China

Study projects new wave of globalization in biopharma

John Carroll — Wed, 11 Jun 2008 11:13:18 -0400

Don't be misguided by dated reports discounting the impact Indian and Chinese scientists are having in drug development and other key technologies, says a new study from Duke and Harvard. Looking at recent data, research teams from those two countries have swiftly expanded their work in the field. A look at 2006 data shows a four-fold increase in the number of patents filed since 1995. And pharma giants like Merck, Lilly and J&J have been shifting research and manufacturing to India and China as they seek new ways to develop drugs on a lean budget, pushing a new wave of globalization.

"Driven by cost pressures and growth opportunities, they are partnering with firms there to do sophisticated drug research and clinical testing," writes Vivek Wadhwa in BusinessWeek. "Indian and Chinese companies are making strides in the segments of global value chains that are most lucrative. They are also now performing their own drug discovery with the hope of marketing new products through their multinational partners."

- read the article from BusinessWeek

Biotech entrepreneurs grow a new CRO in China

Mon, 19 May 2008 06:59:57 -0400

Biotech entrepreneur John Oyler--who helped found Genta and Galanea--sat down with Chemistry World to discuss his three-year-old CRO, BioDuro. He and an old friend founded the CRO with their own money, choosing to base the contract research organization in Beijing rather than Shanghai, where the big multinational drug companies have flocked.

"By the end of this year, we will have nearly 600 chemists and biologists working for the company," Oyler tells the pub. "Most of the world's top pharmaceutical firms are our clients. We have our business and marketing headquarters in San Diego, California. We have a team of more than 20 senior scientists leading the firm, many of whom used to be at multinationals like Merck and Pfizer."

- read the report in Chemistry World

Traditional remedies offer opportunities, challenges

Thu, 08 May 2008 06:59:55 -0400

The Financial Times delves into the push to develop new therapeutics from traditional Chinese and Indian remedies. There have been successes, including the anti-malarial artemether, which was developed from a plant long used to treat fevers. But researchers note that there are some extraordinary challenges. Natural remedies often rely on a volatile mix of natural ingredients that can have a radically varied effect on different people.

"Traditional medicines can be very dangerous," says Paul Herrling, Novartis' chief of corporate research. "Practitioners had no concept of statistics or of long-term consequences such as treatments that may cause cancer when used over many years."

Novartis and Merck were the only two big pharma companies to stay in the field. And a slate of biotechs joined them, including Nicholas Piramal and Phytopharm. MerLion in Singapore has been active as well after acquiring some of GlaxoSmithKline's traditional assets.

- read the article in the Financial Times

Novartis' China plans grew from science roundtables

Wed, 07 May 2008 06:59:55 -0400

PharmAsia News sat down with Paul Herrling, head of corporate research at Novartis, and En Li, VP and head of research for Novartis Institutes for BioMedical Research Shanghai, to discuss the massive R&D efforts the company now has underway in China.

Novartis began its involvement in China 10 years ago with discussions with Chinese scientists about traditional Chinese therapeutics and how that fit in with Novartis' effort to develop new compounds using natural ingredients. Now Novartis is budgeting $96 million for a new R&D center in China and plans to make the Chinese market one of its top 10 globally.

- read the story from In Vivo

Booming Chinese market lures Unigene joint venture

Tue, 29 Apr 2008 06:59:54 -0400

Unigene is racing to complete construction of new facilities in China that will house its joint venture with a Chinese pharma company. The joint venture plans to pursue R&D work as well as drug manufacturing. And they're aiming at capitalizing on the booming Chinese market.

"The PRC (People's Republic of China) pharmaceutical market for Western-style pharmaceuticals in 2006 was $13.1 billion, representing year-on-year growth of 30 per cent, one of the fastest growth rates in the world," said Dr Warren Levy, CEO of Unigene. "It has been projected that the PRC will become the world's leading consumer of pharmaceutical products by the year 2020."

- see Unigene's release
- read the report in In-PharmaTechnologist

Genzyme gets biosimilar rejection, builds R&D plant

Tue, 22 Apr 2008 06:59:58 -0400

The FDA have given a thumbs down to Genzyme's request for permission to sell its Pompe disease drug Myozyme manufactured in an Allston, MA plant. Genzyme is already manufacturing the drug in a smaller Framingham-based plant and wants to ramp up production at the larger Allston location. But the FDA ruled that the Allston-produced Myozyme must "be classified as [a different product] because of differences in the carbohydrate structures of the molecules." The FDA said Genzyme has to submit a separate BLA to gain approval for Myozyme produced on a larger scale.

This rejection underscores the difficulty biosimilars face in the United States. "The FDA decision...suggests that regulators may be reluctant to approve any generic versions of biologic drugs...without clinical data proving the drugs are at least as safe and effective as the originals if there are even slight differences in the compounds," observes the Boston Globe. Currently, the U.S. has no pathway to quickly approve biosimilar drugs.

As Genzyme points out, Myozyme production has already been scaled up in 40 other countries. "Based on the global clinical experience of nearly 900 patients of all ages currently receiving Myozyme produced at the larger scale...Genzyme believes that Myozyme produced at both the 160L and 2000L scales is clinically effective and safe," the company said in a statement. The company expects the FDA to act on the application by the end of the year.

- see this release from Genzyme
- read the Boston Globe article

ALSO: Genzyme is opening a major new R&D center in Beijing. The facility will house 350 employees and will cost an estimated $90 million. Researchers in the Beijing plant will develop drugs in four focused areas: orthopedics, transplant and immune disease, oncology, endocrinology and cardiovascular disease. According the the release, the R&D facility "is part of Genzyme's ongoing global expansion and commitment to establishing a long-term presence in China." Report

ProGenTech gains $21M in third venture round

Wed, 02 Apr 2008 07:59:54 -0400

ProGenTech, with operations in California and China, has pocketed $21 million in its third round of venture financing. The biotech company markets products for research and medical diagnostics and is developing a contamination free, cassette based automated nucleic acid purification system. Bay City Capital and DT Capital led the round. ProGenTech was founded by two engineers: Steve Yu and Jesus Ching. Yu will remain a director of the company and become its president and COO. Ching will become the chief scientific officer of ProGenTech.

- check out the press release

India moves to back up emerging biotech industry

Mon, 24 Mar 2008 07:59:55 -0400

The Times of India lauds new efforts in the subcontinent to encourage the growth of its biotech industry. Under new legislation, the country's department of biotechnology is now setting aside 30 percent of its annual budget to fund public/private collaborations on new drug development. A new council has been created to help coordinate efforts between academics and biotech companies and a new regulatory body has been created. India has a shortage of trained regulators, but the Times editorial suggests that the FDA may step in to help train personnel.

- read the editorial in the Times of India

Related Articles:
India emerging as big drug market. Report
China surges past India in drug discovery work. Report
China now leads India in ongoing clinical trials. Report
Bangalore Bio: India's biotech future is bright. Report

Forecast: BioPharma outsourcing will grow '08

Wed, 16 Jan 2008 06:59:54 -0500

Biotech and Big Pharma alike are taking outsourcing to new heights in 2008, according to IDC's Health Industry Insights report. This year everything from R&D to clinical trials and manufacturing will be outsourced in growing volumes to countries like Singapore, India and China, says the new forecast. Singapore in particular was lauded for its huge investments in the drug development and manufacturing field and a reputation for strong intellectual property provisions.

- see this release
- here's the report from the Birmingham Business Journal

Related Articles:
Chinese outsourcing poses new risks. Report
AstraZeneca to outsource manufacturing. Report
Eli Lilly to outsource half of research by 2010. Report

The low cost of doing business in China

Thu, 10 Jan 2008 06:59:59 -0500

A couple of days ago I made a small blunder on my way toward making a larger point. In summarizing a Wall Street Journal piece comparing the low cost of drug research in China to the United States, I said that China's research scientists earned about $30,000 a year, about 10 percent of what research scientists earned in the U.S. As a number of readers pointed out, the Journal piece was talking about the total cost of a research scientist, which registers at about $30,000 a year in China and $250,000 to $300,000 a year in the U.S.--according to analysis done by Credit Suisse in Hong Kong. It was not only about pay. OK. Point taken.

But the larger point stands. Drug companies don't need a Nobel Prize-winning math expert to tell them that an R&D hub in Shanghai will cost them a fraction of what it would in Boston, or Paris. Scientists would have to cut their salaries to something more in line with a grocery clerk to compete with that. And there's a major shift underway in research activities that makes that point loud and clear. I'd like to know more about what researchers think about that trend--and what it portends for drug development work. Biotechnology thrives in places where scientific talent is plentiful. Many top scientists go on to become entrepreneurs. Any lessening of talent in one region can have some serious long-term repercussions. And if Chinese companies buy into research outfits in the Europe and the U.S., isn't it likely that they will shift much of the work to China? - John Carroll