbursement and pricing decisions,
the pace of market acceptance, or scientific, regulatory and other issues and
risks inherent in the commercialization of pharmaceutical products. These and
additional risks and uncertainties are described more fully in Amylin's and
Lilly's most latterly filed SEC including their Quarterly Reports on Form
10-Q and Annual Reports on Form 10-K. Amylin and Lilly undertake no duty to
update these forward-looking statements.
(1) Noel R, Braun D, Patterson R, Bloomgren G. Increased risk of e
pancreatitis observed in patients with type 2 diabetes. twenty-fourth International
Conference on Pharmacoepidemiology and Therapeutic Risk Management.
Copenhagen, Denmark. International Society for Pharmacoepidemiology.
(2) Kolterman, O, Buse J, Fineman M, Gaines E, Heintz S, Bicsak T, Taylor
K, Kim D, Aisporna M, Wang Y, Baron A. Synthetic exendin-4 (exenatide)
significantly reduces postprandial and fasting glucose in subjects with type
2 diabetes. Journal of Clinical Endocrinology & Metabolism. 2003;
88(7):3082-3089.
(3) The International Diabetes Federation Diabetes Atlas. Available here.Accessed on May 22, 2008.
(4) The International Diabetes Federation, Prevalence / All diabetes.
Available http://www.eatlas.idf.org/Prevalence/All_diabetes/. Accessed on
May 22, 2008.
(5) Turner RC, Cull CA, Frighi V, Holman RR. Glycemic control with dieting,
sulfonylurea, metformin, or insulin in patients with type 2 diabetes
mellitus: progressive requirement for multiple therapies (UKPDS 49). JAMA.
1999; 281 (21):2005-2012.
(6) The International Diabetes Federation Diabetes Atlas. Available
here. Accessed on May 22,
2008.
(7) The International Diabetes Federation, Prevalence / All diabetes.
Available here. Accessed on
May 22, 2008.
(8) The International Diabetes Federation, Complications. Available here. Accessed on May 22, 2008.
(9) The International Diabetes Federation, Diabetes Atlas, Second
edition. Available here.
Accessed August 26, 2008
http://www.amylin.com
View drug information on Byetta; Glucagon.
More info
Thursday 4 September 2008
Monday 25 August 2008
Development Of Schizophrenia And Acute Maternal Stress During Pregnancy Linked
�Pregnant women who endure the psychological stress of being in a war zone ar more likely to establish birth to a small fry who develops schizophrenia. Research published in the opened access journal BMC Psychiatry supports a growing organic structure of literature that attributes maternal exposure to terrible stress during the early months of pregnancy to an increased susceptibility to schizophrenia in the offspring.
According to lead author Dolores Malaspina M.D., M.Sc.P.H., Anita Steckler and Joseph Steckler Professor of Psychiatry at the NYU School of Medicine. "The stresses in question are those that would be experienced in a natural disaster such as an earthquake or hurricane, a terrorist attack, or a sudden bereavement".
Data from 88,829 mass, born in Jerusalem from 1964 to 1976, were collected from the Jerusalem Perinatal Study that coupled birth records to Israel's Psychiatric Registry. The NYU authors discovered that the offspring of women wHO were in their instant month of pregnancy during the height of the Arab-Israeli war in June of 1967 (the "Six Day War") displayed a significantly higher incidence of schizophrenia all over the following 21-33 long time. The study also showed that the pattern was gender-specific, touching females more than males.
Following the 1967 war, females who had been in their second month of fetal life during the conflict were 4.3 times more than likely to develop dementia praecox than females born at other times. Males in their second month of fetal life were 1.2 multiplication more potential to develop schizophrenia. "It's a very striking confirmation of something that has been suspected for quite some clip", said Malaspina.
"The placenta is very sensitive to stress hormones in the mother," explains Malaspina, "these hormones were belike amplified during the time of the war."
The authors point proscribed that the study, which assessed ongoing medical records, only supports, rather than proves, the hypothesis that the sterling vulnerability to schizophrenia is in the second calendar month of maternity. Limitations to the study include a small sampling population as well as the absence of information on the exact length of gestation, which makes it possible that developmental stages were underestimated.
Malaspina also points out that pregnant women in general should not be alarmed about handling day-to-day stressors during pregnancy. "A developing foetus requires some exposure to maternal stress hormones as it normalizes their stress functioning," she says. "But women experiencing anxiety or excessive stress would do well to address it before a planned pregnancy and to have good social support systems."
About NYU Langone Medical Center
Located in the heart of New York City, NYU Langone Medical Center is one of the nation's chancellor centers of excellence in health care, biomedical research, and medical education. For over 167 years, NYU physicians and researchers have made myriad contributions to the practice and scientific discipline of health care. Today the Medical Center consists of NYU School of Medicine, including the Smilow Research Center, the Skirball Institute of Biomolecular Medicine, and the Sackler Institute of Graduate Biomedical Sciences; the trey hospitals of NYU Hospitals Center, Tisch Hospital, a 726-bed acute-care general infirmary, Rusk Institute of Rehabilitation Medicine, the first and largest facility of its kind, and NYU Hospital for Joint Diseases, a leader in musculoskeletal forethought; and such major programs as the NYU Cancer Institute, the NYU Child Study Center, and the Hassenfeld Children's Center for Cancer and Blood Disorders.
1. Acute maternal stress in pregnancy and schizophrenia in offspring: a cohort prospective study.
D Malaspina, C Corcoran, K R Kleinhaus, M C Perrin, S Fennig, D Nahon, Y Friedlander and S Harlap
BMC Psychiatry
2. The co-authors of this study are: Cheryl Corcoran, Karine R Kleinhaus, Mary C Perrin, Shmuel Fennig, Daniella Nahon and Yechiel Friedlander. The study was supported by grants from the National Institutes of Health: and from the National Alliance for Research of Schizophrenia and Depression (NARSAD).
3. BMC Psychiatry is an candid access journal publishing original peer-reviewed research articles in all aspects of the prevention, diagnosis and management of psychiatrical disorders, as well as related molecular genetics, pathophysiology, and epidemiology. BMC Psychiatry (ISSN 1471-244X) is indexed/tracked/covered by PubMed, MEDLINE, CAS, Scopus, EMBASE, Thomson Scientific (ISI) and Google Scholar.
4. BioMed Central (http://www.biomedcentral.com/) is an independent online publishing house committed to providing immediate access without charge to the peer-reviewed biological and medical research it publishes. This loyalty is based on the view that open entree to research is essential to the rapid and efficient communication of science.
Source: Nadine Woloshin
NYU Langone Medical Center / New York University School of Medicine
More info
According to lead author Dolores Malaspina M.D., M.Sc.P.H., Anita Steckler and Joseph Steckler Professor of Psychiatry at the NYU School of Medicine. "The stresses in question are those that would be experienced in a natural disaster such as an earthquake or hurricane, a terrorist attack, or a sudden bereavement".
Data from 88,829 mass, born in Jerusalem from 1964 to 1976, were collected from the Jerusalem Perinatal Study that coupled birth records to Israel's Psychiatric Registry. The NYU authors discovered that the offspring of women wHO were in their instant month of pregnancy during the height of the Arab-Israeli war in June of 1967 (the "Six Day War") displayed a significantly higher incidence of schizophrenia all over the following 21-33 long time. The study also showed that the pattern was gender-specific, touching females more than males.
Following the 1967 war, females who had been in their second month of fetal life during the conflict were 4.3 times more than likely to develop dementia praecox than females born at other times. Males in their second month of fetal life were 1.2 multiplication more potential to develop schizophrenia. "It's a very striking confirmation of something that has been suspected for quite some clip", said Malaspina.
"The placenta is very sensitive to stress hormones in the mother," explains Malaspina, "these hormones were belike amplified during the time of the war."
The authors point proscribed that the study, which assessed ongoing medical records, only supports, rather than proves, the hypothesis that the sterling vulnerability to schizophrenia is in the second calendar month of maternity. Limitations to the study include a small sampling population as well as the absence of information on the exact length of gestation, which makes it possible that developmental stages were underestimated.
Malaspina also points out that pregnant women in general should not be alarmed about handling day-to-day stressors during pregnancy. "A developing foetus requires some exposure to maternal stress hormones as it normalizes their stress functioning," she says. "But women experiencing anxiety or excessive stress would do well to address it before a planned pregnancy and to have good social support systems."
About NYU Langone Medical Center
Located in the heart of New York City, NYU Langone Medical Center is one of the nation's chancellor centers of excellence in health care, biomedical research, and medical education. For over 167 years, NYU physicians and researchers have made myriad contributions to the practice and scientific discipline of health care. Today the Medical Center consists of NYU School of Medicine, including the Smilow Research Center, the Skirball Institute of Biomolecular Medicine, and the Sackler Institute of Graduate Biomedical Sciences; the trey hospitals of NYU Hospitals Center, Tisch Hospital, a 726-bed acute-care general infirmary, Rusk Institute of Rehabilitation Medicine, the first and largest facility of its kind, and NYU Hospital for Joint Diseases, a leader in musculoskeletal forethought; and such major programs as the NYU Cancer Institute, the NYU Child Study Center, and the Hassenfeld Children's Center for Cancer and Blood Disorders.
1. Acute maternal stress in pregnancy and schizophrenia in offspring: a cohort prospective study.
D Malaspina, C Corcoran, K R Kleinhaus, M C Perrin, S Fennig, D Nahon, Y Friedlander and S Harlap
BMC Psychiatry
2. The co-authors of this study are: Cheryl Corcoran, Karine R Kleinhaus, Mary C Perrin, Shmuel Fennig, Daniella Nahon and Yechiel Friedlander. The study was supported by grants from the National Institutes of Health: and from the National Alliance for Research of Schizophrenia and Depression (NARSAD).
3. BMC Psychiatry is an candid access journal publishing original peer-reviewed research articles in all aspects of the prevention, diagnosis and management of psychiatrical disorders, as well as related molecular genetics, pathophysiology, and epidemiology. BMC Psychiatry (ISSN 1471-244X) is indexed/tracked/covered by PubMed, MEDLINE, CAS, Scopus, EMBASE, Thomson Scientific (ISI) and Google Scholar.
4. BioMed Central (http://www.biomedcentral.com/) is an independent online publishing house committed to providing immediate access without charge to the peer-reviewed biological and medical research it publishes. This loyalty is based on the view that open entree to research is essential to the rapid and efficient communication of science.
Source: Nadine Woloshin
NYU Langone Medical Center / New York University School of Medicine
More info
Friday 27 June 2008
Rockers Poison sue label over royalties, seek full accounting review
LOS ANGELES - Members of the rock band Poison claim their recording label has consistently underpaid royalties to the group throughout their career, according to a lawsuit.
The suit, filed Wednesday against Capitol Records and EMI Music Marketing, says the companies breached contracts with the band by improperly categorizing certain record sales and miscalculating everything from producer royalties to foreign taxes.
According to the band's lawsuit, they signed a contract with Enigma Records in 1986, which later transferred control to Capitol Records.
A representative for Capitol and EMI did not immediately return a phone message seeking comment Thursday.
The group claims it tried to audit the band's records kept by Capitol, but the firm didn't fully co-operate.
The band stated in its lawsuit that it cannot determine how much money it is owed and asked a judge to order Capitol Records to allow a full accounting review of the band's records.
Poison gained fame in the late 1980s and early '90s, recording hits such as "Every Rose Has Its Thorn" and "Talk Dirty to Me."
See Also
Sunday 22 June 2008
Moore brings "Grace" to a tragic mother-son story
In Natalie Robins' and Steven M.L. Aronson's book "Savage Grace," which retells a notorious 1972 crime in an oral-history format, there's a telling photograph of a young mother and child. The mother, socialite Barbara Daly Baekeland, is powdered and pale, with dark lipstick and elegantly arranged '40s hair, and she gazes at her baby with quiet rapture. It's an intriguing photograph for two reasons. First, the two people in this peaceful picture, years later, would be entwined in an intricate and (gossip had it) depraved relationship that ended in brutal violence. Second, the woman in the photograph looks uncannily like the actress Julianne Moore, so much so that it could easily be a publicity photo for the movie.
And a very strange movie it is, too, despite marvelous work by Moore as her look-alike. Barbara Baekeland wasn't to the manor born, but was a would-be actress who married into the Bakelite plastics fortune. Lonely in her unhappy, globe-trotting marriage, she became increasingly close to her only child. In the book, gossipy friends describe the mother/son relationship as unnatural; the movie, with some shockingly explicit scenes, depicts it as such. It's a terribly sad story, right down to the final title cards on the screen; no one is left to tell what really happened.
Director Tom Kalin ("Swoon"), working from a screenplay by Howard A. Rodman, turns the story into a languorous mood piece, so slow and sultry it seems not entirely there at all. The characters of Barbara, her husband, Brooks (Stephen Dillane), and teenage/adult Tony (Eddie Redmayne, his hair petulantly tousled) speak so archly you practically see the quotation marks trailing behind them as they stroll through various chic settings, smoking and preening. Though the film looks elegant, with deceptively simple interiors creating an impression of great wealth, it feels remote. We're impressed by the work the actors are doing, yet the characters don't hold our interest.
You can see, though, why Moore was drawn to the role, physical resemblance aside. Her character seems defined by the idea of having almost been an actress (the real Barbara spent a bit of time in Hollywood doing screen tests before her marriage), and Moore lets us see that Barbara is always putting on a bit of a show, keeping her real self mostly hidden. She walks in careful, brittle steps, as if worried about what she's stepping in, and her laughs all seem carefully planned. It's an intricate, layered performance; a touch of soul in a too-often soulless movie.
Moira Macdonald: 206-464-2725
or mmacdonald@seattletimes.com
See Also
Saturday 14 June 2008
DJ Spen and Osunlade
Artist: DJ Spen and Osunlade
Genre(s):
Other
Discography:
Soul Heaven Presents DJ Spen and Osunlade
Year: 2006
Tracks: 10
Monday 9 June 2008
Jackass star arrested in Hollywood
'Jackass' star Steve-O has been arrested by police investigating claims of vandalism and possession of a controlled substance at his Hollywood home.
Police arrested the 33-year-old co-star of the MTV programme after a neighbour made a citizen's arrest following a dispute over a fence, Los Angeles police officer Ana Aguirre said.
The British-born star, whose full name is Stephen Glover, was booked at a Hollywood police station on suspicion of vandalism and an outstanding traffic warrant.
He was also charged for investigation of possessing a controlled substance for allegedly having a small quantity of drugs on him, Aguirre said.
Police arrested the 33-year-old co-star of the MTV programme after a neighbour made a citizen's arrest following a dispute over a fence, Los Angeles police officer Ana Aguirre said.
The British-born star, whose full name is Stephen Glover, was booked at a Hollywood police station on suspicion of vandalism and an outstanding traffic warrant.
He was also charged for investigation of possessing a controlled substance for allegedly having a small quantity of drugs on him, Aguirre said.
Sunday 8 June 2008
Richard Hammond talks about depression
'Top Gear' star Richard Hammond has revealed that he has suffered from depression since being involved in a high-speed car smash in 2006.
Speaking to The Sunday Times, the television presenter said: "I damaged all the complicated bits of the brain to do with processing and emotional control."
"[I was] prey to every single emotion that swept over me and I couldn't deal with it. I had to relearn things from scratch."
Hammond also said: "I'll still have a week when I'm freaking out about something and I'll realise it's because I'm encountering a new emotional state and I have to evolve a new strategy to cope with it."
"My memory is a lot better but the other day I forgot the PIN numbers to all my cards. All of them. Completely gone."
The star suffered a "significant" brain injury in September 2006 when the jet-powered dragster he was driving went off a track and crashed at a speed of 288mph.
Speaking to The Sunday Times, the television presenter said: "I damaged all the complicated bits of the brain to do with processing and emotional control."
"[I was] prey to every single emotion that swept over me and I couldn't deal with it. I had to relearn things from scratch."
Hammond also said: "I'll still have a week when I'm freaking out about something and I'll realise it's because I'm encountering a new emotional state and I have to evolve a new strategy to cope with it."
"My memory is a lot better but the other day I forgot the PIN numbers to all my cards. All of them. Completely gone."
The star suffered a "significant" brain injury in September 2006 when the jet-powered dragster he was driving went off a track and crashed at a speed of 288mph.
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