Biotech Values

[ghmm]

I have been meaning to do a nice write-up on this board on InterMune’s Pulmonology products as I am surprised at how little attention is given to InterMune in particular to their Pulmonology products. Most people think of them as just having a Protease Inhibitor that had good preclinical results and is awaiting EU authorization to start trials…

I will concede Actimmune treatment alone isn’t enough for people with Pulmonary Fibrosis but this is the most advanced drug in development AND its already approved for 2 rare indications. At 60K per year, if approved, this will not take many patients to become a huge drug. I think the company did a lot better job in the INSPIRE trial design to overcome the failed GIPF001 results (The literature would suggest being able to show a survival benefit with this design and the larger trial gives them much more power then the 001 retrospective subset analysis).

I also think Pirfenidone has a very good chance at showing efficacy (improved lung function in this case). My guess is that the company will beat enrollment too based on a few things (INSPIRE enrollment, being an oral compound, no off label use available such as is for Actimmune).

One of these days I’ll put together a better write up… unless INSPIRE Interim analysis stops for efficacy or Shionogi’s Pirfenidone trial does well and the market begins to value in the potential for a drug in Pulmonary Fibrosis.


http://biz.yahoo.com/prnews/061005/cgth065.html?.v=46&printer=1
Pulmonary Fibrosis Prevalence Increases 156 Percent in Six Years
Thursday October 5, 5:25 pm ET
Funding for Research to Find Treatment, Cure Unacceptably Low

SAN JOSE, Calif., Oct. 5 /PRNewswire/ -- Prevalence of pulmonary fibrosis has increased 156 percent in the last six years, according to a new paper published this week in the American Journal of Respiratory and Critical Care Medicine. The article, entitled "Incidence and Prevalence of IPF" appears in the Oct. 1 issue of the Journal.

ADVERTISEMENT
According to the new findings, pulmonary fibrosis now affects 128,000 people and more than 48,000 new cases are diagnosed each year(1). In 2000, the Consensus Statement of the American Thoracic Society estimated prevalence at approximately 50,000(2).

Idiopathic pulmonary fibrosis (IPF) is the deadliest form of pulmonary fibrosis and is a progressive and ultimately fatal lung disease. There is no known cause, no FDA-approved treatment and no cure.

IPF deadliest form of pulmonary fibrosis

IPF is characterized by progressive scarring in the lungs that robs patients of their ability to breathe. The disease is relentlessly progressive, with a median survival time from diagnosis of three to five years, and a five- year survival rate of approximately 20 percent.

"While this study, like all epidemiological studies, has some limitations, it reinforces a prevailing opinion in the pulmonary community that IPF prevalence and incidence is, in fact, higher than people and the medical community realize," said Ganesh Raghu, M.D., lead author of the paper and professor of medicine at University of Washington, Seattle, Wash., and director of the University of Washington Medical Center's Interstitial Lung Diseases/Sarcoidosis/Pulmonary Fibrosis program. "Based on increased awareness in the entities of idiopathic interstitial pneumonia among pulmonologists, the true incidence and prevalence of idiopathic pulmonary fibrosis and interstitial pneumonias is likely to be significantly higher than this study suggests. Increased funding for research is desperately needed to identify new approaches to understanding and treating this devastating disease."

Increases in awareness, education improve diagnosis

According to Dr. Raghu, a world-renowned IPF expert who has dedicated his career to IPF/interstitial lung diseases community, the reasons for the increase in numbers of people across the country diagnosed with disease is more than likely due to an increase in education of the disease both to the public as well as to medical professionals.

"My personal feeling is that more and more doctors are now aware of the disease entities associated with pulmonary fibrosis of unknown cause," said Dr. Raghu. "With routine access to high resolution CT scans of the chest, they are identifying the disease patterns earlier than ever before and hence able to diagnose these conditions better than a few years ago. Non profit organizations like the Coalition for Pulmonary Fibrosis (CPF) and respiratory societies dedicated to enhance education and research of pulmonary fibrosis have certainly contributed greatly in surfacing the problem and helping people to recognize it more."

To view the complete article "Incidence and Prevalence of IPF", please visit http://www.coalitionforpf.org/ipfresearch .

Funding for IPF research unacceptably low

IPF research is often delayed because researchers have difficulty obtaining the funds necessary to fuel new studies. Funding for research, including federal funding, remains a massive challenge for the IPF community, despite clear evidence that new cases are being diagnosed at an alarming rate.

"To make matters worse there is no proven cause of IPF, so research is still needed to better understand disease progression," said Mark Shreve, chief executive officer of the CPF. "Increased research funding is needed now more than ever to help improve understanding of IPF so that new approaches to treat the disease can be identified."

Federal funding for IPF is estimated at $14 million from 2006-2008, primarily through the IPF Research Network (IPFNet) program funded by the National Institutes of Health, according to Shreve. "For a disease that affects so many people, federal funding remains unacceptably low," he said.

CPF funds research to supplement federal dollars

The CPF, the nation's largest nonprofit organization representing the IPF community, is working to fund research to supplement federal dollars. To date, the CPF has awarded more than $250,000 in research gifts to leading medical centers in the U.S., and has also partnered with the American Thoracic Society to jointly fund a $100,000 research award in 2007. The CPF also advocates for improved federal funding of IPF research through its campaign ACT advocacy program in Washington, DC. To learn more about the CPF or campaign ACT, please visit http://www.coalitionforpf.org or call [phone].

Key Facts about IPF:
-- Prevalence of pulmonary fibrosis is on the rise and expected to double
in the next 20 years as the U.S. population continues to age.
-- IPF symptoms (shortness of breath and unexplained, persistent dry
cough) are so similar to other lung ailments that as many as 50 percent
of patients are initially misdiagnosed.
-- The only treatment shown to extend survival is lung transplantation;
however 50 percent of IPF patients who are eligible for transplant pass
away before a donor lung becomes available.

About the Coalition for Pulmonary Fibrosis:

The Coalition for Pulmonary Fibrosis (CPF) is a 501(c)(3) nonprofit organization, founded in 2001 to accelerate research efforts leading to a cure for idiopathic pulmonary fibrosis (IPF), while educating, supporting, and advocating for the community of patients, families, and medical professionals fighting this disease. The CPF funds promising research into new approaches to treat and cure IPF; provides patients and families with comprehensive education materials, resources, and hope; serves as a voice for national advocacy of IPF issues; and works to improve awareness of IPF in the medical community as well as the general public. The CPF's nonprofit partners include many of the most respected medical centers and healthcare organizations in the U.S. With more than 10,000 members nationwide, the CPF is the largest nonprofit organization in the U.S. dedicated to advocating for those with pulmonary fibrosis. For more information please visit http://www.coalitionforpf.org or call [phone].

References
(1) Ganesh Raghu, Derek Weycker, John Edelsberg, Williamson Z. Bradford,
Gerry Oster: Incidence and Prevalence of Idiopathic Pulmonary
Fibrosis: American journal of Respiratory and Crit Care Med; vol 174:
810-816,2006

(2) American Thoracic Society. Idiopathic pulmonary fibrosis: diagnosis
and treatment (international consensus statement). Am J Respir Crit
Care Med. 2000; 161:646-664.