SEOUL - Of the many local Korean pharmaceutical players, vaccine producer Green Cross was the biggest beneficiary of the A/H1N1 flu pandemic last year as increased demand for its vaccines triggered a remarkable upgrade in its rankings to the second-largest from its previous long-time position of No. 5.

Wrapping up its annual earnings report, Green Cross told local analysts that 2009 total sales surged 24.6 percent from 2008 to KRW643.2 billion ($554.24 million). Net profit jumped 64.8 percent to KRW 80.5 billion ($69.36 million) while operating profit reached KRW119.4 billion ($102.88 million), up 75.8 percent from 2008.

Green Cross sales were weaker than those of leading pharmaceutical outfit Dong-A, which saw KRW802.1 billion ($691.17 million) in sales, but were higher than estimated sales of two other leading local Korean drug firms, Yuhan Corp. and Hanmi Pharm.

Pushing up Green Cross's total sales last year was the remarkable performance in the October-December quarter, when sales surged 61 percent to a record quarterly performance of KRW225.3 billion ($194.14 million), thanks to the brisk sales of its H1N1 vaccine, called "Flu-S vaccine" in Korea.

"Flu vaccine sales were remarkable during the last quarter of last year, thanks to the strong sales of our Flu-S vaccine," Green Cross spokesman Park Jun-Young told PharmAsia News. "Our sales are expected to remain strong this year as well, particularly in the first quarter as our [2009 sales of] adjuvanted A/H1N1 vaccine will be reflected in this coming quarter."

Green Cross signed a deal with Novartis to buy its adjuvanted A/H1N1 vaccine, which enabled the Korean firm to expand its own vaccine production volume (Also see "Novartis To Sell Flu Vaccine Adjuvant To Korea's Green Cross" - Scrip, 10 September, 2009.).

Sales of blood products, such as its immune globulin, to Brazil and India also contributed to the surge in sales last year, said Park, adding that first quarter sales of 2010 could exceed that of leading Dong-A.

Biosimilars of Roche's Blockbuster Rituxan and Genzyme's Elaprase in Pipeline

Green Cross is also optimistic about its biosimilar pipeline, which will boost sales considerably.

"We are in the process of developing and launching four biosimiar products now, including those for neutropenia therapeutics and erythropoietins," Park said. "We are also working on two other biosimilar products including Roche's global blockbuster Rituxan and Genzyme's Elaprase ."

Biosimilar therapeutics to treat neutropenia are getting ready to enter Phase II and III clinical trials, and could be used as "supplementary medicine" for current G-CSF (granulocyte colony stimulating factor) products, Park said.

Biosimilars are similar, but not identical, to the innovative products on which they are based. Like generic pharmaceuticals, biosimilars are offered at discounted prices to patients.

In a sign of growing government and public interest in biosimilars, the Ministry for Knowledge Economy - for the first time - added biosimilars to its extra annual budget expenditures for the biopharma industry in 2009 (Also see "Korea FDA Gears Up To Release Biosimilar Guidelines Modeled After EU Rules" - Scrip, 21 May, 2009.).

To clear a regulatory pathway for the new breed of follow-on biologics, South Korea's FDA released guidelines for approval and registration of biosimilars modeled after European Union regulations (Also see "Korea FDA Unveils Initial Biosimilar Guidance; Final Guidelines To Be Released In July" - Scrip, 29 June, 2009.).

Green Cross is one of several local pharmas seeking to grab a solid position in the biosimilar sector, as well as Daewoong Pharmaceutical, Yuhan Corp. and Hanhwa, Samsung and LG Life Sciences.

Positive news pushed up the price of Green Cross stock to a record high of KRW220,500 ($190.17) on Aug. 31, 2009. Since then, it has been on a downward curve, hovering around KRW120,000 level ($103) now.

Green Cross also won a bid last month to supply the World Health Organization's Pan American Health Organization with its chicken pox vaccine Suduvax in a deal worth $10.4 million (Also see "Korea's Green Cross Wins Bid To Supply Chicken Pox Vaccine to WHO" - Scrip, 14 January, 2010.).

- Peter Chang (p.chang@elsevier.com)

Demand For A/H1N1 Vaccine Catapults Green Cross Into No. 2 Spot In Korea; Company Ramps Up Biosimilar Pipeline

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