FG-4592 oral anemia therapy receives CTA approval from SFDA

FibroGen, Inc., today announced that its investigational oral anemia therapy, FG-4592, received Clinical Trial Application (CTA) approval from the Chinese State Food and Drug Administration (SFDA) to commence clinical development for the treatment of anemia associated with chronic kidney disease (CKD) in the People's Republic of China. FG-4592 is a first-in-class hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor (PHI) entering Phase 2b clinical development in the US and Europe for the treatment of CKD anemia. SFDA approved protocols for both Phase 1 and 2 studies. The first of these studies of FG-4592 in China will begin in the fourth quarter of 2010.

“This is a significant milestone in the global expansion of our development program for FG-4592”

"This is a significant milestone in the global expansion of our development program for FG-4592," said Thomas B. Neff, CEO of FibroGen. "With the support of SFDA, we are committed to bringing safe, effective and accessible oral anemia therapy to the people of China."

In October 2009, SFDA accepted FG-4592 for Special Examination and Approval of the Registration of New Drugs, otherwise known as 'Green Chanel.' This designation by the SFDA has allowed FibroGen to establish close communication with the Center for Drug Evaluation (CDE) in the determination of clinical development plans in China. "As we continue a productive dialog with the CDE, we will explore options to bring FG-4592 to the expanding Chinese market as rapidly as possible, including possible submission of FG-4592 as a domestic first-in-class NDA," said Mr. Neff.

Phase 1 and 2 trials in China are expected to have completed dosing by the end of 2011. In parallel with completion of these studies, Phase 3 plans and commercialization strategy, including identification of potential partners, will be determined.

Chronic Kidney Disease (CKD)

CKD is a chronic progressive disease that ultimately leads to end-stage renal disease (ESRD) necessitating kidney transplant or dialysis. Global prevalence rates of CKD are far higher in industrial countries than in rural settings. As the Chinese economy has grown, a large portion of the population has moved to urban settings where accompanying changes in diet and exercise have led to increased prevalence of CKD risk factors including diabetes and hypertension. As a result, studies have shown that CKD prevalence in China has reached levels similar to that of the US, resulting in approximately 125 million Chinese people with CKD.

CKD Anemia

The prevalence of anemia increases as CKD worsens, resulting in fatigue, loss of exercise capacity, diminution of cognitive abilities and reduced independence. The unmet medical need for treatment of anemia in China is large. Nearly all of the approximately 300,000 Chinese CKD patients who reach the end-stage every year are anemic and approximately 6-8 million Chinese CKD patients not yet on dialysis are anemic.

At present, it is estimated that only 10% of anemic patients are treated. This is largely because providing anemia care has been difficult in the past. Erythropoiesis Stimulating Agents (ESA), injectable supplements of recombinant human erythropoetin or analogs, were first made available in China in the early 1990's at high Western prices. In addition, at that time there was a limited health insurance system in China, so provision of care for ESRD patients, including dialysis and anemia treatment, was greatly limited.

The Chinese Government Response to the CKD Crisis

In recent years, China's government has initiated a dramatic revolution in reimbursement that has increased health care affordability, particularly for complex, expensive disease states such as ESRD requiring dialysis treatment. The number of Chinese with health insurance has increased ten-fold in the past decade to an estimated 1.2 billion, nearly all of the 1.3 billion people in China, in 2010. Further, the level of insurance coverage has been expanded to the point where complex medical procedures such as dialysis have become affordable for many.

The scope and scale of insurance reform continues to increase. In particular, the Chinese government has made treatment of CKD a national health care priority. Focused government efforts have resulted in the rapid expansion of dialysis services, including creation of additional hemodialysis facilities in urban areas and increased use of peritoneal dialysis in the countryside, and improved access to ESA therapy.

ESA Market in China and Potential for FG-4592

The current ESA market in China is relatively small but growing with increased patient access to dialysis. Although the anemic patient population is four times that of the US, only one sixth the number of US anemia patients is currently treated. In addition to previous limitations on health insurance and access to dialysis services, high cost of ESA, complexity of administration as well as need for refrigerated transport and storage have contributed to low ESA sales. As a result, the ESA market in China was only $100 million vs. $5 billion in the US in 2009.

In addition, except in certain major hospitals, anemic CKD patients generally go untreated, resulting in low average hemoglobin levels. The only publicly available data on hemoglobin levels in China is from the Shanghai Dialysis Registry where maintenance levels for anemia-corrected patients are on average 10.3 g/dL. Since Shanghai is among the Chinese cities with the highest level of medical treatment in the country, the hemoglobin correction level reached across China is believed to be lower than that in Shanghai, less than 10 g/dL, compared with an average of 11.8 g/dL among dialysis patients in the US.

Given the vast geography, the size of population and the aggregate healthcare cost of dialysis treatment in the country, the need for oral anemia therapy is far greater in China than in Western countries. FG-4592 could potentially revolutionize anemia treatment in China by offering less expensive, more easily administered oral therapy, particularly for the 70% of people residing in rural areas far from tertiary hospitals and predialysis patients who are still employed and are challenged to come to medical centers frequently to receive ESA injections. The greater treatment accesibility offered by FG-4592 will potentially enable more patients to be treated to the higher hemoglobin targets that are recommended by medical associations worldwide, allowing for better patient outcomes.

Source : FibroGen, Inc.