Dr Reddy's launches pain treatment cream 'Supamove' in India

 Dr Reddy's Laboratories today said it has launched 'Supamove' cream used for treating pain and inflammation in India.

The cream helps in reducing pain and inflammation in patients with joint pain, arthritis, bursitis, tendinitis and lower back pain, the company said.

"The product has been in-licensed from Cymbiotics Inc. USA and will be available in a 30 gm tube," it added.

The company has also launched another product, Venusia Soft lotion in 75 ml pack, used for providing relief from dry, itchy skin also in-licensed from Cymbiotics Inc.
"This will complete Dr Reddy's treatment basket in the emollient and protective space which already includes Venusia cream, Venusia lotion, Venusia max and Venusia bathing bar," Dr Reddy's said.

The company claimed that current market size of topical non-steroidal anti-inflammatory drugs (NSAID) segment is over Rs 352 crore and emollients and protectives market in India is currently valued at Rs 208 crore, it added.

The Hyderabad-based firm, which had revenues of USD 1.7 billion in FY 11 is present in three business segments- pharmaceutical services and active ingredients, global generics and proprietary products.

Shares of Dr Reddy's were today trading at Rs 1,573 in the after noon trade on BSE, up 0.45 per cent from its previous close.

2011: An uncomfortable year for pharmaceutical sector

The pharmaceutical industry will remember 2011 as a year in which the government sought more to exercise more control over the business -- be it big ticket acquisitions of domestic firms by MNCs or price controls on drugs.

Amid these tussles with the government, domestic companies carried on with their business as usual.

While Ranbaxy heaved a sigh of relief after finally reaching an agreement with the US health regulator to remove a ban on the sale of drugs from certain Indian plants in the American market, Sun Pharma sought to consolidate its grip over Israeli firm Taro by proposing a complete takeover.

Furthermore, Lupin acquired I'rom Pharmaceutical Company in Japan as part of a global expansion drive.

Nevertheless, policy was the centre of the action during the year as far as the industry was concerned.

Alarmed over the trend of big Indian pharmaceutical firms being acquired by MNCs, which could have an apparent implication on drug prices, the government decided that it was high time some control mechanism was put in place.

After deliberations and debate with stakeholders, the government introduced checks by doing away with automatic approval of foreign direct investment (FDI) in existing domestic pharmaceutical companies.

According to the new guidelines, for any merger or acquisition, overseas investors will now have to seek permission from the Foreign Investment Promotion Board (FIPB).

After six months of such a proposal being approved, monopoly watchdog Competition Commission of India (CCI) will vet such deals.

The decision followed a directive from Prime Minister Manmohan Singh, who, along with his senior Cabinet colleagues, had deliberated over concerns arising out of several acquisitions of domestic pharma firms by overseas firms.

The decision was influenced by acquisitions of Indian firms, including that of Ranbaxy Laboratories by Daiichi Sankyo of Japan, Shanta Biotech by Sanofi Aventis of France and more recently the domestic formulations business of Piramal Healthcare by US-based Abbott Laboratories.

The government feared that a monopoly by MNCs will have an impact on the availability of affordable drugs in India.

However, in the case of greenfield investments, 100 per cent FDI will be allowed under the automatic route, under which investors only inform the Reserve Bank about the inflows and no specific government nod is required.

Drug pricing policy to cause 1.5k cr loss: IMS

Drug market research firm IMS Health India has said the draft drug pricing policy, which proposes to cap prices of essential medicines, would cause a loss of Rs 1,500 crore to the industry but drug firms can offset the impact if they raise prices of brands currently sold below their proposed ceilings.

Half of the estimated Rs 1,500-crore loss would be borne by top 10 companies alone, but this loss could be nullified, said Amit Backliwal, of IMS Health, whose data the government uses to fix prices of medicines.

The draft National Pharmaceuticals Pricing Policy 2011, circulated in October for feedback, plans to cap prices of all 348 essential drugs and their combinations at the average price of the top three brands in the respective segments. Sales of these drugs form three-fifths of the country's 60,000-crore pharmaceutical market.

The anti-infectives segment would be the worst affected with a projected loss of 400 crore followed by cardio vascular and gastro intestinal segment at 150 crore each. Among companies, the country's largest drug maker, Ranbaxy Laboratories, could lose the maximum revenue at 100 crore followed by Glaxosmithkline at 75 crore and Alkem 60 crore.
According to All Indian Origin Chemists & Distributors (AIOCD), the loss to the industry, drug makers and traders is estimated at over 4,000 crore. Indian Pharmaceutical Alliance (IPA), which represents the interests of big Indian drug makers, forecast a decline of 3,000 crore in profit before tax.

In the best case scenario, should drug companies use all provisions to increase prices of brands, the industry could actually gain in revenue.

But Backliwal said revenue gain was a "theoretical" possibility since companies could increase prices of drugs outside price control by mere 1% to 2% despite the existing provision of up to 10% in 12 months. "Market forces don't allow that." A senior executive from a leading Indian company also said it was practically impossible to increase prices because of the cutthroat competition in market. "India is the most competitive drug market in the world," he said.

There could be a volume increase in popular brands if their prices are slashed. If cost was limiting the access of such brands with "intrinsic" value, lower price will push volumes up, Backliwal said, pointing to a similar case when the Philippines government slashed prices of several popular brands by 50%.

However, some health activists and regulatory experts have argued that companies would definitely increase prices of their drugs. "Not even one company will eventually lose in this pricing mechanism," C M Gulati, a Delhi-based drug regulatory expert, said. Prices of medicines that are sold for 3 or less per unit (tablet, capsule, ampoule) will not be regulated, leading to many-fold increases in the cost of most medicines, he said.

Medical electronics mkt to touch Rs 33,800 cr

Indian medical electronics market is set to touch nearly $ 6.4 billion (nearly Rs 33,800 crore) by 2020, growing at a compounded annual growth rate (CAGR) of up to 19 per cent on the back of rising cases of diseases and healthcare facilities expansion.

Indian medical electronics industry has been growing at an average rate of 17 per cent for past couple of years. It is expected that growth will outperform the pace and industry will touch the $ 6.4 billion mark by 2012, a study by FICCI-Deloitte said.

"There are various factors, which will propel growth of the medical electronics industry which are a combination of macroeconomic factors, industry trends and segment consideration," Deloitte Touche Tohmatsu India Pvt Ltd Director Strategy and Operations Anjan Sen told PTI.

Factors like increasing disease burden, expansion of healthcare delivery in Tier II and Tier III towns, increase in non-communicable and lifestyle diseases, rising income levels and demand for better healthcare will drive growth in the short term, he said.

In 2010, the segment had sales of $ 1 billion out of the Indian medical devices market of $ 2.5 billion.

'Medical Electronics' are healthcare products which require external energy source to be operational. The segment includes equipments, diagnostic tools, life support systems, implants and disposables.

"In the longer term shift towards better diagnostics and preventive healthcare coupled with integrated healthcare delivery will drive growth," Sen said.

He said in order to drive growth further in the segment, "the industry has to target both the public and private sectors."

With the Indian government planning to increase the healthcare allocation to 2-3 per cent of the GDP, the report said: "Schemes like National Rural Health Mission (NRHM) and Rashtriya Swasthya Bima Yojna (RSBY) will break the constraint for rural India, offering the economies of the scale to the Industry."

About the prospects of domestic firms in the future growth scenario Sen said: "The market is expected to grow 6.5 times the current size and everything depends on who is able to capture what share of the market."

Deadline to affix barcodes on drugs extended till Jan 2013

In a move that will provide relief to drug exporters, the Commerce Ministry today extended the deadline for mandatory barcoding of pharma products meant for overseas markets till January, 2013.

In June, the Directorate General of Foreign Trade (DGFT) said that from July 2012, medicines exported from India would be required to have barcodes.

A barcode is an optical machine-readable representation of data on the product it is attached to and facilitates its tracking.

"Earlier, the requirement of affixing barcodes on primary level packaging was to come into effect from July 1, 2012. Now more time is being allowed," DGFT said.

The Indian pharmaceutical industry had sought more time to implement the process required for mandatory barcoding as the small-scale pharma firms lack infrastructure.

"We are in constant talks with Commerce Ministry in this regard. The implementation is not feasible for small-scale pharma firms because the cost is very high," Pharmaceuticals Export Promotion Council Chairman N R Munjal said.

DGFT said the deadline for bar coding on primary packaging -- the material that first envelops the product and is in direct contact with the contents such as ampoule, vial, bottle, cartridge, blisters -- is extended till early 2013.

For secondary packaging -- intermediate medical packing -- it has been extended till July 1, 2012. Earlier, the set time line was January 1, 2012, it said.

DGFT had said exporters will need to affix barcodes entailing unique product identification code, unique serial number of the respective packs, batch number and expiry number.

Munjal said the DGFT itself doesn't have the adequate infrastructure to read barcodes. "Only barcoding will not benefit...The DGFT itself must have the central server system that enables the barcode reader," he added.

According to experts, the move is not only aimed at improving reputation of the Indian pharma industry in the international market but it also aims at curbing illegal channels of trade. For instance, spurious drugs found in Nigeria in 2009 were labelled 'Made in India' but were finally traced to China.

Pharmaceutical companies and exporters have been raising concerns that affixing barcode is "not feasible" and expensive. It cannot resolve the problem of spurious drugs, he added.

Zydus Cadila acquires 100% stake Mumbai based Biochem

Drug firm Zydus Cadila today said it has acquired a 100 per cent stake in Mumbai-based Biochem for an undisclosed amount.

"Zydus Cadila has acquired a 100 per cent stake in Biochem, one of the Top 40 pharma companies in India," Zydus Cadila said in a statement.

A privately held firm, Biochem has a presence in various therapeutic segments, including antibiotics, cardiovascular, anti-diabetics and oncology, it added.

Commenting on the development, Zydus Cadila CMD Pankaj R Patel said: "The formulations business in India has always been the bulwark of our operations and we have looked at every strategic opportunity to grow and contribute to this market, either by way of novel initiatives, collaborations or acquisitions."
"Biochem represents the right fit as they have a significant presence in our core therapy areas and also add value to our product offerings in key growth segments," he added.

Biochem reported sales of Rs 264.5 crore for the year 2010-11. The company's top brands include Ampilox, Biotax, Monotax, Amicin and Zithrocin, which together contribute to 40 per cent of the company's sales.

"The acquisition strengthens Zydus' operations in the Indian pharma market," the company added.

Daiichi Sankyo Cuts Pay as Ranbaxy Reaches U.S. Settlement

Daiichi Sankyo Co. cut pay for executives and directors after slashing its profit forecast because of a $500 million provision to settle a legal dispute at its Ranbaxy Laboratories Ltd. unit in India.

Japan’s third-biggest drugmaker by market value expects net income to slump 63 percent to 26 billion yen ($334 million) in the year ending March 2012, from 70.1 billion yen a year earlier, it said in a statement today. Profit will miss the 50 billion yen forecast made in July because of a 37.5 billion yen charge linked to Ranbaxy’s settlement with the U.S. Justice Department, it said.

Chief Executive Officer Joji Nakayama and board members will receive 5 percent to 30 percent less compensation for six months in response to the cut in the earnings forecast, Daiichi Sankyo said today.

The company has lost about half its market value since agreeing to buy a majority stake in Ranbaxy, India’s largest drugmaker, in June 2008. Most of the drop occurred after the U.S. Food and Drug Administration banned imports from two of the unit’s plants because of manufacturing violations.

Daiichi Sankyo rose 2.9 percent, the biggest gain in almost three weeks, to 1,515 yen at the close of trade in Tokyo. The stock has dropped 15 percent this year, compared with the 19 percent decline in the benchmark Topix index. Ranbaxy fell 1.3 percent to 389.3 rupees at 11:39 a.m. in Mumbai.

The Japanese drugmaker will pay a 30 yen dividend for the second half as previously planned. The revised earnings forecast doesn’t account for sales expected from the generic version of Pfizer Inc.’s cholesterol-lowering pill, Lipitor, introduced by Ranbaxy in the U.S. three weeks ago, it said.

Import Ban

Three months after Daiichi Sankyo agreed to buy a controlling stake in Ranbaxy, based near New Delhi, for $4.6 billion, the FDA barred imports from the Indian drugmaker’s Paonta Sahib and Dewas plants because of manufacturing defects.In February 2009, U.S. regulators said they halted reviews of new products from one of Ranbaxy’s factories because the company falsified data about the products’ shelf life.

Ranbaxy agreed to a settlement with the FDA and committed to strengthening procedures and policies to comply with industry standards, it said in a separate statement today. The $500 million provision “will be sufficient to resolve all potential civil and criminal liability,” Ranbaxy said.

The payment, which is 16 percent of Ranbaxy’s market value, “is much above our expectation,” said Bino Pathiparampil, a Mumbai-based pharmaceutical analyst at IIFL Ltd. “This could wipe out the company’s profits for this year and the next,” he said in a telephone interview.

Consent Decree

The agreement paves the way for U.S. exports to resume from the company’s two tainted factories, while drug approvals could take at least 12 months, said Pathiparampil, who downgraded the stock to “reduce” from “add” after the announcement.

The resolution with the FDA is a consent decree which is “not a straight approval to manufacture but more like a plan of action of things to be done to get compliance,” he said.

The consent decree needs to be approved by a U.S. district court in Maryland, the company said.

“While we were disappointed by the conduct that led to the FDA’s investigation, we are proud of the systematic corrective steps we have taken to upgrade and enhance the quality of our business and manufacturing processes,” Arun Sawhney, Ranbaxy’s CEO and managing director, said in the statement.

Dr Reddy's shifts drug discovery focus away from heart disease

Drug firm Dr Reddy's Laboratories (DRL) today said it has shifted focus of its drug discovery to new segments, including dermatology and pain management, from cardiac diseases and diabetes due to high costs involved for the latter.

"We have now selected areas, which are available for innovation...we moved away from cardiovascular diseases (CVDs) and diabetes towards pain and inflammation, dermatology and of course anti-infectives...," Dr Reddy's Laboratories Vice Chairman and CEO GV Prasad told reporters here.

Some of the trials for CVDs required at least 30,000 patients which the company could not afford, he added.

When asked about the new drugs being developed, Prasad said that the company is looking at a product which will address the post surgical infectives.

"We are looking at a product which will directly address this segment of post surgical infections," Prasad said.

The Hyderabad-based firm, which had revenues of USD 1.7 billion in FY 11, said it is looking to improve its performance in India and Europe.

"We would like to improve our performance in Europe and India. In India, the issue is growth while in Europe it is profitability. We are working on that," he added.

The company said that it is looking at biosimilars as major area of growth for the firm from 2016 to 2020.

Shares of Dr Reddy's Laboratories were today trading at Rs 1,584.05 in the afternoon trade on BSE, down 1.38 per cent from its previous close.

Abbott invests Rs 61 cr in social initiatives in India

Drug maker Abbott India today said it has invested over Rs 61 crore in the country towards various social activities, including initiatives to address malnutrition among the public.
According to the '2011 Citizenship Report for India' the "company is making social and economic contribution by investing more than Rs 61 crore in grants, donations and social innovation projects, impacting the lives of more than 15 lakh Indians."
The citizenship report provides details of Abbott's initiatives across four priority areas, including: innovating for the future, protecting patients and consumers, enhancing access and safeguarding the environment, it said.

US-based Abbott Laboratories employs more than 12,000 people in India and is present in the country through its wholly-owned subsidiary Abbott India.

As per the report, Abbott invested USD 3.7 billion globally in R&D in 2010, including two centers in Goa and Mumbai.

The company also began a three-year, Rs 7.6 crore partnership with 'Path', an international non profit organisation to advance a cost-effective strategy to fortify rice to address micronutrient malnutrition in the country.
Commenting on the report Abbott India Managing Director Vivek Mohan said: "Building on our significant outreach in 2011, Abbott plans to expand our efforts in India to deliver even stronger benefit for the people we serve in 2012."

Mohan further said the company plan to reach 10 lakh patients through thyroid and diabetes camps next year.
Last year, Abbott acquired domestic formulation business of Piramal Healthcare for around Rs 18,000 crore to become the largest drug manufacturer in India.



Abbott to market Zydus products in emerging markets by 2013

Pharma major Abbott India, which has entered a licensing and supply agreement with Zydus Cadila of India for a portfolio of pharmaceutical products that the former will commercialize in 14 emerging markets, will commence operations in 2013, a top official said today.

"Our marketing alliance with Zydus Cadila will start by 2013. Abbott will gain rights to at least 25 products in 14 emerging markets," Abbott India's managing director Vivek Mohan told PTI here.

Last year, Abbott and Zydus Cadila entered into an agreement to market Zydus products, which includes indications for pain, cancer and cardiovascular, neurological and respiratory diseases.
Abbott has created the Established Products Division (EPD), dedicated to expanding the market for its established pharmaceutical portfolio outside of the US, with an emphasis on emerging markets.

Meanwhile, Abbott India, with over 100 years of operations in India, has invested over Rs 61 crore (USD 12 million) in grants, donations and social innovation projects in India, impacting the lives of over 15 lakh Indians.

The company employs more than 12,000 people in its two manufacturing facilities and two R&D centres in the country.

The company today released 'Redefining Responsibility' Citizenship Report 2011 for India. The report reflects the company's approach to citizenship in India. Working beyond philanthropy, Abbott applies its science, expertise and technology to address critical health care needs through innovative partnerships with governments, health-care professionals and NGOs.

Building on our significant outreach in 2011, Abbott plans to expand its efforts in India to deliver even stronger benefit for the people it serve in 2012.

It is planning to reach 10 lakh patients through thyroid and diabetes camps next year, Mohan said.

The company said it is working closely with the Ministry of Health and Family Welfare, Ministry of Consumer Affairs and the Ministry of Women and Child Development to advance the safety and quality standards pertaining to Food Laws. The company developed and launched valance solution, a flavored syrup-based preparation of Divalproex for epilepsy patients who cannot take tablets.

Indian drugmakers post 21% growth in November sales: AIOCD

Indian drugmakers posted 21% month-on-month growth in November sales, which was the highest in the past 14 months, driven by an increase in demand for respiratory anti-infective drugs.

According to data from research body All India Organisation of Chemists and Druggists (AIOCD), domestic drugmakers posted sales of Rs 4,912 crore in November compared with Rs 4,668 crore in October. "This is indicative of flare-up in viral and bacterial infections," said Ameesh Masurekar, director, AIOCD.

However, he sees revenue growth falling to 14-15% once the seasonal demand for viral and bacterial infection drugs comes down. Analysts said the November numbers should improve pharma companies' revenues for the October-December quarter at a time when most drugmakers are expected to post mark-to-market loss due to rupee depreciation.

The top 20 drug companies registered a double-digit growth, AIOCD data showed. McLeod's Pharma, which has been growing consistently month-on-month, recorded the highest growth in sales.
Analysts see the drugmaker surpassing Dr Reddy's in total sales within four-five months. "The anti-infective segment seems to have bounced back, as the last couple of months this segment was dragging down sales," said Ranjit Kapadia, vice president, Centrum Capital.

Ranbaxy Laboratories gets less than 3% generic Lipitor market in first week

India's largest drug maker Ranbaxy Laboratories has managed to capture less than 3% market share in the generic Lipitor segment during initial days of its launch in the US.

According to a J P Morgan report, Watson and Ranbaxy, the two generic drug makers collectively captured 14.6% of US prescription volume of the cholesterol-lowering drug, media reports said. J P Morgan report had cited data from prescription-drug tracker IMS Health.

About 97.6% of the generic versions were from Watson in the first few days, with Ranbaxy holding the remainder, it added.

On November 30, the Indian drug maker had launched its low-cost version of the drug after getting regulatory approvals hours before the scheduled launch date. Lipitor, the original drug is the world's best selling drug with annual sales of $7.89 billion in the US alone.

Analysts in India expect Ranbaxy to earn as much as $600 million during the six month period, where no other drug makers other than the three are allowed to market the drug.

The Gurgaon-based company's share price closed almost unchanged at Rs 406.20.

Pfizer is aggressively trying to protect its market share through unprecedented marketing strategies, including discounts to consumers and health plans during the crucial six months.

Generics drugs are expected to capture about 60% share during the Lipitor exclusivity period, as Pfizer has sought to maintain brand share in the face of generic launches, the note said.

Once the 180 days exclusivity ends, several drug companies such as Teva, Mylan and Dr Reddy's can also start selling their drugs.

According to the J P Morgan report, more than 9.38 lakh prescriptions for drugs containing Lipitor's active ingredient, atorvastatin, were prescribed for the week ended December 2. About 8 lakh or 85.4% were written for the branded Lipitor.

Biotech sector in India

2010-11 (Rs Cr)
Segment	Exports	Domestic	Total	% Share Exports	% Share Domestic	Overall Cont
Biopharma	5535	5110	10645	52	48	62
BioServices	2986	260	3246	92	8	19
BioAgri	74	2406	2480	3	97	14
BioIndustrial	150	476	626	24	76	4
Bioinformatics	106	146	252	42	58	1
Total	8852	8397	17249	-	-	100
2009-10 (Rs Cr)
Segment	Exports	Domestic	Total	% Share Exports	% Share Domestic
Biopharma	4768	4061	8829	54	46	62
BioServices	2507	132	2639	95	5	19
BioAgri	58	1878	1936	3	97	14
BioIndustrial	124	440	564	22	78	4
Bioinformatics	74	157	231	32	68	2
Total	7531	6668	14199	53	47	100

Rs Cr	2010-11	CONT
EXPORT	8852	51
DOMESTIC	8397	49
Total	17249	100

		Rs Cr			MS%	Gr%
Rank	Company	2010-11	2009-10	2008-09	2010-11	2010 (%)	2011 (%)
Total		10655	7462	5723	100	24	30
1	Biocon	1483	1180	912	14	29	26
2	Serum Institute of India	1041	850	1114	10	-24	22
3	Panacea Biotec	928	703	597	9	18	32
4	Nuziveedu Seeds	610	477	364	6	31	28
5	Reliance Life Sciences*	490	450	-	5	-	9
6	Quintiles India*	476	375	-	4	-	27
7	NovoNordisk	462	362	316	4	15	28
8	Rasi Seeds	372	359	377	3	-5	4
9	Mahyco*	365	312	211	3	48	17
10	Transasia	350	186	-	3	-	88
11	Ankur Seeds	325	110	80	3	36	197
12	Syngene International	318	252	225	3	12	26
13	Bharat Biotech *	298	272	241	3	13	10
14	Indian Immunologicals	283	273	225	3	21	4
15	Krishidhan Seeds	276	133	63	3	111	107
16	Shantha Biotech*	272	334	247	3	35	-19
17	Novozymes South Asia *	242	224	206	2	9	8
18	Bharat Serums	226	175	140	2	25	29
19	Jubilant Life Sciences	210	249	242	2	3	-16
20	EliLilly	204	187	164	2	14	9