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Lupin FY 2008-09 Consolidated Net Profits up 50.2% to Rs 5015 mn

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Leading transnational pharmaceutical major, Lupin Limited, reported an outstanding performance for the fourth quarter and financial year ended March 31st, 2009. These audited results were taken on record by the Board of Directors at a meeting held in Mumbai on 13th May, 2009.

Key Highlights – Consolidated FY 08-09

 Net sales grew at 39.5% to Rs. 37759 million from Rs. 27064 million last year

  • Net profits grew at 50.2%  to Rs. 5015 million compared to Rs 3338 mn in previous year (excluding IP income)
  • EBITDA margin increased to 19.7%
  • Exports up 63.2% at Rs. 24701 mn
  • Advanced markets sales (including Japan and ANZ) increased 92% over last year and contributed 50% of the Net Sales for the year as against 30% in the previous year.
  • Advanced Markets sales to US and EU grew 70% at Rs 14310  million including API
  • One of the fastest growing generic players in the US by prescriptions and the 9th largest in terms of total prescription base
  • A basket of 22 products in the US with 8 market leaders
  • Domestic Formulations Business grew at 24.6%% to Rs. 10,575 million.
  • Lupin’s Japanese subsidiary, Kyowa contributed 12% of the overall revenues – Rs. 4424 million
  • 28 ANDA’s, 15 DMF’s, 18 MAA’s,6 EDMF’s,3 COS, & 1 AU DMF were filed during FY 08-09.
  • Four Major Acquisitions across Germany, Australia, South Africa and the Philippines
  • Dividend Announcement of 125 %

Key Highlights Q4 FY 08-09

  • Net sales growth for Q4 FY 08-09 was 39% at Rs. 10434 million.
  • Advanced markets sales including Japan increased 60% at Rs 5196 million over Q4 FY 07-08
  • Net profit for Q4 FY 08-09 grew at 64.2% at  Rs. 1574 million compared to Rs 959 million in Q4 FY 07-08

 Commenting on Lupin’s performance, Dr. Kamal K Sharma, Managing Director, Lupin Limited, said,“Lupin’s stellar performance reflects the strong business philosophy guiding us. Lupin has had a very strong year driven by growth and consistent performance across all business segments and markets: a strong business performance in the US, solid domestic growth & increased activity in all key markets. Lupin’s acquisitions have not only consolidated our existing presence in these markets but also leaves us strategically poised to further strengthening our position in the global generics and branded generics market. It has indeed been a year of many achievements and robust growth, and  poised to not only address market needs but also maintain momentum and direction.”

 Financials:

 Advanced markets – US & Europe

 Lupin continued its growth momentum in the US and Europe with it contributing a healthy 36% to our total revenues at Rs. 13634 million. (Formulations)

USA:

 Lupin Pharmaceutical Inc, the company’s US subsidiary reported a stellar performance recording sales of Rs. 12563 million reflecting a growth of  74.4% as compared to Rs. 7205 million in FY 07-08. Lupin’s Generic and the Brand business recorded exponential growth during the financial year.

 More importantly, FY 08-09 saw Lupin increasing its product portfolio in the branded generics segment through the launch of AeroChamber. LPI forged a Strategic Alliance with Forest Laboratories, Inc. for marketing and promoting AeroChamber Plus® thereby extending Lupin’s presence in the respiratory segment and our franchise with Pediatricians which would also additionally open up new offices for Suprax. The brand business contributed 27% to the overall business at USD 74 mn

 The company further expanded and consolidated on its generic product portfolio with the launches of Ramipril caps, Divalproex DR tabs, Cefadroxil suspension and caps & Levetiracetam tabs. The Company now has a total of 22 products in the market, out of which 8 are market leaders. We are in the top 3 market positions  by market share in 17 of these products (IMS Jan 09).

 Lupin today is one of the fastest growing generic players in the US based on growth in prescriptions and the 9th largest in terms of total prescription base.

 LPI was also recognized by Wal-Mart and awarded its prestigious “Supplier Award of Excellence” for the 2nd Quarter 2008 – which is an acknowledgement of the inroads we have made into the US markets.

 During the year, the company demonstrated its capabilities on the Intellectual Property management front by successfully litigating and settling all ongoing Hatch-Waxman litigation relating to Desloratadine tablets, the generic version of Schering-Plough’s “Clarinex”® tablets. 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.

 Lupin also received the final approval for the Company’s Abbreviated New Drug Application (ANDA) for Levetiracetam Tablets 250mg, 500mg, 750 mg and 1000 mg from the U.S. Food and Drug Administration (USFDA). Commercial shipments of the product have commenced.

 Lupin’s Levetiracetam tablets are the AB-rated generic equivalent of UCB Pharmaceuticals’ Keppra® tablets, indicated as adjunctive therapy in the treatment of certain types of seizures associated with epilepsy. Keppra tablets had annual sales of approximately $ 1.2 billion (USD) for the twelve months ended September 2008, based on IMS Health sales data.

Europe:

 Lupin further strengthened its presence in the European Union by completeing its acquisition of Hormosan Pharma GmbH (Hormosan), a German generics company specialized in the supply of pharmaceutical products for the Central Nervous System (CNS).

 We also recorded our first strategic win in the German market through Hormosan in the next two quarters – having received information on the results of the Allgemeine Ortskrankenkassen (AOK) Tender, pursuant to § 130a SGB V. Hormosan has been offered to supply Setraline in all 5 regions of Germany covering all AOK-insured persons. 

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

 Lupin also made strategic inroads into the French market by launching Cefpodoxime Proxetil suspension in Q3. Cefpodoxime Proxetil has over 60 % market share in France.

  AAMLA

Japan:

Kyowa, the Company’s subsidiary in Japan posted robust net sales at Rs 4424 mn contributing 12% of Lupin’s Revenues having grown at over 21 % YoY

 Our products like Amlodipine “Amel” continues to maintain majority market share and Risperidone “Amel”, which was launched last year, continue to exhibit market leadership in unit terms.

South Africa

 Lupin clocked in revenues of Rs 919 million after having acquired a equity stake in Pharma Dynamics (PD) in South Africa in September 08. Pharma Dynamics is one of the fastest growing generic companies in South Africa growing at around 30 % for FY 08-09 with a clear leadership in the cardiovascular segment.

 PD is ranked number 6 amongst generic companies in South Africa. The South African Generics Market is currently valued at close to 800 Million USD and growing rapidly

 Phillipines

In March 2009 the Company acquired a majority stake in Multicare Pharmaceuticals Phillipines, Inc. (MC) in Phillipines. MC is a premium branded generics company with a strong position in women’s health and child care segment.

ANZ

 The Company continued its focus on this important market with aggressive filings in Australia, taking the cumulative MAA filings to 24 till date of which 18 have been approved.

 Emerging Markets

 India: Domestic Formulations forms a very important part of Lupin overall growth. In the current financial year, it contributed about 28% of the net sales at Rs 10,575 million as against Rs. 8,487 million registering a growth of 24.6% over the previous year.

 This growth was driven by the good performance in the CVS, Diabetes, CNS, Asthma and Gastro therapy Segments. The divisions catering to branded segments continued to outpace the industry growing over 27%. 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.

 Research and Development

 Research & Develpment has always been a strategic and key focus area for Lupin and this year – 2008-09 was no exception with 6% of the sales earmarked for R&D and related spends.

 The year 2008-09 was a landmark year with Lupin filing 28 Abbreviated New Drug Application (ANDA) with the USFDA, 11 DMF’s, 15 MAA’s and two EDMF’s during the year.

 The cumulative ANDA filings were at 90 with 34 approvals granted by the USFDA.

 Lupin also received the final approval for the Company’s Abbreviated New Drug Application (ANDA) for Levetiracetam Tablets 250mg, 500mg, 750 mg and 1000 mg from the U.S. Food and Drug Administration (USFDA) during the quarter. 

Other

 The USFDA issued a warning letter for the Cephalosporin facility of the Mandideep plant.  The facility was inspected in November, 2008 for a routine GMP inspection.  As a result Lupin had received 15 procedural observations.  Lupin responded to the observations in December and provided corrective actions for each of the responses.  

The warning letter was issued to provide Lupin with an opportunity to submit additional documentation and explanation to a few selected observations where the  FDA felt that the initial responses were inadequate and could be strengthened by further evidence of compliance with enhanced documentation practices.

 All products maintain their approved status. Lupin manufacturing will not be disrupted and it will continue to provide quality products to customers without interruption. 

Lupin has formulated a strategy to address and resolve the USFDA and is confident of being able to satisfy the USFDA’s observations expeditiously.

Dividend

In view of excellent performance, the Board of Directors recommended a dividend of 125 % i.e Rs. 12.50 per equity share of the face value of Rs. 10 each.

Written by sreelakshmi

22 May, 2009 at 7:08 am

Lupin Announces Litigation Settlement with Wyeth for Venlafaxine Extended Release Capsules

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 Pharma Major, Lupin Ltd. announced on 11th May, 2009 that it has settled all ongoing Hatch-Waxman litigation relating to Venlafaxine extended release capsules, Lupin’s generic version of Wyeth’s antidepressant “Effexor XR®” capsules.

 
 

As per the terms of the settlement, Lupin Ltd. will be licensed under the relevant patents and would be free to commercially launch its generic product on or after 1st of June, 2011, or earlier in certain limited circumstances, but in no event earlier than January 1, 2011.

 
 

Lupin had earlier filed a Paragraph IV certification to U.S. Patent Nos. 6,274,171, 6,403,120 and 6,419,958, contesting that these patents were either invalid or had not been infringed.- resulting in the subsequent litigation by Wyeth.

 
 

Wyeth’s “Effexor XR®” capsules had U.S. sales of $3.01 billion for the year 2008 (IMS) and accounted for 17 percent of the company’s net revenue last year.

 
 

Commenting on the settlement, Dr. Kamal Sharma, Managing Director, Lupin said – “The settlement with Wyeth is in line with our growth strategies and would help us further strengthen our product pipeline and build strong market positions in the U.S. It is a testament to our prowess in Research & Development and our Intellectual Property management competencies – not to mention our strong focus to deliver high value, high quality products.”

 

Written by sreelakshmi

22 May, 2009 at 12:33 am

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.

    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 ties up with leading Institutes for PhD Program

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    Leading pharmaceuticals major, Lupin Limited, today announced a strategic tie-up with top academic echelons – Manipal University (Karnataka), Birla Institute of Technology and Sciences (Pilani) and Pune University – in a move to allow employees of Lupin’s R&D wing, Lupin Research Park, to pursue their industry specific research while concurrently working with Lupin. Through this industry – academia interface, Lupin employees can pursue industry specific research, making them eligible for a Doctorate degree to be awarded by these universities.

    Launching the program, Nilesh Gupta, Group President and Executive Director to the Board, Lupin Limited, commented, “This is a win-win for both our people and the company and is a happy confluence of our scientific staff’s professional aspirations and the need to get an academic and research bent of mind built within our Research”. As a next step, the company plans to increase its reach to Top 10 institutes of Chemistry/Pharmacy in India.

    Situated at Pune, the Lupin Research Park is spread across 19 acres and acts as the hub for Lupin’s global research and development programme. Its culture fosters innovation and helps shape inventions into innovative life saving drugs. Home to over 450 scientists who work in four broad areas of research and development – Generics Research, New Chemical Entities, Advance Drug Delivery Systems and Biotechnology – the facility creates new innovative life-saving drugs and technologies for a healthier tomorrow.

    Written by sreelakshmi

    9 March, 2009 at 8:52 pm