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Dune Medical Devices Receives FDA Approval for Breast Cancer Assessment Tool

dune medical devices

BOSTON, Jan. 2, 2013 /PRNewswire/ -- Dune Medical Devices, Inc., announced today that its breakthrough intra-operative tissue assessment tool for early-stage breast cancer surgery, the MarginProbe System, has received Premarket Approval (PMA) by the United States Food and Drug Administration. The technology significantly improves surgeons' ability to intra-operatively identify "cancer on the margin" and significantly reduce pathologically positive margins following a patient's initial lumpectomy surgery.

FDA approval of the MarginProbe System was based on a 664 patient prospective, multi-center, randomized, double arm study to evaluate the effectiveness of MarginProbe in identifying cancerous tissue along the margins of removed breast tissue during initial lumpectomy procedures. MarginProbe, which uses electromagnetic "signatures" to identify healthy and cancerous tissue, was found to be over three times more effective in finding cancer on the margin during lumpectomy, compared to traditional intra-operative imaging and palpation assessment. This enabled surgeons to significantly reduce the number of patients with positive margins following initial surgery.

"Up to this point our ability to assess the microscopic margin status in the operating room has been limited. Frequently, early-stage breast cancers are detected by mammography. This can make the process of achieving negative margins more challenging," said Dr. Susan K. Boolbol, an investigator for the pivotal clinical trial and Chief of Breast Surgery at Beth Israel Medical Center. "Following their breast cancer surgery, telling a patient that they need more surgery can be an emotional issue for doctors and patients. This may result in tremendous anxiety and frustration. I believe that the MarginProbe System can help advance the field of breast surgery."

It is estimated that 30 to 60 percent of early-stage breast cancer patients who have an initial lumpectomy procedure will undergo a repeat surgery.[i] This is because cancerous cells are found to be present on the rim or edge of the removed tissue, increasing the possibility that cancer still remains in the breast.

Susan Scanlan, breast cancer survivor and Chair of the National Council of Women's Organizations, said, "When I was first diagnosed with breast cancer I decided to undergo a lumpectomy, but like many others, I was told I had cancer on the margin following the procedure. The mental distress of having to go back for a repeat surgery undermined my confidence. I believe MarginProbe offers women the additional peace of mind that they can move on to the next step in fighting the disease and put breast cancer in their rearview mirror."

"The MarginProbe System was developed to address one of the longest standing unmet medical needs in the breast cancer surgical community," said Daniel Levangie, Chief Executive Officer of Dune Medical Devices. "We have received resounding support from clinicians, advocacy organizations and patients alike, who have recognized the value of MarginProbe and intra-operative, real-time detection of cancer on the margin to potentially improve patient outcomes."

MarginProbe has been available in Europe since 2008 and is now available in select locations throughout the U.S., with national availability expected in early 2013. For more information, please visitwww.dunemedical.com.

About Early-Stage Breast Cancer Treatment
Breast cancer is the most common type of cancer affecting women in the U.S., with over 285,000 women diagnosed each year.[ii] Increased breast screening awareness and advancements in imaging technology such as mammograms now catch more breast cancer cases in earlier stages, when they are most treatable. In fact, over half of all breast cancer diagnoses are for early-stage cancers. Many of these cases are non-palpable, meaning a tumor cannot be felt during a breast exam.

It is estimated that in 60 to 75 percent of breast cancer cases, patients will undergo a lumpectomy procedure as their initial treatment versus mastectomy, which involves the removal of the whole breast[iii]. Lumpectomy in combination with radiation therapy is as effective in combating breast cancer as mastectomy, as long as no cancer cells are present on the rim or edge of the removed tissue, also known as "clean margins." Research shows there is no significant difference in overall survival between the two procedures;[iv] however, if there is cancer at the edge, or a "positive margin," the risk of recurrence increases significantly.

Following a lumpectomy, surgeons will send the removed tissue to the pathology lab where it is analyzed for cancer on the margin. This is critical information because if there is cancer present on the edges of the removed tissue, there is a possibility that cancer still remains in the breast. Once a tissue sample is sent to pathology for analysis, it can take approximately one week or more to receive the lab results that determine if the patient must undergo a repeat surgery.

Inability to know if all cancerous cells have been removed from the breast during the initial lumpectomy procedure results in repeat surgery rates ranging from 30 to 60%.

About Dune Medical Devices
Dune Medical Devices was founded in 2002 by Dr. Dan Hashimshony to realize the extraordinary medical potential of its proprietary tissue characterization technology. Offering surgeons and radiologists the real time ability to identify cancerous tissues and react immediately, this technology holds the promise for a broad range of surgical and diagnostic applications. Dune Medical Devices is a privately held company financed by Apax Partners since 2004. It has offices in the U.S., Israel, Germany and Switzerland.

 

Source: Dune Medical Devices

Last Updated: 1/2/13; 10:30AM EST

2012 Year in Review: SPJ Top 10 Articles

SPJ year in review

As we enter a new year, Specialty Pharma Journal (SPJ) looks back at the most read articles of 2012, reviewing the most popular news based off our readers. Below are reviews on SPJ’s top 10 articles of 2012.

1. The announcement that The National Association of Specialty Pharmacy (NASP) Plans Launch, created an immense amount of interest in the specialty pharmacy industry. In September, NASP announced its scheduled launch, which commenced with its inaugural event at the Academy of Managed Care Pharmacy (AMCP) Educational conference in Cincinnati. Since then, NASP has announced its collaboration with AMCP by hosting the Inaugural AMCP/NASP Specialty Pharmacy Conference held on April 2-3, 2013.

2. In February of 2012, the Food and Drug Administration (FDA) announced draft rules for biosimilars. The article, Draft Rules for Biosimilar Drugs Issued by the FDA, reviewed specialty pharmaceutical drugs that could potentially be replicated with biosimilars, as well as guidelines including that the FDA has 10 months to decide whether to approve a biosimilar drug after receiving the application. The FDA also issued guidance on quality considerations for biosimilarity and a question and answer document for manufacturers.

3. The national crisis of the fungal meningitis outbreak linked to tainted steroids made by the New England Compounding Pharmacy (NECC) was, and continues to be, a major topic throughout the nation. The Implications of the Meningitis Outbreak on Specialty Pharmacy reviews the impact of the outbreak during the initial announcement when the NECC was repeatedly referred to as a specialty pharmacy. Specialty Pharma Journal interviews Diplomat’s Specialty Pharmacy President, Gary Kadlec, regarding the initial impact of the outbreak and the communication effort put in place to differentiate what their pharmacy does. According to the Centers for Disease Control and Prevention (CDC), the outbreak has currently caused 656 people to be sickened and been responsible for 39 deaths throughout 19 states.

4. In September of 2013, The Specialty Pharmacy Certification Board Announces Inaugural Board of Directors, including Board members that represent a wide range of specialty pharmacy industry stakeholders from across the United States. The Board is leading a national effort to develop a professional certification program exclusively for Specialty Pharmacists, known as the Certified Specialty Pharmacist (CSP) credential. The CSP credential will recognize individuals who have demonstrated a sufficient level of knowledge and skill to provide competent Specialty Pharmacy Services. SPCB is currently inviting specialty pharmacists to help contribute to defining Specialty Pharmacy through the skills and knowledge required for a successful practice by participating in a national Role Delineation Study survey. To take the survey, click here.

5. CSL Behring announced in March that a Study Confirms Early Berinert Treatment Provides Faster Relief for Hereditary Angioedema Patients. Data was presented at the 2012 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting showing symptoms resolving considerably faster among patients who were treated earlier. Ralph Shapiro, MD, of the Midwest Immunology Clinic in Plymouth, MN, and the study’s lead investigator concluded, “Given the importance of timely treatment, the idea of home-based therapy for HAE attacks has gained support in recent years. Our findings suggest that self-administration of Berinert can provide patients with a new confidence in managing their HAE symptoms.”

6. Mergers and acquisitions were very common in 2012. In May this year, Walgreens announced that Walgreens Completed Acquisition of BioScrip’s Community Specialty Pharmacies & Centralized Specialty Mail Service Pharmacy Businesses. The transaction represented a total deal value of approximately $225 million. The acquisition is one of many that occurred this year, advancing Walgreens’ strategy to advance community pharmacy and bring additional specialty pharmacy products and services closer to patients. The acquisition also boosted Walgreens’ centralized specialty and mail service pharmacy operations. Walgreens obtained a national network with 30 location across 16 states in the US and the District of Columbia.

7. During the beginning of 2012, Market Dynamics, Biosimilars, HIT and Other Issues were Highlighted at the Center for Healthcare Supply Chain Research’s First “Specialty Pharmaceutical Supply Chain Issues and Trends Seminar”. The seminar included discussions from Doug Long of IMS Health, who spoke about the future for biologics and its pipeline, as well as the therapeutic categories which will be leading the total pharmaceutical marketplace by 2015. He also discussed “Pharmerging” markets. The article reviews some of the key topics and presentations delivered at the seminar. The upcoming “Specialty Pharmaceutical Supply Chain Issues and Trends Seminar” will be held from February 12-13, 2013 in Ponte Vedra Beach, Florida.

8. In May of 2012, Aimee Tharaldson, PharmD, Senior Clinical Consultant, Emerging Therapeutics at Express Scripts provided SPJ with a Specialty Pharmaceuticals: Pipeline Update. The article reviews research and projections on specialty pharmaceutical products, as well as therapeutic classes. The article focuses on the development of four specialty therapy classes including cancer, inflammatory conditions (rheumatoid arthritis, psoriasis, gout and lupus), multiple sclerosis (MS), and hepatitis C.

9. In April of 2012, Express Scripts Completed the Acquisition of Medco Health Solutions, costing Express Scripts $29.1 billion. This merger was widely discussed, especially during the initial announcement in 2011. This acquisition was the largest deal in at least a decade among US companies that manage prescription-drug benefits. Following the close of the acquisition, both Express Scripts, Inc and Medco Health Solutions, Inc are wholly-owned subsidiaries of Express Scripts Holding Company, which is the new, publicly-traded entity.

10. Our final most-read article was the Armada Summit 2012: Key Highlights, which reviewed topics that were discussed throughout the meeting. Armada announced their new technology and service platform including ApproveRx, ASPN, and OTM. The article discusses some of the speakers and presentations related to the specialty pharmacy industry. Armada will be hosting the Ninth Annual Armada Specialty Pharmacy Summit, which will be held in Las Vegas from May 7-10, 2013, including keynote speaker, Dennis Miller, special guest speaker Eric Topol, MD, and general session speakers Rob Bazemore and Mike Ellis.

Watson Confirms Patent Challenge for Oncology Drug

watson

Watson Pharmaceuticals, Inc confirmed that Actavis, Inc, a company acquired by Watson in October, has filled for an Abbreviated New Drug Application (ANDA) seeking approval from the US Food and Drug Administration (FDA) to market a generic version of a cancer drug.

Actavis’ ANDA product is a generic version of Millennium Pharmaceuticals’ Velcade (bortezomib) approved for the treatment of patients suffering from multiple myeloma and patients with mantle cell lymphoma who have previously received at least one therapy. The drug is a proteasome inhibitor for intravenous or subcutaneous administration.

On December 21, 2012, Millennium filed suit against Actavis in the US District Court for the District of Delaware. Millennium is seeking to prevent Actavis from commercializing its ANDA product until certain US patents expire. According to Watson, the lawsuit was filed under the provisions of the Hatch-Waxman Act resulting in a stay of final FDA approval of the ANDA for up to 30 months from the date the plaintiffs received notice of Actavis’ ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.

According to IMS Health data, Velcade had US sales of approximately $740 million in the US for 12 months ending October 31, 2012.

Watson Pharmaceuticals, Inc. is a global, integrated specialty pharmaceutical company that is focused on developing, manufacturing and distributing generic, brand and biosimilar products. Watson is committed to developing and marketing biosimilars products in Women’s Health, Oncology, and other therapeutic areas.

Source: Watson Pharmaceuticals, Inc.

Last Updated: 12/28/12; 12:25PM EST

Phil Hagerman of Diplomat Specialty Pharmacy Named A Michigander to Watch by MLive Media

Phil Hagerman

Phil Hagerman, RPh, Diplomat Specialty Pharmacy’s CEO and co-founder, has recently been named one of the thirteen Michiganders to Watch by MLive Media Group, a collaborative network of local and statewide Michigan news outlets.

Diplomat Specialty Pharmacy is the nation’s largest privately held specialty pharmacy company servicing the needs of patients and physicians nationwide with 765 employees and counting.

Phil Hagerman has had many accomplishments. In 2010 he was named the Ernst & Young Entrepreneur of the Year for the Michigan and Northwest Ohio Region; and in 2011 he was named Grant Thornton Leader and Innovator of the Year. Due to the company’s hiring trend, Diplomat was recognized on Inc magazine’s inaugural list of the nation’s top 100 job creators, known as the Hire Power Awards. Diplomat has also been listed as one of the nation’s fastest-growing companies in Inc magazine for the past four years.

Additionally, MLive applauded Hagerman for Diplomat’s philanthropic efforts to help revitalize Flint, Michigan, the company’s home town, which was significantly affected by the downsizing in the auto industry. Diplomat’s job creation initiative is set to launch in 2013 with St. Luke’s N.E.W. (North End Women’s) Life Center, a program based in Flint Michigan that assists at-risk women in becoming self-sufficient providers for their families.

To view Phil Hagerman’s MLive program, click here.

 

Source: Diplomat Specialty Pharmacy

Last Updated: 12/28/12; 11:45 AM EST

Victory Pharma Pays $11.4 Million to Settle Kickback Claims

DOJ

The Department of Justice announced that Victory Pharma Inc, a San Diego-based specialty pharmaceutical company, has agreed to pay $11.4 million to resolve allegations of using kickbacks to entice doctors to prescribe its products.

The settlement resolves allegations that the company offered kickbacks such as tickets to sporting events, concerts and plays; spa outings; golf and ski outings; expensive dinners; and many other events. The settlement will clear the company of federal civil and criminal liability from its marketing of the products Naprelan, Xodol, Fexmid, and Dolgic.

The company was also accused of improperly using paid “preceptorships” where its sales representatives would shadow the doctors in their offices. The company also settled accusations that it used these opportunities to induce doctors to prescribe Victory’s products.

“Kickback schemes undermine the integrity of medical decisions, subvert the health marketplace and waste taxpayer dollars,” Stuart F. Delery, Principal Deputy Assistant Attorney General for the Civil Division stated. “We will continue to hold accountable those who refuse to play by the rules and provide illegal incentives to influence the decision making of health care providers.”

The settlement resolves a False Claims Act lawsuit, which was filed by Chad Miller, a former sales representative for the company. As part of the resolution, he will receive $1.7 million.

“This resolution underscores the need for physicians to make treatment decisions based on their own independent medical judgment, without being influenced by kickbacks or other improper benefits,” Laura E. Duffy, US Attorney for the Southern District of California said. “Protecting taxpayers from health care fraud is a priority of this office. We will continue to work closely with our investigative partners in taking both criminal and civil measures to combat health care fraud.”

 

Source: Department of Justice

Last Updated: 12/28/12; 10:00AM EST

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