March 06 update

The New York-based drug manufacturer is considering building a $660 million facility, and have narrowed down their choices to Rhode Island, Massachusetts, New York and North Carolina as a possible location.

The plant would manufacture viruses, serums, and toxins for the diagnosis, treatment, or prevention of animal diseases.

Company spokesman Tony Plohoros said locations in Rhode Island, North Carolina, Massachusetts, and New York are being considered.

North Carolina is Likely Site for New United Therapeutics Facility

Carolina lost the battle to Maryland last year for United Therapeutics' $32 million lab facility, but the woman-led biotechnology company is looking at the Triangle again for a $50 million project.

United, which is based in Silver Spring, MD, wants to build a 200,000-square-foot manufacturing and laboratory building in Research Triangle Park that could employ as many as 300 workers.

Roger Jeffs, United's president and chief operating officer, says the company's current focus is on building sites in RTP, and United has been working with state, Wake County and RTP economic developers for a suitable location. "We hope to finalize the decision on the selection of an appropriate site in the coming months," says Jeffs, who is based in RTP. United Chairwoman and CEO Martine Rothblatt works out of the firm's Maryland office.

Jeffs hinted that the company is looking at some other sites outside of RTP. He said the facility will manufacture and package the oral tablet form of the company's lead drug, Remodulin. The research and development group and related sales and marketing teams associated with the drug would be housed in the same facility. The tablet form of Remodulin has yet to be approved by the FDA.

Interestingly, United Therapeutics chose two lots in the park only to be told they had been "reserved" for another company. That company is Fidelity Investments of Boston, which is considering construction of a campus off Louis Stephens Road that could grow into an operation with as many as 5,000 employees.

As for United Therapeutics' project, Maryland again is competing against RTP. Economic development officials in both states are discussing economic incentives, with Maryland hoping the company decides to stay put and grow its footprint there.

Eisai Will Invest in $90 Million Expansion in RTI

Eisai Inc., a U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., will expand its Research Triangle Park facility, creating 59 new jobs and investing $90 million over the next three years. The company plans to add an additional 25 jobs by 2011. The announcement was made possible in part by a $150,000 One North Carolina Fund grant.

Eisai Inc. is headquartered in Teaneck, New Jersey and maintains its only U.S. pharmaceutical production and formulation research and development operations in Research Triangle Park. The new jobs will include quality control analysts, manufacturing and packaging operators, chemists, engineers and technicians.

"We are excited to expand our operations in RTP, where our high compliance standards will be instrumental for regulatory approvals and production of our first anticipated oncology product," said Lou Arp, vice president of production operations at Eisai Inc. "Constructing the new facility at our current location allows for seamless integration between our production and research and development departments as well as access to North Carolina’s strong talent pool."

The One North Carolina Fund assists the state in industry recruitment and expansion by providing financial assistance through local governments to attract business projects that will stimulate economic activity and create new jobs in the state. One North Carolina Fund grants require and are contingent upon a local match. Through the use of this Fund, more than 18,000 jobs and $2.5 billion in investment have been created since 2001.

The new 65,000 ft² plant will accommodate aseptic processing suites, laboratories and other support functions. Furthermore, a separate $15 million central utilities building is planned to supply power, steam, chilled water and compressed air to the existing operations and the new parenteral facility.

Groundbreaking is expected in the autumn and completion is anticipated in three years, with operations starting in 2009.

The new facilities will lead to 59 new jobs over the next three years and a total of 84 new jobs over the next five years.

“The new facility will be used for production and formulation R&D specifically for oncology products, as oncology has long been one of Eisai's therapeutic areas of focus,” Eisai spokeswoman Cathy Pollini told In-PharmaTechnologist.com.

“Eisai's existing 190,000-square-foot facility is devoted to manufacturing its $1bn-a-year Alzheimer's drug Aricept and $1.2bn-a-year acid pump inhibitor Aciphex tablets, as well as formulation research and development and manufacturing of compounds for use in clinical trails.

Novo Nordisk in $100 Million Expansion of Clayton Plant

Novo Nordisk is in the first phase of a $100 million insulin plant expansion. Novo Nordisk is a pharmaceutical company focused on diabetes care and biopharmaceuticals. The company posted net income of about $957 million in 2005 and has recently completed the first phase of construction on a $100 million expansion of its Clayton insulin plant. The plant is expected to create 187 new jobs paying an average annual salary of $52,000 when it is finished.

Hospira to Expand Plant in McPherson, KS to 440,000 ft²

This pharmaceutical company’s plan to expand a pharma plant with 172 new employees has moved forward to ground breaking.

“This is a pretty big deal for us,” said Marvin Peters, executive director at the McPherson Industrial Development Co.

Earlier this month, Hospira announced it was closing its plants in Ashland, OH, and Montreal, Canada. It’s also started a four-year “phase out” of its manufacturing facility in North Chicago, IL.

It remains unclear how many, if any, of the displaced workers will land jobs at the 440,000-square-foot facility in McPherson.

The company also has plants in Rocky Mount, NC, and Austin, TX.

Once a division of Abbott Laboratories, Hospira manufactures a wide range of pharmaceutical and medication delivery products. In McPherson, Hospira’s manufacturing operations are focused mostly on so-called injection drugs, those administered by shots or IV setups. It’s also involved in freeze-drying certain medications.

Before Abbott Laboratories, the McPherson facility was part of Sterling Drug. It opened in 1974.

Ferro Pfanstiehl has New Class IV Containment Kilo Lab in Waukegan, IL

Ferro Pfanstiehl Laboratories has commissioned a new Class IV containment kilo lab in Waukegan, IL, for low-volume production of high-potency APIs. John A. Minatelli, senior director for commercial development, said Pfanstiehl's existing facility primarily serves pharmaceutical companies with drugs in Phase II or III of clinical development.

The $4.3 million addition, he said, offers production quantities up to 5 kg for customers with preclinical or Phase I compounds.

American Peptide in $10 Million Expansion at Vista, CA

American Peptide said it plans later this year to invest roughly $10 million to expand a large-scale cGMP peptides manufacturing plant in Vista, CA. New equipment will enable peptide production up to the 50-kg scale.

Although best known for its catalog peptides business, American Peptide is gaining recognition for custom peptides manufacturing. Currently, American Peptide is producing two commercialized peptide drugs. The drug master file has been completed for a third product, with a New Drug Application expected to be filed later this year. As such, "we expect to reach maximum capacity in 2007 and will need to build new capacity in late 2006/early 2007 to meet business demand," said Chris Bai, the firm's president and chief executive officer.

California Firm Will Boost Kendall Square Staff

Amgen plans to increase to 400 the number of scientists and support staff at its Kendall Square laboratories over the next few years, substantially expanding its footprint in Cambridge, chief executive Kevin Sharer said in Boston recently.

Amgen, with headquarters in Thousand Oaks, CA, and more than 14,000 employees, is the largest biotechnology company in the world. It had revenue of $12.4 billion in 2005.

Amgen's Cambridge research operation is relatively small, with 135 employees in a 300,000-square-foot building that Amgen opened in 2001. The expansion, however, will gradually move its Cambridge facility to among the top dozen pharmaceutical and biotechnology labs in Massachusetts.

The company said the Cambridge operation would employ 200 people by the end of this year.

Sharer said Boston's concentration of academic medical centers, universities, and biotechnology companies were the main reason Amgen decided to expand here.

Sharer also cited a positive regulatory environment as a reason for doing business in Massachusetts, a view not often voiced by the state's business leaders.

''This is a great place to do business," said Sharer, a former high-ranking executive at MCI Communications who joined Amgen in 1992 and rose to chief executive in 2000. Amgen's larger Cambridge operation, he said, will have a ''fully capable, fully scalable research site."

He discussed the company's plans in an interview at The Boston Globe recently and in response to a question after speaking before the Boston College Chief Executives' Club at the Boston Harbor Hotel. He told business leaders that Amgen is looking to make acquisitions.

''Boston's full of companies that may some day want to be part of the Amgen family," he said.

Amgen grew from a tiny California start-up in the 1980s on the back of its star drug, Epogen, which treats anemia in cancer patients and patients undergoing renal dialysis. It has continued to focus on expensive injectable drugs.

More recently, its growth accelerated with several acquisitions: Kinetix Corp., of Medford, in 2000; Immunex Corp., of Seattle, in 2002; and Tularik Inc., of San Francisco, in 2004. Late last year it struck a deal to acquire Abgenix Inc., of Fremont, CA. The Immunex deal allowed it to acquire Enbrel, a popular drug used to treat rheumatoid arthritis and psoriasis that it manufactures at a plant in East Greenwich, RI.

Last month, Amgen said it would spend heavily in 2006 on new research and development activities in the United States and Europe.

Mark Duggan, senior director of medicinal chemistry said Amgen researchers in Cambridge will be heavily focused on finding treatments for neurological ailments, like pain, Alzheimer's disease, and schizophrenia. Cancer also will be a key target, he said.

Accentia Considering 195,000 ft² Plant in St Louis

St. Louis is fighting to lure Accentia BioPharmaceuticals, which is now based in Tampa, FL. The company went public in October and has two promising drugs in clinical trials. The chief executive, Francis O'Donnell, says the company wants to decide within 90 days where to build a plant that could total 195,000 square feet.

"We'd be tickled pink to bring it to St. Louis," said O'Donnell, who grew up in south St. Louis. "Most of my directors are from St. Louis; most of my investors are from St. Louis."

O'Donnell lives in west St. Louis County, heads three other companies and is founder and managing director of the Hopkins Capital Group, a Town and Country venture capital firm.

An Accentia plant could take up as much as 20 acres and generate as many as 850 jobs.

A number of hurdles are blocking the plant. Tampa is offering as much as $30 million in incentives to keep Accentia, according to media reports. In St. Louis, Accentia has applied for $10 million in federal tax credits and a variety of incentives from the city and state, O'Donnell says.

SAFC Completes Expansion of High Potency Intermediates in Wisconsin

SAFC, a leading custom chemical manufacturer and a member of the Sigma-Aldrich Group, has completed a major $12 million expansion program at its high potency advanced pharma intermediates (API) facility in Madison, WI. The 38,000 square foot expansion more than doubles the size of SAFC's existing 23,500 square foot building and its cGMP manufacturing capacity at Madison.

The two-story infrastructure adds new analytical laboratories; expanded

R&D laboratories; three new kilo laboratories; a hydrogenation suite; cGMP

drying suite and increased warehousing and storage capacity.

The expansion has been driven by an increase in demand for custom chemical manufacturing services for highly potent APIs, including category III

and category IV compounds.

Guidant Corp. Plans 300,000 Ft² Facility for Medical Devices

Guidant Corp. plans to put up two new buildings, totaling 300,000 square feet, a 60 percent expansion of its Temecula facility, which produces stents, catheters and a range of other vascular products. A Guidant spokeswoman said the company hadn't decided how many jobs would be added to the more than 3,000 already there, but plans to replace part of its parking lot with a 1,600-space parking garage.

Though Indianapolis-based Guidant is itself being acquired and split up, spokeswoman Kim Boetsch said the company's acquisition doesn't significantly affect plans for the new buildings.

Boston Scientific plans to complete its $27 billion acquisition of Guidant early next month. Partly to help finance the deal, Boston Scientific plans a $6.4 billion sale of Guidant's vascular division, which includes the Temecula facilities and a smaller research facility in Santa Clara.

Genetech Expansion in Oregon will be Complete in 2008

Genentech has selected Hillsboro for the construction and development of a facility that will fill and package commercial drugs. The expansion could bring as many as 300 new jobs to the area by 2015.

San Francisco-based Genentech will locate its new campus on a 100-acre site on Shute Road in Hillsboro. The company expects to break ground on the facility in late 2006, with completion in 2008. The facility is expected to be licensed and operational in 2010.

"Oregon offers an advantageous business environment, and its single-sales factor apportionment tax policy is particularly attractive to growing companies like Genentech. In addition, Oregon meets our needs for a high-quality available labor force and development-ready land with supporting infrastructure," said Genentech's executive vice president for product operations, Patrick Y. Yang.

Genentech uses human genetic information to discover, develop, commercialize and manufacture biotherapies to address medical needs. The company has the largest proportion of Food and Drug Administration-approved manufacturing capacity for the production of biotech medicines in the world. It has existing manufacturing facilities in California and Spain.

Abbott Plans Pharma Plant in Kenosha, WI

Now that pharmaceutical giant Abbott Laboratories Inc. has acquired 500 acres of land just across the Wisconsin state line for what figures to be a major expansion, some technology observers believe the impending development bodes well for creating synergies with the state's existing biotech companies.

While Abbott has set the stage for an expansion just 15 miles north of its world headquarters in northern Illinois, the hop across the border into Wisconsin is significant because of perception and the connections that could follow, said Tom Still, president of the Wisconsin Technology Council.

Abbott has purchased 500 acres west of I-94 in Pleasant Prairie and the neighboring town of Bristol. The site is envisioned to house multiple buildings with a variety of uses including office, laboratory, light manufacturing and support facilities, according to a statement released by Doyle's office. While the development timeline will depend on future growth and market factors, the land is expected to be zoned to accommodate up to 12,000 employees, the statement said.

If Abbott creates 2,400 new jobs, the Kenosha Area Business Alliance does not have to repay $12.5 million it was loaned by the state to help with development, the statement issued by Doyle's office said.

Amgen to add 500,000 ft² in South San Francisco

Amgen, the world's largest biotechnology company, plans to aggressively expand in South San Francisco with the addition of 500,000 square feet of research and development space expected to be built during the next three years.

Amgen CEO Kevin Sharer said the company, which employs 360 workers at its current South San Francisco site, expects to add 200 employees this year alone. The new construction will be able to accommodate well over 1,000 new employees in the next few years.

CANADA

Alphora Now Operating Kilo Lab in Ontario

Alphora Research, a specialist in API technology development services, also recently opened a kilo lab at its Mississauga, Ontario, site. Alphora was launched in late 2003 by Jan Oudenes, an entrepreneur who earlier started Torcan, a Canadian fine chemicals company that Avecia acquired in 2000. It now has 30 employees.

ASIA

CHINA

Lonza Is Building a $250 Million Biopharmaceutical Plant in Singapore but Already Planning Expansion
Swiss life sciences company Lonza is already thinking of expansion even as construction work begins on its new plant in Singapore. Its new biopharmaceutical plant, worth US$250 million, is a 50-50 joint venture between Lonza and Bio*One Capital, the biomedical investment arm of EDB. Lonza says it plans to expand the plant within the next four years.

The groundbreaking took place on Wednesday at the Tuas Biomedical Park.

The new biopharmaceutical plant will pave the way for Lonza to expand its customer base in Asia. It will have four reactor lines, each with a potential sales turnover of up US$50 million.

Lonza expects the Singapore plant to contribute about a quarter of its overall biopharmaceutical business.

Said Stefan Borgas, chief executive officer, Lonza, "This plant for us is the entrance into the Asian market in the biopharmaceutical area and at the same time, it is the second source for all of our customers in the US and Europe. With this, we will achieve worldwide leadership as a contract manufacturer in biopharmaceuticals."

Lonza currently produces active ingredients to 18 of the world's largest pharmaceutical firms.

It expects global demand for biopharmaceuticals to grow about 20 percent each year. Right now, Lonza is building up its presence in the Asian market. Lonza says most of its initial customers for this plant will be from the US and Europe. But in the longer term, it hopes to target more of customers in the Asia-Pacific region, especially Japan and Australia, where companies are developing a pipeline of biopharmaceutical drugs.

The plant is expected to become operational at the end of 2009, with about 350 highly-skilled workers.

Even though construction has just begun, Lonza says it is already planning to expand the plant within the next four years to meet growing demand.

Said Mr Borgas, "Long term, if we are very honest, this facility will be too small to survive very long term on its own. So we need to grow it into a scale where it gets really globally competitive. Not only now, but also in 2020. We have received very positive feedback from customers, so right now, we are rather optimistic we can hopefully in this decade kick-off the second built-out here."

The new plant could potentially triple in size, given the additional eight hectares of land available next to it.

Novo Nordisk Begins Major Expansion in Tianin

Novo Nordisk recently inaugurated a major expansion of its production facilities in Tianjin, China. The Tianjin plant has been designated Novo Nordisk’s primary production base in the Asia Pacific region and will supply both China and export markets.

The expansion includes a new assembly plant for Novo Nordisk’s NovoPen^® 3 insulin pen as well as an expansion of current packaging facilities for Penfill^® insulin cartridges and FlexPen^® prefilled insulin pens.

“Our expansion in China reflects the internationalization of our production base and our commitment to the Chinese market. The new plant is yet another example of the increasingly important role China is playing in Novo Nordisk’s global operations, and we will continue to build the Tianjin plant into a world-class insulin production base,” says Kåre Schultz, chief operating officer of Novo Nordisk.

To celebrate the completion of the new plant, Novo Nordisk held a grand opening ceremony with representatives from among others the Chinese Ministry of Health, officials from Tianjin Municipal Government, the Danish embassy in China and leading diabetologists from China.

“The new plant will create more than 100 new jobs in China, and will help meet the increasing demand for Novo Nordisk’s insulin products in Asia and other countries. With the new plant and our R&D centre in Beijing, Novo Nordisk now has a strong platform for future growth in China,” says Ronald Frank Christie, president of Novo Nordisk China.

Novo Nordisk’s first plant in Tianjin was built in 2002, and the new plant has been built on the existing 40,000 square meter site. With the opening of the new plant, the production of NovoPen^® 3 in Denmark will be phased out. The Danish plant has been re-equipped, and employees are being transferred to the production of NovoPen® 4, the latest version of Novo Nordisk’s durable insulin pen system. Almost three and a half million people worldwide use a NovoPen^® system for their daily insulin injections, and NovoPen^® 3, which was launched in 1992, is the highest-selling insulin pen in the world.

Novaratis Building $83 Million Pharma Plant in Changshu

Novartis AG yesterday began constructing an US$83 million drug production and development plant in Changshu in the eastern Chinese province of Jiangsu, the China Daily reported.

The new site is Novartis' sixth investment project in China, and will analyze, develop and produce chemicals for drugs used to treat leukemia, epilepsy, high blood pressure and other ailments.

The plant is expected to become fully operational by the end of 2007, the newspaper said.

Products from the plant will be exported worldwide, the report said.

For the first time, the global pharmaceutical company is conducting drug development operations outside Switzerland and the US.

With an ageing population and increasing need for healthcare, China is expected to become the world's No. 2 or No. 3 pharmaceutical market in the next five to ten years.

The new site is part of Novartis' long-term strategy for China. Last month, it started a project to double the size of its plant in Beijing.

TAIWAN

Good Potential for Pharma in Taiwan

Located in Tainan County, Southern Taiwan, Active Pharmaceutical Ingredient ( API) manufacturer ScinoPharm is often touted as a shining example of the success of Taiwan's government-formulated biotech development policy. In fact, in producing pharmaceutical ingredients on contract for some of the international brand and non-brand drug companies, ScinoPharm's business model is closer to the OEM model that propelled Taiwan to become the world's greatest manufacturer of electronics, than to the knowledge-creation model seen in the modern biotech environment of gene identification and drug discovery. It's all because 'biotechnology' in Taiwan is defined as including the pharmaceutical, medical device and modern biotech sectors, and besides, the API manufacturing model fits well to Taiwan's seemingly natural propensity to excel in engineering and precision manufacturing.

There are a number of other quality API manufacturers in Taiwan, including Yung Zip Pharmaceuticals, subsidiary of generics manufacturer Yung Shin Pharmaceuticals; and China Chemical Synthesis Biotech Company, 45 percent owned by the locally-listed pharmaceutical manufacturer China Chemical and Pharmaceutical Corporation (CCPC), but none has the pedigree, the scale or the customer list of ScinoPharm.

Its founders, including CEO Dr. Jo Shen and VP Dr. Hardy Chan, came from executive positions in US-based drugmaker Syntex. With accumulated revenues for the first 6 months of 2005 amounted to over US$15 million, the company now boasts clients from the world's top 10 biggest drug makers, as well as some of the largest generics companies, even some in India.

Although the company's success is seen as a model for others in Taiwan to follow, it may be a while before we see another ScinoPharm, as the investment amount required and ROI is still beyond the patience limits of most local investors. But API manufacturing is alive and well in Taiwan.

While the island doesn’t yet have any big-name research-based pharmaceutical companies, there are a very large number of generic drugmakers, many hundreds at last count. While most are too small to compete with giant overseas generics companies, these companies are being kept alive by their cozy relationships with hospitals, in turn supported by the policies of the Bureau of National Health Insurance (BNHI).

Representatives of overseas business groups in Taiwan such as the American Chamber of Commerce and the European Chamber of Commerce have long claimed that while more expensive drugs, particularly cancer drugs, produced by US, European and Japanese firms are not being paid for by the BNHI, hospital purchasing departments were buying cheaper drugs and being reimbursed by BNHI for more then what they paid. This is leading to over-prescribing; with drug prescribing becoming a profit center for a hospital. This may led to prescription decisions being based on profit instead of efficacy and value of the drug to the patient, according to the scheme's critics. It's been estimated that over US$600 million is lost annually in BNHI funds due to this payment reimbursement mechanism. Just where these funds get lost may explain how many small generics companies are still keeping their doors open, and why many of Taiwan's big hospitals are doing very well for themselves.

While very few local generics companies have obtained U.S. FDA certification for their factories or products, and the number with export success in western markets counted with a closed thumb and forefinger, there are industry observers who say that with Taiwan's proven expertise in engineering and manufacturing, generics is where it should be able to compete, if not on price then on quality, flexibility or for where more precise or complicated processes are required to make the end product.

A lifeline thrown to the generics manufacturing sector has been the recent government emphasis on self sufficiency in certain supplies of drug, vaccine and medical consumables, policy put in place from lessons learnt during the SARS crisis of 2003 when vital medical supplies ran out, and the policy reinforced by the current H5N1 scare and worldwide shortage of the antiviral Tamiflu.

While not exactly in the same league as Pfizer or GSK, there are a small number of research-based pharmaceutical companies producing innovative drugs, or at least modified existing drugs for new uses. One such company is TTY Biopharm, a publicly-listed company making oncology drugs with improved disease-targeting behavior. TTY is unusual for the fact that it does its own research, its own manufacturing, and has its own network of distributors island-wide.

Other drug discovery companies are quietly working away in the wings, and have good prospects in therapeutics for Asian-prevalent diseases such as hepatitis. While some will look towards the traditional 'licensing-to-Big-Pharma' model for their big break, others will try to go it alone and research, manufacture and market their own products as TTY has done. Companies in this bracket may include TaiGen Biotechnology and PharmaEssentia. TaiGen is headed by Dr. Hsu Ming-chu, previously Research Director for Oncology and Virology for over 10 years at Hoffmann-La Roche, USA. Taipei-based TaiGen focuses on oncology, chronic inflammation and viral infection therapeutics and received early financing from MPM Capital to the extent of US$37 million. The company is also in research collaboration with TTY. PharmaEssentia, headed by ex-Biogen executive Dr. Lin Ko-chung, is a drug discovery company with promising liver disease drugs in the pipeline.

Perhaps the biggest problem is the oldest problem, funding for the inevitably long drug development process. Taiwanese life science companies have not yet opted for listings on overseas stock markets, thereby limiting their access to larger fund pools. This is in contrast to the growing numbers of pharmaceutical and biotech companies in mainland China, even Hong Kong, which have not only taken the plunge with listings on US, UK and other overseas stock markets, but have raised their international profiles with the inevitable press release flurry which accompanies—and follows—such a listing.

While Taiwan has its own vibrant venture capital industry, local funds are not yet flowing into the life sciences on their own accord. Until this happens many local companies with great potential will remain small and under-funded.

However, with its continued efforts to fund and promote the industry's development, and to source and set up international collaboration opportunities, the government remains a force behind much of the continued growth of Taiwan's life sciences industries, including the pharmaceutical sector. When measured together with the prospects for the island's burgeoning drug discovery industry, and considering the boost the recent government emphasis on drug self sufficiency has had on Taiwan's bio-product manufacturing industry, it all adds up to future growth.

CDC Awards GlaxoSmithKline Contract for Taiwan Vaccine Production Facility

The Center for Disease Control (CDC) announced this week that the winner of its tender to set up a vaccine production facility in Taiwan is GlaxoSmithKline (GSK), beating out three other companies for guaranteed government orders of vaccines produced at the plant, once completed.

With plants already in Shanghai and Singapore, GSK has vast experience in the R&D and manufacturing of vaccines, which was apparently a deciding factor in winning the tender. The company is one of the top thee vaccine manufacturers in the world, and is the largest vaccine supplier in Taiwan, accounting for 24 percent of market share.

The facility will focus on the production of flu vaccines, which must be made fresh each season according to the flu virus that will be prevalent that year.

Shaped by its experiences during SARS when vital medical products ran out and the island was isolated from the latest health information from WHO due to its exclusion from the international body, Taiwan's health authorities' recent strategy has been to ensure the island is self-sufficient in certain basic medical supplies, especially the kind needed during SARS-like public health crisis conditions. This includes a policy of self sufficiency in vaccines.

With the fear of a pandemic developing from the current H5N1 flu strain circling the globe, this policy has taken on a new urgency, and with the current global shortage of the antiviral drug Tamiflu, this thinking appears to be vindicated.

For GSK, the 'build, own, operate” (BOO) contract requires it to produce 16 million vaccine doses each year, and also guarantees government purchase of 2.5 million seasonal influenza vaccine doses every year for ten years, spending a guaranteed NT$4 billion to do so. This additional capacity is to encourage export, part of the desire of the government here that Taiwan becomes a regional bio-product production center for the Asia-Pacific region.

UK-based GSK beat out the leading local contender, vaccine producer ADImmune, with others bidding including an alliance between local pharmaceutical company Purzer and cord blood storage company Health Banks, and Dutch chem-pharm company Akzo Nobel.

GSK will use so-called “special pathology free” (SPF) eggs in the production of their vaccines in this new facility. With the vaccines grown inside these eggs, this is the traditional method of production, as opposed to a newer method where the vaccines are engineered and produced in cell lines.

Akzo Nobel uses and promotes this newer method, claiming the time from development to production of a flu vaccine can be cut to only two months, three times faster than the SPF egg method. While this was appealing to the CDC's goal of having a facility with rapid response capability, the technology has not yet been commercialized and was considered not mature enough to be awarded the CDC contract.

According to the contract requirements, GSK should finish building the factory by 2008 and start production within two years after that.

INDIA

Softgel Starting Up Pharma Plant at Vadalur

Chennai based Softgel Healthcare Pvt Ltd, a subsidiary of Madras Pharmaceuticals and manufacturer of softgel capsules, is inaugurating its new state-of-the-art pharmaceutical plant at Vandalur.

The advanced manufacturing facility, spread over 65,000 sq ft with four manufacturing lines for pharmaceuticals and nutraceuticals, has been set up at an investment of Rs 25 crore.

The plant has a capacity to manufacture 120 to 150 crore capsules per annum depending on their size, Softgel MD, A. M. Sulaiman told reporters here.

The plant has already received WHO-GMP certification and the company is working towards obtaining compliance certification from other regulatory agencies such as U.S. FDA, MHRA (UK), TPD (Canada), ENVISA (Brazil) and TGA (Australia), he said.

Mr Sulaiman said discussions on utilizing the facility for contract manufacturing of the products with leading pharma majors from UK, US, Canada, Singapore, Philippines, Sri Lanka and Mexico were in advanced stages.

He further said the company's primary focus was the generic market adding that the firm expects a turnover of Rs 100 crore in the next three years. PTI starting in 2009.

The new facilities will lead to 59 new jobs over the next three years and a total of 84 new jobs over the next five years.

International Specialty Products is Expanding in India

The company put down roots in the country in late 2005 with the opening of the ISP India Technical Center in Hyderabad, intended to provide R&D support for ISP Pharma Technologies and customer support for its excipients business.

On the basis of strong initial customer interest, ISP expects to quickly outgrow the Hyderabad facility, which currently employs 10 researchers. "We're now exploring larger sites with room to expand," said Albert W. Brzeczko, vice president of global pharma R&D at ISP. His goal in the next three to five years is to increase headcount at the site to 50. The company may even consider expanding its activities in India into commercial manufacturing, which could include formulation or finished-product operations.

CiVentiChem is Expanding Indian Manufacturing

Research Triangle Park, NC-based CiVentiChem, which has since 2002 performed contract research and custom synthesis in India through its subsidiary Indus BioSciences, is expanding its manufacturing capabilities in the region. CiVentiChem is making an initial $2 million investment in a cGMP pilot plant in Hyderabad, India, that should be operating by the end of the year, according to President Bhaskar R. Venepalli. Venepalli said customers, including Eli Lilly & Co., Cephalon, Novartis, and Amgen, are now more willing to work with contract manufacturers with operations in India than they were two years ago because of new laws protecting intellectual property. He says the company will eventually spend about $10 million on the facility.

Nicholas Piramal Planning Big Increase in Production

Nicholas Piramal announced at Informex its ambition of becoming a top-three player in the global custom manufacturing market. The company's custom manufacturing business currently brings in about $70 million in sales, a figure that Executive Director Michael J. Fernandes said would need to grow to the $350 million to $400 million range to put it among the top three.

As a first step, the company bought Avecia Pharmaceuticals late last year. Fernandes also sees finished-dose drug formulation becoming an integral part of a full offering to pharma customers. He said Nicholas Piramal, which already has formulation assets in India, is considering adding formulation capacity at the former Avecia API facility in Toronto.

The company believes such organic growth will take it a long way toward its ambition, but it is also looking at adding technology assets, particularly those that can bring down the cost of large-scale manufacturing, as well as alliances and acquisitions.

Actavis Building 3000 M² Generic Drug Plant at Kormangala

Actavis Group, a leading global generic drugs company, inaugurated a new premises for its subsidiary Lotus Labs at Kormangala, India.

The new premises of Actavis, which is headquartered in Iceland, will house offices, laboratories and facilities for clinical bioequivalence studies, a company release said.

About 200-300 people will work in the production plant, which has a total area of about 3000 square meters.

Iceland's Minister for Education, Culture and Science, Borgerdur Katrin Gunnaredottir, recently inaugurated the new premises in the presence of Iceland's newly-appointed Ambassador to India, Sturia Sigurjonsson and a trade delegation currently on a visit to India.

Speaking on the occasion, Stefan Jokuli Sveinsson, Chief Executive of Actavis' R and D said, the company's success has been built on strong local roots and this expansion in India was in line with the company's ongoing strategy of drawing on the large skill base and expertise in the region.

Actavis exapansion plans include opening a centre for stability studies which will provide additional support for the group's operation in Europe and USA. The company also plans to use Lotus Labs old premises for other activities like development of active pharmaceutical ingredients.

During the past year the company has greatly expanded its operations in India, investing around €20 million in Lotus Labs, a pharmaceutical research company, in February 2005. It also entered into a partnership agreement with three Indian pharmaceutical companies last year, Emcure, Shasun and Orchid.

Genome Valley in India is Location for More than 50 Biotech Companies

Confirming its reputation as India's biotechnology hub, a Genome Valley that is fast developing here will house among other things an international life sciences institute, a world-class animal resource facility and a biotech incubation centre for start-ups.

Genome Valley is the first state-of the-art biotech cluster in India for life science research, training and manufacturing activities. More than 50 biotech companies, including several multinationals, have already set up their units in this cluster spread over 600 sq km around the city.

The international institute of life sciences, coming up on Hyderabad University campus, will be modeled on the lines of Johns Hopkins University.

"It will be an industry-driven centre of excellence in life science research and the funding for it will come from a consortium of companies," said BP Acharya, vice chairman and managing director, Andhra Pradesh Industrial Infrastructure Corporation Limited.

The Indian Council of Medical Research (ICMR) will set up the National Animal Resource Facility for Biomedical Research in collaboration with the National Institutes of Health (NIH), US.

The government has allotted 100 acres of land for the facility, which will come up at a cost of Rs.1 billion ($22 million) near ICICI Knowledge Park.

"This will be the largest facility for primates in South Asia," said Acharya, who played a key role in the development of Genome Valley.

An umbilical cord stem cell bank and bio-medical research centre and state-of-the-art maternity hospital to be set up by the Pacific Health Care Holdings, Singapore; an agri biotech park at International Crop Research Institute for Semi Arid Tropics (ICRISAT)) at Patancheru on the city outskirts; a dedicated township life city for those employed in Genome Valley; and a marine biotech park in the coastal city of Visakhapatnam are the other initiatives planned by the state.

The state had also set up India's first biotech venture fund with a corpus of $30 million, launched as a joint venture between the Andhra Pradesh Industrial Development Corporation (APIDC) Venture Capital Ltd and Dynam Venture East, USA, to fund start-up biotech companies.

The ICICI Knowledge Park, which offers wet labs for research and development, and SP Biotech Park in Genome Valley have already attracted 54 leading biotech companies.

United States Pharmacopeia, the official public standards-setting authority for medicines in the US, has also set up its facility here, its first outside Washington.

"Such is the response that the first two phases of both the Knowledge Park and Biotech Park are fully occupied and we are going for rapid expansion," said D Ashok, director, biotechnology, Andhra Pradesh. With two phases of the SP biotech park fully occupied, the state government has allotted 300 acres of land for the third phase.

"The Genome Valley has already become a role model for other states and countries," he added.

MALAYSIA

Inno Biologics Starts Biopharm Construction in Nilai

The modules for building Malaysia's first current Good Manufacturing Practice (cGMP) biopharmaceutical production plant have arrived at the Inno Biologics site in Nilai.

“This first cGMP plant represents one of the investments of the Government in the biotech industry,” Science, Technology and Innovation Minister Datuk Seri Dr Jamaludin Jarjis told reporters following a ceremony to mark the arrival of the modules recently.

Inno Biologics chairman Tan Sri Dr Ahmad Zaharudin Idrus said the cGMP plant was located within the company's biotech facility, which also housed its headquarters, supporting facilities and laboratories.

The construction of the modules for the plant was carried out in Germany and the reassembling has already begun here.

“Over RM50mil have been invested in the plant, which will create new opportunities for Malaysians to venture into the production of biopharmaceuticals. The cGMP plant has signified a new milestone for biotechnology development in the country,” he said.

Pharmaplan International of Germany was appointed Inno Biologics' contractor and was responsible for shipping the entire modular plant from Germany to Malaysia. It will be ready for testing, commissioning and validation once reassembled and will be scheduled to commence production in 2007.

“With this facility, contract manufacturing will be offered to pharmaceutical and biopharmaceutical companies, as well as research institutes for the production of novel biologics for clinical testing,” said Zaharudin.

Inno Biologics is the flagship company of Inno Bio Ventures Sdn Bhd, a Ministry of Finance incorporated company, with close affiliation to the Science, Technology and Innovation Ministry, Bernama.

EUROPE

ITALY

FIS Expanding in Montecchio Italy

Italian custom synthesis company FIS unveiled both small- and large-scale manufacturing expansions, which add to the $120 million the company has invested over the past 10 years in its Montecchio, Italy, facility.

In 2005, FIS opened three current Good Manufacturing Practices (cGMP) kilo labs at the site to widen the range of services available to its customers. Kilo labs installed last April for active pharmaceutical ingredients (APIs) and steroids are currently in use, while a cytotoxics kilo lab is scheduled to be operational by the end of the third quarter.

The cytotoxics lab complements an existing commercial-scale production suite at Montecchio, installed in 2003 for a specific customer project. The addition of smaller scale production capabilities will help feed more cytotoxics into the company's pipeline, said Stephen N. DiSalvo, U.S. area manager for FIS's custom manufacturing division.

In a similar linkup, a commercial-scale steroid production unit is also being added at Montecchio to support a project coming out of the new kilo lab.

The company is also installing a cGMP production unit at its Termoli, Italy, facility, which previously had been dedicated to non-cGMP manufacture of intermediates. The new unit is expected to be completed by the end of the year.

SWITZERLAND

Helson Expands at Two European Facilities

Helsinn recently increased capacity at two European facilities, adding 8,000 L of reactor capacity in Biasca, Switzerland, and a 6,000-L reactor with receiving vessels and drying capacity in Dublin, Ireland, according to Gabriel Haering, commercial director. Helsinn is expanding its production to meet current customer needs and accommodate projects advancing from lab-scale production.

In parallel with investment in internal capabilities, companies are adjusting to the new world order in the custom chemical manufacturing industry. Indian companies have become formidable competitors, and some U.S. and European companies are reacting by establishing or expanding their strategies in India.

MALTA

Siegfried Generics Expanding in Malta

Siegfried Generics, the pharmaceutical company, is to invest Lm5.7 million in Malta and generate some 50 jobs, Investments Minister Austin Gatt said recently as he visited the site of the new factory at Hal-Far industrial estate.

The Siegfried Group was founded in 1873 and is a global chemical supplier and service provider to the pharmaceutical and chemical industry alike. Based in Switzerland, it also has production sites in Germany and the US, with 1,000 employees in all.

Dr Gatt said works were well underway and the plant should become validated and operational by the middle of this year when the promoters expect to start initial trial production runs to gear up for full swing production by the end of the year. In the past two years, Malta Enterprise has approved nine foreign projects in this sector which are expected to increase the global sales figure of this industry to €200 million by next year. By that time, the sector will employ over 800 people. This will include companies like Actavis, Siegfried, Arrow Pharm, Medichem, Combino, Amino Chemicals and Starpharma.

Siegfried vice president and head of project development, Paul Senn said Malta featured strongly as a location to establish a new facility, especially given the fact that an area was already available to house the plant and equipment.

SCOTLAND

TSS Starts Work on New 18,000 Ft² Facility in Scotland

TEPNEL Scientific Sciences (TSS) said it planned to create 20 high-level science-based jobs as it consolidates its Edinburgh and Glasgow operations in a new 18,000sq ft Livingston facility.

The international life sciences firm, which provides analytical services to the bio-medical market, said it would begin work on the new plant, understood to involve investment of £3 million, next month in a move that will expand its workforce to 58, from the current 38.

Dave Scott, general manager at TSS, said he expected to move into the new building, which will bring lab, storage and office operations under one roof, early next year.

"We have a 1.7 acre site in Livingston, so there's scope for further development," he added.

With pharmaceutical companies under pressure to bring new products to the market as soon as possible, outsourcing of clinical trials and analytical services has become a booming business.

Currently, TSS employs 30 people in Edinburgh on micro-biological and chemistry service work, with eight people employed in Glasgow on bio-analytical servicing.

UNITED KINGDOM

PLC Expanding in Cambridge

British drug maker Shire PLC said recently it will prepare for new product launches by adding 100 employees to a 400-person unit in Cambridge that develops treatments for genetic diseases. The expansion was announced about eight months after Shire completed a $1.6 billion acquisition of Transkaryotic Therapies Inc. TKT operated what is now Shire's Human Genetic Therapies division focusing on drugs to treat rare diseases linked to protein deficiencies.

Shire said it was recruiting to fill openings in departments ranging from research to drug manufacturing, including a Cambridge unit that operates around the clock to produce bioengineered medicines.

One of the experimental medications that Shire acquired when it bought TKT is a treatment for Hunter syndrome, a genetic disorder that can prevent patients from being able to properly break down fats. An application to market the drug, called Elaprase, is pending before the U.S. Food and Drug Administration.

McIlvaine Company,

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