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For Saladax Biomedical, China Could Be the Largest Market
5-FU (5-fluorouracil) is a chemotherapy given mainly to patients with colorectal, head and neck, or metastatic breast cancers. In the US, there are about 200,000 patients treated with 5-FU each year, said Erickson. That pales in comparison to China. In the well-developed sections of China, there are about 600,000 patients annually on 5-FU by infusion, a number that probably rises almost to 1 million if the more rural sections of the country are included.
Among oncologists, 5-FU is a well-known, highly familiar treatment. The problem, according to Saladax, is the dosing of 5-FU, which is far from optimal under current best practices. “At present, oncologists typically use body-surface-area (BSA) or weight to determine dosage,” Erickson declared. “But differences in individual metabolism may be the greater cause of variability. These differences can cause a 10-fold or greater variation in the blood concentration of 5-FU among patients.”
Researchers have identified a well-known optimal range of concentration in the blood – known as the “therapeutic window,” where the upper limit is the level at which serious toxicity may occur. Too high a level and the patient’s immune system is harmed, which may negatively affect treatment outcome – not to mention other serious side effects. Too low a level, and the regimen is often not effective.
Studies have shown that about 40% to 70% of 5-FU patients are under-dosed; 10% to 20% of patients are over-dosed; while somewhere between 10% and 30% are in the optimal range.
“China wants to be cost effective,” Erickson pointed out. “That’s not just a matter of saving money by preventing overdosing of the chemotherapy. A patient who is dosed optimally has almost twice as good chance of an effective round of chemotherapy.” In a Phase III trial among patients with metastatic colorectal cancer, patients whose 5-FU dose was optimized (though not with My5FU) demonstrated a 33.7% response rate against 18.3% in the group that followed usual dosing procedures.
According to Erickson, the impact of Saladax’s My5-FU test may yield a better result than a more expensive regimen of 5-FU plus a high-end biologic treatment.
In the US, the assay for 5-FU is marketed by Myriad Genetics (NSDQ: MYGN) under the name OnDose™. It is marketed as a service rather than a medical diagnostic reagent, which means it does not require FDA approval. However, where it is offered as an approved medical diagnostic product, it is possible to perform the My5-FU tests in hospitals as well as centralized reference labs, which may be more appropriate for China.
Saladax is seeking financial backing for its China venture, which will be used to underwrite the cost of setting up local manufacturing, clinical trials and marketing. The company anticipates that a validation trial will enroll 200 patients who are undergoing 5-FU chemotherapy. It is likely that the company will also run trials to compare the benefits of monitoring with My5-FU versus a non-monitored arm. The hope is to have a registered product ready for the China market by the end of 2013 or the beginning of 2014.
As for gaining market approval in China, Erickson said China’s regulatory processes are “rigorous, but not onerous.” It protects the public, he means, while it doesn’t stifle innovation. Saladax will probably follow a “provincial” strategy for its MyCare assays, getting it approved first in the province where it locates its manufacturing. The strategy is possible because MyCare is a medical diagnostic, not a drug.
According to Erickson, prices for MyCare assays will be lower in China than those in the US for the lab service, but China will support prices that are equal or higher than the ones in Europe. Saladax can live with that pricing schedule.
As Saladax currently sees its future in China, there will initially be a small manufacturing facility located in the PRC. Some of the basic materials of the company’s MyCare assay will be manufactured at the existing US facility, then sent to China for fill and finish and release for sale.
Saladax has two high-profile China nationals to help its China initiative. The company recently asked Li Zhang, MD to serve as a member of the company’s scientific advisory board. A man with impeccable credentials in China’s oncology community, Dr. Zhang is a professor of medical oncology and deputy director of the Lung Cancer Research Centre of Sun Yat-Sen University, along with numerous other titles. Dr. Zhang is well-known internationally for his work with cancer therapeutics, and he is overseeing a China clinical trial that shows the variability of 5-FU concentrations in the blood of Chinese cancer patients.
To market Saladax’s products in China and other Pacific Rim countries, the company had to look no further than one of its research group leaders, Dr. Yunying Li, PhD. Dr. Li did her undergraduate work at Peking University and her PhD at University of Pennsylvania. She moved to Shanghai and became Director of Market Development, Asia for Saladax.
Saladax intends to build a web of agents and distributors to distribute products in China, though it will also have its own core marketing team. “Our job is to educate the community of physicians,” says Erickson, because the MyDose product involves a new set of procedures. The community of doctors will have to be convinced that the test pays for itself in terms of improved patient outcomes.
Once the 5-FU dose monitoring kit is being distributed in China, Saladax will add on other assays that also target dose management of generic chemotherapies. Saladax is developing tests for paclitaxel and docetaxel – two drugs used in many cancers including breast and lung cancer.
Saladax doesn’t consider the prospect of a China initiative daunting. Erickson finds something very familiar in the atmosphere there. When he conducted educational sessions among physicians in China, he found them interested, asking pertinent, incisive questions. “I like the entrepreneurial energy of China, the energy to get things done,” concluded Erickson. “And it is fascinating what China has been able to do in a short space of time.”