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NEW DELHI, May 01, 2014:

RG Stone Urology and Laparoscopy Hospitals plans to expand to 25 centres in two-and-a-half years, Hanish Bansal, Executive Director, said.

The Delhi-based hospital chain, which achieved a turnover of Rs.110 crore last year and hopes to achieve Rs.130-135 crore this year, is trying to garner the third round of funding for its expansion plans. Bansal told Business Line that it intends to raise Rs.100 crore by September this year.

Growth story

The chain, which was just three-centres-strong till 2005, is now present in seven cities with 15 hospitals. The company is clocking 15-20 per cent annual growth. “We are very keen to expand in the South (Chennai, Bangalore and Hyderabad), where we are not present yet,” Bansal said. In Chennai, the company is already looking at tying up with some corporate hospitals to run the urology departments.

Other than South India, RG Stone hospitals are set to open new centres in Delhi-NCR (already has six centres), Kolkata (has two centres), Mumbai (has four centres) and the North-East. Each new hospital requires an approximate investment of Rs.9 crore and takes about six months to set up, Bansal said.

Some outreach or satellite centres would also be started by the super-specialty hospital chain in tier II and III cities. “In two years, we could open about 10-15 satellite centres since the infrastructure cost is low.”

Besides constructing brand new facilities, the hospital is depending on other modes of expansion, such as taking charge of the urology department in existing multi-speciality hospitals and acquiring the practices of independent doctors.

Sub-specialities

More sub-specialities are also being added at RG Stone Hospitals, such as female urology, male infertility, bariatric surgery and laparoscopic gynaecology.

Bansal hopes to more than double RG Stone’s turnover following the latest round of expansion. “We hope to have a turnover of Rs.300 crore three years from now,” he said.

 
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Bangalore, April 25, 2014 - Commenting on the quarterly performance and highlights, Chairman and Managing Director, Kiran Mazumdar-Shaw stated,
“Biocon ended fiscal 2014 on a strong note. We delivered 16% revenue growth along with a healthy EBITDA Margin of 25%. This fiscal we recorded robust performance, an outcome of our efforts aimed at optimising our product mix, augmenting capacities and driving operational efficiencies.

We have delivered on our promise of affordable innovation through commercialization of Alzumab™, an anti-CD6 novel biologic for Psoriasis; and CANMAb™, the world’s most affordable trastuzumab. We are pleased that a large number of patients benefitted from these two products. We continue with our innovation led business strategy and look forward to deliver superior value to our stakeholders.”



Highlights:

  • Diversified Revenue growth in FY14
    • Biopharmaceuticals Segment: 14% YoY
    • Research Services Segment: 28% YoY
  • Group EBITDA and PAT margins at 25% and 14% respectively
  • R&D investments of Rs131 Crores (6% of Biopharma Segment sales)
  • Commercial Launch of the world’s most affordable trastuzumab, CANMAb®
  • Inauguration of Baxter’s Global Research Centre at Syngene
  • Elevation of Dr. Arun Chandavarkar to Chief Executive Officer and Joint Managing Director
  • Appointment of Mr. Ravi Limaye, as President – Marketing, Biocon

Business Performance


Financial Highlights: Q4 FY14 (In Rs. Crores)


Revenue : 746
R&D Expenses: 29
EBITDA: 193
( EBITDA Margin: 26%)
PAT: 113 (PAT Margin: 15%)

Revenue Breakup:
  • Biopharmaceuticals: 535
  • Research Services: 188
  • Other Income: 23


Biopharma

The biopharma segment delivered a growth of 14% YoY and 15% YoY for FY14 and Q4 FY14 respectively.

Commenting on this performance, Ravi Limaye, President - Marketing, Biocon, said The healthy growth of 14% this fiscal from our biopharma segment reflects our ability to manage the rapidly changing business environment. We continue our efforts to rebalance our product portfolio in the biopharma segment to ensure higher margin accretion despite the underlying current of commoditization in some of our key product portfolios. The strong traction in biosimilars, supported by capacity augmentation should hold us in good stead till our Malaysian facility comes online. The return to growth of our branded formulations segment is a positive sign, and we expect this vertical to deliver strong growth going forward .”

Small Molecules

Our sustained focus on optimizing our product portfolio in Small Molecules has helped us deliver a healthy set of numbers this fiscal. The recent portfolio realignment helped us offset the impact of continuous commoditization in the statins space. We have witnessed good business traction in Immunosuppressants and specialty products and expect it to sustain in FY15.

We have made investments this fiscal to progress from APIs to generic formulations and ANDAs, thereby moving up the pharma value chain. These investments will help us sustain our growth momentum in the coming years by ensuring a healthier product mix. We expect to initiate our dossier filings from this portfolio in FY15, which will bear dividends over the next few years.

Biosimilars

Our generic Insulins portfolio has delivered strong growth this fiscal through our expanding geographical footprint and increasing market penetration. Our generic rh-Insulin is now approved in over 55 countries. This growth has been supported by our enhanced capacities over the course of fiscal 2014. Our Malaysia project is on track to be commissioned in FY15. We continue to make progress on our various developmental programs, and hope to bring some of them to the clinic in FY15.

Branded Formulations

The branded formulations vertical grew at 9% YoY this quarter, vis-à-vis the industry growth of 7% YoY, delivering revenues of Rs. 93 Crs in Q4 FY14. We closed FY14 with sales of Rs. 391 Crs and a growth of 13% vs. the overall industry growth of 6%, driven by our flagship brands of BioMAb EGFR®, Abraxane™, Insugen® and Basalog®. We launched our trastuzumab product, CANMAb® in India in Q4 FY14.

Novel Molecules

We continue with the clinical development of our novel oral insulin molecule, IN 105, in USA, in partnership with BMS.

We have initiated the groundwork to explore expanded indications for our novel Anti CD6 molecule, Itolizumab. We are in discussions with potential partners for the out-licensing of this molecule.

Research Services

The research services segment grew at 28% YoY in FY14 and 14% in Q4 FY14. The quarter also saw the inauguration of the Baxter Global Research Centre, another multi-year dedicated services engagement with a global pharma company.

Commenting on this performance, Peter Bains, Director Syngene International, said, “We are pleased to report a strong set of numbers for FY14 with 28% YoY revenue growth which has also translated into a strong EBITDA growth. It is encouraging to see strong, broad based business momentum across our chemistry, biology, biologics and clinical service platforms. Our latest long term, dedicated research Centre for Baxter reflects the strong value that we bring to biopharma through wide ranging quality services and flexible business models. Our order book and outlook for the coming year remains robust, and, in line with our midterm outlook, we continue to invest in strengthening and enhancing our discovery and development service platforms.” BWI

 
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New Delhi, April 18, 2014 - 

Drug major Lupin is voluntarily recalling 9,210 bottles of its antibiotic drug Suprax, used to treat bacterial infections, in the U.S. market, according to the U.S. Food and Drug Administration (USFDA).

As per the information available on the USFDA website, Lupin Pharmaceuticals Inc., the U.S.-based unit of the company, is recalling two lots of Suprax as the “product did not meet specification in total impurities at the nine-month stability station”.

The company is recalling 4,038 bottles of Suprax in the first lot, and 5,172 bottles of the drug in the second lot in the U.S. market, it added. The nation-wide recall has been initiated by the company on January 27 this year.

The recall of the drugs has been initiated under Class-III, which FDA defined as “a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences“.

‘Voluntary recall’

When contacted, a Lupin spokesperson said: “This is a voluntary recall initiated on our own and of no business consequence.”

Last year also, the Mumbai-based firm had voluntarily recalled 64,368 bottles of Suprax in the U.S. market on account of discolouration.

Suprax contains cefixime, which is a third-generation oral cephalosporin that has an important role in treating common infections.

 
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Mumbai, April 08,2014 - Drugmaker Sun Pharma sent ripples across the pharmaceutical industry on Monday morning as it agreed to buy out the troubled Ranbaxy in a $4-billion (including $800-million debt), all-stock deal, in the process creating India’s largest drug company.

The landmark deal also makes the combined Sun-Ranbaxy entity the fifth largest generic drug-maker in the world, with estimated revenues of $4.2 billion for the year ended December 31, 2013.

The mega-deal underlines Sun Pharma Managing Director Dilip Shanghvi’s image as a “risk-taker”, since Ranbaxy is currently under intense scrutiny from the US Food and Drug Administration for compliance lapses at four of its manufacturing facilities in India.

Explaining the deal, Shanghvi said Ranbaxy was distinctive in nature, as it has several attractive brands, strengths and capabilities that can be leveraged.

On whether it would be Sun Pharma’s most challenging acquisition yet, he replied: “It is the largest for sure. I would not say challenging, but interesting …a validation of many of my principles.”

Ranbaxy is owned by Japanese major Daiichi-Sankyo and four of its India-based plants are at present barred from exporting to the US. Daiichi had bought Ranbaxy in 2008 from its erstwhile promoter-family, led by Malvinder and Shivinder Singh.

Arun Sahwney, Ranbaxy’s Managing Director and Chief Executive Officer, said that Sun Pharma was an ideal partner, as it had a good and proven track record of creating significant long-term shareholder value and successfully integrating acquisitions into its growing portfolio of assets.

Sun also indicated, as part of the transaction that “Daiichi Sankyo has agreed to indemnify Sun Pharma and Ranbaxy for, among other things, certain costs and expenses that may arise from the recent subpoena which Ranbaxy has received from the United States Attorney for the Toansa facility”. Top Sun Pharma and Ranbaxy executives present at the joint call in Mumbai to announce the transaction, however, did not give details on this.

The transaction is expected to close by the end of calendar year 2014, and Daiichi will get about nine per cent in Sun Pharma, making it the second largest shareholder after the promoter-family. Daiichi will also have the right to a representative on Sun’s board of directors.

Combined force

Shanghvi said the product portfolios of the two companies did not overlap, and as a result, Sun, for instance, could get access to Ranbaxy’s branded and over-the-counter products. The management expects revenues of $250 million and operating synergies three years after the deal is closed with Daiichi.

In the period till the transaction is done, an integration committee with representation from both companies will help iron out issues, Shanghvi said.

Under the agreements, Ranbaxy shareholders will receive a 0.8 Sun Pharma share for each share of Ranbaxy, a company note said.

This exchange ratio represents an implied value of Rs.457 for each Ranbaxy share, a premium of 18 per cent to Ranbaxy’s 30-day volume-weighted average share price and a premium of 24.3 per cent to Ranbaxy’s 60-day volume-weighted average share price, in each case, as on April 4, 2014. Sun Pharma’s shares were up nearly 3 per cent to close at Rs.587.25 on the BSE, while Ranbaxy’s were down a little over 3 per cent at Rs.445.20.

The transaction will represent a tax-free exchange to Ranbaxy shareholders, who are expected to own around 14 per cent of the combined company.

The proposed transaction has been unanimously approved by the boards of directors at Sun Pharma, Ranbaxy, and Ranbaxy’s controlling shareholder, Daiichi Sankyo. It still requires shareholder and other regulatory approvals. 

 
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Mumbai March 13,2014:
Global drugmakers have had a nauseous time in India`s USD 14 billion market. Prices have dropped and valuable patents have been overruled as the authorities strive to make medicines affordable for the 70 percent of people living on less than USD 2 a day.

From a regulatory perspective, the government has "messed up", as one top industry consultant put it. But with 1.2 billion people increasingly seeking both on- and off-prescription drugs, the market is too big for firms to simply throw in the towel.

The two top foreign players, Abbott Laboratories and GlaxoSmithKline Plc, are actually stepping up investment, and others such as AstraZeneca Plc are considering doing so.

GSK has just spent USD 1 billion on raising its stake in locally listed GlaxoSmithKline Pharmaceuticals Ltd and plans to double Indian drug production by building a second factory for about USD 140 million.

"There is a real excitement about India in GSK, in both consumer products and pharmaceuticals," said Roger Connor, GSK`s global head of manufacturing on a visit to Mumbai.

India harbours an army of companies driving prices down with copies of off-patent drugs. It also has a government imposing wide-ranging price reductions and a legal system with a history of disallowing patent protection. Perturbed, global drugmakers are soldiering on.

Abbott, local No. 1 since buying Piramal Healthcare for USD 3.7 billion in 2010, has launched 40 drugs in India in the last two years and will open a new factory for nutritional products later this year, said head of Indian operations Bhasker Iyer.

Other drugmakers may raise stakes in local units made cheaper by a rupee that has fallen 12 percent in value over the past year compared with the US dollar, said Aditya Khemka of brokerage Ambit Capital.

AstraZeneca has said it hopes to take full control of AstraZeneca Pharma India Ltd, at a cost of more than USD 100 million, to give it greater flexibility in India.

Khemka believes Sanofi SA, which has said emerging markets are important for growth, could well be the next to raise its stake in Sanofi India Ltd. A Sanofi spokesman declined to comment.

Even Novartis AG, whose cancer drug Glivec was refused a patent by the Supreme Court last April, is launching new drugs.

COMPULSORY LICENCE

India stunned the pharmaceutical industry in 2012 by overriding a valid patent on cancer drug Nexavar from Bayer AG and issuing a so-called compulsory licence to Natco Pharma Ltd, allowing the local firm to sell a copy for a fraction of the price.

The threat of more such licences has since been hanging over the sector like a Sword of Damocles, said Ranjit Shahani, head of Novartis` India unit.

Yet the long-term prospects of the Indian market have not deterred Shahani from launching new patented drugs.

"Based on activities on the ground, multinational companies are actually taking larger bets on India," said Sujay Shetty, pharmaceuticals leader for PricewaterhouseCoopers in India.

"Of course, there is dissatisfaction - but if you really analyse the problems, many of them are working their way out of the system. From a regulatory shock point of view, pretty much everything the government could do to mess up, it has messed up. So this is the worst you`re going to see."

The probable handover of government following an upcoming election to the pro-business Bharatiya Janata Party means the threat of compulsory licences may be receding, Shetty said.

PRICE CUTTING

Market growth fell below 10 percent last year, largely due to government-imposed price cuts on many basic drugs, while even high-end biotech specialist Roche Holding AG agreed to voluntary price cuts for some cancer drugs to improve market access.

Pricing pressure was a factor in researcher IMS Health projecting India will be the world`s 11th biggest pharmaceutical market by 2017, from 13th in 2012, rather than eighth by 2016 as forecast less than two years ago.

Nevertheless, growth should return to double digits in 2014 and stay there for years to come, said Hasit Joshipura, the head of GSK`s local subsidiary.

GSK is working within the low-price environment by chasing volume. In some cases, the company charges just 10 percent of international prices.

"On a volume basis, 20 percent of what I make globally is sold in India, so it is a massive business," said GSK`s Connor. Yet that makes up only around 3 percent of revenue.

The strategy`s success depends on an efficient supply chain, in a country where local companies such as Ranbaxy Laboratories Ltd have been banned from exporting drugs or drug ingredients to the United States because of quality concerns.

"You can be absolutely successful in India from a quality and safety perspective," said Connor.

GSK not only makes medicines in the country but also buys ingredients from local suppliers which are audited by GSK staff.

The US regulator last month called on its Indian counterpart for more collaboration on drug safety. In the meantime, Indian officials have tightened rules surrounding clinical trials to the extent that local firms Biocon Ltd and Lupin Ltd have moved studies offshore.

Uncertainty over patent security and obstacles to clinical trials are discouraging Western companies from conducting drug research in India, though that was not enough to deter Novartis from recently launching patented drugs such as Tasigna and Jakavi for cancer and Galvus for diabetes.

"While we certainly would be cautious in our investments in innovation, we do consider India to be an important market," said Novartis` Shahani. "You have to bet on demographics." Business Standard

 
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New Delhi March 10, 2014 : Indian companies export about $14 billion worth pharmaceuticals every year and a majority of this are US-bound. In recent months, however, India's drug-makers have been rattled by a rash of US regulatory rebukes, including a record fine for Ranbaxy Laboratories. While increased on-the-ground oversight reflects India's growing importance as a supplier to the United States, it has also raised questions about its manufacturing practices and the quality of products made in the country.

Have these developments impaired the image ofbrand India? Or will the FDA's stepped-up scrutiny inculcate a more rigorous attitude towards compliance in a country whose cheap generics have made it the low-cost pharmacy to the world?
The US has a lot more to lose than India: Anand Nandkumar

To know whether the FDA objections with regard to the violations of good manufacturing practices by generic drug majors like Ranbaxy and Wockhardt will adversely affect India's position as the preferred generic drugs' supplier to US, it is imperative to understand how patients make decisions about prescription drugs in that country.
Pharmacy Benefit Management or PBMs play a critical role in the purchase decision of patients.

PBMs are most often third party administrators of prescription drug programmes. Sometimes they may also operate as a service inside of an integrated healthcare system. They are responsible for processing and paying prescription drug claims. They negotiate with drug makers and pharmacies to get the best possible prices for the drugs. In many cases PBMs operate formularies, which is a list of equivalent generic drugs for a given prescribed drug. The main focus of the PBMs is to minimise costs, including those related to prescription drugs and in many cases using formularies they often provide financial incentives to patients to select lower-cost drugs.

PBMs, thus, exercise a significant amount of discretion and in many cases even switch between an expensive, branded drug and a generic drug independent of the prescribing physician. If the consumer wishes to buy a drug that is not on the formulary maintained by the PBM that she is affiliated with, she has to dip into her own funds and often this involves a significant co-pay element. In sum, consumers will likely only exercise their discretion when the health hazards are significant.

That said there may, however, be some short-term repercussions such as increased scrutiny of processes or tightening of FDA regulations. But in my opinion, drugs manufactured in India are largely safe for consumption and this is a one-off event. Most companies will likely be found to comply with the FDA rules and emerge unscathed from the shadow of this controversy.

Moreover, given that 30-40 per cent of the generics sold in the US are sourced from India currently, even the short-term impact cannot be that dramatic - a sudden shift in sourcing destination require substantial investments in building capacity.

Alternatives to the Indian generic drugs will likely be more costly. So even if the US explores alternatives, it will be unlikely to act on that intent given the recent concerns about the cost of healthcare in the US. Hence in some sense, the US has a lot more to lose than India. For India, assuming that the generics manufactured in India are largely safe for human consumption, what is at stake is economic growth, which depends upon the large scale success in export markets such as the US. For the US, it is a question of how much more its governments and people should spend just to stay healthy.

The big caveat to this is the recent diplomatic row between the two countries. If the Ranbaxy incident gets included in the larger diplomatic game of one-upmanship, resolution may not be as forthcoming or immediate or even palatable to the people of both countries. Business Standard
 
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New Delhi March 7, 2014 : Sun Pharmaceutical Industries Ltd, India's biggest drugmaker by market value, is looking for partnerships or acquisitions to enter , an especially lucrative market for manufacturers of low-cost drugs, a senior executive said.

Politicians are lobbying for more generic drugs to go on sale in Japan to bring down healthcare costs for a rapidly ageing population.

Indian pharmaceutical firms are the world's biggest manufacturers of , but  Ltd is the only Indian drugmaker that has so far made significant inroads in Japan.

"At an intent level, we would like to participate in the Japanese generic market. But we are still thinking through as to what's the best way to participate," Uday Baldota, senior vice president for finance and accounts at Sun, told Reuters.

"It could be a partnership, or an acquisition. We haven't really narrowed down the specific way of doing it."

Mumbai-based Sun gets more than half its sales from the United States, the world's biggest pharmaceuticals market.

Sun has expanded in the last few years, mainly through acquisitions, and Baldota said the company was on the look out for more purchases. He declined to give details, however.

"We will do acquisitions and remain keen to do acquisitions, but it's not necessary for us to do an acquisition just to grow our business," Baldota said. "We feel comfortable doing large deals. That is not something that will deter us."

Sun was said to be in talks last year to buy speciality drugmaker Aptalis from private equity firm TPG Capital. In January, Forest Laboratories Inc agreed to buy Aptalis for $2.9 billion.

Sun's talks in the same year to buy Swedish drugmaker Meda, a maker of speciality products, over-the-counter drugs and branded generics, foundered on valuation, sources with direct knowledge had told Reuters.

In 2012, Sun bought US-based Dusa Pharmaceuticals Inc for about $230 million, as well as URL Pharma from Japan's Takeda Pharmaceutical Co for an undisclosed amount - boosting its growth and market share in the United States.

Sun also sought to take full control of its US-listed Israeli unit Taro Pharmaceutical Industries Ltd , but the deal was terminated last year after a long-drawn battle.

 
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