The Barbara Ann Karmanos Cancer Institute continues its longtime tradition during National Breast Cancer Awareness Month recognizing 12 outstanding individuals and organizations at its 21st annual Heroes of Breast Cancer Awards event, held on Oct. 28 at the Max M. and Marjorie S. Fisher Music Center. Nearly 250 guests were in attendance to celebrate this year's honorees for their demonstrated leadership in raising awareness of breast cancer through education, the promotion of breast health, early detection and research breakthroughs, and inspirational stories of survivorship. Ann Delisi, radio and television personality and host of Ann Delisi's Essential Music on WDET 101.9 FM, served as emcee.

"We have made significant progress in the breast cancer fight but there is more work to be done," said Gerold Bepler, M.D., Ph.D. president and CEO, Karmanos Cancer Institute. "Our team at Karmanos works tirelessly to provide exceptional care to our patients, providing numerous therapies, clinical trials and advancements in cancer research to help discover new effective treatments. We also encourage women and men to be proactive about their health by talking with their physician about cancer screenings.

"We're privileged to shine light on those who support us in this fight and inspire us by their selfless contributions to improve the lives of those faced with breast cancer. It's with our sincerest gratitude that we congratulate our 2015 Heroes of Breast Cancer."

Katrina Studvent, director, Breast Cancer Special Programs at Karmanos Cancer Institute echoed Dr. Bepler's sentiments.

"We know those impacted by breast cancer are dealing with this disease every day of every month, so it's important that we take time to honor and celebrate those whose outstanding work is helping us make this disease more manageable for others," said Studvent.

"Everyone has the opportunity to make a difference for someone touched by breast cancer. This year's honorees demonstrate that in a variety of ways and teach us through their generosity what it means to a hero. We invite others to help us in this fight to end breast cancer." 

Gilead Sciences, Inc., and WuXi PharmaTech (Cayman) Inc. (NYSE: WX), today announced that they have entered into a strategic partnership to conduct analytical and stability studies of small-molecule new chemical entities to support global marketing applications and commercial products.

Under the agreement, WuXi will equip and operate a dedicated, fully cGMP-compliant 12,500-square-foot analytical testing facility in Shanghai. The facility will provide analytical and stability services, including analytical method development, transfer and validation for IND/NDA submissions; commercial API and drug product testing; stability studies of APIs, drug products for registration, and commercial products; and reference standard qualification.

"This strategic partnership further strengthens our close, broad-based collaboration with Gilead over many years," said Ge Li, PhD, Chairman and CEO of WuXi PharmaTech. "WuXi is determined to enable our innovative partners like Gilead through our open-access R&D platform, and we are very honored to help advance some of the most innovative medicines faster to patients."

"The opening of this analytical and stability testing center is an important milestone in the ongoing long-term relationship between Gilead and WuXi," said Bob Miller, Vice President of Quality Assurance – Gilead Sciences.

MiMedx Group, Inc. (NASDAQ: MDXG), the leading regenerative medicine company utilizing human amniotic tissue and patent-protected processes to develop and market advanced products and therapies for the Wound Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic, and the Dental sectors of healthcare, commented on the proposed Draft Guidance on Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products ("HCT/Ps") that the Food and Drug Administration ("FDA") published for comment on October 28, 

2015 and the Notice of Public Hearing and Request for Comments released today indicating the agency would hold a public hearing on April 13, 2016 to obtain input on that Guidance as well as three other recently issued guidance documents on HCT/Ps.

Parker H. "Pete" Petit, Chairman and CEO, stated, "It is our management's opinion that we are and have been in compliance with the homologous use requirements.  We have always marketed our products with general intended uses that have been documented by the FDA as being homologous use for amniotic tissue.   Our marketing does not reflect statements about our membranes being intended for use for specific indications such as dermal ulcers.  Our materials are much more general, and reflect uses that the FDA has already declared as homologous use for amniotic tissue."

Bill Taylor, President and COO continued, "It also seems that the market does not understand that the homologous use element of the regulation is related only to marketing.  It specifically references that the HCT/P be 'intended for homologous use only, as reflected by the labeling, advertising, or other indication of the manufacturer's objective intent.'  In instances where companies have labeling outside of those requirements, the companies generally have not been required to remove their products from the market if a labeling change could bring them back into compliance with the requirements."

Parker H. "Pete" Petit, Chairman and CEO, stated, "We view the announcement of the April 13 meeting as a positive.  This meeting is designed to allow industry and outside sources to communicate with the FDA relative to the issues highlighted in their Guidance Documents.  This is part of the FDA's formal process of 'notice and comment' which we believe is appropriate to use in this situation.  We look forward to providing our comments on the Homologous Use Guidance Document, and we have previously provided comments on the Minimal Manipulation Guidance Document that was published late last year."

"In terms of the impact to MiMedx, we find the significant price decline in our stock today to be an overreaction of the market to this issue, likely because the market misunderstands the significance of the documents and the lengthy process that is involved in bringing matters to closure," continued Petit.  "What has been released by the FDA is an initial proposed draft, which is subject to modification as comments are received and testimony is submitted.  Additionally, a determination will need to be made as to whether the process will involve rulemaking and legislative oversight, which will further extend the process."

"We do not see issues related even to this version of the Draft Guidance that will be materially disruptive to our business," commented Bill Taylor, President and COO.  "These are highly complex regulatory issues, and should not be read without some broader understanding of this regulatory category.  To that end, we spent some time this morning on our earnings call clarifying these matters, and we hope that the market will take these facts under advisement in assessing the implications of the Draft Guidance," said Taylor.

Warner Chilcott to Pay 125 Million to Resolve Kickback Allegations Seeger Weiss LLP Represented Relators in Historic Healthcare Fraud Whistleblower Lawsuit

 

Seeger Weiss, LLP www.seegerweiss.com

Seeger Weiss LLP, along with The Simmer Law Group and MoloLamken, represented the two former Warner Chilcott drug sales representatives who brought the whistleblower lawsuit.

According to DOJ, the company's marketing scheme involved paying kickbacks to health care professionals to prescribe its drugs as well as filling out and submitting fraudulent prior authorization requests to evade Medicare and Medicaid formulary restrictions, also a violation of patients' privacy protections under HIPAA. In addition to Warner Chilcott pleading guilty, DOJ also today announced the indictments of former company president Carl Reichel and district managers Timothy Garcia and Landon Eckles.  On Tuesday, DOJ filed an indictment against Rita Luthra, a Massachusetts physician.  Last July, district manager Jeffrey Podolosky also pled guilty.

"Our clients risked their careers and personal wellbeing in coming forward with these allegations and assisting DOJ with its investigation," said relators' counsel, Stephen A. Weiss of Seeger Weiss LLP in New York. "It's deeply gratifying that their perseverance and dedication has resulted in these criminal indictments and the end of Warner Chilcott's corrupt practices.  They each actively cooperated with the government's criminal investigation for many months, helping to confirm just how important and valuable the whistleblower provisions of the False Claims Act are in rooting out and bringing an end to corporate fraud."

The civil settlement was handled by Assistant U.S. Attorneys Sonya Rao and Susan Poswistilo of Ortiz's Civil Division and Trial Counsel Colin Huntley of the Commercial Litigation Branch of the Justice Department's Civil Division.

Leading Independent Proxy Advisory Firm ISS Recommends Shareholders Vote FOR DATATRAKs Entire Slate of Director Nominees on the WHITE Card

 

ISS is a leading independent U.S. proxy advisory firm and its voting analyses and its recommendations are relied upon by hundreds of major institutional investment funds, mutual funds and fiduciaries throughout the country.

In its analysis ISS concluded that the dissident, Arosa, had not made a compelling case that change at the Board level is warranted, and recommends shareholders vote FOR the management nominees on the WHITE card. In reaching its conclusion that DATATRAK shareholders support the Company's nominees, ISS not only went through a thorough analysis and evaluation of the Company's performance and Arosa's critiques but also heard directly from Arosa and its nominees, as well as DATATRAK and its Board of Directors. 

Commenting on the ISS report, Laurence Birch, the Company's President and CEO said, "We are very pleased that ISS, a highly respected independent proxy advisory service, recognizes the substantial progress we have made in executing the turnaround of the Company, positioning the Company for long-term, profitable growth, and creating long-term value for shareholders. It is clear that Arosa's attempt to take control of the Board without paying shareholders a premium and without a strategic plan for the Company is not in the best interest of DATATRAK shareholders. We encourage shareholders not to be misled by Arosa's false claims and to take the ISS recommendation into strong consideration and vote in favor of all three of DATATRAK's nominees so we can continue to execute on behalf of all shareholders."

In reaching its conclusion, ISS remarked on the significant turnaround that has taken place at DATATRAK since the Company was near bankruptcy in 2008 and directly rebuked several of Arosa's claims. 

With regard to total shareholder return (TSR) under the leadership of current CEO Laurence Birch, which Arosa has erroneously focused its TSR calculation on periods where the current management team was not in place, ISS said,

"In the two years prior to the Jan. 21, 2009 appointment of CEO Birch, the company's shares declined 97.2 percent, 55.9 percentage points below the Russell 3000 Index. However, since the CEO's appointment through the Oct. 9, 2015 unaffected date, the company's shares have increased 210.1 percent, 69.0 percentage points above the Russell 3000 Index… The Company has outperformed its peer group by 50.7% over the past three years."*

With regard to the operational performance of the Company under CEO Laurence Birch, which Arosa has criticized, ISS said:

"According to the dissident [Arosa], the company's net losses suggest that change is needed at the board level. However, revenue and cash from operations have been growing since the current CEO took office in 2009.  Since 2010, revenue and cash from operations have grown at a compound annual rate of 10.4 percent and 73.6 percent, respectively."*

Moreover, ISS stated: "The company was at risk of insolvency in 2008. It appears that management guided a significant turnaround from near bankruptcy and continues to show progress moving forward. Cash from operations, revenue, and backlog are all trending in a positive direction."*

With regard to Executive Compensation, which Arosa has incorrectly characterized at DATATRAK, ISS issued a direct reprimand to Arosa:

"According to the 2014 Annual Report, the company paid CEO Birch and CFO Mabe base salaries of $357,231 and $181,809, respectively. Therefore, the cash paid to the CEO and CFO does not appear to be as problematic as stated by the dissident."* (bolded for emphasis).

With regard to Arosa's vague "plan" for DATATRAK, ISS once again rebuked Arosa's claims:

"The fact that the dissident's own plan for the company highlights the need to invest in sales & marketing does not seems to support claims that current capital allocation is inappropriate. As evidenced by the year-over-year increase in backlog, management already appears to be executing a strategy that addresses several objectives of the dissident plan."*

DATATRAK urges stockholders to vote the WHITE proxy and allow us to execute on our strategic plan, which ISS acknowledges is working. We strongly believe any disruption to management and the Board would derail the progress we have made.  We believe in the future of DATATRAK. Please do not be misled by Arosa.  If you have already voted a Blue proxy card, a later dated WHITE proxy card will revoke that vote. 

DATATRAK urges shareholders to vote "FOR ALL" of DATATRAK's highly qualified, experienced director nominees: Laurence Birch, William Coates, and Nicholas Loiacono on the WHITE PROXY CARD.

These nominees have a significant track record of aligning themselves with shareholders and are the right individuals to build upon the Company's current momentum.

If you have any questions on how to vote your shares, please call Morrow & Co., LLC toll free at (800) 662-5200 or (203) 658-9400.

*permission to use quotations was neither sought nor obtained.

WebMD Health Services today announced two executive appointments to lead its sales and customer service organizations. John Harrison, who joined the Company in March 2015 as head of Client Delivery, has been named Senior Vice President, Customer Experience. Donna J. Geringer, a leader at driving new business development, client retention and revenue growth in the health insurance and medical services industries, has joined as Chief Client Officer. 

They will each report to Ben Slocum, CEO of WebMD Health Services.

WebMD Health Services is a health and wellness management platform that is committed to helping its customers' employees and health plan participants make smarter healthcare decisions, lower their healthcare costs, and improve health outcomes.

"WebMD Health Services is focused on developing innovative, solutions-oriented products and services that empower consumer decision-making and motivate positive action," said Slocum. "John and Donna's extensive experience and proven leadership bring important perspectives to our entire team."

John Harrison, Senior Vice President, Customer Experience

Harrison has spent more than 20 years in client experience, building and transforming teams that deliver results-driven strategies on behalf of customers. Prior to joining, he was Executive Vice President Operations, Product and Client Experience at MobilePaks, a startup focused on providing sales tools based on retention science. Previously, he was Vice President of Client Experience at Webtrends and President of Client Services at Yesmail. He also held senior product and client service positions at @Once, GeoTrust, and Symantec.

Donna J. Geringer, Senior Vice President, Chief Client Officer

Geringer has driven new business development, client retention and revenue growth for large health insurance and medical services organizations in the commercial payer and public sector markets for more than 25 years. Prior to joining, she was Senior Vice President, Sales and Exchange Development for Davis Vision, Vice President, Growth and Business Development at KEPRO, and served in leadership sales positions at Ingenix, Aetna National Accounts, Anthem Blue Cross and Blue Shield and WellPoint, Inc. 

Select Medical Holdings Corporation ("Select Medical") (NYSE: SEM) today announced results for its third quarter ended September 30, 2015.

For the third quarter ended September 30, 2015, net operating revenues increased 34.7% to $1,021.1 million, compared to $758.1 million for the same quarter, prior year.  Income from operations was $48.2 million for the third quarter ended September 30, 2015, compared to $66.0 million for the same quarter, prior year.  Income before income taxes included a non-operating, one-time gain of $29.6 million on the sale of an equity investment in the third quarter ended September 30, 2015. Net income attributable to Select Medical was $29.4 million for the third quarter ended September 30, 2015, compared to $26.5 million for the same quarter, prior year.  Net income before interest, income taxes, depreciation and amortization, gain (loss) on early retirement of debt, stock compensation expense, Concentra acquisition costs, equity in earnings (losses) of unconsolidated subsidiaries, and gain on sale of equity investment ("Adjusted EBITDA") for the third quarter ended September 30, 2015 decreased to $84.5 million, compared to $86.8 million for the same quarter, prior year.  A reconciliation of net income to Adjusted EBITDA is presented in table VIII of this release. Income per common share for the third quarter ended September 30, 2015 was $0.22 on a fully diluted basis compared to income per common share of $0.20 for the same quarter, prior year. 

Nu Skin Enterprises, Inc. (NYSE: NUS) today announced that its board of directors has increased its stock repurchase authorization to $500 million, an increase of approximately $260 million. 

"We remain confident in our ability to grow the business as we begin to introduce our innovative new ageLOC products," said Ritch Wood, chief financial officer. "We plan to use our financial strength to repurchase shares and create shareholder value."