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Increased use of NT-proBNP could help curb India’s heart disease toll

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International Consensus Statement calls for routine screening for at-risk patients

The biomarker, NT-proBNP should be widely used in
both primary care, as well as the emergency department, to more accurately diagnose patients with heart failure, claims Dr Antoni Bayes-Genis, a renowned cardiologist from Barcelona, Spain. Indian cardiologists will hear first hand from Dr Bayes-Genis, who is also one of the authors of the International Consensus Statement on the use of NT-proBNP in the management of heart failure – an important issue given India will have the highest number of heart failure patients in the world by 2015.

The international panel of experts, including Dr. Bayes-Genis, Director of Heart Failure and Heart Transplant Unit in Hospital de la Santa Creu i Sant Pau. Barcelona, recently released a set of recommendations on the use of NT-proBNP. These recommendations, which are being discussed in India by Dr. Bayes-Genis, were published in the American Journal of Cardiology. The panel concluded that NT-proBNP holds great promise as a routine screening tool in high risk populations, as well as a useful screening tool in the general population for detection of cardiac abnormalities and the prediction of future cardiovascular events, such as heart failure.

“By routinely testing people at-risk of developing heart disease for levels of NT-proBNP, doctors are able to diagnose the condition earlier and more accurately, which can have a significant impact on the long term health outcomes of patients. It enables the detection of even early stages of heart failure, a time in the disease process where there are generally no obvious symptoms”, said Dr. Bayes-Genis.

NT-proBNP is an inactive protein with a long half-life, thus it is more stable,, and remains in the blood stream longer than other markers., This makes NT-proBNP a more sensitive test for use in the early detection and management of congestive heart failure.

Cardiovascular disease, including heart failure, is still the single most common cause of death worldwide. Unlike many conditions, heart failure is expected to continue to rise, due to ageing populations, the adoption of increasingly Westernised lifestyles and increased survival after other cardiovascular events. The incidence of heart failure in India is growing at a rate of 1.57million cases each year.

“Indians are more susceptible to heart failure, due to genetic pre-disposition as well as changes in dietary habits and lack of physical exercise. The NT-proBNP test can assist in the early diagnosis of heart failure which could reduce the incidence in the country,” said Dr Bhuwnesh Agrawal, Managing Director and Chairman of Roche Diagnostics, India.

As heart failure is a degenerative condition, it is not reversible and therefore an early and accurate diagnosis is crucial to ensure positive healthcare outcomes for patients. However, the condition is difficult to diagnose as early symptoms are non-specific and similar to those observed in many pulmonary disorders. As many as 50% of patients referred to cardiologists by general practitioners are initially misdiagnosed.

“The understanding of heart failure is still relatively low both among the public and healthcare professionals,” said Dr Bayes-Genis. “Yet early and accurate diagnosis can significantly impact treatment outcomes, and could moderate or even halt disease progression. Therefore it is important to fully utilise NT-proBNP and incorporate it into routine screening for at-risk patients. As NT-proBNP can detect even mild and moderate stages of the disease, it has been proven to be the most reliable and accurate marker to diagnose and assess a person’s risk of heart failure.”

NT-proBNP was approved by the US Food and Drug Administration (FDA) as an objective marker for the diagnosis and prognosis of heart failure as well as the risk assessment in patients with acute coronary syndrome. It also offers strong prognostic value to help assess the increased risk of cardiovascular events and mortality in patients with stable coronary artery disease.

In addition to its diagnostic and prognostic capabilities, NT-proBNP is being evaluated to guide treatment, to ensure patients receive the appropriate form and level of treatment, reducing cardiovascular event and ultimately improving patient management.

The potential benefit of regular NT-proBNP screening is particularly significant for at-risk population groups. High-risk patient groups include people suffering from diabetes, high cholesterol, high blood pressure, known coronary artery disease, or those aged 60 years and older among others.

“Regular screening of at-risk patients’ NT-proBNP levels can not only help save lives, but will also significantly reduce the patient’s cost burden. Medical and lifestyle interventions can be very effective treatment options for mild- to moderate heart failure. However, it is crucial that they are started early as the damage done to the heart in the severe stages of the disease is irreversible and ultimately fatal,” concluded Dr Bayes-Genis.

References for the article:

  1. Januzzi, JL. Comments from the International NT-proBNP Consensus Panel. Presented at: proCardio Symposium, Baveno, Italy. 2008.
  2. Mair, J. et al. The impact of cardiac natriuretic peptide determination on the diagnosis and management of heart failure. Clinical Chemistry & Laboratory Medicine 2001; 39: 571-588.
  3. Ordonez-Llanos, J. NT-proBNP: Analutical Considerations. In: NT-proBNP as a biomarker in cardiovascular diseases. Eds: Bayes-Genis, A. and Januzzi, JL. Thomson Reuters, 2008.
  4. Elin, RJ. et al. Laboratory and clinical aspects of B-type natriuretic peptides. Archives of Pathology and Laboratory Medicine 2004; 128: 697-699.
  5. Pemberton, CJ. et al. Deconvolution analysis of cardiac natriuetic peptides during acute volume overload. Hypertension 2000; 36: 355-359.
  6. World Health Organisation. The Atlas of Heart Disease and Stroke. 2004. Accessed on 3 October 2008 at: http://www.who.int/cardiovascular_diseases/resources/atlas/en/
  7. Joint scientific symposium of ICMR and university of Minesota
  8. National Heart, Lung, and Blood Institute. National Institutes of Health Data Fact Sheet: Congestive Heart Failure. September 1996.
  9. Roche Diagnostics. Data on File 2002.
  10. Roche Diagnostics. Elecsys proBNP – A novel approach for the management of heart failure.
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    Mumbai High Court Order Against Firms Selling Counterfeits of Piramal Healthcare’s Esgipyrin

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    Piramal Healthcare Ltd. obtained a common ex-parte ad-interim order from the Mumbai High Court on Thursday, April 9, 2009 restraining four companies from using trademarks similar to its product Esgipyrin. Piramal Healthcare is a registered proprietor of the mark ‘Esgipyrin’ and the company has been using the trademark since 1974.

    The four companies that have been restrained via this order are:

    • Endolabs Healthcare Pvt. Ltd., for their trademark Easipyrin
    • Endolabs Lifescience, for their trademark Elgipyrin
    • Spachem Laboratories Pvt. Ltd., for their trademark Zypyrine
    • Endolabs Ltd., for their trademark Agepyrine

    The order states that the companies have introduced the infringing products for the same ailment as countered by Piramal’s Esgipyrin and that it has been prima facie seen that the product is deceptively similar to that of the original product. The order further goes on to state that the companies have been engaged in a deliberate, dishonest and fraudulent act of counterfeiting and are passing off their products as that from Piramal Healthcare.

    A counterfeit drug is a medication or pharmaceutical product which is produced and sold with the intent to deceptively represent its origin, authenticity or effectiveness. The prevalence of counterfeit drugs appears constantly to be on the rise and these drugs are a major cause of morbidity, mortality, and loss of public confidence in medicines, the manufacturers and the overall health structures.

    Written by sreelakshmi

    15 April, 2009 at 5:38 pm

    Lupin Limited announces alliance with Natco Pharma

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    Alliance to commercialize generic equivalent of FOSRENOL® Tablets

    Lupin Ltd. and Natco announced today an alliance to jointly commercialize generic equivalents of Shire plc’s FOSRENOL® (lanthanum carbonate) tablets. Shire had filed a lawsuit against Natco for infringement of two patents for FOSRENOL® in response to an ANDA (Abbreviated New Drug Application) filing by Natco seeking US FDA approval to market and sell generic versions of Shire’s 500 mg, 750 mg, and 1 g of the FOSRENOL® tablets.

    Natco and Lupin believe that they are amongst one of the first-to-files which would likely lead to 180 days exclusivity. FOSRENOL® had sales of USD 108 Million as of December – 2008 (IMS).

    Commenting on the development, Mr. Nilesh Gupta, Group President and Executive Director to the Board, Lupin Limited said, “The alliance creates synergies that will enable portfolio expansion and contribute to consolidating our presence in the US markets. Lupin’s proven IP management capabilities, marketing reach and expertise coupled with Natco’s solid development and manufacturing abilities make for a great combination.”

    Mr. Rajeev Nannapaneni, Chief Operating Officer, Natco Pharma
    said, “Our alliance brings together a strong philosophy of working together to maximize opportunities in an increasingly competitive generic business. We are very happy to be associated with Lupin given their intellectual property management competencies and market strengths in the U.S.”


    Written by sreelakshmi

    10 April, 2009 at 6:37 am

    Cadila Pharmaceuticals commissioned a revolutionary research on Cardiac diseases targeted at Asymptomatic Healthy people

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    To launch a product that will considerably reduce the mortality due to sudden cardiac disorder, world wide

     

     

    Ahmedabad Based Pharma major Cadila Pharmaceuticals, one of the most reputed, Research based, Tech savvy pharmaceutical company in collaboration with McMaster University of Hamilton, Canada, has done a revolutionary research targeted to Asymptomatic Healthy people.

     

    Shri I. A. Modi, Chairman Cadila Pharmaceuticals said, “Cadila Pharmaceuticals has carved a niche for itself by being the front runner in introducing research driven innovative products for the benefit of mankind. Worldwide Cardio Vascular diseases are the leading cause of death and disability. Despite the best of diagnostic and therapeutic approaches, the challenge to decrease mortality and morbidity stands, because cardiac malfunction does not necessarily happen in patients with symptoms. Various therapies are currently available for secondary prophylaxis of cardiovascular diseases but none for primary prophylaxis.
    Studies show that Cardio Vascular death burden in developed countries were 5.3 million in the year 1990 whereas in developing countries it was 7-8 million. With the burgeoning epidemic of CVD, especially in low income countries, effective preventive strategies need to be urgently implemented. Cadila Pharma took it as a challenge to develop a therapy to address primary prophylaxis.”

    Mr J.P Parswani, President, Cadila Pharmaceuticals Limited commented, “A research team comprising of 57 cardiologists, led by Dr Salim Yusuf, Dean Cardiovascular Services worked for two years at McMaster University, Hamilton to make the hypothesis a success. The Research findings of the same would be revealed by Dr Salim Yusuf on March 30th 2009 at the American College of Cardiology, Orlando, in presence of more than 25,000 cardiologists all over the world. The research team has come up with a new therapy, a new approach, a comprehensive treatment that is going to set a benchmark in the treatment of Cardio Vascular diseases. The launch of this product marks Cadila’s contribution to science, academics and mankind. The Product is not just
    a substitute for lifestyle management, but it complements the same.The product would help to bring down the cardiovascular morbidity and mortality.”

    Dr Arun Maseeh, Vice President – Medical Services, is of the opinion, “Risk prevention in CVD can be approached from two levels: at the individual level and at population level. And two interventions are available to reduce risk factor levels, namely lifestyle modifications and drugs. Unfortunately lifestyle modifications related interventions have not largely been successful, as individuals were targeted rather that entire population with a few exceptions. It is therefore time to seriously consider drugs to halt the rapid advancement of CVD related mortality, especially in developing countries. The best results are obtained when multiple risk factors a re targeted at the same time. We have tested the hypothesis of Wald and Law, comprehensively in a multicentre, randomized, controlled, double-blind trial – The Indian Polycap Study (TIPS). The trials conducted in 53 hospitals all over India on 2053 healthy people. The Indian Coordinating Center was St. John’s Medical College, Bangalore, and the International Coordinating Center was Population Health Research Institute HHS and McMaster University, Hamilton, Canada.”

    For further information please contact:    

    medical@cadilapharma.co.in


    Lupin acquires majority stake in Multicare Pharmaceuticals Philippines, Inc

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    Strengthens its position in the ASEAN market

    Lupin Limited recently announced the acquisition of a 51 percent stake in Multicare Pharmaceuticals Philippines, Inc (MC) of Philippines. MC is a premium branded generics company with a strong position in the women’s health and child care segment. The company reported revenues of Php 272 Mill (approx. USD 6mn) for the year ending December 2008. The acquisition has been made with internal cash accruals by Lupin.

    This acquisition, which is Lupin’s sixth since 2008, marks the company’s entry into the USD 2.5 bn pharmaceuticals market in Philippines, currently dominated by multinational companies. Under the agreement, Mr. Romeo Sy, founder, MC will continue to lead the company as President.

    Commenting on the development, Dr. Kamal Sharma, Managing Director, Lupin Limited
    said, “This is a very positive step ahead for Lupin to establish its stronghold as a top league generics company in the promising market of Philippines in the ASEAN Region. We have seen immense success with our previous acquisitions, all of which have been profitable. Taking this philosophy forward, we believe that MC is a strategic fit in Lupin’s business model. We will continue to focus and leverage on operational efficiencies and capitalize on synergies between the two companies to drive revenues at robust growth rates from the region in the near term.”

    Multicare President, Romeo Sy said that the partnership will be of considerable benefit to MC’s position in the generics industry locally. “The equity acquisition by Lupin gives us increased access to international research and development, world-class manufacturing capabilities which will further strengthen our local position”, he said.

    MC, with field strength of about 140 people enjoys a commendable franchise with the medical fraternity and harbors strong distribution alliances. The dedicated Global Business Development department of Lupin will ensure continual exposure to international companies and product opportunities. Lupin is amongst the fastest growing pharmaceutical company in India with dedicated R&D facilities and is vertically integrated with presence in many global markets. This strategic partnership will provide significant benefits for both parties. MC will gain access to Lupin’s existing product pipeline and manufacturing expertise, while Lupin will gain access to the established brands and supply chains in Philippines.

    Lupin Q3 FY 08-09 – Strong Growth & Consistent Performance with Consolidated Sales up 32% to Rs. 9719 Mn and Net Profit – Rs 1165 Mn

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    Pharma Major, Lupin Limited, yesterday reported revenues of Rs. 9719 mn for the quarter ended December 2008, a rise of 32 % from revenues of Rs. 7381 mn in the corresponding period last year.

    International market revenues at Rs. 6505 mn, recorded a rise of 48%. Of these, Formulation Business in Advanced Markets constituted 77% at Rs. 4990 mn.

    Earnings before Interest, Tax, Depreciation and Amortization (EBITDA) were Rs. 1761 mn (Rs. 1477 mn*) a rise of 19%. After Interest and Finance charges of Rs. 146 mn (Rs. 101 mn) and Depreciation of Rs. 219 mn (Rs.175 mn), Profit before Tax grew by 16% to Rs. 1396 mn (Rs. 1202 mn*). Provision for taxation including Fringe Benefit Tax was Rs. 219 mn (Rs. 201 mn*)

    Net profit for the quarter was at Rs. 1165 mn. Increase in Net Profit for quarter over the corresponding quarter in the previous year (adjusted for IP income) works out to 16%.

    For like representation IP income of Rs 1127 mn for the corresponding quarter of the previous year has been excluded to make the quarters comparable on an operational basis.

    Commenting on the Company’s business results, Dr. Kamal Sharma, Managing Director, Lupin, said,”The past ten quarters have been noteworthy. We have continued to outpace and outperform across business segments and markets consistently having steadily consolidated our footprint globally. Recent launches, product approvals and patent settlements, substantial growth in filings, and more importantly – growth in market shares – are an affirmation of the success of our “Strategic Approach” & the effectiveness of our “Go to market” programs. Our strengths in Research & Development and the quality of our Intellectual property is a testimony to Lupin’s vision & commitment to developing and delivering quality & cost-effective drugs for everybody.”

    Operational Summary

    • Growth in overall Sales in the U.S – Continued Market Leadership in 7 of the 20 products in the market.
    • Litigation Settlement with Schering-Plough Corporation for Desloratadine®
    • Hormosan AOK Tender win
    • Substantial Growth in Filings with two potential First to Files.
    • Domestic Formulations Business at Rs. 2791 mn – outpaces and outperforms the market with a growth of 27% on net sales basis. (Industry growth as per IMS MAT Nov 08 – 10.3%)

    Advanced markets

    The Company’s Advanced markets formulation business in USA and Europe clocked in sales of Rs 3405 mn during the Q3, 2008-09, ( Q3 2007-08: Rs 2297 mn) reporting a growth of 48%

    USA

    LPI has garnered a steady growth in prescriptions for generics as well as branded formulations during the quarter. The company achieved market leadership in 7 of the 20 products in the US markets (IMS Sept 08).

    Lupin also settled all ongoing Hatch-Waxman litigation relating to Desloratadine tablets, the generic version of Schering-Plough’s “Clarinex”® tablets during the quarter. As per the terms of the settlement, Lupin Ltd. will be licensed under the relevant Desloratadine patents, and free to commercially launch its generic Desloratadine product, on July 1, 2012, or earlier in certain circumstances. Schering-Plough’s Clarinex® tablets had U.S. sales of $329 million for the year 2007-MAT June 2008, according to IMS Health.

    Europe

    Lupin further consolidated its market position in Europe by completing its acquisition of Hormosan Pharma GmbH (Hormosan), a German generics company specialized in the supply of pharmaceutical products for the Central Nervous System (CNS).

    Lupin also reported its first strategic win in the German market through Hormosan in the very first three months post-acquisition – having received information on the results of the Allgemeine Ortskrankenkassen (AOK) Tender, pursuant to § 130a SGB V. Hormosan has been offered 1 products in all 5 regions of Germany covering all AOK-insured persons. The AOK tender process is currently under judicial review.

    Hormosan has a strong brand identity in the German generics market through its strong patient compliance message, essential for patients within the CNS sector.

    Emerging Markets:

    The Formulations revenues from emerging markets including India reported a growth of 24% recording sales of Rs 3236 Mn during Q3, 2008-09 (Rs 2605 Mn, 2007-08)

    API revenues from emerging markets (including India) were at Rs 1328 Mn. The Company’s CRAMS business through the new entity Novodigm is progressing well, reporting sales of Rs 125 mn for the third quarter. .

    Domestic Market: India:

    Company’s domestic formulations business in the third quarter registered gross Sales of Rs. 2791, registering a growth of 27% at the net sales level. For better representation, the sales arising from deemed exports of Rs. 104 mn (Rs.93 mn), and formerly recorded under domestic sales have not been classified along with the domestic formulations business. This growth was driven by the good performance in the CVS, Diabetes, CNS, Asthma and Gastro Segments. The divisions catering to branded segments continued to outpace the industry growing over 29%. Lupin has maintained its leadership in Anti-TB segment and has secured a double digit market share in the anti-asthma market riding high on the strengths of its offerings in this segment.

    Other World Markets

    The RoW Markets reported sales of Rs 445 Mn for the third quarter recording a growth of 40%.

    Japan

    Kyowa, the Company’s subsidiary in Japan posted robust sales at Rs 1319 mn registering a growth of 21% over the corresponding period of previous year. The recently launched Amlodipine “Amel” continues to maintain majority market share and Risperidone “Amel”, which was launched last year, continued market leadership in unit terms.

    South Africa

    Lupin also completed and consolidate its acquisition of a majority stake in Pharma Dynamics (PD) in South Africa. Pharma Dynamics is the fastest growing generic companies in South Africa (over 33% growth for Quarter 3 – 08-09) with a clear leadership in the cardiovascular segment.

    PD ranks at number 6 amongst generic companies and is currently growing at 33% per annum as per IMS. The South African Generics Market is currently valued at close to 800 Million USD and growing rapidly.

    Research & Development

    Progress on Approvals & Filings

    Lupin also filed Seven ANDAs filed in the quarter, taking the cumulative ANDA filings total to 76. The company has received 32 approvals to date including Levetiracetam, which has already been launched. Four (4) DMF filings have been made in the quarter, taking the total to 79. The company also filed four (4) MAAs with the European regulatory authorities.

    Two (2) Potential first to files were filed in the quarter. Furthermore, litigation was initiated against Lupin on filing the generic versions of Fortamet ER (Metformin extended release tablets) and Antara (Fenofibrate tablets) during the quarter. The company believes that it is the first to file on both. The total tally of first to files stands at eight (8).

    About Lupin Limited

    Headquartered in Mumbai, India, Lupin Limited is an innovation led transnational pharmaceutical company producing a wide range of quality, affordable generic and branded formulations and APIs for the developed and developing markets of the world.

    The Company has secured global leadership position in Anti-TB and Cephalosporins and has a significant presence in the areas of Cardiovasculars (prils and statins), Diabetology, Asthma and NSAIDs. The Company’s R&D endeavors have resulted in significant progress in its NCE program. The Company’s foray into Advanced Drug Delivery Systems has resulted in the development of platform technologies that are being used to develop value-added generic pharmaceuticals.

    Currently positioned amongst the top six pharmaceutical companies of India, the Company is committed to achieve sustainable earnings and growth for all its stakeholders.

    For the financial year ended March 2008, the Lupin’s Revenues and Profit after Tax were Rs.27,730 million (US$ 694 million) and Rs.4,083 million (US$ 102 million) respectively.

    For further information please contact:

    Lupin Limited:

    Shamsher Gorawara

    Head – Corporate Communications

    Ph: 9820338555

    Email: shamshergorawara@lupinpharma.com