Aug 12, 2010



Drug maker Venus Remedies today said it has received an approval to sell a generic version of anti-biotic pharmaceutical combination product of Imipenem and Cilistatin in Portugal.

"This is a widely used antibiotic in Europe with a market of more than $300 million. We plan to tap 5 per cent of this market in the coming 2-3 years," Venus Remedies Chairman and Managing Director Pawan Chaudhary said.

The company’s German arm Venus Pharma Gmbh will launch and market the product in Portugal during the fourth quarter of this calendar year.

The combination (Imipenem and Cilistatin) was originally developed by Merck, Sharpe and Dhome and is marketed in Europe, including Portugal by the brand name of Tienam.
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"The patent for this product has recently expired, and therefore holds a strong promise for Venus Remedies," Chaudhary added.

The product is an ultra-broad spectrum antibiotic used in the treatment of wide variety of infections, including abdominal and urinary tract infections.

This will be Venus' second product during the year that has received a marketing approval from Portugal, the earlier being Meropenem.

"Portugal is fast growing generic market, where generics have already more than 10 per cent of market share. This growth is in line with the government policy to increase generics prescription in order to reduce cost of medicines," Chaudhary said.

The company is already marketing this generic product under its brand name Lastinem in countries of Africa, Latin America, Middle East, Asia, South East Asia and Commonwealth of Independent States (CIS).

The product is also under registration in South Africa, where the company has already tied up for marketing of this product with one of the leading pharmaceutical companies.

Shares of Venus Remedies closed at Rs 268.85 in late afternoon trade on the Bombay Stock Exchange, up 0.96 per cent from its previous close.

August 12, 2010

 

Pharmaceutical major Aurobindo Pharma is gearing up to make an aggressive foray into the institutional supply market in the US. Though it has already started raking in revenues from such sales, the volumes and revenues are expected to shoot up this financial year.

“We are expecting about $10 million through the institutional route this year. We are all set to tap the growing opportunity in the US in the form of supplies to institutions including hospitals. This opportunity was not available to us during the previous financial year,” a company spokesman told pharmaquest.biz.

Aurobindo recently acquired a manufacturing facility from Sandoz in New Jersey for about Rs 225 crore. The facility went into production only during the last quarter of the previous financial year.

“We have three products approved and these are being manufactured in the US facility. The objective of buying the unit in New Jersey was to start focusing on institutional sales,” he said. In fact, the necessity to have a manufacturing facility in the US for supplying to the US institutions was the primary entry barrier for the drug company.

After acquiring and stabilising the acquired facility, the company is now seeking approvals for a variety of products to be manufactured and supplied to the US hospitals.

“We have filed several products for approvals in the US. We are expecting approvals for at least seven products shortly. These fresh approvals would take the total number of products available for manufacturing in the US to ten. The number would gradually increase as we get more approvals and the unit’s capacity too would get ramped up accordingly,” the officials said.

The institutional sales in the US happen through a tender process. Aurobindo has started participating in the tenders after acquiring the Sandoz facility. The total value of tenders that have come into the company’s fold is about $3 million.

Though the US sales in the first quarter were said to be lower than expected, the company is confident of ramping up sales for the full year. “We are expecting $300 million in revenues from the US. Normally, the penicillin and cephalosporin sales are higher from August to March due to the seasonality of the products,” the spokesperson said.

Last financial year, the company had about $200 million revenue from the US.

August 5, 2010

Pankaj Patel has used acquisitions and alliances to take the group to the next level.

Pankaj R Patel is chairman and managing director of the Zydus Cadila group, whose turnover has grown from a modest Rs 250 crores in 1995 to over Rs 3700 crores today. The group is poised to join the billion dollar league in the current financial year (2010-11) and become a global research-driven company by 2020.

Read more: Founded by the late Ramanbhai B Patel in 1952, Zydus Cadila is one of the top five pharma companies in India. In 1995, the group restructured its operations and in 1996 it became a public limited company, operating as Cadila Healthcare Ltd. Pankaj Patel is the founder’s son, and has 30 years of experience in the pharmaceutical industry.

The company has its manufacturing facilities in Ahmedabad, Ankleshwar and Vadodara in Gujarat, Ponda in Goa, Raigad in Maharashtra and Solan in Himachal Pradesh. The company’s operations include pharmaceuticals (human formulations, veterinary formulations and bulk drugs), diagnostics, herbal products, skin care products and OTC products.

Patel has made numerous acquisitions and struck a series of strategic alliances. In 1996, Cadila entered into a strategic alliance with Gulin Pharma of China and launched Falcigo in India, an anti-malarial drug. In May 2000, it acquired the formulations business of Recon Ltd, which strengthened the company in the southern market. In 2001, it acquired German Remedies (this was then the largest pharma M&A in Indian). In the same year, it entered into a joint venture with US-based Onconova for collaborative research in the field of Oncogenomics.

In 2002, the company acquired Banyan Chemicals, a Vadodara-based company with a US FDA approved plant. In 2003, German Remedies, Recon Healthcare, Zoom Properties and Zydus Pathline merged with the company. Also, they acquired Alpharma France, which spearheaded the group operations in France. Also in 2003, the company emerged as a ‘partner of choice’ for Schering AG to manufacture and market the products in India.

In 2004, the company entered into a strategic alliance with Zambon Group in Italy to explore new avenues in contract manufacturing. In the same year, it entered into a long-term strategic pact with Boehringer Ingelheim India Ltd, a wholly-owned subsidiary of Boerhringer Ingelheim, (BI) to manufacture and market BI’s products in India.

In 2005, the company entered into a strategic alliance with Mallinckrodt Pharmaceuticals Generics, a business unit of Tyco Healthcare, to market products manufactured by the company under a joint label. In the same year, the company signed a 50:50 joint venture agreement with Mayne Pharma of Australia to manufacture generic injectable, cytotoxic (anti-cancer) medicines as well as active pharmacetical ingredients (API) for global markets. The examples abound.

In recognition of his entrepreneurial vision, Patel was awarded the Ernst &Young Entrepreneur of the Year — Life Sciences Award for the year 2009.

August 2, 2010

Dr Reddy’s Laboratories (DRL) is scouting for partners in Japan to explore the $80-billion generic drug market. Japan is the second-largest pharmaceutical market in the world.

GV Prasad, vice-chairman and CEO, Dr Reddy’s Laboratories, said: “We are in the process of identifying partners in the generic segment in Japan, which is a tough market.’’ The company has shortlisted three players and is expected to sign an agreement by the year end. Analysts say global companies are now increasingly establishing a presence in Japan for both R&D and marketing.

Currently, two Indian companies Ranbaxy Laboratories (through Daiichi Sankyo) and Lupin are tapping the generic drug opportunity. While Daiichi Sankyo acquired a controlling stake in Ranbaxy, Lupin is present though Kyowa Pharmaceutical.

The Japanese market holds immense potential for global generic pharmaceutical companies. With the Japanese government focused on increasing adoption and generics penetration, the market is estimated to grow rapidly in the next three years. Umang Vohra, CFO, DRL, said that despite being the second largest market for pharmaceuticals in the world, Japan is a difficult, but a very qualitative market to be in, given the extremely stringent manufacturing and quality norms that prevail there.

The government plans to convert at least 30% of the country’s drug prescription to low-cost generics by 2012. Currently, generic or off-patent drugs have only a 17% market share in Japan.

An analyst pointed out that the industry has been seeking fast track of regulatory approvals and time lines. Companies also seek meaningful relaxation in regulatory norms, specifically with regards to bio-equivalence studies to make them more conducive to facilitate the entry of generics drugs. This will lead to substantial reduction in government healthcare expenditure.

The leading pharmaceutical companies within Japan are Takeda, Astellas, Daiichi Sankyo, Pfizer, Roche (Chugai), Eisai, Dainippon Sumitomo, Novartis, Taisho, Mitsubishi Pharma.

Lupin is the only Indian company and one of the few global generic pharma companies to have built significant presence in Japan through its subsidiary, Kyowa Pharmaceutical. Kyowa, Lupin's 100 % subsidiary, is the fastest growing generic company in the Japanese market. The company is focused on tapping into this emerging opportunity and has identified neurology, cardiovascular, gastroenterology and respiratory segments as core therapeutic areas of focus for drug development and marketing. It is also exploring in-licensing arrangements and strategic alliances with various Japanese, European and Indian companies to introduce new products into the Japanese market.