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InterMune Provides an Update on Pirfenidone Development Plans

Posted on: Tuesday, 29 March 2005, 18:00 CST

BRISBANE, Calif., March 29 /PRNewswire-FirstCall/ -- InterMune, Inc. 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.

About InterMune

InterMune is a biopharmaceutical company focused on developing and commercializing innovative therapies in hepatology and pulmonology. The Company has a broad and deep late-stage product portfolio addressing hepatitis C virus (HCV) infections, particularly nonresponders, or those patients who do not respond to first-line therapy, and IPF. Leading the hepatology portfolio is the DIRECT Trial, a Phase III study of daily Infergen(R) (interferon alfacon-1) plus ribavirin, and a Phase IIb trial of daily Infergen plus Actimmune(R) (interferon gamma-1b) with and without ribavirin for the treatment of HCV patients who do not respond to first-line therapy. In addition, InterMune has an early stage small molecule program targeted at the HCV protease. The pulmonology portfolio includes pirfenidone and Actimmune. Pirfenidone is being developed for the treatment of IPF and for the treatment of HPS. Actimmune is being investigated in the INSPIRE Trial, a Phase III study in patients with IPF. For additional information about InterMune and its development pipeline, please visit http://www.intermune.com/.

Except for the historical information contained herein, this press release contains certain forward-looking statements that involve risks and uncertainties, including without limitation the statements related to anticipated future financial results and product development. All forward- looking statements and other information included in this press release are based on information available to InterMune as of the date hereof, and InterMune assumes no obligation to update any such forward-looking statements or information. InterMune's actual results could differ materially from those described in InterMune's forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in detail under the heading "Risk Factors" in InterMune's Form 10-K filed with the SEC on March 16, 2005 and other periodic reports filed with the SEC, including the following: (i) the risk that if physicians do not prescribe Actimmune for the treatment of IPF, an indication for which Actimmune has not been approved by the FDA, or if patient referral rates continue to decline, InterMune's revenues will decline; (ii) risks related to regulation by the FDA and other agencies with respect to InterMune's communications with physicians concerning Actimmune for the treatment of IPF; (iii) risks related to potential increases in Infergen sales; (iv) reimbursement risks associated with third-party payors; (v) risks related to whether InterMune is able to obtain, maintain and enforce patents and other intellectual property; (vi) risks related to significant regulatory, supply and competitive barriers to entry; (vii) risks related to the uncertain, lengthy and expensive clinical development and regulatory process, including having no unexpected safety, toxicology, clinical or other issues; (viii) risks related to achieving positive clinical trial results; (ix) risks related to timely patient enrollment and retention in clinical trials. The risks and other factors discussed above should be considered only in connection with the fully discussed risks and other factors discussed in detail in the 10-K report and InterMune's other periodic reports filed with the SEC.

InterMune, Inc.

CONTACT: investors, Judy Hayes of InterMune, Inc., +1-415-466-2242, orir@intermune.com; or media, Carolyn Bumgardner Wang of WeissComm Partners,Inc., +1-415-946-1065, or carolyn@weisscommpartners.com, for InterMune, Inc.

Web site: http://www.intermune.com/

Source: PRNewswire-FirstCall

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