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Can a medical device defend market share for a prescription drug?

Proctor & Gamble Pharmaceuticals France (Asnières-sur-Seine) has captured an 80% share of the market for oral anti-coagulants in France with Previscan, its brand name for the molecule fluindione.

That works out to 480,000 daily 20 mg doses among the 600,000 patients in France who are currently on an anticoagulant. Each prescription pack costs €3.97 ($5.90).

French physicians overwhelmingly prefer the anti Vitamin K (AVK) treatment of fluindione as opposed to Coumadin (crystalline warfarin sodium) for its stability and to avoid stone formation in blood vessels, said Fadel Zaidan, regulatory affairs manager with P&G France.

By contrast, Coumadin, manufactured by DuPont Pharmaceuticals (Wilmington, Delaware), is the hands-down favorite in the Nordic markets with a 90% market share.

As with Coumadin, Previscan therapy needs to be closely monitored, especially when a patient first begins treatment, to determine and then maintain the correct dosage to match the prescribed international normalized ratio (INR) profile that is set according to variables such as age, weight, and sex.

The drug works and is stable if the patient complies with the treatment and the physician adjusts the dosage to find the right balance. A patient’s AVK levels are determined by regular blood workups and the international normalized ratio (INR).

The problem is that 50% of all patients on any given day are out of their prescribed INR zone.

P&G learned that by providing physicians with a software program to track patient’s blood test results, the compliance rate improved by 50% with three out of four patients within their prescribed range during routine check ups.

In 2004, P&G France distributed 13,000 disks to prescribing doctors with a 16-megabyte Previscan software package that could chart histories, predict the adjustment to the patient’s dosage, set the date for the next blood check and then print out a calendar reminder for the patient.

Yet fewer than 3,000 French practitioners bothered to install the software and only 760 used it enough to send data for a clinical study.

“French doctors do not use computers, and they certainly don’t carry laptops to patients in the hospital or at home,” said Zaïdan, who was at the French Society of Cardiology’s annual European Cardiology conference at the Palais des Congès in Paris last week, demonstrating the company’s newest technique to keep French physicians loyal and defend its dominant market share.

PreviscanPlus is a hand-held calculator for monitoring up to 50 AVK patients that P&G is distributing beginning this month to its 13,000 physician base. It is a stand-alone database with no possibility to connect to a computer, either with or without wires, to input or download patient data.

The oversized pocket calculator has a keyboard and numeric keypad for data input. The stripped down software is onboard requiring the physician to push just one of three buttons to enter, update or display patient statistics.

The screen display is nearly primitive by today’s standards, with graphs of patient histories looking like something out of a 1970s Apollo space flight rather than something futuristic from Star Trek. And patients need to write down the date for the next blood test rather than receiving a printout.

“We kept it really simple, and really responsive to the French market. A doctor can take this to a patient’s home, a care center or a hospital to update the data and verify the dosages prescribed,” Zaïdan said.

But apparently it is working, as Zaïdan continually interrupted the interview with Medical Device Daily to take requests from passing cardiologists. “I have 70 orders and it is not even lunch on the first day,” he said.

On overhearing the comment, a physician waiting to order his calculator said, “That does not surprise me. I have a lot of patients on Previscan, and it can move around a lot, especially with older patients and people who don’t pay attention to what they eat.”

PreviscanPlus has the CE mark, as it is technically a medical device used to store patient data and then assist with a diagnosis. It also conforms with Europe’s tough data protection laws by offering absolutely no external treatment of the records.

In what Zaïdan called an extremely rare move, the French drug authority, l’Agence Fran aise de Sécurité Sanitaire des Produits de Santé (AFSSAPS), approved an increase of 14 centimes to the price of each prescription packet to help P&G recover the cost of the device. The decision was based on a clinical study by two prestigious institutes showing improved compliance with AVK saved almost 300 lives in one year and globally saved France €32 million treating patients with fibrillation arriculaire.

Procter & Gamble has operated in France since 1954 and today has 30 brands on the national market, with revenues of €2.4 billion ($3.5 billion) for the 2007 fiscal year.

The pharmaceutical division does not report revenues separately, but the company says sales have doubled since 2000, and that the division is a significant source for growth.

Progenika names key executives

Molecular diagnostics company Progenika Biopharma (Derio, Spain) has named Richard Lussier as COO/general manager, Ignacio Martinez as CFO and Dr. Duncan Whitney as chief scientific officer.

Lussier has more than 20 years of experience in the biotech industry, including more than 13 years at Applera. He most recently was at Solexa.

Whitney has expertise in developing and commercializing biotech products and diagnostic assays.

Martinez joined Progenika in Spain as CFO in 2005 after many years in the international venture capital industry, investing in high-tech companies, particularly in biotechnology.

Progenika is a private firm founded in 2000 to develop tools for personalized medicine.

The company says it is seeking collaborations with commercial and academic partners in development of genetic-based diagnostic and prognostic tools.