Indian Stock Market

Orchid has got USFDA nod for anti-epileptic tablets.

I love this company not only for its business but also since its located near my locality.

Orchid Chemicals & Pharmaceuticals today said it has received US health regulator’s approval to sell anti-epileptic levetiracetam tablets in the American market. The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for levetiracetam tablets,” Orchid Chemicals said in a filing to Bombay Stock Exchange (BSE). The company has received approval from USFDA for levetiracetam tablets in strength of 1,000 mg, it said.

Piramal Healthcare is all set to sell off its diagnostic business arm, reports CNBC-TV18, quoting sources. Malvinder Singh’s Super Religare Laboratories is likely to be the buyer.

This comes less than two months after Piramal struck the USD 2 billion Abbott deal. CNBC-TV18 learns that this deal is expected to be between Rs 600 to Rs 700 crore.

Piramal’s diagnostic business currently has revenues of close to Rs 200 crore. CNBC-TV18 had in May reported that the Piramals plan to shut down their diagnostic business due to losses sustained over the last two years.

Parabolic Drugs is launching a Rs.200 crore IPO.

Parabolic IPO Date , Price:

Date: June 14 2010 – June 16 2010
Price Band: Rs 75-85 per share
The issue comprises an offer for sale of 20,25,702 equity shares by BTS India Private Equity Fund and Alden Global (Mauritius).

About Parabolic Drugs IPO:

Parabolic drugs is a Chandigarh based contract manufacturer of active pharmaceutical ingredients (APIs) and API intermediate company in the SME segment, Parabolic Drugs (PDL) intends is planning to come out with an Initial Public Offer (IPO) for Rs 200 crore. The company will use the raised funds for capacity expansion of existing as well as for the new facility. PDL will use its IPO earning also in reducing its debt.

Management Talk:

Pranav Gupta, Managing Director, PDL said, “We believe that the scope of outsourcing will increase day by day and we are trying to accomplish as much as possible. In line with our growth plans, we have filed a draft red herring prospectus (DRHP) and received observation report from Securities and Exchange Board of India’s (SEBI) and targeting to launch IPO in a month’s time. Through the IPO we will be raising Rs 200 crore which will be utilised for our existing as well as for upcoming facilities. Also we have Rs 38 crore debts which will be settled through IPO proceeds.”

Manafucturing facilities:

PDL has two full-fledged manufacturing facilities at Derabassi, Punjab and Panchkula, Haryana and obtained WHO GMP certification and US FDA approval respectively.

R&D center:

The company is also setting up a new pilot R&D centre at Barwala, Haryana for custom synthesis research on a larger scale and targeting to commission the facility soon. Besides, it is also setting up a new manufacturing facility as per US FDA guidelines at Chachrauli, Haryana which will be operational by November 2011.

Speaking on the funds break up Vineet Gupta, Director, PDL shares the details, “Currently, we have two facilities one each at Derabassi and Panchkula. Besides, we are also setting up two more facilities at Barwala and Chachrauli. Through the IPO we plan to expand and scale up these facilities further. Also, we have planned to set up one more R&D centre at Panchkula but this completely depends on the IPO proceeds and we are targeting to commission this facility by 2012.”

Expansion plans:

At Barwala, PDL will be doubling its existing capacity of 200-250 kilo lab with an investment of Rs 50 crore for phase III. Likewise, it will be investing Rs 16 crore for phase II expansion of Chachrauli facility and Rs 47 crore for the Panchkula site. The company had taken term loans to fund previous expansion plans and will be repaying debts of Rs 38 crore from a part of the IPO proceeds. The company has products in antibiotics and is further diversifying into the lifestyle disease segments. Presently, its product portfolio holds 42 APIs and seven API intermediates. In a span of two years, PDL filed 15 dossiers and few more are in the process. Overall, it has manpower strength of 968 people of which 81 scientists and 24 PhDs. The company is keen on hiring more people.

International Business:

PDL is present in over 45 countries and its export business contributes nearly 32 percent of total turnover. During half year of 2009-10, teh company reported a turnover of Rs 230 crore. With a CAGR of 40 percent the company has grown rapidly during the last five years. Commenting on the international business potential, Vineet Gupta said, “Turkey and Middle East are the major markets for us especially for antibiotics. We are continuously eyeing US, Japan and the European market for further growth.”

CIPLA to get 40% stake in Indian Biotech Company

The Pharma company is going to acquire stake in 2 biotech companies. The company will acquire 40% stake in Indian Biotech Co and 25% stake in Hong Kong-based biotech company.

There will be total investment of USD 65 million for both acquisitions, reports CNBC-TV18.

Buy Venus Remedies – Pharma Sector – Small cap pick

About Venus Remedies:

Currently the stock is trading at Rs.265 per share. I expect the price to be in the range of Rs.350-400 in 1 year.

Chandigarh-based Venus Remedies is a major producer of oncological and cephalosporine injectable products. The company has de-risked its business model by having presence in the high growth therapeutic segments such as anti-infective, oncology, cardiology and neurology.

The company follows the strategy of forging marketing tie-ups with companies in India and abroad for specialty products. The company is also looking at contract manufacturing opportunities. It has filed many international patents for sophisticated formulations of anti-biotics and oncological therapeutics.

Last week, Venus launched world’s first once-a-day painkiller injectable in India. The company hopes to capture 10% market share in the early years of its launch and is already in talks with global pharma companies for out-licensing the product.

In March 2010, the company got Indian patent for one of its product Sulbactomax and has also filed patent for this product in another 50 countries including the US, Europe, Australia, Japan and Latin American countries.

Growth Strategy :

Registrations approved in 19 semi-regulated markets in 2008-09 are expected to drive the company’s prospects and profitability. Its launch of innovative products in India and other international geographies (through marketing alliances) will strengthen revenues.

Contract manufacturing opportunities with leading global brands are expected to yield attractive results. In-licensing initiatives are likely to reinforce our performance.

Financials :

The company’s net sales have grown at a compound annual growth rate (CAGR) of 55% over the past five years to Rs 310 crore in FY10. The net profits have grown at a CAGR of 62% to Rs 45 crore in FY10. The company has undergone a capex of Rs 200 crore over the past five years.

It has logged a strong performance for the first quarter ended March 2010. With 27% increase in net sales and 31% increase in net profit, the company has logged an improved performance sequentially.

Company Valuations:

The company has outperformed the Sensex and is currently valued at little over than its annual turnover. The stock is trading at a price-to-earnings multiple of 5.

These relatively lower valuations indicate the scope for the company’s stock to appreciate further as company continues to deliver growth. Investors looking at bottom-fishing in the small-cap space can consider this scrip.

Source: Economictimes.com

Ranbaxy has declared Rs.963 crores net profit this quarter.  Last year the company declared a loss of Rs.761 crore in the same quarter. Ranbaxy is the India’s largest Pharma company.

Net sales during the period were Rs 2,486.7 crore, up by 60 per cent over the Rs 1,577.1 crore during the comparable period in 2009.

Forex gains and a one-time spike in US revenues due to a limited period exclusive market opportunity for its anti-herpes drug, Valacyclovir, were the major reasons for the growth

The result exceeded Ranbaxy’s own estimates, as the company had expected Glaxo to authorise one generic competitor to launch Valacyclovir (generic name of GlaxoSmithKline’s Valtrex) during the exclusivity period – which did not happen. The drug cornered a 60 per cent market share, hence the 266 percent increase in revenues from USA, said Atul Sobti, chairman and managing director. The company registered sales of Rs 1,151.5 crore in the US during the period under review.

Analysts termed the performance as impressive. “The company has made use of its first-to-file opportunity well. It has also got $50 million from a patent dispute settlement with Boehringer over heart burn drug Flomax,” said Ranjit Kapadia, vice president, institutional research, HDFC Securities.

The foreign exchange gain on foreign currency option derivatives for Ranbaxy was Rs 387.2 crore, as against a forex loss of Rs 954.8 crore during the corresponding quarter the previous year. Other operating income such as export benefits and income arising out of milestone payments and patent settlements accounted for Rs 280.3 crore in revenues during the quarter. The income under this head during the corresponding previous year’s quarter was Rs 22.3 crore.

Sobti said the company would better its performance once the synergy with Ranbaxy’s majority shareholder, Daiichi Sankyo of Japan, was completely in place.

The synergies are under various stages of implementation and Daiichi had recently announced the establishment of a new company, Daiichi Sankyo Espha Co Ltd, to market generic drugs primarily sourced from Ranbaxy in the Japanese market.

Research synergies – where Daiichi would make use of Ranbaxy’s low-cost drug discovery skills and also make maximum use of its strengths in developing generic medicines – is another area expected to be rolled out during the year, Sobti said.

HCL Technologies  has signed a 5 Year $500 million Strategic Agreement With Merck .

HCL Technologies , a leading global IT services provider, today announced it has signed a five-year, $500 million strategic engagement with MSD (also known as Merck & Co., Inc. with headquarters in Whitehouse Station, NJ, USA), a global research-driven pharmaceutical company.

HCL will extend its existing relationship with MSD, dating back to 2004, to become an integral business & technology services partner and provide a multitude of services including software-led IT solutions, remote infrastructure management, engineering and business and knowledge process services.

“”For five years, MSD has leveraged HCL’s extensive expertise in life sciences and healthcare to streamline operational efficiencies and consolidate its IT portfolio,” said Richard G. Branton, Vice President of Application Services, MSD. “As we continue to leverage global delivery services to meet our business imperatives, we have chosen HCL as our strategic partner for its depth of technology and pharmaceutical domain experience, coupled with its flexibility to engage and a commitment to deliver.”

“This is a landmark win for HCL, and we are proud that our growing leadership in pharmaceutical and healthcare, coupled with our previous delivery for MSD has positioned HCL as a strategic partner for MSD,” said Shami Khorana, president HCL Americas. “We are committed to creating transformational value for MSD in this engagement and we look forward to playing a key role in the organization’s growth across global markets.”

“MSD will leverage HCL’s near-shore delivery network in the U.S. comprised of its operations center in Raleigh, North Carolina and its global data center delivery ecosystem, powered by its partner footprints across the globe. As a result of this engagement, HCL will expand its U.S. team in North Carolina, relying on local hires to staff projects, thus creating jobs for the local community. In total, HCL will deliver services out of 20 worldwide locations including USA, Poland, China and Brazil.

Pfizer and Wyeth have sued Ranbaxy in US court for infringing on patent of drug Rapamune.

Wyeth is owned by Pfizer filed a patent-infringement case against Ranbaxy and its US subsidiaries, Ranbaxy Pharmaceuticals Inc and Ranbaxy Inc, three days ago in the United States District Court for the District of Delaware. Pfizer and Wyeth also filed a similar case against Watson Pharmaceuticals, said patent experts.

Rapamune (generic sirolimus), approved by the US Food and Drug Administration in 2000, is an immuno-suppressant developed to reduce organ rejection in patients receiving kidney transplants. For the 12 months ended February 2010, Rapamune had total US sales of $210.5 million, according to IMS Health data.

The suit is in response to the applications filed by Ranbaxy and Watson with the US drug regulator to launch generic versions of sirolimus, challenging the patent rights of Rapamune. Watson and Ranbaxy are believed to be the first to challenge the patents of this drug. Ranbaxy executives were unavailable for comment, but Watson confirmed the patent infringement suit from Pfizer and Wyeth.

Ranbaxy had earlier waged a five-year patent battle with Pfizer over the world’s largest-selling drug, Lipitor, in over 40 countries, and on Caduet, a high blood pressure drug. In June 2008, Pfizer and Ranbaxy settled the cases out of court. Ranbaxy was given the licence to sell the generic versions of Lipitor and Caduet in the US effective November 30, 2011, and on varying dates in seven other countries.

A few weeks ago, Ranbaxy had settled with Takeda Pharmaceutical Company a patent dispute related to a generic version of the Japanese company’s anti-diabetes drug, Actos.

Such out-of-court litigation settlements and patent infringement suits are common in the US generic drug business. According to the rules for selling generic drugs in the US, an innovator has to sue an ANDA filer with Para IV certification (which details patent challenge) within 45 days of intimation. The suit automatically bars the FDA from not approving the drug before patent expiry or for the next 30 months. Normally, companies go-for-out of court settlements than continue the litigation.

Aurobindo Pharma has got approvals for cefprozil tablet from canada.

Aurobindo Pharma Ltd. is pleased to announce that it has received the approvals for its Abbreviated New Drug Submission for Cefprozil Tablets 250 mg & 500 mg and Cefprozil Powder for Oral Suspension (PEOS) 125 mg/5ml & 250 mg/5 ml from Health Canada.

Cefprozil is the generic equivalent of Canadian reference product Cefzil of Bristol-Myers Squibb Canada Inc and falls under the antibiotic therapeutic category.

With these approvals Aurobindo now has 11 products approved by Health Canada.

Biocon SA to buy 49% stake in Biocon Biopharmaceuticals, reports CNBC-TV18. The company is a wholly-owned subsidiary of Biocon.

The stake is presently held by CIMAB SA. Biocon is in a joint venture with CIMAB to manufacture products based on monoclonal antibodies.

Recently, Biocon’s custom research arm Syngene International and Endo Pharmaceuticals had recently tied-up to jointly discover and develop new biological drug molecules to fight cancer. As per the agreement, all rights to the molecules developed will remain with Endo, while Syngene International will get research fees, milestone payments and success fees from Endo.

Speaking to CNBC-TV18, Kiran Mazumdar Shaw said the company is committed to make Syngene public in FY11. Syngene’s biggest client is BMS. “We are making all the kind of preparations to list the company sometime in this calendar year,” she added.

Biocon had tied up with Amylin Pharmaceuticals last year to jointly develop, make and market a novel peptide drug to treat diabetes.

CIPLA doesnt like iPill anymore. It has sold its iPill to Piramal.

India’s largest domestic drug maker, Cipla, sold its emergency contraceptive brand, i-pill, to Piramal Healthcare in a deal worth Rs 95 crore. i-pill, a two-year-old brand, is sold over the counter (OTC) and does not require a prescription. It is India’s largest-selling emergency contraceptive, followed by Mankind Pharma’s ‘Unwanted 72′ and Morepan Laboratories’ ‘Option-72′.

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

Amar Lulla, joint managing director of Cipla, said the sale was driven by the company’s decision to focus on prescription drugs, its core competence.

Cipla is the largest seller of drugs in the country. It sells 924 prescription drugs and has a market share of 5.38 per cent. Ranbaxy, the second largest seller, has a market share of 4.91 per cent, with 565 products.

The i-pill is among the top 300 pharmaceutical products in the country and had sales of Rs 30.9 crore for the past 12 months, shows the data from ORG IMS, the drug sales tracking agency. Actual sales would be much higher, as ORG IMS only tracks sales through stockists and not those through other channels.

The Drug Controller General of India had allowed OTC sales of emergency contraceptives in 2006.

The OTC market in India is estimated to be around $1.8 billion (Rs 8,190 crore) and growing annually at 18 per cent, Piramal Healthcare said in a statement.

“In two years, the emergency contraceptive market has grown to about Rs 100 crore and we are confident that i-pill has big growth opportunities in future in the country,” said Murari Rajan, executive director of Piramal Healthcare.

“i-pill empowers Indian women to remain in control of their future without resorting to emotionally and medically stressful alternatives like abortion,” said Swati Piramal, executive director, Piramal Healthcare.

The pill contains Levonorgestrel, a progestogen hormone which helps prevent unwanted pregnancies if taken within 72 hours of unprotected sexual intercourse.

The government had recently banned advertisement of emergency contraceptives, following concerns that the young generation might misuse the product as a routine contraceptive pill, instead of using it in emergency situations.

Rajan said the company would continue to look at acquiring more brands for the local market.

He said Piramal Healthcare’s OTC division, started five years earlier, had a turnover of over Rs 100 crore, powered by popular brands such as the Lacto Calamine skin care range, nutritional supplement Supractiv Complete, Saridon and the Polycrol antacid.

NSR Partner gets 30% stake in Nectar Lifesciences .

Deal values Nectar pharma at Rs.35 per share .

NSR is investing close to 250 crores for this stake .

CIPLA is now India’s No:1 Pharma Company.

Drug company Cipla maintained its top position in the domestic market for the 12 months ended December, 2009, with a market share of 5.38 per cent — up 18 per cent over the year and ahead of Ranbaxy Laboratories and GlaxoSmithKline (GSK).

The total domestic drug market is valued at Rs 40,051.74 crore, an increase of 17 per cent over the previous year, according to data from drug sales tracking agency, ORG-IMS. The agency tracks drug sales among more than 500,000 traders in the country, through stockist data.

Cipla’s domestic market share grew 18 per cent during the year, thanks to its product basket of 924 products, which is way ahead of Ranbaxy’s 565 and GSK’s 177 products.

Ranbaxy got a market share of 4.91 per cent and GSK had a market share of 4.35 per cent, with a growth of 13.7 per cent and 18 per cent, respectively, in 2009.

During the period, Cipla had sales of Rs 2,155.29 crore in the domestic market, ahead of Ranbaxy’s Rs 1,968.24 crore and GSK’s Rs 1,743.15 crore.

Cipla had overtaken Ranbaxy and GSK India to become the largest pharmaceutical company in the domestic market for the first time in May, 2007, according to sources.
]
Piramal Healthcare, Zydus Cadila, Sun Pharma, Alkem Laboratories, Mankind, Lupin and Aristo Pharma occupied the 4th-10th positions in ORG-IMS rankings, respectively.

Interestingly, Elder Pharma emerged as the fastest growing company in the domestic market among the top 50 players, with a year-on-year (YoY) growth rate of 28.1 per cent over the previous year. Elders’ growth in the domestic market is ahead of Mankind (27.9 per cent), Wanbury ( 25.2 per cent), Piramal Healthcare (22.8 per cent), Zydus Cadila (21.2 per cent), Sun Pharma (22.9 per cent), Micro Labs and Alembic (24.7 per cent).

“A focused approach on promoting flagship brands like Shelcal, which grew 22 per cent, along with Chymoral Forte (30 per cent) and Formic-O (100 per cent), and prioritising the market opportunities helped us achieve this growth,” Elder Healthcare Director Alok Saxena said.

Among brands, Pfizer’s cough syrup, Corex, regained its position as the largest drug brand in the country with sales of close to Rs 182 crore.

CIPLA to supply generics for GSK , TEVA

Orchid chemicals loses its GEM to Hospira.