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Boehringer Ingelheim receives positive recommendation from European scientific committee for a new once daily Mirapexin® (pramipexole) formulation for the treatment of Parkinson?s disease
Ingelheim/Germany, 26 June 2009 ? Boehringer Ingelheim announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending the approval of a once daily formulation for Mirapexin®/ Sifrol® (pramipexole), in all countries of the European Union, Norway, Iceland and Liechtenstein. The CHMP recommendation states that the new prolonged-release formulation is indicated for treatment of the signs and symptoms of idiopathic Parkinson?s disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or ?on off? fluctuations).
The CHMP recommendation follows clinical trial results confirming the high therapeutic benefits of Mirapexin® / Sifrol® also when administered in a convenient once-a-day formulation.1-4
?We are very pleased about the positive recommendation. This effective new treatment option combines the trusted clinical benefits of Mirapexin® with the convenience of a single daily dose. The once daily administration of the new Mirapexin® prolonged-release formulation has been shown to cause less frequent fluctuations in the pramipexole plasma concentration over 24 hours compared to the three times daily administration of pramipexole immediate release tablets. Once approved, PD patients already taking Mirapexin® may be switched overnight from the immediate release tablets to the Mirapexin® prolonged-release tablets, at the same daily dose.5 In addition to benefiting from the high therapeutic value of Mirapexin®, the reduced pill burden will mean added convenience for patients and their carers. It is important for physicians to have effective and flexible treatment regimens to choose from so that they can offer individualised treatments in line with the patient?s needs,? commented Dr. Manfred Haehl, MD, Senior Vice-President Medicine at Boehringer Ingelheim Corporate Headquarters.
(Note: Mirapexin® / Sifrol® is currently registered as immediate release formulation only.)
A new drug application (NDA) for a once daily, extended release formulation of Mirapex® is in review with the U.S. Food and Drug Administration (FDA) for the treatment of Parkinson?s disease (currently available in the U.S.A. as immediate release formulation). Boehringer Ingelheim is looking forward to making the new formulation available to patients with PD in the U.S.A. should the FDA approve the filed submission.
Notes to Editor:
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.
About Parkinson?s disease (PD)
Parkinson?s disease is the second most common chronic neurological disorder in older adults after Alzheimer?s. Its worldwide prevalence is estimated to be approximately one to two percent of those over 65 years.6-8 Although traditionally PD is associated with motor symptoms (such as tremor, rigidity, slowed motion, imbalance, shuffling gait, loss of facial expression), the non-motor symptoms, including depressive symptoms, pain, cognitive impairment and sleep disorders can be significant. Symptoms can vary from patient to patient, but worsen over time.
About Mirapexin®/Sifrol® (pramipexole)
Pramipexole (known under the trade names Mirapexin®, Sifrol®, Mirapex® and Pexola®) 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 available in over 70 countries across the globe.
The most commonly (≥ 5%) reported adverse drug reactions in patients with Parkinson?s disease treated with pramipexole were nausea, dyskinesia, hypotension, dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue. Pramipexole may cause patients, particularly with Parkinson?s disease, to fall asleep without any warning even while doing normal daily activities such as driving. When taking pramipexole hallucinations can occur and sometimes patients may feel dizzy, sweaty or nauseated upon standing up.
Patients and caregivers should be aware of the fact that abnormal behaviour (reflecting symptoms of impulse control disorders and compulsive behaviours) such as binge eating, compulsive shopping, hypersexuality and pathological gambling have been reported in patients treated with dopaminergic drugs, including pramipexole. Dose reduction/tapered discontinuation should be considered.
Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world?s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and 41,300 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 2008, Boehringer Ingelheim posted net sales of 11.6 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.
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Expedition to Mount Everest offers new insights into chronic disease
Milan/Italy, 22 June 2009 - Results of the HIGHCARE2008 Project were announced during the recent 19th Scientific Meeting of the European Society of Hypertension (ESH), Milan, Italy. The first-ever ambulatory blood pressure (ABPM) study conducted at high and very high altitude investigated treatment with telmisartan and showed that:1- in conditions of hypobaric hypoxia (oxygen deficiency), 24-hour blood pressure increased in a sustained manner proportional to the altitude reached
- the effects of hypobaric hypoxia at high altitude are similar to the effects of reduced oxygen availability observed in diseases associated with respiratory disorders, such as chronic heart failure (CHF), chronic obstructive pulmonary disease (COPD), arterial hypertension related to sleep apnea syndrome and/or severe obesity.2-5 Together, these diseases affect more than 600 million people worldwide6,7 giving the study results great significance
- treatment with telmisartan, a modern angiotensin II receptor blocker, reduces blood pressure compared with placebo at high altitude, up to at least 3500m above sea level, demonstrating potential control of hypoxia-induced blood pressure alterations
- at very high altitude, 5400m above sea level, blood pressure effects between the telmisartan and placebo groups was comparable, consistent with changes in the functioning of the renin-angiotensin-aldosterone system (RAAS).
Physiological changes occurring at high altitude are mainly due to decreased atmospheric pressure leading to hypoxia (deprivation of adequate oxygen supply) and hypoxemia (decreased partial pressure of oxygen in blood).
Professor Gianfranco Parati, Chairman and Principle Investigator of the HIGHCARE2008 Project and Professor of Medicine at the Department of Clinical Medicine and Prevention, University of Milano-Bicocca commented, People with sleep apnea syndrome develop high blood pressure in response to hypoxia, a lack of oxygen in their blood. In the HIGHCARE2008 Project, this condition has been simulated by hypobaric hypoxia, often associated with sleep-related breathing disorders, which occurs at high altitude. We found that telmisartan the antihypertensive drug we tested was able to control this effect at altitudes of up to 3500m, at which the lack of oxygen is similar to the degree of hypoxemia most commonly experienced by sleep apnea sufferers.
The randomised, parallel group, double-blind, placebo-controlled trial with telmisartan 80mg was conducted in 38 healthy subjects with a moderate level of physical fitness. The effects of telmisartan on 24-hour ambulatory blood pressure were measured under acute and prolonged exposure to high altitude hypoxia. Key results showed that:1- following treatment with telmisartan for six weeks at sea level and also following acute exposure to high altitude (3500m):
- 24-hour SBP/DBP** at sea level were significantly reduced with telmisartan compared with placebo (SBP: 112.0±7.8 vs. 116.4±8.6, p=0.0025; DBP: 69.0±5.8 vs. 74.0±5.8, p=0.002)
- 24-hour SBP/DBP at 3500m were also significantly reduced with telmisartan compared with placebo (SBP: 120.0±9.7 vs. 125.0±8.7,p=0.0056; DBP: 75.7±6.5 vs. 81.1±5.7, p=0.009)
- at very high altitude, 5400m, 24-hour SBP/DBP was comparable between the telmisartan and placebo groups (SBP: 130.1±11.1 vs. 130.7±11.2, p=NS; DBP: 82.1±7.1 vs. 84.2±6.6, p=NS), consistent with changes in functioning of the RAAS. These changes may explain why a treatment that works on the RAAS may not provide benefits at very high altitude.
The RAAS is involved in the occurrence of a number of cardiovascular (CV) conditions, including hypertension and heart failure. Therapeutic agents acting on the RAAS, including angiotensin II receptor blockers such as telmisartan, have beneficial CV effects.
Dr. Grzegorz Bilo, Istituto Auxologico Italiano and Department of Clinical Medicine and Prevention, University of Milano-Bicocca, commented, When moving to an even higher altitude, and thus further increasing the hypoxia above the levels often experienced in sleep apnea, the blockade of the RAAS was no longer able to control the hypoxia-induced blood pressure increase. This suggests that other mechanisms were involved and could explain the blood pressure changes observed. Even though this is an artificial setting, the data we have collected will provide important insights into the physiological and molecular basis of hypoxia induced hypertension.
Professor Gianfranco Parati concluded, While the data that we have collected need to be confirmed by further studies, what we can take away from this expedition is that although Everest is one of the most hostile places on earth, it might actually help us save lives by giving us a better understanding of the changes induced by hypoxia in the human body.
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.
About telmisartan (Micardis/Kinzalmono/Pritor)
Telmisartan is approved for the treatment of essential hypertension. It 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 were enrolled to investigate the cardiovascular protective effects of telmisartan
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.
Boehringer Ingelheim
The Boehringer Ingelheim group is one of the worlds 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and 41,300 employees. Since it was founded in 1885, the independent, family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2008, Boehringer Ingelheim posted net sales of 11.6 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.
About the HIGHCARE2008 Project
The HIGHCARE2008 Project was organised by the Istituto Auxologico Italiano (Ospedale S. Luca, Milano, Osp. S. Giuseppe, Piancavallo, Verbania) and University of Milano-Bicocca (Dept. of Clinical Medicine and Prevention). The aim was to assess the physiological changes induced by the exposure to more marked and more prolonged hypobaric hypoxia as compared to what can be done on the Alps, and to determine how these changes may be influenced by angiotensin AT1 receptor blockade and by other non-pharmacological interventions. The expedition took place in September-October 2008 For further information on the HIGHCARE Expedition, please visit: http://highcare2008.eu/index-en.php
About Mount Everest8
Mount Everest, is the highest mountain on Earth, as measured by the height above sea level of its summit, 8,848 metres (29,029 ft). The mountain, which is part of the Himalaya range in High Asia, is located on the border between Sagarmatha Zone, Nepal, and Tibet, China.
In 1856, the Great Trigonometric Survey of India established the first published height of Everest, then known as Peak XV, at 29,002 ft (8,840 m). In 1865, Everest was given its official English name by the Royal Geographical Society upon recommendation of Andrew Waugh, the British Surveyor General of India at the time. Chomolungma had been in common use by Tibetans for centuries, but Waugh was unable to propose an established local name because Nepal and Tibet were closed to foreigners.
* HIGHCARE = HIGH altitude CArdiovascular Research
** SBP systolic blood pressure; DBP diastolic blood pressure
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Boehringer Ingelheim and Vitae Pharmaceuticals announce a major collaboration to research and develop novel treatments for Alzheimer`s disease
Fort Washington/Pennsylvania and Ingelheim/Germany, 15 June 2009 - Boehringer Ingelheim and Vitae Pharmaceuticals, Inc., announced today that they have entered into a significant worldwide collaboration to research and develop beta-secretase (BACE) inhibitors for the treatment of Alzheimer?s disease. Current therapies for Alzheimer?s disease can improve symptoms, but do not affect the progression of the disease. The inhibition of BACE - an enzyme involved in the formation of amyloid-beta plaques which accumulate in the brains of patients with Alzheimer?s disease - offers the potential to slow or even halt disease progression.
Under the terms of the collaboration agreement, Vitae will receive $42 million in upfront and near-term payments from Boehringer Ingelheim, consisting of upfront cash, an equity investment in Vitae, and research funding to support further discovery efforts. In addition, Vitae will be eligible to receive $200 million in pre-commercial milestone payments based on the achievement of clinical and regulatory goals, as well as further milestone payments based on potential additional compounds and / or other approved indications. Vitae will receive commercial performance payments and royalties from Boehringer Ingelheim on all potential future product sales. Further financial details were not disclosed.
The companies will work jointly to identify and advance candidates for clinical development. Thereafter, Boehringer Ingelheim will lead development and commercialization of all products for Alzheimer?s disease to capitalize on its global marketing and sales expertise. Vitae will have the right to develop products independently for certain other indications.
?I am very pleased to be working with Boehringer Ingelheim?s exceptional neuroscience group on this program?, said Jeffrey Hatfield, CEO of Vitae. ?This collaboration accomplishes three important objectives for our company. It adds substantial neuroscience expertise and specialized resources to the BACE program, which has advanced remarkably during its 16-month life. It also extends what is already a very successful partnership model with Boehringer Ingelheim, stemming from our existing diabetes and metabolic syndrome collaboration. Boehringer Ingelheim?s team-oriented culture presents an ideal environment for partnership success. And finally, it continues Vitae?s business model of financing the company?s growth through rapid value creation and partnering versus relying on the capital markets ? which is favorable for our shareholders.?
Dr Manfred Haehl, Corporate Senior Vice President R&D and Medicine of Boehringer Ingelheim worldwide, added that ?Based on our research experience in Alzheimer`s disease and our excellent experience in collaborating with Vitae for the diabetes program, we will be using our overall expertise in CNS disease research, drug development and commercialization to strengthen our current neuroscience portfolio. Ultimately, we all aim to create new treatments for patients suffering from this serious debilitating disease. We therefore will see the companies` joint efforts expanding to create medicines that are urgently needed in two widespread disease areas, namely diabetes and Alzheimer?s disease. It is part of our core development strategy to establish long-term alliances with innovative companies that broaden the scope of our own exciting pipeline successes."
About BACE Inhibition
Alzheimer?s disease is a chronic neurodegenerative disorder characterized by progressive memory loss associated with the deposition of neuritic plaques in the brains of patients. The amyloid-beta peptide is the major component of such plaques and is considered to be the major culprit in the pathogenesis of Alzheimer?s disease. Amyloid-beta is generated from amyloid precursor protein (APP) by proteolytic processing by beta and gamma secretases. Since beta-secretase (beta-site APP cleaving enzyme 1, or BACE1) cleavage is rate limiting for the production of amyloid-beta, inhibition of this enzyme represents an attractive strategy to ameliorate amyloid-beta plaque deposition in Alzheimer?s disease. Supporting this notion are studies demonstrating that deletion of the BACE1 gene in mice prevents the formation of amyloid-beta in cultured neurons and the brain. In addition, it has been shown that amyloid-beta-associated memory deficits, which occur in mutant mice overexpressing APP, are prevented when the BACE1 gene is deleted. Thus in patients, it is anticipated that inhibitors blocking BACE1 could prevent the build up of amyloid-beta plaques and help slow or stop the progression of disease.
About Alzheimer?s Disease
Alzheimer`s disease (AD) is the most common form of dementia in adults. It is estimated to affect 4.5 million American?s and over 30 million people worldwide with an average course of 8 -12 years. It is projected that the prevalence of AD will double over the next 20 years. Marketed treatments address some symptoms, however there are no treatments available that delay or halt the progression of the disease. Global sales of Alzheimer?s drugs were approximately $5 billion in 2008 and are expected to exceed $14 billion by 2015.
Vitae Pharmaceuticals
Vitae Pharmaceuticals is an emerging pharmaceutical company building a clinical stage pipeline of novel drug candidates in important therapeutic categories, such as cardiovascular disease, diabetes and Alzheimer?s disease. Vitae discovers and develops solutions to biologically validated but hard-to-drug targets by fully integrating its proprietary structure-based drug design platform - delivering unprecedented accuracy, speed and novelty ? with the targeted efforts of highly experienced and successful discovery scientists. Vitae Pharmaceuticals is financed by leading corporate and venture capital investors, completing its last venture round in 2004. Vitae?s forty scientists are located in Fort Washington, Pennsylvania..
Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world?s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and 41,300 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 2008, Boehringer Ingelheim posted net sales of 11.6 billion euros while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.
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New investigational combination telmisartan and amlodipine shows effective and well-tolerated 24-hour blood pressure control in hypertensive patients at risk of cardiovascular events
Milan/Italy, 14 June 2009 - Data presented today at the 19th Scientific Meeting of the European Society of Hypertension, Milan, Italy has demonstrated that treatment with an investigational combination of telmisartan (an angiotensin receptor blocker [ARB]) and amlodipine (a calcium-channel blocker [CCB]) shows substantial and sustained 24-hour blood pressure (BP) lowering and is well-tolerated in a range of patients with hypertension at risk of cardiovascular (CV) events. This includes patients with Type 2 diabetes, obese patients, the elderly, black patients and those not controlled by amlodipine alone.1-8
Suboptimal treatment of hypertension has recently been highlighted by the World Health Organization as the number-one risk of death globally;9 the majority of patients do not achieve BP control on one therapeutic agent alone,10 with treatment intolerance and non-compliance being common problems.11 The unmet need for a convenient and tolerable treatment that helps the majority of patients control their BP clearly persists.
Professor Giuseppe Mancia, Professor of Medicine and Chairman of the Department of Clinical Medicine, Prevention and Applied Biotechnologies of the University of Milan, Bicocca commented, ?Recent data from a large population-based study in Italy shows a lack of blood pressure control with monotherapy, which is frequently abandoned after just a few months ? a trend that continues over time. Interestingly, however, the study also highlighted differences in discontinuation rates between treatment classes, with ARBs, such as telmisartan resulting in the best treatment compliance rates. The new telmisartan and amlodipine combination data show that this combination is effective and well-tolerated in difficult-to-treat patients at cardiovascular risk and in patients not controlled by amlodipine alone, which may aid patient compliance and help to improve cardiovascular disease management.?
Study results
The telmisartan and amlodipine combination was investigated in a double-blind trial involving 1,461 patients with hypertension who were randomised to one of 16 treatment arms involving telmisartan 0, 20, 40 or 80mg plus amlodipine 0, 2.5, 5 or 10mg for eight weeks.12
New results presented at ESH show that in a broad range of hypertensive at-risk patients (Type 2 diabetes, obese patients, the elderly), combination treatment with telmisartan 40-80mg and amlodipine 5-10mg1-8:
- provides effective 24-hour BP control, including the last six hours of the dosing interval and early morning hours when the risk of CV events is highest
- is well-tolerated with less peripheral oedema (telmisartan 40-80mg and amlodipine 5-10mg 5.2%/amlodipine 10mg 17.8%) compared with amlodipine 10mg alone
- provides effective BP reductions and control (<140/90mmHg) in patients whose BP is not controlled with amlodipine 5-10mg alone.
In patients receiving telmisartan 80mg plus amlodipine 10mg:
- Type 2 diabetes: 87.0% (n=20) of patients achieved BP control, with a third (30.4%) reaching the more stringent BP goal of <130/80mmHg (n=7, subgroup n=23, all treatment groups n=231). BP reductions in non-diabetics and diabetics were -25.1/-19.4mmHg and -29.1/-20.2 mmHg, respectively 2,5
- Obesity: 81.7% (n=71) and 83.1% (n=65) of obese and non-obese patients achieved BP control with BP reductions of -24.6/-19.9 mmHg and -27.1/-19.2 mmHg, respectively (clinically obese at baseline, BMI ≥30 kg/m2, subgroup n=87, all treatment groups n=783)3,5
- Elderly: 77% (n=22) of patients ≥ 65 years of age achieved BP control with BP reduction in patients ≥ 65 and < 65 years of age -27.2/-22.8 mmHg and -25.5/-18.9 mmHg, respectively (subgroup n=29, all treatment groups n=202)1,6
In patients not controlled with amlodipine 5-10mg:7,8- 66% of patients (n=277) achieved BP control with telmisartan 80mg plus amlodipine 5mg when previously not controlled with amlodipine 5mg
- 60% of patients (n=310) achieved BP control with telmisartan 80mg plus amlodipine 10mg when previously not controlled with amlodipine 10mg
- the oedema rate with telmisartan 80mg plus amlodipine 5mg (3.6%) was significantly lower, than with amlodipine 10mg alone (27.2%), which may make the combination a better solution than up titrating amlodipine.7
Dr. Sarah Jarvis, Richford Gate Medical Practice, London,?Patients who are at higher risk of cardiovascular events often need more than one treatment to control their blood pressure, but a treatment that works is only half the story. Tolerability is essential to ensure patients keep taking their treatment and are protected. Regardless of Type 2 diabetes, obesity or age, the telmisartan and amlodipine combination shows excellent blood pressure control and a good tolerability profile, which could make it a good option for patients and physicians alike.?
Proven 24-hour blood pressure reductions and cardiovascular protection
Unlike many anti-hypertensive treatments, telmisartan and amlodipine are once-daily treatments that provide both substantial and sustained 24-hour BP reductions13-15 and have an evidence base in CV outcomes demonstrating protective benefits16,17. As demonstrated in The ONTARGET? Trial Programme, telmisartan is the only ARB proven to achieve CV protective benefits in a broad range of high CV risk patients, reducing the risk of CV death, myocardial infarction, stroke and hospitalisation for congestive heart failure16.
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.
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 were enrolled to investigate the cardiovascular protective effects of telmisartan
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.
Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world?s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and 41,300 employees. Since it was founded in 1885, the independent, family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2008, Boehringer Ingelheim posted net sales of 11.6 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.
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New data once more show high therapeutic benefits of Boehringer Ingelheim`s Mirapexin®/Sifrol® (pramipexole) once-daily extended release formulation, also in patients with advanced Parkinson`s disease
Ingelheim/Germany, 10 June 2009 - New data presented today at the Movement Disorder Society?s 13th International Congress of Parkinson?s Disease and Movement Disorders (MDS) further confirms high therapeutic benefit of Mirapexin®/Sifrol® (pramipexole) once-daily, extended release formulation (also referred to as prolonged release formulation). The trial, performed in patients with advanced Parkinson?s disease (PD), showed results comparable to pramipexole?s already long-established immediate release formulation.1 This study supports data from a previous trial that demonstrated the efficacy, safety and tolerability of the once daily formulation in the treatment of early PD at 18 weeks,2 and non-inferiority between pramipexole extended release and pramipexole immediate release at 33 weeks as presented for the first time today at the MDS.4
The randomised, placebo-controlled trial assessed the efficacy and safety of a once-daily, extended release formulation of pramipexole - administered as adjunctive therapy in advanced PD - compared to its immediate formulation when administered under the same therapeutic conditions. Both the primary and the key secondary endpoints were met in the study as measured by the change from baseline in UPDRS II+III and percentage of off-time during waking hours.
"These most recent study data show that the pramipexole once-daily, extended release formulation is effective not only in early but also in the more advanced stages of Parkinson?s disease. The improvement seen in ?off-time? (known as a period of dramatically reduced motor functioning at the end of the dosing interval), as well as the convenience of a once-daily formulation, is a benefit both patients and physicians will welcome. Having a once-daily pill is especially important for those in an advanced stage of the disease when the need for multiple medications often increases,? commented Professor Anthony Schapira, lead investigator of the study, Chairman of the University Department of Clinical Neurosciences, Institute of Neurology, Queen Square, UCL and Professor of Neurology at the National Hospital and Royal Free Hospital, London, UK.
(Note: Mirapexin®/Sifrol® (pramipexole) is currently registered as immediate release formulation only.)
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 Editor:
Summary of early PD and advanced PD pramipexole trial results
- A randomised, placebo-controlled, double-blind trial comparing pramipexole extended.release (ER) and immediate release (IR) formulations versus placebo, as adjunctive therapy, after 18 weeks of treatment, in patients with advanced PD:
- A total of 507 patients were included in the efficacy analyses at week 18.
- In these patients, the adjusted mean change in UPDRS* II+III score from baseline to week 18 was -6.1 points for placebo, -11.0 points for prolonged release (p=0.0001 vs. placebo) and -12.8 points for immediate release (p<0.0001 vs. placebo).
- The adjusted mean change in percentage off-time was -8.8 points for placebo, -13.3 points for prolonged release (corresponding to an improvement of -2.1 hours from baseline; p=0.0122 vs. placebo) and -15.9 for immediate release (corresponding to an improvement of -2.5 hours from baseline p<0.0001 vs. placebo).
- Adverse event rates were similar for pramipexole ER (54.9%) compared to placebo (55.6%) and numerically lower than pramipexole IR (64.0%).
- A randomised, placebo-controlled trial double-blind trial comparing pramipexole extended release (ER) and immediate release (IR) formulations versus placebo after 18 weeks and 33 weeks of treatment, in patients with early PD:
- A total of 253 patients were included in the 18-week analysis testing for superiority of pramipexole extended release versus placebo.
- In these patients, the adjusted mean change in the UPDRS II+III score from baseline to week 18 was ?5.1 points in the placebo group, ?8.1 points in the pramipexole extended release group (p=0.0282 vs. placebo), and ?8.4 points in pramipexole immediate release group (p=0.0153 vs. placebo).
- A sub-group of 84 patients had completed 33 weeks of treatment at the first analysis cut-off and were included in the descriptive analysis of maintenance of efficacy. The UPDRS II+III score was almost unchanged from week 18 to week 33 in both pramipexole groups, while a worsening was observed in placebo patients. In the pramipexole extended release group, the adjusted mean change from baseline in the UPDRS II+III score was ?11.5 points at week 33 versus ?11.8 points at week 18, a difference of +0.3 point (or 2.5 percent). For the pramipexole immediate release group, both changes (week 33 and week 18) were ?11.9 points, a difference of 0 percent. For the placebo group, the mean change was ?2.7 points at week 33 versus ?4.2 points at week 18, a worsening of +1.5 points (or 35.7 percent).3
- Non-inferiority between pramipexole extended release and pramipexole immediate release was assessed at week 33. The adjusted mean change in the UPDRS II+III score from baseline to week 33 were ?8.6 points in the pramipexole extended release group (n = 213) and ?8.8 points in the pramipexole immediate-release group (n = 223), a between-group difference of ?0.2 points, 95% CI=[?2.2; 1.7]. The lower bound of the 95% CI (?2.2 points) was higher than the pre-defined non-inferiority margin of ?3 points, demonstrating non-inferiority between pramipexole extended release and pramipexole immediate release at week 33.4
*The Unified Parkinson?s Disease Rating Scale (UPDRS)
The Unified Parkinson?s Disease Rating Scale (UPDRS) is a comprehensive tool, which was developed to follow the longitudinal course of PD-related disability and impairment. The UPDRS II+III score was used as the primary efficacy endpoint in both trials. UPDRS Part II relates to activities of daily living and UPDRS Part III relates to motor symptoms. The UPDRS II+III score ranges from 0 (no disability) to 160 (worst disability).
About Parkinson?s disease (PD)
Parkinson?s disease is the second most common chronic neurological disorder in older adults after Alzheimer?s. Its worldwide prevalence is estimated to be approximately one to two percent of those over 65 years.5-7 Although traditionally PD is associated with motor symptoms (such as tremor, rigidity, slowed motion, imbalance, shuffling gait, loss of facial expression), the non-motor symptoms, including depressive symptoms, pain, cognitive impairment and sleep disorders can be significant. Symptoms can vary from patient to patient, but worsen over time.
About Mirapexin®/Sifrol® (pramipexole)
Pramipexole (known under the trade names Mirapexin®, Sifrol®, Mirapex® and Pexola®) 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 available in over 70 countries across the globe.
The most commonly (≥ 5%) reported adverse drug reactions in patients with Parkinson?s disease treated with pramipexole were nausea, dyskinesia, hypotension, dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue.
Pramipexole may cause patients, particularly with Parkinson?s disease, 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.
Patients and caregivers should be aware of the fact that abnormal behaviour (reflecting symptoms of impulse control disorders and compulsive behaviours) such as binge eating, compulsive shopping, hypersexuality and pathological gambling have been reported in patients treated with dopaminergic drugs, including pramipexole. Dose reduction/tapered discontinuation should be considered.
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 138 affiliates in 47 countries and 41,300 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 2008, Boehringer Ingelheim posted net sales of 11.6 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.
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New data from Boehringer Ingelheim`s ongoing linagliptin trial programme show promising safety and efficacy results
Ingelheim/Germany, 6 June 2009 - Study results presented for the first time in the scientific sessions of this year?s American Diabetes Association Annual Meeting (ADA) show clinically relevant and statistically significant reductions in haemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) levels when linagliptin, a dipeptidyl peptidase 4 (DPP-4) inhibitor, is given as add-on therapy in Type 2 diabetic patients inadequately controlled with metformin. Furthermore, these phase II study results show a placebo-like safety and tolerability profile under these therapeutic conditions. Notably, in the study no case of hypoglycaemia was recorded with linagliptin treatment.1
?To date, metformin is the most widely used oral therapy in Type 2 diabetes. However, many patients do not achieve adequate glycaemic control with metformin alone. As HbA1c and FPG levels are key diagnostic indicators for effective management of Type 2 diabetes, the significant efficacy results together with the favourable safety profile shown in this trial for the investigational drug linagliptin are very encouraging. Based on the results seen to date, we are very confident that linagliptin, if approved, can provide additional benefit to patients with Type 2 diabetes,? said Dr. Manfred Haehl, MD, Senior Vice-President Medicine at Boehringer Ingelheim headquarters. ?Type 2 diabetes is a progressive chronic condition which frequently requires long-term treatment. Physicians treating patients with Type 2 diabetes need to have a range of treatment options including combination regimens so they can tailor the therapy to the individual patient?s need and response. We are now awaiting results from additional ongoing studies which will further assess the full potential of linagliptin for the treatment of Type 2 diabetes.?
Trial objective and results:
The aim of the 12-week, international, randomised, double-blind placebo-controlled study was to assess the safety and efficacy profile of linagliptin as add-on therapy in patients with Type 2 diabetes who were failing to achieve glycaemic control despite being treated with metformin. Primary endpoint was the change in HbA1c from baseline to week 12. Out of the 333 randomised patients, 268 patients received double-blind treatment with linagliptin or placebo. Three doses of linagliptin were investigated in this study: 1 mg, 5 mg and 10 mg. An open-label arm with 65 patients on glimepiride was added for descriptive control.
- The addition of linagliptin to metformin treatment for 12 weeks resulted in clinically relevant and statistically significant reductions in HbA1c and FPG levels (p-values of less than 0.05%).
- All doses of linagliptin showed superior HbA1c reduction compared to metformin alone after treatment for 12 weeks (the placebo-corrected changes from baseline were ?0.40% for the 1 mg dose, ?0.73% for the 5 mg dose, and ?0.67% for the 10 mg dose). Statistically significant reductions in mean HbA1c levels with linagliptin 5 mg and 10 mg compared with metformin alone (both p<0.001) were observed already from week four onwards.
- In addition, all linagliptin doses showed significant reductions in FPG levels compared with metformin alone (the placebo-corrected mean changes from baseline were ?19.2 mg/dL for 1 mg, ?34.7 mg/dL for 5 mg, and ?29.0 mg/dL for 10 mg).
- In the open-label comparator arm, the placebo-corrected mean change from baseline in HbA1c was ?0.90%.
- The predefined efficacy criterion of more than 80% DPP-4 inhibition in more than 80% of patients was reached with the 5 mg and 10 mg linagliptin doses, but not with the 1 mg dose, which fully supports the 5mg dose as optimal dosage.
- HbA1c reductions of ≥ 0.5% were achieved in 44% to 53% of patients on linagliptin, but only in 13% of the patients receiving metformin alone.
- Linagliptin had a placebo-like safety/tolerability profile.
- The incidence of adverse events was similar in all treatment groups. No dose relationship of adverse event was observed
- No cases of hypoglycaemia were recorded in the linagliptin groups, whereas three hypoglycaemic episodes were reported in the glimepiride group.
Linagliptin is the most advanced compound for the treatment of Type 2 diabetes within Boehringer Ingelheim?s diabetes portfolio. Linagliptin belongs to the class of DPP-4 inhibitors and is being developed as an oral once-daily tablet. It is currently in phase III clinical development.
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 Editor:
About the Boehringer Ingelheim diabetes pipeline
Metabolism is one of Boehringer Ingelheim?s core R&D areas and diabetes one of the indications at the centre of interest within the company?s global research network. As a result, Boehringer Ingelheim is pursuing various modes of action. The company?s most advanced compounds targeting Type 2 diabetes are linagliptin (planned trade name Ondero), an oral once-daily tablet which belongs to the novel class of dipeptidylpeptidase (DPP-4) inhibitors and is currently in Phase III development, and a compound in Phase II which belongs to another class of novel antidiabetics, the sodium-dependent glucose transporter-2 (SGLT-2) inhibitors.
About Diabetes and Type 2 Diabetes
There are approximately 246 million people with diabetes in the adult population.2a The International Diabetes Federation estimates the number of people with diabetes will increase to 380 million people worldwide by 2025.2a Some 3.8 million men and women worldwide were estimated to have died from diabetes-related causes in the year 2007. This is more than 6% of the total world mortaliy.2b
Type 2 diabetes is the most common type of diabetes accounting for up to 95% of all diabetes cases in the developed world.2a Type 2 diabetes rates continue to increase and patients continue to be burdened by serious diabetes-related complications,2a also reflected in the fact that approximately 50% of people with diabetes die of cardiovascular disease, and more than 10% die of renal failure.3 Traditional therapies have frequently failed to meet the demands of today?s Type 2 diabetes landscape and new, effective and tolerable treatments are required.
To address this unmet need, Boehringer Ingelheim is committed to researching and developing new compounds in this disease area.
HbA1c = The erythrocyte haemoglobin become irreversibly glycosylated in proportion to circulating glucose concentrations, and the resultant product is commonly referred to as haemoglobin A1c (HbA1c). Because of the half-life of the erythrocyte, the percentage of haemoglobin represented by HbA1c provides an index of the average plasma glucose concentration during the previous two to three months.4
FPG = Fasting plasma glucose is the level of glucose in blood after an overnight fast.5
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 138 affiliates in 47 countries and 41,300 employees. Since it was founded in 1885, the independent, family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2008, Boehringer Ingelheim posted net sales of 11.6 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 and DxS sign an agreement for a companion diagnostic to identify EGFR mutations in patients with lung cancer
Manchester/UK and Ingelheim/Germany, 29 May 2009 - DxS, a personalised medicine company, and Boehringer Ingelheim, a global group of pharmaceutical companies, headquartered in Germany, have entered into an agreement to provide a companion diagnostic test kit for Boehringer Ingelheim?s compound BIBW 2992 (Tovok?) to identify mutations of the EGFR (epidermal growth factor receptor) in patients with non small cell lung cancer. Financial terms of the agreement are not disclosed.
Clinical data published to date suggest that BIBW 2992 offers a marked increase in efficacy in comparison to standard treatments, for lung cancer patients carrying mutations in the EGFR gene. Under the terms of the agreement, DxS and Boehringer Ingelheim will work jointly to make a suitable companion diagnostic test kit globally available.
BIBW 2992 is a novel tyrosine kinase inhibitor that acts by irreversibly blocking the EGFR /HER2 receptors, which are promoters of tumour growth. As with other tyrosine kinase inhibitor therapies, patients with mutations in the EGFR gene will be more likely to respond to a medication that targets these receptors, thereby allowing doctors to prescribe the most effective and individual treatment. Furthermore BIBW 2992 has demonstrated preclinical activity against erlotinib and gefitinib resistant mutations. With this approach, Boehringer Ingelheim is among the few companies advancing molecules of their pipeline within the area of personalised medicine.
The DxS EGFR companion diagnostic is a real-time PCR assay, designed to detect the most common mutations in the EGFR gene. The diagnostic has been developed and manufactured at DxS? head office in Manchester, UK. and will be available later in the summer for Boehringer Ingelheim?s global, multi-centre Phase III clinical trial for BIBW 2992.
Commenting on this announcement, Dr Stephen Little, CEO of DxS says ?This is another great endorsement of our companion diagnostic assays for predicting patient response to targeted therapies. It is an exciting step forward for personalised medicine and DxS is pleased to be at the forefront of this revolution in cancer treatment?.
?As this year?s theme at ASCO highlights, it is very likely that personalised medicine will play an important role in selecting the most effective treatment for patients with cancer. We are convinced that the collaboration agreement with DxS can expedite our efforts in the field of personalised medicine. And both companies are excited to investigate how molecular diagnostics can support patient selection and help to maximise treatment outcome with our medication?, said Dr Manfred Haehl, Corporate Senior Vice President Medicine of Boehringer Ingelheim.
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 138 affiliates in 47 countries and 41,300 employees. Since it was founded in 1885, the independent, family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2008, Boehringer Ingelheim posted net sales of 11.6 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.
About DxS
DxS is a personalised medicine company providing molecular diagnostics to aid doctors and drug companies in selecting therapies for patients. Working in partnership with pharmaceutical companies to support the development and sales of targeted cancer therapies by providing biomarkers and companion diagnostics.
DxS has a continually expanding portfolio of cancer mutation products. The TheraScreen® range of CE-marked clinical diagnostic kits can identify genetic tumour mutations that affect how patients respond to cancer therapies, thus enabling doctors to provide the most beneficial treatment. DxS produce two clinical diagnostic kits, K-RAS and EGFR-29.
The TheraScreen: K-RAS Mutation kit is a companion diagnostic for Vectibix® (Amgen) and Erbitux® (Merck KGaA) for the treatment of colorectal cancer. DxS has an exclusive global distribution agreement with Roche Diagnostics for the distribution of the TheraScreen: K-RAS and TheraScreen: EGFR29 Mutation kits.
DxS? pioneering real-time PCR technology Scorpions® is highly regarded for its proven speed and sensitivity, and is combined with ARMS (allele specific PCR) to develop each unique DxS product. This class-leading technology is also available for licence to diagnostic companies, for research, or for other varied applications.
DxS is a private, venture capital-backed company operating from the heart of Manchester?s Technology Quarter in the UK.
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Boehringer Ingelheim and the World Stroke Organization announce partnership in the World Stroke Academy
Ingelheim/Germany, 27 May 2009 ? Boehringer Ingelheim announced today that it will become the founding sponsor of the World Stroke Academy, a novel training initiative for stroke professionals being developed by the World Stroke Organization (WSO). This latest educational initiative from the WSO will bring together an international group of stroke experts ? led by Professor Michael Brainin of the Danube University Krems, Austria ? to provide information about stroke and knowledge for health professionals and medical doctors in order to improve prevention, therapy and management of stroke.
Professor Bo Norrving, President of the WSO said: ?The World Stroke Academy is a project of the World Stroke Organization and aims at improving education on a global scale. It is a platform open to all stroke societies aiming at global effectiveness of fighting stroke and its physical and mental consequences.?
Dr. Manfred Haehl, Corporate Senior Vice President Medicine, Boehringer Ingelheim said: ?Boehringer Ingelheim is committed to patient care and we are proud to support initiatives that have potential to benefit all patients. Stroke is one of the biggest causes of death and severe disability worldwide, and a great many patients simply don?t have access to specialist care. We hope the World Stroke Academy will contribute to training a new generation of specialists who can help provide that care.?
The World Health Organization estimates that 5.7 million people in the world die each year from stroke.1 Among survivors, 40% experience moderate to severe disability and 10% require institutional care.2
The World Stroke Academy aims to provide a mixture of online and conventional activities to educate and help facilitate training of stroke professionals across all regions of the world. Key objectives of the initiative include:
- Promoting knowledge and education on stroke management on a global level according to the WSO mission statement
- Improving and standardising educational standards in primary and secondary stroke prevention, acute management and rehabilitation
- Leveraging guidelines to ensure best practice is implemented within all regions of the world
- Further developing the WSO as a leading global educator.
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 Editor
About the World Stroke Organization
The World Stroke Organization (WSO) was established in October 2006 from the merger of the International Stroke Society (ISS) and the World Stroke Federation (WSF), the two lead organisations representing stroke globally. The mission of WSO is to provide access to stroke care and to promote research and teaching in this area that will improve the care of stroke victims throughout the world.
Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world?s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and 41,300 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 2008, Boehringer Ingelheim posted net sales of 11.6 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 present new phase II clinical data on two lead oncology compounds at ASCO 2009
Ingelheim/Germany, 15 May 2009 - Boehringer Ingelheim will present new data on the company`s two lead oncology compounds, BIBW 2992* and BIBF 1120** at the 2009 Annual Meeting of the American Society of Clinical Oncology (ASCO), the company announced today. Two studies in the LUX-Lung clinical development programme for BIBW 2992 and a Phase II study of BIBF 1120 in ovarian cancer patients will be presented.
LUX Lung 2 interim results
Interim Phase II data from the LUX-Lung 2 study suggest BIBW 2992 has anti-tumour activity in advanced second-line non-small cell lung cancer (NSCLC) patients who have epidermal growth factor receptor (EGFR) mutations.1
"Lung cancer kills more people than any other cancer.3 The LUX-Lung 1 and 2 studies represent an opportunity to investigate BIBW 2992 across a range of different patient populations," said Dr Manfred Haehl, Corporate Senior Vice President Medicine at Boehringer Ingelheim. "The preliminary data from the LUX-Lung 2 study suggests that BIBW 2992 may have activity in the second-line setting among NSCLC patients with EGFR mutations, which is encouraging news."1 BIBW 2992 is an orally administered irreversible dual inhibitor of the epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) tyrosine kinases.4 It is the first irreversible EGFR-TKI (tyrosine kinase inhibitor) to reach Phase III for third/fourth-line NSCLC.5
In the emerging era of personalised cancer medicine, Boehringer Ingelheim is one of the first companies to prospectively identify appropriate patients for clinical trials based on biomarkers. As part of the LUX-Lung clinical development programme, Boehringer Ingelheim is evaluating BIBW 2992 in NSCLC patients who test positive for EGFR activating mutations.
"It is well documented that `activating` mutations that arise in the tyrosine kinase (TK) domain of the EGFR gene are associated with an increased sensitivity to first generation EGFR TKIs.6,7,8 The majority of patients who initially respond to EGFR TKIs such as gefitinib or erlotinib will eventually develop resistance, often through gaining another mutation, such as the so-called T790M resistance mutation,"9,10 said Dr Haehl.
Detailed Findings from LUX-Lung 2:1
To date, 409 NSCLC patients have been screened in the LUX-Lung 2 study and 104 patients with EGFR mutations have started treatment with BIBW 2992 once daily. Preliminary data will be presented at ASCO for the first 73 second line patients, all of whom had previously received one regimen of chemotherapy. 67 patients are evaluable for response.
Interim data show:1- 64% of patients (43/67) taking BIBW 2992 in the 2nd line setting experienced a partial response (75% among patients with deletion 19 and 66% in patients with L858R mutations)
- 31% (21/67) of patients taking BIBW 2992 in the 2nd line setting experienced stable disease
- Median progression-free survival (PFS) in 2nd line setting is 10.2 months
- The most common related adverse events were diarrhea and skin-related disorders in 86% and 89% of patients respectively [16% and 18% being grade 3 respectively]
- 37 patients had dose reduction and 4 patient discontinued treatment due to adverse events.
Findings from LUX Lung1
In addition, preliminary data on the demographic and blinded safety data from the ongoing Phase III study, the LUX-Lung 1 trial, will be presented at ASCO for the first time.11
The LUX-Lung 1 study addresses a critical need for treatment options for NSCLC patients after failure with a second-line or third-line reversible EGFR inhibitor (i.e. erlotinib or gefitinib). This study recently moved from Phase IIb into Phase III.2
"The LUX-Lung 1 study is important as it investigates BIBW 2992 in a group of patients for whom there are no other approved treatment options. These are patients who have already been through standard first-line or second-line chemotherapy and then received treatment with an EGFR TKI. The LUX-Lung 1 study will evaluate whether BIBW 2992 will extend the lives of these cancer patients."11 said Dr. Haehl.
First presentation of Phase II data for BIBF 1120 in ovarian cancer
Data from a Phase II study of BIBF 1120 in patients with ovarian cancer who responded to at least second-line chemotherapy will be presented at ASCO in Orlando. The study showed a potential delay in disease progression: with BIBF 1120 the median time to RECIST progression was 4.8, and 2.8 for placebo.2 BIBF 1120 is an oral compound that works by simultaneously inhibiting vascular endothelial growth factor receptors (VEGFRs), platelet-derived growth factor receptors (PDGFRs) and fibroblast growth factor receptors (FGFRs) - all factors which are crucially involved in the formation of blood vessels, a process known as angiogenesis.12,13
"There is a great need for more effective and well tolerated treatment options for women with ovarian cancer. We have a growing body of evidence that anti-angiogenic agents may represent an important treatment approach for this disease," commented Prof. Jonathan A Ledermann, MD, Professor of Medical Oncology & Director at the Cancer Research UK & UCL Cancer Trials Centre, University College London. "These data indicate BIBF 1120 may have a potential role in delaying disease progression in patients with ovarian cancer who had previously responded to chemotherapy."
Because angiogenesis plays a pivotal role in the growth of solid tumours,13 BIBF 1120 is currently being investigated in a number of cancer types including advanced NSCLC. The LUME-Lung Phase III clinical trial programme is investigating BIBF 1120 in combination with standard second-line chemotherapy treatments for patients with advanced NSCLC. Approximately 2,600 patients will be enrolled, making this one of the largest Phase III study programmes in this NSCLC patient population to date.
Notes to editors
About Lung Cancer
Lung cancer is the world`s most common cancer and kills more people than any other cancer.3,14 In 2008, approximately 1.52 million new cases of lung cancer were diagnosed worldwide, with 1.31 million people dying from the disease.14 In the United States, an estimated 161,840 deaths, accounting for 29 percent of all cancer deaths, occurred in 2008, according to the American Cancer Society (ACS).15
About Ovarian Cancer
According to the 2008 World Health Organization World Cancer Report, as of 2002, ovarian cancer was ranked as the 6th most common cancer in women. Additionally, approximately 204,000 new cases were diagnosed worldwide and 125,000 women died from the disease in 2002.14 The ACS estimates that about 21,650 new cases of ovarian cancer were diagnosed in the United States (U.S.) during 2008. Only forty-five percent of women with ovarian cancer are still alive at least five years after diagnosis in the U.S.16
About Boehringer Ingelheim in Oncology
Building on scientific expertise and excellence in the fields of pulmonary and cardiovascular medicine, metabolic disease, neurology, virology and immunology, Boehringer Ingelheim has embarked on a major research programme to develop innovative cancer drugs. Working in close collaboration with the international scientific community and a number of the world2E8s leading cancer centres, Boehringer Ingelheim is committed to discovering and developing novel cancer treatments. This commitment is underpinned by using advances in science to develop a range of targeted therapies in areas of medical need, including various solid tumours and haematological cancers.
The current focus of research includes compounds in three areas: angiogenesis inhibition, signal transduction inhibition and cell-cycle kinase inhibition. BIBW 2992 entered Phase IIb/III clinical development in NSCLC earlier in 2008 and was granted Fast Track designation for a third/fourth line treatment indication in NSCLC by the US Food & Drug Administration. In addition, the LUME-Lung Phase III clinical trial programme, which is investigating BIBF 1120 in combination with standard second-line chemotherapy treatments for patients with advanced NSCLC, is currently ongoing. In the area of cell-cycle kinase inhibition, Boehringer Ingelheim is developing inhibitors of polo-like kinase 1 (Plk1), a protein that is involved in the processes of cell division. These molecules are in the early stages of clinical 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 138 affiliates in 47 countries and 41,300 employees. Since it was founded in 1885, the independent, family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2008, Boehringer Ingelheim posted net sales of $11.6 billion euro (17 billion) while spending one-fifth of net sales in its largest business segment, Prescription Medicines, on research and development.
For U.S. journalists, please visit http://us.boehringer-ingelheim.com
Note:
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.
* (planned trade name Tovok™)
** (planned trade name Vargatef™)
References:
1 Shih J-Y et al. "A Phase II study of BIBW 2992, a novel irreversible dual EGFR and HER2 tyrosine kinase inhibitor (TKI), in patients with adenocarcinoma of the lung and activating EGFR mutations after failure of 1 line of chemotherapy (LUX-Lung 2)." Poster Discussion Presentation. 1 June 2009, Session Time: 8:00AM - 12:00PM. #8013
2 Ledermann, J. A. "A randomised Phase II placebo-controlled trial using maintenance therapy to evaluate the vascular targeting agent BIBF 1120 followign treatment of relapsed ovarian cancer (OC)." Oral presentation, Clinical Science Symposium. Monday, 1 June 2009, Session Time 9:45AM - 11:15AM. # 5501
3 "Ask the Expert Online Q&A: Are the number of cancer cases increasing or decreasing in the world?" 1 April 2008. World Health Organization. 5 May 2009. http://www.who.int/features/qa/15/en/print.html.
4 Li D et al. "BIBW2992, an irreversible EGFR/HER2 inhibitor highlyeffective in preclinical lung cancer models." Oncogene 2008;27:4702-4711
5 Boehringer Ingelheim Pharmaceuticals. "BIBW 2992 and BSC Versus Placebo and BSC in Non-Small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib (LUX-LUNG 1)" 23 April 2009. ClinicalTrials.gov. 5 May 2009.
http://clinicaltrials.gov/ct2/show/NCT00656136?term=BIBW+2992+and+Phase+III&rank=1.
6 Lynch, T. J. et al. "Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib." N. Engl. J. Med. 350, 2129-2139 (2004). Available at: http://content.nejm.org/cgi/reprint/350/21/2129.pdf. Accessed on 5 May 2009.
7 Paez, J. G. et al. "EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy." Science 304, 1497-1500 (2004). Available at: http://www.sciencemag.org/cgi/reprint/1099314v1.pdf?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=egfr&searchid=1&FIRSTINDEX=0&fdate=//&tdate=//&resourcetype=HWCIT. Accessed on 5 May 2009.
8 Pao, W. et al. "EGF receptor gene mutations are common in lung cancers from `never smokers` and are associated with sensitivity of tumors to gefitinib and erlotinib." Proc. Natl Acad. Sci. USA 101, 13306-13311 (2004). Available at: www.pnas.org/cgi/doi/10.1073/pnas.0405220101. Accessed on 5 May 2009.
9 Riely G. J. et al. "Clinical Course of Patients with Non -Small Cell Lung Cancer and Epidermal Growth Factor Receptor Exon19 and Exon 21 Mutations Treated with Gefitinib or Erlotinib." Clin. Cancer Res, 12, 839-844(2006). Available at: http://clincancerres.aacrjournals.org/cgi/reprint/12/3/839. Accessed on 5 May 2009.
10 Balak, M. N. et al. "Novel D761Y and common secondary T790M mutations in epidermal growth factor receptor-mutant lung adenocarcinomas with acquired resistance to kinase inhibitors." Clin. Cancer Res. 12, 6494-6500 (2006). Available at: http://clincancerres.aacrjournals.org/cgi/reprint/12/21/6494. Accessed on 5 May 2009.
11 Yang C-H et al. "Phase IIb/III double-blind randomized trial of BIBW 2992, an irreversible, dual inhibitor of EGFR and HER2 plus best supportive care (BSC) versus placebo plus BSC in patients with NSCLC failing 1-2 lines of chemotherapy (CT) and erlotinib or gefitinib (LUX-Lung1): a preliminary report. General Poster Session: Lung Cancer - Metastatic." Saturday 30 May 2009, Session Time: 2:00PM - 6:00PM. # 8062
12 Hilberg F. et al. "BIBF1120 a novel, small molecule triple angiokinase inhibitor: profiling as a clinical candidate for cancer therapy." European Journal of Cancer Supplements. 2004; 2:50.
13 Lewis J. Kleinsmith. "Understanding Cancer and Related Topics: Understanding Angiogenesis." Rockville: National Cancer Institute, 2006. Available at: http://cancer.gov/cancertopics/understandingcancer. Accessed on 5 May 2009.
14 P Boyle and B Levin (eds). "World Cancer Report 2008.", World Health Organization: International Agency for Research on Cancer. Lyon: 2008.
15 American Cancer Society. "Cancer Facts and Figures 2008." Atlanta: 2008. Available at: http://www.cancer.org/downloads/STT/2008CAFFfinalsecured.pdf. Accessed on 5 May 2009.
16 American Cancer Society. "Ovarian Cancer Detailed Guide." Atlanta: 2008. Available at: http://documents.cancer.org/114.00/114.00.pdf. Accessed on 5 May 2009.
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Boehringer Ingelheim and DeveloGen AG announce agreement in the field of diabetes, obesity and the metabolic syndrome
Goettingen and Ingelheim/Germany, 13 May 2009 - Boehringer Ingelheim and DeveloGen AG, today announced the signing of an asset sale and purchase and collaboration agreement in the field of diabetes, obesity, the metabolic syndrome and other insulin resistance associated disorders.
Under the terms of the agreement, DeveloGen will receive an upfront payment of ? 7 million, but has the opportunity to earn additional deferred payments such as potential milestone payments of up to ?237 million as well as tiered sales performance payments. The milestone payments will be due upon achievement of certain preclinical and clinical as well as regulatory and commercial events. Further milestone payments may be achieved with additional compounds and/or additional approved indications. DeveloGen will also receive research payments to support further discovery and development efforts.
Dr. Cord Dohrmann, Chief Executive Officer of DeveloGen commented: "Using a unique functional genomics approach, DeveloGen has identified and validated a relevant target directly addressing insulin resistance. Initial compounds, that have been discovered and optimized by DeveloGen, have proven to be effective in preclinical models of type 2 diabetes and obesity, improving carbohydrate and lipid metabolism while reducing weight gain and preserving beta cell function." Dr. Dohrmann continued: "Boehringer Ingelheim has built an impressive late stage pipeline of innovative metabolic disease programs. We are convinced that the leadership by Boehringer Ingelheim will provide optimal support for further development of this program."
Prof. Andreas Barner, Chairman of the Board of Managing Directors and Head of Corporate Board Division Pharma Research, Development and Medicine, added, "The steadily increasing prevalence of diabetes can only be addressed by new and improved therapies involving novel mechanisms with improved safety and efficacy. Boehringer Ingelheim is looking forward to collaborate with DeveloGen on this program which will complement and expand Boehringer Ingelheim?s current diabetes pipeline beyond our two late stage development compounds targeting DPP-4 and SGLT-2. We will continue to use our expertise in metabolic research, drug development and commercialization to make advances for patients suffering from these serious lifelong diseases."
About Diabetes
Diabetes is a global epidemic with devastating human, social and economic consequences. In 2007 it was estimated that 246 million people worldwide have diabetes, representing roughly 6% of the adult population. The number is expected to reach 380 million by 2025, representing over 7% of the adult population. Diabetes/obesity is the fastest growing disease in the U.S., afflicting one in four Americans and accounting for well over 30% of the Medicare budget. Global pharmaceutical sales for diabetes drugs has grown over the last ten years to over US$ 17 billion in 2005. Overall, anti-diabetic drugs sales are expected to grow to over US$ 22 billion by 2012.
About DeveloGen
DeveloGen AG is a biopharmaceutical company engaged in the discovery and development of novel therapeutics for the treatment of metabolic and endocrine diseases. The Company has a highly innovative and deep preclinical discovery pipeline addressing the key drivers in the development of diabetes and obesity such as insulin resistance and loss of insulin-producing beta cells. This pipeline includes two programs at advanced stages of lead optimization, a small molecule inhibitor program based on a novel and proprietary target to address insulin resistance (type 2 diabetes) and a growth factor targeting beta-cell regeneration (type 1 and type 2 diabetes). In addition, the Company is developing DG3173 (Somatoprim), a potentially best-in-class somatostatin analogue for the treatment of acromegaly, carcinoid tumors and diabetic retinopathy, which has recently completed a Phase 1 clinical trial. DeveloGen is based in Goettingen, Germany.
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 138 affiliates in 47 countries and 41,300 employees. Since it was founded in 1885, the independent, family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2008, Boehringer Ingelheim posted net sales of 11.6 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.
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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