Eisai And Arena Announce Publication Of Phase 3 Clinical Trial Analysis Of BELVIQ; EXACT Shares On The Move Following FDA Approval Print E-mail
By Marilyn Mullen   
Friday, 10 October 2014 17:50
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 10, 2014.
Eisai Inc. and Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today that a pooled analysis of the BLOOM and BLOSSOM pivotal, Phase 3 clinical trials of BELVIQ® (lorcaserin HCl) was published in the October issue of Postgraduate Medicine, a peer-reviewed medical journal for physicians. In the pooled analysis, BELVIQ 10 mg twice daily, as compared to placebo and both in conjunction with diet and exercise, was associated with statistically significant weight loss and clinically relevant improvements in cardiometabolic parameters.

BELVIQ is a serotonin 2C receptor agonist approved in the United States as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults who have a body mass index (BMI) of 30 kg/m2 or greater (obese), or BMI of 27 kg/m2 or greater (overweight) with at least one weight-related medical condition such as high blood pressure, high cholesterol, or type 2 diabetes. It is not known if BELVIQ is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products, nor is it known if BELVIQ changes the risk of heart problems or stroke, or death due to heart problems or stroke.

The BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management) and BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management) trials were conducted in overweight and obese adults without diabetes. The pooled, modified-intent-to-treat results show that a statistically significantly greater number of patients taking BELVIQ lost greater than or equal to 5% and greater than or equal to 10% of body weight compared to placebo (47.1% vs. 22.6% and 22.4% vs. 8.7%, respectively) after one year of treatment. The mean percent weight loss for patients taking BELVIQ was also statistically significantly greater than placebo (-5.8% vs. -2.5%). Mean percent weight loss for those completing one year of treatment was -8.0% for BELVIQ and -3.7% for placebo, respectively. Echocardiograms were conducted on all patients as part of the primary safety endpoint of the trials. There was no apparent increased risk of cardiac valvulopathy associated with use in the combined dataset. The rates of FDA-defined valvulopathy were 2.3% and 2.2% for patients taking BELVIQ or placebo, respectively.

"The publication of this pooled analysis includes part of the dataset reviewed by the FDA in approving BELVIQ as the first new treatment for obesity in over a decade," said Gary Palmer, Chief Medical Officer, Global Neuroscience Business Unit at Eisai Inc. "This analysis provides evidence demonstrating the safety and efficacy profile of BELVIQ, and may be helpful to physicians as they consider pharmacotherapy for patients as part of their overall weight management plan."

Additionally, the data showed that after one year, there were statistically significant improvements in lipid parameters, including total cholesterol, triglyceride levels and HDL cholesterol. Changes in glycemic indicators demonstrated a decrease of 0.11% in HbA1c for BELVIQ treated patients compared to a decrease of 0.05% for placebo treated patients. Mean decreases in both systolic and diastolic blood pressure were also seen and statistically significant for BELVIQ versus placebo.

"We are facing an obesity epidemic in the United States, and it's important for physicians and patients to understand that when behavioral modifications alone are not enough to produce meaningful weight loss, effective pharmacotherapeutic options are available that can be added to a diet and exercise regimen," said William R. Shanahan, M.D., Executive Vice President and Chief Medical Officer of Arena Pharmaceuticals, Inc. "We know that weight loss can improve health parameters for patients who are obese or overweight with a related condition, and this pooled analysis further demonstrates that BELVIQ, in combination with diet and exercise, can be an effective intervention."

The most common adverse events in the pooled analysis included headache, upper respiratory tract infection and nasopharynigtis. Discontinuation rates for adverse events were 8.6% for patients taking BELVIQ and 6.8% for patients taking placebo, and the overall rates for serious adverse events were similar (2.7% and 2.3%, respectively).


Shares of EXACT Sciences Corporation (NASDAQ: EXAS) are up sharply Friday morning following the company’s announcement that its stool DNA test to detect colorectal cancer has been approved for coverage by the Centers for Medicare and Medicaid Services.

The company reports that, “the approval makes it the only FDA stool test covered by Medicare.”

Shares of EXACT closed Thursday at $18.12 and were recently trading at $24.44, up 34 percent.

Also Friday:

Analogic Corporation (Nasdaq:ALOG)
, enabling the world's medical imaging and aviation security technology, today announced that the Flex Focus™ 400 exp ultrasound system will be showcased at Anesthesiology™ 2014, the American Society of Anesthesiologists' Annual Meeting, October 11-15, in New Orleans.

Cellular Biomedicine Group Inc. (Nasdaq:CBMG), a biomedicine firm engaged in the development of new treatments for degenerative and cancerous diseases, today announced that Professor Zhong Chen Kou, Chief Scientist of Immunology for the Company, will present "Assay for Monitoring T Cell Clonality Response to Cancer Immunotherapy" at the 2014 China Biotherapy Conference on October 12, at 9:55 a.m. Beijing time at the Beijing National Convention Center.

CytoDyn Inc. (OTCQB:CYDY)
, a biotechnology company focused on the development of new therapies for combating infection with human immunodeficiency virus (HIV), today announced that the Company will host a live conference call and webcast with the investment community on Tuesday, October 14, 2014 at 1:00 p.m. PT to discuss the results from its ongoing Phase 2b treatment substitution clinical trial in patients with HIV.

The Ensign Group, Inc. (Nasdaq:ENSG)
,  the parent company of the Ensign™ group of skilled nursing, rehabilitative care services, home health and hospice care, assisted living and urgent care companies, will visit the Nasdaq MarketSite in Times Square.

HempMeds™ – a Medical Marijuana, Inc. (OTC Pink:MJNA)
portfolio company and the world's most trusted supplier of cannabidiol (CBD)-rich hemp oil products – is bringing CBD-rich hemp oil products to New York as a sponsor and exhibitor of the International Cannabis Association's East Coast Regulatory Summit and Educational Conference.

IPC The Hospitalist Company, Inc. (Nasdaq:IPCM), a leading national hospital medicine and post-acute physician group practice company, announced today that it has appointed Kelli Newman to the position of General Counsel and Corporate Secretary.
Phibro Animal Health Corporation (Nasdaq:PAHC)
will host a webcast and conference call to review first quarter financial results.

PositiveID Corporation (OTCQB:PSID), a developer of biological detection and diagnostics solutions, today announced that it, in conjunction with its partner, ENSCO, Inc., has been awarded a SenseNet Program contract from the U.S. Department of the Interior on behalf of the U.S. Department of Homeland Security Science & Technology Directorate.

Prosensa Holding N.V. (NASDAQ: RNA), the biopharmaceutical company focusing on RNA-modulating therapeutics for rare diseases with high unmet need, today announced that it has commenced the submission process for a New Drug Application (NDA) regulatory filing to the United States Food and Drug Administration (FDA) for its lead exon-skipping drug candidate, drisapersen, for treating Duchenne muscular dystrophy (DMD).

Repligen Corporation (Nasdaq:RGEN) today announced that the Company will host an Investor & Analyst Event on October 16, 2014 in New York.

Sanomedics International Holdings, Inc. (OTCQB:SIMH); a medical technology holding company that focuses on providing game changing products, services and ideas, announced today that the Company's Thermomedics, Inc. division has shipped the first group of devices to Atlanta Headquarters of the Center for Disease Control ("CDC") for immediate distribution to selected ports of entry, where touch-free temperatures are destined to identify fevers in arriving travelers from at-risk countries.

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