Cipla In The News Archives

02 March 2011 Cipla introduces new pain free screening technology for early detection of breast cancer in India - No Touch Breast Scan 30 November 2010 Cipla extends an innovative Mother-Baby Pack for preventing motherto-child transmission of HIV/AIDS 20 October 2010 Cipla launches the worlds first generic Pirfenidone in India, giving hope to sufferers of IPF (Idiopathic Pulmonary Fibrosis) 06 July 2010 Life sciences industry in Asia grew 3.4% in 2009: survey 10 April 2010 Public Notice 23 March 2010 Piramal Healthcare Acquires "i-pill", a Leading Emergency Contraceptive Brand from Cipla 12 November, Cipla launches generic drug to treat H1N1 2009 25 September, Pharmaceuticals Export Promotion Council Awards 2009 15 July, 2009 Cipla FY09 net up 10% at Rs 771 cr 23 June, 2009 Pharma market grows 10% in May 12 June, 2009 Swine flu declared a 'pandemic', first in 41 years 07 May, 2009 Cipla Pharmaceuticals' Yusuf Hamied: 'I Am Not Against Patents ... I Am Against Monopolies' 06 May, 2009 Cipla Gets Tentative USFDA Approval 02 May, 2009 St gives thumbs down to cos with foreign ops 01 May, 2009 New Delhi rejects American firm's plea to patent Hepatitis B drug 27 April, 2009 Cipla wins Erlotinib case against Roche 25 April, 2009 Cipla Q4 net profit up on better product-mix 02 March, 2009 Pharma retail market grows 15% 25 February, 2009 Patents yes, but monopoly no 03 December, 2008 Cipla gets USFDA nod for Pamidronate disodium injection 27 October, 2008 Pharma holds steady, Cipla pips Ranbaxy 23 July, 2008 Cipla: Active in overseas markets 07 July, 2008 Cipla Gets Thumbs Up for Generic HIV Drug 01 July, 2008 Cipla gets patent for Nexium, Fosamax modified versions 23 June, 2008 Cipla gets tentative approval from USFDA read more

05 May, 2008 Cipla offers free know-how of essential drugs to PSUs 30 April, 2008 Cipla: Overseas sales a booster 20 March, 2008 Cipla scores a generic win over Roche 01 January, 2008 Cipla maintains No.1 position in Indian mkt Wednesday, 02 March 2011 Cipla introduces new pain free screening technology for early detection of breast cancer in India - No Touch Breast Scan

Cipla, one of the leading pharmaceutical companies from India, today announces the launch of a breakthrough screening technology in India today called the No Touch Breast Scan (NTBS); ' the first-ever painless, non-invasive and radiation-free breast scanning technique for detecting breast cancer at an early stage. As of today, 1 in every 22 women in India is expected to be diagnosed with breast cancer in their lifetime. Dr. Shekhar Kulkarni, Consultant Breast Cancer Surgeon, Magnolia Breast Surgery Clinic, Pune said, Breast cancer is rising rapidly among urban women and is now the most common cancer in cities such as Mumbai and Delhi . Unfortunately most cancers are diagnosed when the disease is advanced leading to low chances of cure. Although Mammography has been available for years it is not used that widely. There are many reasons for it such as lack of awareness, pain and discomfort during the procedure and a concern about repeated exposure to

radiation. Welcoming the introduction of NTBS in India , Dr. Rakesh Sinha, Consultant Gynaecologist Surgeon, BEAMS Hospital , Mumbai said, The No-Touch Breast scan is a painless option for women who wish to get themselves regularly screened. It is of particular use in younger women who have dense breasts and mammography is inconclusive. If a woman shows changes on the NTBS then she is sent for further investigation which includes mammography, sonography etc. At BEAMS Mumbai, of the 41 patients who have undergone the NTBS test, only 1 had to be referred for mammography. Thermal imaging has been approved by the FDA several years ago for early diagnosis of breast cancer. With improvements in digital camera technology during the last few years, thermal imaging is fast gaining acceptance. Developed by UE Life Sciences Inc, the No Touch Breast Scan' is the World's first fully computerized thermal imaging technology' with dual IR cameras which can find thermal changes at less than 0.08 deg. C. The NTBS using infrared imaging creates a sophisticated heat-map of the breast without using any radiation. Breast cancer is associated with increased formation of new blood vessels and these show up as 'hot spots' which could indicate a cancerous growth. At Dr Kulkarni's Magnolia Beauty and Clinic in Pune, the NTBS test was taken by about 165 women and only 12 of them needed further investigation. Mrs. Ambike, an asymptomatic woman who has untaken the NTBS test said, I had taken a mammography test earlier but it was quite traumatic. With this totally touch-free and quick NTBS test, I would not defer my annual check-up anymore. The No-Touch Breast Scan' would be exclusively marketed by Cipla across diagnostic centres and hospitals in India . It has already been installed at BEAMS Hospital , Mumbai and Indore and Magnolia Beauty and Clinic, Pune and would be extended by Cipla on a requirement-basis to over 20 more diagnostic centres or hospitals across India . Addressing the press, Dr. Jaideep Gogtay, Medical Director Cipla said , Cipla has been working in the area of cancer by manufacturing drugs for the last 20 years but this is for the first time we have taken a step towards focusing on early diagnosis of breast cancer. There are 3 NTBS machines available in the US , UK , Turkey and Kazakhstan , but women in India would have greater access to this landmark technology and have more control over their breast health. The cost of per NTBS test would range between Rs 800 1000, depending on the pricing determined individually by the hospitals and centres. Quick Facts on Breast cancer in India

Breast Cancer has practically replaced cervical cancer as the leading site of cancer among women in all urban cancer registries As of today, 1 in every 22 women in India in their lifetime is expected to be diagnosed with breast cancer More than 92% of breast cancers are diagnosed at stage II or later 1 out of every 2 women diagnosed with breast cancer does not survive the disease;

mostly due to late stage diagnosis. Counter to common thinking, breast cancer is in fact a younger woman's disease, it is more prevalent in urban than rural parts and the rates are dramatically rising, faster than any other female cancer. According to a study by International Agency for Research on Cancer (IARC) a branch of WHO, there will be approximately 250,000 new cases of breast cancer in India by 2015. According to National Institutes of Health, nearly 90% diagnosed will survive at least 5 years

About Cipla: Cipla laid foundations for the Indian pharmaceutical industry back in 1935 with the vision to make India self-reliant in healthcare. Over the years Cipla has emerged as one of the most respected names not just in India but worldwide. Its state of the art R&D centre has given the country and the world many firsts. This includes the revolutionary AIDS cocktail for less than a dollar a day. With over 40 manufacturing units across the country, Cipla manufactures over 1200 products in 80 therapies. With a turnover of over US $ 1 billion, Cipla serves doctors and patients in over 183 countries. It has earned a name for maintaining one global standard across all its products and services. Cipla continues to support, improve and save millions of lives with its high-quality drugs and innovative devices. ( www.cipla.com ) Media Contact:Antara Mukherjee Corporate Communications Cipla Mob: (+91) 9967516441 E Mail: antara.mukherjee@cipla.com Jaisingh Balakrishnan Corporate Communications Cipla Mob: (+91) - 9833836185 E Mail: jaisingh.krishnan@cipla.com

Top Tuesday, 30 November 2010 Cipla extends an innovative Mother-Baby Pack' for preventing mother-to-child transmission of HIV/AIDS India, 30 th November 2010: In keeping with its commitment to reduce mother-to-child transmission of HIV/AIDS, Cipla, one of the world's leading generic pharmaceutical companies has developed the first-of-its kind Mother-Baby Pack' in collaboration with UNICEF and other partners . The Mother-Baby Pack contains the entire range of anti-retroviral drugs and antibiotics required by an HIV infected mother starting from the 14 th week of pregnancy un til the 6th week after delivery . Developed in line with the latest World Health Organization (WHO) guidelines on Prevention of Mother-to-Child Transmission (PMTCT) Option A , the Mother-Baby Pack is a color-coded take-home kit with simple graphics to help mothers identify

the different sets of drugs each to be taken during pregnancy, during labour and breastfeeding, covering the entire period when the transmission can occur. Also, the pack contains drugs for the new born baby. Launched in Kenya , Cameroon , Zambia and Lesotho , the Mother-Baby Pack thereby addresses the logistical challenge of access to essential HIV drugs during the entire term of pregnancy and the susceptible period thereafter. Over 1,000 infants contract HIV everyday from their mothers at the time of birth with the highest rate reported in sub-Saharan Africa . The risk of transmission from an infected mother to her infant ranges from about 15% to 45%, with 25 to 35% transmission occurring antenatally, 70-75% of transmission occuring during labor and delivery and about 14% is attributable to breastfeeding. The intrapartum period provides a crucial window of opportunity for prevention. With the launch of the Mother-Baby Pack, n ow an HIV positive mother-to-be even in the remotest corner of the least developed nations would have daily access to essential PMTCT drugs during her entire term of pregnancy at the convenience of her own home. On making another landmark contribution in the fight against HIV/AIDS, Dr. Y. K. Hamied, Chairman and Managing Director, Cipla said, We were approached by UNICEF to produce this pack for the PMTCT program. Cipla is proud to extend its world-class antiretrovirals to the infected expectant mothers and the specially designed Mother-Baby Pack will increase adherence and play a pivotal role in the total prevention of mother-to-child transmission of HIV/AIDS. The drugs for the Mother-Baby Pack are being manufactured and packaged in Cipla's world class manufacturing units in Goa and Patalganga which are approved by WHO-Geneva, USFDA, MHRA-UK and various other regulatory bodies. Cipla's contribution to PMTCT dates way back to the Nevirapine donation program' aimed at reducing the rate of mother-to-child transmission by 50% in the developing countries. Through this program, Cipla offered the the anti-HIV drug Nevimune' free of cost to any agency or Ministry of Health that approached Cipla with its HIV/AIDS treatment programmes. Dr. Y. K. Hamied further added, Cipla would make the Mother-Baby Pack available to various Ministries of Health in sub-Saharan Africa , various NGO's and donor agencies for their treatment programmes. This reinforces Cipla's commitment to make affordable medicines accessible to all and its promise that None shall be denied. About Cipla's fight against HIV/AIDS: At a time when the world had already lost 20million people to HIV/AIDS, the cost of HIV/AIDS treatment of at least $12,000 per patient per year had made the scientific achievements in drug innovation inaccessible to the ordinary people of the developing nations who were worst hit with the disease. Cipla then revolutionized the treatment of HIV/AIDS in 2001 by bringing down the cost of HIV treatment and making the ARVs available at below Dollar a Day.' With the reduced cost of $300 per patient per year, HIV/AIDS treatment became a reality and the survival rates went up dramatically. Further, Cipla's innovation of a Fixed Dose Combination (FDC) in 2001 of the triple cocktail drug' called Triomune was a significant step which simplified treatment and fostered adherence. Cipla was also the first to prepare a child-friendly three-in-one paediatric formulation (Triomune Baby and Junior) for the young population infected with HIV/AIDS. Cipla thereafter

initiated a patient education campaign Living with Hope' in 2004 and has been conducting several ongoing training programs and CMEs in India and internationally to cover various aspects of HIV/AIDS treatment including adult, paediatric, MTCT, PEP etc. Currently, with more than 45 ARV formulations in its portfolio, Cipla supplies these to over 120 countries including various Ministries of Health, Government of India and to several international AIDS agencies like UNICEF, MSF, SCMS/PEPFAR, Clinton Foundation, IDA, PAHO among others. Today, almost 1 out of 3 HIV-infected patients in the third world is on Cipla drugs and Cipla continues to work towards its commitment that None shall be denied.' About Cipla: Cipla laid foundations for the Indian pharmaceutical industry back in 1935 with the vision to make India self-reliant and self-sufficient in healthcare. Over the years Cipla has emerged as one of the most respected pharma names not just in India but worldwide. Its R&D centre has given the country and the world many firsts. This includes the revolutionary HIV/AIDS cocktail for less than a dollar a day. With over 40 state of the art manufacturing units across the country, Cipla manufactures over 1200 products in 80 therapeutic areas. With a turnover of over US $ 1.2 billion, Cipla serves doctors and patients in over 180 countries. It has earned a name for maintaining one global standard across all its products and services. Cipla continues to support, improve and save millions of lives with its high-quality drugs and innovative devices. (www.cipla.com) Media Contact : Antara Mukherjee Head Corporate Communications Mob: (+91) 9967516441 E Mail: antara.mukherjee@cipla.com

Jaisingh Balakrishnan Corporate Communications Mob: (+91) 9773372487 E Mail: jaisingh.krishnan@cipla.com

Top Wednesday, 20 October 2010 Cipla launches the world's first generic Pirfenidone in India, giving hope to sufferers of IPF (Idiopathic Pulmonary Fibrosis) Cipla, among the world's leading generic pharmaceutical companies has introduced Pirfenidone in India; under the brand name Pirfenex, for the treatment of IPF. A chronic progressive form of lung disease, IPF has average survival rates as low as 3-5 years which is less than many cancers. Till now there is no approved treatment for IPF. Pirfenidone is a novel anti-fibrotic drug which through clinical trials has shown to slow down progression of this terminal disease and stabilize lung function. Cipla's technical prowess along with leadership in terms of range of drugs and therapeutic categories in the respiratory segment, is leading the fight to provide world class affordable treatment for patients with orphan diseases. Commenting on the launch, Dr. Jaideep Gogtay, Medical Director, Cipla said, The launch of Pirfenex is a significant step forward. With

increased availability and affordability, Pirfenex could now offer hope to those afflicted with this condition. Pirfenex will be manufactured at Cipla's state-of-the-art manufacturing facility at Himachal Pradesh, India which is approved by WHO, MCC South Africa and TGA Australia. In addition to the launch, Cipla will host and disseminate a series of lectures on IPF to physicians in India and across the world. Addressing the delegates Prof Luca Richeldi, Director, Center for Rare Lung Diseases, University of Modena and Reggio Emilia, Italy said "Patients affected by IPF have a distinctively poor prognosis, and until now no drugs have been approved to treat IPF. Pirfenidone represents the first concrete chance of slowing down disease progression. The effect on increasing progression free survival, as showed in three combined studies, coupled with an acceptable safety profile, opens up a new path for better management of IPF." Last year Cipla launched the world's first generic Bosentan, for the treatment of Pulmonary Arterial Hypertension. With the launch of Pirfenex, Cipla reaffirms its leadership in the respiratory arena with products and services in 8 therapeutic areas viz. asthma, COPD, allergic rhinitis, respiratory infections, pulmonary and critical care, pulmonary arterial hypertension, lung cancer and IPF. About Cipla: Cipla laid foundations for the Indian pharmaceutical industry back in 1935 with the vision to make India self-reliant in healthcare. Over the years Cipla has emerged as one of the most respected names not just in India but worldwide. Its state of the art R&D centre has given the country and the world many firsts. This includes the revolutionary AIDS cocktail for less than a dollar a day. With over 40 manufacturing units across the country, Cipla manufactures over 1200 products in 80 therapies. With a turnover of over US $ 1 billion, Cipla serves doctors and patients in over 180 countries. It has earned a name for maintaining one global standard across all its products and services. Cipla continues to support, improve and save millions of lives with its high-quality drugs and innovative devices. (www.cipla.com) Media Contact : Jaisingh Balakrishnan Corporate Communications M: (+91) 9773372487 Email: jaisingh.krishnan@cipla.com

Top Business Standard / Tuesday, 06 July 2010 Life sciences industry in Asia grew 3.4% in 2009: survey BS Reporter

The Life Sciences industry in Asia clocked a growth of 3.4 per cent to record revenues of $110.89 billion in calendar year 2009, according to a survey by BioSpectrum Asia, a journal for life sciences industry in the Asia Pacific region. Listed companies contributed nearly half the revenues at $54.24 billion as they grew at 24.03 per cent. BioSpectrum Asia estimates the growth of Life Sciences, covering pharma, biotech and medtech segments, in 2010 to surpass that of 2009, even though the range is likely remain the same: 3 to 5 per cent, as the economic climate begins to change for the better. The combined revenues of Indian life sciences companies was $21 billion taking India to the number two spot behind China. India accounted for 19 per cent of the total revenues in Asia Pacific. South Korea, Australia and Singapore followed India in terms of revenue. With revenues of $22 billion Chinese publicly listed companies grew the fastest at 51.82 per cent, followed by Taiwan. With revenues of $2 billion, Taiwan posted a robust 46.29 per cent growth. Indian publicly listed with revenues of $14.59 billion grew the slowest, at 1.42 per cent. Seven Indian companies were in the Asia's Top 20 Publicly Listed Life Science Companies, which accounted for 82% of the overall revenues of publicly listed companies. These include Cipla, Ranbaxy Laboratories, Dr Reddy's Laboratories, Cadila Healthcare, Lupin, Aurobindo Pharma and Sun Pharma. Cipla became India's No. 1 company, clocking revenues of $1.17 billion. It also became the one of the two Indian companies in the billion-dollar club. Last year, Ranbaxy held India's Top slot. The India Top 20 Life Sciences list comprises pharma companies with the lone exception of a biopharmaBiocon, at Rank 1 Bottom of Form

Top Saturday, 10 April 2010 Public Notice Public Notice Public Notice - Environmental Clearance Letter View JPG View PDF

Top Tuesday, 23 March 2010 Piramal Healthcare Acquires "i-pill", a Leading Emergency Contraceptive Brand from Cipla Mumbai, March 23, 2010: Piramal Healthcare Limited [NSE: PIRHEALTH, BSE: 500302] (Piramal) and Cipla Limited [NSE: CIPLA, BSE: 500087] (Cipla) today announced the signing of a definitive agreement for purchase of all intellectual property rights in India related to "i-pill" for an aggregate consideration of Rs 95 crore.

"i-pill" features in the top-300 pharmaceutical products and recorded sales of Rs. 31 crore for the previous 12 months as per data from ORG IMS. The acquisition of "i-pill" strengthens Piramal's over the counter (OTC) portfolio which has strong consumer brands such as Lacto Calamine skin care range, Supractiv Complete, Saridon and Polycrol antacid. Commenting on the transaction, Dr. (Mrs.) Swati A. Piramal, Executive Director - Strategic Alliances & Communications, Piramal Healthcare Ltd. said, At Piramal Healthcare, propelled by our core values of Knowledge, Action and Care, we are devoted to making a real difference to our consumers' lives by enabling informed choices. i-pill magnifies the indomitable spirit of the new Indian woman who is resilient in the face of every adversity. It empowers Indian women to remain in control of their future without resorting to emotionally and medically stressful alternatives like abortion." Commenting on the sale of i-pill, Mr. Amar Lulla , Joint Managing Director, Cipla Ltd. said, In 2007, we had created i-pill which is currently India 's No. 1 OTC emergency contraceptive brand. Our decision to divest the brand is driven by our current domestic product portfolio focused on prescription drugs. We are pleased that another Indian healthcare company with a strong OTC portfolio has bought the brand and are confident that Piramal Healthcare will successfully accelerate the future growth of the brand. i-pill is an emergency contraceptive pill (ECP) used to prevent unplanned pregnancy and is available over the counter at local chemists. It is not an abortion pill. i-pill contains Levonorgestrel, a progestogen which helps prevent unwanted pregnancies if taken within 72 hours of unprotected sex. "i-pill has no long term or serious side effects and is safe to use for almost all women except those who are allergic to Levonorgestrel. i-pill has been instrumental in building awareness about the emergency contraceptive pill category in India . The OTC market in India is estimated to be around US $1.8 billion and is growing annually at 18%. Piramal Healthcare has been an active player in the OTC space in the last few years with a strong distribution reach covering both chemists and general stores. Commenting on the OTC market, Mr. Ajay Piramal, Chairman, Piramal Healthcare Ltd. noted that, We believe the OTC segment is still in its nascent stages in India and presents us with high growth opportunities. In particular the ECP segment which is approximately a Rs 100 crores industry and has grown by 250% in the last two years". Kotak Investment Banking acted as the exclusive financial advisor to Cipla for this transaction. About Cipla Incorporated in 1935, Cipla is the No. 1 pharmaceutical com pany in India as per ORG-IMS. Cipla is exporting its products to over 170 countries worldwide. With approximately 150 Active Pharmaceutical Ingredients (APIs) and more than 1600 formulation products in its portfolio, the Company offers a wide range of products across all the major therapeutic categories. The Company owns and operates 19 manufacturing facilities across India . Cipla is listed in India on the National Stock Exchange (Ticker: CIPLA) and Bombay Stock Exchange (Ticker:

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Top Thursday, 12 November 2009 Cipla launches generic drug to treat H1N1 Business Standard Reporter/Mumbai Indian drug major Cipla has launched generic versions of anti-flu drugs oseltamivir and zanamivir in the local market to treat the H1N1 influenza, which is spreading across the globe and in India. Cipla will brand oseltamivir in the local market as Antiflu and zanamivir as Virenza. Antiflu will cost Rs 475 for 10 capsules, in line with the price of competing products in the market. Virenza an inhaled drug will cost Rs 800, which includes the price for an inhalation device. Cipla's Antiflu is a copycat version of Swiss multi-national Hoffmann-La Roche's Tamiflu and Virenza is the copy of GlaxoSmithKline's Relenza. Both drugs, used globally to treat the ongoing H1N1 pandemic, lack patent protection in India as these are pre-1995 innovations. Such innovations are not granted patents in India, according to the product patent regime introduced in the country since 2005. Dr Y K Hamied, chairman and managing director of Cipla, said his company was equipped to make 2 million doses of oseltamivir a month, in case of any eventuality. Already 450 people have died of H1N1 in India and the winter season may cause further spread of the virus, he said. Now the US is facing a shortage of oseltamivir and we have informed our readiness to supply the drug if needed. We make about 20 drugs in the antiviral segment and are among the global leaders in this category, said the Cipla chief, who revolutionised HIV/AIDS treatment globally by selling generic drug cocktails at less than a $1 per day. Both drugs have patent protection in many developed countries, including the US and Europe. Hyderabad-based Hetero is the only supplier licensed by Roche to market oseltamivir in India under the brand name Fluvir. On August 28, the Indian government had allowed restricted retail sale of the drug under Schedules X category of the Drugs and Cosmetics Act, similar to the sale of narcotics drugs. Six Indian companies Ranbaxy, Cipla, Strides Acrolab, Hetero, Hetco and Roche were allowed to manufacture and sell the drug. The government has also stockpiled the drug from these manufacturers for supply through government channels. Two months ago, Natco Pharma had launched its version Natflu in the Indian market at a price of Rs 475 for a bottle of 10 capsules.

In 2005, we had stockpiled about 2.5 tonnes of oseltamivir but there was no demand and about $15-20 million worth products had just piled up as inventory, said Hamied. Cipla has so far exported about $10 million worth of Antiflu to countries in Latin America, Africa, South-East Asia and West Asia, where the drug lacks patent protection. Countries with patent protection for these drugs can also allow generic players to manufacture and market it, invoking compulsory licence provisions of the patent rules, which allow breaking of patent rules during emergency, said Hamied. Shortage or monopoly of any drug will cause panic among people during such pandemic attacks, he added. Hamied has suggested that governments should encourage stockpiling of shikimic acid, which is extracted from the Chinese Star Anise' and is used as a base material for production of oseltamivir through a 14-step chemical process, instead of stockpiling the finished drug.

Top Friday, 25 September 2009 Pharmaceuticals Export Promotion Council Awards

Top Press Trust of India / Wednesday, 15 July 2009

Cipla FY09 net up 10% at Rs 771 cr Drug maker Cipla today reported a growth of 10 per cent in its consolidated net profit for the financial year ended March 31 to Rs 771.02 crore. The company had a consolidated net profit of Rs 701.04 crore during the 2007-08 financial year, Cipla said in a filing to the Bombay Stock Exchange (BSE). The consolidated total income of pharmaceutical firm rose to Rs 5,326.04 crore in the latest fiscal from Rs 4282.92 crore of a year earlier. The company has declared a dividend of Rs 2 per share for the year 2008-2009. On a standalone basis, Cipla posted a net profit of Rs 776.82 crore during FY'09, an 11 per cent rise compared to Rs 701.43 crore of FY'08. Shares of Cipla today closed at Rs 272.15, almost flat from its previous close on the BSE.

Top The Times Of India / Tuesday, 23 June 2009 Pharma market grows 10% in May Rupali Mukherjee, TNN New Delhi: The domestic pharma retail market posted a healthy growth of 10% in May over the previous month. The pharma market registered a strong growth over the first three months, January to March growing double digit. The growth seems to have dipped slightly during two months April and May to a little over 10% 10.1 and 10.2% respectively. On a moving annual total basis (April'08 to May'09), the organized pharma retail market grew by 10.4% to Rs 36,048 crore, which was slightly higher than the previous month's value of Rs 35,675 crore, according to consulting company, ORG-IMS. The market was valued at Rs 3,104.12 crore during May, slightly lower than previous month's figure of Rs 3,146 crore. During the month, there was little change in the top rankings of companies. Cipla occupied the top slot in terms of market share, followed by Ranbaxy and GlaxoSmithKline on the third position. Piramal Healthcare was ranked fourth, followed by Zydus Cadila which moved to the fifth slot. Zydus displaced Sun Pharma, which had moved to the fifth position in April. For some time now, Cipla has been dominating the top slot followed by Ranbaxy and GSK in terms of market shares. Also, there were some movements as far as the top 20 companies were concerned with Dr Reddy's Labs, Wockhardt-Merind and Emcure gaining one rank each, to move up to rank 11, 14 and 16 positions respectively, according to ORG-IMS.

Amongst medicine brands, pain killer drug Voveran maintained its top position. Iron supplement Dexorange and lipid lowering medicine, Strovas leaped three ranks and jumped to rank five and 20 respectively. Oral rehydration salt Electral, pain killer Spasmo-proxyvon and Asthalin (for managing asthma) were the highest gainers, moving four ranks each to nine, 15 and 16 positions respectively. Among the top 20 products, antibiotic drug Taxim, health supplement Liv-52, antibiotic Mox, Taxim-O, gained one rank each and moved up to ranks eight, 11, 13, and 17 respectively. Aciloc gained seven ranks and entered the top 20 list at rank 18 during May.

Top CNBC-TV18 / Tuesday, 12 June 2009 Swine flu declared a 'pandemic', first in 41 years The World Health Organization (WHO) has declared Swine Flu a 'pandemic'. Swine Flu has thus become the first global pandemic in 41 years. Official reports say there are 28,000 cases of Swine Flu globally. Amar Lulla, Joint MD, Cipla , said India needs to have adequate stocks of drugs like Oseltamivir and Zanamivir to fight this pandemic. Here is a verbatim transcript of the exclusive interview with Amar Lulla on CNBC-TV18. Also see the accompanying video. Q: The fact that the WHO (World Health Organisation) has now declared the Swine Flu a global pandemic, what does this mean for somebody like you? A: It just means that we need to be prepared. I think more than us it is important that the country is prepared to face this eventuality. Q: Has the WHO or any other government got in touch with Cipla for Tamiflu? A: Yes, there have been various Latin American countries that have been in touch with us and have been procuring Oseltamivir from us. Q: How does it impact the pharma industry as well materially? Is there a race on now to perhaps get a Swine Flu vaccine going? A: Yes, that would be the objective. Ultimately, that would be the way forward. But right now it is still very early to have the vaccine. So, we need the treatment, we need Oseltamivir, and need Zanamivir. These drugs should be adequately stocked.

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India Knowledge@Wharton / Thursday, 07 May 2009 Cipla Pharmaceuticals' Yusuf Hamied: 'I Am Not Against Patents ... I Am Against Monopolies' Many basic, life-saving medications remain unaffordable in low- and middle-income countries. Spurred on by that fact, Yusuf Hamied, chairman and managing director of Cipla Pharmaceuticals, has steered his enterprise to the forefront of global pharmaceutical development by manufacturing low-cost drugs for diseases like AIDS, diabetes and arthritis, among others. Cipla has faced challenges in India and abroad from multinational pharmaceutical companies looking to protect their patents on particular medications, including antiretroviral drugs used to combat HIV infections in countries like South Africa, where access is severely limited by the annual per-person cost of US$10,000 to US$15,000. Most recently, the Delhi high court awarded Cipla the right to continue selling a low-cost generic equivalent of the lung cancer drug Tarceva following a patent-infringement suit by the drug's manufacturer, Swiss pharmaceutical company Hoffman-LaRoche. Born in Lithuania but raised in Mumbai, Hamied received a PhD in chemistry from Christ's College, Cambridge University . In 2005, the Indian government gave him the Padma Bhushan award, one of the country's highest civilian honors. In an interview with India Knowledge@Wharton, Hamied describes his company's skirmishes with multinationals looking to protect their patents on particular medications and explains why rules governing intellectual property rights in industrialized nations should not apply to poorer countries. India Knowledge@Wharton: What are the key lessons to be learned by Indian lawmakers from the controversy in AIDS-ravaged South Africa ? Yusuf Hamied: The controversy in AIDS-ravaged South Africa gives you a glimpse of what's in store in a monopoly. India must seriously examine its Intellectual Property Rights (IPR) position and see how best TRIPS (Trade Related Intellectual Property Rights) can be interpreted, as IPR laws are national laws. India should cull the best points from various laws to suit her future needs. For example, American patent laws include the Bolar Provision, so that generic companies can have products ready for sale as soon as a patent expires. Compulsory licensing is valid under TRIPS and can be invoked when there is a national emergency. But diseases like malaria, tuberculosis and leprosy are permanent, perpetual and even perennial emergencies in countries like India, and I'd say that we need a system of automatic license of right for a fixed royalty to the patent holder (typically, about 2% to 4% of net sales). In fact, many of these issues were raised in the I.K. Gujral Committee Report in 1993. The committee was of the opinion that India should insist on automatic licensing in certain circumstances, besides recognizing the need that countries at different stages of development need to be treated differently. India Knowledge@Wharton: Are you suggesting that India reconsider TRIPS itself?

Hamied: I'd suggest a "TRIPS north" and a "TRIPS south," where the north comprises 600 million people in the developed world while the south comprises the 3 billion people of the Third World . The rules of industrial nations should not necessarily apply to poorer nations. Ninety percent of the profits of multinationals are made in the north and not the south, and that's what constitutes the R&D component [for these companies]. In fact, I would go so far as to say that if TRIPS is not changed, India and other like-minded countries should walk out of the WTO and form the TWTO (Third World Trade Organization). India Knowledge@Wharton: The WTO supports legal protection of intellectual property rights of multinational pharmaceutical patents, as does the U.S. government, which is strongly lobbied by the multinational pharma industry. Then we have the UN, which is slow when it comes to fighting for the have-nots to ensure that they have access to reasonably priced generic medication. On the other hand, we see World Health Organization endorsing your generic drugs for quality and approving processes used in generic factories. Where do you stand in this difficult situation? Hamied: Only once a patent expires in a particular country can that product be manufactured in the country. "Generic" is "post-patent" -- or, by extension, off patent, and therefore nonmonopolistic. This question of monopoly of drugs in the future -- if the Americans, Europeans and Big Pharma get their way -- could be a disaster for the third world. India Knowledge@Wharton: With the re-introduction of patent rights in 2005 in India , what happened to the companies that sprouted up after 1972, when generic copies were legalized? What happened to Cipla's production of generic drugs? Did it come to a grinding halt? If you are still producing, is it now illegal? Hamied: No. The cut-off point is 1995: It is legal to replicate any drugs invented and patented in India pre-1995, but post-1995 it is not permitted. However, the drugs invented after 1995 will only enter the market around 2012-2015, which is when we will begin to feel the pinch. Currently, in the Third World , older drugs don't die. They coexist with newer ones. As patents expire, we acquire the legal right to manufacture off-patent drugs, making it a continuous process. India Knowledge@Wharton: There have been a number of new judgments related to intellectual property protection that Cipla contributed to, such as your win over Roche that ensured an uninterrupted supply in India of a low-cost medicine for treating lung cancer. What do you think about the country's evolving IP legislation? Hamied: I'm told that the judges and staff at the patent office have been trained by American officials, which means that they will be blinkered. But I am particularly interested in these questions: How is it that so many health care patents have been granted in such a short time period? Are the patents properly examined? Just because a patent is granted in Europe or America , does that mean it passes the Indian Patent Law, which is different? These questions are of particular relevance to the new clause 3d in the Indian Patent Act (which refuses patent protection to new forms, uses or minor modifications of existing drugs unless

they differ significantly with regard to efficacy). Approximately 7,000 patents were filed before clause 3d [came into existence]. In the presence of this new clause, 60% of these patents are not valid. Why aren't they voluntarily withdrawn? It is only fair that those who filed for these patents revise them. India Knowledge@Wharton: Why do you think the Government is bringing changes to the IP regime? Hamied: If you ask the Indian government, they have a ready answer: "We can't upset the international community." I told them, "But gentlemen, the patent law is a national law. How are you upsetting the international community when India 's overall international trade is 0.8% of world trade? We'll reach 1% by 2010. What is the big deal? Who is benefitting?" While the world [pharmaceutical] trade market is pegged at US$700 billion, India stands at a mere US$7 billion.... I am not against patents, but India cannot afford them. I am against monopolies. India Knowledge@Wharton: Can drugs from Big Pharma reach all of India ? Hamied: They can only do so in an aura of monopoly. That is why [multinationals] gave up India in 1972. We didn't reach this position overnight. It took 10 to 20 years for Indian companies to grow. Right now, we are in a period of stabilization. The multinationals will stand to gain when we start losing out. The cutoff date is 2012 or 2015, when patents for older drugs die and newer drugs, which doctors will want to use, enter the market. And that is when I will say that the Indian government has committed selective genocide in India . India Knowledge@Wharton: In your opinion, how does India balance the rights of a patent holder while providing affordable health care for all? Hamied: The fact is that health care in India has always been in a state of perpetual crisis. The disease profile is frightening: 80 million cardiac patients, 80 million affected with mental illness, 60 million diabetics, 50 million asthmatics, 50 million hepatitis B cases, and one in three Indians is a latent carrier of TB. The World Bank has said that India will have 35 million HIV cases by 2015, approximately half of all the AIDS cases in the world. Given these facts, the patent regime in this country should be so devised that utmost priority is given to secure the people's right to access affordable, quality health care without monopoly. This can be achieved by an automatic license of right with a suitable royalty payment on net sales to the innovator. Even a developed country like Canada followed this policy from 1969 to 1992, under the Canadian bill S-91. Apart from this, if at all, the government should only allow patents filed after January 1, 2005, [to be considered] product patents. (As a member of the WTO, India set a goal to make its patent legislation TRIPS-compliant by January, 2005.) Also, problems such as "evergreening" (when innovator pharmaceutical companies abuse the patent and regulatory systems to delay the legitimate entry of generic competition) and frivolous patenting should be carefully reviewed. Compulsory licensing provisions have to be favorable for the indigenous industry, as also patenting by Indians internationally. Importation of a patented product alone should not be considered as operative of a working patent.

We need to take a closer look as to what is best for India . One cannot have the same laws for 600 million people in the developed world and 3 billion people in the Third World . Globalization of health care does not mean that the sick and needy are denied access to drugs at affordable prices. India Knowledge@Wharton: How do you explain this to politicians and policy makers? Hamied: I try. I'll give you an example of what happened to me. All over the world, we [offer] a certain medicine that stops AIDS transmission from mother to child, free of cost. I showed it to an Indian politician several years ago. He asked me if I give this drug free of cost, and I said "yes." Do you know what his response was? "You must have an ulterior motive." I laughed and said, "Yes, I do have an ulterior motive. I want to do some good before I die. I am not going to take any of this [with me] when I die!" You see the mindset?

Top TopNews - Noida, Uttar Pradesh, India / Wednesday, 06 May 2009 Cipla Gets Tentative USFDA Approval Shilpa Mahapatre Major Indian pharma firm Cipla has notified that it has secured tentative approval from the United States Food and Drug Administration (USFDA) for its tenofovir disoproxil fumarate tablets. In a disclosure to the Bombay Stock Exchange, the company said that Tenofovir disoproxil fumarate tablets are indicated for use in combination with other antiretroviral agents. The drugs are prescribed for the treatment of HIV-1 infection in adults. The company has received tentative approval to sell the drug in tablet form in dosages of 300 milligram under the President's Emergency Plan for AIDS Relief program. It can be recalled that Tenofovir disoproxil fumarate tablets are the generic version of Gilead Sciences Inc.'s (GILD) truvada. The Indian company is known for producing low-cost anti-AIDS drugs for HIV-positive patients in developing countries. Moreover, Cipla makes drugs to treat cardiovascular disease, arthritis, diabetes, weight control, depression and many other health conditions. The products produced by the company are distributed in nearly 200 countries of the world.

Top ET Bureau / Saturday, 02 May 2009 St gives thumbs down to cos with foreign ops Kiran Kabtta Somvanshi Indian companies that had ventured abroad riding on a wave of globalisation and cross-border M&As are finding life tough abroad. The prized foreign assets are now turning out to be millstone around the neck, pulling down the consolidated finances even if domestic operations are profitable. The point has not been missed on the stock market and the companies with foreign exposure have been hit hardest in the market meltdown. In contrast, domestic-market focused companies are going strong as Indian economy continues to grow despite a global recession. The contrast comes clearly when we compare Tata Steel and SAIL. In the past 12 months, stock price of Tata Steel is down nearly 75% while SAIL's share price has kept pace with the benchmark indices and is down just 35%. The market has punished Tata Steel despite it being a more cost-efficient steel producer. What's pulling down Tata Steel is Corus, which it acquired for $13.7 billion to become world's sixth largest steel maker. The story is similar in case of Nalco and Hindalco. Though the latter is India's largest and one of the world's lowest cost aluminium producers, its shares have been one of worst performers in the sector. Hindalco is being weighed down by the market concerns regarding the financial health of its American subsidiary - Novelis. Companies who have set up operations abroad have seen considerable erosion in value as against companies with predominant Indian operations. For instance, Cipla is now twice more valuable than Ranbaxy and Dr Reddy's Laboratories, despite it being the smallest of the three. And this is not without merit. Cipla is now one of India's most profitable drug makers. What has worked in its favour is its steadfast strategy to serve the domestic market and use India as a low-cost manufacturing hub and stay away from cross-border M&A. In contrast, Dr Reddy's and Ranbaxy have aggressively expanded overseas through a series of acquisitions. The story is same in the auto sector, where domestic-market focused companies such as Maruti Suzuki, Hero Honda and Bosch are doing much better than their counterparts with deep connections to rest of the world. The contrast is becoming even more evident as companies report their latest quarterly numbers. Foreign operations are not only hit by a global recession, but they also expose Indian owners to foreign currency risk and rising cost of servicing the acquisition cost. Reliance Industries, for instance, made a provision of Rs 370 crore towards possible diminution in value of overseas subsidiaries. Praj Industries also has made a similar type of write-off of Rs 11.2 crore. This is for the first

time that these companies have made such provisions. Ranbaxy is facing losses in their European business and has witnessed significant drop in growth. Marico has also reported poor performance in Egyptian operations. In such scenario, companies have no option but to undertake restructuring of their overseas operations. But this is costly and time-consuming exercise. Besides, it may deflect companies' attention from the domestic market, which may prove costly in the long-run.

Top ET Bureau / Friday, 01 May 2009 New Delhi rejects American firm's plea to patent Hepatitis B drug Khomba Singh NEW DELHI: The Delhi Patent Office has rejected American company Gilead Sciences' plea to patent its Hepatitis B drug adefovir dipivoxil sold under the brand name Hepsera. India's largest drugmaker Ranbaxy had filed a pre-grant opposition against Gilead's patent application saying that it is not a new drug and lacked inventions. This is Gilead's second drug to be rejected by the Delhi Patent office in the last two months. Last month, the same patent office turned down the company's patent application for its popular antiflu drug Tamiflu as the patent office found merit in Cipla's opposition that the drug lacked invention to be given a patent under Indian patent laws. Hepsera is also used by HIV patients infected with Hepatitis B. As per Gilead's website, Hepsera is used to treat chronic infection with hepatitis B virus (HBV) in adults. It stop Hepatitis B virus (HBV) from multiplying by blocking HBV DNA polymerase, an enzyme that is necessary for the replication of the virus in the body. A patent grant to Gilead for Hepsera would have prevented any other generic company from making a low cost version of the drug without the consent of the patent-holder for the next two decades. The drug has an annual sales of around $285 million. In its order last month, the Delhi patent office's assistant controller of patents & designs N R Meera refused to grant patent for Hepsera. Mumbai-based patent consultancy firm IP Feathers' Varun Chhonkar who reviewed the decision said the patent office found Gliead's application lacking inventive step and failed to provide comparative data with respect to known substance to prove improvement enhanced thereupatic efficacy. Gilead has reportedly said it will contest the rejection of its patent application for its other drug, Tamiflu. The rejection came as a timely booster for generic drugmakers ahead of the global Swine flu outbreak. Cipla and other generic companies can now legally manufacture and sell their generic drug in India and other countries where Roche does not hold patent.

Swiss company Roche has the marketing license for the drug in India and as per Gilead's website it earned around $33 million globally for the quarter ended March 31, as royalties for Tamiflu from Roche.

Top moneycontrol.com / Monday, 27 April 2009 Cipla wins Erlotinib case against Roche Cipla touched a 52-week high of Rs 247.50. At 10 am, the share was quoting at Rs 247, up Rs 6.70, or 2.79% on the NSE. The company has won Erlotinib case against Roche in Delhi HC. The Roche's appeal has dismissed with Rs 5 lakh penalty, reports CNBC-TV18. It was trading with volumes of 104,410 shares. On Friday the share closed up 3.94% or Rs 9.10 at Rs 240.30. Share Price Movement During The Last 12 Months Period 3-Days 5-Days 7-Days 15-Days 1-Month 3-Month 6-Month 9-Month 1-Year Price 227.15 222.70 230.00 227.20 203.30 191.10 160.10 231.70 226.60 Latest Price 247.00 247.00 247.00 247.00 247.00 247.00 247.00 247.00 247.00 Gain/Loss (Rs.) 19.85 24.30 17.00 19.80 43.70 55.90 86.90 15.30 20.40 % Gain/Loss 8.74 10.91 7.39 8.71 21.50 29.25 54.28 6.60 9.00

Top The Hindu Business Line / Saturday, 25 April 2009 Cipla Q4 net profit up on better product-mix Expects tough year ahead.

Our Bureau Mumbai, April 24 Drug-maker Cipla Ltd sees the year ahead being tough, as a result of intense generic competition and the slowdown in global markets. But the negative impact could be blunted by the company's spread of exports across geographies, besides having products in several therapeutic segments, said Cipla's Chief Executive, Mr Amar Lulla. Cipla's net profit for the quarter increased on the back of a better product-mix, he said. But the company also saw a forex hit of Rs 10 crore in the current quarter, against Rs 25 crore in the corresponding last quarter. Cipla is unlikely to be hit by forex-related activity, going ahead, since it has accounted for all such activity, provided there is no major rupee-related fluctuation, he said. There has been an increase of 49 per cent in other expenditure (Rs 122 crore) on account of sales expenditure, foreign exchange loss and year-end provisions, the company said. Domestic Sales Cipla saw domestic sales grow by 16 per cent, while exports grew by 11 per cent, during the quarter under review. The company's exports of active pharmaceutical ingredients, though, saw close to five per cent dip in the quarter. Cipla will increasingly focus on formulations that make for a more sustainable segment, he said. Material cost has decreased during the quarter mainly because of favourable exchange rate and changes in product mix. This impact is also reflected in increased operating margins, as compared to the previous year, since exports are booked at prevailing exchange rates, the company said.

The company posted a net profit of Rs 767 crore for the year ended March 31, 2009, as compared to Rs 701 crore in the corresponding period last year. Total income increased from Rs 4,271 crore for the year ended March 31, 2008 to Rs 5,338 crore for the year ended March 31, 2009. Cipla's shares were up close to four per cent on the BSE, at Rs 239 on Friday.

Top The Times Of India / Monday, 02 March 2009 Pharma retail market grows 15% NEW DELHI: The domestic pharma retail market has started the year with a bang, recording nearly 15% growth in January. The market had grown by nearly 10% during January-December 2008, and over 13% in December alone. There was no major change in rankings of pharma companies in January in terms of market share, with Cipla garnering the largest, followed by Ranbaxy and GlaxoSmithKline at third position, according to consulting company, ORG-IMS. Piramal Healthcare was ranked fourth, followed by Zydus Cadila at the fifth slot in terms of market share. During January, Pfizer moved up two ranks to the 10th position among companies with the largest retail sales in the market. Abbott (rank 12), Dr Reddy's Labs (rank 14), Intas Pharma (rank 18) and Micro Labs (rank 20) gained one rank each, as against December last year. The domestic retail market valued at Rs 2,908 crore in January, has been recording a growth for the last three consecutive months since November 2008, after a slight blip in October. The value growth for 12-month period ended January (moving annual total basis) was 9.9%, which is almost the same as December's growth of 9.8% (as per December MAT). Industry experts pointed out that pharmaceuticals and healthcare are recession-proof sectors, and will keep growing at a steady pace over the next few months. In January, pain killer drug, Spasmo-Proxyvon was the highest gainer in ranks, amongst the largest selling drugs, moving up from the 24th slot in December to the 18th. The other major gainers are vitamin supplement Revital, having moved up from the 11th slot in December to seventh position in January, and iron supplement Dexorange, gaining four ranks (rank 11 as per January '09). Zinetac used to treat peptic ulcer moved up three slots to the 14th position, up

from rank 17 in December. Among the therapeutic areas, cardiovascular segment recorded a 14% growth, while antiinfective medicines grew 10% during the month.

Top The Hindu Business Line / Wednesday, 25 February 2009 Patents yes, but monopoly no India needs to protect its national interests and not worry about ruffling feathers internationally.

DR YUSUF K. HAMIED, CHAIRMAN, CIPLA P. T. Jyothi Datta It is in this room that Parvinder and I started the IPA (Indian Pharmaceutical Alliance), says the Cipla Chairman, Dr Yusuf K. Hamied, pointing to his office, where M. F. Hussain paintings sit easy with stacks of papers on intellectual property, the Doha debates and speeches crusading against monopolistic practices of drug companies. We were indigenous companies, coming together to jointly fight, he reminisces. Under the leadership of its former chairman, the late Parvinder Singh, Ranbaxy had joined companies such as Cipla and Dr Reddy's in taking the generic-drugs battle right into the

backyard of multinational companies, by selling into developed and developing markets. But almost a decade later, there has been no easing of challenges for generic drug-makers, with the latest weapon being Intellectual Property Rights (IPR) and the hydra-headed manner in which it is being interpreted and implemented, globally and at home. As a scientist, I believe in patentsbut I do not believe in monopoly, he says, responding to what the generic drugs industry perceives as covert global efforts to raise obstacles in their way, including equating generics or chemically similar medicines to counterfeits. In the last three-odd months, Indian generic drug-makers Ind-Swift, Dr Reddy's and Cipla have had their medicine consignments seized at Amsterdam, though these shipments were just transiting to South American destinations. The export consignments were held on IPR investigations and the companies involved have since taken back their consignments or abandoned them. The seizure of the export consignment was done using a European Commission regulation of 2003. And such an interpretation of this rule, five years after being brought into force, was again, a ploy to retain monopoly, says Dr Hamied. At home too, a cocktail of IPR challenges has only added to the woes of local companies, he says, tracing back to the build-up and amendment of the Indian Patent Law in 2005, after which the country started honouring product patents. Then came the more recent attempts in the country to link the issue of patents (given by the Patent Controller's office) with the marketing approvals on medicines given by the Drug Controller General of India's office, an issue currently being fought in the courts here. Frivolous patents Elaborating on his concerns of companies trying to retain monopoly, he explained that an amendment to the Indian Patent Act had been introduced through Section 3d essentially to stop the ever-greening of patents. Ever-greening refers to the practice of drug companies that are known to make small incremental changes to existing drug molecules to extend the patent even as the original 20-year protection expires. There were about 7,000 patents pending clearance once the amended Patent Law came into effect. I am repeating this, again and again and again, that of those 7,000 patents, according to me, 5,000 would be in the 3d category of no novelty, he says, adding that the observation was based on existing pharma patents. Novelty salts, esters, polymorphs, etc., could be not eligible for patents; moreover, some of these patents with minor variations are not legally patentable. We are seeing the same patent under different applications coming in. My contention is, of the

patents that the multinationals have put into India and that do not qualify under 3d or on novelty, such as combinations, they should voluntarily withdraw. Not a single patent has been voluntarily withdrawn (till) today, he observes. Out of bounds Referring to the patent-related litigation that Cipla is involved in, he says, We do not like breaking laws. Where we felt we had a very strong case and a good case, we have challenged. Where we have no case, like in the third and fourth generations ARVs (anti-retroviral drugs for AIDS), we have not challenged, he says. Such an admission should have set off alarm bells among the powers that be, coming from Cipla. The Mumbai-based drug-maker had in 2001 set the cat amongst the pigeons when it offered its generic AIDS drugs at a fraction of the MNC price in the African market, forcing the bigger companies to slash prices. Eight years later, Cipla admits that the next generation of AIDS-drugs are out of bounds for generic drug-makers, as they are product patent-protected. The ramifications of Dr Hamied's admission on next-generation AIDS drugs is worrying, as it is not restricted to just this segment of medicines or market. Indian generic drug-makers supply medicines across therapeutic segments to several countries in the world, and this could take a hit, affecting not just the companies, but patients as well. A permanent compulsory licensing (CL) system, where generic companies are allowed to make copies of the innovator's medicine, but on the payment of a royalty of, say, four per cent of their sales, is what Dr Hamied suggests to break the impasse. But whether this suggestion will have takers in the Government or among other innovator companies is still to be seen. We were promised categorically by the Government that product patents will only kick in post-2005. Not back-dated to 1995, he laments. What is wrong is India's defensive attitude. Why are we defending all the time?, he asks, in his characteristic rhetorical style. The EMR (exclusive marketing rights), that was thrust on us, was done retrospectively, he says. The rationale was that process patents filed from 1995 till 2000 could be converted into product-patents on EMRs. World trade rules do not allow patenting in retrospect, he adds. You cannot backdate. Some of the products that were invented in this five-year period, we were working on, thinking that these were process patents and not product patents, he says. National, not international India needs to protect its national interests and not worry about ruffling feathers internationally, he states emphatically. When India is nowhere in the human development report, how are we

classified as a developed country. Just because there are pockets in India that are super developed, doesn't make India a shining country, he observes, campaigning for a workable CL system. Third world countries including India cannot afford monopoly. I am repeating it to such an extent that people say you have nothing else to talk about, he exclaims. Distancing the discussion from his company and my newspaper, he says: I am saying what is best for our country, irrespective of Cipla, irrespective of everything. And genuinely, believe me. I have been saying it now for 50 years. Even in 1961, before the patent laws were changed in 1972, we had meetings with the multinationals I said, as a scientist, I believe in patents, I am not saying no. But I do not believe in monopoly. I am willing to pay a royalty. Citing Canada's CL system, he says, nobody objected to it neither the Americans nor the Europeans. Why can't India have a similar system, without worrying about upsetting international friends? When people cannot afford drugs, particularly anti-cancer drugs, at some time it was the antiAIDS drugs, only competition can help you. We are willing to pay royalty but do not stop us from manufacturing, he says.

Top IRIS / Wednesday, 03 December 2008 Cipla gets USFDA nod for Pamidronate disodium injection

Leading drug maker, Cipla has received final approval from the US Food and Drug Administration (USFDA) to market Pamidronate disodium injection, in the strengths of 30 mg/vial, 60 mg/vial and 90 mg/ vial. Pamidronate disodium acts on bone to help regulate blood calcium levels. It is used to treat Paget`s disease of bone and to treat high blood calcium levels. The medication is also been used in the treatment of osteoporosis, to reduce bone pain associated with certain illnesses and to treat bone loss due to breast cancer. Shares of the company declined Rs 2.1, or 1.13%, to settle at Rs 183. The total volume of shares traded was 231,412 at the BSE (Wednesday).

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The Times Of India - New Delhi / Monday, 27 October 2008 Pharma holds steady, Cipla pips Ranbaxy Rupali Mukherjee, TNN Amidst all the gloom confronting the economy, the pharma sector posted a robust growth of over 14% in September, with Cipla emerging as leader in the domestic retail market with a market share of 5.31% in September, overtaking Ranbaxy. Till July this year, Ranbaxy had been leading with a 5.10% share of the market. In September, Ranbaxy ranked second garnering a 5.11% share, while GlaxoSmithKline occupied the third slot with 4.47% market share. Piramal Healthcare and Zydus Cadila were ranked fourth and fifth in the domestic market with shares of 3.75% and 3.59% respectively. The domestic pharma market posted a healthy growth of over 14% in September, with the market valued at Rs 33,605 crore, according to consulting company, ORG IMS. The market had grown by over 12% in August. Pharma companies are, however, not posting strong financial results in the second quarter due to other factors like input and over-head costs. In September last year, the company rankings were pretty much the same with Cipla leading with a share of 5.09%, followed by Ranbaxy at 4.90% and GSK at 4.86%. Cipla has maintained the top slot in the market for the last two years. On a moving annual total basis in September (12-month period ended September), major gainers (in value terms) include Cipla at 17.7%, Ranbaxy and Sun Pharma each at 17.6%, Lupin at 20.9% and Mankind at 35.4%. Overall, the pharma market grew by nearly 13% on a MAT basis in September. During the month, the respiratory segment has shown a healthy growth of 14%, while antiinfectives have recorded over 18% growth and cardio-vascular drugs grew by 18%. Unlike other sectors of the economy, the domestic pharma market has been able to sustain its growth over the past one year, with a CAGR of 15%. Chronic therapy has consistently increased its contribution to the domestic market with the share of acute segment considerably shrinking over the past few years. Within the chronic segment, anti-diabetic drugs have shown the highest value growth, followed by cardiac therapy during first half of the year. Anti-infective drugs have also recorded a robust growth during the period. During the six-month period, gastro-intestinal therapy grossed the third highest value in the market, followed by the respiratory category.

Top Business Standard / Wednesday, 23 July 2008 Cipla: Active in overseas markets Shobhana Subramanian & Varun Sharma

Stronger exports have helped boost revenues. Driven by a smart 50 per cent growth in exports, the Rs 4,227 crore Cipla posted a top line growth of nearly 34 per cent in the June 2008 quarter. The relatively low base of Q1FY08 and a weaker rupee notwithstanding, this is the fourth quarter of successive good growth recorded by the drug major. Revenues from the home market in June too have grown at a reasonably good 16 per cent and consequently the operating profit margin expanded 360 basis to 22 per cent, after adjusting for a forex loss of Rs 75 crore. The forex loss, however, depressed the net profit which rose just 17 per cent to Rs 140 crore. Exports accounted for about half the firm's revenues of Rs 1207 crore last quarter. Analysts believe the higher sales of active pharmaceutical ingredients (API) could have included supplies to Teva, for a product sold exclusively in the US for a period of 180 days. However, since such orders for supplies during periods of exclusivity do not recur too often, it will be sales of formulations that will determine the pace of Cipla's exports in subsequent quarters. To sustain a 25-30 per cent growth in exports, however, the company will need to increase the proportion of high value products, like inhalers, to regulated markets. Cipla, which has launched asthma inhalers in Germany , Spain and Portugal , is looking to gain a foothold in the CFC-free inhaler market. Cipla has one of the strongest pipelines of generics among Indian companies. The company has pursued a strategy of teaming up with players overseas but does not get involved in patent litigation. It has recently roped in a couple of partners in the US and EU and plans to supply over 100 products to overseas markets in the next few years. The management believes the company's revenues can grow at 12-15 per cent in FY09 and net profits at around 11-13 per cent. The earnings per share is estimated to increase by about 20 per cent. In a weak market, the pharma sector has been outperforming, with Cipla's stock gaining 7 per cent since the start of 2008. At the current price of Rs. 238, the stock trades at a shade over 21 times estimated FY09 earnings and is a tad expensive.

Top FDAnews Drug Daily Bulletin / Monday, 07 July 2008 Cipla Gets Thumbs Up for Generic HIV Drug Indian drugmaker Cipla has received FDA approval for its HIV treatment zidovudine oral

solution 50 mg/5 mL, a generic version of GlaxoSmithKline's Retrovir. The generic Retrovir application was considered under the expedited review provisions of the President's Emergency Plan for AIDS Relief (PEPFAR), a five-year, $15 billion program aimed at combating HIV and other diseases in 114 countries including 15 focus countries primarily in Africa that President Bush announced in 2003. Zidovudine is a nucleoside reverse transcriptase inhibitor intended to be used with other antiretroviral agents to treat HIV-1 infection. The approval means no patents or exclusivity prevent marketing the drug in the U.S. The FDA often tentatively approves generic versions of HIV drugs still under patent protection in the U.S. so the generics may be eligible for purchase under PEPFAR for use in other countries, the FDA said. In February, Matrix Laboratories received FDA approval for its generic version of Retrovir 300-mg tablets.

Top The Economics Times - New Delhi /Tuesday, 01 July 2008 Cipla gets patent for Nexium, Fosamax modified versions Khomba Singh, ET Bureau Domestic pharma major Cipla has received product patents for new forms of two blockbuster drugsOsemaprazole and Alendronatefrom the Indian authorities. While the company's patent on Osemaprazole is a modified form of Astrazeneca's blockbuster drug marketed under the brand name Nexium, Alendronate is one of the best-selling drug of Merck sold under the brand name Fosamax. Nexium, the world's second-largest selling drug, has annual sales of around $5.2 billion while Fosamax recorded sales of $3 billion in 2007. Fosamax's patent expired in February this year while Nexium's patent expires in 2014. When contacted, Cipla joint MD Amar Lulla said, These are novel formulations with a significant thereupatic advantages than though it uses the same chemical. We plan to launch the drug globally. The company has sought patents globally through an application with the Patent Cooperation Treaty (PCT) filing. If a company files a patent application with the PCT, its application will automatically go to all TRIPS compliant countries. Cipla also got the patent in India through its PCT application. According to the Indian patent office website, the Mumbai patent office granted in April this year.

Top The Economic Times - New Delhi / Monday, 05 May 2008 Cipla offers free know-how of essential drugs to PSUs

Khomba Singh, TNN At a time when the government is aggressively imposing price controls on essential drugs, Cipla has made an unconditional offer to share the know-how of making all 354 essential drugs with the public sector drug manufacturers . This follows the pharma industry's offer to sell the essential drugs at half its maximum retail price (MRP) to the government subject to certain conditions. Incidentally, Cipla, the largest drug maker in the country by sales, is not a part of the industry association which made the separate offer to the authorities. The firm is willing to share the know-how of making these drugs without any monetary consideration. Cipla joint MD Amar Lulla told ET, We are willing to give the technological know-how to manufacture all the 354 essential drugs to the government. He added that instead of bringing selective price control on brands and drugs, the government can manufacture these drugs in the state-owned units and distribute it through the primary healthcare centres, medical hospitals and public health institutions at reasonable prices. According to him, this will not only meet the government's objective of providing essential medicines at most reasonable prices, but also make the public sector organisations economically viable. Recently, industry body Indian Pharmaceutical Alliance (IPA) offered to sell essential medicines to the government at 50% of their MRP. They also offered to finance a mechanism to deliver these drugs at a concessional price by contributing 0.25% of their total profits to the government, which could be a little less than Rs 10 crore. This would be in addition to the corporate taxes the companies pay to the exchequer. However, this offer was conditional upon the government limiting the number of drugs under price control to the existing 74 drugs. Cipla markets 803 products in the Rs 32,000-crore domestic pharmaceutical market with 5.2% market share, according to the latest monthly sales figures of ORG-IMS. The string of such proposals from drug makers comes in the wake of a policy proposal by the government to extend the list of drugs under price control to all essential drugs. However, a senior industry official said that all the proposals would be irrelevant now as the ministries responsible for regulation and implementation of drug policies have to first sort out their internal differences. The two ministriesChemical & Fertiliser and Health which oversee drug firms have overlapping jurisdiction.

Top IRIS / Monday, 23 June 2008 Cipla gets tentative approval from USFDA

Cipla has received tentative approval from the US Food and Drug Administration (USFDA), for Lamivudine/Stavudine 30 mg/6 mg tablets and Lamivudine/Stavudine 60 mg/12 mg tablets for pediatric use. Lamivudine and stavudine are anti-viral drugs indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. Shares of the company closed down Rs 5.25, or 2.42%, at Rs 212.1. The total volume of shares traded at the BSE was 470,501 (Friday).

Top Business Standard / Wednesday, 30 April 2008 Cipla: Overseas sales a booster The drug firm has managed to grow its top line but operating margins remain uninspiring. The Rs 4,227 crore drug major Cipla has just seen its best ever quarter for international sales logging a growth of 23 per cent, driven by higher sales of international active pharmaceuticals ingredients and finished dosages. Cipla follows a strategy where it has partners in foreign markets to sell products. While this model limits aggressive profit expansion, since the company has to share profits with the overseas partner, it also involves a lower risk because expenses on marketing and allied costs are lower. Unlike in recent quarters, where profits have been boosted by technology fees, the March 2008 quarter has seen the both domestic and overseas businesses fare well, the former growing 13 per cent. However, while Cipla's domestic sales in the March quarter were reasonably good, they were not as brisk as those of players like Ranbaxy, which posted an increase of 16 per cent. Technology fees too brought in some money for Cipla, though less than in previous quarters. As a result, the company's operating profit grew a fairly impressive 39 per cent to 203 crore, on a revenue growth of 19.6 per cent. However some of it was due to foreign exchange gains rather than from the core business. So while Cipla may have managed to improve its operating profit margin for the March 2008 quarter by 240 basis points to 18.1 per cent, this was well below the company's run rate for the

past two years. Besides,the higher margins also came off a low base. The street was expecting much more and was disappointed because the margin expansion was more the result of a much lower other expenditure,which dropped nearly 200 basis points as a percentage of sales. For the full year FY08, the company's operating profit margin fell 290 basis points to just over 20 per cent, because of higher raw material costs. Moreover, the Cipla management expects to grow revenues by just about 12-15 per cent and maintain margins in FY09, numbers that have not enthused industry watchers. Technology fees could be lower in the coming years and forex gains are unlikely to sustain. Analysts believe that earnings should grow by about 10-14 per cent over the next couple of years. Other large generic players like Ranbaxy saw operating profit margins improve by 290 basis points to 15 per cent in the March 2008 quarter. The Cipla stock stayed flat on Tuesday at around Rs 215. At this price the stock trades at 21.6 times estimated FY 09 earnings and are not cheap given the risks in the business. Thus, the stock should be a market performer going forward. Ranbaxy, at the current price of Rs 485, is somewhat cheaper and trades at under 21 times estimated CY 08 earnings, but that too is expected to perform only in line with the broader market.

Top The Econonic Times / Thursday, 20 March 2008 Cipla scores a generic win over Roche NEW DELHI: In what could be a shot in the arm for Indian generic drug makers, the Delhi High Court on Wednesday rejected an injunction plea by Swiss drug major Roche to prevent Cipla from manufacturing and selling generic versions of its patented anti-cancer drug Tarceva (Erlotinib) in India. The Indian drug makers generic version of Tarceva is priced at one-third the price of Tarceva and the HC rejected Roche appeal in public interest given the huge cost difference between the two drugs. However, this is only an interim order and HC will deliver its final judgement at the completion of the hearing. The court has also directed Cipla to keep a separate record of the sale of its generic anti-cancer drug as it will have to compensate Roche if the final verdict goes in favour of the Swiss company. Roche has applied for a stay (on the sale of the generic version of Tarceva). This is an interim

order for not granting the stay, said Cipla joint MD Amar Lulla. The court has given an interim order which allows Cipla to market the generic copy of Tarceva. However, Cipla has been asked to keep the sales record of Tarceva separately, as Cipla would have to pay profit and damages cost to Roche if the Swiss company gets a favourable verdict after the complete hearing, an executive of an Indian drug maker who attended the hearing told ET. Ciplas share closed at Rs 206 on BSE, up 0.76% from Tuesdays close of Rs 204.45. Roche received patent for Tarceva in India last year, but has been subsequently facing post-grant patent opposition from Cipla and NGOs. Two months ago Cipla decided to market copy cat versions of the drug in India at Rs 1,600 per tablet one-third the cost of the patented drug. India, with a strong generic drug industry is fast becoming a battle ground between domestic drug makers and big pharma MNCs. With the Indian pharma industry set to grow annually at 13%, drug discovery companies are keen to establish a strong presence in India and protect their patents here. Domestic drug makers, on the other hand, want a liberal interpretation of the Indian patent laws and any favourable verdict strengthens their case. Watching closely from the sidelines are consumers who stand to gain if generic versions are introduced at lower costs. In addition, there are concerns in the government that once drugs are patented, the cost of medical treatment could become unaffordable and will prevent many patients from getting treatment of diseases such as HIV and cancer. Several Indian companies and NGOs have filed both pre-patent and post-patent oppositions to prevent global companies from getting patent protection. In the much publicised Glivec case, Novartis had unsuccessfully challenged section 3(d) of the Indian patent law which states that an innovation to a drug can only be granted patent if the new drug provides significant therapeutic advantages. This decision had made Indian patent laws one of the most effective in the world. Another Indian drug maker, Hyderabad-based Natco has also sought compulsory licensing (CL) from the government for two cancer drugs Tarceva and Pfizers Sunitnib (Sutent). However, the decision on Ciplas case is not expected to have any bearing on Natcos plea for a CL.

Top Business Standard / Tuesday, 01 January 2008 Cipla maintains No.1 position in Indian mkt P B Jayakumar Mumbai

Tops pharma rankings with 5.42% market share, a head of Ranbaxy and GSK. Cipla Laboratories continues to be the largest pharmaceutical company in the domestic market. Cipla has topped the ORG-IMS rankings for the month of November with a market share of 5.42 per cent and sales of Rs 146.32 crore, edging out Ranbaxy which stood at second position with 5.09 per cent market share and Rs 137.49 crore sales. In October, Cipla topped with Rs 152.04 crore sales and a market share of 5.23 per cent, ahead of Ranbaxy, which garnered Rs 148.40 crore sales and 5.11 per cent market share, said sources. Cipla overtook Ranbaxy and GlaxoSmithKline India (GSK) to become the largest pharmaceutical company in the domestic market for the first time in May 2007. While GSK has maintained its number three position in November, Zydus Cadila (fourth), Alkem Laboratories (fifth) and Sun Pharma (sixth) have moved one rank up from October. Nicholas Piramal, which faced raw material shortages for its largest selling codiene based formulations, like Phensydyl, in recent months, slipped three positions to number seven in November. ORG-IMS, the largest market intelligence company in India focusing on the healthcare sector, tracks sales of Indian pharmas on a monthly basis, through over 3,000 stockists and 6,000 doctors. Indian companies are increasing their share in the domestic market mainly due to increased number of high value new introductions, though the number of new introductions have reduced recently, Shailesh Gadre, managing director, ORG-IMS, said in an interview last week. Ranbaxy's growth has been largely driven by new introductions such as Volix, an anti-diabetes drug launched in January, Oframax-Forte and anti-asthmatic drug Synasma, which it in-licensed from Eurodrug Laboratories. Ranbaxy's antibiotic Mox (amoxyllin), which was not among the top ten brands a year ago, has grown to become the fourth largest brand in the domestic market with monthly sales at Rs 9.8 crore in November, sources said. Cipla's growth was powered by positive growth in their existing portfolio, especially its respiratory products. However, GSK has lost market share mainly in its main portfolios such as anti- infectives, dermatologicals and pain management drugs which grew slower than the market for these products, ORG-IMS said. ORG-IMS named Alkem Laboratories as the only company among the top ten for which both older products (10 per cent) and new introductions (12 per cent) have contributed significantly

to value growth. Our growth in the domestic market is mainly due to the growth of our anti-infective Taxim and other brands such as Taximo, Clavem, A to Z and Gemcal, explained Vinod Dua, head, domestic business of Alkem Laboratories. Alkem's Taxim is now the third largest brand in the domestic market with sales of Rs 10.3 crore, behind Pfizer's cough syrup Corex (Rs 15.2 crore) and Novartis India's pain killer Voveron (Rs 11.6 crore).

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