Cipla in the News

8/2/2019 Cipla in the News

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Cipla In The News

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02 March 2011 Cipla introduces new pain free screening technology for early detection ofbreast cancer in India - No Touch Breast Scan

30 November 2010 Cipla extends an innovative Mother-Baby Pack forpreventing mother-to-child transmission of HIV/AIDS

20 October 2010 Cipla launches the worlds first generic Pirfenidone in India, giving hopeto 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,2009

Cipla launches generic drug to treat H1N1

25 September,2009

Pharmaceuticals Export Promotion Council Awards

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 injection27 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

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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 2011Cipla 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 ofa breakthrough screening technology in India today called the No Touch Breast Scan(NTBS); ' the first-ever painless, non-invasive and radiation-free breast scanningtechnique 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 SurgeryClinic, Pune said, Breast cancer is rising rapidly among urban women and is now the mostcommon cancer in cities such as Mumbai and Delhi . Unfortunately most cancers are diagnosedwhen the disease is advanced leading to low chances of cure. Although Mammography hasbeen available for years it is not used that widely. There are many reasons for it such as lack ofawareness, pain and discomfort during the procedure and a concern about repeated exposure to
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radiation. Welcoming the introduction of NTBS in India , Dr. Rakesh Sinha, ConsultantGynaecologist Surgeon, BEAMS Hospital , Mumbai said, The No-Touch Breast scan is apainless option for women who wish to get themselves regularly screened. It is of particular usein younger women who have dense breasts and mammography is inconclusive. If a womanshows 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 undergonethe 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 breastcancer. With improvements in digital camera technology during the last few years, thermalimaging is fast gaining acceptance. Developed by UE Life Sciences Inc, the No Touch BreastScan' is the World's first fully computerized thermal imaging technology' with dual IR cameraswhich can find thermal changes at less than 0.08 deg. C. The NTBS using infrared imagingcreates a sophisticated heat-map of the breast without using any radiation. Breast cancer isassociated with increased formation of new blood vessels and these show up as 'hot spots' whichcould indicate a cancerous growth.

At Dr Kulkarni's Magnolia Beauty and Clinic in Pune, the NTBS test was taken by about 165women and only 12 of them needed further investigation. Mrs. Ambike, an asymptomaticwoman who has untaken the NTBS test said, I had taken a mammography test earlier but itwas quite traumatic. With this totally touch-free and quick NTBS test, I would not defer myannual check-up anymore.

The No-Touch Breast Scan' would be exclusively marketed by Cipla across diagnostic centresand hospitals in India . It has already been installed at BEAMS Hospital , Mumbai and Indoreand Magnolia Beauty and Clinic, Pune and would be extended by Cipla on a requirement-basisto 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 cancerby manufacturing drugs for the last 20 years but this is for the first time we have taken a steptowards focusing on early diagnosis of breast cancer.

There are 3 NTBS machines available in the US , UK , Turkey and Kazakhstan , but women inIndia would have greater access to this landmark technology and have more control over theirbreast health.

The cost of per NTBS test would range between Rs 8001000, depending on the pricingdetermined 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 canceramong women in all urban cancer registries

As of today, 1 in every 22 women in India in their lifetime is expected to be diagnosedwith 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;


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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 thanany other female cancer.

According to a study by International Agency for Research on Cancer (IARC) a branchof WHO, there will be approximately 250,000 new cases of breast cancer in India by2015.

According to National Institutes of Health, nearly 90% diagnosed will survive at least 5years

About Cipla:

Cipla laid foundations for the Indian pharmaceutical industry back in 1935 with the vision tomake India self-reliant in healthcare. Over the years Cipla has emerged as one of the mostrespected names not just in India but worldwide. Its state of the art R&D centre has given thecountry 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 over1200 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 andinnovative devices. (www.cipla.com )

Media Contact:-

Antara Mukherjee

Corporate CommunicationsCiplaMob: (+91) 9967516441E Mail:[email protected]

Jaisingh Balakrishnan

Corporate CommunicationsCiplaMob: (+91) - 9833836185E Mail:[email protected]

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Tuesday, 30 November 2010Cipla extends an innovative Mother-Baby Pack' for preventing mother-to-child transmission ofHIV/AIDS

India, 30 th November 2010: In keeping with its commitment to reduce mother-to-childtransmission of HIV/AIDS, Cipla, one of the world's leading generic pharmaceutical companieshas developed the first-of-its kind Mother-Baby Pack' in collaboration with UNICEF and otherpartners . The Mother-Baby Pack contains the entire range of anti-retroviral drugs andantibiotics required by an HIV infected mother starting from the 14 th week of pregnancy un tilthe 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 , theMother-Baby Pack is a color-coded take-home kit with simple graphics to help mothers identify
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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 forthe new born baby. Launched in Kenya , Cameroon , Zambia and Lesotho , the Mother-BabyPack thereby addresses the logistical challenge of access to essential HIV drugs during theentire term of pregnancy and the susceptible period thereafter.

Over 1,000 infants contract HIV everyday from their mothers at the time of birth with thehighest rate reported in sub-Saharan Africa . The risk of transmission from an infected motherto 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 tobreastfeeding. 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 theremotest corner of the least developed nations would have daily access to essential PMTCTdrugs during her entire term of pregnancy at the convenience of her own home. On makinganother landmark contribution in the fight against HIV/AIDS, Dr. Y. K. Hamied, Chairmanand 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 infectedexpectant mothers and the specially designed Mother-Baby Pack will increase adherence andplay 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 worldclass 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 atreducing the rate of mother-to-child transmission by 50% in the developing countries. Throughthis 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 variousMinistries of Health in sub-Saharan Africa , various NGO's and donor agencies for theirtreatment programmes. This reinforces Cipla's commitment to make affordable medicinesaccessible 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 ofHIV/AIDS treatment of at least $12,000 per patient per year had made the scientificachievements in drug innovation inaccessible to the ordinary people of the developing nationswho 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 belowDollar a Day.' With the reduced cost of $300 per patient per year, HIV/AIDS treatment becamea reality and the survival rates went up dramatically.

Further, Cipla's innovation of a Fixed Dose Combination (FDC) in 2001 of the triple cocktaildrug' 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


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initiated a patient education campaign Living with Hope' in 2004 and has been conductingseveral ongoing training programs and CMEs in India and internationally to cover variousaspects 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 severalinternational 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 onCipla 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 tomake India self-reliant and self-sufficient in healthcare. Over the years Cipla has emerged asone of the most respected pharma names not just in India but worldwide. Its R&D centre hasgiven the country and the world many firsts. This includes the revolutionary HIV/AIDS cocktailfor 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 180countries. It has earned a name for maintaining one global standard across all its products andservices. Cipla continues to support, improve and save millions of lives with its high-qualitydrugs and innovative devices. (www.cipla.com)

Media Contact :

Antara MukherjeeHeadCorporate CommunicationsMob: (+91) 9967516441

E Mail:[email protected]

Jaisingh BalakrishnanCorporate CommunicationsMob: (+91) 9773372487

E Mail:[email protected]

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Wednesday, 20 October 2010Cipla 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 Pirfenidonein India; under the brand name Pirfenex, for the treatment of IPF. A chronic progressive form oflung 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-fibroticdrug which through clinical trials has shown to slow down progression of this terminal diseaseand stabilize lung function.

Cipla's technical prowess along with leadership in terms of range of drugs and therapeuticcategories in the respiratory segment, is leading the fight to provide world class affordabletreatment 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
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increased availability and affordability, Pirfenex could now offer hope to those afflicted withthis condition.

Pirfenex will be manufactured at Cipla's state-of-the-art manufacturing facility at HimachalPradesh, India which is approved by WHO, MCCSouth Africa and TGAAustralia.

In addition to the launch, Cipla will host and disseminate a series of lectures on IPF tophysicians in India and across the world. Addressing the delegates Prof Luca Richeldi,Director, Center for Rare Lung Diseases, University of Modena and Reggio Emilia, Italysaid "Patients affected by IPF have a distinctively poor prognosis, and until now no drugs havebeen approved to treat IPF. Pirfenidone represents the first concrete chance of slowing downdisease progression. The effect on increasing progression free survival, as showed in threecombined studies, coupled with an acceptable safety profile, opens up a new path for bettermanagement 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 therespiratory arena with products and services in 8 therapeutic areas viz. asthma, COPD, allergicrhinitis, 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 tomake India self-reliant in healthcare. Over the years Cipla has emerged as one of the mostrespected names not just in India but worldwide. Its state of the art R&D centre has given thecountry and the world many firsts. This includes the revolutionary AIDS cocktail for less than adollar 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 andinnovative devices. (www.cipla.com)

Media Contact :Jaisingh BalakrishnanCorporate CommunicationsM: (+91) 9773372487

Email:[email protected]

Top

Business Standard / Tuesday, 06 July 2010Life sciences industry in Asia grew 3.4% in 2009: surveyBS Reporter
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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 forlife sciences industry in the Asia Pacific region. Listed companies contributed nearly half therevenues at $54.24 billion as they grew at 24.03 per cent.

BioSpectrum Asia estimates the growth of Life Sciences, covering pharma, biotech andmedtech segments, in 2010 to surpass that of 2009, even though the range is likely remain thesame: 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 thenumber two spot behind China. India accounted for 19 per cent of the total revenues in AsiaPacific. 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 percent, followed by Taiwan. With revenues of $2 billion, Taiwan posted a robust 46.29 per centgrowth. 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 includeCipla, Ranbaxy Laboratories, Dr Reddy's Laboratories, Cadila Healthcare, Lupin, AurobindoPharma and Sun Pharma.

Cipla became India's No. 1 company, clocking revenues of $1.17 billion. It also became theone of the two Indian companies in the billion-dollar club. Last year, Ranbaxy held India'sTop slot. The India Top 20 Life Sciences list comprises pharma companies with the loneexception of a biopharmaBiocon, at Rank 1 Bottom of Form

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Saturday, 10 April 2010Public Notice

Public Notice View JPG

Public Notice - Environmental Clearance Letter View PDF

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Tuesday, 23 March 2010Piramal 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 thesigning of a definitive agreement for purchase of all intellectual property rights in India relatedto "i-pill" for an aggregate consideration of Rs 95 crore.
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"i-pill" features in the top-300 pharmaceutical products and recorded sales of Rs. 31 crore forthe previous 12 months as per data from ORG IMS. The acquisition of "i-pill" strengthensPiramal's over the counter (OTC) portfolio which has strong consumer brands such as LactoCalamine skin care range, Supractiv Complete, Saridon and Polycrol antacid.

Commenting on the transaction, Dr. (Mrs.) Swati A. Piramal, Executive Director - StrategicAlliances & Communications, Piramal Healthcare Ltd. said, At Piramal Healthcare, propelledby our core values of Knowledge, Action and Care, we are devoted to making a real differenceto our consumers' lives by enabling informed choices. i-pill magnifies the indomitable spirit ofthe new Indian woman who is resilient in the face of every adversity. It empowers Indianwomen to remain in control of their future without resorting to emotionally and medicallystressful 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 emergencycontraceptive 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 companywith a strong OTC portfolio has bought the brand and are confident that Piramal Healthcare willsuccessfully accelerate the future growth of the brand.

i-pill is an emergency contraceptive pill (ECP) used to prevent unplanned pregnancy and isavailable over the counter at local chemists. It is not an abortion pill. i-pill containsLevonorgestrel, a progestogen which helps prevent unwanted pregnancies if taken within 72hours of unprotected sex. "i-pill has no long term or serious side effects and is safe to use foralmost 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 at18%. Piramal Healthcare has been an active player in the OTC space in the last few years with astrong distribution reach covering both chemists and general stores. Commenting on the OTCmarket, Mr. Ajay Piramal, Chairman, Piramal Healthcare Ltd. noted that, We believe the OTCsegment is still in its nascent stages in India and presents us with high growth opportunities. Inparticular the ECP segment which is approximately a Rs 100 crores industry and has grown by250% in the last two years".

Kotak Investment Banking acted as the exclusive financial advisor to Cipla for this transaction.

About CiplaIncorporated 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 ActivePharmaceutical 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. TheCompany owns and operates 19 manufacturing facilities across India . Cipla is listed in Indiaon the National Stock Exchange (Ticker: CIPLA) and Bombay Stock Exchange (Ticker:


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500087)

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Thursday, 12 November 2009Cipla launches generic drug to treat H1N1Business Standard Reporter/Mumbai

Indian drug major Cipla has launched generic versions of anti-flu drugs oseltamivir andzanamivir in the local market to treat the H1N1 influenza, which is spreading across the globeand in India.

Cipla will brand oseltamivir in the local market as Antiflu and zanamivir as Virenza. Antifluwill cost Rs 475 for 10 capsules, in line with the price of competing products in the market.Virenzaan inhaled drugwill cost Rs 800, which includes the price for an inhalationdevice.

Cipla's Antiflu is a copycat version of Swiss multi-national Hoffmann-La Roche's Tamiflu andVirenza is the copy of GlaxoSmithKline's Relenza. Both drugs, used globally to treat theongoing 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 regimeintroduced in the country since 2005.

Dr Y K Hamied, chairman and managing director of Cipla, said his companywas equipped to make 2 million doses of oseltamivir a month, in case of anyeventuality. Already 450 people have died of H1N1 in India and the winterseason may cause further spread of the virus, he said.

Now the US is facing a shortage of oseltamivir and we have informed ourreadiness to supply the drug if needed. We make about 20 drugs in the anti-

viral segment and are among the global leaders in this category, said the Cipla chief, whorevolutionised HIV/AIDS treatment globally by selling generic drug cocktails at less than a $1per 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 Indiaunder the brand name Fluvir.

On August 28, the Indian government had allowed restricted retail sale of the drug underSchedules X category of the Drugs and Cosmetics Act, similar to the sale of narcotics drugs.Six Indian companiesRanbaxy, Cipla, Strides Acrolab, Hetero, Hetco and Rochewereallowed to manufacture and sell the drug. The government has also stockpiled the drug fromthese manufacturers for supply through government channels.

Two months ago, Natco Pharma had launched its version Natflu in the Indian market at a priceof Rs 475 for a bottle of 10 capsules.
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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 manufactureand market it, invoking compulsory licence provisions of the patent rules, which allow breakingof patent rules during emergency, said Hamied.

Shortage or monopoly of any drug will cause panic among people during such pandemicattacks, he added.

Hamied has suggested that governments should encourage stockpiling of shikimic acid, whichis extracted from the Chinese Star Anise' and is used as a base material for production ofoseltamivir through a 14-step chemical process, instead of stockpiling the finished drug.

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Friday, 25 September 2009Pharmaceuticals Export Promotion Council Awards

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Press Trust of India / Wednesday, 15 July 2009
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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 thefinancial 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 latestfiscal 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 centrise 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.

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The Times Of India / Tuesday, 23 June 2009Pharma market grows 10% in MayRupali Mukherjee, TNN

New Delhi: The domestic pharma retail market posted a healthy growth of 10% in May over theprevious 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 twomonths 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 grewby 10.4% to Rs 36,048 crore, which was slightly higher than the previous month's value of Rs35,675 crore, according to consulting company, ORG-IMS.

The market was valued at Rs 3,104.12 crore during May, slightly lower than previous month'sfigure of Rs 3,146 crore. During the month, there was little change in the top rankings ofcompanies. Cipla occupied the top slot in terms of market share, followed by Ranbaxy andGlaxoSmithKline on the third position. Piramal Healthcare was ranked fourth, followed byZydus Cadila which moved to the fifth slot. Zydus displaced Sun Pharma, which had moved tothe fifth position in April.

For some time now, Cipla has been dominating the top slot followed by Ranbaxy and GSK interms of market shares.

Also, there were some movements as far as the top 20 companies were concerned with DrReddy's Labs, Wockhardt-Merind and Emcure gaining one rank each, to move up to rank 11, 14and 16 positions respectively, according to ORG-IMS.


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Amongst medicine brands, pain killer drug Voveran maintained its top position. Ironsupplement Dexorange and lipid lowering medicine, Strovas leaped three ranks and jumped torank five and 20 respectively. Oral rehydration salt Electral, pain killer Spasmo-proxyvon andAsthalin (for managing asthma) were the highest gainers, moving four ranks each to nine, 15and 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.

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CNBC-TV18 / Tuesday, 12 June 2009Swine 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 ofSwine Flu globally.

Amar Lulla, Joint MD, Cipla , said India needs to have adequate stocks of drugs likeOseltamivir 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 aglobal 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 thecountry 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 andhave been procuring Oseltamivir from us.

Q: How does it impact the pharma industry as well materially? Is there a race on now toperhaps get a Swine Flu vaccine going?

A: Yes, that would be the objective. Ultimately, that would be the way forward. But right now itis still very early to have the vaccine. So, we need the treatment, we need Oseltamivir, and needZanamivir. These drugs should be adequately stocked.

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Hamied: I'd suggest a "TRIPS north" and a "TRIPS south," where the north comprises 600million people in the developed world while the south comprises the 3 billion people of theThird 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'swhat 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 theWTO and form the TWTO (Third World Trade Organization).

India Knowledge@Wharton: The WTO supports legal protection of intellectual property rightsof multinational pharmaceutical patents, as does the U.S. government, which is strongly lobbiedby the multinational pharma industry. Then we have the UN, which is slow when it comes tofighting for the have-nots to ensure that they have access to reasonably priced genericmedication. On the other hand, we see World Health Organization endorsing your generic drugsfor quality and approving processes used in generic factories. Where do you stand in thisdifficult situation?

Hamied: Only once a patent expires in a particular country can that product be manufactured inthe country. "Generic" is "post-patent" -- or, by extension, off patent, and therefore non-monopolistic. This question of monopoly of drugs in the future -- if the Americans, Europeansand 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 , whathappened 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 youare 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 willonly 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 patentsexpire, we acquire the legal right to manufacture off-patent drugs, making it a continuousprocess.

India Knowledge@Wharton: There have been a number of new judgments related tointellectual property protection that Cipla contributed to, such as your win over Roche thatensured an uninterrupted supply in India of a low-cost medicine for treating lung cancer. Whatdo 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 Americanofficials, which means that they will be blinkered. But I am particularly interested in thesequestions: How is it that so many health care patents have been granted in such a short timeperiod? Are the patents properly examined? Just because a patent is granted in Europe orAmerica , 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 (whichrefuses patent protection to new forms, uses or minor modifications of existing drugs unless
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they differ significantly with regard to efficacy). Approximately 7,000 patents were filed beforeclause 3d [came into existence]. In the presence of this new clause, 60% of these patents are notvalid. Why aren't they voluntarily withdrawn? It is only fair that those who filed for thesepatents revise them.

India Knowledge@Wharton: Why do you think the Government is bringing changes to the IPregime?

Hamied: If you ask the Indian government, they have a ready answer: "We can't upset theinternational community." I told them, "But gentlemen, the patent law is a national law. Howare 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 theworld [pharmaceutical] trade market is pegged at US$700 billion, India stands at a mere US$7billion.... 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 upIndia in 1972. We didn't reach this position overnight. It took 10 to 20 years for Indiancompanies to grow. Right now, we are in a period of stabilization. The multinationals will standto gain when we start losing out. The cutoff date is 2012 or 2015, when patents for older drugsdie and newer drugs, which doctors will want to use, enter the market. And that is when I willsay that the Indian government has committed selective genocide in India .

India Knowledge@Wharton: In your opinion, how does India balance the rights of a patentholder 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. Thedisease profile is frightening: 80 million cardiac patients, 80 million affected with mentalillness, 60 million diabetics, 50 million asthmatics, 50 million hepatitis B cases, and one inthree Indians is a latent carrier of TB. The World Bank has said that India will have 35 millionHIV 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 thepeople's right to access affordable, quality health care without monopoly. This can be achievedby 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 theCanadian 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 itspatent legislation TRIPS-compliant by January, 2005.) Also, problems such as "evergreening"(when innovator pharmaceutical companies abuse the patent and regulatory systems to delay thelegitimate entry of generic competition) and frivolous patenting should be carefully reviewed.Compulsory licensing provisions have to be favorable for the indigenous industry, as alsopatenting by Indians internationally. Importation of a patented product alone should not beconsidered as operative of a working patent.
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We need to take a closer look as to what is best for India . One cannot have the same laws for600 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 ataffordable 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] acertain medicine that stops AIDS transmission from mother to child, free of cost. I showed it toan 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 andsaid, "Yes, I do have an ulterior motive. I want to do some good before I die. I am not going totake any of this [with me] when I die!"

You see the mindset?

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TopNews - Noida, Uttar Pradesh, India / Wednesday, 06 May 2009Cipla Gets Tentative USFDA ApprovalShilpa Mahapatre

Major Indian pharma firm Cipla has notified that it has securedtentative approval from the United States Food and DrugAdministration (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 incombination 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 300milligram under the President's Emergency Plan for AIDS Relief program.

It can be recalled that Tenofovir disoproxil fumarate tablets are the generic version of GileadSciences Inc.'s (GILD) truvada.

The Indian company is known for producing low-cost anti-AIDS drugs for HIV-positivepatients 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 aredistributed in nearly 200 countries of the world.
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ET Bureau / Saturday, 02 May 2009St gives thumbs down to cos with foreign opsKiran Kabtta Somvanshi

Indian companies that had ventured abroad riding on a wave of globalisation and cross-borderM&As are finding life tough abroad. The prized

foreign assets are now turning out to be millstone around the neck, pulling down theconsolidated finances even if domestic operations are profitable.

The point has not been missed on the stock market and the companies with foreign exposurehave been hit hardest in the market meltdown. In contrast, domestic-market focused companiesare 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 thebenchmark indices and is down just 35%. The market has punished Tata Steel despite it being amore cost-efficient steel producer. What's pulling down Tata Steel is Corus, which it acquiredfor $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 oneof the world's lowest cost aluminium producers, its shares have been one of worst performers inthe sector. Hindalco is being weighed down by the market concerns regarding the financialhealth 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 morevaluable 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 useIndia as a low-cost manufacturing hub and stay away from cross-border M&A. In contrast, DrReddy'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 MarutiSuzuki, Hero Honda and Bosch are doing much better than their counterparts with deepconnections 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 toforeign currency risk and rising cost of servicing the acquisition cost. Reliance Industries, forinstance, made a provision of Rs 370 crore towards possible diminution in value of overseassubsidiaries.

Praj Industries also has made a similar type of write-off of Rs 11.2 crore. This is for the first


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time that these companies have made such provisions. Ranbaxy is facing losses in theirEuropean business and has witnessed significant drop in growth. Marico has also reported poorperformance 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.

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ET Bureau / Friday, 01 May 2009New Delhi rejects American firm's plea to patent Hepatitis B drugKhomba Singh

NEW DELHI: The Delhi Patent Office has rejected American company Gilead Sciences' plea topatent its Hepatitis B drug adefovir dipivoxil sold

under the brand name Hepsera. India's largest drugmaker Ranbaxy had filed a pre-grantopposition against Gilead's patent application saying that it is not a new drug and lackedinventions.

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 popularantiflu drug Tamiflu as the patent office found merit in Cipla's opposition that the drug lackedinvention 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 stopHepatitis B virus (HBV) from multiplying by blocking HBV DNA polymerase, an enzyme thatis necessary for the replication of the virus in the body.

A patent grant to Gilead for Hepsera would have prevented any other generic company frommaking a low cost version of the drug without the consent of the patent-holder for the next twodecades. 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 RMeera 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 substanceto 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 globalSwine flu outbreak. Cipla and other generic companies can now legally manufacture and selltheir generic drug in India and other countries where Roche does not hold patent.


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

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moneycontrol.com / Monday, 27 April 2009Cipla 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 Rs6.70, or 2.79% on the NSE.

The company has won Erlotinib case against Roche in Delhi HC. The Roche's appeal hasdismissed 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 Price Latest Price Gain/Loss (Rs.) % Gain/Loss

3-Days 227.15 247.00 19.85 8.74

5-Days 222.70 247.00 24.30 10.91

7-Days 230.00 247.00 17.00 7.39

15-Days 227.20 247.00 19.80 8.71

1-Month 203.30 247.00 43.70 21.503-Month 191.10 247.00 55.90 29.25

6-Month 160.10 247.00 86.90 54.28

9-Month 231.70 247.00 15.30 6.60

1-Year 226.60 247.00 20.40 9.00

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The Hindu Business Line / Saturday, 25 April 2009

Cipla Q4 net profit up on better product-mix

Expects tough year ahead.


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Our Bureau

Mumbai, April 24 Drug-maker Cipla Ltd sees the year ahead being tough, as a result of intensegeneric competition and the slowdown in global markets. But the negative impact could beblunted by the company's spread of exports across geographies, besides having products inseveral 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 thecompany also saw a forex hit of Rs 10 crore in the current quarter, against Rs 25 crore in thecorresponding last quarter.

Cipla is unlikely to be hit by forex-related activity, going ahead, since it has accounted for allsuch activity, provided there is no major rupee-related fluctuation, he said. There has been anincrease 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 thequarter under review. The company's exports of active pharmaceutical ingredients, though, sawclose to five per cent dip in the quarter. Cipla will increasingly focus on formulations that makefor a more sustainable segment, he said.

Material cost has decreased during the quarter mainly because of favourable exchange rate andchanges in product mix. This impact is also reflected in increased operating margins, ascompared to the previous year, since exports are booked at prevailing exchange rates, the

company said.


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The company posted a net profit of Rs 767 crore for the year ended March 31, 2009, ascompared to Rs 701 crore in the corresponding period last year. Total income increased from Rs4,271 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.

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The Times Of India / Monday, 02 March 2009Pharma retail market grows 15%

NEW DELHI: The domestic pharma retail market has started the year with a bang, recordingnearly 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 marketshare, with Cipla garnering the largest, followed by Ranbaxy and GlaxoSmithKline at thirdposition, 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 thelargest 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 forthe 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 willkeep growing at a steady pace over the next few months.

In January, pain killer drug, Spasmo-Proxyvon was the highest gainer in ranks, amongst thelargest selling drugs, moving up from the 24th slot in December to the 18th. The other majorgainers are vitamin supplement Revital, having moved up from the 11th slot in December toseventh position in January, and iron supplement Dexorange, gaining four ranks (rank 11 as perJanuary '09). Zinetac used to treat peptic ulcer moved up three slots to the 14th position, up


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from rank 17 in December.

Among the therapeutic areas, cardiovascular segment recorded a 14% growth, while anti-infective medicines grew 10% during the month.

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The Hindu Business Line / Wednesday, 25 February 2009Patents yes, but monopoly no

India needs to protect its national interests and not worry about ruffling feathersinternationally.

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 paintingssit easy with stacks of papers on intellectual property, the Doha debates and speeches crusadingagainst monopolistic practices of drug companies. We were indigenous companies, comingtogether to jointly fight, he reminisces.

Under the leadership of its former chairman, the late Parvinder Singh, Ranbaxy had joinedcompanies such as Cipla and Dr Reddy's in taking the generic-drugs battle right into the


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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, withthe latest weapon being Intellectual Property Rights (IPR) and the hydra-headed manner inwhich 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 towhat 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 havehad their medicine consignments seized at Amsterdam, though these shipments were justtransiting to South American destinations. The export consignments were held on IPRinvestigations and the companies involved have since taken back their consignments orabandoned them.

The seizure of the export consignment was done using a European Commission regulation of2003. And such an interpretation of this rule, five years after being brought into force, wasagain, 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, hesays, tracing back to the build-up and amendment of the Indian Patent Law in 2005, after whichthe country started honouring product patents. Then came the more recent attempts in thecountry to link the issue of patents (given by the Patent Controller's office) with the marketingapprovals on medicines given by the Drug Controller General of India's office, an issuecurrently being fought in the courts here.

Frivolous patents

Elaborating on his concerns of companies trying to retain monopoly, he explained that anamendment to the Indian Patent Act had been introduced through Section 3d essentially to stopthe ever-greening of patents.

Ever-greening refers to the practice of drug companies that are known to make smallincremental changes to existing drug molecules to extend the patent even as the original 20-yearprotection 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 tome, 5,000 would be in the 3d category of no novelty, he says, adding that the observation wasbased on existing pharma patents.

Novelty salts, esters, polymorphs, etc., could be not eligible for patents; moreover, some ofthese patents with minor variations are not legally patentable.

We are seeing the same patent under different applications coming in. My contention is, of the


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patents that the multinationals have put into India and that do not qualify under 3d or onnovelty, such as combinations, they should voluntarily withdraw. Not a single patent has beenvoluntarily withdrawn (till) today, he observes.

Out of bounds

Referring to the patent-related litigation that Cipla is involved in, he says, We do not likebreaking 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 forAIDS), we have not challenged, he says.

Such an admission should have set off alarm bells among the powers that be, coming fromCipla. The Mumbai-based drug-maker had in 2001 set the cat amongst the pigeons when itoffered its generic AIDS drugs at a fraction of the MNC price in the African market, forcing thebigger companies to slash prices.

Eight years later, Cipla admits that the next generation of AIDS-drugs are out of bounds forgeneric drug-makers, as they are product patent-protected.

The ramifications of Dr Hamied's admission on next-generation AIDS drugs is worrying, as it isnot restricted to just this segment of medicines or market. Indian generic drug-makers supplymedicines across therapeutic segments to several countries in the world, and this could take ahit, affecting not just the companies, but patients as well.

A permanent compulsory licensing (CL) system, where generic companies are allowed to makecopies of the innovator's medicine, but on the payment of a royalty of, say, four per cent of theirsales, is what Dr Hamied suggests to break the impasse.

But whether this suggestion will have takers in the Government or among other innovatorcompanies is still to be seen.

We were promised categorically by the Government that product patents will only kick inpost-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, hesays. The rationale was that process patents filed from 1995 till 2000 could be converted intoproduct-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, wewere 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


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classified as a developed country. Just because there are pockets in India that are superdeveloped, doesn't make India a shining country, he observes, campaigning for a workable CLsystem.

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 isbest for our country, irrespective of Cipla, irrespective of everything. And genuinely, believeme. I have been saying it now for 50 years. Even in 1961, before the patent laws were changedin 1972, we had meetings with the multinationalsI said, as a scientist, I believe in patents, Iam 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 itneither the Americans nor theEuropeans. Why can't India have a similar system, without worrying about upsettinginternational friends?

When people cannot afford drugs, particularly anti-cancer drugs, at some time it was the anti-AIDS drugs, only competition can help you. We are willing to pay royalty but do not stop usfrom manufacturing, he says.

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

Leading drug maker, Cipla has received final approval from theUS Food and Drug Administration (USFDA) to marketPamidronate disodium injection, in the strengths of 30 mg/vial, 60mg/vial and 90 mg/ vial.

Pamidronate disodium acts on bone to help regulate bloodcalcium levels. It is used to treat Paget`s disease of bone and totreat 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 ofshares traded was 231,412 at the BSE (Wednesday).

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The Times Of India - New Delhi / Monday, 27 October 2008Pharma holds steady, Cipla pips RanbaxyRupali Mukherjee, TNN

Amidst all the gloom confronting the economy, the pharma sector posted a robust growth ofover 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 thirdslot with 4.47% market share. Piramal Healthcare and Zydus Cadila were ranked fourth andfifth 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 themarket valued at Rs 33,605 crore, according to consulting company, ORG IMS. The market hadgrown by over 12% in August. Pharma companies are, however, not posting strong financialresults 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 leadingwith a share of 5.09%, followed by Ranbaxy at 4.90% and GSK at 4.86%. Cipla has maintainedthe top slot in the market for the last two years.

On a moving annual total basis in September (12-month period ended September), majorgainers (in value terms) include Cipla at 17.7%, Ranbaxy and Sun Pharma each at 17.6%, Lupinat 20.9% and Mankind at 35.4%. Overall, the pharma market grew by nearly 13% on a MATbasis in September.

During the month, the respiratory segment has shown a healthy growth of 14%, while anti-

infectives 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 itsgrowth over the past one year, with a CAGR of 15%. Chronic therapy has consistentlyincreased its contribution to the domestic market with the share of acute segment considerablyshrinking over the past few years.

Within the chronic segment, anti-diabetic drugs have shown the highest value growth, followedby cardiac therapy during first half of the year. Anti-infective drugs have also recorded a robustgrowth during the period. During the six-month period, gastro-intestinal therapy grossed thethird highest value in the market, followed by the respiratory category.

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Business Standard / Wednesday, 23 July 2008Cipla: Active in overseas marketsShobhana Subramanian & Varun Sharma
http://www.cipla.com/whatsnew/news.htm#tophttp://www.cipla.com/whatsnew/news.htm#tophttp://www.cipla.com/whatsnew/news.htm#tophttp://www.cipla.com/whatsnew/news.htm#tophttp://www.cipla.com/whatsnew/news.htm#tophttp://www.cipla.com/whatsnew/news.htm#tophttp://www.cipla.com/whatsnew/news.htm#tophttp://www.cipla.com/whatsnew/news.htm#tophttp://www.cipla.com/whatsnew/news.htm#tophttp://www.cipla.com/whatsnew/news.htm#tophttp://www.cipla.com/whatsnew/news.htm#tophttp://www.cipla.com/whatsnew/news.htm#tophttp://www.cipla.com/whatsnew/news.htm#tophttp://www.cipla.com/whatsnew/news.htm#tophttp://www.cipla.com/whatsnew/news.htm#tophttp://www.cipla.com/whatsnew/news.htm#tophttp://www.cipla.com/whatsnew/news.htm#tophttp://www.cipla.com/whatsnew/news.htm#tophttp://www.cipla.com/whatsnew/news.htm#tophttp://www.cipla.com/whatsnew/news.htm#tophttp://www.cipla.com/whatsnew/news.htm#tophttp://www.cipla.com/whatsnew/news.htm#tophttp://www.cipla.com/whatsnew/news.htm#tophttp://www.cipla.com/whatsnew/news.htm#tophttp://www.cipla.com/whatsnew/news.htm#tophttp://www.cipla.com/whatsnew/news.htm#tophttp://www.cipla.com/whatsnew/news.htm#tophttp://www.cipla.com/whatsnew/news.htm#tophttp://www.cipla.com/whatsnew/news.htm#tophttp://www.cipla.com/whatsnew/news.htm#tophttp://www.cipla.com/whatsnew/news.htm#tophttp://www.cipla.com/whatsnew/news.htm#tophttp://www.cipla.com/whatsnew/news.htm#top


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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 linegrowth of nearly 34 per cent in the June 2008 quarter. The relatively low base of Q1FY08 and aweaker 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 andconsequently the operating profit margin expanded 360 basis to 22 per cent, after adjusting for aforex loss of Rs 75 crore. The forex loss, however, depressed the net profit which rose just 17per cent to Rs 140 crore.

Exports accounted for about half the firm's revenues of Rs 1207 crore last quarter. Analystsbelieve the higher sales of active pharmaceutical ingredients (API) could have included suppliesto 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, itwill be sales of formulations that will determine the pace of Cipla's exports in subsequentquarters.

To sustain a 25-30 per cent growth in exports, however, the company will need to increase theproportion of high value products, like inhalers, to regulated markets. Cipla, which haslaunched asthma inhalers in Germany , Spain and Portugal , is looking to gain a foothold in theCFC-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 getinvolved in patent litigation. It has recently roped in a couple of partners in the US and EU andplans 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 netprofits at around 11-13 per cent.

The earnings per share is estimated to increase by about 20 per cent. In a weak market, thepharma sector has been outperforming, with Cipla's stock gaining 7 per cent since the start of2008. At the current price of Rs. 238, the stock trades at a shade over 21 times estimated FY09earnings and is a tad expensive.

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FDAnews Drug Daily Bulletin / Monday, 07 July 2008Cipla Gets Thumbs Up for Generic HIV Drug

Indian drugmaker Cipla has received FDA approval for its HIV treatment zidovudine oral


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solution 50 mg/5 mL, a generic version of GlaxoSmithKline's Retrovir.

The generic Retrovir application was considered under the expedited review provisions of thePresident's Emergency Plan for AIDS Relief (PEPFAR), a five-year, $15 billion program aimedat combating HIV and other diseases in 114 countriesincluding 15 focus countries primarily

in Africathat President Bush announced in 2003.

Zidovudine is a nucleoside reverse transcriptase inhibitor intended to be used with other anti-retroviral agents to treat HIV-1 infection. The approval means no patents or exclusivity preventmarketing the drug in the U.S. The FDA often tentatively approves generic versions of HIVdrugs still under patent protection in the U.S. so the generics may be eligible for purchase underPEPFAR for use in other countries, the FDA said.

In February, Matrix Laboratories received FDA approval for its generic version of Retrovir300-mg tablets.

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The Economics Times - New Delhi /Tuesday, 01 July 2008Cipla gets patent for Nexium, Fosamax modified versionsKhomba Singh, ET Bureau

Domestic pharma major Cipla has received product patents for new forms of two blockbusterdrugsOsemaprazole and Alendronatefrom the Indian authorities. While the company'spatent on Osemaprazole is a modified form of Astrazeneca's blockbuster drug marketed underthe brand name Nexium, Alendronate is one of the best-selling drug of Merck sold under thebrand name Fosamax.

Nexium, the world's second-largest selling drug, has annual sales of around $5.2 billion whileFosamax recorded sales of $3 billion in 2007. Fosamax's patent expired in February this yearwhile Nexium's patent expires in 2014.

When contacted, Cipla joint MD Amar Lulla said, These are novel formulations with asignificant thereupatic advantages than though it uses the same chemical. We plan to launch thedrug globally. The company has sought patents globally through an application with the PatentCooperation Treaty (PCT) filing. If a company files a patent application with the PCT, itsapplication will automatically go to all TRIPS compliant countries.

Cipla also got the patent in India through its PCT application. According to the Indian patentoffice website, the Mumbai patent office granted in April this year.

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


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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 drugswith the public sector drug manufacturers . This follows the pharma industry's offer to sell theessential 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 industryassociation which made the separate offer to the authorities. The firm is willing to share theknow-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 tomanufacture all the 354 essential drugs to the government. He added that instead of bringingselective price control on brands and drugs, the government can manufacture these drugs in thestate-owned units and distribute it through the primary healthcare centres, medical hospitals andpublic health institutions at reasonable prices.

According to him, this will not only meet the government's objective of providing essentialmedicines at most reasonable prices, but also make the public sector organisations economicallyviable. Recently, industry body Indian Pharmaceutical Alliance (IPA) offered to sell essentialmedicines to the government at 50% of their MRP. They also offered to finance a mechanism todeliver these drugs at a concessional price by contributing 0.25% of their total profits to thegovernment, which could be a little less than Rs 10 crore. This would be in addition to thecorporate taxes the companies pay to the exchequer. However, this offer was conditional uponthe 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 suchproposals from drug makers comes in the wake of a policy proposal by the government toextend 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 theministries responsible for regulation and implementation of drug policies have to first sort outtheir internal differences. The two ministriesChemical & Fertiliser and Healthwhichoversee drug firms have overlapping jurisdiction.

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


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past two years.

Besides,the higher margins also came off a low base. The street was expecting much more andwas disappointed because the margin expansion was more the result of a much lower otherexpenditure,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 over20 per cent, because of higher raw material costs.

Moreover, the Cipla management expects to grow revenues by just about 12-15 per cent andmaintain margins in FY09, numbers that have not enthused industry watchers. Technology feescould 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 ofyears. Other large generic players like Ranbaxy saw operating profit margins improve by 290basis 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 21.6times estimated FY 09 earnings and are not cheap given the risks in the business. Thus, thestock should be a market performer going forward.

Ranbaxy, at the current price of Rs 485, is somewhat cheaper and trades at under 21 timesestimated CY 08 earnings, but that too is expected to perform only in line with the broadermarket.

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The Econonic Times / Thursday, 20 March 2008Cipla scores a generic win over Roche

NEW DELHI: In what could be a shot in the arm for Indian generic drug makers, the DelhiHigh Court on Wednesday rejected an injunction plea by Swiss drug major Roche to preventCipla 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 Tarcevaand the HC rejected Roche appeal in public interest given the huge cost difference between thetwo drugs.

However, this is only an interim order and HC will deliver its final judgement at the completionof the hearing. The court has also directed Cipla to keep a separate record of the sale of itsgeneric anti-cancer drug as it will have to compensate Roche if the final verdict goes in favourof the Swiss company.

Roche has applied for a stay (on the sale of the generic version of Tarceva). This is an interim


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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 ofTarceva. However, Cipla has been asked to keep the sales record of Tarceva separately, as Ciplawould 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 thehearing told ET.

Ciplas share closed at Rs 206 on BSE, up 0.76% from Tuesdays close of Rs 204.45. Rochereceived patent for Tarceva in India last year, but has been subsequently facing post-grantpatent opposition from Cipla and NGOs. Two months ago Cipla decided to market copy catversions 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 domesticdrug makers and big pharma MNCs. With the Indian pharma industry set to grow annually at13%, 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 lawsand any favourable verdict strengthens their case. Watching closely from the sidelines areconsumers 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 ofmedical treatment could become unaffordable and will prevent many patients from gettingtreatment 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 thatan innovation to a drug can only be granted patent if the new drug provides significanttherapeutic advantages.

This decision had made Indian patent laws one of the most effective in the world. AnotherIndian drug maker, Hyderabad-based Natco has also sought compulsory licensing (CL) fromthe government for two cancer drugs Tarceva and Pfizers Sunitnib (Sutent). However, thedecision on Ciplas case is not expected to have any bearing on Natcos plea for a CL.

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Business Standard / Tuesday, 01 January 2008Cipla maintains No.1 position in Indian mktP B Jayakumar

Mumbai


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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 positionwith 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, aheadof 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 largestpharmaceutical 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 basedformulations, like Phensydyl, in recent months, slipped three positions to number seven inNovember.

ORG-IMS, the largest market intelligence company in India focusing on the he

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