PolyHeme Hemoglobin moving to FDA

hawkaw

( http://tscquote.thestreet.com/BBStory.jhtml?tkr=NFLD&id=115944475&src=PRNEWSWIRE

08-28-2001 01:18:35 PM Northfield Laboratories Submits Biologics License Application to FDA For Approval of Its Blood Substitute, PolyHeme(TM)
EVANSTON, Ill. Aug. 28 /PRNewswire/ -- Northfield Laboratories Inc.
(Nasdaq: NFLD), a leading developer of an oxygen-carrying blood substitute, today reported that it has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) seeking approval to market its patented blood substitute product, PolyHeme, as an ideal oxygen-carrying resuscitative fluid for use in the treatment of urgent, life-threatening blood loss.
"The submission of the BLA for PolyHeme is a significant milestone for
Northfield, and marks a first for a blood substitute for human use in the U.S.," said Richard DeWoskin, chairman and chief executive officer. "PolyHeme provides a remarkable clinical benefit, and represents more than 16 years of product development, clinical studies and data analysis. More importantly, it addresses a large market opportunity and fills an important clinical need.
"We plan to continue working with the FDA to support the strength of our application and to provide any additional information that may be necessary to achieve a favorable determination," said DeWoskin.

Dr. Steven A. Gould, president, said, "The data from our clinical trials demonstrate that PolyHeme will support life in seriously injured, bleeding patients in the virtual absence of circulating red blood cells, and thereby improve survival in situations when blood cannot be used. We believe these results demonstrate the ability of PolyHeme to effectively and safely transport oxygen. This extraordinary survival benefit indicates that PolyHeme is capable of addressing a critical, unmet medical need, and has led us to file for priority review and fast-track status with the FDA, which we hope will lead to accelerated approval of PolyHeme."
PolyHeme is the only blood substitute that has been safely infused rapidly and at large enough dosages to be considered a substitute for acute blood loss in trauma and surgical settings. As a result of the process used to manufacture this product, essentially a solution of polymerized hemoglobin, PolyHeme has a longer shelf life than blood, requires no cross matching and does not transmit disease.
The current market for blood in the United States is estimated to be in the multiple billions of dollars. There were 12.4 million units of blood transfused into approximately 4 million recipients in 1999, according to the latest figures available from the National Blood Data Resource Center. Of that amount, about 2.5 million units are used in urgent, acute blood loss situations -- Northfield's primary focus.
Annual Business Update
The company will provide more detail on its regulatory progress in its
annual business update on August 31, 2001. This presentation will be webcast after the close of the market, at 4:30 p.m. central time, that day. Anyone interested in accessing the presentation should log on to http://www.northfieldlabs.com or http://www.videonewswire.com , or, for those without Internet access, you may dial in to 888-413-4411 to listen to the call. A replay of the webcast will be available for 30 days after the presentation. The telephonic replay will be available for seven days by dialing 888-266-2086 and providing the passcode, 5458560.
Northfield's annual meeting will take place earlier that day at 2:00 p.m. central time to vote on business matters as outlined in its August 3rd proxy statement. Only questions related to those business matters will be taken at the meeting. The business update will not be webcast at corporate headquarters......

hawk

I've been reading in the NY Times that there is a severe shortage of blood in the U.S. JWs are a drain, of course. It takes 2500 gallons (liters?) just to provide Factor VIII, I believe, for hemophiliacs.

Hawkaw, in your opinion, will PolyHeme be available for humanitarian use?

How long would it take to get full FDA approval?

hawkaw

Hi EH,

Your answer to your questions are found in the second last paragraph of the news report that I posted. In other words listen to what they say on August 31, 2001 and we can both find out together.

hawk

blondie

Did you say, JW hemophiliacs are a drain on the blood supply because it takes so much blood to make Factor VIII? What do you think the percentage of JWs is that makes up the total hemophiliac population? You aren't suggesting that hemophiliacs in general are a drain on the blood supply? Do non-JW hemophiliacs donate blood?

The main reasons for the shortages are the failing health and loss of many of the country's older, more dependable donors, apathy and increasing restrictions. It is expected to get worse this fall under new rules by the American Red Cross, which manages nearly half the nation's blood supply.

The organization, seeking to protect the public from a human form of "mad cow" disease, will bar people from donating if they have spent at least three months in the United Kingdom or six months in Europe since 1980.

and some other reasons:

Blood has always been a precious quantity, but advances in medical technology have increased the number of medical procedures such as organ transplants requiring a lot of blood, Healy said. She noted several other factors that have contributed to the rising demand for blood and plasma, such as the increase in this country's older adult population as the baby boomer generation enters their fifties and sixties. At that point in life, Healy said, cancer rates rise, a disease that requires chemotherapy and blood transfusions.

Eusebius Hieronymus

My point, Blondie:

Jehovah's Witnesses TAKE but do not GIVE BACK. No one begrudges JW hemophiliacs, certainly not me. I just wanted to point out that it takes a huge quantity of blood to care for just one hemophiliac--percentage of JWs is beside my point. I didn't remember the requirement figures and I hope someone will be specific for me.

But has no Witness EVER at some time thought,

"How is this showing love of neighbor?
"To take blood but not give it!"

What do you think?

Jerry

blondie

Well, I'm not happy with it...but then a large part of the problem with the low blood supply is that people in general (even non-JWs who take blood and have taken blood) do not donate either. I have known very few JW hemophiliacs but many non-JW ones...amazingly, having a hemophiliac in one's family does not necessarily motivate family members to donate blood. I would not try to even go there to suggest that because JWs do not donate blood that they are substantially responsible for the low blood supply. If it really bothers anyone here, then each one should donate themselves. If you are willing NOW to accept blood, you should donate NOW and not wait until you suddenly need blood.

Eusebius Hieronymus

I'm not stating JWs are responsible for reduced blood supply.

I'm addressing the INCONSISTENCY of the Witness position.

On another thread many posters noted they themselves donate blood, and there were many comments about how good it felt.

I think love of neighbor mandates that we donate blood, period.

My $0.02.5

blondie

The world is full of inconsistencies, even among JWs...I agree...if you use products that are made from blood...everyone physically able to give blood should do so...as well as anyone who would take blood if necessary in the future. Obviously, many people who are not JWs are also being inconsistent. The blood issue is very emotional...just remember who makes the policy is not the the JW hemophiliac or their family. If change is desired, the people with the power to make changes need to be convinced.

PolyHeme Hemoglobin moving to FDA

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