BEIJING - The heads of Germany's Bayer Schering Pharma AG and the Polish biotech firm Bioton, which produces human recombinant insulin, met in the Chinese capital this week to sign an agreement that sets the stage for Bayer to market the biopharmaceutical SciLin across China.

"We just signed an agreement with Bioton to in-license this new biotech product," said Ulrich Köstlin, who as one of the seven members of the Board of Management at Bayer Schering Pharma is one of the company's most powerful leaders.

Köstlin said in an interview that top executives from both Bayer and Bioton jetted into Beijing to launch the partnership because the recombinant insulin would be distributed to China's exploding populace of diabetes patients.

"There are now 40 million diabetics in China," explained Köstlin, and this group is expanding exponentially as the adoption of Western diets and lifestyles increases in tandem with China's remarkable economic rise, born of three decades of capitalist-style reforms.

Bayer executives estimate that more than 240 million people across the globe suffer from diabetes, and project that this patient pool will rise to more than 380 million people by the year 2025.

Inside China, Köstlin said, Bayer's antidiabetes drug Glucobay (acarbose), an alpha-glucosidase inhibitor, is already one of the company's strongest products. Worldwide, Glucobay - marketed as Precose in the U.S. - ranked as one of Bayer's top ten best-selling products in 2008, when it chalked up sales revenues of €304 million.

Acarbose was first approved as a prediabetes therapy in China in 2002, and can be prescribed as a monotherapy in patients receiving lifestyle modification advice in terms of diet and exercise, or as a combination therapy with insulin, according to Bayer scientists.

Bayer is also a global leader in terms of producing portable blood glucose meters, with successive generations of these devices for diabetes patients featuring meters with memories and computer interfaces.

[Editor's note: PharmAsia News recently spoke with Bayer Asia Pacific Regional Head Chris Lee about the company's vision of China as a global growth driver. Bayer leads all healthcare companies in sales in China ( PharmAsia News, Feb. 26, 2009 ).]

Meanwhile, Bayer Schering's Köstlin said that the new agreement with Bioton, which includes an upfront payment of €31 million, gives the German healthcare giant the right market and distribute the Polish-produced recombinant insulin inside China for the next 15 years.

Köstlin oversees Bayer Schering operations in North America, Latin America, and the Asia-Pacific region.

Bayer has engineered a series of acquisitions over the last several years, from the mega-merger with the German drug firm Schering to the takeover of the Cologne-based Direvo Biotech AG and purchase of a small Chinese maker of over-the-counter products, Topsun Science and Technology, last year. Yet Köstlin said that Bayer Schering had opted to partner with Bioton in the form of a licensing deal rather than an all-out takeover of the Polish biotech outfit.

Ryszard Krauze, the head of Bioton's supervisory board who touched down in Beijing to finalize the deal with Köstlin this week, said that the Warsaw-headquartered firm had already received regulatory approval from China's State FDA to market SciLin insulin here.

"SciLin contains insulin produced by recombinant DNA technology using a special non-disease producing strain of E. coli cell bacteria," Krauze said. "The insulin molecule in SciLin is identical to natural human insulin in composition."

Bayer board member Köstlin said: "The next important step is to launch this product in the [Chinese] market, probably at the beginning of next year."

And although China's pool of diabetes patients is rapidly expanding, the German and Polish partners will face strengthening competition over the next several years in terms of marketing insulin.

Late last year, the Danish-headquartered biopharmaceutical outfit Novo Nordisk started building a massive, $400 million insulin plant in the Chinese east coast city of Tianjin to serve diabetes patients across China and Asia, according to company executives and government officials (Also see "Novo Nordisk To Construct One Of World’s Largest Insulin Plants In Tianjin, China Biopharma Center" - Scrip, 11 November, 2008.).

The facility, set to start operations in 2012, will be the biggest insulin plant Novo Nordisk has ever built outside of Denmark.

- Kevin Holden (k.platt@elsevier.com)

Bayer Schering Partners With Polish Biotech Firm To Provide Recombinant Insulin To China's Exploding Diabetics Population

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