April 15 marks the 10-year anniversary of the Food and Drug Administration’s approval of Botox for cosmetic use. But it has been nearly two centuries since the toxin was identified. Here’s a timeline in the development of the now-popular wrinkle reliever, beginning in the early part of the 19th century. Apparently, it all started when someone encountered a spoiled sausage.

And the rest is history …

1820s: German doctor Justinus Kerner identifies a toxin in spoiled sausages that causes food poisoning. the paralytic illness caused by Kerner’s “sausage poison” earns the name “botulism,” from a Latin word (“botulus”) for sausage. Kerner speculates that small doses of the toxin might be used to treat nerve disorders and excessive sweating.

1895: Belgian bacteriologist Emile Pierre van Ermengem discovers that Clostridium botulinum bacteria produce the botulism toxin.

1920s: Botulinum Toxin Type A is first isolated from the Clostridium botulinum bacteria in a purified form as a stable acid precipitate by Dr. Herman Sommer at the University of California, San Francisco.

1940s: During World War II, American scientists explore potential use of botulinum toxin as a weapon. the U.S. produces botulinum toxin capsules for Chinese prostitutes to drop into the food of high-ranking Japanese officials. the plan is not put into effect because the military found it to be ineffective as a weapon.

1946: Researcher Edward J. Schantz, Ph.D. succeeds in purifying Botulinum Toxin Type A into crystalline form, for the first time providing scientists with the raw material necessary to study the molecule in greater detail.

1949: Researcher Dr. Arnold Burgen and colleagues in London discover that botulinum toxin blocks communication between nerves and muscles.

1960s: Ophthalmologist Alan Scott in San Francisco injects botulinum toxin into monkeys to see whether it relaxes muscles that cause crossed eyes.

1978: Scott wins approval from the Food and Drug Administration for extensive multi-site tests of botulinum toxin as a treatment for crossed eyes in humans. He calls the drug Oculinum and establishes Oculinum inc. to make and sell it.

1987: Canadian ophthalmologist Dr. Jean Carruthers (pictured above with her husband) notices that patients injected with the toxin were losing their frown lines. Her husband, Canadian dermatologist Dr. Alastair Carruthers, injects botulinum toxin into the forehead of their receptionist, Cathy Bickerton Swann, to smooth her wrinkles.

Late 1980s: Doctors begin using botulinum toxin as a treatment for involuntary contraction of neck muscles, also called cervical dystonia.

1988: Allergan acquires the rights to Dr. Scott’s product, Oculinum.

1989: Allergan secures the first FDA approval for Oculinum as a treatment for crossed eyes and excessive blinking and received FDA approval to change the name to Botox.

1993: Doctors in England notice that spasm patients sweat less when treated with Botox.

December 2000: FDA approves Botox as a treatment for cervical dystonia.

April 15, 2002: FDA approves Botox injections for frown lines between the eyebrows under the name Botox Cosmetic.

2004: Allergan launches clinical trials of Botox for migraine sufferers.

2004: Los Angeles socialite Irena Medavoy sues Allergan for ailments that she says were caused by Botox that was injected to ease her migraines. A 9-3 jury verdict goes against her.

July 2004: FDA approves Botox as a treatment for severe underarm sweating.

May 2007: Actress Virginia Madsen becomes the first celebrity to openly discuss her Botox cosmetic treatments and is featured in the Botox advertising campaign, “Keep the Wisdom. Lose the Lines.” She tells People magazine, “I am not using these injectables to look 25. I don’t want to be 25. I just want to look like me. I am 45, and I am in the best shape that I have ever been in my life.”

2008: U.S. Department of Justice launches probe of Allergan’s marketing practices, subpoenas documents related to off-label use of Botox as a treatment for migraines.

2008: Advocacy group Public Citizen urges FDA to impose stricter regulations on Botox and similar products, cites 16 patient deaths that occurred after neurotoxin injections.

2009: Actress and singer Vanessa Williams reveals she has been treated with Botox cosmetic. She becomes the spokesperson for a charitable education campaign whereby Botox Cosmetic donates $250,000 to non-profit Dress for Success.

April 2009: FDA requires Allergan to expand warnings on the Botox label, but says cosmetic use of Botox is not linked to deaths.

October 2009: Allergan sues the FDA, seeking the right to tell doctors about all the effects of Botox and other drugs, not just the effects related to FDA-approved therapies.

March 2010: In $60 million lawsuit, Santa Ana jury decides that Botox injections did not cause the death of cerebral palsy patient Kristen Spears, 7.

March 2010: FDA approves Botox as a treatment for spasms of the arms and hands in adults.

May 2010: Oklahoma jury orders Allergan to pay $15 million to Dr. Sharla Helton, 47, who says cosmetic Botox injections left her in pain and unable to work.

September 2010: In court in Santa Ana, Allergan settles the case of Sondra Bryant of Texas, a 70-year-old nurse who died in 2008 after injections to ease her neck pain. Terms of the settlement were not announced.

October 2010: FDA approves Botox to treat chronic migraines.

April 2011: A federal jury in Virginia orders Allergan to pay $212 million to a 67-year-old man who said he was left brain-damaged and bedridden in 2007 after receiving off-label Botox injections to ease trembling and cramps in his hand. the Virginia jury rejects Allergan’s contention that Botox was not to blame for Douglas Ray Jr.’s disabling injuries. the panel awarded him $12 million in compensatory damages plus $200 million in punitive damages.

August 2011: the FDA approves Botox for treating overactive bladders in those who lose control because of damage to the nervous system, including those with multiple sclerosis or spinal cord injury.

September 2011: Allergan settles the case of a San Francisco-area woman who had cosmetic injections and said she developed systemic problems, including weakness and fatigue, her attorney Ray Chester said. Terms of the settlement were not released.

October 2011: Actress Courtney-Thorne Smith becomes the latest actress to promote Botox, and tells People magazine she’d been getting the injections for about 10 years.

October 2011: A suit brought by Cynthia Van Den Boom of Richmond, Va., was settled before trial was to start the following month. Van Den Boom, who was injected with Botox for neck pain, suffered brain damage, her attorney Ray Chester said. Terms of the settlement were not disclosed.

February 2012: an Orange County jury hangs on the question of whether Allergan is to blame for a 46-year-old man contracting a devastating disease — Guillain-Barre Syndrome – that he says he got four days after getting Botox injections for back pain. Allergan’s attorney, Vaughn Crawford, said while the company was looking into potential risks in 2008, the year Thomas McGee got his injections, there was no medical evidence that Botox caused the disease.

March 2012: After Allergan alleges its trade secrets were stolen, a federal judge in Santa Ana blocks another company, Merz, from marketing Botox rival Xeomin. U.S. District Judge Andrew J. Guilford says he was troubled that some Allergan employees signed contracts with Merz and then e-mailed themselves Allergan company data before giving their final notice.

March 2012: Allergan discloses it has submitted an application with the FDA for the use of Botox as treatment of overactive bladder in adult patients with symptoms of urinary incontinence who have not responded to other treatments for OAB (overactive bladder).

An advisory panel on Wednesday recommended that U.S. health regulators reject the use of Amgen Inc’s drug Xgeva to delay the spread of prostate cancer to the bone, dimming the chance of a wider use for one of the company’s key growth drivers.

The outside advisers to the Food and Drug Administration voted 12-to-1 that the benefits of the injectable drug, known chemically as denosumab, did not outweigh the risk of developing a jawbone-destroying condition.

Xgeva is already approved to prevent fractures and related problems in advanced prostate cancer that has spread to the bone, and the company is seeking additional approval for use of the drug to delay or prevent the spread.

The drug did delay the spread of cancer to the bone by a little longer than four months in a clinical trial of 1,432 men with prostate cancer who had stopped responding to hormone therapy.

But about one in 15 men who took the drug developed osteonecrosis of the jaw, a severe side effect in which jawbone tissue dies, exposing the bone. that rate is far higher than has been seen with widely used osteoporosis drugs.

“If you ask a patient, ‘Do you want to delay your disease by five minutes, but get significant toxicities?’ I think that would give them pause,” said panel member Maha Hussain, a professor of medicine in the hematology and oncology division at the University of Michigan.

The FDA usually follows the recommendations of its expert panels and will make a final decision by April 26.

Most analysts had expected the unfavorable panel vote because the FDA had questioned whether delaying the spread of cancer to the bone was a meaningful benefit to patients given that the drug did not help men live longer or delay the growth of prostate cancer..

“We believe the panel recommendation reinforces the FDA’s view, which has been consistently negative, and approval is unlikely,” said Geoff Meacham, analyst at JP Morgan, in a research note.

However, he said the risk of a rejection of wider approval for Xgeva had only a modest risk to his long-term revenue estimates for Amgen, the world’s largest biotechnology company.

Benefits to patients?

Xgeva and a related osteoporosis drug Prolia are seen as among the most important growth drivers for Amgen and are expected to help offset declining sales of the anemia drugs that had been the company’s backbone.

In the fourth quarter of 2011, sales of Xgeva rose to $134 million from $100 million in the prior quarter, and it is expected to eventually become a $1 billion-a-year drug.

The company said the new use for Xgeva would be targeted at about 50,000 men in the United States at that advanced stage of the disease.

Panel members questioned whether using the drug earlier actually benefited patients, as many did not have symptoms of the disease, but would suffer any drug-related side effects.

However, the patient representative on the panel voted in favor of approval.

“There isn’t a treatment that a man with prostate cancer gets that doesn’t have devastating effects on his masculinity and his quality of life,” said James Kiefert, of Olympia, Washington. “In my opinion, the men who would be candidates for this treatment would be standing up and cheering another option for them.”

His views echoed the favorable comments of several urologists, who testified in favor of the drug during the public hearing.

Amgen said Xgeva provided a meaningful benefit to prostate cancer patients by preventing the spread of their disease to the bones, which is not uncommon.

“We look forward to further discussions with the FDA as they continue to review our application,” the company said in a statement after the vote.

If Xgeva gains wider approval, it would be the first drug to delay the spread of prostate cancer to the bone, Amgen said.

Amgen said it was also testing Xgeva in other cancers, including breast and lung cancer and the blood cancer multiple myeloma.

Bristol-Myers Squibb (NYSE:BMY) announced today that BARACLUDE® (entecavir) has been approved by the European Commission on February 28th 2011 to treat chronic hepatitis B (CHB) in adult patients with evidence of decompensated liver disease.

Paris (PRWEB) March 7, 2011

Bristol-Myers Squibb (NYSE:BMY) announced today that BARACLUDE® (entecavir) has been approved by the European Commission on February 28th 2011 to treat chronic hepatitis B (CHB) in adult patients with evidence of decompensated liver disease.

BARACLUDE® was already approved in Europe in June 2006 for use in adult patients with CHB with compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.

This approval grants BARACLUDE® marketing authorisation in the 27 countries of the European Union. in the U.S., the Food and Drug Administration (FDA) approved the decompensated indication for BARACLUDE® in October 2010.

Decompensated liver disease is characterised by failure of the liver to maintain adequate function, usually due to severe scarring, leading to fibrosis and/or cirrhosis caused by chronic liver inflammation.¹ it represents the end stage of hepatitis. Natural history data demonstrate that up to 40% of patients with CHB develop cirrhosis over their lifetimes, at a reported rate of 2-6% per year. Among CHB patients with cirrhosis, 3-5% per year progress to decompensated cirrhosis and 2-5% develop hepatocellular carcinoma (HCC).²,³ Currently, the median survival rate in decompensated patients is two to three years, with only 28% of patients surviving for more than five years.¹,⁴

Once liver disease progresses to the decompenstated stage, a liver transplant is often necessary.

“The approval of this additional indication is an important milestone for CHB patients living with decompensated liver disease, a difficult to treat population whose mortality rates are high,” said Professor Jorg Petersen. “The data used to support this indication shows that BARACLUDE® is efficacious in treating decompensated patients.”

This approval is based on a randomised, open-label, multi-centre study (ETV-048) that compared the efficacy & safety of BARACLUDE® (1.0 mg once daily) with adefovir (10.0 mg once daily) administered in patients with HBeAg positive or negative CHB who had evidence of liver decompensation.

Data demonstrated that BARACLUDE® showed greater viral suppression compared to adefovir at 24 and 48 weeks following treatment initiation. At 48 weeks, 57% (57/100) of patients treated with BARACLUDE® achieved an undetectable viral load (d300 copies/ml) compared to 20% (18/91) of patients on adefovir.

ETV-048 Study ResultsThe 048 study evaluated 191 patients who were either HBeAG-positive or HBeAG-negative. Patients were either treatment-naïve or had been previously treated excluding pre-treatment with BARACLUDE®, adefovir or tenofovir.

Patients were randomised to receive BARACLUDE® (1.0 mg once daily) or adefovir (10.0 mg once daily) and were analysed through 48 weeks.

Baseline demographics were similar for both groups. Importantly, at baseline, patients had a mean CPT (child-pugh score) of 8.81 in the BARACLUDE® arm and 8.35 in the adefovir arm, and the mean MELD (Model for end stage Liver Disease) score was 17.1 and 15.3, respectively. both of these parameters measure the severity of hepatic decompensation.

The mean age of the study population was 52 years and the majority of the subjects were male (74%) and either Asian (54%) or Caucasian (33%).⁵

In the primary efficacy endpoint of mean change from baseline in serum HBV DNA at Week 24, BARACLUDE® was superior to adefovir (-4.48 versus -3.40; p < 0.0001).

Secondary efficacy endpoints included mean change from baseline in serum HBV DNA at Week 48 (-4.66 in the BARACLUDE® arm and -3.90 in the adefovir arm). in addition a greater proportion of patients on BARACLUDE® achieved an undetectable viral load compared to patients on adefovir at 48 weeks: 57% (57/100) versus 20% (18/91), respectively. Also patients on the BARACLUDE® arm decreased their MELD score from baseline by -2.6% versus -1.7% in the adefovir arm at Week 48, even though baseline MELD score had been higher with 17.1 for BARACLUDE® than 15.3 for adefovir. Further the normalization of ALT (Alanine Aminotransferase enzyme) was achieved to a higher proportion in the BARACLUDE®-treated patients (d1 x Upper Limit of Normal) at Week 48 [63% (49/78)] compared with adefovir-treated patients [46% (33/71)].

The time to onset of HCC or death was comparable in the two treatment groups; on-study cumulative death rates were 23% (23/102) and 33% (29/89) for patients treated with BARACLUDE® and adefovir, respectively; and on-study cumulative rates of HCC were 12% (12/102) and 20% (18/89) for BARACLUDE® and adefovir, respectively.

BARACLUDE® was generally well tolerated and safety results were comparable between the treatment groups and consistent with those previously reported for a population with decompensated liver disease. Serious adverse events occurred in 69% of the BARACLUDE® patients and 66% of the adefovirpatientsand discontinuations due to adverse events occurred in 7% of the Baraclude patients and 6 % of the adefovir patients.⁵

Important Information About BARACLUDE®

Discovered at Bristol-Myers Squibb, BARACLUDE® is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with:

• Compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.
• Decompensated liver disease.

a higher rate of serious hepatic adverse events (regardless of causality) has been observed in patients with decompensated liver disease, in particular in those with Child-Turcotte-Pugh (CTP) class C disease, compared with rates in patients with compensated liver function. in addition, patients with decompensated liver disease may be at higher risk for lactic acidosis and specific renal adverse events such as hepatorenal syndrome. Clinical and laboratory parameters should be closely monitored in this patient population.

*For full prescribing information for BARACLUDE®, please consult the Summary of Product Characteristics.

About Chronic Hepatitis B (CHB)Chronic hepatitis B is a serious global health issue. Worldwide, more than 2 billion people have been in contact with the hepatitis B virus and approximately 350 million people are chronically infected.⁶

About Decompensated Liver DiseaseDecompensated liver disease is characterised by failure of the liver to maintain adequate function, often due to severe scarring leading to fibrosis and/or cirrhosis caused by chronic liver inflammation.¹ Symptoms of liver decompensation can include but are not limited to: jaundice (yellowing of the skin or eyes), ascites (swollen abdomen from abnormal accumulation of fluid), oesophageal varices (distorted blood vessels that may cause potentially fatal bleeding), and hepatic encephalopathy (neuropsychiatric abnormality resulting in personality changes, intellectual impairment and reduced levels of consciousness).¹

About Bristol-Myers SquibbBristol-Myers Squibb is a global biopharmaceutical company committed to discovering, developing and delivering innovative medicines that help patients prevail over serious diseases.

BARACLUDE® (entecavir) is a registered trademark of Bristol-Myers Squibb Company.

Contact:Media: Annie Simond, office: +33 1 58 83 65 66, annie(dot)simond(at)bms(dot)com

References¹ D’Amico G, Garcia-Tsao G, Pagliaro L. Natural history and prognostic indicators of survival in cirrhosis: a systematic review of 118 studies. J. Hepatol. 2006; 44: 217–31. ² Chu C-M and Liaw Y-F. Hepatitis B virus-related cirrhosis: Natural history and treatment. Seminars in Liver Disease 2006;26(2):142-152.³ Fattovich G, Stroffolini T, Zagni I, Donato F. Hepatocellular carcinoma in cirrhosis: Incidence and risk factors. Gastroenterology 2004;127(5 Suppl 1):S35-S50.⁴ Fattovich G, Pantalena M, Zagni I et al. Effect of hepatitis B and C virus infections on the natural history of compensated cirrhosis: a cohort study of 297 patients. am. J. Gastroenterol. 2002; 97: 2886–95.⁵ Y. Liaw, et al. Efficacy and Safety of Entecavir versus Adefovir in Chronic Hepatitis B Patients with Evidence of Hepatic Decompensation. Abstract and Poster 442. AASLD 2009.⁶ World Helath Organization Web site. Fact sheet N• 204. who.int/mediacentre/factsheets/fs204/en/. Accessed 3 December 2010.

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Annie SimondBristol-Myers Squibb+33 1 58 83 65 66Email Information

WEDNESDAY, March 9 (HealthDay News) — the U.S. Food and Drug Administration on Wednesday gave lupus patients their first new treatment option in more than 50 years when it approved Benlysta as a way to ease the painful symptoms of this debilitating autoimmune disorder.

Injected directly into a vein, Benlysta is the first drug designed to target a protein that may reduce the number of abnormal B cells believed to be at the root of lupus, the FDA said in a news release. the last lupus drugs approved by the agency were Plaquenil (hydroxychloroquine) and corticosteroids; both were given the agency's blessing in 1955. back in 1948, aspirin was approved to treat the disease.

Lupus strikes women far more often than men, and symptoms typically first appear between the ages of 15 and 44. the joints, skin, kidneys, lungs, heart and brain can all be affected, and when symptoms flare up they include swelling in the joints or joint pain, light sensitivity, fever, chest pain, hair loss and fatigue, the FDA said.

According to the agency, there are between 300,000 and 1.5 million lupus sufferers in the United States. Black women are three times more likely than white women to get the disorder.

"Benlysta, when used with existing therapies, may be an important new treatment approach for health-care professionals and patients looking to help manage symptoms associated with this disease," said Dr. Curtis Rosebraugh, director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research.

The approval was widely expected after an FDA advisory panel voted 13-2 in November to recommend approval of the drug, the Los Angeles Times reported, and Benlysta is expected to become a top seller for its maker, Human Genome Sciences inc., of Rockville, Md.

Benlysta's arrival has been much heralded because it comes on the heels of decades of disappointing efforts to craft new treatments for lupus, Sandra Raymond, president of Lupus Foundation of America, told the Times.

"It's an historic day. it really does open a door," Raymond told the newspaper. "Not that Benlysta is a miracle drug. It's not. I think the lupus community is sanguine about that. but they know that there are other companies coming behind" Human Genome.

More information

For more on lupus, go to the U.S. National Institutes of Health.

Even as snow socked Washington, the Food and Drug Administration managed to get a letter to GlaxoSmithKline rejecting the company’s proposal to sell the pill Avodart as a way to reduce the risk of prostate cancer.

The medicine, known generically as dutasteride, is prescribed to ease the symptoms and reduce the need to operate on enlarged prostates. Glaxo has been looking to get the drug approved for the prevention of prostate cancer in men with high PSAs and who’ve had a biopsy for prostate cancer that didn’t find any.

Back in December, a panel of experts advising the FDA about the proposal voted it down 14-2 because the benefit of reducing some cancers didn’t outweigh the risks that some aggressive cancers would go unnoticed.

FDA said at the meeting that the company’s data showed 60 men would need to be treated with Avodart for four years to prevent a single “clinically meaningful” case of prostate cancer, the Wall Street Journal reported at the time. Among the same men over the same period, about 1 in 200 treated with Avodart would develop an aggressive type of prostate cancer.

In an e-mail, a Glaxo spokesman said the company is still reviewing the letter, which it received around 7 p.m. Wednesday. (That’s when parts of suburban Washington near FDA headquarters were hit with thundersnow.) Glaxo expects to talk it over with the agency, but the company hasn’t made a decision about whether to continue work on approval.

The Cancer Institute of new Jersey Explores Blocking Mechanism for Cancer Cell Survival

Newswise — Building upon recent laboratory discoveries on resistance by cancer cells to therapies that attempt to starve cancer, scientists at the Cancer Institute of new Jersey (CINJ) are conducting a clinical trial that further explores how to prevent that action. the goal is to discover if an anti-malaria drug approved by the Food and Drug Administration is able to block a cellular process that acts as a survival method for malignant cells in human melanoma, the most life threatening form of skin cancer. CINJ is a Center of Excellence of UMDNJ-Robert Wood Johnson Medical School and new Jersey’s only National Cancer Institute-designated Comprehensive Cancer Center — one of only 40 in the country.

Hydroxychloroquine, which is commonly used to treat malaria and certain types of arthritis, has been shown to block autophagy, the process by which cells eat themselves in order to survive through times of stress. this process allows cells to become resistant to cancer therapies. Research by CINJ Associate Director for Basic Science, Eileen White, PhD, adjunct professor of surgery at UMDNJ-Robert Wood Johnson Medical School and professor of molecular biology and biochemistry at Rutgers, the State University of new Jersey, and other laboratories at CINJ indicates that drugs such as hydroxychloroquine may help cancer treatments work more effectively by providing an easier path for the cancer drugs to enter the cell.

In this trial, investigators want to learn how to detect the process of autophagy in humans with melanoma, a goal lead researcher Janice Mehnert, MD, medical oncologist at CINJ and assistant professor of medicine at UMDNJ-Robert Wood Johnson Medical School, says is key. “By further examining the process of autophagy and learning if hydroxychloroquine is able to interrupt this process in human blood and tumor samples, we may be able to find a way to maximize the benefit of hydroxychloroquine in order to improve clinical outcomes,” she said.

Adults with stage III or stage IV melanoma tumor or tumors (cancer that has spread beyond where it first occurred) who can be scheduled for surgery to either cure the cancer or lessen the symptoms of cancer are eligible to take part in the trial, although other criteria must be met. Patients with newly diagnosed melanoma tumors or who have disease that has returned also are eligible to participate. Prior to being accepted into the study, participants would undergo a number of tests including blood work and a physical.

If accepted for participation in the trial, individuals will take a hydroxychloroquine pill each day for two weeks leading up to surgery. Participants will keep a pill diary and undergo periodic blood work during this time.

For more information on how to take part, individuals should call CINJ’s Office of Human Research Services at 732-235-8675 or e-mail cinjclinicaltrials@umdnj.edu.

The trial is supported by grants from the National Cancer Institute and the Harry Lloyd Foundation.

Clinical trials, often called cancer research studies, test new treatments and new ways of using existing treatments for cancer. at CINJ, researchers use these studies to answer questions about how a treatment affects the human body and to make sure it is safe and effective. there are several types of clinical trials that are currently underway at CINJ, including those that diagnose, treat, prevent, and manage symptoms of cancer. Many treatments used today, whether it is drugs or vaccines; ways to do surgery or give radiation therapy; or combinations of treatments, are the results of past clinical trials.

As new Jersey’s only National Cancer Institute-designated Comprehensive Cancer Center, CINJ offers patients access to treatment options not available at other institutions within the state. CINJ currently has more than 1,000 patients enrolled in clinical trials, including approximately 15 percent of all new adult cancer patients and approximately 70 percent of all pediatric cancer patients. Enrollment in these studies nationwide is fewer than five percent of all adult cancer patients.

About the Cancer Institute of new JerseyThe Cancer Institute of new Jersey (cinj.org) is the state’s first and only National Cancer Institute-designated Comprehensive Cancer Center dedicated to improving the detection, treatment and care of patients with cancer, and serving as an education resource for cancer prevention. CINJ’s physician-scientists engage in translational research, transforming their laboratory discoveries into clinical practice, quite literally bringing research to life. to make a tax-deductible gift to support CINJ, call 732-235-8614 or visit cinjfoundation.org. CINJ is a Center of Excellence of UMDNJ-Robert Wood Johnson Medical School.

The CINJ Network is comprised of hospitals throughout the state and provides the highest quality cancer care and rapid dissemination of important discoveries into the community. Flagship Hospital: Robert Wood Johnson University Hospital. system Partner: Meridian Cancer Care (Bayshore Community Hospital, Jersey Shore University Medical Center, Ocean Medical Center, Riverview Medical Center, and Southern Ocean Medical Center). Major Clinical Research Affiliate Hospitals: Carol G. Simon Cancer Center at Morristown Memorial Hospital, Carol G. Simon Cancer Center at Overlook Hospital, and Cooper University Hospital. Affiliate Hospitals: CentraState Healthcare system, JFK Medical Center, Mountainside Hospital, Raritan Bay Medical Center, Robert Wood Johnson University Hospital Hamilton (CINJ Hamilton), Somerset Medical Center, the University Hospital/UMDNJ-New Jersey Medical School*, and University Medical Center at Princeton. *Academic Affiliate

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Press Release Source: Sinovac Biotech Ltd. on Tuesday December 28, 2010, 8:35 am EST

BEIJING, Dec. 28, 2010 /PRNewswire-Asia/ — Sinovac Biotech Ltd. (Nasdaq:SVA – News), a leading provider of biopharmaceutical products in China, announced today that it received approval from the China State Food and Drug Administration (SFDA) to commence clinical trials for its proprietary inactivated EV71 vaccine against Hand, Foot and Mouth Disease (HFMD). according to the approval document, Sinovac is required to conduct each phase of the human clinical trials in accordance with SFDA requirements, to conduct studies to assess safety and immunogenicity in the phase I and II clinical trials, and to conduct efficacy study in the phase III clinical trial. Sinovac filed in late December 2009 with the SFDA the application to commence human clinical trials for its inactivated EV71 vaccine.

Dr. Weidong Yin, Chairman, President & CEO, stated, “We are very pleased to advance our near term vaccine development pipeline with the approval from the SFDA to commence clinical trials for our internally developed EV 71 vaccine. Currently, there is no vaccine available worldwide for this disease. We had no precedent to go by during the development, so we had to start with the basic research on this vaccine. moreover, our R&D people has successfully completed pre-clinical research and made significant breakthroughs during the development. We will move forward with our research and development of vaccines with the objective to supply high quality vaccine products to children worldwide as soon as possible and to contribute to the prevention and control of HFMD.”

As previously announced, the Company began preclinical research in 2008 for its independently developed EV 71 vaccine.  The animal model, built by researchers at Sydney University, showed cross protection and demonstrated that the vaccine is effective in animals. in addition, Sinovac has already filed five patent applications covering the EV 71 vaccine.

About EV 71

Enterovirus 71, or EV 71, causes Hand, Foot, and Mouth Disease (or HFMD). more than 90% of the reported cases occur in children under five years old. HFMD is a common and usually mild childhood disease. however, there has been an increase in severe HFMD cases reported associated with neurological symptoms caused by EV 71. a number of outbreaks of EV 71 HFMD in the Asia-Pacific region have been reported since 1997. Outbreaks have been reported in Malaysia (1997), Taiwan (1998, 2000 & 2001), mainland China (1998-2008), Australia (1999) and Singapore (2000) among other areas in the region. no specific treatment for this enterovirus infection and no vaccine are currently available.

HFMD has become a very serious problem in China, some other Asian countries and other areas in recent years given that no vaccine and specific treatment is currently available to protect against this disease. EV 71 has evolved into a severe health threat to children as a growing number of HFMD cases have been reported in parts of Asia, including mainland China, Hong Kong, Singapore, South Korea, and Taiwan. according to the Chinese Ministry of Health’s data available for the period from January 1 to November 30, 2010, the disease caused 876 deaths in China and over 1.73 million HFMD infection cases during the 2010 eleven-month period, as reported by health authorities, as compared to 353 fatalities in China and over 1.15 million reported HFMD infectious cases for the entire year of 2009.  HFMD is common among infants and children, as most of the recently reported cases have occurred in children under five years of age.

About Sinovac

Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses on the research, development, manufacture and commercialization of vaccines that protect against human infectious diseases including hepatitis a, seasonal influenza, H5N1 (bird flu) pandemic influenza and H1N1 influenza. in 2009, Sinovac was the first company worldwide to receive approval for its H1N1 influenza vaccine, PANFLU.1, and has received orders from the Chinese Central Government pursuant to the government stockpiling program. The Company is developing a number of new vaccine products, including vaccines for pneumococcal conjugate, enterovirus 71 (EV71) (against Hand, Foot & Mouth Disease), Japanese Encephalitis, animal and human rabies, HIB and epidemic meningitis, chickenpox, mumps and rubella. its wholly owned subsidiary, Tangshan Yian, is focusing on the research, development, manufacturing and commercialization of animal vaccines and has completed the field trials for an independently developed inactivated animal rabies vaccine, which is anticipated to be launched into market in 2011.

Safe Harbor Statement

This announcement contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by words or phrases such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. Among other things, the business outlook and quotations from management in this press release contain forward-looking statements. Statements that are not historical facts, including statements about Sinovac’s beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. a number of important factors could cause actual results to differ materially from those contained in any forward-looking statement. Sinovac does not undertake any obligation to update any forward-looking statement, except as required under applicable law.

Press Release Source: BG Medicine, inc. On Tuesday November 23, 2010, 8:00 am EST

WALTHAM, Mass.–(BUSINESS WIRE)– BG Medicine, inc., a U.S.-based life sciences company, announced today that the U.S. Food and Drug Administration has cleared the company’s Galectin-3 test for use in conjunction with clinical evaluation as an aid to assess the prognosis of patients diagnosed with chronic heart failure. this marks the first time the FDA has cleared a test to measure galectin-3 blood levels, and is the first novel cardiac test cleared by the FDA in five years.

Galectin-3 is a protein that has been shown to play an important role in the development and progression of heart failure in approximately 30% of the patients diagnosed with heart failure.i this galectin-3 mediated form of heart failure is associated with progressive fibrosis, or stiffening, in the heart muscle, which impairs the heart’s ability to pump.ii the role of galectin-3 in heart failure was first established in 2004iii, and the clearance of the company’s Galectin-3 blood test now for the first time allows physicians to use this product in the evaluation of patients diagnosed with heart failure.

“The availability of a galectin-3 test to identify high risk patients with cardiovascular disease and myocardial fibrosis represents another step toward the goal of enabling more efficient targeting of therapeutic approaches to reduce fibrosis in patients with chronic heart failure,” said Bertram Pitt, M.D., F.A.C.C., professor of internal medicine, Division of Cardiology, University of Michigan School of Medicine.

Heart failure is caused by a combination of factors that reduce blood flow and damage or overwork the heart muscle, so that it cannot circulate blood efficiently to meet the needs of other body organs.iv Heart failure may lead to serious medical complications and is a leading cause of death. According to the American Heart Association, heart failure affects an estimated 5.8 million Americans with 670,000 new diagnoses each year. the estimated direct and indirect cost of this condition in the U.S. is $39.2 billion.v

“In recent times many major medical conditions have been redefined from a classical definition based on signs and symptoms to a science-based definition taking into account the underlying biology. With the introduction of our Galectin-3 test, we are offering physicians the first opportunity to identify those patients with higher levels of galectin-3. Galectin-3 has been implicated in important biological processes in heart failure, including myofibroblast proliferation, fibrogenesis, and cardiac remodeling,” indicated Pieter Muntendam, M.D., president and chief executive officer of BG Medicine. “It is an important step towards improved medical management in heart failure.”

the BGM Galectin-3 test is based on the common ELISA format using the standard microtiter plate presentation. BG Medicine is currently finalizing its commercialization plans with LabCorp, one of the world’s largest clinical laboratories, in order to make the BGM Galectin-3 test available within 45 days of the FDA clearance.

BG Medicine has also entered into agreements with Abbott Laboratories (NYSE:ABT – News), Alere inc. (NYSE:ALR – News), and bioMérieux SA (EURONEXT:BIM – News) for the development and commercialization of automated versions of the BGM Galectin-3 test for Abbott’s Architect immunochemistry instrument platform (i1000SR and i2000SR), Abbott’s hand-held i-STAT System, Alere’s Triage Meter Pro and the bioMérieux VIDAS/miniVIDAS systems.

BG Medicine is a life sciences company focused on the discovery, development, and commercialization of novel diagnostics to improve patient outcomes and contain healthcare costs. for further information about galectin-3 and the BGM Galectin-3 test, visit galectin-3.com.

i BGM Galectin-3 Product Insert.

ii de Boer, Rudolf A. et al. “Galectin-3: A novel Mediator of Heart Failure Development and Progression,” European Journal of Heart Failure. 2009; 11: 811–817.

iii Sharma, Umesh C. et al. “Galectin-3 marks Activated Macrophages in Failure-Prone Hypertrophied Hearts and Contributes to Cardiac Dysfunction,” Circulation, Journal of the American Heart Association. 2004;110:3121-3128.

iv hearthub.org/hc-heart-failure.htm. Accessed on October 25, 2010.

v Heart Disease and Stroke Statistics, 2010 Update. American Heart Association.