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Boehringer Ingelheim FENS Award for Pascal Fries for his exceptional research in neuroscience
Ingelheim/Geneva, 15 July 2008 – The 2008 Boehringer Ingelheim FENS Research Award goes to Pascal Fries, MD, PhD, from the F.C. Donders Centre for Cognitive Neuroimaging in Nijmegen, The Netherlands. Today, at the Congress of the Federation of European Neuroscience Societies (FENS) taking place from 12-16 July 2008 in Geneva, on the occasion of a special lecture by the prize winner, the Boehringer Ingelheim FENS Research Award will be presented for the fourth time. Boehringer Ingelheim donates the award endowed with 25,000 Euro to young European scientists for exceptional research in any field of the neurosciences with the intention to ultimately promote potential benefits for patients by creating value through innovation.
36 year-old Pascal Fries received the award for his pioneering scientific work on the neurobiological organisation of human perception, how perception is influenced by attention, and which neural mechanisms instantiate these functions. His theories address one of the major challenges in latest cognitive neuroscience: to link descriptions and explanations of perception, action and memory at the psychological level to descriptions and explanations at the neuronal substrate level.
"It is a great honour for me to receive this award. I deeply appreciate the recognition of our scientific progress", said Dr Fries, who has conducted research at Institutes in Frankfurt, Germany, Maryland, USA and Nijmegen, the Netherlands.
"I hope that the results of our research help to better understand how behaviour and its neuronal basis is linked”, he added.
"Fostering science and research excellence is an important value and a key element of our strategy. We therefore continue to offer the Boehringer Ingelheim FENS Research Award - now for the fourth time - and therewith support the advancement of excellent young scientists", said Dr Manfred Haehl, Corporate Senior Vice President Medicine Boehringer Ingelheim.
"We again demonstrate Boehringer Ingelheim’s commitment to basic research in the area of neuroscience and are glad to be able to support the discovery and explanations of basic neuroscientific principles, independent of our pharmaceutical drug discovery”, said Dr Bernd Sommer, Head of Boehringer Ingelheim’s Department of CNS Diseases Research, who presented the prize to Dr Fries.
The speech to honour Dr Fries was delivered by PD Dr Pico Caroni from the Friedrich-Miescher-Institute in Basel and member of the local organizing committee. Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 135 affiliates in 47 countries and 39,800 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2007, Boehringer Ingelheim posted net sales of 10.9 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.
For more information please visit
www.boehringer-ingelheim.com
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Further steps in generation change at Boehringer Ingelheim
Ingelheim, Germany, 26 June 2008 - Dr Alessandro Banchi (62), Chairman of the Board of Managing Directors at Boehringer Ingelheim GmbH and responsible for Marketing and Sales, has decided after more than 35 years with the Corporation to retire at the end of 2008. His successor will be the Vice-Chairman of the Board of Managing Directors, Dr Andreas Barner (55), who is currently responsible for Research, Development and Medicine. He will continue to lead this Corporate Board Division as Chairman of the Board of Managing Directors. The new Member of the Board of Managing Directors responsible for Marketing and Sales will be the Dutch Medical Doctor Bert Tjeenk Willink (47).
Christian Boehringer, Chairman of the Shareholders’ Committee, thanked Dr Banchi for his long and lasting contribution to the company. ”Dr Banchi has fundamentally shaped Boehringer Ingelheim’s entrepreneurial success as well as decisively driven forward its profitability and internationalisation, especially in the USA.“ Under his responsibility, important decisions were taken and successfully implemented for innovative medicines and therapies to benefit humankind with which he rendered great service to Boehringer Ingelheim.
Dr Hans-Jürgen Leuchs, the longest-serving Member of the Board of Managing Directors, has decided to leave the Board and retire, also at the end of 2008. Dr Leuchs (58) has had Board responsibility for Operations since 1994 and additionally since 1999 for the Animal Health business area. The new Member of the Board of Managing Directors, responsible for Operations and Human Resources, will be Dr Wolfram Carius (46).
Mr Boehringer expressed profound gratitude to Dr Leuchs for his contribution of many years with which he rendered great service to Boehringer Ingelheim. His sustained efforts have represented a milestone in Boehringer Ingelheim’s technological development. “Under Dr Leuchs’ leadership, the competitive preconditions in production technology and worldwide structure were established for manufacturing innovative medications at competitive cost,” Mr Boehringer said. The company’s leading position in Biotechnology and Animal Health should also be highlighted.
As previously announced, Professor Marbod Muff (66), responsible on the Board of Managing Directors for Finance and Human Resources, will after 40 years of service with Boehringer Ingelheim be retiring on 31 December 2008. Hubertus von Baumbach (40) will succeed him in the area of Finance on the Board of Managing Directors. In addition, Mr von Baumbach will be responsible for Animal Health.
On behalf of the Shareholders, Mr Boehringer thanked Prof. Muff for his long and lasting contribution to the corporation with which he rendered great service to Boehringer Ingelheim. “Prof. Muff successfully structured our financial and human resources affairs to meet the future challenges during our transformation from an internationally orientated company to a globally operating pharmaceutical group. He also kept an especially close eye on the company’s responsibility for its employees. Acting globally and being firmly rooted locally are for Prof. Muff no contradiction, but a daily reality,” said Mr Boehringer, who also drew attention to Prof. Muff’s social engagement in an honorary capacity.
Successors prepared well in advance
Mr Boehringer described the succession arrangements for the Board of Managing Directors ensure continuity in the implementation of the corporate strategy, being forward-looking oriented and in keeping with Boehringer Ingelheim’s international alignment. “We are also thereby well set up for the next decade, the unit of measure of our family-owned company.“
The new Members of the Board of Managing Directors are internationally experienced, have held responsibility in various business areas within the corporation and have been prepared for their forthcoming tasks with long-term planning.
Dr Andreas Barner, who has doctorates in medicine and mathematics, joined Boehringer Ingelheim in 1992 as head of the Medicine Division, becoming a Member of the Board of Managing Directors in 1999.
Bert Tjeenk Willink, Medical Doctor, has been Boehringer Ingelheim’s Country Manager in Mexico since 2005. With Boehringer Ingelheim since 1994, his positions have included Head of Marketing & Sales, Canada, and, from 2001 to 2005, responsibility for the Corporate Division Marketing Prescription Medicines.
Dr Wolfram Carius, a pharmacist, currently Head of the Corporate Division Pharmaceuticals Production, has held various management functions at Boehringer Ingelheim since 1987. These have included posts in Japan and Brazil and membership of the Board of Boehringer Ingelheim Germany. At the last-mentioned he was responsible for the development and production of biopharmaceuticals and for industrial customers.
Hubertus von Baumbach has been a Member of the Board of Boehringer Ingelheim Germany since 2006, with Board responsibility for Finance. Previously, after posts in the USA and at Boehringer Ingelheim in Canada, he held various positions in Finance at Boehringer Ingelheim.
Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 135 affiliates in 47 countries and 39,800 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2007, Boehringer Ingelheim posted net sales of 10.9 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.
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European CHMP issues positive opinion on Cymbalta for the treatment of Generalised Anxiety Disorder
Indianapolis/US, 26 June 2008 – Eli Lilly and Co (NYSE: LLY) and Boehringer Ingelheim today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion supporting the approval of Cymbalta® (duloxetine hydrochloride) for the treatment of Generalised Anxiety Disorder (GAD).
The positive opinion is based upon the results of five clinical studies– four double-blind placebo-controlled studies and a relapse prevention study – involving more than 2,000 non-depressed adults with GAD. In each of the four placebo-controlled studies safety and efficacy were assessed. Duloxetine significantly improved core anxiety symptoms (as measured by the Hamilton Anxiety Scale), compared with placebo (p≤0.001, p=0.02, p=0.007, p≤0.001 respectively)1-4 and demonstrated improvement in role functioning, including ability to perform everyday activities in work, home and in social situations.5,6 In addition, duloxetine significantly decreased the likelihood of relapse in those patients who initially responded to duloxetine and were maintained on treatment for six months compared with those switched to placebo.7 The most common side effects in these studies included nausea, fatigue, dry mouth, drowsiness, constipation, insomnia, decreased appetite, hyperhidrosis, decreased libido, vomiting, ejaculation delay and erectile dysfunction.
Although global prevalence is not currently known, more than nine million Europeans8,9 and six million people in Central and South America are estimated to suffer from GAD.10 Difficult to detect, due to the fact that the condition presents with a variety of symptoms,11 GAD is characterised by more than simple anxiety. The disorder is diagnosed when patients suffer from excessive anxiety and worry about a number of events and activities (such as performance at work or school) over a sustained period of at least six months.12
“If left untreated, symptoms of Generalised Anxiety Disorder may progress to prevent patients from working and operating in daily social situations,” said Dr. Christer Allgulander of the Department of Clinical Neuroscience, Karolinska Institutet in Stockholm, “According to population and primary care surveys the majority of people suffering from anxiety, and their physicians, still have unmet needs. This positive opinion on duloxetine creates another effective pharmacotherapy option that will help patients feel better, and help physicians in their aim to improve functioning for those suffering from this debilitating condition.”
Duloxetine, a member of a class of drugs commonly referred to as serotonin and noradrenaline reuptake inhibitors,13 is already approved to treat major depressive disorder and diabetic peripheral neuropathic pain. Duloxetine gained marketing authorisation for the treatment of GAD in Mexico in 2006 and in the United States in 2007.
Notes to Editors:
About Generalised Anxiety Disorder
Approximately nine million Europeans8, 9 and six million people in Central and South America are estimated to suffer from GAD.10 Quality of life is affected as symptoms of GAD can include exaggerated worry or chronic anxiety, irritability and poor concentration. Ability to work is often compromised with the manifestation of physical symptoms such as muscle tension, fatigue, sleep disturbance and nausea.12 The illness tends to be chronic with periods of exacerbation and remission. Patients report that episodes of generalized anxiety disorder are often brought on, or worsened, by stressful life events.14
About Duloxetine
While duloxetine’s mechanism of action in humans is not fully known, it is believed to affect both serotonin and norepinephrine/noradrenaline mediated nerve signalling in the brain and the spinal cord. Based on pre-clinical studies, duloxetine is a balanced and potent reuptake inhibitor of serotonin and norepinephrine/noradrenaline. Scientists believe its effect on pain perception is due to increasing the activity of serotonin and norepinephrine in the central nervous system.
Duloxetine is approved for the treatment of depression and diabetic peripheral neuropathic pain, in many countries and is approved in some countries for the treatment of stress urinary incontinence, Major Depressive Disorder and Generalized Anxiety Disorder. Duloxetine is approved only for adults 18 and over. There is a possibility of an increased risk of suicidal thoughts or behaviour in children and young adults treated with antidepressants. Patients should call their doctor right away if they experience worsening depression symptoms, unusual changes in behaviour or thoughts of suicide, especially at the beginning of treatment or after a change in dose.
Patients taking duloxetine may experience dizziness or fainting upon standing. The most common side effects of duloxetine include:
- For depression: Nausea, dry mouth, headache, insomnia, diarrhea
- For diabetic peripheral neuropathic pain: Nausea, somnolence (sleepiness), fatigue, headache, dizziness
- For stress urinary incontinence: Nausea, dry mouth, fatigue
- For Generalised Anxiety Disorder: Nausea, fatigue, dry mouth, drowsiness, constipation, insomnia, decreased appetite, hyperhidrosis, decreased libido, vomiting, ejaculation delay and erectile dysfunction.
(This is not a complete list of side effects.)
Duloxetine is contraindicated in patients who are allergic to it, who have liver disease resulting in hepatic impairment, who are taking a monoamine oxidase inhibitor (MAOI), fluvoxamine, ciprofloxacin or enoxacine or who have severe kidney disease. The initiation of treatment with duloxetine also is contraindicated in patients with uncontrolled hypertension that could expose them to a potential risk of hypertensive crisis.
Eli Lilly and Company and Boehringer Ingelheim
In November 2002, Eli Lilly and Company and Boehringer Ingelheim signed a long-term agreement to jointly develop and commercialize duloxetine hydrochloride. This partnership covers neuroscience indications in most countries outside of the United States and Japan, with few exceptions.
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information – for some of the world`s most urgent medical needs. Additional information about Lilly is available at www.lilly.co.uk.
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 135 affiliates in 47 countries and almost 38,900 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine. In 2007, Boehringer Ingelheim posted net sales of 10.9 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.
Duloxetine for major depressive episodes is marketed by Lilly and Boehringer Ingelheim in all countries included in the partnership under the brand name Cymbalta, except for Greece, Italy and Spain. In Greece, Italy and Spain Lilly markets the product as Cymbalta and Boehringer Ingelheim markets the product as Xeristar®. In the United States, Cymbalta is marketed by Lilly and Quintiles. In Japan, duloxetine will be co-developed and co-marketed by Lilly and Shionogi & Co., Ltd.
Duloxetine for stress urinary incontinence is marketed by Lilly under the brand name Yentreve.®
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Following the decision by the Indian Patent Office:- Boehringer Ingelheim will not legally contest the decision- Generic manufacture of nevirapine for developing countries permitted since 2007
Ingelheim/Germany, 25 June 2008 - The Opposition Division of the Patent Office in New Delhi has allowed the opposition of an Indian patent organisation against Boehringer Ingelheim`s patent application for the suspension form of an HIV/AIDS drug nevirapine (trade name VIRAMUNE®). According to Indian law, this decision can be contested in the Indian courts.
Boehringer Ingelheim will not legally challenge this decision. In any case, the company had, in 2007, already permitted the generic manufacture of nevirapine in and for developing countries. Nevertheless, the decision not to contest this case does not constitute a precedent for subsequent decisions on other Boehringer Ingelheim drugs that are protected in India.
The basic decision to apply for a patent for the nevirapine suspension was important for Boehringer Ingelheim because without patent protection the company cannot prevent what may be poor-quality versions of the HIV/AIDS drug from Boehringer Ingelheim research from being produced and sent to industrialised nations or other countries.
Patents for pharmaceutical products are essential not just for securing the markets in the industrialised nations, but also for ensuring that all patients are supplied with innovative, high-quality drugs.
Nevertheless, the company accepts the proposition that patents should not prevent access to nevirapine in developing countries for their own needs. In order to strengthen this position, Boehringer Ingelheim is offering manufacturers of nevirapine products for developing nations special agreements (non-assert declarations) so that patents do not obstruct the supply of the drug in these countries. The selection criteria for countries with free access to nevirapine are broad, i.e. in addition to the low-income countries according to the World Bank classification, they include all countries with a low Human Development Index. A total of 77 countries will be able to make use of this concession. Boehringer Ingelheim is waiving any form of licensing fees for the production, distribution and sale of nevirapine in these countries. Nine manufacturers of generics, including seven in India, have already made use of this offer.
Drug donations
Since 2000 Boehringer Ingelheim has granted cost-free access to individual doses of Viramune® (nevirapine), used on its own or in combination with other drugs, for preventing the mother-child transmission of the HI virus during birth. The company currently donates the preparation in 59 countries in Africa, Asia, Latin America and Eastern Europe. To date, more than a million individual doses have been supplied free of charge to mothers and children.
Reduced prices for Viramune®
Another measure designed to ensure access to HIV drugs is the significant reduction in the price of Viramune® for continuous treatment in developing countries. As a founder member of the Accelerating Access Initiative (AAI)* Boehringer Ingelheim offers drugs in developing countries at a substantially reduced price.
New hope through new medicines
It was back in 1996 that Boehringer Ingelheim launched Viramune®, the first non-nucleoside reverse-transcriptase inhibitor, and for two years now the company has been supplying the protease-inhibitor Aptivus®, a drug for HIV-positive patients who fail to respond adequately to currently available anti-HIV preparations. Other antiviral substances are also in clinical development. For many years now Boehringer Ingelheim has been focusing strongly on virological research. Without this substantial investment by research-based drugs manufacturers such as Boehringer Ingelheim, advances in the drug treatment of illnesses such as AIDS would not be possible.
* AAI: A joint venture between pharmaceutical companies and WHO, UNICEF, UNAIDS, World Bank, etc.
Please be advised
This release is from Boehringer Ingelheim Corporate Headquarters in Germany. Please be aware that there may be national differences between countries regarding specific medical information, including licensed uses. Please take account of this when referring to the information provided in this document. This press release is not intended for distribution within the U.S.A.
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New Aptivus® (tipranavir) Oral Solution Approved for
Treatment-Experienced Pediatric and Adolescent HIV Patients
For U.S. Media
Ridgefield/Conn., 24 June 2008 – Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) granted approval of Aptivus® (tipranavir) capsules/oral solution with dosing information for treatment-experienced pediatric patients between the ages of 2-18 infected with HIV-1. The oral solution formulation, which is a new dosage form of Aptivus, was also approved for treatment-experienced adults. The oral solution formulation will be available in the U.S. beginning in mid-September. The FDA granted full (traditional) approval to Aptivus capsules for treatment-experienced adults in October 2007.
“Due to significant advances in HIV therapy and care, many perinatally infected children are growing into young adulthood and beyond. Most of these children have received multiple courses of anti-HIV medications and many have evidence that their HIV strains have developed resistance to the majority of currently approved antiretrovirals. An unmet need remains for pediatric indications and new formulations of antiretroviral therapies,” said Dr. Juan Salazar, Associate Professor in Pediatrics, University of Connecticut’s Department of Pediatrics, Division of Pediatric Infectious Diseases, and Director of the Pediatric and Youth HIV Program at the Connecticut Children’s Medical Center. “This approval is an important development for treatment-experienced children and teenagers who may have limited therapeutic options.”
Aptivus Indications and Usage
Aptivus, a protease inhibitor co-administered with ritonavir (Aptivus/r), is indicated for combination antiretroviral treatment of HIV-1 infected patients who are treatment-experienced and infected with HIV-1 strains resistant to more than one protease inhibitor.
This indication is based on analyses of plasma HIV-1 RNA levels in two controlled studies of Aptivus/r of 48 weeks duration in treatment-experienced adults and one open-label 48-week study in pediatric patients age 2 to 18 years. The adult studies were conducted in clinically advanced, 3-class antiretroviral (NRTI, NNRTI, PI) treatment-experienced adults with evidence of HIV-1 replication despite ongoing antiretroviral therapy.
The following points should be considered when initiating therapy with Aptivus/r:
- The use of Aptivus/r in treatment-naïve patients is not recommended.
- The use of other active agents with Aptivus/r is associated with a greater likelihood of treatment response.
- Genotypic or phenotypic testing and/or treatment history should guide the use of Aptivus/r. The number of baseline primary protease inhibitor mutations affects the virologic response to Aptivus/r.
- Use caution when prescribing Aptivus/r to patients with elevated transaminases, hepatitis B or C co-infection or patients with mild hepatic impairment.
- Liver function tests should be performed at initiation of therapy with Aptivus/r and monitored frequently throughout the duration of treatment.
- The drug-drug interaction potential of Aptivus/r when co-administered with other drugs must be considered prior to and during Aptivus/r use.
- Use caution when prescribing Aptivus/r in patients who may be at risk for increased bleeding or who are receiving medications known to increase the risk of bleeding.
- The risk-benefit of Aptivus/r has not been established in pediatric patients less than 2 years of age.
There are no study results demonstrating the effect of Aptivus/r on clinical progression of HIV-1.
Aptivus/r does not cure HIV or help prevent passing HIV to others.
According to Centers for Disease Control and Prevention (CDC) data for 33 states, an estimated 8,545 children and adolescents under the age of 20 were living with HIV/AIDS in the U.S. at the end of 2006.1 The estimated number of 13 to 19-year-olds living with HIV/AIDS increased by 28 percent from 2003 to 2006.1
Aptivus/r has been studied in a total of 135 HIV-1 infected pediatric patients age 2 through 18 years as combination therapy. This study enrolled HIV-1 infected, treatment-experienced pediatric patients (with the exception of 3 treatment-naïve patients), with baseline HIV-1 RNA of at least 1,500 copies/mL. One hundred and ten (110) patients were enrolled in a randomized, open-label 48-week clinical trial (study 1182.14) and 25 patients were enrolled in other clinical studies including Expanded Access and Emergency Use Programs.
All patients initially received Aptivus oral solution. Pediatric patients who were 12 or older and received the maximum dose of 500/200 mg twice daily could subsequently change to Aptivus capsules at day 28. The trial primarily compared two doses for safety and tolerability based on adverse events and laboratory findings, and secondarily evaluated pharmacokinetics and virologic and immunologic response and time to treatment failure at 48 weeks.
Based on the results, the recommended pediatric dose of Aptivus for both capsules and oral solution is 14 mg/kg with 6 mg/kg ritonavir, or 375 mg/m2 co-administered with ritonavir 150 mg/m2, taken twice daily. A greater proportion of patients receiving this dose achieved a viral load of less than 400 copies/mL. For children who develop intolerance or toxicity and cannot continue with the higher dose, physicians may consider decreasing the dose to Aptivus 12 mg/kg with 5 mg/kg ritonavir, or Aptivus 290 mg/m2 co-administered with 115 mg/m2 ritonavir, taken twice daily, provided their virus is not resistant to multiple protease inhibitors.
Prescribers should calculate the appropriate dose of Aptivus for each individual child based on body weight (kg) or body surface area (BSA, m2) and should not exceed the recommended adult dose of Aptivus 500 mg co-administered with ritonavir 200 mg twice daily.
At 48 weeks, 40 percent of patients had a viral load of less than 400 copies/mL. The proportion of patients with viral load less than 400 copies/mL tended to be greater (70 percent) in the youngest group of patients, who had less viral resistance at baseline, compared to the older groups (37 percent and 31 percent). Agents approved by the FDA in the past five months were not included in the trial.
The most frequent adverse reactions in pediatric patients were similar to those in adults. Fever, vomiting, cough, rash, nausea and diarrhea were most frequently reported, and rash was reported more frequently in pediatric patients than in adults. The most frequent treatment-emergent laboratory abnormalities were increases in CPK, ALT and amylase.
Patients taking Aptivus oral solution should be advised not to take supplemental vitamin E greater than a standard multivitamin as Aptivus oral solution contains 116 IU/mL of vitamin E which is higher than the Reference Daily Intake (adults 30 IU, pediatrics approximately 10 IU).
“The approval of a new formulation and the pediatric indication demonstrates Boehringer Ingelheim’s commitment to the community and patients with advanced stage HIV,” said Dr. Thor Voigt, Senior Vice President, Medicine and Drug Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “Aptivus oral solution provides physicians and patients with an important treatment option in the fight against HIV/AIDS.”
Important Safety Information for Aptivus
- Aptivus/r has been associated with reports of clinical hepatitis and hepatic decompensation, including some fatalities. Extra vigilance is warranted in patients with chronic hepatitis B or hepatitis C co-infection, as these patients have an increased risk of hepatotoxicity. Patients with signs or symptoms of clinical hepatitis should discontinue Aptivus/r treatment and seek medical evaluation.
- Aptivus/r has been associated with reports of both fatal and non-fatal intracranial hemorrhage (ICH).
- All patients should be followed closely with clinical and laboratory monitoring, especially those with chronic hepatitis B or C co-infection, as these patients have an increased risk of hepatotoxicity. Liver function tests should be performed prior to initiating therapy with Aptivus/r, and frequently throughout the duration of treatment.
- Treatment-experienced patients with chronic hepatitis B or hepatitis C co-infection or elevations in transaminases are at approximately 2-fold risk for developing Grade 3 or 4 transaminase elevations or hepatic decompensation. In the RESIST trials, Grade 3 and 4 increases in hepatic transaminases were observed in 10.3 percent (10.9/100 PEY) of patients receiving Aptivus/r through week 48. In a study of treatment-naïve patients, 20.3 percent (21/100 PEY) experienced Grade 3 or 4 hepatic transaminase elevations while receiving Aptivus/r through week 48.
- Aptivus/r is contraindicated in patients with moderate or severe (Child-Pugh Class B or C, respectively) hepatic impairment.
- The drug-drug interaction potential of Aptivus/r when co-administered with multiple classes of drugs must be considered prior to and during Aptivus/r use.
- Aptivus/r is contraindicated with amiodarone, bepridil, flecainide, propafenone, quinidine, rifampin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, St. John’s wort, lovastatin, simvastatin, pimozide, midazolam (oral) and triazolam due to the potential for serious and/or life-threatening events or loss of efficacy.
- A drug interaction study in healthy subjects has shown that ritonavir significantly increases plasma fluticasone propionate exposures. Concomitant use of Aptivus/r and fluticasone propionate may produce systemic corticosteroid side effects, including Cushing’s syndrome and adrenal suppression. Aptivus/r should not be taken with fluticasone propionate, inhaled or intranasally administered, unless the potential benefit to the patient outweighs the risk.
- Caution should be used when prescribing sildenafil, tadalafil, and vardenafil with Aptivus/r because concentrations of these drugs may increase.
- Caution should be used when prescribing carbamazepine, phenobarbital and/or phenytoin. Aptivus may be less effective due to decreased tipranavir plasma concentrations.
- Caution should be used when prescribing valproic acid. Valproic acid may be less effective due to decreased valproic acid plasma concentrations.
- Use caution when prescribing Aptivus/r in patients who may be at risk of increased bleeding from trauma, surgery or other medical conditions, or who are receiving medications known to increase the risk of bleeding such as antiplatelet agents and anticoagulants, or who are taking supplemental high doses of vitamin E.
- Patients taking Aptivus oral solution should be advised not to take supplemental vitamin E greater than a standard multivitamin as Aptivus oral solution contains 116 IU/mL of vitamin E which is higher than the Reference Daily Intake (adults 30 IU, pediatrics approximately 10 IU).
- Rash, including urticarial rash, maculopapular rash, and possible photosensitivity, has been reported in patients receiving Aptivus/r. In some, rash was accompanied by joint pain or stiffness, throat tightness, or generalized pruritus. In controlled clinical trials, rash (all grades, all causality) was observed in 10 percent of females and in 8 percent of males receiving Aptivus/r through 48 weeks of treatment. The median time to onset of rash was 53 days and the median duration of rash was 22 days. The discontinuation rate for rash in clinical trials was 0.5 percent. In an uncontrolled compassionate use program (n=3,920), cases of rash, some of which were severe, accompanied by myalgia, fever, erythema, desquamation, and mucosal erosions were reported. In the pediatric clinical trial, the frequency of rash (all grades, all causality) through 48 weeks of treatment was 21 percent. Most of these patients had mild rash and 5 percent had moderate rash. Overall, 3 percent interrupted Aptivus treatment due to rash and the discontinuation rate for rash was 0.9 percent. Discontinue and initiate appropriate treatment if severe skin rash develops.
- Aptivus should be used with caution in patients with a known sulfonamide allergy.
- New onset diabetes mellitus, exacerbation of pre-existing diabetes mellitus, hyperglycemia and increased bleeding (in patients with hemophilia) have been reported in patients taking protease inhibitors. A causal relationship between protease inhibitors and these events has not been established.
- Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including Aptivus/r.
- Redistribution and/or accumulation of body fat have been observed in patients receiving antiretroviral therapy. A causal relationship has not been established.
- Treatment with Aptivus/r has resulted in large increases in total cholesterol and triglycerides, which should be monitored prior to and during Aptivus/r therapy.
- Because the potential for HIV-1 cross-resistance among protease inhibitors has not been fully explored in Aptivus/r-treated patients, it is unknown what effect therapy with Aptivus will have on the activity of subsequently administered protease inhibitors.
- Aptivus must be co-administered with ritonavir to exert its therapeutic effect. Failure to correctly co-administer Aptivus with ritonavir will result in reduced plasma levels of tipranavir that will be insufficient to achieve the desired antiviral effect and will alter some drug interactions.
- Please refer to the complete ritonavir prescribing information for a description of ritonavir contraindications and additional information on precautionary measures.
- In adults, the most frequent adverse reactions (incidence greater than 4 percent) were diarrhea, nausea, fever, vomiting, fatigue, headache, and abdominal pain. In pediatric patients (age 2 to 18 years) the most frequent adverse reactions were generally similar to those seen in adults. However, rash was more frequent in pediatric patients than in adults.
Please see full Prescribing Information, including boxed WARNINGS, for Aptivus at www.aptivus.com.
Aptivus is also approved for the treatment of adult patients in Argentina, Australia, Canada, Finland, Switzerland, Mexico, Iceland, Taiwan and the European Union.
About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 135 affiliates in 47 countries and approximately 39,800 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2007, Boehringer Ingelheim posted net sales of US $15.0 billion (10.9 billion euro) while spending approximately one-fifth of net sales in its largest business segment, Prescription Medicines, on research and development.
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Micardis®-based regimens help more patients achieve their blood pressure goals
Berlin, Germany, 18 June, 2008 – The results of two new studies of Micardis® (telmisartan) in free combination with amlodipine or fixed combination with hydrochlorothiazide (HCTZ) 25 mg confirm that a telmisartan-based approach to treating hypertensive patients at risk of cardiovascular events can provide powerful and sustained blood pressure control in a broad range of people, including those who are difficult-to-treat.1-5 The study results were presented today at the 18th Scientific Meeting of the European Society of Hypertension and the 22nd Scientific Meeting of the International Society of Hypertension, held in Berlin, Germany.
Commenting on the results, Professor Thomas Unger, Chair of Pharmacology and Director of the Institute of Pharmacology at the Charité – Universitätsmedizin Berlin, said “Controlling patients’ blood pressure is a challenge that usually needs more than one antihypertensive to achieve optimal control. Telmisartan already provides proven effective blood pressure lowering and cardio & vascular protection in a broad range of patients at high-risk of cardiovascular disease. These new blood pressure studies now show that combining telmisartan with other antihypertensive treatments - amlodipine and hydrochlorothiazide - that act via different mechanisms, may reduce the risk of heart attack or stroke even further”.
"Round the clock" powerful blood pressure lowering with telmisartan and amlodipine combination
In a study combining telmisartan (a modern angiotensin II receptor blocker, ARB) and amlodipine (the most widely-used calcium channel blocker, CCB) 1,461 patients were randomized to receive treatment with a combination of telmisartan 0 (placebo), 20, 40, or 80 mg plus amlodipine 0 (placebo), 2.5, 5 or 10 mg.1
After 8 weeks, significant blood pressure reductions were observed for all combinations of clinical interest (telmisartan 40 or 80 mg plus amlodipine 5 or 10 mg; p<0.05) with the greatest reductions (-26.4/-20.1 mmHg) shown and greatest blood pressure control rate (76.5% patients) achieved by telmisartan 80 mg in combination with amlodipine 10 mg.1 All treatment combinations were well tolerated.4
A substudy of 562 patients confirmed that 24-hour “round the clock“ blood pressure control rate (measured by ambulatory blood pressure monitoring) with the combination of telmisartan and amlodipine, including the early morning hours when uncontrolled blood pressure is known to put patients at greatest risk of a heart attack or stroke, was up to twice the rate of that achieved with the monotherapy compounds.2
Difficult-to-treat patients benefit from fixed-dose combination of telmisartan 80 mg / HCTZ 25 mg
In a second long-term study, patients with essential hypertension and whose blood pressure had not previously been adequately controlled, received treatment with either telmisartan 80 mg / HCTZ 25 mg (n=321) or telmisartan 80 mg / HCTZ 12.5 mg (n=318).5
After 24-weeks treatment with telmisartan 80 mg / HCTZ 25 mg, the percentage of patients achieving blood pressure control (DBP <90 mmHg) increased from 52.4% at the study start to 71.4%.5 The increase in control was observed very early (at 4 weeks), was maintained until the study end, at which point most patients (85.6%) did not require additional antihypertensive therapy. Treatment was well tolerated.5
The fixed-dose combination of telmisartan 80 mg / HCTZ 25 mg was recently approved by the European Commission for difficult-to-treat patients whose blood pressure is not adequately controlled with telmisartan / HCTZ lower dose.
Proven cardio & vascular protection and tolerability shown in recent ONTARGET® trial
Telmisartan is the only angiotensin II receptor blocker (ARB) proven to achieve effective blood pressure lowering AND to have proven cardio & vascular protective benefits in a broad range of high-risk cardiovascular patients.6 The first results of the ONTARGET® Trial, presented earlier this year at ACC 2008, demonstrated that telmisartan was as protective as ramipril (the previous gold standard) in terms of reducing the risk of cardiovascular death, myocardial infarction, stroke and hospitalisation for congestive heart failure in a broad cross-section of high-risk patients and was better tolerated. 6
Telmisartan also provides superior blood pressure lowering power compared with the ARBs losartan7 and valsartan8and has also been shown to achieve blood pressure reductions at least as efficacious as leading antihypertensives of other classes, including enalapril, lisinopril, ramipril, amlodipine and atenolol.9-13
~ENDS~
Notes to editors
Please be advised
This release is from Boehringer Ingelheim Corporate Headquarters in Germany. Please be aware that there may be national differences between countries regarding specific medical information, including licensed uses. Please take account of this when referring to the information provided in this document. This press release is not intended for distribution within the U.S.A.
Addressing the world’s largest healthcare burden
Cardiovascular disease (CVD) is the leading cause of death worldwide, causing over 17.5 million deaths per year.14 7.6 million people die from a heart attack and 5.7 million die from a stroke every year. 4 Global deaths from CVD are predicted to reach approximately 25 million by 2020.15 CVD is also currently a leading cause of disability, and is predicted to be the largest cause of disability worldwide by 2020.15 A major stroke is viewed by more than half of those at risk as being worse than death.16
About telmisartan (Micardis®/Kinzal®/Pritor®)
Telmisartan is a modern member of the Angiotensin II Receptor Blocker (ARB) class and is being investigated in the most ambitious and far-reaching research programme conducted with an ARB. In the clinical trial programmes ONTARGET®, PROTECTION® and PRoFESS®, over 58,000 patients have been enrolled to investigate the cardiovascular protective effects of telmisartan (for more information please visit www.news-landmarktrials.com ).
Telmisartan was discovered and developed by Boehringer Ingelheim. Under the trademarks Micardis® and MicardisPlus® (combination with hydrochlorothiazide) the company markets telmisartan in 84 countries around the world, including the USA, Japan and European countries. Telmisartan is marketed in cooperation with Astellas Pharma Inc. in Japan, Bayer HealthCare in Europe and GlaxoSmithKline in selected markets.
Astellas Pharma Inc. co-promotes telmisartan under the trademark Micardis®, Bayer HealthCare promotes telmisartan under the brand names Kinzalmono®, Kinzalkomb® (combination with hydrochlorothiazide), and Pritor® and PritorPlus® (combination with hydrochlorothiazide) in markets across Europe. Pritor® and PritorPlus® is also marketed by GlaxoSmithKline in selected markets.
About ONTARGET®
The ONTARGET® Trial Programme consists of two randomised, double-blind, multicentre international trials: the principle trial, ONTARGET® which has reported its results on 31 March 2008, and a parallel trial TRANSCEND® (Telmisartan Randomized AssessmeNt Study in ACE-I INtolerant subjects with cardiovascular Disease), which is planned to be reported later in the year.6
The treatment arms for the ONTARGET® Trial were telmisartan 80mg, ramipril 10mg, and combination therapy with telmisartan 80mg and ramipril 10mg. In the TRANSCEND® trial the treatment arms are telmisartan 80mg or placebo – both on top of standard blood pressure care, not including an ACE or another ARB.6,17
Patients enrolled in The ONTARGET®
Trial Programme were aged ≥ 55 years, had a history of coronary artery disease, stroke or recent (> 7 days, < I year) transient ischaemic attack, peripheral vascular disease, or diabetes mellitus with target-organ damage such as microalbuminuria, ankle-brachial index < 0.8, or left ventricular hypertrophy.17
The ONTARGET® Trial had a four-fold composite endpoint:-
cardiovascular death
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myocardial infarction
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stroke and
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hospitalisation for heart failure.
Patients intolerant to ACEs were not eligible for the ONTARGET® study. Intolerance to ACE was a requirement for enrolment into TRANSCEND®.
The sponsor of the ONTARGET® Trial Programme is Boehringer Ingelheim; co-funders in selected countries are Bayer HealthCare and GlaxoSmithKline.
Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 135 affiliates in 47 countries and 39,800 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2007, Boehringer Ingelheim posted net sales of 10.9 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.
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Professor Albertino Damasceno is announced as winner of the ISH Boehringer Ingelheim Developing World Award during the 2008 International Society of Hypertension (ISH) Biennial Scientific Meeting
Berlin, Germany, 18 June, 2008 – The ISH Boehringer Ingelheim Developing World Award has been presented to Professor Albertino Damasceno, currently Professor of Cardiology, Faculty of Medicine, Eduardo Mondlane University, Maputo, Mozambique.
Professor Damasceno was judged by the ISH Awards Committee to be the ideal candidate to receive the 2008 ISH Boehringer Ingelheim Developing World Award, presented for the fourth time during the 22nd Scientific Meeting of the International Society of Hypertension (ISH 2008) in Berlin, Germany. The award recognises outstanding work in the field of hypertension in the developing world. It is sponsored by Boehringer Ingelheim and carries a prize of €7,500 to be used for scientific research projects in the field of hypertension.
“The ISH is delighted to present this prestigious award to Professor Damasceno,” commented Professor Anthony Heagerty, University of Manchester, United Kingdom and President of the International Society of Hypertension. He continued, “He has contributed to the promotion of high quality research in the field of hypertension and related cardiovascular diseases in Africa, has provided invaluable contributions to the organisation of the 1st ISH Teaching Seminar held in Maputo, Mozambique, September 2006, and was involved, as a faculty member, in the 2nd Society Teaching Seminar in Douala, Cameroon March 2008. We would also like to thank our sponsor Boehringer Ingelheim for making this award possible and supporting vital work into cardiovascular disease in the developing world.”
All members of the ISH are eligible to apply for the award. Application particulars will be available on the ISH website shortly.
~Ends~
Notes to Editors
The International Society of Hypertension
The International Society of Hypertension (ISH) was established in 1966 and now has an active membership of more than 750 doctors from more than 60 countries. The ISH organises major Biennial Scientific Meetings with up to 8,000 participants. It also sponsors smaller meetings, some of them jointly with the WHO.
Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 135 affiliates in 47 countries and 39,800 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2007, Boehringer Ingelheim posted net sales of 10.9 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.
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Boehringer Ingelheim to acquire Actimis Pharmaceuticals
Ingelheim/Germany, San Diego/United States, 17 June 2008 - Boehringer Ingelheim GmbH today announced an agreement to acquire Actimis Pharmaceuticals, Inc., a privately owned biotech company based in San Diego. The acquisition will occur through a structured buyout in which Boehringer Ingelheim will acquire shares of Actimis depending on the achievement of several successive milestones with Actimis’ leading asthma compound AP768. If AP768, currently in phase I clinical development, is successfully advanced into a phase III, Boehringer Ingelheim will own 100% of Actimis’ shares. Upon successful completion of the entire development programme, the total deal will be worth US$ 515 million. Further financial details were not disclosed.
The compound AP768 interacts with CRTH21 , a novel target for asthma and allergic rhinitis. Previous to the currently ongoing phase I clinical trial, the compound has been shown to have a more effective mechanism of action across multiple available animal models compared to currently marketed leukotriene receptor antagonists.
“Actimis’ compound provides an innovative addition to Boehringer Ingelheim’s portfolio of development candidates for the potential treatment of respiratory diseases”, said Dr. Andreas Barner, Vice-Chairman of the Board Corporate Division Pharma Research, Development and Medicine at Boehringer Ingelheim. “For many decades Boehringer Ingelheim has been advancing research and development in the respiratory area with new medicines, such as Spiriva®, which has significantly improved the treatment of COPD patients.”
“Actimis and its investors are delighted with the highly innovative structure of this transaction with Boehringer Ingelheim” says Dr. Peter McWilliams, President and Acting CEO of Actimis. “The scientific team at Actimis, under the leadership of founder, Dr. Kevin Bacon, have done a great job in bringing the program into the clinic and we are excited to have consummated an agreement with a company possessing the expertise and capabilities of Boehringer Ingelheim and are convinced they will do a superb job in taking the compound through the critical and demanding further steps in development.”
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 135 affiliates in 47 countries and 39,800 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2007, Boehringer Ingelheim posted net sales of 10.9 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.
About Actimis Pharmaceuticals
Actimis is a privately held biopharmaceutical company focused exclusively on the research and development of small molecule therapeutics for severe respiratory, inflammatory and autoimmune diseases such as asthma, inflammatory dermatoses, inflammatory bowel disease and rheumatoid arthritis. Actimis was spun off from Bayer Healthcare AG in November 2004. Investors include Sanderling Ventures and Mitsui & Co. Venture Partners.
1 CRTH2: chemo-attractant receptor-homologous molecule expressed on TH2 mice cells
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New data shows pramipexole (Mirapexin®/Sifrol®) can significantly reduce limb pain in patients with Restless Legs Syndrome (RLS)
New data shows pramipexole (Mirapexin®/Sifrol®) can significantly reduce limb pain in patients with Restless Legs Syndrome (RLS)
First ever study to demonstrate efficacy of pramipexole in treating RLS-associated limb pain
Ingelheim, Germany, 10 June 2008 – A new study demonstrating that pramipexole (Mirapexin®/Sifrol®) can significantly reduce RLS-associated limb pain in patients with Restless Legs Syndrome (RLS)1 was presented today at the SLEEP 2008 22nd Annual Meeting of the Associated Professional Sleep Societies (APSS) in Baltimore, U.S.A., This effect is in addition to delivering effective relief from the broad range of RLS symptoms, including sleep disruption, daytime tiredness and mood disturbance. Pain associated with RLS symptoms, such as leg pain, is highly frequent in RLS patients (approximately 60 percent)2 and has been shown to have a negative impact on their health-related quality of life.3
The results of a large, multi-national, randomised, double-blind, placebo-controlled study showed for the first time that pramipexole, a non-ergot dopamine agonist indicated to treat moderate to severe RLS symptoms, significantly reduced limb pain as soon as after five days of treatment and the reduction in pain continued to improve throughout the study period (12 weeks). Improvements with placebo were consistently lower than with pramipexole and were only observed during the first weeks, and declined thereafter.1
“To date, clinical studies with available pharmacologic agents for limb pain have not demonstrated longer term benefits for RLS patients. These new findings with pramipexole will be well received by both doctors and patients who are often looking for a fast-acting and effective treatment for the characteristic RLS symptoms, while seeking the added benefit of alleviating the uncomfortable and painful sensations so often associated with RLS,” said Professor Markku Partinen, MD, PhD, Department of Neurology, University of Helsinki, Finland.
In the study, limb pain was measured at baseline, after one day, five days, nine days, two weeks, four weeks and 12 weeks using a 100-mm visual analogue scale (VAS)* where 0 equalled ‘no pain’ and 100 ‘unbearable pain’. At five days, limb pain was reduced by -15.5 points in the pramipexole group (n=178) versus -5.0 points in the placebo group (n=179). At two weeks and 12 weeks the reductions were -27.5 and -33.5 respectively in the pramipexole group versus -15.0 and -11.0 respectively in the placebo group. The difference versus placebo was statistically significant already from day 5 on over the entire study period.1 Throughout the study period pramipexole was well tolerated. The proportion of patients who discontinued due to adverse events was similar between the treatment groups (8.6 percent for placebo and 9.3 percent for pramipexole).4
The new data presented at APSS reaffirm pramipexole as a highly effective treatment that addresses the broad range of RLS patient needs. Pramipexole has been shown to rapidly alleviate the characteristic symptoms of the condition5, including relief from limb pain which is so frequently associated with RLS.
Please be advised
This release is from Boehringer Ingelheim Corporate Headquarters in Germany. Please be aware that there may be national differences between countries regarding specific medical information, including licensed uses. Please take account of this when referring to the information provided in this document. This press release is not intended for distribution within the U.S.A.
Notes to the Editor:
*Visual analogue scale (VAS)
The visual analogue scale (VAS) is a pain assessment tool to help patients describe the intensity of their pain. The VAS consists of a straight line with the left end of the line representing no pain and the right end of the line representing the worst pain. Patients are asked to mark where they think their pain is on this line.
About Restless Legs Syndrome (RLS)
Restless Legs Syndrome is a neurological disorder characterised by an uncontrollable urge to move the legs, usually accompanied by unpleasant and sometimes painful sensations in the legs. Restless Legs Syndrome affects up to ten percent of the population worldwide aged between 30 and 79 years6 and around one-third of sufferers experience symptoms more than twice weekly causing moderate to severe distress.2 The motor-restlessness worsens during the evening and night causing difficulty initiating and maintaining sleep. The sleep disruption can lead to excessive daytime sleepiness and compromise work performance. Restless Legs Syndrome also has considerable impact on social activities that require immobility.
About pramipexole
Pramipexole (known in Europe under the trade names Mirapexin® and Sifrol® and in the U.S.A. as Mirapex®) is a compound from Boehringer Ingelheim research first approved in 1997 for the treatment of the signs and symptoms of idiopathic Parkinson`s disease, as monotherapy or in combination with levodopa. Pramipexole was approved in 2006 for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (RLS). Pramipexole is currently registered in over 80 countries across the globe.
The most commonly reported adverse reactions in clinical trials for Restless Legs Syndrome were nausea, headache, dizziness and fatigue. The most commonly reported adverse reactions in early and late Parkinson’s disease in clinical trials were nausea, dyskinesia, hypotension, dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue.
Pramipexole may cause patients to fall asleep without any warning, even while doing normal daily activities such as driving. When taking pramipexole hallucinations may occur and sometimes patients may feel dizzy, sweaty or nauseated upon standing up. It should be noted that impulse control disorders/compulsive behaviours may occur while taking medicines to treat Parkinson`s disease, including pramipexole.
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 135 affiliates in 47 countries and 39,800 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2007, Boehringer Ingelheim posted net sales of 10.9 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.
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Boehringer Ingelheim announces first positive health technology assessments for novel oral anticoagulant Pradaxa® (dabigatran etexilate)
Ingelheim/Germany, 9 June 2008 - The Scottish Medicines Consortium (SMC) has accepted Pradaxa® (dabigatran etexilate) for routine use within the National Health Service (NHS) of Scotland for its currently licensed indication: the prevention of venous thromboembolic events in adults who have undergone total hip or knee replacement surgery. The European Commission granted marketing authorisation for Pradaxa® in all 27 EU member states in March 2008.
Also the Danish Institute for Rational Pharmacotherapy (IRF) which belongs to the Danish Medicines Agency has endorsed Pradaxa® as a good alternative to low molecular weight heparins (LMWH) both with respect to efficacy and ease of use.
These decisions on Pradaxa® are the first by European health technology assessment bodies and their positive outcomes are likely to be viewed favourably by decision makers considering the implementation and reimbursement of Pradaxa® across the EU as they indicate Pradaxa® has fulfilled all clinical and cost-effectiveness criteria necessary for use within the NHS in Scotland and clinical criteria necessary for use in Denmark.
Data from the phase III RE-NOVATE™ and RE-MODEL™ studies showed oral, once daily administration of both 150 and 220 mg Pradaxa® was as effective and safe as injectable enoxaparin (40 mg) in preventing venous thromboembolism (VTE) and all cause mortality following total hip and total knee replacement surgery.1,2 In contrast to low molecular weight heparins (LMWH), which require subcutaneous injection, Pradaxa® is administered as a fixed, oral dose making it significantly easier to administer both in the hospital setting and, more importantly, in the home setting after discharge. Unlike both LMWH and warfarin, Pradaxa® does not require monitoring.
Patients undergoing hip and knee replacement surgery are at particularly high risk of developing VTE.3 Without thromboprophylaxis, up to 60 percent of orthopaedic surgery patients have been shown to develop DVT (deep vein thrombosis; including asymptomatic thrombi), and 0.2-10 percent are at risk of a potentially fatal PE (pulmonary embolism) according to previous studies.3 It is estimated that 543,454 deaths in Europe per year are VTE-related, more than double the number from breast cancer, prostate cancer, HIV/AIDS and road traffic accidents combined.4
Professor Simon Frostick, Professor of Orthopaedics at the University of Liverpool, UK said:
“We know that thromboprophylaxis after orthopaedic surgery is crucial to protect patients from potentially life-threatening thrombi. Now, with Pradaxa® as a new therapeutic option, we have an effective oral, once-daily anticoagulant with a good efficacy and safety profile to facilitate convenient thromboprophylaxis both in and out of hospital.”
The registered charity AntiCoagulation Europe (ACE) which works to prevent thrombosis and provide information for patients also welcomed the decision. Executive Director Eve Knight said:
“This could mean saving lives. Pradaxa® is potentially a huge benefit for patients. One of the reasons why patients are not given thromboprophylaxis is that they have to have heparin which has to be injected. Following hospital discharge, many patients have to learn to self-inject which may result in inadequate treatment duration due to poor compliance. Pradaxa® is so much more convenient; just two capsules once a day.”
Pradaxa® has a rapid onset and offset of action and a predictable anticoagulation effect. It prevents thrombus formation by specifically and selectively inhibiting thrombin, the central and essential enzyme in the coagulation cascade that enables conversion of fibrinogen into fibrin. In contrast to warfarin, Pradaxa® exhibits no drug-food interactions and has a low potential for drug-drug interactions.5,6< br>
Boehringer Ingelheim continues to evaluate the efficacy and safety of Pradaxa® in a range of thromboembolic disease conditions. RE-VOLUTION™ is an extensive clinical trial programme involving more than 38,000 patients worldwide. Recent progress includes the announcement in January 2008 of the completion of enrolment of 18,114 patients in RE-LY™, the largest stroke prevention atrial fibrillation outcomes trial to date. Other ongoing studies are evaluating the efficacy and safety of Pradaxa® in the treatment of acute VTE, the secondary prevention of VTE and prevention of cardiac events in patients with acute coronary syndrome.
Notes to Editors
The wording of the SMC advice following a full submission is:
“dabigatran etexilate (Pradaxa) is accepted for use within NHS Scotland for the primary prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.
“In two large phase III studies, in patients undergoing either total knee or total hip replacement surgery, dabigatran was non-inferior to low molecular weight heparin in the incidence of VTE and all cause mortality with patients having a similar incidence of major bleeding events. The two drugs have similar costs per dose but dabigatran has lower administration costs and is an oral therapy. This may facilitate longer duration of thromboprophylaxis; however the risks and benefits of this longer treatment duration need to be considered on a case-by-case basis.”7
Please be advised
This release is from the Corporate Headquarters of Boehringer Ingelheim and is intended for international markets. This being the case, please be aware that there may be some differences between countries regarding specific medical information including licensed uses. Please take account of this when referring to the material.
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 135 affiliates in 47 countries and 39,800 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2007, Boehringer Ingelheim posted net sales of 10.9 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.
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