23andMe Takes First Step Toward FDA Clearance

MOUNTAIN VIEW, Calif., July 30, 2012 /PRNewswire/ -- 23andMe, the leading personal genetics company, today announced that it has delivered its first round of 510(k) documentation to the Food and Drug Administration (FDA).  Since its 2006 inception, 23andMe largely created the direct-to-consumer market for genetic analysis.  As a leader in personal genetics, the company is now the first in the industry to announce it is working towards FDA clearance. The FDA will review the filing over the next several months and the process of gaining clearance will take time as both the FDA and 23andMe attempt to apply current regulations to a new and growing industry.

"23andMe has pioneered the direct-to-consumer genetic testing industry and we are committed to helping individuals understand their own genetic information through proven DNA analysis technologies and web-based interactive tools," stated 23andMe CEO and Co-Founder Anne Wojcicki.  "23andMe is working proactively with the FDA to ensure the industry delivers high quality information that consumers can trust."

23andMe's Personal Genome Service^® enables individuals to explore their own DNA and now provides more than 200 health and trait reports as well as genetic ancestry information.  The extensive package of health and ancestry reports offered by 23andMe has grown dramatically as the body of research in the general scientific community has continued to make significant advances in assessing the role of genetics in health and diseases. That body of peer-reviewed, published research is regularly curated by the team of 23andMe scientists to determine which information meets the rigorous 23andMe criteria to be incorporated into its health and trait reporting as detailed inhttps://www.23andme.com/for/scientists/.   

"23andMe has always valued the guidance of the FDA and, in fact, engaged the agency in conversations prior to launching the Personal Genome Service^® in 2007. Our ongoing conversations with the FDA in the last year, in particular, resulted in a focused approach that resulted in our ability to compile a comprehensive analysis of 23andMe's direct-to-consumer testing for FDA consideration," stated 23andMe VP Corporate Development and Chief Legal Officer Ashley Gould.

In providing personalized health reports 23andMe believes that individuals have a fundamental right to their personal genetic data and that genetic data is an essential complement to family history for people to make informed decisions in conjunction with their healthcare provider.

The 23andMe platform is designed to be both fluid and transparent and the filing with the FDA is designed to accommodate this data-driven paradigm. The body of information provided by 23andMe grows over time, not only in adding more traits and health reports, but also in interpreting results based on the continued evolution of scientific literature. 

23andMe uses a CLIA-certified laboratory to process customer DNA samples. The 510(k) documentation provided to the FDA builds upon the company's scientifically sound practices by demonstrating the clinical and analytical validity of its reporting.

"FDA clearance is an important step on the path towards getting genetic information integrated with routine medical care," explained Ms. Wojcicki.  "As the knowledge around personalized medicine continues to grow, consumers should expect their healthcare providers to begin to incorporate genetic information into their treatments and preventative care."

"We believe our ongoing conversations with the FDA and ultimately securing clearance will be very important as we continue to serve our customers with genetic information that is an essential consideration in their personal health, and continue to grow our community, which is now more than 150,000 strong," concluded Ms. Wojcicki.

An ongoing service, 23andMe's Personal Genome Service^® provides a wealth of information about an individual's DNA and updates about new research.  Customers can also choose to participate in the company's unique research programs. By completing online surveys, customers contribute directly to genetic research that can potentially lead to better understanding of and new treatments for a variety of health conditions.

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SOURCE 23andMe

Clinical Research on Accuray's CyberKnife and TomoTherapy Systems to Be Presented at Key Industry Event for Medical Physicists

SUNNYVALE, Calif., July 29, 2012 /PRNewswire/ -- Accuray Incorporated (Nasdaq: ARAY), the premier radiation oncology company, announced today that more than 70 studies on the clinical use of the CyberKnife Robotic Radiosurgery® System and the TomoTherapy® System will be presented at the 54^th Annual Meeting of the American Association of Physicists in Medicine (AAPM) taking place in Charlotte, N.C. July 29 - August 2, 2012. The Annual AAPM Meeting usually draws about 4,000 attendees.

Studies from leading centers will showcase both the CyberKnife System and the TomoTherapy System. The presentations continue to validate Accuray's standard-setting treatment planning and delivery techniques, accurate patient setup and intrafraction motion tracking, as well as quality assurance practices for the industry's premier, fully-integrated radiosurgery and intensity-modulated radiotherapy platforms. Of note are studies that emphasize the benefits of each technology in demanding clinical situations. Key examples are the TomoTherapy System's unmatched ability to provide organ sparing and dose homogeneity in hippocampal-avoidance whole brain radiotherapy and the CyberKnife System's ability to maintain continual tracking accuracy during treatment of liver tumors undergoing a large degree of respiratory motion.

Accuray will also host a symposium on Monday, July 30, 2012 from 12:30 p.m. EDT – 1:30 p.m. EDT at The Westin Charlotte Hotel. The session will focus on Accuray's new VoLO™ technology for the TomoTherapy System, a treatment planning platform that leverages advanced parallel processing technology and a new dose calculation algorithm to increase clinical efficiency, throughput and flexibility in developing even the most complex treatment plans. In addition, the symposium will highlight TomoTherapy's new Dose Control System, improving system stability during and between treatments.

"Medical physicists play a vital role in the radiation therapy field, ensuring patient safety and treatment quality, two areas to which Accuray is strongly dedicated," said Euan S. Thomson, Ph.D., Accuray president and chief executive officer."We are pleased by the quantity and quality of clinical research being presented. This work adds to the growing body of scientific evidence validating the safe and effective use of our products for an expanding range of clinical indications."

Accuray will be exhibiting at booth #909. Presenters include Robert Staton, Medical Physicist, MD Anderson Orlando who will be presenting on his experience with the TomoTherapy Dose Control System and Kenneth Ruchala, Ph.D., Accuray Incorporated who will be presenting information on the Non-Voxel Broad Beam algorithm for a GPU-based dose calculator. Additionally, Accuray will host demonstrations of its VoLO technology for the TomoTherapy System at the booth.

The TomoTherapy System is a fully integrated 3D image guided intensity modulated radiation therapy system that provides patients with the most accurate, personalized cancer care. The technology uses daily computed tomography (CT) imaging to identify the exact position of the tumor on each day of treatment, enabling clinicians to customize treatment for each patient, minimize radiation exposure to healthy tissue and reduce side effects. The TomoTherapy System uses a radiation beam that continually rotates in 360 degree arcs about the patient, meaning that treatments can be delivered continuously to the tumor from every angle.

The CyberKnife System is the first and only robotic radiosurgery system that provides a pain-free, non-invasive treatment option for patients who are looking for an alternative to surgery or who have an inoperable or surgically complex tumor. CyberKnife treatment is typically completed in just one to five days, instead of the 40 or more treatment sessions typically required with conventional radiation therapy. The CyberKnife System offers unique capabilities that automatically account for the natural motion of the tumor throughout treatment. The ability to manage motion in real time helps ensure that radiation is delivered only to the tumor while sparing healthy tissue and critical structures.

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SOURCE Accuray Incorporated

Expanded Analysis of HPTN 052 Study Results Show Cost-Effectiveness of Early Treatment of HIV

RESEARCH TRIANGLE PARK, N.C., July 27, 2012 /PRNewswire-USNewswire/ -- When the HIV Prevention Trials Network (HPTN) 052 investigators released their landmark study results last year showing that treatment can reduce HIV transmission by 96% in serodiscordant couples, questions were raised about the cost of early antiretroviral therapy (ART) and if it should be universally implemented. Data presented today at the XIX International AIDS Conference in Washington, D.C. show that treatment as prevention is "very cost-effective". Using an HIV microsimulation model (CEPAC-International) to further expand analysis of HPTN 052 data, study investigators were able to project the clinical impact, costs, and cost-effectiveness of early ART. They found that this strategy increases survival, prevents costly opportunistic infections, averts early transmissions and is very cost-effective.

Commenting on the findings, Rochelle Walensky, MD, MPH, Associate Director of the Program in Epidemiology and Outcomes Research at the Harvard Center for AIDS Research said, "Early ART is a triple winner: HIV-infected patients do better, their partners are protected and it is very cost-effective. Regardless of the country setting, over the long term treatment as prevention offers excellent return on investment across a wide range of assumptions about transmission and treatment effects."

The cost-effectiveness analysis was modeled in South Africa and India using trial-derived data. These two geographic locations were selected to illustrate how regional economic distinctions may, or may not, change the conclusions. Early ART was designated as very cost-effective or cost-effective if its cost-effectiveness ratio is < 1x or < 3x per capita GDP (GDPs: $8,100 [South Africa]; $1,400 [India]). In making the distinctions between cost-effective and cost-saving it is important to note that interventions need not save money to be cost-effective and worth implementing. Widely accepted international standards exist to help define when the health benefits of an intervention justify the additional costs. Using those standards, early ART is very cost-effective.

"This expanded analysis of the HPTN 052 study results provides more evidence that treatment as prevention is a strategy we can't afford to ignore," said  Myron Cohen, MD, Co-Principal Investigator of HPTN, and the HPTN 052 Protocol Chair. "Clearly the results of the model indicate there is a great return on this important health investment."

HPTN 052 is an ongoing randomized clinical trial. A total of 1763 HIV serodiscordant couples were enrolled in HPTN 052 between April 2005 and May 2010.The study is being conducted at 13 sites in Africa, Asia, and North and South America. The majority of couples (97%) are heterosexual. All participants receive couples risk-reduction counseling, free condoms and testing and treatment for sexually transmitted infections Primary HIV care is also provided to the HIV-infected partner.   Following the public announcement of results in May 2011, all HIV infected participants in the study were offered ART. All participants will continue to be followed until the planned study end in April 2015, to assess the durability of the prevention and clinical benefits.

The release of the initial prevention and clinical study results of HPTN 052 in 2011 led to the revision of both World Health Organization (WHO) and U.S. treatment guidelines.

HPTN 052 is funded by the Division of AIDS (DAIDS)/U.S. National Institute of Allergy and Infectious Diseases (NIAID)/U.S. National Institutes of Health (NIH). HPTN 052 is conducted in collaboration with the AIDS Clinical Trials Group (ACTG). Study drugs are donated by Abbott Laboratories; Boehringer Ingelheim Pharmaceuticals, Inc.; Bristol-Myers Squibb; Gilead Sciences, Inc.; GlaxoSmithKline/ViiV Healthcare; and Merck & Co., Inc.

To learn more about the HIV Prevention Trials Network, visit www.hptn.org.

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ViroPharma's Cinryze (C1 esterase inhibitor [human]) Open Label Prophylaxis Study Showed Up To 2.6 Years Of Effectiveness In Majority Of Subjects With Hereditary Angioedema

EXTON, Pa., July 27, 2012 /PRNewswire/ -- ViroPharma Incorporated (Nasdaq: VPHM) today announced the publication of data demonstrating that routine prophylactic use of Cinryze® (C1 esterase inhibitor [human]) provided effectiveness and maintained a generally favorable safety profile in the majority of treated subjects with hereditary angioedema (HAE). HAE is a rare, severely debilitating, life-threatening genetic disorder caused by a deficiency of a human plasma protein called C1 inhibitor. The paper entitled Safety and Efficacy of Prophylactic Nanofiltered C1-inhibitor in Hereditary Angioedema by Drs. Bruce L. Zuraw and Ira N. Kalfus describes the maintenance of effectiveness and the safety profile of Cinryze as continuing prophylactic therapy in a large cohort of subjects with HAE. These data have been published in the July 14th online edition of The American Journal of Medicine (AJM).  The company expects the data to appear in the September print issue.

According to the publication, subjects were to be treated with Cinryze 1000 units every 3 to 7 days based on the decision of the investigator; subjects in the study experienced a 93.7 percent reduction in attacks while taking prophylactic Cinryze (median of 0.19 attacks per month) compared with the median historical rate at baseline (3 attacks per month). Some 87.7 percent reported an attack frequency of one or less attack per month during prophylactic Cinryze and 34.9 percent had no attacks during the study. Some 7.5 percent of subjects experienced relatively frequent attacks despite twice-weekly Cinryze. Additionally, though 18 subjects (12.3 percent) had an overall attack rate of more than 1 per month on Cinryze, only 4 subjects (2.7 percent) failed to achieve an attack rate of one or less per month when treated with Cinryze at the recommended twice per week schedule.

Overall, subjects on average received 1.4 injections per week throughout the study period. The efficacy of Cinryze directly correlated with the interval between injections where 1000 units every 2 to 4 days resulted in 1 attack for every 132 days of treatment compared to 1000 units every 6 to 7 days which resulted in 1 attack for every 46 days of treatment. No clinical characteristics predicted the response to prophylactic C1INH-nf, including historical attack frequency.

At enrollment, 42 subjects (28.8 percent) were taking regular prophylactic androgens in an effort to prevent attacks of HAE. During the study, 23 subjects (54.8 percent) discontinued androgens, 6 subjects (14.3 percent) discontinued regular use and switched to as-needed use, 5 subjects (11.9 percent) reduced the androgen dose, and 8 subjects (19 percent) remained on the same dose. The median monthly attack rate in the 23 subjects who discontinued androgens went from 3 attacks per month while on androgens to 0 attacks per month when switched to prophylactic Cinryze.

No subjects discontinued the study drug because of an adverse event. Eighty-six percent of treatment-emergent adverse events were of mild or moderate intensity.  A total of 99 of 101 serious adverse events reported were considered not related to Cinryze, and 2 serious adverse events (musculoskeletal chest pain and major depression) were of unknown relationship.

"The results of this study reinforce the efficacy and safety profile of Cinryze when used up to 2.6 years and the clinically relevant impact Cinryze can offer to people living with HAE who are experiencing recurrent attacks," commented Dr. Bruce L. Zuraw, professor of medicine and program director of the Allergy and Immunology Fellowship Program at theUniversity of California at San Diego. "These data suggest that prophylactic Cinryze should be considered by the physician for any patient with hereditary angioedema who requires or desires prophylactic treatment."

Study Design

An open-label, multicenter extension study was performed to evaluate the safety and efficacy of Cinryze involving 146 subjects with HAE who were treated for up to 2.6 years in centers throughout the United States. Subjects were to be treated with Cinryze 1000 units every 3 to 7 days based on the decision of the investigator. The primary efficacy variable was the number of attacks of angioedema experienced.

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Mylan Launches Generic Version of Sporanox Capsules

PITTSBURGH, July 27, 2012 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Itraconazole Capsules, 100 mg. This product is the generic version of Janssen Pharmaceutical Inc.'s Sporanox^® and is indicated for the treatment of fungal infections that begin in the lungs, blatsomycosis, histoplasmosis, and aspergillosis in patients who are intolerant of or who are refractory to amphotericin B therapy. Itraconazole capsules are also indicated for the treatment of fungal infections of the toenails and fingernails in non-immunocompromised patients(1).

Itraconazole Capsules, 100 mg, had U.S. sales of approximately $60 million for the 12 months ending March 31, 2012, according to IMS Health. Mylan is shipping this product immediately.

Currently, Mylan has 166 ANDAs pending FDA approval representing $82.6 billion in annual sales, according to IMS Health. Thirty-five of these pending ANDAs are potential first-to-file opportunities, representing $25.1 billion in annual brand sales, for the 12 months ending Dec. 31, 2011, according to IMS Health.

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