manufacturing

A bright future for Merck's NC vaccine plant

Maureen Martino — Thu, 16 Oct 2008 12:23:08 -0400

Construction hasn't even finished at Merck's new Durham, North Carolina vaccine plant and the company's already considering what to do next. The $750 million plant, which is expected to be completed in 2011, will house 400 workers and the production of childhood vaccines and a shingles shot for adults. But Merck has two more experimental vaccines in testing that will need a home--another pediatric vaccine and jab to prevent staph infections. The company has vaccine ops in Elkton, VA and West Point, PA that will compete with the Durham site for the new vaccines.

When Merck initially chose North Carolina, it did so with the possibility of expansion in mind. And it's already enhanced the original plans for the site. In July, the company announced that it would invest an additional $300 million in the vaccine plant and create 180 new jobs."I'm not about to make an announcement," CEO Richard Clark (photo) told the News & Observer. "But I have a suspicion that we haven't stopped at $750 million [in Durham]." The region's growing biotech hub, along with a potential $45 million in tax breaks, will certainly make it more attractive. Merck will need to win FDA approval of the North Carolina site before vaccines manufactured there can be sold.

- read this News & Observer article for more

UC center wants efficient biotech drug production

John Carroll — Mon, 13 Oct 2008 11:30:24 -0400

When the UC-Berkeley Center for Biopharmaceutical Operations opens next year, its founders plan to find more efficient methods to manufacture biologics. And their goal is to make biotech drugs less expensive while ensuring a reliable supply of the therapies. Bayer Healthcare and Genentech have already signed on as supporters of the center, and the founders plan to approach other biotech companies in the San Francisco area to gauge their willingness to get involved as well.

"It's not sufficient to hire a bunch of people in manufacturing to look at these problems," acting co-director Rick Johnston tells the East Bay Business Times. "Biotech issues are complex. You really need to have academics look at a problem and say, ‘You know what? That's similar to a problem that we solved 10 years ago in the semiconductor industry.' "

- read the report in the East Bay Business Times

Pfizer cuts 180 jobs in Ireland

Maureen Martino — Wed, 06 Aug 2008 16:26:44 -0400

There's bad news for Cork, Ireland today. After an 18-month search, Pfizer announced plans to cut 180 jobs after failing to find a buyer for five manufacturing facilities there. In a statement, the company said all opportunities to find a buyer have been pursued, with no results. "We were initially optimistic that we would find a buyer because there was considerable interest," said Paul Duffy, Pfizer's vice president of manufacturing for Ireland. "Unfortunately, that interest has not translated into a sale." The first layoffs will begin in October and the entire site will be closed by the end of 2009.

Pfizer is still trying to sell a facility Ringaskiddy, where 300 people are employed. The company is selling the plants because its planned blockbuster torcetrapib failed and the extra manufacturing capacity is no longer needed.

- read this report for more

Developers tout protein manufacturing breakthrough

John Carroll — Mon, 16 Jun 2008 07:14:21 -0400

A joint venture between Crucell and DSM Biologics--Percivia--has produced a new, more efficient approach to manufacturing monoclonal antibodies and proteins. By relying on human cell lines rather than a traditional chemical approach, officials for the two companies say they can significantly cut the cost of manufacturing. And researchers for the joint venture say they achieved fermentation yields in human cells of 27 grams a liter--a record.

"This new achievement surpasses all other reported titer levels to date with any mammalian system and clearly demonstrates the robustness and power of the PER.C6 platform," said Marco Cacciuttolo, CEO and President of Percivia. "We are particularly enthused with the user-friendliness of the platform and pleased to be able to provide this to our licensees. We strive to revolutionize the pharmaceutical industry in protein production."

Less expensive manufacturing, they add, will allow developers to advance some new products to the market that would not have been able to generate a profit before.

- read the release

Pfizer builds plant, creates jobs in Ireland

Fri, 02 May 2008 06:59:58 -0400

Pfizer has finally confirmed earlier reports about its plan to build a biologics manufacturing facility in County Cork, Ireland. The company is investing €190 million ($297 million) in the new facility and anticipates creating 100 jobs. The plant will manufacture small amounts of biologic treatments for use in Phase II and III cancer and diabetes clinical trials. It will be situated next to Pfizer's other Cork facility and is expected to be completed in 2009.

"Our aim is to gain access to the best science inside and outside our walls, and the new Shanbally facility will ensure that we can produce the product for clinical trials which could ultimately impact the lives of millions of patients," said Nat Ricciardi of Pfizer Global Manufacturing.

Pfizer's investment is good news for Ireland. Late last year Amgen said it would "postpone indefinitely" a planned €800 million manufacturing facility in Cork, much to country's disappointment.

- here's the report for more

Genmab buys antibody plant in $240M deal

Thu, 21 Feb 2008 06:59:58 -0500

PDL BioPharma has inked a deal to sell its U.S. antibody manufacturing plant to Denmark's Genmab for $240 million. The deal--which will enable Genmab to transition three antibody products from research to manufacturing--covers a facility that can produce multiple antibodies as well as leased space for a development lab. And PDL will continue to obtain testing material from the plant. Genmab has tapped Torben Lund-Hansen to run the operation in Brooklyn Park, MN, where all 170 employees are being retained.

This deal is just the latest in a string of asset sales for PDL, which announced plans to maximize shareholder value last fall. Its cardiovascular products were acquired by EKR Therapeutics and Japan's Otsuka bought out Busulfex IV in December.

"We are pleased to enter into this agreement with Genmab, which we believe is the optimal transaction to fully realize the value of our biologics manufacturing facility. Importantly, it also represents another step in delivering on our commitment to maximize the value of PDL's assets for our stockholders, following on the recent sale of our commercial assets," said L. Patrick Gage, the company's interim chief executive.

- see this release
- and here's the report from The Street

Related Articles:
PDL BioPharma puts out 'for sale' sign. Report
PDL sells assets, cuts jobs. Report
Rumors of buyout interest heat GenMab stock. Report
Genmab shares up on new antibody tech. Report

ALSO NOTED: BMS falls prey to subprime crisis;AZ cuts 200 U.K. workers;much more...

Fri, 01 Feb 2008 06:59:50 -0500

What's a drugmaker doing, investing in securities at least partly backed by subprime mortgages? Ask Bristol-Myers Squibb, which took a $275 million write-down on so-called "auction rate securities" that had fallen in value to $419 million from $811 million. Report

> In the U.K., 200 AstraZeneca workers may lose their jobs as the company restructures its operations. Report

> Vyteris has redirected its business to focus on the development of peptide delivery using its Smart Patch technology. The change will allow for the further development of small molecule delivery using its technology as well. Release

> An in-development vaccine that weans addicts from their substance of choice has shown the most promise against cocaine addiction so far, but its developers are testing it against other substances now. Report

> The FDA has warned Novartis Vaccines and Diagnostics of the "significant deviations" found at its manufacturing plant in Marburg, Germany, accusing the pharma giant of producing contaminated vaccines and failing to come up with a comprehensive response to the problem. Report

> A federal grand jury is investigating Merck's marketing of Vioxx. Report

> As if patient lawsuits and government investigations weren't enough, now Eli Lilly shareholders are suing. Report

> The FDA has issued a sobering warning: the risk of suicide and suicidal behavior doubles for patients taking epilepsy drugs. Report

And Finally... Scientists have created a genetically modified strain of E. coli that produces substantial amounts of hydrogen. They hope the strain can be used for hydrogen-based energy in the future. Release

Amgen shelves Irish manufacturing facility plans

Thu, 04 Oct 2007 06:59:58 -0400

Much to Ireland's disappointment, Amgen said it would "postpone indefinitely" a planned €800 million manufacturing facility in County Cork. The biotech giant said that a review of its business plan and the evolving business environment led to the decision. All 75 jobs in Ireland will be eliminated. The facility was to bring 1,100 jobs to the country. Irish officials were quick to point out that Amgen's decision was related to the company's business goals and not to the economic environment in Ireland.

"We understand that this is a very disappointing development for our employees, the government, the neighbors around our site and the broader Cork community," said Mark Sawyer, general manager and vice president of Operations, Amgen Technology Ireland. Amgen said that it expects to maintain ownership of the site, though other sources say the biotech is likely to sell. Amgen is in the midst of a company-wide restructuring designed to cut about 14 percent of its workforce and cut a billion dollars in expenses.

- see the release on the decision
- read the report from the Irish Independent

Related Articles:
Amgen selects manufacturing site. Report
Rhode Island feeling effects of Amgen cuts. Report
At corporate HQ, Amgen drops the axe. Report
Amgen makes big workforce, budget cuts. Report
Ireland trumpets Pfizer biotech facility. Report

Boston officials herald big Genzyme expansion

Tue, 18 Sep 2007 06:59:55 -0400

Genzyme broke ground today on a $150 million expansion on its manufacturing facility on the Charles River in Boston. The expansion will add 90 new workers to the 400 already employed at the plant. Local economic development groups have heralded the new project. The Boston Redevelopment Authority launched a new effort a few years ago to create 10,000 new life science jobs in the area by 2010. And they say that Genzyme's project will help them meet that goal. One wonders how they're doing the exact head count. Philadelphia threw a bunch of healthcare workers into its biotech pot when counting jobs a few years ago. These figures can be very creative.

- see Genzyme's release
- read the report from The Boston Globe

Related Articles:
Top Five Regions Targeting Biotech Companies--2007. Special Report
AstraZeneca to outsource manufacturing. Report
Boston biotech booming as scientific research flourishes. Report
Manufacturing woes plague launch of Myozyme. Report

CEL-SCI blueprints new manufacturing plant

Mon, 22 Jan 2007 19:01:34 -0500

BioProperties has committed $15 million to CEL-SCI to build a manufacturing plant for its cancer drug Multikine. The therapy is approved for a Phase III trial for head and neck cancer. The facility will cost up to $14 million, which CEL-SCI will pay for through a long-term lease.

"We will be able to produce our drug Multikine in our own CGMP facility for Phase III trials as well as for sale once marketing approval is granted," says Geert Kersten, CEO of CEL-SCI. "An additional benefit of having this facility," Kersten adds, "is that during the Phase III study, it may also be used for contract manufacturing work with other biotech companies and/or the U.S. government since it will contain a clean cold-fill suite."

- see the release on the deal

Insulin debate spurs push for generic biologics

Wed, 10 Jan 2007 19:01:36 -0500

The heat is on the FDA to find a way to approve a generic insulin, the oldest existing biologic on the market. And some observers say that the push is likely to spur a broader effort for a generic regulatory pathway for all biologics. Insulin has been used in form or another since the 1920s, but there has never been a generic form approved. Some $3.3 billion dollars a year is spent on insulin.

- read the report from FierceHealthcare
- here's the article from The New York Times

ALSO: Eli Lilly has decided to stop construction of a new insulin manufacturing plant in Virginia. Another 250 U.S. plant workers are losing their job as Lilly expands a biotech manufacturing facility in Ireland. Release

Related Article:
Insulin delivered in tiny carbohydrate shells. Report

Press Release: Amgen Announces $5 Billion Stock Repurchase Plan

Maureen Martino — Tue, 12 Dec 2006 13:05:34 -0500

Amgen Announces $5 Billion Stock Repurchase Plan

Amgen today announced that its board of directors has authorized additional repurchases of up to $5 billion in Amgen common stock. The company currently has $1.5 billion remaining under its previous stock repurchase authorization. This new authorization reflects Amgen's confidence in its long-term prospects.

About Amgen

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com.

Forward-Looking Statements

This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and others that can be found in our Form 10-K for the year ended December 31, 2005, and in our periodic reports on Form 10-Q and Form 8-K. Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. The Company's results may be affected by our ability to successfully market both new and existing products domestically and internationally, sales growth of recently launched products, difficulties or delays in manufacturing our products, and regulatory developments (domestic or foreign) involving current and future products and manufacturing facilities. In addition, sales of our products are affected by reimbursement policies imposed by first party payors, including governments, private insurance plans and managed care providers, and may be affected by domestic and international trends toward managed care and healthcare cost containment as well as possible U.S. legislation affecting pharmaceutical pricing and reimbursement. Government regulations and reimbursement policies may affect the development, usage and pricing of our products. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We, or others could identify side effects or manufacturing problems with our products after they are on the market. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate will be successful and become a commercial product. In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors. Further, some raw materials, medical devices, and component parts for our products are supplied by sole first party suppliers.

SPOTLIGHT: Lonza buys Genentech plant

Tue, 07 Nov 2006 19:01:33 -0500

Switzerland's Lonza has struck a deal to buy a manufacturing plant in Spain from Genentech for $150 million. Genentech, meanwhile, gained an option to buy a huge new manufacturing plant Lonza is building in Singapore for $290 million plus $70 million in milestones. Lonza expects the FDA to license the new plant in 2010. Lonza gains a short-term pact to produce Avastin in the deal. Report

BMS selects Massachusetts site for new plant

Thu, 01 Jun 2006 20:01:36 -0400

Bristol-Myers Squibb has selected a site in Ft. Devens, MA for a $1.1 billion manufacturing plant that will employ up to 550 people. The plant--which will fill 750,000 square feet of space--will produce the recently approved Orencia and other pharmaceuticals. The decision by BMS is a big boost for Massachusetts biotech cluster. The state's main claim to biotech fame has been in R&D. Massachusetts had to beat out North Carolina and other states' ambitious economic development groups. Ft. Devens is about 35 miles from Boston.

- here's the AP report on the new plant

ALSO NOTED: Inhibitex cuts staff; SRI buys QCL; and much more...

Sun, 23 Apr 2006 20:00:50 -0400

> Inhibitex announced Friday that it is planning to cut 35 of its 83 workers following a disappointing Phase III trial of Veronate that failed to hit its primary endpoint. CEO William Johnston said that the company was making the cuts to "appropriately reflect the stages of our clinical and pre-clinical development programs." Report

> SRI International has struck a deal to acquire Quality Clinical Labs. QCL has about 50 biotech clients in the San Francisco Bay area. Release

> Akorn announced that the FDA had OK'd the return of Inapsine for nausea to the market. The injectable has been off the market for five years due to compliance issues at Akorn's manufacturing plant. Report

> Safetek International has inked an agreement to acquire the rights to all of Resdevco's intellectual property relating to its antioxidant compounds. Release

> India's Aurobindo Pharma has received tentative approval for a generic version of Merck's blockbuster Zocor, which is nearing the end of its patent protection. Report

> Israel's Taro Pharmaceutical has received FDA approval to market a generic version of GSK's Coreg for cardiovascular conditions. Report

And Finally… Democrats are hopeful that their position on stem cell research will help the Party's candidates get elected this fall. Article

Dynavax buys German vaccine maker

Mon, 27 Mar 2006 19:01:37 -0500

Berkeley, CA-based Dynavax, a vaccine maker, is buying Germany's Rhein Biotech from Crucell for $12 million. Dynavax gains a European-certified vaccine manufacturing plant and new antigens for its clinical program. Dynavax says the deal will help it develop a diversified vaccine franchise.

- read the East Bay Business Journal report

Nonprofit develops pipeline in fight against TB

Wed, 22 Mar 2006 19:01:36 -0500

The Washington Post profiles the nonprofit Aeras Global TB Vaccine Foundation, which has built up a pipeline of drugs intended to provide the first new tuberculosis vaccine since the 1920s. If they are successful, Aeras has a chance to rid the planet of a stubborn disease that kills more than two million people a year. Aeras is operating with funds from the Bill and Melinda Gates Foundation. TB is largely restricted to poor countries, making it an orphan disease in the drug development world. What separates Aeras from other specialized nonprofit developers is the extent of its pipeline. Aeras has a number of therapies in development, hoping that one or two can survive the long and arduous development path to regulatory approval. It also has built a manufacturing plant that can make whatever is approved.

- here's The Washington Post report

Maryland wins new MedImmune drug manufacturing plant

Wed, 16 Nov 2005 19:01:37 -0500

After agreeing to pay $19 million to cover capital costs and staff development, Maryland won a commitment from Gaithersburg, MD-based MedImmune to build a new drug manufacturing plant in the state that will employ up to 840 people. That money will come on top of more than $105 million being spent on new infrastructure work designed to help encourage other drug developers to move to Maryland. Baltimore is opening two biotech parks and one is planned for Montgomery County.

- read this report from the Baltimore Sun for more

ALSO: Birmingham, AL-based TransMolecular is moving to Cambridge, MA. The biotech's CEO said the company wants easier access to biotech professionals and enhanced chances of partnerships. The move is seen as a blow to Birmingham's hopes of building a biotech cluster of its own. Report

ALSO NOTED: European panel recommends Exubera; genOway takes over IngenKO; Regeneration Technologies recalls tissue; and much m

Thu, 13 Oct 2005 20:00:50 -0400

> Pfizer and Nektar Therapeutics announced that a European advisory panel has recommended approval of Exubera inhalable insulin. An FDA expert panel has already endorsed the therapy. Report

> France's genOway has taken over the commercial activities of Australia's IngenKO. Report

> Regeneration Technologies of Alachua, FL, has issued a recall of donor tissues after questions were raised about donor documentation. Release

> Chutes & Ladders: Canada's ConjuChem has named Mark Perrin as its new president and CEO. Release

> Inspire Pharmaceuticals says that new data submitted to the FDA warrants a Phase III trial of denufosol for cystic fibrosis. Release

> Nabi Biopharmaceuticals has completed a $20 million bulk vaccine manufacturing plant in Boca Raton, FL. Release

> DOR BioPharma has issued a pipeline update. Release

> Curis has received $1.25 million in additional funding from Genentech. Report

And Finally... Researchers say in this week's BMJ that an analysis of drugs approved over the last year shows that the promise of cheaper and better drugs using biotechnologies has not been met. Article

HGS reveals $230M gamble in new manufacturing facility

Thu, 22 Sep 2005 20:01:38 -0400

Human Genome Sciences has taken the wraps off of its brand new, $230 million manufacturing plant. The facility in Rockville, Maryland is the fourth-largest of its kind on the East Coast and represents a big gamble for HGS. The biotech won't get FDA approval to operate before next year, and it was built in anticipation of regulatory approval of new drugs still in the pipeline.

- read this story from The Washington Post for more information