Today's Top Stories
Eli Lilly ($LLY) CEO John Lechleiter really likes what the company is getting for its $1 billion in investments in Kinsale, Ireland. Lilly has started work on its second manufacturing plant there and during a recent visit Lechleiter said Kinsale will become the focal point of new products.
"We intend to have Kinsale as our primary launch site for all our new products," Lechleiter told the Irish Examiner.
In February, Lilly announced that it was building a $442 million, 240,000-square-foot commercialization and manufacturing facility, which will employ about 200 people when it is operational in 2016. In 2010, it completed a €300 million ($368.6 million) facility. The company has said that together the two plants are "intended to ensure manufacturing capacity for Lilly's biotech pipeline."
As margins have slimmed in the industry, companies are looking to site new manufacturing where it will get the most bang for its buck, often in Asia where costs can be lower and markets are growing. But with the more sophisticated biologics in mind, Lechleiter waved the advantages of Asia aside, GEN reports.
In his tabulation of Ireland's assets, Lechleiter included the workforce, the universities and Ireland's Industrial Development Agency. Those have allowed the company to move the work in Ireland up the food chain from small molecule drugs to biologics. There is more to come given the advances in sequencing the human genome and a better understanding of the biology underlying many diseases, he said.
"All these things, I think, add up and augur well for a renaissance in productivity for the advent of new medicines in the years ahead."
Lilly is not alone in liking what Ireland offers the pharmaceutical industry. In October, the Sanofi ($SNY) unit Genzyme unveiled a $207 million plant expansion in Waterford.
- read the Irish Examiner story
- here's more from GEN
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Lilly outlines $442M Ireland plans
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Read more about: Ireland, Eli Lilly
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Some companies making drugs for World Health Organization programs in Africa are manufacturing substandard products that can lead to resistance, two new studies find. To get a handle on the problem, the studies' author is recommending that the WHO institute a three strikes and you are out rule for companies that are churning out low-quality products.
The studies by the American Enterprise Institute, the conservative think tank that takes on economic issues, are published in Research and Reports in Tropical Medicine. The study's lead author, Roger Bate, has researched and written extensively on the issue of substandard drugs in Africa. In the most recent study, 2,652 malaria, tuberculosis and anti-bacterial drugs were bought off-the-shelf in low- and middle-income countries and then tested for quality. It found 13% of drugs that are not approved by a stringent regulatory authority or the World Health Organization failed quality tests. Of those drugs that the WHO had approved, 7% failed, and of those, 18% were made in China.
Bate, a resident scholar at the AEI, estimated that maybe half the failures were counterfeit drugs and the other half were just poorly made. Many drugs bought at the same locations were high-grade. "This suggests that shoddy manufacturing, as opposed to product degradation, is the more likely cause of these failures," Bate says.
In the other study, 8% of antimalarial drugs that were approved either by the WHO or a strict regulatory authority, and sold in Accra, Ghana, and Lagos, Nigeria, didn't have enough active ingredient to meet quality standards. None had too much active ingredient, suggesting again "systemic poor manufacturing practices," not chance, Bate says. And underdosing fuels drug resistance, the study points out.
While the WHO and others are buying high-quality drugs from makers that are closely regulated, the findings suggest that fake and low-quality products can still get into the supply chain, either from lack of oversight or criminal intent, Bate says.
Some companies have taken the watchdog responsibility on themselves. Merck KGaA and GlaxoSmithKline ($GSK) are trying a system in some African countries where consumers can text a code to check the legitimacy of the drug.
But Bate suggests that donors need to "step up post-market surveillance and increase penalties for repeat offenders." He says if a company's drugs fail quality testing three times in a year, it should lose its WHO prequalification status for all of its registered products. "If we took drug quality control as seriously in poor countries as we do in the West, we could save lives and dramatically increase the impact of our public health programs," he says.
- here's the release
- see the studies here and here
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Counterfeit drugs threaten strides against malaria
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Read more about: WHO
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For the first time ever, the European Parliament has rejected a trade agreement posed by the European Commission, killing for now protections aimed at attacking drug counterfeiting.
Resistance to the Anti-Counterfeiting Trade Agreement (ACTA) was mostly from those who saw it as a threat to Internet freedoms, the BBC reports. However, it also had been opposed by some nongovernmental organizations that distribute drugs in developing countries. They say its vague language and hard-line penalties put them at risk for moving legitimate generic medications.
"The way it was written, ACTA would have given an unfair advantage to patented medicines and restricted access to affordable generic medicines, to the detriment of patients and treatment providers alike," Pharma Times reports Aziz ur Rehman, an adviser to Medecins Sans Frontieres (MSF), as saying.
The European Parliament's international trade committee says it favors efforts to ensure that generic drugs meet international standards but worried that ACTA's over-broad definition of "counterfeiting" left too much room for error. It said with the defeat of ACTA, the EU should now reconsider similar trade agreements, like one in the works with India, the world's leader in generic drug production.
The agreement, which was seen as a way to better fight counterfeiting internationally, was negotiated by the EU and its member states, as well as the U.S., Australia, Canada, Japan, Mexico, Morocco, New Zealand, Singapore, South Korea and Switzerland. It was approved by 22 EU members but its defeat in the Parliament means none of them can be a party to the agreement, Pharma Times explains. The vote, the first to reject a trade agreement, was decisive with 478 against, 39 in favor and 165 abstaining.
The EU is taking other anti-counterfeiting measures including implementing a track-and-trace system to help monitor drugs through the supply chain. That measure, however, is pitting generic drugmakers, which believe it will cost too much, against branded drugmakers, which want to stop their products from being illegally copied.
- read the PharmaTimes story
- get more from the BBC
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EU homes in on track and trace rules
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Read more about: anticounterfeiting, Europe
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The FDA says a drug and API manufacturing facility in Spain was dirty, in disrepair and couldn't guarantee it consistently provided pure water for drug processing.
The warning letter was sent June 20 to Ercros, after inspectors visited its plant last year in Madrid. And the FDA is not pleased. Among other problems the inspectors says the company did not validate the water system it began using in 2004. For 11 months, before the arrival of inspectors, rather than testing daily, testing was limited to one data point checked each month. The agency wants more details, after the company's promise to do more and improve testing lacked specifics.
The letter also says the company released lots of products, even after some tests were incompliant with standards. Inspectors also found dirt on top of tanks, leaking pipes and areas had not been cleaned for three months. The inside of some equipment had "an inch of a white substance and contained a shallow pool of liquid at the bottom," the letter says.
The agency also says that some of Ercros quality testing was unverified and said the company made changes in some processes, without determining if they might affect drug expirations. Again, the company's responses did not satisfy the agency.
On top of that, the buildings had holes where pests could get in and inspectors found bird feathers and spiders that confirmed their suspicions. The company's indication that it would fix things up didn't contain the kind of details the agency expected.
With about 80% of drug and API products in U.S. now coming from foreign manufacturers, the FDA has been stepping up inspection of foreign drug and API plants. It says that with additional resources from the just-passed user fee law will make more inspections possible. The law also gives it the power to keep foreign products from coming into the U.S. if foreign makers don't agree to be inspected.
- here's the FDA warning letter
Special Report: Fierce's 2012 Top 10 FDA Red Flags
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Funding would allow FDA to target more foreign plants
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Read more about: FDA warning, Spain
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The FDA wants drugmakers to conduct new tests to make sure that any glycerin and other ingredients are not coming from a recently embraced plant that contains toxins.
The agency has issued new guidance about ingredients made from the Jatropha curcas, a plant that has become popular in making biodiesel. The glycerin extracted in that process may contain toxins that would be unhealthy in drugs but which conventional testing may not find. Jatropha plants may contain phorbol esters, which could be toxic "both acute and chronic, to exposed humans and animals."
The agency says it has not discovered any problems yet but is trying to get out in front of the issue with the new rules. The plant has become popular in biodiesel production, the FDA says, because its seeds contain high levels of oil, the drought-resistant plant grows well in tropical and semi-tropical climates and it is relatively cheap to grow.
The agency is trying to develop a test for the presence of Jatropha, and InPharm says it welcomes any assistance in that effort from the industry. Until then it is asking drugmakers to pay close attention to their supply chain for any indication ingredientmakers are using products derived from the plant.
"Given the significant overlap among the supply chains of FDA-regulated products," the agency is advising the industry to audit its suppliers for "the potential for substitution or use of oils, glycerin, and proteins derived from the Jatropha plant."
- here's the FDA guidance
- more from InPharm
Read more about: FDA
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Every week there is some news, recall or event that reminds us that the give and take with the FDA over manufacturing often means poor GMPs give companies major headaches and take a lot of time and money to resolve.