manufacturing

Indonesia: To sell here, produce here

Tracy Staton — Mon, 24 Nov 2008 10:16:44 -0500

Big Pharma may be waxing eloquent on the promise of emerging markets, but those markets aren't necessarily happy that they top the list of future revenue boosters. Some want pharma to dole out a piece of the pie locally. And one has joined a handful of countries that require it.

That one is Indonesia, which recently issued a decree requiring drug companies that hawk their wares in-country to establish production facilities in-country, too. The new rules are designed to encourage foreign investment to create jobs. Obviously. "If they want to get licenses (to sell their products) they have to invest here also, not just take advantage of the Indonesian market," Health Minister Siti Fadilah Supari told Dow Jones today. "They can't just operate like a retailer here, with an office that's three meters by three, and make billions of rupiah. That's not fair."

More than a dozen multinational drugmakers would have to set up new plants in Indonesia under the rules, including Merck, Novartis, Wyeth, Eli Lilly, Novo Nordisk, AstraZeneca and Astellas Pharma. Supari said Indonesia's $2 billion drugs market would make building those production facilities worthwhile. Other countries that sport similar requirements include China and India, both of which boast a multiplicity of foreign joint ventures and investment.

Indonesia's rules have drawn protest from the U.S. Chamber of Commerce, which is urging Indonesian President Susilo Bambang Yudhoyono to consider revising the decree. But so far, the country has taken a hard line. To companies that threaten to abandon the market rather than build factories there, Minister Supari said, "If they want to go away, go ahead."

- read the story in the Straits Times

Glaxo to shutter 620-worker U.K. plant

Tracy Staton — Tue, 11 Nov 2008 11:04:24 -0500

The latest casualty of impending drug-patent expirations is a GlaxoSmithKline plant in Kent, England. The drugmaker says it will shutter the manufacturing facility by 2013, eliminating more than 600 jobs in the process.

Just a decade ago, that plant employed 3,000 workers. Now, it's winding down even more as two treatments produced there face generic competition. One epilepsy drug made at the plant, Lamictal, just fell off patent. Another, the herpes drug Valtrex, is due to expire next year. Because those drugs amount to 60 percent of the plant's output, Glaxo is negotiating with local unions over upcoming layoffs.

This is the second time in less than six months that Glaxo has announced it's closing a British plant. In July, the drugmaker said it would shutter a facility in Sussex in 2011, claiming 493 jobs.

- see the BBC story

Pfizer hangs sale sign on Exubera plant

Tracy Staton — Tue, 11 Nov 2008 10:27:54 -0500

Call your Realtor: Pfizer has put its ex-Exubera plant up for sale. The Terre Haute, Indiana, facility had been in the Pfizer family since 1948, when the drugmaker bought it from the U.S. government. Since then, it's undergone a variety of expansions and upgrades, including more than $300 million in investment since 1999. At its peak, the 580,000-square-foot facility on almost 1,000 acres employed some 800 people.

Most recently, the plant was used to make Exubera, Pfizer's inhaled insulin product. But just one year into the product's launch, Pfizer pulled the plug on the formulation because of lackluster sales. Exubera just hadn't caught on with patients, who disliked the oversized inhaler device. And payers were slow to adopt the inhaled formula, too. Pfizer took a $2.8 billion charge to shut down production; about 600 Terre Haute workers were idled at the time.

- read the story in the Indianapolis Star
- see the Wall Street Journal Health Blog post

FDA sends Sandoz warning letter

Christe Bruderlin-Nelson — Wed, 27 Aug 2008 02:53:02 -0400

On August 12, FDA issued a warning letter to Novartis's Sandoz generic unit. The letter focused on manufacturing processes for a blood pressure medication. According to the letter, the manufacturing process did not undergo proper validation and FDA therefore questioned whether further distributing the product was prudent given the lack of solid process controls. The manufacturing process in question was for a generic version of Toprol XL, made by AstraZeneca.

The FDA said in its letter that it also had concerns about how the problems it found in process validation might affect other products the company has.

A spokesperson for Novartis said the company is working with FDA to address the concerns in the warning letter, which the spokesperson says were mainly about "documentation and validation."

- read the Pharmalot post
- see the FDA Warning Letter here

Microbix teams with China on vaccine plant

Tracy Staton — Tue, 24 Jun 2008 10:08:01 -0400

More evidence that Asia is the place to be these days: Canada's Microbix Biosystems is plotting a $200 million flu vaccine plant in Hunan province. The cooperative deal puts Microbix in partnership with the Hunan government, which will put up $100 million of the funding. The rest will come from Microbix's licensing partners.

Considering the growing importance of Asian markets, the steady drumbeat of avian flu news, the fact that flu viruses tend to emerge first in Asia, and the burgeoning vaccine market worldwide, Microbix could find itself perfectly positioned when the plant is up and running in 2013. The plant will be capable of churning out 100 million doses of flu vaccine annually using Microbix's proprietary Virusmax technology, for which it garnered a Chinese patent last month.

In a funny little quirk, the deal includes a "token of goodwill and friendship" for the Chinese people onsite: a full-scale replica of the birthplace of Dr. Norman Bethune, a Canadian doctor who became a hero in China for his medical work with the communist army resisting Japan in the late 1930s.

- check out the Microbix release
- see the Canadian Press article

Mylan to cut 100 in Puerto Rico

Tracy Staton — Thu, 12 Jun 2008 10:58:09 -0400

Workers in Caguas, Puerto Rico, braced for the axe as Mylan announced it would eliminate 100 of the 500 positions at that manufacturing plant. The generics maker announced back in March that it would embark on a big restructuring plan to cut costs, eliminating some jobs in the process, but this the first tangible evidence of that plan in motion. In cutting back on the manufacturing side, Mylan joins a host of other drugmakers, some of which have shuttered entire plants as they streamline operations and outsource more operations. In Puerto Rico alone, pharma has sliced some 3,000 jobs.

- read the Associated Press story
- see the Pharmalot post

GSK plant closure begins 5,000 job cuts

Thu, 25 Oct 2007 06:59:58 -0400

Count GlaxoSmithKline's Puerto Rican plant as an early Avandia casualty. The drug maker will close the factory in Cidra, Puerto Rico, and transfer production of the diabetes med (and its cousin Avandamet) to other plants. The 900-strong workforce in Cidra will be cut to 250 by year's end.

Of course, the Puerto Rican shutdown is just part of the cost-cutting pain at Glaxo. Yesterday, the company announced a big restructuring plan that will trim $1.4 billion in costs over the next four years and shrink its payroll by at least 5,000. Glaxo also plans to outsource manufacturing of its off-patent drugs, so some 40 percent of the job cuts will come in that sphere. Implementing the restructuring plan is expected to cost $3.1 billion.

- get more about the Puerto Rican cuts from Orange
- read the article on restructuring from The Times

Related Articles:
Glaxo to cut $1.4B on falling sales. Report
Top five layoffs of 2007. Special report
VA marks Avandia off formulary. Report
What to do with Avandia sales force? Report
Expert committee says Avandia should stay. Report
Docs shunning Avandia in wake of safety study. Report

FDA warns Genzyme on French plant

Wed, 03 Oct 2007 06:59:55 -0400

Clean up your act, Genzyme--or so says the FDA, which found "significant violations" of manufacturing rules at a French plant that produces the company's Thymoglobulin drug for kidney transplants.

Inspectors found higher-than-allowable levels of bacteria in some of the drug's components and concluded that the company didn't investigate those failures rigorously enough. Nor did the company thoroughly investigate the death of two animals during drug-safety tests. The company says it's heeding the FDA warning and already working to address the agency's concerns.

- read the FDA warning letter
- check out the report from the Boston Herald

Related Articles:
Boston officials herald big Genzyme expansion. Report
Manufacturing woes plague launch of Myozyme. Report
Genzyme reports successful late-stage stem cell study. Report
Genzyme shifts focus after hylastan fails trial. Report

Novartis, MIT to overhaul manufacturing

Fri, 28 Sep 2007 06:59:54 -0400

Novartis is teaming up with the Massachusetts Institute of Technology to develop new ways to manufacture drugs. The pharma giant, whose global headquarters for drug research is based in Cambridge near MIT, will give the university $65 million over 10 years to create a new research program.

The aim is to move away from manufacturing drugs batch by batch, and toward continuous processes that would save both time and money. It won't be an easy task: There are plenty of reasons why drug makers haven't taken the Henry Ford route to manufacturing before. But it's one of MIT's largest collaborations with industry, ever. We'll see what the great minds can do.

- see the press release
- read the Boston Globe article

Related Articles:
MIT computer model designs better therapies. Report
MIT readies real-time drug safety monitoring. Report
Universities, public institutes lead biotech revolution. Report

AstraZeneca: Just a bit of outsourcing

Tue, 25 Sep 2007 06:59:57 -0400

Did we say that? AstraZeneca is now denying any intention of outsourcing all its manufacturing, saying the EVP who'd called production "not a core activity" was misquoted. But, the company says, it will begin looking to contract manufacturers in India and China for some active ingredients in various meds.

-read this article in Pharmafocus

Related Articles:
AstraZeneca to outsource manufacturing. Report
Americans distrust drugs from China, India. Report
Research points to rapid growth of R&D outsourcing. Report
China pushes drug development as R&D soars. Report

AstraZeneca to outsource manufacturing

Mon, 17 Sep 2007 06:59:58 -0400

How many drugs would a drugmaker make if a drugmaker didn't make drugs? More, says AstraZeneca, or at least more profitable ones. The company is planning to outsource its manufacturing--all of it--starting with the basic, active ingredients in its products and then fanning out from there. Contract manufacturers in China and India are most likely to get the business, company officials told the Times of London.

AstraZeneca now has 27 manufacturing facilities in 19 countries, but the company already has been whittling away at them. Most of the company's previously announced job cuts--7,600 so far--have hit manufacturing and supply-chain operations. In the end, AstraZeneca aims to be simply an R&D and marketing organization.

Will other drug makers follow suit? Big Pharma has been fairly conservative about handing over manufacturing to others, but several companies have jumped on the outsourcing bandwagon lately. Perhaps there's more to come.

- read this article on AstraZeneca's outsourcing decision
- see this report for more on the trend

Related Articles:
AstraZeneca cuts 7,600 jobs. Report
AstraZeneca announces restructuring and buyout. Report
AstraZeneca to continue ambitious deal-making. Report
AstraZeneca lays out road map for recovery. Report

MedImmune gets green light for FluMist

Mon, 10 Sep 2007 06:59:56 -0400

Head 'em up, move 'em out. MedImmune says it's cleared up its FluMist manufacturing problems, just in time to ship the product for this year's flu season. The FDA had warned the company in May for "significant deviations from current good manufacturing practice" at its U.K. facility, where FluMist is made. At issue were mold and bacteria found in the plant (but not in the vaccine itself).

The manufacturing clearance also opens the way for MedImmune to pursue approval of FluMist in children under five. Just before the manufacturing warning, an FDA advisory panel had said that the company's flu preventive works in that age group, though they were unsure whether it would be safe for kids under two.

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

Related Articles:
MedImmune wins backing for expanded FluMist use. Report
MedImmune boosted by new data on FluMist. Report
MedImmune touts new FluMist version. Report
FluMist disappoints MedImmune yet again. Report