Record $46.7 Million In Recoveries For The Massachusetts Medicaid Program In 2008
Attorney General Martha Coakley’s Office announced that recoveries by the office’s Medicaid Fraud Division totaled more than $46.7 million during 2008, breaking the previous recovery record, set in 2007, by over $20 million. Approximately $73.2 million has been returned to the state Medicaid program by the Medicaid Fraud Division during Attorney General Coakley’s two years in office. The Medicaid Fraud Division is responsible for the investigation and prosecution of fraud against the state Medicaid program.
The $46.7 million recovered in 2008 is primarily the result of 13 civil settlements, nine of which were multi-state agreements. Representatives from the Attorney General’s Medicaid Fraud Division serve on national multi-state fraud teams that negotiate the resolution of these cases, which in 2008 resulted in the return of over $1.4 billion to the federal government and state Medicaid programs across the country.
“We have built strong partnerships with other state and federal agencies,” Attorney General Coakley said. “This broad based approach has allowed us to aggressively pursue both local and national providers whose fraudulent practices cause great harm to this vital program which provides the most fundamental services to the Commonwealth’s most vulnerable citizens. While we are extremely proud of these results, we are troubled that this fraudulent behavior seems to be increasing at a time when health care costs are rising. Our office will continue to be a leader in the efforts to combat this growing epidemic and to assist the Medicaid program in operating as efficiently and cost effectively as possible.”
During 2008, the Attorney General reached multi-million dollar agreements with three generic drug manufacturers to settle a False Claims Act case pending in the United States District Court in Boston. Most recently, in December 2008, Teva Pharmaceuticals USA, Inc., and its wholly-owned subsidiary, Ivax Corporation, agreed to pay a combined $7 million to settle allegations against them. Boehringer Ingelheim Roxane, Inc. similarly agreed to pay $1.8 million in September 2008.
In March 2008, as a result of a seven-year investigation initiated and led by the Massachusetts Medicaid Fraud Division, the National Association of Medicaid Fraud Control Units reached a settlement with CVS/Caremark to resolve allegations that the retail pharmacy chain violated various state and federal statutes and regulations. The settlement recovered a total of $36.7 million for 23 states Medicaid programs and returned $3.7 million to the Massachusetts Medicaid program.
In one of the largest healthcare fraud settlements ever reached, Massachusetts received $10.5 million in February 2008 as part of two separate global settlements with the pharmaceutical giant Merck & Co., Inc, totaling $649 million dollars. An Assistant Attorney General in the Medicaid Fraud Division served as a member of the four-person national Medicaid fraud team that negotiated on behalf of the 49 states that participated in the settlements.
In another multistate settlement, Massachusetts received $9.2 million from international pharmaceutical manufacturer Bristol-Myers Squibb Company in July 2008. The joint investigation was conducted by the U.S. Department of Justice, the U.S. Attorney’s Office for the District of Massachusetts, and a five-person national Medicaid fraud team which included an Assistant Attorney General from Attorney General Coakley’s Medicaid Fraud Division.
Medicaid is a multi-billion dollar joint state and federal program that provides health insurance for the economically disadvantaged. The monies recovered by the Medicaid Fraud Division are returned to the Medicaid program.
Attorney General Martha Coakley’s Office
Chinese Women Want More Children
The Chinese authorities released on Thursday the results of a 2006 survey that showed most women in China would like to have more than the
one child they are currently allowed under the country’s strict one child per couple rule.
The Chinese government says the one child per couple rule has slowed down the country’s birth rate and helped millions of people to become
wealthier. They are not going to change the rule.
The Chinese National Population and Family Planning Commission 2006 survey found that 71 per cent of Chinese women want two or more
children. According to China Daily, vice minister of the Commission, Jiang Fan, said:
“The figure rose 7.6 percentage points between 2001 and 2006, which indicates a possible baby boom.”
Jiang said 83 per cent of the women in the survey said they wanted a son and a daughter, adding that many women thought an only child gets lonely and
can become spoiled.
The current policy in China is that couples can only have one child, unless both partners are only children, in which case they can have two children.
This is the same for ethnic minorities.
The one-child policy was introduced in the late 1970s, following a massive population rise from 542 to 963 million between 1949 and 1978. The
result was a slowing in population growth of 1.2 per cent per year in 1978 to 0.52 per cent in 2007, said a report in Xinhua, a state run news
agency.
At the end of 2007, China’s population was 1.32 billion; the government wants to keep this under 1.36 billion by the end of 2010.
The pressure to contain population growth however is being increasingly challenged as people live longer, the economy grows, and people’s quality of
life improves, leading them to want more children.
But Li Bin, minister of the commission, said the government would be sticking to the existing plan to keep the birth rate low. She told a meeting on
Thursday that:
“China’s family planning policy underpins the country’s economy and demographics.”
Other figures released by the National Population and Family Planning Commission at the same time showed that the trend of gender imbalance
among newborn babies has slowed since 2005 but the problem is still “very grave”.
The 2005 figures cover 28 Chinese provinces and show that the imbalance of baby boys to baby girls fell in 17, rose slightly in seven, but was still a
major problem in 4 provinces.
Overall, the ratio is still not even, but thought to be about 103 to 107 boys to every 100 girls, according to a comment vice minister Jiang Fan made at
a conference.
According to Xinhua, the sex imbalance problem started in the late 1980s after ultrasound scans began to show the sex of fetuses, causing many
women to abort females, in line with the cultural preference for male infants.
Jiang said the authorities were making strenuous efforts to crack down on illegal gender identification of fetuses and illegal abortions and this was the
most likely reason for the improvement in the figures.
Sources: Xinhua.
Written by: Catharine Paddock, PhD
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today
FDA Approves Fibromyalgia Drug – Savella(TM) (milnacipran HCl), A Selective Serotonin And Norepinephrine Dual Reuptake Inhibitor
Forest Laboratories, Inc. (NYSE: FRX) and Cypress Bioscience, Inc. (Nasdaq: CYPB) today announced that Savella(TM) (milnacipran HCl), a selective serotonin and norepinephrine dual reuptake inhibitor, was approved by the U.S. Food and Drug Administration (FDA) for the management of fibromyalgia. Fibromyalgia is a chronic condition characterized by widespread pain and decreased physical function, afflicting as many as six million people in the United States. The safety and efficacy of Savella was established in two US pivotal phase III clinical trials involving over 2,000 patients with fibromyalgia. The studies showed that Savella doses of 100 mg/day and 200 mg/day demonstrated statistically significant and clinically meaningful concurrent improvements in pain, patient global assessment, and physical function. The companies expect Savella to be available in pharmacies by March 2009.
“Fibromyalgia is a complicated chronic pain condition, so it is important that physicians and patients have access to treatments that have been shown to help manage the symptoms that define the experience of fibromyalgia,” said Dr. Daniel Clauw, Professor of Anesthesiology and Medicine (Rheumatology) at the University of Michigan. “The introduction of Savella is important because it is the first drug approved to treat the symptoms of fibromyalgia using a composite responder analysis.”.
“Savella is the product of a unique clinical development program, one that considered a patient to be a responder to therapy only if they demonstrated concurrent clinically significant changes in multiple aspects of their fibromyalgia, including pain, patient global assessment and physical function. Savella is the only product approved for the management of fibromyalgia that used this complete responder analysis as its primary endpoint,” said Jay D. Kranzler, MD, PhD, Chairman and CEO of Cypress Bioscience.
Howard Solomon, Chairman and Chief Executive Officer of Forest said, “We and our partner Cypress Bioscience are very pleased to receive marketing approval for Savella, following a first-cycle review, from the FDA. Fibromyalgia is a chronic and often debilitating condition with a significant need for new therapies. Savella is a valuable new treatment for patients afflicted with fibromyalgia. Its effectiveness was evaluated based upon the multiple symptoms included in the responder analysis.”
“This approval is crucial for Pierre Fabre Laboratories as milnacipran is one of the flagship products of our portfolio and represents another product of Pierre Fabre research registered in the United States,” said Jean-Pierre Garnier, Chief Executive Officer of Pierre Fabre SA.
Although the exact mechanism by which Savella improves the symptoms of fibromyalgia is unknown, some researchers believe that abnormalities in certain brain neurotransmitters may be central to fibromyalgia. Savella blocks the reuptake of both norepinephrine and serotonin, with greater selectivity for the inhibition of norepinephrine reuptake in vitro. This may be the mechanism by which Savella acts to improve the symptoms of fibromyalgia.
Data Highlights
The clinical development program for Savella was unique in its use of a composite responder analysis as the primary endpoint. This endpoint required individual patients to demonstrate concurrent improvement to multiple validated measures, including pain (visual analog scale), patient global assessment (patient global impression of change), and physical function (Short Form-36 Physical Component Summary).
The efficacy of Savella was established in two US pivotal Phase III clinical trials involving 2,084 treated patients (1,460 Savella; 624 placebo), which showed that Savella demonstrated clinically significant improvements compared to placebo in treating fibromyalgia. The first study was 6 months in duration and the second study was 3 months in duration.
In both studies, a greater proportion of patients in the Savella treatment arms (100 mg/day and 200 mg/day) as compared with placebo treatment, at 3 months, experienced at least a 30% reduction in pain from baseline and also rated themselves as “very much improved” or “much improved” based on the patient global assessment. In addition, a greater proportion of patients treated with Savella as compared with placebo treatment met the criteria for a treatment response as measured by concurrent improvements in pain, physical function, and patient global assessment. In both studies, some patients who rated themselves as globally “much” or “very much” improved experienced a decrease in pain as early as week 1 of treatment with a stable dose of Savella that persisted throughout these studies.
The clinical development program demonstrated that Savella was safe and generally well tolerated. The most frequently occurring adverse reaction was nausea. Other common adverse reactions reported in these clinical trials were constipation, hot flush, hyperhidrosis, vomiting, palpitations, heart rate increased, dry mouth and hypertension. The majority of adverse reactions reported were mild to moderate in nature.
About Savella
Savella is a dual-reuptake inhibitor that preferentially blocks the reuptake of norepinephrine with higher potency than serotonin (in-vitro), two neurotransmitters thought to a play a central role in the symptoms of fibromyalgia. Savella will be marketed by Forest and its licensor, Cypress Bioscience. Pierre Fabre, who originally developed and sells milnacipran outside the U.S., licensed the rights for North America to Cypress Bioscience.
About Fibromyalgia
Fibromyalgia is a chronic and debilitating condition characterized by widespread pain and decreased physical functioning. According to the American College of Rheumatology fibromyalgia is estimated to affect over 6 million Americans. It is most often diagnosed in the primary care setting and is the second most commonly diagnosed condition in rheumatology clinics in the United States after osteoarthritis. Despite the high prevalence and severity of this condition, there are limited treatment options specifically approved for fibromyalgia in the United States.
Important Safety Information
Savella is a selective serotonin and norepinephrine inhibitor (SNRI), similar to some drugs used for the treatment of depression and other psychiatric disorders. Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of such drugs in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on Savella should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Savella is not approved for use in the treatment of major depressive disorder. Savella is not approved for use in pediatric patients.
Savella is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs) concomitantly or within 14 days of discontinuing treatment of an MAOI or in patients with uncontrolled narrow-angle glaucoma.
Development of a potentially life-threatening serotonin syndrome may occur with agents that inhibit serotonin reuptake, including Savella, particularly with concomitant use of serotonergic drugs (including triptans and tramadol) and with drugs which impair metabolism of serotonin (including MAOIs). The concomitant use of Savella with serotonin precursors is not recommended.
Blood pressure and heart rate should be monitored prior to initiating treatment with Savella and periodically throughout treatment. SNRIs, including Savella, have been associated with reports of increases in blood pressure and heart rate. Pre-existing hypertension, tachyarrhythmias and other cardiac diseases should be treated before starting therapy with Savella. Savella should be used with caution in patients with significant hypertension or cardiac disease. For patients who experience a sustained increase in blood pressure or heart rate while receiving Savella, either dose reduction or discontinuation should be considered.
Savella should be prescribed with caution in patients with a history of a seizure disorder, mania or controlled narrow-angle glaucoma.
Savella has been associated with mild elevations of ALT and AST. Rarely, fulminant hepatitis has been reported in patients treated with milnacipran. Savella should be discontinued in patients who develop jaundice or other evidence of liver dysfunction and should not be resumed unless another cause can be established.
Savella should ordinarily not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease.
As with other SNRIs and SSRIs withdrawal symptoms have been observed following discontinuation of milnacipran. A gradual dose reduction is recommended.
Hyponatremia may occur as a result of treatment with SSRIs and SNRIs, including Savella. Discontinuation should be considered for patients with symptomatic hyponatremia.
SSRIs and SNRIs, including Savella, may increase the risk of bleeding events. Patients should be cautioned regarding the risk of bleeding associated with concomitant use of Savella and NSAIDs, aspirin, warfarin or other drugs that affect coagulation.
Male patients with a history of obstructive uropathies may experience higher rates of genitourinary adverse events.
Savella is unlikely to be involved in clinically significant pharmacokinetic drug interactions. Pharmacodynamic interactions of Savella with other drugs can occur.
Savella contains FD&C Yellow No. 5, which may cause allergic-type reactions in susceptible persons.
In clinical trials, the most frequently occurring adverse reaction was nausea. The most commonly occurring adverse reactions (greater than or equal to 5% and twice that of placebo) were constipation, hot flush, hyperhidrosis, vomiting, palpitations, heart rate increased, dry mouth, and hypertension.
About Forest Laboratories
Forest Laboratories (NYSE: FRX) is a U.S.-based pharmaceutical company with a long track record of building partnerships and developing and marketing products that make a positive difference in people’s lives. In addition to its well-established franchises in therapeutic areas of the central nervous and cardiovascular systems, Forest’s current pipeline includes product candidates in all stages of development and across a wide range of therapeutic areas. The company is headquartered in New York, NY. To learn more about Forest Laboratories, visit www.FRX.com.
Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories’ Annual Report on Form 10-K, Quarterly Report on Form 10-Q, and any subsequent SEC filings.
About Cypress Bioscience
Cypress Bioscience, Inc. provides therapeutics and personalized medicine services, facilitating improved and individualized patient care. Cypress addresses the evolving needs of specialist physicians and their patients by identifying unmet medical needs in the areas of pain, rheumatology, and physical medicine and rehabilitation, including challenging disorders such as fibromyalgia and rheumatoid arthritis. This approach to improving patient care creates a unique partnership with physicians.
For more information about Cypress, please visit the Company’s website at http://www.cypressbio.com.
This press release, as well as Cypress’ SEC filings and website at www.cypressbio.com, contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 including statements about the potential of Savella to treat fibromyalgia syndrome and its availability in pharmacies by March 2009. Actual results could vary materially from those described as a result of a number of factors, including those set forth in Cypress’ Annual Report on Form 10-K, the most recent Quarterly Report on Form 10-Q and any subsequent SEC filings and including, but not limited to, that Savella may not achieve market acceptance.
About Pierre Fabre
The Pierre Fabre group, France’s second biggest independent pharmaceutical laboratory, achieved a turnover of 1.7 billion euros in 2007. It employs nearly 10,000 people including 1,400 in the research sector. Its business sectors are ethical products, healthcare products and dermocosmetics with the brands Avene, Ducray, A Derma, Galenic, Klorane and Rene Furterer. The Pierre Fabre group dedicates 25% of its annual turnover to R&D in five main therapeutic directions: oncology (PFM’s priority R&D sector with 50% of the over all R&D budget), the Central Nervous System, cardiology, internal medicine /urology and dermatology.
Pierre Fabre
What Are The Needs Of Cancer Survivors When They No Longer Require Specialized Care?
According to the National Cancer Policy Board, it is estimated that by the year 2050 there will be more cancer survivors in the United States than those newly diagnosed with the disease. That is why researchers at The Cancer Institute of New Jersey (CINJ) are taking a closer look at the specific needs of cancer survivors as they transition from specialty care back to their primary care provider. CINJ is a center of excellence of UMDNJ-Robert Wood Johnson Medical School.
A research study sponsored by the National Cancer Institute, CINJ and the U.S. Department of Defense will look at how breast and prostate cancer survivors view their medical needs as they no longer need to be under the care of an oncologist and go back to their regular family doctor, internist or gynecologist for follow-up care. Breast and prostate cancer survivors were chosen as the focus of this trial, because those groups represent the most common forms of cancer in survivors and screenings such as mammograms or blood work to see if the cancer has returned are often performed in a primary care setting.
Shawna V. Hudson, PhD, director of community research at CINJ and assistant professor of family medicine at UMDNJ-Robert Wood Johnson Medical School, is the lead investigator of the trial: “There have only been a few previous studies on this topic and the cancer survivor population continues to grow; therefore, it is critical to identify patterns of care that are most optimal for this group and to help them communicate their needs to general healthcare providers.”
A selected group of 36 survivors will undergo a 60 to 90 minute phone interview and will be asked a number of questions pertaining to how they view care from their primary care physician in relation to follow-up cancer care. Data from this first phase will then be used to develop a separate, self-conducted survey of 15 to 20 minutes featuring similar, but more specific questions targeted toward 720 survivors. While the entire study is expected to last five years, participants will only take part in their individual interview or questionnaire just one time.
Those who are survivors of breast or prostate cancer and are 30 years of age or older are eligible to take part in the study, although other criteria must be met. The study will recruit patients who were seen at CINJ and the Fox Chase Cancer Center in Philadelphia, as well as the affiliated network of hospitals for both institutions. For more information on how to participate, individuals should call CINJ’s Office of Human Research Services at 732-235-8675.
As New Jersey’s only National Cancer Institute-designated Comprehensive Cancer Center, CINJ provides patients with access to treatment options not available at other institutions within the state. CINJ currently enrolls more than 1,000 patients on clinical trials, including approximately 15 percent of all new adult cancer patients and approximately 70 percent of all pediatric cancer patients. Enrollment in clinical trials nationwide is fewer than five percent of all adult cancer patients.
About The Cancer Institute of New Jersey
The Cancer Institute of New Jersey is the state’s first and only National Cancer Institute-designated Comprehensive Cancer Center, and is dedicated to improving the prevention, detection, treatment and care of patients with cancer. CINJ’s physician-scientists engage in translational research, transforming their laboratory discoveries into clinical practice quite literally bringing research to life. The Cancer Institute of New Jersey is a center of excellence of UMDNJ-Robert Wood Johnson Medical School. To support CINJ, please call the Cancer Institute of New Jersey Foundation at 1-888-333-CINJ.
The Cancer Institute of New Jersey Network is comprised of hospitals throughout the state and provides a mechanism to rapidly disseminate important discoveries into the community. Flagship Hospital: Robert Wood Johnson University Hospital. Affiliate Hospitals: Bayshore Community Hospital, Carol G. Simon Cancer Center at Morristown Memorial Hospital, Carol G. Simon Cancer Center at Overlook Hospital, CentraState Healthcare System, Cooper University Hospital*, Jersey Shore University Medical Center, JFK Medical Center, Raritan Bay Medical Center, Robert Wood Johnson University Hospital at Hamilton (CINJ at Hamilton), Saint Peter’s University Hospital, Somerset Medical Center, Southern Ocean County Hospital, The University Hospital/UMDNJ-New Jersey Medical School*, and University Medical Center at Princeton. *Academic Affiliate
The Cancer Institute of New Jersey
Source
Michele Fisher
Media Relations Specialist
Office of Communications
The Cancer Institute of New Jersey
195 Little Albany Street
New Brunswick, NJ 08903
http://www.umdnj.edu
Modigene Announces Positive Results Of Pilot Toxicity Study Of Its Long-Acting Human Growth Hormone HGH-CTP
Modigene Inc. (OTC Bulletin Board: MODG) reported results from a pilot toxicity study in primates designed to assess the safety of hGH-CTP, its long-acting human growth hormone (hGH), as well as to provide preliminary information on the approximate injection frequency that will be needed in human patients. The study was designed to elicit potential adverse effects from a single, very large dose of hGH-CTP, also known as MOD-4023. No adverse effects were observed, and the data from this study also support once-weekly or bi-monthly injection frequency in humans.
The pilot study included a group of primates that received a single injection of hGH-CTP containing a dose that was 1,040 times the daily dose of growth hormone recommended for use in human patients. No adverse effects were observed in any of the primates. In addition, the half-life and AUC (area under the curve) of hGH-CTP as measured in primates support a potential once-weekly or bi-monthly injection frequency in humans. This would replace the multiple injections per week that are currently required, as there is presently no long-acting hGH on the market.
“Our long-acting hGH-CTP has exhibited excellent safety in all preclinical studies to date, so we were not surprised by these first data in primates showing that huge single doses of hGH-CTP appear very safe,” said Dr. Avri Havron, CEO of Modigene. “We also were pleased to report a significant increase in the half-life of hGH-CTP as we moved from rats to primates, in line with industry-accepted extrapolation models for the expected increase in the half-life of therapeutic proteins between these species. Based on the results of this pilot study, we anticipate that hGH-CTP could potentially achieve weekly or bi-monthly dosing frequency in humans.”
Dr. Havron added, “We look forward to completing these toxicology studies and finalizing the IND for hGH-CTP in the coming months. We are pleased too that our current cash resources should enable us to complete the hGH-CTP Phase I clinical program and continue into Phase II trials over the next 24 months.”
ABOUT hGH-CTP (MOD-4023)
hGH-CTP, also known as MOD-4023, is Modigene’s proprietary long-acting version of human growth hormone. hGH is used for the long-term treatment of children and adults with growth failure due to inadequate secretion of endogenous growth hormone. Patients using hGH must currently inject the drug between two and seven times each week, a frequency that can be particularly burdensome for pediatric patients. In contrast, hGH-CTP is expected to require only weekly or bi-monthly injections. The primary indications for hGH in children are growth hormone deficiency, kidney disease, Prader-Willi Syndrome and Turner Syndrome. In adults, the primary indications are replacement of endogenous growth hormone and the treatment of AIDS-induced weight loss. In 2007 the annual market for hGH was estimated at $2.5 billion. In addition to its use for medical indications, hGH has been shown to promote a number of “lifestyle” benefits including reversal of non-voluntary weight loss, increased energy levels, enhanced sexual performance, lower cholesterol and improved appearance of the skin.
ABOUT CTP
Modigene’s CTP technology was discovered by researchers at Washington University in St. Louis and is based on a short amino acid sequence that occurs naturally in humans, the carboxyl terminal peptide (CTP). When attached to a therapeutic protein, CTP extends the time that the protein is active in the body. The potential utility of the technology has been demonstrated by Schering-Plough, which licenses the CTP technology for fertility applications only. In July 2008 Schering-Plough announced successful data from its Phase III ENGAGE trial demonstrating that women receiving a single injection of the fertility drug FSH-CTP achieved the same pregnancy rates as women receiving seven consecutive daily injections of commercial FSH. This 1,509 patient trial, which was the largest double-blind fertility trial ever conducted, formed the basis for a Marketing Authorization Application by Schering-Plough that was recently accepted for review by the European Medicines Agency. Modigene is using the same CTP technology to extend the duration of action of human growth hormone and other therapeutic proteins. It has an exclusive license from Washington University to the CTP technology for use with all therapeutic proteins except for the four endocrine hormones licensed to Schering-Plough.
ABOUT MODIGENE
Modigene Inc. is a biopharmaceutical company applying its patented CTP technology to develop longer-acting, proprietary versions of already approved therapeutic proteins that currently generate billions of dollars in annual global sales. The CTP technology is applicable to virtually all proteins, and Modigene is currently developing long-acting versions of human growth hormone, interferon beta and erythropoietin, which are in late preclinical development, as well as GLP-1. For more information on Modigene, visit http://www.modigeneinc.com.
Safe Harbor Statement: This press release contains forward-looking statements, including statements regarding the results of current studies and preclinical experiments and the effectiveness of Modigene’s long-acting protein programs, that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Modigene’s business and prospects, including the risks that Modigene may not succeed in developing any commercial products based upon its long-acting protein technology, including any long-acting versions of human growth hormone, erythropoietin, interferon beta or GLP-1; that the long-acting products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The development of any products using the CTP platform technology could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors set forth above, investors should consider the economic, competitive, governmental, technological and other factors discussed in Modigene’s filings with the Securities and Exchange Commission.
Modigene Inc.
http://www.modigeneinc.com
ISTA Pharmaceuticals’ New Drug Application For Bepreve(TM) Accepted For Review By U.S. Food And Drug Administration
.ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), announced that ISTA’s New Drug Application (NDA) for Bepreve(TM) (bepotastine ophthalmic solution) has been accepted for review by the U.S. Food and Drug Administration (FDA). The Company is seeking approval for Bepreve as an eye drop treatment for ocular itching associated with allergic conjunctivitis. The Company expects a standard review of ten months and has been given a user fee action date of September 12, 2009.
ISTA’s Phase III clinical studies with Bepreve demonstrated highly statistically significant reductions in the primary endpoints of ocular itching. In addition, the results showed Bepreve had a statistically significant effect on the rapidity of response and on additional signs or symptoms of ocular allergy, including improvement in nasal symptoms. There were no serious ocular adverse events reported in patients dosed with Bepreve.
About Bepreve(TM) (bepotastine ophthalmic solution)
Assuming approval from the FDA, Bepreve would participate in ISTA’s largest market to date. IMS Health estimates the U.S. ocular allergy market generated approximately $560 million in sales in 2007. Bepreve is a non-sedating, highly selective antagonist of the histamine (H1) receptor. It has a stabilizing effect on mast cells and it suppresses the migration of eosinophils into inflamed tissues. The compound’s primary mechanisms of action are believed to make it an effective treatment against the signs and symptoms of allergic conjunctivitis.
Bepotastine was approved in Japan for use as a systemic drug in the treatment of allergic rhinitis and urticaria/pruritus in July 2000 and January 2002, respectively, and is marketed by Mitsubishi Tanabe Pharma Corporation (formerly Tanabe Seiyaku Co., Ltd.) under the brand name TALION(R). TALION was co-developed by Tanabe Seiyaku and Ube Industries, Ltd., who discovered bepotastine. In 2001, Tanabe Seiyaku granted Senju Pharmaceutical Co., Ltd., exclusive worldwide rights, with the exception of certain Asian countries, to develop, manufacture and market bepotastine for ophthalmic use. In 2006, ISTA licensed the exclusive North American rights from Senju to an eye drop formulation of bepotastine for the treatment of allergic conjunctivitis.
About ISTA Pharmaceuticals
ISTA Pharmaceuticals is an ophthalmic pharmaceutical company. ISTA’s products and product candidates addressing the $4.7 billion U.S. prescription ophthalmic industry include therapies for inflammation, ocular pain, glaucoma, allergy, and dry eye. The Company currently markets three products and is developing a strong product pipeline to fuel future growth and market share, thereby continuing its growth to become the leading niche ophthalmic pharmaceutical company in the U.S. For additional information regarding ISTA, please visit ISTA Pharmaceuticals’ website at http://www.istavision.com.
Any statements contained in this press release that refer to future events or other non-historical matters are forward-looking statements. Without limiting the foregoing, but by way of example, statements contained in this press release related to the FDA’s timely review and approval of Bepreve, ISTA’s belief the FDA will review and take action on Bepreve within ten months of filing and ISTA’s expectation of becoming the leading niche ophthalmic pharmaceutical company are forward-looking statements. Except as required by law, ISTA disclaims any intent or obligation to update any forward-looking statements. These forward-looking statements are based on ISTA’s expectations as of the date of this press release and are subject to risks and uncertainties that could cause actual results to differ materially. Important factors that could cause actual results to differ from current expectations include, among others, delays and uncertainties related to the FDA or other regulatory agency approval or actions; uncertainties and risks regarding market acceptance of and demand for ISTA’s approved products; and such other risks and uncertainties as detailed from time to time in ISTA’s public filings with the U.S. Securities and Exchange Commission, including but not limited to ISTA’s Annual Report on Form 10-K for the year ended December 31, 2007, and its most recent Quarterly Report on Form 10-Q for the quarter ended September 30, 2008.
ISTA Pharmaceuticals, Inc.
http://www.istavision.com
VProtect(TM) Luminal Shield Stabilizes Life-Threatening Plaque
The first patient receiving focal preventive treatment for vulnerable plaque recently underwent a 6-month follow-up examination that revealed successful stabilization of the target plaque. The interventional cardiology team led by Professor Patrick W. Serruys, MD, PhD, of Erasmus University, placed a vProtect(TM) Luminal Shield in the left anterior descending (LAD) coronary artery of the patient at Erasmus Medical Center in Rotterdam in June of 2008. The 64-year-old man is enrolled in SECRITT I, a pilot study designed to evaluate the vProtect(TM) Luminal Shield as a treatment for vulnerable plaques–”silent” atherosclerotic deposits in the coronary arteries that do not produce symptoms until they rupture with potentially fatal consequences.
To date, the treated artery demonstrated excellent blood flow and healing. As part of the healing process the Shield is now covered by a thin layer of tissue, incorporating it into the arterial wall. This is a hallmark of a successful implant and demonstrated that the Shield performed much better than would be expected for traditional bare metal stents and comparable to the first generation of drug-eluting stents.
“The self-expanding vProtect(TM) Luminal Shield minimizes injury on deployment enabling safe placement over rupture-prone vulnerable plaques,” said Patricia Scheller, CEO of Prescient Medical, the manufacturer of the vProtect(TM) Luminal Shield. “Given that there are more than 500,000 sudden cardiac deaths in the US, and more than 300,000 in Europe each year, we are pleased that our device addresses untreated vulnerable plaques, the culprit in a majority of sudden cardiac deaths.”
Patients enrolled in SECRITT I have been referred to the cath lab for treatment of clinically significant coronary lesions, which are treated according to current standards of care. Using a combination of ultrasound and optical imaging techniques, the SECRITT I investigators examine the coronary arteries for signs of additional, non-flow-limiting vulnerable plaques, for which patients would not generally receive treatment. Patients with vulnerable plaques undergo follow-up diagnostic catheterizations 6 months post-treatment, at which time investigators determine the Shield’s impact.
According to Professor Serruys, the vProtect(TM) Luminal Shield represents a logical extension of modern cardiac medicine: “We are very good at opening arteries that are blocked, but we have not succeeded in preventing heart attacks related to plaque rupture. The vProtect(TM) Luminal Shield has demonstrated that it can be safely placed over a vulnerable lesion without rupturing the plaque, and the results at six months are extremely promising. The Shield performed exactly as intended, allowing us to prevent plaque rupture and an acute event, rather than trying to repair the damage after the fact.”
About Prescient Medical, Inc.
Prescient Medical, Inc. is a privately held medical device company dedicated to reducing deaths from heart attacks, the leading cause of death in much of the world. For more information, please visit our website at http://www.prescientmedical.com
Prescient Medical, Inc.
http://www.prescientmedical.com
Despite Economic Woes, Physician Compensation Increases
Sullivan, Cotter and Associates, Inc. (SullivanCotter) has published its 16th 2008 Physician Compensation and Productivity Survey Report, the industry standard. Notable findings this year include an average salary increase of 4.4% for specialists and 4.0% for primary care physicians. Nearly three-quarters (72%) of the survey participants provided salary increases to their employed physicians in 2008, which is comparable to last year, when 73% reported providing a salary increase. The results also point to increased use of incentive plans, compensation tied to quality measures, and a decrease in the rates paid per work Relative Value Units (wRVUs). A total of 257 healthcare organizations nationwide participated in the survey, which includes compensation data for over 41,000 physicians in over 150 specialties.
According to Kim Mobley, a principal at SullivanCotter and the survey director, “While the majority of organizations provided salary increases to physicians, some organizations also decreased compensation for at least some of their physicians. In fact, 10% percent of survey participants decreased cash compensation levels in 2008.” This is less than the 18% of organizations reporting decreases in cash compensation in 2007. “When organizations decrease physician compensation, most often it is linked to individual productivity and/or labor market benchmark norms,” she adds.
The current physician recruitment environment is highly competitive and survey results indicated an increase in hiring bonuses. This year, 57% of the participants used hiring bonuses, compared to only 49% last year. Interestingly, the amounts paid have remained relatively stable, with average hiring bonuses of $10,000 for primary care physicians and $17,500 for specialists.
According to the survey, 70% of organizations use incentive compensation for their physicians; up from 60% in 2005. While productivity is still the most common variable used to determine incentives, Mobley states, “There is an increase in the use of quality measures as part of an incentive payment; however, the relative amount of compensation tied to quality is small, typically not more than 2% to 3% of total cash compensation.”
The 2008 Physician Compensation and Productivity Survey Report is now available for purchase. The survey reports compensation levels for PhDs, mid-level providers, and medical group executives. The results contain comprehensive information on physician productivity levels (gross patient charges, collections, work Relative Value Units/wRVU); pay practices; incentive compensation; benefits and perquisites; hourly rates; resident compensation and more. The cost to healthcare organizations agreeing to participate in next year’s survey is $600, while the cost of healthcare organizations not wishing to participate next year is $1,800. For all other types of organizations, the cost is $3,200. A CD containing the survey data tables is also available for purchase by the organizations purchasing the survey.
SullivanCotter specializes in the development and implementation of strategic total compensation and reward programs for the healthcare industry. Since 1992, SullivanCotter has worked closely with healthcare organization executives, boards and compensation committees to devise innovative compensation solutions that attract and retain physician and leadership talent while satisfying not-for-profit missions and regulatory requirements. A leader in independent consulting, benchmarking, trends and analyses, SullivanCotter has also developed the most widely recognized physician and executive compensation surveys in the United States. SullivanCotter has offices in Atlanta, Boston, Chicago, Dallas, Denver, Detroit, New York, Parsippany, San Francisco and Westport.
Sullivan, Cotter and Associates, Inc.
http://www.sullivancotter.com
Rules-Based Medicine, Inc. Launches Human Kidney Damage Biomarker Panel
Rules-Based Medicine, Inc. (RBM), the world’s leading multiplexed biomarker testing laboratory, announced the launch of its Human Kidney Multi-Analyte Profile (MAP), a cost-effective biomarker testing service designed to aid pharmaceutical and biotechnology companies in their efforts to improve drug development through better understanding of drug toxicity. The Human Kidney MAP will be used in clinical trials to reveal early signs and locations of drug-induced kidney damage, known as renal toxicity or nephrotoxicity, thereby guiding important decisions on lead compounds and dosage.
“The Human Kidney MAP is an important response to the FDA’s Critical Path Initiative, which highlighted the need for new tools to better understand the safety profile of new drugs,” said Craig Benson, RBM president and chief executive officer. “By providing a quantitative and predictive multiplexed biomarker test for renal toxicity, we will help our customers improve safety, mitigate risk, and reduce costs associated with drug development.”
RBM’s Human Kidney MAP utilizes a multiplexed panel of 16 biomarkers to detect early renal damage and pinpoint the location within the kidney. Both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) recently decided to accept data related to certain biomarkers of kidney damage as part of the drug approval process in conjunction with new safety initiatives. Historically, regulatory agencies have required drug companies to provide results of blood urea nitrogen (BUN) and serum creatinine tests as indicators of kidney damage. Studies, however, suggest these tests detect only late signs of kidney damage and provide no information on the location of damage.
The Human Kidney MAP was developed using a translational medicine approach. In 2008, RBM commercialized a Rat Kidney MAP based on an ambitious study funded by the FDA’s Critical Path Initiative through the Predictive Safety Testing Consortium. The Human Kidney MAP contains many of the same biomarkers and is designed to detect general signs of kidney damage. Drugs in circulation are concentrated up to 1000-fold in the kidney compared to plasma, magnifying the potential for renal toxicity of any drug.
Kidney damage also occurs in connection with diseases such as diabetes, hypertension, and autoimmune conditions, among others. RBM has established and is seeking additional collaborations with leading academic and pharmaceutical researchers to develop diagnostic applications based on the Human Kidney MAP.
About Rules-Based Medicine
Rules-Based Medicine (RBM) provides comprehensive protein biomarker products and services centered on its Multi-Analyte Profiling (MAP) technology. Its service platform (RodentMAP(R) and HumanMAP(R)) provides pre-clinical and clinical researchers with reproducible, quantitative, multiplexed immunoassay data for hundreds of proteins cost-effectively in multiple species, and from a small sample volume. The Company also offers innovative and proprietary ex vivo testing systems such as TruCulture(TM), the first fully-closed, reproducible whole blood culture system. RBM is actively developing multiplexed diagnostic tests to detect the presence of complex diseases and conditions in areas of unmet medical need such as neuropsychiatry, nephrology, immunology and cardiology. More information about RBM is located at http://www.rbmmaps.com.
RodentMAP(R) and HumanMAP(R) are registered trademarks of Rules-Based Medicine Inc.
Rules-Based Medicine, Inc.
http://www.rbmmaps.com
Schizophrenia And Bipolar Disorder Share A Genetic Cause
A new study from Sweden found evidence that schizophrenia and bipolar disorder partly share a common genetic cause; if one disorder runs in the
family there is a good chance that the other will too. The researchers said their finding challenges the view that these disorders are separate entities,
and call for a change in the way they are currently diagnosed.
The study was the work of lead author Paul Lichtenstein, a genetic epidemiologist at the Karolinska Institutet in Stockholm, Sweden, and other
colleagues from Sweden and the US, and is published in the 17 January issue of The Lancet.
For the study, Lichtenstein and colleagues examined records of all patients discharged from psychiatric hospitals in Sweden from 1973 to 2004 and
found 35,985 cases of schizophrenia (0.40 percent of the population) and 40,487 cases of bipolar disorder (0.45 percent of the population). They
then looked in the Swedish multi-generation register, which contains information about all children and their parents in the country, and identified
over 9 million individuals living in more than 2 million nuclear families between 1973 and 2004.
By comparing the patient discharge data for schizophrenia and bipolar disorder with the register, the researchers were able to identify parents, children,
brothers and sisters who shared the disorders. Using a sophisticated statistical tool they then assessed risks for the two disorders, separately and
together, for biological and adoptive parents, their children, full and half siblings, of patients with either of the two disorders. The tool they used was
a multivariate generalised linear mixed model, and they assessed both genetic and environmental contributions to risks.
The results showed that:
- First degree relatives of patients whose discharge record showed they had either schizophrenia or bipolar disorder were at higher risk of having these disorders.
- Having a mother or father with schizophrenia raised the risk of a person having the disorder by 9.9 times, compared with someone who did
not.
- Having a mother or father with schizophrenia raised the risk of a person having bipolar disorder by 5.2 times, compared with someone whose
mother or father did not have schizophrenia.
- Having a mother or father with bipolar disorder raised the risk of a person having it 6.4 times, and the risk of having schizophrenia, 2.4 times,
compared with a person whose mother or father did not have bipolar disorder.
- Having a brother or sister with one of the disorders significantly increased their risk of having them too, with half siblings having a lower risk than
full siblings.
- Overall, relatives of patients with bipolar disorder showed increased risk for schizophrenia, including adopted children whose biological parents
had the disorder.
- Heritability for schizophrenia and bipolar disorder was 64 and 59 per cent respectively.
- For both together, the figure was 63 per cent, mostly due to additive genetic effects common to both disorders, wrote the authors.
- Shared environmental effects were small but subtantial, they added.
Lichtenstein and colleagues concluded that:
“Similar to molecular genetic studies, we showed evidence that schizophrenia and bipolar disorder partly share a common genetic cause.”
“These results challenge the current nosological dichotomy between schizophrenia and bipolar disorder, and are consistent with a reappraisal of these
disorders as distinct diagnostic entities,” they added.
In a separate press statement reported by Scientific American, Lichtenstein said he and his colleages suggest there are hundreds if not thousands of
genes involved in the development of these two disorders, and many of them overlap. However, many of them have not yet been discovered.
Lichtenstein said there were many large scale studies happening around the world searching for the genes behind these disorders, and he is also
researching in this area. He said scientists should look not only for overlap between these two disorders but with other psychiatric conditions too, like
depression for instance.
The study was funded by the Swedish Council for Working Life and Social Research, and the Swedish Research Council.
“Common genetic determinants of schizophrenia and bipolar disorder in Swedish families: a population-based study.”
Paul Lichtenstein, Benjamin H Yip, Camilla Björk, Yudi Pawitan, Tyrone D Cannon, Patrick F Sullivan, Christina M Hultman.
The Lancet Volume 373, Issue 9659, Pages 234 – 239, 17 January 2009.
doi:10.1016/S0140-6736(09)60072-6
Click here for
Abstract.
Sources: Journal Abstract, Scientific American.
Written by: Catharine Paddock, PhD
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today
