>>BRISBANE, Calif., March 29 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN - News) today provided its promised first quarter update on its development plans for pirfenidone. A recent end-of Phase II meeting with the U.S. Food and Drug Administration (FDA) focused on the completed development work supporting the design and initiation of a Phase III program in idiopathic pulmonary fibrosis (IPF). Following that meeting, InterMune is now working with the FDA to finalize details of a Phase III development program in IPF.
As previously disclosed, InterMune also plans to conduct a Phase III pirfenidone development program for Hermansky-Pudlak Syndrome (HPS), a rare genetic disorder often complicated by pulmonary fibrosis.
Prior to initiating a Phase III pirfenidone program for either IPF or HPS, InterMune must first finalize the details of the Phase III IPF program with U.S. and European regulatory authorities and manufacture sufficient quantities of drug product to complete the Phase III trials for both indications.
"Assuming we reach agreement in a timely manner with U.S. and European regulatory authorities on an acceptable Phase III program in IPF, we expect to initiate both the IPF and HPS programs in the first half of 2006," stated Dan Welch, President and CEO of InterMune. "As our regulatory and manufacturing efforts progress, we are also exploring European partnering opportunities for this promising compound."
About pirfenidone
Pirfenidone is an orally active, small molecule that shows a wide range of biologic activity. In vitro evidence has shown that pirfenidone inhibits collagen synthesis, down-regulates profibrotic cytokines and decreases fibroblast proliferation. Data presented from Phase II clinical trials suggest that pirfenidone may impact disease progression in patients with IPF. In these clinical experiences, pirfenidone was generally well tolerated with the most frequent side effects reported being photosensitivity rash and gastrointestinal symptoms. In 2004, the FDA and European Medicines Agency (EMEA) granted pirfenidone orphan drug designation for the treatment of IPF. InterMune has worldwide rights, excluding Japan, Korea and Taiwan, to develop and commercialize pirfenidone for all fibrotic diseases.
About IPF
IPF is a disabling and ultimately fatal disease that affects approximately 80,000 people in the U.S., with an estimated 30,000 new cases developing each year. Those diagnosed with IPF are usually between the ages of 50 and 70, and the disease tends to affect men more than women. IPF causes inflammation and scarring (fibrosis) in the lungs, hindering a person's ability to process oxygen and causing shortness of breath (dyspnea) and cough. IPF is a progressive disease, meaning that over time, lung scarring and symptoms increase in severity. Median survival time from diagnosis is two to five years in patients with IPF. There are currently no drugs approved by the FDA for the treatment of IPF.
About HPS
HPS is a rare autosomal recessive genetic disorder that is characterized by oculocutaneous albinism (a defect in melanin production that is expressed in the hair, skin and eyes) and a bleeding disorder due to a platelet storage pool deficiency. Pulmonary fibrosis is a common complication of HPS.<<
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I haven't followed closely for a while, so I do not know how this update compares to prior guidance about timing of the above developmental milestones.
Cheers, Tuck |
