Merck Unit, Sun Pharma File Suit Against Glenmark

NEW DELHI--A unit of Merck & Co. and Sun Pharmaceutical Industries Ltd. 524715.BY +0.32% have filed a patent-infringement lawsuit in India against Glenmark Pharmaceuticals Ltd. 532296.BY +0.20% over an anti-diabetes drug. 

This is the latest among a series of legal disputes in India between multinational pharmaceutical companies which want to protect their patents and local generics drug makers that sell cheaper versions of drugs. In this case, the lawsuit is over a drug to treat a chronic disease, unlike in most cases where the disputes are over live-saving medicines. 

In a landmark verdict this week, India's Supreme Court rejected Novartis AG's NOVN.VX -0.30% attempt to win patent protection for Glivec, a major cancer drug. the judgment was roundly criticized by foreign pharmaceutical companies but praised by public-health activists, who said it would protect India's ability to make inexpensive generics for the developing world. 

In its suit filed in the Delhi High Court, Merck Sharp and Dohme Corp. said Glenmark's drug infringed on the patents of its products branded JANUVIA and JANUMET. 

Merck is known outside the U.S. and Canada as Merck Sharp and Dohme Corp. or MSD. MSD India is the local unit. 

"We believe our patents for JANUVIA and JANUMET are valid and enforceable and will vigorously defend them," it said in a statement Wednesday. 

Sun Pharmaceuticals said it has joined MSD's suit against Glenmark. 

Sun Pharmaceuticals, India's biggest pharmaceutical company by market capitalization, last year signed a license agreement with U.S.-based Merck to market the drug in India under the brand name Istavel Istamet. 

In a statement Wednesday, Glenmark said it has not infringed on the patents. 

The company said it "respects patent laws" and that it launched the drug, sitagliptin, "after due diligence and research." The statement didn't provide details. 

Foreign pharmaceutical companies see a huge potential in the South Asian nation, but at the core of most disputes are issue of patent protections. 

Consulting firm PricewaterhouseCoopers forecasts India's pharmaceutical market to grow to at least $48.8 billion in sales by 2020 from about $11 billion last year. A large chunk of the sales currently come from low-cost generics produced by local companies.

Glenmark eyes 20% sales growth in India speciality biz in 3yrs

Glenmark Pharmaceuticals expects sales of its speciality business, which focuses on branded products, to grow by around 20 percent in India in the next three years.

"The objective of the India business is to grow 18-20 percent sales CAGR for the next three years. India, Russia and Brazil to remain focus markets," Glenmark said in an investor report.

The Mumbai-headquartered firm's sales from speciality segment from the Indian market stood at USD 55 million (over Rs 280 crore) for the second quarter ended September 30, 2011.

The company said it also plans to build expertise around therapeutic areas like dermatology, respiratory and oncology, across all operating regions.

In generics segment, which focuses on marketing of active pharmaceutical ingredients (APIs) and generic formulations, the company intends to focus its ANDA filings in three niche therapeutic areas -- dermatology, hormones and oncology.

Commenting on its first-to-file opportunities in the generics segment, the company said it will be launching four drugs between March, 2012 and December, 2016, including cholesterol-lowering Ezetimibe.

The drugs, which the company plans to launch as first-to-file, includes Hydrocortisone Butyrate Cream, used to treat skin inflammation and Fluticasone Lotion used to treat skin pain and itching caused by eczema.

Glenmark has already launched Atovaquone & Proguanil HC, an anti-malaria drug, in September, 2011.

According to MAT January data 2011, Ezetimibe, Hydrocortisone Butyrate and Fluticasone Lotion had sales of USD 1.3 billion, USD 38 million and USD 49 million, respectively.

On the innovation front, the company plans to initiate clinical development of at least one new molecular entity (NME) each year.

"New target areas to be preferably first in class globally. Focus areas for research will remain inflammation, pain and oncology," the report said.

The company also plans to continue with the out-licensing model and simultaneously build capabilities to do late stage development work, it added.

Glenmark Pharma gains as anti-diarrhoeal drug enters pivotal trials

Glenmark Pharmaceuticals rose 0.23% to Rs. 280.40 at 13:59 IST on BSE after the company said it has obtained the DCGI (India) approval for conduct of the pivotal study of Crofelemer in acute watery diarrhoea patients.
The company made this announcement during trading hours today, 28 December 2011.Meanwhile, the BSE Sensex was down 175.85 points, or 1.11% to 15,698.10.On BSE, 12,000 shares were traded in the counter as against average daily volume of 51,684 shares in the past one quarter.The stock hit a high of Rs. 282.40 and a low of Rs. 278.05 so far during the day. The stock had hit a 52-week high of Rs. 372.10 on 6 January 2011. The stock had hit a 52-week low of Rs. 241.60 on 28 February 2011.The large-cap stock had underperformed the market over the past one month till 27 December 2011, falling 11.71% compared with Sensex's 1.14% rise. The scrip had also underperformed the market over the past one quarter, declining 13.82% as against Sensex's 3.93% fall.The company has an equity capital of Rs. 27.04 crore. Face value per share is Re 1.Glenmark Pharmaceuticals (GPL) said that post approval from the DCGI (India) for conducting the pivotal study of Crofelemer in acute watery diarrhoea patients, dosing in patients has also commenced. This is a randomized, double blinded, placebo controlled, parallel Group, three arm, multicenter and multinational pivotal study that is being carried out to assess the efficacy and safety of two dosage regimens of Crofelemer tablets in the treatment of moderate to severe Acute Watery Diarrhoea in adult patients including cholera. This phase III study will be done at leading centres in India and Bangladesh, Glenmark Pharmaceuticals said in a statement.Commenting on the development Mr Glenn Saldanha, Chairman & MD, Glenmark Pharmaceuticals said, We are delighted to commence Phase III trials for Crofelemer in adult acute diarrhoea. Adult diarrhoea is a big concern around the world especially in emerging markets and globally millions of patients suffer from diarrhoea every year.Glenmark remains committed to the development of Crofelemer across various diarrhoea indications that it holds exclusive rights, the company said in a statement.Glenmark Pharmaceuticals has an exclusive license from Napo Pharmaceuticals,Inc. to distribute and commercialise Crofelemer in 140 emerging countries (restof world, or ROW territories) including India for indications related to HIV,use in acute adult and pediatric diarrhoea. Crofelemer is a novel, first-in-classanti-diarrhoeal agent that has a physiological and different mechanism ofaction from traditional anti-diarrhoeal agents. Besides its potential efficaciousrole in multiple diarrhoeal indications, Crofelemer controls diarrhoea with nodrug-drug interactions, minimal systemic adsorption and, unlike current antidiarrhoeals, no serious side effects.Although Napo has purported to terminate Glenmark's license, Glenmarkvehemently denies that Napo has any basis for terminating its license and isseeking a declaration from an arbitration panel that Napo's claims of breach areunfounded, Glenmark Pharma said in a statement.On a consolidated basis, Glenmark Pharmaceuticals' net profit fell 35.2% to Rs. 55.86 crore on 45.9% growth in net sales to Rs. 1055.45 crore in Q2 September 2011 over Q2 September 2010.Glenmark Pharmaceuticals (GPL) is a research-driven, global, integrated pharmaceutical company headquartered at Mumbai, India. It is a leading player in the discovery of new molecules, both NCEs (new chemical entity) and NBEs (new biological entity). The company has eight molecules in various stages of clinical development and is primarily focused in the areas of Inflammation (asthma/COPD, rheumatoid arthritis etc) and Pain (neuropathic pain and inflammatory pain). The company has a significant presence in branded generics markets across emerging economies including India. GPL along with its subsidiary has twelve manufacturing facilities in four countries and has five R&D centres.

Glenmark gets Rs 110 cr from Sanofi as final upfront payment

Glenmark Pharmaceuticals today said it has received Rs 110 crore from Sanofi, as second tranche of oulicensing fee for a deal with French drug major, taking the total upfront receipts to about Rs 220 crore.In May, a Glenmark Pharmaceuticals SA, a wholly-owned subsidiary of Glenmark Pharma had outlicenced to Sanofi its monoclonal antibody, GBR 500, which is used for treatment of digestive disorders.For Glenmark, the deal has a potential to generate revenue of as much as $613 million (around Rs 2,720 crore).

"With this payment, Glenmark has now received the entire upfront payment of $50 million from Sanofi pertaining to the GBR 500 deal," the company said in a filing to the Bombay Stock Exchange (BSE).

It had received the first upfront payment of $25 million in June after receiving regulatory approvals from the US authorities.

As per the agreement, Sanofi would have exclusive marketing rights for the GBR 500 products in North America, Europe, Japan, Argentina, Chile and Uruguay.

The products will be co-marketed by the Indian and the French company in Russia, Brazil, Australia and New Zealand.

On the other hand, Glenmark would retain exclusive marketing rights in India and the rest of the world.

Glenmark has six different molecules under different stages of development, including GBR 401, GBR 600, GBR 900. It acquired GBR 500 and GBR 600 from a Canadian pharmaceutical company at the early stages of its development.

Glenmark shares were trading today at Rs 308.30 on the BSE in late afternoon trade, down 0.64% from previous close.

Buy Glenmark Pharma; target of Rs 400: Firstcall Research

“Glenmark Pharmaceuticals, together with its subsidiaries, engages in the manufacture and marketing of pharmaceutical formulations and active pharmaceutical ingredients in India and internationally. The company has a significant presence in branded generics markets across emerging economies including India. Its subsidiary, Glenmark Generics Limited has a fast growing and robust US generics business. The company’s net sales and net profit are expected to grow at a CAGR of 15% and 44% over FY09 to FY12E. It is the most successful Indian company in novel drug discovery research and has earned USD 137 million. The company out-licensed GRC 15300 to Sanofi-Aventis with a total deal value of USD 325 million. Glenmark received USD 20 million as upfront payment.”

“For the Second quarter, the top line of the company increased 23%YoY and stood at Rs 7413.83 million against Rs 6025.01 million of the same period of the last year. The bottom line of the company for the quarter stood at Rs 1116.25 million from Rs 808.65 million of the corresponding period of the previous year i.e. an increase of 38%YoY.”

“At the market price of Rs 356.05, the stock is trading at 18.94 x and 16.49 x for FY11E and FY12E respectively. On the basis of EV/EBDITA, the stock trades at 11.26 x for FY11E and 10.09 x for FY12E. Price to book value of the company is expected to be at 3.36 x for FY11E and 2.79 x for FY12E respectively. EPS of the company is expected to be at Rs 18.80 and Rs 21.59 for the earnings of FY11E and FY12E respectively. The company’s net sales and net profit are expected to grow at a CAGR of 15% and 44% over FY09 to FY12E. We recommend ‘BUY’ in this particular scrip with a target price of Rs 400 for medium to long term investment,” says Firstcall Research Report.

Glenmark Pharmaceuticals Poland Signs 5-Year Contract for Eluzzion CRM

Data3s today announced that Glenmark Pharmaceuticals Sp. z o.o., the Polish division of Glenmark Pharmaceuticals Ltd. (GPL), has signed a 5-year agreement with Data3s for eluzzion CRM, a leading customer relationship management and sales force support platform.

An additional contract for the same period was signed with pureIT, Data3s’ service partner in Poland, covering a range of IT support services on behalf of Glenmark Poland.

Glenmark Pharmaceuticals Ltd. (GPL), a research-driven, global, integrated pharmaceutical company headquartered in Mumbai, India, is one of the leading providers of generic medicines in Central Europe. Data3s is a leading provider of CRM software solutions for the pharmaceutical industry, with a rapidly-growing roster of clients across Europe.

Asked why his company chose eluzzion CRM, Artur Mazurkiewicz, National Sales Manager at Glenmark Poland, responded that the decision was based partly on the positive experience of his colleagues in other CEE countries.

“The Data3s system fulfilled our prior expectations and it had the recommendation of our colleagues from Glenmark [Czech Republic and Slovakia],” said Mr. Mazurkiewicz.

The tender for CRM was overseen by Jindrich Strnad, IT Manager, Europe for Glenmark.

Describing the rationale behind their decision-making process, Mr. Mazurkiewicz added:

“The decision to search for a new ETMS system was connected with the increasing demand from our Sales Department for better possibilities for targeting, planning and monitoring visits and activities.

“Additionally, we were seeking a system which would support us in the management of other fields, including medical samples distribution and financial documents distribution, and which would contain an HR module and an e-learning platform.”

According to Mr. Mazurkiewicz, eluzzion CRM fulfilled all of Glenmark Poland’s requirements and more.

“For our Area Sales Managers, additional benefits of the system are the wide range reports covering the quantity and quality of visits and activities performed by Representatives,” said Mr. Mazurkiewicz, noting that “receiving such reports promptly has a direct effect on good team management.”

Unsurprisingly, Mr. Mazurkiewicz said that price was also an important factor. “We searched for a system which would be cost effective,” he said, adding, “I am sure that our cooperation with Data3s regarding the eluzzion CRM system will be beneficial for our Sales, Marketing and Financial Departments.”

Reacting to the news, Data3s’ CEO, Antonin Lukes, said, “After successfully serving Glenmark in the Czech Republic and Slovakia for more than two years, we are very glad to see our relationship with Glenmark growing in Europe. This development reflects not just the quality of our product, but the strength of our business.”

The decision to implement eluzzion CRM in Glenmark’s largest CEE subsidiary allows Glenmark countries to band together around a common platform with the advantage of generating accurate and consistent reports across the region.

Asked whether the expansion within Glenmark reflects Data3s’ growth strategy for the coming year, Data3s’ Sales Director, Cristian Burrows, replied that corporate relationship building is a cornerstone – not just a result – of good service.

“We believe we are the most effective when serving multiple countries or corporate affiliates together. It allows for greater standardization without losing sight of the unique demands of individual countries. When more countries are operating on the same platform, there tends to be greater interest from headquarters and more ways for top management to be involved and know what’s going on in the region.”

Glenmark Pharma net up 38% to Rs 112 cr; shares zoom

Glenmark Pharmaceuticals, a global pharmaceutical company, has posted an increase of 38 per cent in its consolidated net profit at Rs 111.62 crore during the quarter ended September compared with Rs 80.88 crore in the previous corresponding quarter.

The company's consolidated revenues grew to Rs 724.26 crore against Rs 590.32 crore in the same quarter last year, up 23 per cent.The company's revenues from the generic business was up 27 per cent to Rs 327.65 crore from Rs 257.58 crore while in the speciality formulation space, revenues moved 19 per cent north to Rs 396.6 crore against Rs 332.74 crore last year.

"During the quarter, Glenmark's income saw growth buoyed by our largest businesses - India and the US, where new product launches assisted growth and also helped us increase market share across operating therapeautic cateogories," said Glenn Saldanha, CEO & MD of the company.

The company also witnessed good growth in the Latin America and the Central Eastern Europe region.

Saldanha sounded optimistic about the second half of the current financial year. "For the remaining part of the year, we expect demand conditions to further improve whieh will aid further growth in all operating markets. We will also continue our aggressive launch of new products across all branded generics markets," he added.

During the last quarter, the company had launched seven products in the US.

On the Bombay Stock Exchange, the company's shares traded strong at Rs 329.10, up 4.57 per cent at 1:07

Glenmark Pharmaceuticals quarter net beats forecast, shares rise

Glenmark Pharmaceuticals' consolidated quarterly net profit rose 38.3 percent, beating street estimates, on robust growth in generics and Active Pharmaceutical Ingredients (APIS), pushing its shares up more than 5 percent on Wednesday. The Mumbai-based firm reported a consolidated net profit of 1.12 billion rupees on net sales of 7.24 billion rupees for July-September. [ID:nBMB011761] A Reuters' poll of 23 brokerages had forecast a consolidated net profit of 997 million rupees on net sales of 6.85 billion rupees in July-September for Glenmark.

The drugmaker's U.S. unit Glenmark Generics Inc registered revenue of 2.24 billion rupees in July-September, up 26 percent on year, it said in a statement. The Mumbai-based firm's API business grew 30 percent in Q2, it added. "For the remaining part of the year, we expect demand conditions to further improve, which will aid further growth in all operating markets," Glenn Saldanha, chief executive officer and managing director, said in a statement.

"We will also continue our aggressive launch of new products across all branded generics markets (in the current year)," he added. Glenmark's speciality formulations business grew 19 percent to 3.97 billion rupees in July-September while India sales rose 22 percent to 2.24 billion rupees, it said in a statement. At 1:18 p.m., shares of Glenmark Pharmaceuticals were trading at 328 rupees, up 4.54 percent in a weak Mumbai market.

Value Pick: Glenmark Pharmaceutical

Leading brokerage house Canara Bank Securities (CanMoney) has picked up Glenmark Pharmaceutical as `value pick`.

It has recommended to `Buy` the stock in Rs 275-277 range for medium term target of Rs 330-335.

Valuations:

``The EPS registered by Glenmark (Q,N,C,F)* for the financial year ending March 2010 was Rs 4.79. Based on the healthy growth projections, on account of good performance by its subsidiaries and better realization from mainline verticals, EPS is likely to be around Rs 5.51 for financial year ending March 2011. Keeping this in view, Glenmark is currently trading at P/E Multiples of 60.26 xs and 52.05xs for FY2010 and FY 2011(E) respectively. Keeping the same P/E guidance, the expected price works out to Rs 332.``

Positive factors for Glenmark:

> Surge in business demand

> Out licensing pharmaceutical and R&D Business

> Better mix of operating verticals

> New growth engines

> Opportunities arising from new US healthcare reform bill

> Strong R&D setup

Negative factors for Glenmark:

Due to the huge capital requirement & lesser chances of success, for any novel drug discovery project, revenue earning chances are always unclear. Some negative factors pertaining to Glenmark are following:

> Total absence in some of the important segments such as multi-vitamins etc.

> Postponing of the IPO of GGL.

> Nill or very less presence in highly lucrative OTC segment.

> PLC, Maturing profile, for various dermatology related drugs in domestic market.