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Take a look at a selection of our recent media coverage:
13th December 2011
Celution® One System, the next-generation device of the Cytori’s Celution® platform, has been granted CE Mark approval.
Celution® One is tailored specifically for the hospital as a platform device with potential life-critical applications across multiple specialties.
The Celution® platform is a GMP compliant technology that extracts and concentrates a patient’s own stem and progenitor cells from adipose at the point of care.
The Celution® One is intended for hospital-based use with key improvements including greater cell yield, greater range of processing volumes and faster processing times, increasing the versatility and efficiencies of potential treatments.
Additionally, it contains new features for improved operator ease-of-use.
“Approval of Celution® One in Europe is an important achievement that lays the foundation for further growth in the European hospital market,” said Christopher J. Calhoun, Chief Executive Officer of Cytori.
“In addition to offering the device to hospitals in Europe, we are using the Celution® One in our pivotal heart attack trial, ADVANCE, with the goal of seeking expanded market access through broader indications-for-use and subsequent reimbursement applications.”
21st November 2011
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending marketing authorisation of a new formulation of Rebif (interferon beta-1a) for the treatment of relapsing multiple sclerosis (MS).
The new formulation has been developed to increase treatment benefit by improving injection tolerability and reducing immunogenicity.
The CHMP recommendation will now be considered by the European Commission, which will deliver its final decision on the granting of the marketing authorisation.
Rebif, which was originally approved in Europe in 1998, has been proven effective on the following three key measures of treatment effectiveness: MRI lesion area and activity, relapse rates, and disability progression.
“Merck Serono’s efforts over the years to continuously provide enhanced therapeutic solutions for patients with multiple sclerosis are commendable,” said Professor Per Soelberg Sørensen, from the Danish MS Research Center, Copenhagen University Hospital, Rigshospitalet.
“Clinical trial data show that the new formulation of Rebif offers promising improvements which could translate into additional benefits to the patient.”
One-year (48-week) data from an ongoing two-year (96-week) Phase III study of the new formulation of Rebif were presented at the 17th Meeting of the European Neurological Society (ENS), in Rhodes, Greece.
The data showed that the rate of injection-site reactions in patients with MS who received the new formulation of Rebif over one year was three times lower when compared with historical data from previous trials.
The data also showed that 13.9% of patients treated with the new formulation of Rebif had neutralising antibodies after one year’s treatment.
The results at one year showed that patients who tested positive for neutralising antibodies at both 24 and 48 weeks represented 2.5% of the patients.
The most frequent side effect was flu-like syndrome, which is typical of interferon therapy.
Flu-like syndrome tends to be most prominent at the initiation of therapy, is relatively easy to treat and decreases in frequency with continued treatment.
9th November 2011
Janssen Pharmaceutica NV (Janssen) presented new data for INCIVO® (telaprevir) at the American Association for the Society of Liver Disease (AASLD) Annual Meeting, highlighting the safety and efficacy of a telaprevir based regimen in cirrhotic patients who had previously failed treatment.
Results from a sub-analysis of the REALIZE Phase 3 study showed that telaprevir, in combination with peginterferon alfa and ribavirin (PR), was associated with cure rates (defined as a sustained virologic response (SVR)) significantly higher than PR alone in patients with genotype-1 chronic HCV and cirrhosis (47% vs. 10% respectively).
Cirrhotic patients experienced significantly higher cure rates following treatment with a telaprevir-based regimen compared with PR alone.
Overall, cirrhotic patients had lower cure rates than those without cirrhosis (except previous treatment relapsers), however, treatment with a telaprevir-based regimen cured nearly half of all patients with cirrhosis.
“This year has seen significant advances in the treatment of HCV with the availability of direct-acting antivirals (DAAs), including telaprevir,” said Prof. Stanislas Pol, Lead Study Investigator, Hôpital Cochin, Paris, France.
“This is even more important for those patients who are experiencing the potentially devastating effects of HCV, such as cirrhosis.
“The REALIZE sub-analysis demonstrates that telaprevir maintains superior efficacy compared to PR alone in a group of patients that is typically hard to treat.”
REALIZE was a randomised, double-blind, placebo-controlled Phase 3 trial to compare the efficacy, safety and tolerability of telaprevir in 662 patients with chronic genotype-1 HCV who failed prior treatment with PR.
Patients received 48 weeks total treatment with PR alone or one of two telaprevir- based regimens (T/PR): 12 weeks T/PR plus 36 weeks PR alone, or four weeks PR alone followed by 12 weeks T/PR and 32 weeks PR alone.
In this sub-analysis, efficacy and safety variables were reanalysed for 662 patients with and without baseline cirrhosis.
Adverse events were consistent with those reported in the Phase 3 studies. Rash, pruritus and anemia (Hb <10 g/dL) were more frequent in cirrhotic patients receiving telaprevir (42%, 53% and 39% respectively) than PR alone. Adverse events led to discontinuation of telaprevir in 15% of cirrhotic and 12% of non-cirrhotic patients.
Telaprevir was approved by the European Commission for the treatment of genotype-1 chronic HCV in previously untreated and treatment-experienced patients in combination with peginterferon alfa and ribavirin in September 2011.
The approval was based on the results of three Phase 3 studies in 2,290 patients: ADVANCE, ILLUMINATE and REALIZE.
5th October 2011
Orion Corporation announced today at the annual congress of the European Society of Intensive Care Medicine (ESICM) in Berlin that the company is launching its new intensive care sedative dexdor® (dexmedetomidine).
Orion received European centralised marketing authorisation for dexdor® in September and the product is already available in Germany, Austria, Denmark, Sweden, Finland, the UK and Ireland, and will be introduced in many other European countries during 2012.
Orion’s dexdor® is indicated for sedation of adult intensive care unit (ICU) patients requiring a sedation level not deeper than arousal in response to verbal stimulation (corresponding to a Richmond Agitation-Sedation Scale [RASS] 0 to -3).
Dexmedetomidine is the first new intensive care sedative introduced in Europe for over a decade. According to Mervyn Singer, Professor of Intensive Care Medicine at University College London, dexmedetomidine is a welcome innovation.
“Sedation in intensive care has been belatedly recognised as a big issue,” said Professor Singer.
“For years we complacently administered opiates, benzodiazepines and propofol, comfortable in our mistaken belief that these drugs were ‘non-toxic’ or, at least, a necessary evil.
“However, a plethora of recent studies suggest the opposite. Not only do these agents contribute to delayed weaning and an increased incidence of delirium, but their haemodynamic and immune suppressant effects may induce additional covert harm, such as a greater risk of nosocomial infection and an increased dependency on catecholamines to treat ‘shock’.
“These complications spill over into long-term neurocognitive and psychological problems, greater degrees of physical debilitation and delayed/truncated recovery.
“Thus, survival is achieved but at the cost of decreased survivorship, i.e. quality. The recent licensing of dexmedetomidine for use in European critical care provides a new option that merits further exploration to build on the vast experience in US and the new promising studies coming from the EU.
“It offers sedation albeit with ready rousability (increasing patient cooperativeness and communication), analgesia and a lack of respiratory depression, thus circumventing many of the downsides of our current armamentarium.
“While dexmedetomidine shouldn’t be viewed as a panacea, it does provide an important alternative means of sedation that could facilitate recovery of our patients.”
The marketing authorisation for dexdor® was based on the results of two clinical Phase III studies.
The results of the MIDEX and PRODEX studies conducted by Orion Corporation with dexmedetomidine indicate that dexmedetomidine met its first primary endpoint in providing similar sedation in intensive care compared to midazolam and propofol, the standard ICU sedative agents, in patients requiring light to moderate sedation for mechanical ventilation.
At the same time, dexmedetomidine showed additional advantages over standard sedatives. Safety findings were consistent with the known effects of dexmedetomidine and no significant new safety concerns were detected.
Dexmedetomidine is a sedative agent with selective alpha2-agonist activity originated by Orion’s pharmaceutical R&D. The product has been available with the brand name Precedex® in the USA since 2000 and Japan since 2004, where the distributor is Hospira under Orion’s license.
23rd September 2011
UCB’s Board of Directors has announced that Gerhard Mayr will become its new chairman, as of May 2012.
Mayr will take over the reins from Karel Boone, whose term is due to end in April, due to reaching the upper age limit of 70.
“I am delighted to hand over to Gerhard Mayr,” said Boone.
“I am convinced that all internal and external stakeholders will give him their full support.
“With his excellent knowledge of UCB and his exceptional experience especially in the innovative pharma industry he will continue to support the transformation of UCB becoming the patient-centric biopharma leader.”
Mayr, a member of UCB’s Board of Directors since 2005, is Independent Director and Member of the Remuneration and Appointments Committee.
A native of Austria, he received a master’s degree in chemical engineering from the Swiss Federal Institute of Technology (Zurich, Switzerland) in 1969, and a master of business administration degree from Stanford University in 1972.
In March, 2004, he retired as executive vice president of pharmaceutical operations at Eli Lilly & Company after 32 years of service.
He had been responsible for global pharmaceutical operations and sales and marketing worldwide at Lilly – a leading innovation-driven corporation.
Mayr is past chairman of both the International Executive Committee and the Europe Committee of the Pharmaceutical Research Manufacturers of America.
He was a board member of the European Federation of the Pharmaceutical Industry from 1995-97 and 2000-2002.
Karel Boone has been a member of UCB’s Board of Directors since 2000 and chairman since 2008.
He is also member of the Audit Committee and the Remuneration and Nomination Committee.
Boone started in 1966 as an executive member of the Board of Directors of Lotus Bakeries (Lotus Biscuits at this time) and became CEO in 1974 when Lotus Biscuits merged with Corona.
He was also Executive Chairman of the Board of Directors from 1992 until 2006, when he became non-Executive Chairman of the Board of Directors.
20th September 2011
The European Commission has granted centralised marketing authorisation for dexdor® (dexmedetomidine), indicated for sedation of adult intensive care unit (ICU) patients requiring a sedation level not deeper than arousal in response to verbal stimulation (corresponding to Richmond Agitation-Sedation Scale 0 to -3).
Dexdor® (dexmedetomidine) is now licensed across all 27 European Union countries.
The active substance of dexdor® is dexmedetomidine, a sedative agent originated by Orion Corporation’s pharmaceutical R&D.
Dexmedetomidine is available with the brand name Precedex® in more than 30 countries outside Europe, including the USA (since 2000) and Japan (since 2004).
The distributor for the product outside Europe is Hospira, under Orion’s license.
19th August 2011
Oceana Therapeutics has announced that the company’s President & COO, David Tierney, has been featured in PharmaVOICE’s 2011 listing of the 100 Most Inspiring People in the Life Sciences Industry.
Now in its seventh year of publication, this listing pays tribute to 100 life-science professionals selected from thousands of nominees, representing a broad cross section of the industry, including pharmaceutical, biotechnology, device technology, clinical trial, R&D, and many others sectors.
According to Taren Grom, PharmaVOICE’s Editor-in-Chief and cofounder, the PharmaVOICE 100 are individuals who think outside the box, pioneer new paths to success, and who inspire their colleagues in the industry. They are individuals who translate industry issues into opportunities and take the time to mentor the next generation of leaders in the life sciences.
Tierney is a repeat recipient of this honour, having previously been on the 2005 and 2006 lists. More recently, in June of this year, Tierney was also named, along with John T. Spitznagel, Oceana’s Chairman & CEO, as a co-recipient of the Ernst & Young Entrepreneur Of The Year® 2011 award for the New Jersey region Emerging company category.
Prior to Oceana, Tierney served as CEO of Valera Pharmaceuticals, a company he joined in 2002 and transformed from an obscure research firm into a commercial specialty pharma enterprise, which was acquired in 2007 and has since become part of Endo Pharmaceuticals.
Earlier, he collaborated with Spitznagel at Roberts Pharmaceutical, a company they both joined in the late 1990s to successfully salvage that company’s failing operations and dramatically build earnings and asset value, which led to Roberts’ purchase in 1999 by Shire plc. for over $1.2 billion.
“I have known David for more than 15 years and there is no question he is highly deserving of the PharmaVOICE 100 honour,” said Spitznagel.
“David’s abilities as a life-science professional are exceptional and have significantly influenced the dramatic growth of Oceana from a start-up in mid 2008 to a global specialty company today. I am proud to call him a friend as well as a colleague.”
Tierney said: “I am sincerely delighted to be included in the PharmaVOICE 100. This and other honours and awards bestowed upon Oceana and several of our management team in the past couple of years reflect the hard work and support of many talented people who continue to drive the success of our company.”
“It is our team commitment to excellence that has placed Oceana on the threshold of an exciting new growth phase as we prepare for the US launch of Solesta.
“Recently approved by FDA, Solesta is a minimally invasive, out-patient treatment option for faecal incontinence that we believe represents a major advancement in addressing the needs of many underserved patients afflicted with this life-limiting condition.”
The invendoscopy system has been found to be safe and effective in the screening of colorectal cancer, following a study published in the American Journal of Gastroenterology.
The Invendo SC20, a new, self-propelled colonoscope (manufactured by Invendo Medical) was also found to be helpful in reducing sedation.
Consisting of a sheathed endoscope within an inverted sleeve, the Invendo SC20 has an instrument channel and an electrohydraulic bendable tip and is steered using a handheld device and propelled by a motorized drive unit.
A total of 61 volunteers (34 men, 27 women), aged between 50 and 70-years-old, were subjected to total colonoscopy, using carbon dioxide insufflation or water instillation on demand. All procedures were started without sedation.
Cecum was reached in 60 volunteers (cecal intubation rate of 98.4%) and the median time to reach the cecum was 15 min (range 7–53.5).
Sedation was given in three participants. On withdrawal (median time 15 min), the material for histological evaluation was obtained from 33 polyps (mean size 4.8 mm) in 23 people by biopsy forceps or snare. No device-related complications were encountered.
The researchers concluded: “A new computer-assisted colonoscope, controlled using a handheld device, showed excellent cecal intubation rates during screening examinations, with sedation required in only ~5% of participants. Further clinical and comparative studies are warranted.”
With bases in New York, USA, and Kissing, Germany, invendo medical is a leading developer of disposable endoscopy products in the field of gastroenterology that are hygienically safe and employ “no manual push” remote control advancement technology.
6th July 2011
The 2011 Frost & Sullivan Western Europe New Product Innovation Award in Advanced Wound Management is presented to PhytoCeuticals for its 1 PRIMARY WOUND DRESSING® (‘1’).
This innovative wound dressing spray is specially formulated from a proprietary combination of Neem oil and St. John’s Wort oil. ‘1’ is an easy-to-use, 100% natural and highly effective treatment for a wide range of wounds, including acute and chronic wounds.
“It has obtained CE marking and is approved in the European Union as a medical device,” notes Frost & Sullivan Research Associate Brahadeesh Chandrasekaran. “The technology has already gained a lot of attention and received positive testimonials from clinicians.”
‘1’ works by creating a moist wound environment, thereby promoting cell proliferation and activating the wound healing process. The oil layer prevents the adhesion of secondary dressings to the wound, enabling easy and painless dressing changes.
“In addition, Neem and St. John’s Wort oils have an antimicrobial and skin protecting effect through the fatty acids present in the specially formulated mixture,” remarks Brahadeesh. “Another value-added feature is the reduced time for a dressing change due to the rapid non-touch spray application.
The product is applied onto the wound bed, the wound edge and the periwound skin (all-in-one product) and therefore significantly reduces the steps involved in conventional wound treatment. These properties make the product an attractive first choice for the treatment of acute and chronic wounds.
“Simple and painless treatment, the painless removal of secondary dressings and the antimicrobial effect have underpinned ‘1’s widespread acceptance by both patients and clinicians,” states Brahadeesh. “This comprehensive solution successfully meets the needs and demands of the wound management industry with Phytoceuticals gaining an edge over other advanced wound management market participants with this 100% natural product.”
Using similar formulations, the company also plans to expand to the veterinary wound and human inflammatory skin disorders market.
XARELTO® (rivaroxaban tablets), marketed by Janssen Pharmaceuticals Inc. in the U.S., is the only once-daily, oral anticoagulant with FDA approval for the prevention of deep vein thrombosis (DVT) in patients undergoing surgery for knee or hip replacements.
Annually, over 800,000 Americans have knee or hip replacements, and the surgery holds an increased risk of DVT and pulmonary embolism (PE), which can be life-threatening conditions. As PE can result if a DVT breaks off and travels to the lungs, the American College of Chest Physicians recommend anticoagulants are used post surgery and post discharge for up to 35 days. However, DVT and PE remain the leading causes of rehospitalisation after these types of surgery.
“The approval of once-daily XARELTO® tablets will provide a new option to help protect patients from developing venous blood clots following knee or hip replacement surgery,” said Louis M. Kwong, M.D., Professor of Orthopedic Surgery at Harbor-UCLA Medical Center and researchers in the clinical trials. “XARELTO® has a proven clinical benefit over one of today’s most widely used options in preventing these potentially life-threatening blood clots, and the use of a once-daily pill may play an essential role in helping to simplify clinical practice.”
XARELTO® is approved for use at a 10 mg dose, once-daily for 35 days following hip replacement and for 12 days following knee replacement surgery.
“Shorter hospital stays following hip and knee replacement surgeries have made the prevention of venous blood clots an outpatient issue, and XARELTO® provides a safe and effective oral treatment option that can be easily transitioned from use in hospital to home,” said Paul Chang, M.D., Vice President, Medical Affairs, Internal Medicine, Janssen Pharmaceuticals, Inc. “We’re pleased to make XARELTO® tablets available to physicians to help them better protect their patients from these highly preventable surgical complications.”