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Prof. G.W.Canonica's lecture
2011, November 14th, Launch of Ismigen in Georgia
New launch of Lallemand Pharma’s bacterial lysates ISMIGEN® in Georgia, where chronic respiratory diseases are largely underestimated We are pleased to announce the launch in Georgia of our Polyvalent Mechanical Bacterial Lysates (PMBL), by our partner GM Pharmaceuticals, the only GMP pharma accredited company in Georgia. The PMBL will be marketed in Georgia as a registered drug under brand name Ismigen®. For the official launch of Ismigen in Georgia, Professor Clive Page, a renowned lung expert from King’s College London (UK), gave a lecture about the benefits of bacterial lysates in the prevention of respiratory infections, such as Chronic obstructive pulmonary disease (COPD) or bronchitis, to an audience of 70 lung specialists in Tbilisi on October 18th. A recent survey (Chkhaidze, 2009) indicates that COPD prevalence was largely under-estimated in Georgia and that 365 per 100.000 people were affected by chronic respiratory diseases, almost five times more than the official statistics. WHO estimates that 210 million people suffer from COPD in the world, and predicts that it will become the third leading cause of mortality worldwide by 2030 (source: WHO, 2007).
2011, June 1st.PMBL SHOW UNIQUE ACTION ON BOTH ADAPTIVE AND INNATE IMMUNE RESPONSE OFFERING OPTIMAL PROTECTION AGAINST RESPIRATORY INFECTIONSJune 1st; Lugano, Switzerland… During the South American Congress of Allergy and Asthma, that took place in Cordoba, Argentina, from April 28th to 30th, Pr. Melioli, from University of Genoa (Italy), presented the initial results of a double blind placebo controlled study conducted with Polyvalent Mechanical Bacterial Lysates (PMBL)*[1] in COPD patients, and discussed the immunological significance of these results. While the new study corroborates previous clinical studies in COPD (Cazzola, 2006 & 2009), it also brings new evidence of PMBL immunogenic potential in vivo, and their power to stimulate both the innate and specific immune response. This presentation was part of a symposium jointly organized by Lallemand Pharma International and Merck/Merck Serono Latin America, which attracted around 300 physicians.
Professor Melioli summarizes the state of the art about PMBL mode of action: “PMBL is able to induce the secretion of specific antibodies directed against the surface antigens of pathogens in patients’ blood and salivary fluid: these antibodies allow the opsonization of pathogens, which will then trigger their capture and destruction by granulocytes. Seven out of ten patients treated with PMBL had the ability to produce these antibodies, and clinical outcomes were linked to this ability. This is probably the first time that the presence of antibodies directed against the surface of bacteria has been demonstrated in patients after administration of bacterial lysates. Finally, PMBL are able to induce: a) maturation of dendritic cells, both circulating and plasmacytoids, This is of importance as circulating dendritic cells are able to express the surface receptors TLR2 and TLR4 involved in bacterial antigens recognition, while plasmacytoids dendritic cells are able to express other TLR involved in viral antigens recognition. b) enlargement of the repertoire of early naïve B cells that can then be converted into plasma cells through further stimuli. C) the capacity to ‘consume’ memory B cells in order to induce the differentiation of these cells into plasma cells. D) increase of T helper population. This population is involved in the secretion of specific cytokines allowing to trigger the differentiation of B lymphocytes into plasma cells which in turn secrete specific immunoglobulins. E) the increase of all the Natural Killer cells population. These cells are involved in the suppression of cancer and virus infected cells.
Clearly, all this demonstrates that PMBL are able to switch on and off extremely precise mechanisms of the immune response. This means that the administration of PMBL results in a cascade of events all directed to produce an antigenic immune response, which is very relevant in terms of modes of action and clinical outcome.”
Thanks to these original results, it can be assessed that PMBL are able to act on each step of the whole immune cascade, triggering both the innate and adaptive immune response to allow dual action on prevention of viral and bacterial respiratory tract infections
The symposium, titled: Respiratory infections, immunity and polyvalent mechanical bacterial lysates (PMBL), was introduced by Pr Anahi Yanez, Director of the Institute of Allergy and Respiratory diseases in Buenos Aires and Co-President of the Congress, who presented the ‘Clinical spectrum of Respiratory infections’. Pr Melioli, Director of the Department of Experimental and Laboratory Medicine at the Institute Giannina Gaslini in Genoa in Italy discussed ‘The potentiation of the innate and adaptive immunity with PMBL in recurrent and/or severe respiratory infections.’ Finally, Pr Sanchez Borges, Chief of the Department of Allergy and Immunology at the Medical center Trinidad de Ensenanza in Caracas brought the clinician’s point of view with a review of PMBL clinical results. More information about these presentations is available on demand.
The South American Congress of Allergy and Asthma 2011 takes place in Cordoba, Argentina, It is a multidisciplinary forum for allergists, pulmonologists, ENTs, dermatologists, clinicians, pediatricians and primary care physicians to discuss the present and latest advances in allergy and immunology diseases with high impact in South America. More information on: http://www.alergiayasma2011.org/en/
May 2nd 2011 : New COPD clinical study presented at the IV World Asthma & COPD Forum in Paris by Pr. BraidoResults of the new PMBL clinical study in COPD patients will be presented on Monday 2nd May during the IV World Asthma & COPD Forum in Paris, as part of a symposium dedicated to Bacterial Lysates and Chaired by Pr. Braido from University of Genoa (Italy).
Content of the Satellite Symposium sponsored by Lallemand Pharma
(Monday, May 2, 17.00 – 18.00, Paris Marriott Rive Gauche Hotel & Conference Centre, LA SEINE Meeting Room B)
Guido Ferlazzo, University of Messina, Italy:
Immune system cellular cross-talk in the presence of bacterial components
Fulvio Braido, University of Genoa:
Polyvalent mechanical bacterial lysate treatment in COPD: New immunological evidence
The IV World Asthma & COPD Forum is organized by the World Immunopathology Organization and takes place in Paris April 30-May 3. This Congress is mainly dedicated to allergologists, pulmonologists, immunologists, paediatricians, dermatologists, and critical care physicians. The lectures and discussions will cover every aspect of basic research in the field of asthma, COPD and respiratory allergy, and will also bring forth the latest innovations in treatment. More info on http://wipocis.org
May 2nd, 2011The World Immunopathology Organization (WIPO) organizes the World Asthma & COPD Day.
The prevalence of asthma and COPD around the world, their severity and mortality rates allow us to consider them as the most socially significant diseases of today and the nearest future.
April 29th, 2011 : COPD clinical study unveiled at the South American Congress of Allergy and Asthma by Pr. Melioli.A new double blind placebo controlled study has been conducted with PMBL (Ismigen/Immubron®), in order to analyse their immunological effects in vivo, in COPD patients. Results of this study corroborate previous clinical studies in COPD (Cazzola, 2006 & 2009) and bring new evidence of PMBL immunogenic potential in vivo, stimulating both the innate and specific immune response.
This new study will be presented for the first time by Pr. Melioli, from University of Genoa, on April 29th in Cordoba (Argentina) during the South American Congress of Allergy and Asthma 2011. This presentation will be part of a symposium jointly organised with Merck, our distributor in Latin american countries , and titled: Respiratory infections, immunity and polyvalent mechanical bacterial lysates (PMBL).
The clinical study will be introduced by Pr Anahi Yanez, Director of the Institute of Allergy and Respiratory diseases in Buenos Aires and co-president of the Congress. Pr Sanchez Borges, Chief of the department of Allergy and Immunology at the Medical center Trinidad de Ensenanza in Caracas, will then present a review of PMBL clinical results.
Professor Melioli is Director of the Department of Experimental and Laboratory Medicine at the Institute Giannina Gaslini in Genoa in Italy. He is also Professor of Biotech Application in Diagnosis, Clinical Pathology (School of Pediatrics) and Laboratory Management (School of Clinical Pathology) at the University of Genoa. He supervised the clinical study.
The South American Congress of Allergy and Asthma 2011 takes place in Cordoba, Argentina, from April 28th to 30th. It is a multidisciplinary forum for allergists, pulmonologists, ENTs, dermatologists, clinicians, pediatricians and primary care physicians to discuss the present and latest advances in allergy and immunology diseases with high impact in South America. More information on http://www.alergiayasma2011.org/en/
January 17th, 2011
Ismigen is Launched in Sri Lanka by Lifeline Pharmaceuticals We are pleased to announce that our Polyvalent Mechanical Bacterial Lysate ISMIGEN® is now marketed in Sri Lanka by Colombo-based Pharmaceutical company Lifeline Pharmaceuticals. To support the launch of Ismigen, Lallemand Pharma and Lifeline Pharmaceuticals have organized a medical seminar in Colombo , dedicated to specialists of respiratory medicine: pneumologists, ENT, chest physicians... Professor Mario Cazzola, Chief of the Respiratory Clinical Pharmacology Unit at the University of Rome ‘Tor Vergata’ and a recognised expert in respiratory medicine, gave a presentation about the rationale of using Polyvalent Mechanical Bacterial Lysates in the prophylaxis of respiratory infections. According to a recent report by the World Lung Foundation, acute respiratory infections (pneumonia, influenza, respiratory syncytial virus ..), described as a forgotten pandemic, are responsible for over 4 million deaths each year. They represent the third largest cause of mortality in the world and the leading cause of illness and death in children (source: World Lung Foundation, November 2010). ISMIGEN® has also proven its efficacy in the prophylaxis of exacerbations in chronic obstructive pulmonary disease (COPD) (M. Cazzola, 2006; 2009), another major public health concern around the world.
January 7th, 2011LALLEMAND PHARMA AND GLAXOSMITHKLINE PARTNER TO LAUNCH ISMIGEN IN POLAND
Lallemand Pharma Europe and GlaxoSmithKline (GSK) announced today the launch of its Polyvalent Mechanical Bacterial Lysate (PMBL) ISMIGEN® in Poland. For the occasion a medical symposium organized by GSK and dedicated to pneumologists and allergologists was hold today in Warsaw. ISMIGEN® is produced by Lallemand and recommended in the prevention of acute, sub-acute, recurrent or chronic infections of the upper and lower airways and the bronchopulmonary tree. According to the World Health Organization, respiratory diseases represent today a soaring public health concern around the world.
Warsaw’s symposium was the opportunity to discuss up-to-date data and applications of ISMIGEN® with leading lung experts. Professor M. Cazzola, Chief of the Respiratory Clinical Pharmacology Unit at the University of Rome ‘Tor Vergata’, gave a lecture titled: ‘Bacterial extracts for the prevention of acute exacerbations in chronic obstructive pulmonary disease (COPD)’. Professor Cazzola devoted his research to pharmacology of airway diseases, and he was the co-chairman of the European Respiratory Society/American Thoracic Society Task Force "Outcomes for COPD pharmacological trials: from lung function to biomarkers". He was involved in several clinical trials with ISMIGEN.
The primary therapeutic areas for Polyvalent Mechanical Bacterial Lysates (PMBL) are infections of the upper and lower respiratory tract. PMBL have already proven effective in the prophylaxis of exacerbations in COPD (M. Cazzola, 2006; 2009), a major public health concern. According to the latest World Health Organization (WHO) estimates, 210 million people suffer from COPD in the world, and 3 million people died of COPD in 2005. WHO predicts that COPD will become the third leading cause of mortality worldwide by 2030 (source: WHO, 2007).
November,19, 2010The Journal of the World Allergy Organization recently published a review of literature about the immunomodulatory effects and clinical efficacy of bacterial lysates, concluding to a “ positive trend in terms of overall reduction of infection rates and duration, beneficial effect on symptoms, reduction in antibiotics use and possibility to improve the patient’s quality of life in several diseases.”
More specifically, the authors acknowledged the superior immunomodulatory power of Polyvalent Mechanical Bacterial Lysates (Ismigen®; Immubron®, Respibron®; PIR-05®; Provax® - Lallemand Pharma), as compared to Chemical Lysates, both in vitro and in vivo. This is linked to the fact that the mechanical lysis involved in their production process preserves the structure of the bacterial antigen, while chemical lysis leads to ‘lower immunogenicity of the antigens’.
The scientific review, written by Prof Canonica and col. from the Allergy Respiratory Disease Department, at University of Genoa in Italy, and Prof. Melioli from Giannina Gaslini Institute in Genoa is available on-line through the Journal of the World Allergy Organization website
October 1st, 2010Lallemand Pharma International will be present at CpHI Worldwide, the world's leading event for the global pharmaceuticals ingredients industry, which takes place in Paris Villepinte, October 5-7, 2010. Meet us in Hall 6, Booth 6M74.
December 21, 2009Lallemand Pharma International and Laboratorios Dispert S.A. have signed a distribution agreement for Ismigen in Uruguay.
Based in Montevideo, Uruguay, Laboratorios Dispert is the pharmaceutical company that already distributes Lallemand Pharma’s Immubron in Uruguay.
November 19, 2009Lallemand Pharma International has signed a distribution agreement with Hygis S.A. for the distribution of its immunostimulant PMBL in Switzerland. The Company VP, Mr AMMANN has an extensive experience and in-depth understanding of bacterial lysates applications, making Hygis a partner of choice for the distribution of Ismigen in Switzerland.
Hygis SA distributes and markets pharmaceutical and healthcare products in Switzerland. The company is based in Bussy-Chardonney
August 20, 2009Lallemand Pharma International has signed an agreement with Innofarma for the distribution of Ismigen in Turkey.
Based in Istanbul, Innofarma is committed to bringing the highest quality prevention products and services to the healthcare community across Turkey and the region. The company innovative products for preventive medicine include personalized micronutrient modules.
More info on: www.innofarma.com
June 5, 2009Read the news about Ismigen launch in Argentina in Scrip World Pharmaceutical News (by Asher Mullard)
June 15, 2009Professor Cazzola to present Ismigen’s latest clinical study at the Annual ERS Congress in Vienna, 15th September 2009
The results of Ismigen latest clinical trial in COPD patients (Cazzola, 2009), will be presented at the 18th Annual European Respiratory Society Congress (ERS), to take place in Vienna, Austria, September 12-16, 2009. The ERS Congress is the world’s largest congress of pulmonary medicine, gathering each year around 17 000 participants from around the world.
Ismigen clinical study will be presented by Professor Mario Cazzola, from University of Rome, co-Chairman of the European Respiratory Society/American Thoracic Society Task Force, on Tuesday, 15th September, at 14.45, Room A3. For more information about the ERS Congress, visit www.ersnet.org
May 14, 2009Results of a pilot clinical study published ahead of time in Therapeutic Advances in Respiratory Disease Online, confirm the potential of Ismigen® in the management of chronic obstructive pulmonary disease (COPD) .
The new study, directed by Professor Mario Cazzola (University of Rome, Italy) over a nine month period on 63 patients in total, confirms previous trials.
In this study, the administration of Ismigen in addition to regular treatment (salmeterol/fluticasone) reduced the rate of exacerbations per patient per year by 20% (0,54 vs. 0,67 in control group). The immunostimulant drug also reduced the number of exacerbations that needed treatment with oral corticosteroids, as well as the total number of hospitalizations.
(Mario Cazzola, Paolo Noschese and Felice Di Perna : “Value of adding a polyvalent mechanical bacterial lysate to therapy of COPD patients under regular treatment with salmeterol/fluticasone.” Ther Adv Respir Dis.2009; Pubished online May, 14, 2009, DOI: 10.1177/1753465808104677)
May 7, 2009Lallemand Pharma has signed a distribution agreement for Polyvalent Mechanical Bacterial Lysate in Russia with Makiz Pharma, a branch of German Healthcare company Stada Arzneimittel AG. The product has now entered drug registration process under trade name Respibron.
More about Stada: http://www.stada.de/english/home.asp
May 6, 2009
Lallemand Pharma International will be present at Vitafoods in Geneva, Switzerland. This international trade show will be the occasion to meet up with some of our partners and customers. More information about Vitafoods International on: http://www.vitafoods.eu.com/
April 30, 2009
Lallemand Pharma International has concluded an agreement with Kalbe Farma for the distribution of Ismigen in Indonesia.
Kalbe Farma is one of the leading pharmaceuticals and health products companies in Indonesia and is recognized as the largest regional pharmaceutical company in Southeast Asia. More information on http://www.kalbe.co.id/
April 20, 2009Following the registration of Polyvalent Bacterial Mechanical Lysates last December, our partner Merck Serono has successfully launched Ismigen in Argentina.
The launch was accompanied by a series of medical conferences chaired by Professor Giorgio Walter Canonica (Italy) and Professor Carlos E. Baena-Cagnani (Argentina), in Cordoba, Buenos Aires and Rosario, gathering over 500 physicians.
Merck Serono is the division for innovative small molecules and biopharmaceuticals of Merck KGaA . The company has a strong and growing presence on the Argentinean pharmaceutical market with a range of prescription drugs through Merck Química Argentina. More information on: http://www.merck.com.ar/en/index.html
April 2, 2009Ismigen is now registered in Peru and will be launched by our partner Merck Serono within the coming months.
Merck Serono is the division for innovative small molecules and biopharmaceuticals of Pharmaceutical and Chemical company Merck KGaA .The company is present in Peru since 1962 through Merck Peruana S.A. More information on http://www.merck.com.pe/en/index.html
March 26-29, 2009
Lallemand Pharma International takes part in the First Middle East-Asia Allergy Asthma Immunology Congress in Dubai, UAE (MEAAAIC 2009).
On Wednesday, 27th March, Professor G. Walter Canonica, President of the World Allergy Organization gives a lecture about the effects and potential of Polyvalent Bacterial Mechanical Lysates, titled: "May we strengthen the human natural defenses with Bacterial Lysate?"
A video of his presentation will be posted shortly on this website.
For more information about the Congress: http://www.meaaaic.com/index.html
October 10, 2008Lallemand Pharma International has signed an agreement with Healol Pharmaceuticals for the distribution of Ismigen in Malaysia, Cambodia, Thailand and Vietnam.
Healol Pharmaceuticals distributes and markets pharmaceutical products in Malaysia, Cambodia, Lao PDR, Myanmar, Thailand and Vietnam. More information on http://www.healol.com/
December 4, 2008Lallemand Pharma International has signed a distribution agreement with APC Pharmaceuticals & Chemical for Respibron in Vietnam. The drug has now entered registration process.
Headquartered in Hong Kong, with key offices in China, India, Vietnam, the United Kingdom, Hungary and America, the APC Group is specialised in pharmaceuticals and chemicals, food and beverages, nutritional supplements and technology services. More information on http://www.apcgroup.com
November 5-8, 2008Lallemand Pharma International sponsors the XIX World Congress of Asthma in Monte Carlo, Monaco, organised by the International Association of Asthmalogy and chaired by Prof. Carlos E. Baena-Cagnani (Argentina), and Prof. G. Walter Canonica (Italy).
Program and registration: http://www.aim-internationalgroup.com/2008/wca/index.html
October 4-8, 2008Lallemand Pharma International is present at the 17th Annual Congress of the European Respiratory Society in Berlin, Germany. Program and registration: http://dev.ersnet.org/412-welcome-address.htm
September 30-October 2, 2008Lallemand Pharma International exhibits at CPhI Worldwide, the International Congress of Pharmaceutical Ingredients, in Frankfurt (Germany). Meet us on booth 42J40. Registration: www.cphi.com
September 15, 2008Greek pharmaceutical company Rafarm has completed the registration of Polyvalent Mechanical Bacterial Lysate and will launch the drug on the Greek market under trade name Pir05 by mid-2009.
Established in Athens in 1974, Rafarm is today among Greece top ten pharma companies . More information on http://www.rafarm.gr
September 15, 2008Ismigen is launched in India by Lupin Limited, one of India’s top ten pharmaceutical companies. Headquartered in Mumbai, Lupin Ltd positioned itself as an innovation led transnational pharmaceutical company. Lupin develops and markets a wide range of quality, affordable generic and branded formulations and APIs in multiple markets across the world, with a strong presence in the US. Today, it has a significant presence in Cephalosporins, Cardiovasculars (prils and statins), Diabetology, Asthma and NSAIDs therapy segments.
To support the launch of Ismigen®, Pr. Mario Cazzola, Associate Professor of Respiratory Medicine at the University of Rome, and Dr Frédéric Durmont, General Manager for Lallemand Pharma International will give lectures about Polyvalent Mechanical Bacterial Lysates and their applications during a promotional tour in India aimed at the pharmaceutical/medical community, early December.
September 5, 2008Lallemand Pharma has signed a distribution agreement with Zuoz Pharma S.A., a leading Venezuelan pharmaceutical company based in Caracas, for the distribution of Ismigen® in Venezuela.
More info about our partner: www.zuozpharma.com
August 20, 2008
Lallemand Pharma and Mili Healthcare Ltd. have signed a distribution agreement for Respibron in Ukraine.
More information: http://www.mili.com.ua/