Egyptian firm in fake Avastin scam proves elusive

CAIRO (Reuters) - The trail of counterfeit copies of the multibillion-dollar cancer drug Avastin leads to an address in a crowded Cairo suburb, with no sign of the firm named by international suppliers as the source of the product.

Last week's discovery in the United States of the fake Avastin -- containing no active ingredient -- sent shock-waves through the medical community by showing how even expensive injectable medicines, not just pills like Viagra and Lipitor, are at risk from criminal counterfeiters.

Now healthcare regulators on both sides of the Atlantic are investigating how bogus packs of Roche's cancer therapy entered the supply chain in the world's biggest market, after travelling from Egypt through Switzerland to Britain en route to California.

Hadicon, based in Zug, Switzerland, told Reuters it imported the Avastin from a business called "SAWA for importing and exporting" in Giza, near the pyramids on the outskirts of Cairo.

But there was no company by the name of SAWA at the address given by Hadicon -- 2 El Eshreen Street, Feassal -- and the nondescript five-storey building appeared to house only a small mosque, with a real estate office above it, when visited by a Reuters correspondent on Tuesday.

Local residents said there were doctors' offices on upper floors and there was also a sign outside for an accountant. Several people in the area, including staff at a nearby pharmacy, had no knowledge of any company by the name of SAWA.

A spokesman for the Egyptian health ministry, responsible for the import and export of drugs, said officials had made checks and found that SAWA was not registered with the ministry in any capacity, making it illegal for the company to deal in pharmaceuticals.

Hadicon said in an email that it had never had problems in the past with deliveries from SAWA, adding that Hadicon was licensed to export pre-packaged and sealed medicines, but was not allowed to open them.

"If the fake Avastin did indeed go through Hadicon in the supply chain, we will have been the victim of a large scam, despite all our possible preventative measures," it added.

Hadicon gave no other contact details for SAWA. A second address in Giza for a company called SAWA, found on the Internet, led to a block of flats a few streets away from the first address.

A doorman said a man named on the Internet as the contact for the company was away and had been travelling for at least a month. There were no signs for SAWA at this building either.

The chase after counterfeit Avastin highlights the growing complexity of the global drug supply chain, including both legitimate and counterfeit medicines, and how regulators will be hard-pressed to address potential safety breaches.

The phony Avastin was sold by Hadicon to Danish drug distributor CareMed, which shipped it on directly to Britain's River East Supplies, according to Danish and British regulators.

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Denmark's CareMed says shipped fake Avastin unwittingly

LONDON/COPENHAGEN (Reuters) - Danish drug distributor CareMed said it was an unwitting link in the journey of fake cancer medicine Avastin from Switzerland to Britain, in the latest twist in a saga that began when the counterfeit drugs surfaced in the United States last year.

The fake version of the multi-billion dollar Roche drug had been traced back as far as Egypt before entering a complex supply chain that ended in California.

CareMed told Reuters on Friday it had sourced the drug from fully licensed Swiss distributor Hadicon, and the 167 vials of Avastin 400mg were sold from a transit warehouse in Switzerland directly to a transit warehouse in Britain.

Hadicon was also identified to Reuters as handler of the fake batch by Britain's medicines regulator but the company has yet to confirm its role.

"We did not investigate the packages and the vials," CareMed managing director Casper Tingkaer told Reuters in an emailed response to questions.

"In fact under our distribution license -- for patient safety reasons -- as a distributor, we are not even entitled to open the packages and check that, for example, batch numbers of the vials correspond to the batch numbers of the packages."

The discovery of the fake medicine, which does not contain the active ingredient bevacizumab, highlights the growing problem of counterfeit drugs.

"This is a global industry problem, in particular we have now seen that falsified products have found a way into the validated supply chain," Tingkaer said.

CareMed sold the drugs to a "highly valued and experienced customer" in Britain, which informed it at the end of November that the batch numbers on the vials did not match the packages.

Tingkaer said the company immediately launched an investigation and told the Danish Medicines Agency, which contacted its counterpart in Britain.

The Danish Medicines Agency said that the Danish wholesale company had acted correctly.

Britain then informed Roche, which gets about $6 billion a year from Avastin sales globally, and the U.S. Food and Drug Administration.

Tingkaer said CareMed demanded documentation from Zug-based Hadicon but added the Swiss company did not supply the papers.

Hadicon said it was still not sure it was part of the supply chain that shipped the fake Avastin.

"We have no confirmation of evidence that the goods are definitely from us," chief executive Klaus-Rainer Toedter said.

Regulator Swissmedic would not confirm Hadicon's involvement, but said the fake drug was not sold in the country and it believed it was only stored in a Swiss warehouse.

A Swissmedic spokeswoman said it looked as if the distributor had no knowledge that the drugs were fake, a view echoed by Britain's Medicines and Healthcare Products Regulatory Agency.

"There is no suggestion (CareMed and Hadicon) knew it was counterfeit," a MHRA spokesman said.

Roche, which does not make Avastin in Egypt, said it was working with the FDA in the United States to stop the source of the counterfeit drugs.

"Is anyone making the casing of Avastin here and exporting it illegally?" said Yousef Ehab, the head of the company's operations in Egypt. "I do not know and would like to since this is something of great concern."

Fake medicines are a particular problem in emerging markets, where up to 30 percent of drugs might be counterfeit, the European Parliament said last year.

MEP Marisa Matias said at the time that falsified medicines were "silent killers" and the absence of a legal framework encouraged counterfeiting, an organized crime.

Europe is introducing a series of measures to clamp down on fake medicines over the next three years, including authentication stamps on packaging.

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Doctors scour drug supplies after fake Avastin found

NEW YORK (Reuters) - A U.S. distributor of phony vials of the widely-used cancer drug Avastin aroused suspicion at doctor's offices as early as July, well before health regulators issued their own warning and sparked new alarm over counterfeit medicines.

The U.S. Food and Drug Administration said this week it notified 19 oncology practices they had purchased drugs from a supplier not approved by the agency, including a counterfeit version of Roche Holding AG's, Avastin, that did not contain the multibillion-dollar drug's active ingredient, bevacizumab.

The FDA and Roche's Genentech division said on Wednesday they were still investigating how widely the fake medicine was distributed. They do not know how many patients might have been affected, or if anyone was harmed.

Connie Jung of the FDA's Office of Drug Security said it was possible more practices could be involved.

"Clinics need to know who they're buying their medicines from, they need to make sure they're buying them from legitimate sources, licensed sources in the United States," she said.

The FDA said the drugs came from an overseas supplier called Quality Specialty Products, which does business in the United States with a distributor identified as Montana Healthcare Solutions.

Most of the doctors' offices contacted by the FDA are located in southern California, with one practice in Chicago and another in Corpus Christi, Texas. Several said they were scouring their inventories to see if they had any of the fake medicine and would monitor patients for any problems.

An official from one California oncology practice told Reuters it stopped buying drugs from Montana Healthcare in July when it noticed the products were missing a national health code necessary for billing and reimbursement.

"When we called Montana Healthcare to ask for their national health code they gave me the runaround. At that point we ceased all business," said the source, who asked not to be named because they did not have permission to speak to the media.

The practice did not contact the FDA at the time, but received a visit from agency officials a month ago who said they were investigating the supplier and that the medicines were being sourced abroad.

"They came in ... and said in the middle of my waiting room 'we got a problem,'" the official said of the surprise visit. "This story is horrific for me. I want to find out who the heck is doing this."

A list of expensive biotech medicines offered by Montana Healthcare Solutions and obtained by Reuters priced Avastin 400 mg vials for under $1900, compared with the nearly $2400 that Genentech charges in the United States. It listed Avastin under its Turkish brand name Altuzan.

The list offered "lower-priced European alternatives" of products from Amgen Inc, Eli Lilly and Co, Celgene Corp and Novartis AG. The company did not return telephone calls or e-mails seeking comment.

UK DISCOVERY

Jung said the FDA encountered a wide variety of fake drugs, from conventional pills to injectable medicines that need to be administered by a doctor. The trend is fueled in part by the high cost of certain medicines, pressuring patients and doctors to seek cheaper alternatives.

The FDA said it first found out about the bogus Avastin in late December after the UK Medicines and Healthcare Products Regulatory Agency alerted U.S. officials and Roche about the problem. Roche confirmed via testing earlier this week that the Avastin was fake, the FDA said.

The Beverly Hills Cancer Center, one of the 19 practices notified by the FDA, said it was in the process of determining whether it purchased any fake Avastin from Montana Healthcare.

"At the time the Center purchased drugs from MHS, we believed that the drugs were legal and approved and only recently learned from the FDA that some of the drugs may have been counterfeit or unapproved," the center said in a statement.

"The Center has identified no adverse effects for any of its patients who may have received drugs purchased from MHS," it said, adding it had no idea they were coming from overseas.

Genentech said it is monitoring side effect reports for any spike in safety issues that might arise from the fake Avastin.

The bogus Avastin distributed in the United States has several difference in its package and label that should make it easy to spot. For example, the counterfeit says Roche on the packaging and writing on the box is in French rather than English. Roche distributes Avastin outside the United States, but all legitimate Avastin meant for U.S. patients says Genentech.

The South Texas Comprehensive Cancer Centers said it has conducted a preliminary investigation of its records to assist the FDA. Executive Director Benno Kaufmann declined to say whether it did business with Montana Healthcare or whether it had uncovered any counterfeit Avastin in its investigation.

Genentech said it limits the distribution of many of its products and only sells directly to a defined number of fully licensed and contracted wholesalers and specialty distributors.

An expert on counterfeit medicines said clinics buying medicines from overseas or unapproved suppliers was becoming an increasing problem.

"What we've seen is that there are active efforts underway by persons to specifically target clinics and doctors," said Tom Kubic, president of the Pharmaceutical Security Institute, a non-profit, industry-supported organization that collects information on counterfeit medicines.

"We're well beyond the traditional counterfeit medicines we've seen in certain therapeutic categories," Kubic said, citing phony versions of erectile dysfunction drugs such as Pfizer Inc's Viagra.

(Additional reporting by Lewis Krauskopf in New York and Anna Yukananov in Washington; editing by Michele Gershberg and Andre Grenon)

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