Re: {LONGTERMINVESTORS} Pharma Sector............Thread
RAJESH DESAI
Sept. 28 (Bloomberg) -- GlaxoSmithKline Plc and Cipla Ltd. may have the most to lose from a new policy in India that would limit the retail prices of drugs that generate 23 percent of the pharmaceutical industry’s revenue.
Price caps will be widened to include 348 drugs such as antibiotics, anti-hypertensives and cancer medicines, Srikant Jena, junior minister for chemicals and fertilizers, said yesterday in New Delhi.
India’s pharmaceutical market is mostly composed of so- called branded generics, where often dozens of companies are selling the same drug under different brand names. There is a wide variation among the prices of these brands, and Indian units of multinational drug companies Glaxo and Abbott Laboratories may be the biggest losers of the new policy because their products are often priced at the top end of the range, said Bino Pathiparampil, an analyst at IIFL Ltd.
“The biggest impact will be for the multinationals because their products are often the most expensive,” Pathiparampil said by telephone from Mumbai. “Indian players have a wide variety of other generic products which are outside price control, so they’ll be less affected.”
Under the new policy, every drug in the National List of Essential Medicines will be capped at the weighted average price of all brands with a market share exceeding 1 percent, Jena said. That’s different from the existing system, which covers 74 drugs and sets a cap based on the product’s manufacturing costs.
Antibiotics, Multivitamins
The list, formulated by the health ministry, includes 64 antibiotics, 27 cardiovascular treatments, and 24 hormonal drugs, in addition to multivitamins and pain relievers.
The Indian unit of London-based Glaxo gets about 31 percent of its sales from drugs included in the list, making it the publicly traded company with the largest exposure, Barclays Plc said in a Sept. 24 report. Among Indian drugmakers, Mumbai-based Cipla would face the biggest loss in revenue, with 28 percent of sales coming under price control, analysts Balaji Prasad and Rohit Goel wrote.
“We are still analyzing the policy internally and cannot comment on the impact on sales,” Cipla Executive Director S. Radhakrishnan said in a phone interview. Glaxo spokeswoman Rupali Kalav didn’t reply to an e-mail and a phone call after office hours.
India has 92,000 brand names of registered pharmaceuticals, according to a compendium of medicines sold in the country. The World Health Organization, in contrast, recommends 340 essential drugs.
90 Percent
About 90 percent of prescriptions are generics, which their manufacturers seek to differentiate with unique names. Glaxo’s Augmentin, a combination drug containing two antibiotics, is sold by Ranbaxy Laboratories Ltd. as Moxclav, by Cipla as Advent and by Mankind Pharma Ltd. as Moxikind-CV.
Prices of the brands can differ by as much as 75 percent for six tablets, according to the drug encyclopedia CIMS.
When prescribing medication, Indian doctors typically refer to brands rather than chemical names. Pharmacists are prohibited from substituting one generic for another, even if it’s cheaper, so drugmakers try to persuade doctors to think of their brands first.
“The new proposal will have an impact on industry as the span of price controls will now increase to cover around 30 percent of the pharmaceutical market,” Ranjit Shahani, managing director of Basel, Switzerland-based Novartis AG’s Indian unit and the president of a pharmaceutical lobby group, said in an e- mailed statement.
All the major pharmaceutical companies in the country derive from 30 to 40 percent of their sales from exports and that would shield them from this policy change, IIFL’s Pathiparampil said.
Sun Pharmaceutical Industries Ltd., the country’s biggest drugmaker by market value, got 37 percent of sales from India last fiscal year. Lupin Ltd., the world’s biggest maker of tuberculosis drugs, got 27 percent from its home country.
The company is still “awaiting more clarity” from the government on the new policy recommendations, Mumbai-based Lupin said in an e-mailed statement.
To contact the reporter on this story: Adi Narayan in Mumbai at anar...@bloomberg.net
To contact the editor responsible for this story: Jason Gale at j.g...@bloomberg.net
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CA. Rajesh Desai
RAJESH DESAI
Abbott suspends giving gifts to doctors in India
Accepting
gifts or travel arrangements from drugmakers is against the law in
India, but enforcement is inconsistent. Abbott Laboratories has
instructed its sales representatives in India not to give gifts to
doctors, who are prohibited by local law from accepting them, a practice
that has been used as a bargaining chip by companies wanting a piece of
the country's burgeoning healthcare market. Full Article
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CA. Rajesh Desai
Rajesh Desai
· More importantly, the government may ask the drugmaker to continue producing an essential drug at a certain level for another year in public interest. The government can do this for any of the 348 drugs that are part of the National List of Essential Medicine, or NLEM.
· The government may, in public interest, direct the manufacturer of the scheduled formulation (essential drug) to continue with required level of production and/or import for a period not exceeding one year, from the intended date of such discontinuation within 60 days of receipt of such intimation.
CA. Rajesh Desai
Rajesh Desai
Aurobindo Pharma has received final approvals from the US Food & Drug Administration (USFDA) to manufacture and market Valsartan and Hydrochlorothiazide Tablets USP, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg and 320mg/25mg (ANDA 202519). The product is ready for launch.
Valsartan and Hydrochlorothiazide Tablets USP, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg and 320mg/25mg is generic equivalent to Novartis Pharmaceuticals Corp.’s Diovan HCT Tablets 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg and 320mg/25mg respectively. The product is indicated for the treatment of hypertension, to lower blood pressure and falls under the cardiovascular (CVS) therapeutic category. The market size of the product is approximately US$1.7 Billion for the twelve months ending September 2012.
Aurobindo now has a total of 181 ANDA approvals (156 Final approvals including 2 from Aurolife Pharma LLC and 25 Tentative approvals) from USFDA.
Venus Remedies has launched its first OTC product ‘Ezenus’, a stress reliever. Ezenus is a unique medical nutrition product which is absolutely safe, zero calorie, non-addictive, herbal candy, with clinically proven anti-stress activity. With the launch of Ezenus, the company is entering into the OTC segment for the first time. The company is hopeful that this novel research Ezenus will acquire 5% of the product 100 million dollar direct market of stress segment in India, other than lifestyle disorders, within 3 years of its launch.
Ezenus is world’s first anti stress product launched in easy to use candy form even suitable for diabetic patients. It is highly safe in acute stress management such as exam stress in children and in chronic stress like in alcoholic and smoking population, without change in life style by continuous detoxification and strong antioxidant activity.
Ezenus reduces more than 60% stress within 30 days without change in life style and significantly improves the quality of life in terms of physical, social, emotional and functional well- being. This breakthrough innovative product is suitable for all ages with safety established upto 10 times advised dose.
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CA Mihir Desai
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CA. Rajesh Desai
Rajesh Desai
(Reuters) - Drugmaker Cadila Healthcare Ltd(CADI.NS) received regulatory approval to market a new diabetes drug in India that it developed and is aiming for more than $1 billion in sales globally, the company said on Wednesday.
Cadila, India's sixth-largest drugmaker by sales, spent $250 million developing Lipaglyn, a new chemical entity or new discovery, and aims to spend another $150 million to $200 million to launch the drug outside India, the company's chairman, Pankaj Patel, said.
"We expect this to be a blockbuster drug, which means over $1 billion sales a year" when the drug is sold globally, he told a news conference. For now the company is hoping for Lipaglyn sales of 1 billion rupees in India over three years, he said.
Cadila took about eight years to develop the molecule and conducted clinical trials on more than 1,000 patients in India, Patel said.
The company plans to launch two other new chemical entities in the next seven years and has eight drugs in various stages of clinical development, he added.
Traders on Tuesday had driven up the company's shares by 5.2 percent in anticipation the company would make a bigger announcement than the drug approval on Wednesday such as a stake buy and drove the shares down 4.2 percent in afternoon trading. (Reporting by Kaustubh Kulkarni; Writing by Ranjit Gangadharan; Editing by Matt Driskill)
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CA. Rajesh Desai