ViroPharma Incorporated announced that the U.S Food and Drug Administration (FDA) issued a complete response letter regarding CinryzeZ (C1 Esterase Inhibitor [Human]) industrial scale manufacturing expansion activities.

Specifically, the FDA has three comments related to a portion of the cleaning validation for industrial scale manufacturing, of which only one requires additional unplanned activity. The company expects that the additional activity required to address this comment can be completed in a short time frame.

The FDA also noted that it has not yet completed the review of ViroPharma’s January 2012 updated responses to observations specific to the September 2011 inspection of the Amsterdam facility.

There are no remaining technical comments posed by FDA in the complete response letter. The company intends to provide an update to shareholders on specific timing of resubmission and expected action dates during the 2011 Financial Results conference call to be held later this month.

“We and our partner Sanquin will begin working immediately to respond to the FDA as expeditiously as possible.” – Robert Pietrusko ViroPharma’ Vice President Global Regulatory Affairs and Quality.

Cinryze is a highly purified, pasteurized and nanofiltered plasma-derived C1 esterase inhibitor product. In the U.S., Cinryze is approved by the FDA for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE.

In the E.U., the product is approved by the EMA for the treatment and pre-procedure prevention of angioedema attacks in adults and adolescents with hereditary angioedema (HAE), and routine prevention of angioedema attacks in adults and adolescents with severe and recurrent attacks of hereditary angioedema (HAE), who are intolerant to or insufficiently protected by oral prevention treatments or patients who are inadequately managed with repeated acute treatment.

Cinryze is for intravenous use only.

Severe hypersensitivity reactions to Cinryze may occur. Thrombotic events have occurred in patients receiving Cinryze, and in patients receiving off-label high dose C1 inhibitor therapy. With any blood or plasma derived product, there may be a risk of transmission of infectious agents.

The risk has been reduced by screening donors for prior exposure to certain virus infections and by manufacturing steps to reduce the risk of viral transmission including pasteurization and nanofiltration.

The most common adverse reactions in clinical trials associated with Cinryze were rash, headache, nausea, erythema, phlebitis and local reactions at the injection site. Adverse events of sinusitis and upper respiratory infection also were observed in clinical trials. No drug-related serious adverse events (SAEs) were reported in clinical trials.

Please visit http://www.viropharma.com/products/cinryze.aspx for the full U.S. Prescribing Information; the prescribing information for other countries can be found at www.viropharma.com.

Popularity: 1% [?]

Results from an international multi-center Phase II clinical trial suggest that extracorporeal photopheresis (ECP) may be effective in treating patients with clinically active (OR symptomatic) Crohn’s disease who cannot tolerate or are refractory to immunosuppressants and/or anti-TNF agents. A 50% response rate after 3 months of ECP treatment was noted in the study, using standard disease activity criteria, as presented this afternoon at a scientific research session of Digestive Disease Week (DDW). The majority of patients who responded to ECP therapy had a notable improvement in their disease symptoms and signs after only six weeks of treatment.

“We show in this pilot study that ECP is effective in patients with Crohn’s disease (CD) that have previously failed the strongest therapies we currently have,” explains Maria Abreu, MD, Associate Professor in The Henry D. Janowitz Division of Gastroenterology and in the Center for Immunobiology at The Mount Sinai Medical Center. ECP is believed to bolster tolerance in the immune system, which may be important in immune-mediated diseases such as Crohn’s. In contrast, most patients with inflammatory bowel disease are currently treated with medicines that suppress the immune system. Unlike ECP, those medications can have many serious side effects.

The 28 patient trial studied the safety and efficacy of ECP in patients with a Crohn’s Disease Activity Index (CDAI) of at least 220 and less than 450 indicating that at least moderately active symptomatic CD was present. Clinical response was defined as a CDAI decrease of 100 or greater from baseline and/or a CDAI of less than 150 at week 12. Patients received two treatments of ECP weekly from weeks 0-4 and two treatments every other week from weeks 6-12 with no infectious complications reported.

“The findings of our study suggest that Crohn’s disease patients who have not responded to other therapies may benefit from ECP,” concludes Dr. Abreu.

About Extracorporeal Photopheresis (ECP)
During ECP treatment, a small portion of the patient’s white blood cells are collected and treated with 8-methoxypsoralen, a drug that belongs to a class of naturally occurring compounds known as psoralens. Once activated by exposure to UVA (ultraviolet-A) light, the activated 8-methoxypsoralen induces apoptosis, or programmed cell death, in the white blood cells, which are then promptly returned to the patient. In this way the patient is only exposed to minute amounts of drug. ECP is usually performed on an outpatient basis over several treatment visits.

The Therakos UVAR instrument, in conjunction with 8-methoxypsoralen, is the only ECP system approved by the Food and Drug Administration for the palliative treatment of the skin manifestations of Cutaneous T-cell Lymphoma that is unresponsive to other forms of treatment. The UVAR is also the only device in Europe that is CE marked for ECP.

ECP as performed on UVAR systems has an established safety profile and more than 500,000 treatments have been conducted since 1987. The most common side effects are transient non-serious hypotensive episodes and mild transient decreases in hematocrit and hemoglobin.

Popularity: 2% [?]

Exton-based Analytical Graphics, Inc. today introduced STK/EOIR—commercial modeling and simulation software for electro-optical infrared sensors used in space surveillance, missile defense and Earth remote sensing. Developed for use with AGI’s STK analysis and visualization software, STK/EOIR models sensor detection, tracking and imaging performance. It allows users with a basic understanding of system-level sensor specifications to improve their STK mission model with radiometric performance prediction.

STK/EOIR was developed by Space Dynamics Laboratory (SDL), an AGI business partner and industry leader in electro-optical and infrared sensor systems. For more than 50 years, SDL has designed, fabricated, tested and deployed sensors for customers including NASA, the U.S. Air Force and the U.S. Missile Defense Agency.

“STK/EOIR gives systems engineers access to radiometric performance models with a level of detail matched to their needs. It also complements sensor engineers’ complex models by serving as a fast, accurate screening tool for trade studies. And it integrates sensor and mission modeling in one package, helping engineers quickly arrive at optimal system designs,” says Kevin Flood, AGI’s vice president of product management and support.

For further information on STK/EOIR, go to the product page or register for a live webinar to be held on January 28.

Popularity: 3% [?]

Kensey Nash Corporation, a regenerative medicine company, announced it has entered into a manufacturing agreement with, and made a minority equity investment in, Orteq Sports Medicine, a medical device company specializing in the field of biodegradable polymer technology for meniscus repair.

Orteq, with headquarters in London, UK, created Actifit®, a biocompatible synthetic meniscal scaffold offering sports medicine surgeons a new arthroscopic option for the treatment of irreparable partial meniscal tears.  Orteq expects to receive FDA approval to start its Actifit® clinical trial in the U.S. in 2011.  Actifit® received its CE Mark approval in 2008 and is currently available throughout Europe.

The FDA approval of the U.S. clinical trial will trigger an additional $1 million investment in Orteq, which will, on a cumulative basis, total approximately $5 million which includes the exclusive worldwide manufacturing rights and represents an approximate 10% ownership in Orteq.

Under the terms of the manufacturing agreement, Kensey Nash will receive a transfer price and royalties.  Other terms of the agreement were not disclosed.

“Kensey Nash is very pleased to work with the talented and innovative Orteq team and its world-renowned clinicians who have generated outstanding clinical evidence,” commented Joseph W. Kaufmann, President and CEO of Kensey Nash.  ”We believe Orteq’s Actifit meniscus repair product can provide a safe and effective repair that will address over a $1 billion target market potential in sports medicine.  We look forward to a successful and long term relationship,” he concluded.

“We are delighted that Kensey Nash Corporation has made an investment in Orteq.  The Kensey Nash team brings us world-class expertise to manufacturing and developing safe, effective and innovative medical devices for our customers, sports medicine surgeons,” commented Dianne Blanco, CEO of Orteq.

Popularity: 2% [?]

Physiotherapy Associates, the nation’s foremost provider of outpatient rehabilitation services, announced its new MS Specialty Program, which includes physical therapy services and a health and wellness program designed to reduce or alleviate the symptoms of MS for patients, available in its more than 600 clinics throughout the United States.

“Our new MS Specialty Program will benefit the more than 400,000 people living with MS and their families on a local, regional and national basis,” said Dan Connors, Chief Executive Officer, Physiotherapy Associates. “The program will include education as well as physical therapy, health and wellness services customized for people living with MS, and will be available at more than 600 of our clinic locations from highly-qualified, licensed physical therapists in a wide range of local communities. Our MS Specialty Program is one aspect of Physiotherapy Associates’ commitment to people with MS. This goes hand-in-hand with our recent announcement that we have identified the National Multiple Sclerosis Society as our national community service partner.”

The more than 1,300 clinicians involved in the MS Specialty Program include outpatient physical/occupational therapists, as well as orthotics and prosthetics clinicians that provide services to MS patients who need physical/occupational therapy, custom orthotics or custom-fabricated prosthetic devices.

Physiotherapy Associates’ COO Pete Grabaskas, PT, stated, “We know physical therapy is an integral part of helping MS patients overcome pain, fatigue and muscle spasticity. Our clinicians who practice one-on-one care will help patients improve their daily functions through the MS Specialty Program. This program allows us to take a structured approach to delivering positive outcomes for our MS patients. We are well-suited to give MS patients the care they need and provide the outcomes they deserve, no matter where they live.”

Popularity: 3% [?]

Analytical Graphics, Inc. (AGI) today welcomed the progress that U.S. and Korean negotiators have made in advancing the U.S.-Korea Free Trade Agreement (KORUS FTA) and supported the President’s efforts to quickly gain Congressional ratification. AGI is the producer of software applications and development kits for integrated analysis of space, defense and intelligence systems.

“This trade agreement will spotlight U.S. products and encourage the acceptance of American technology, which is good for our country, our company and our Korean allies,” says AGI CEO Paul Graziani. “Our hope is that our commercial software products will help Korea ramp up quickly in the global space race and allow them to interoperate with the broader international space community.”

Founded in 1989, AGI has been exporting since the mid- to late-1990s, but only recently began emphasizing exports as a part of its strategic plan.  Today, AGI has grown to 12 foreign markets. A small-to-mid-size business, AGI works closely with the U.S. Department of Commerce’s Export Assistance Center, building an expanding network of software reseller partners, including KCEI Co., Ltd. based in Seoul, Korea. This trade agreement will allow AGI to bring even more value to the Korean space sector.

Popularity: 3% [?]

Governor Edward G. Rendell today announced a new partnership with the Wawa convenience store chain that will significantly expand the Pennsylvania Lottery network and boost ticket sales by as much as $37 million annually.

If that sales increase is realized, it could potentially bring up to $11 million more a year to support the Lottery-funded programs that protect older Pennsylvanians’ independence, preserve their health and improve the quality of their lives.

“When I became Governor, one of my first priorities was to direct the Lottery to grow its retail network to maximize sales and profits,” Governor Rendell said. “We wanted the Pennsylvania Lottery to operate more like a business, and it is.

“After courting Wawa for nearly two decades, a self-service sales model developed by the Pennsylvania Lottery finally attracted the partnership of the Pennsylvania-based company that never partnered with a lottery until this year,” the Governor said. “The Lottery’s industry-leading technology and innovation combined with a sales model designed to fit Wawa’s needs created a terrific new partnership between two Pennsylvania institutions.”

In June, Wawa began a pilot program in 20 locations to test customers’ receptiveness to self-service Lottery sales in its stores. In October, after Lottery sales proved successful in all pilot locations, Wawa approved expanding Lottery sales to all 210 Pennsylvania Wawa stores by springtime 2011.

Wawa President and CEO Howard Stoeckel joined Rendell for today’s announcement at a Wawa store in Philadelphia’s Chinatown neighborhood.

“Wawa has always embraced change and innovation as a way of continually simplifying our customers’ lives,” said Stoeckel. “I’m excited to introduce our latest innovation, self-serve Play Central Terminals from the Pennsylvania Lottery, which will give our customers the added convenience of purchasing lottery games and tickets at Pennsylvania Wawa stores.”

Today, Lottery tickets are available in 68 Wawa stores, and by the end of December, 89 Wawa stores in the greater Philadelphia area, Lehigh Valley, Poconos and northeast Pennsylvania will be selling tickets for instant and terminal-based Lottery games.

In 2004, Pennsylvania became the first U.S. lottery to offer touch-screen, self-service terminals that sell instant, numbers and lotto-style games. Today there are more than 1,000 self-service terminals located at retailers statewide. The sales model developed specifically for Wawa incorporates these terminals and back-office accounting mechanisms tailored to Wawa’s needs.

“This partnership is great news for Wawa, for the Pennsylvania Lottery and for customers and players who will soon be able to buy their Lottery tickets at Wawa stores,” said Governor Rendell.  ”But even better news is that 210 new Wawa stores as Lottery retailers have the potential to increase Lottery sales by as much as $37 million annually and contribute approximately $11 million more a year to support programs benefiting older Pennsylvanians.

“The Pennsylvania Lottery has grown – despite challenging economic times – to become the fifth-most-profitable lottery in the nation. And that growth translates into real, everyday benefits for the hundreds of thousands of older Pennsylvanians who rely on the free rides, hot meals, senior centers, reduced-cost prescriptions, property tax relief and long-term living services the Lottery funds.”

Since Governor Rendell took office in 2003, the Lottery has grown its retail network by 24 percent, or more than 1,700 locations. Lottery sales have grown by more than $1.1 billion, or 59 percent, since fiscal year 2001-02, and last year, the Lottery generated more than $915 million in profits, an increase of 22 percent from fiscal year 2001-02.

Popularity: 3% [?]

Governor Edward G. Rendell today lauded the work of the state Budget Office and Department of Revenue for the accuracy of their revenue projections.

This fiscal year, revenue collections in every month but September have been within less than one-half of one percent of the estimates certified by the Budget Office and Department of Revenue.

“This proves the incredible accuracy of our revenue estimate for the current fiscal year as developed by the Budget Office and Department of Revenue,” Governor Rendell said. “Budget Secretary Mary Soderberg and Revenue Secretary Dan Hassell, and their staffs, have done an outstanding job.”

Through Nov. 30, fiscal year-to-date General Fund collections were $14 million, or 0.2 percent, above estimates; in October collections were $18.5 million, or 0.2 percent, above estimate; in September collections were $75.8 million, or 1.3 percent, above estimate; in August collections were $6 million, or 0.2 percent, above estimate.

Popularity: 2% [?]

BioTrends Research Group, Inc. released ChartTrends®: Renal Anemia in Chronic Kidney Disease Non-Dialysis (CKD-ND), an annual syndicated publication based on patient and laboratory data collected from over 1,000 US CKD-ND patient charts. ChartTrends® compare what physicians self-report about disease management to what actually occurs at the patient level. This report evaluates the management of renal anemia including patient characteristics, demographics, lab values, co-morbidities and concomitant medications that drive both decisions to treat and brand selection of erythropoietin stimulating agents (ESAs) and intravenous (IV) iron. Brand use dynamics such as dosing (including dosing interval and titration), persistency, administration location, brand switching and reasons for switching are also evaluated.

Both the percent of CKD-ND patients treated with ESAs and the mean hemoglobin at initiation of ESAs have decreased significantly compared to last year. While in prior years, the vast majority of IV iron treated patients were on ESAs, this year, those numbers have decreased. There are a number of patient characteristics that distinguish ESA treated vs. non-treated patients; a higher percent of treated patients have hypertension, type 2 diabetes and congestive heart failure, to name a few. Despite treatment, close to one-third of patients are not managed to goal (have hemoglobin levels less than 10g/dL). ESA dose tends to increase as kidney disease worsens but average monthly dose for epoetin alfa (Centocor Ortho-Biotech’s Procrit, Amgen’s Epogen) has declined compared to the prior year.

In terms of IV iron, nephrologists tend to over-report the percent of their CKD-ND patients that are treated, although compared to last year, there is an increasing trend in the percent of stage 4 and 5 patients that are on IV iron. The majority of patients treated with IV iron tend to graduate from oral iron. Lack of testing appears to be an issue that may be preventing increased use of IV iron; while almost all patients have a hemoglobin in their record, a much smaller percent have a TSAT or ferritin level in their chart. Hemoglobin levels are also measured more frequently than iron studies. While nephrologists report initiating IV iron at a TSAT of 19 percent, the audited TSAT at IV iron initiation is in fact lower. From a brand perspective, the percent of patients on AMAG’s Feraheme has increased significantly compared to last year, although American Regent’s Venofer remains the market share leader.

Popularity: 4% [?]

More than 3,800 Pennsylvania drivers responded to PennDOT’s Highway Safety Survey earlier this year, offering answers that showed most motorists believe they are safe drivers. But the survey also found that many motorists underestimate the risk of being ticketed for driving under the influence.

“We appreciate the insight that motorists were able to provide through this survey,” said PennDOT Secretary Allen D. Biehler, P.E. “We’re pleased that most of their answers reflect safe driving behaviors, but we want to make sure that all drivers are making smart choices each time they get behind the wheel.”

Nearly 80 percent of motorists reported that within the past 60 days they did not drive within two hours after drinking alcohol. Ninety-one percent of drivers also indicated they used a seat belt all or most of the time.

More than half of respondents said they rarely thought someone would be arrested or cited for impaired driving or not wearing a seatbelt.

However, the perceived risk of a ticket increased when related to speeding as 55 percent of drivers thought they would be cited most or half of the time. Despite the perceived risk, nearly half of respondents admitted to speeding, with 44 percent saying they drive faster than 70 miles per hour in a 65-mph zone most or half of the time.

On driving while distracted – one of the leading highway safety concerns – 81 percent indicated that they never or rarely talk on a handheld phone. Ninety-two percent said they do not text or e-mail while driving.

Seventy-seven percent of the 500 motorcycle riders who responded said they wore helmets or other protective gear always or most of the time. Ninety-two percent said they never drink and ride, while 72 percent said they never or rarely travel more than 10 miles per hour over the posted speed limit.

The National Highway Traffic Safety Administration requires states to conduct this survey annually. Survey respondents were 55 percent male and 45 percent female.

Popularity: 2% [?]