Friday June 19, 1998 I spoke with Dr. Drees. With his permission I am posting highlights from our very informative conversation.
I asked Dr. Drees if there was any way that Green Cross could sell this product or the previous product that they had previously used on approximately 13,000 people. Dr. Drees replied that they could not. The reason why is that when they falsified the date (not data) that they had given one patient the drug, eventually they got caught, and were forced to withdraw their application for product approval in Japan. Green Cross also dropped their FDA approval in the United States.
Does Green Cross have the patent on the first generation drug?
No, the reason why is that the professors from Harvard, Pennsylvania University, and the University of Cincinnati were the ones that started the research. When these professors applied to Washington to get funding they were denied 2 years in a row. Japan heard about the research and invested in it. However, it was not their (Green Cross) invention and therefore they never got a patent.
Currently Dr. Drees has filed patent application papers, all claims have been approved, and he continues amending the application so that it keeps current and timely.
Difference between first generation and second generation drug.
Both drugs use an emulsion. In Japan's version 1st generation drug they used 2 flurocarbons, 8 adjuvent solutions, and 2 surfactants. Sanguine's 2nd generation drug uses 1 flurocarbon and 1 surfactant. This version is a much cleaner product.
Another very important thing to remember is that with this being a 2nd generation drug the time frame for approval should be much shorter. It took about 10 years when Dr. Drees was head of Alpha ( US subsidiary of Green Cross) to get FDA approval. Now that the 1st generation drug has been tested on approximately 13,000 people and saved lives, the process should be quicker, cheaper, and smoother. He is hoping for FDA approval in 3 years.
Pre-Animal testing is the next major step. They have a contract signed with Batelle to do this.
Sanguine has had a working relationship with Batelle since 1994.
Dr. Drees has seen many animal testing facilities and he says Batelles is the best.
Dr. Drees said that there are 2 ways to proceed with animal testing. First you can raise lots of money, build a facility, acquire equipment, hire technical people etc. Or you can hire Batelle. Advantages of using Batelle:
1. With Batelle comes a high degree of credibility.
2. Even though they are more dollars per hour, in the long run it's cheaper than building or buying your own facilities.
Demand for product. Current estimate is that in the world each year, there are 60 million transfusions of blood. According to the World Health Organization (WHO), if there was not the shortage of donors, refrigeration problems, typing and cross matching, availability of testing equipment, etc. there could be 120-180 million transfusions per year.
Availability of materials. Materials for the fluorocarbons can be purchased from companies such as 3M and Dupont, they are plentiful and cost about $30.00 /pint of blood substitute.
What price are you planning on selling a pint of this product for? Same as a pint of donated blood, about $300.00 to begin with.
Other significant points.
1. No testing need be done for AIDS, hepatitis, CJD., or any future diseases.
2. This is a universal donor product--it doesn't need to be typed and crossmatched.
3. Shelf life expectancy of Red Cross blood = 6 weeks refrigerated.
Shelf life expectancy of fluorocarbons = 3 years, no refrigeration.
4. Flurocarbons are about 1/900 the size of red blood cells, allowing them to get around and through vessels clogged or restricted, while carrying about 4 times as much oxygen as blood per weight volume.
5. Product could be made readily available for every medical facility, ambulance, armed services medic,etc.
Possibility of a buyout? There is always the possibility that a drug company will make an offer. Dr. Drees would prefer not to sell. However, depending on what the offer is, considerations for the shareholders would have to be evaluated and considered. Positives about buyout include:
1. They would have a sales force in place.
2. Have specialist to deal with regulations and FDA.
3. Medical and technical professionals in place.
Competition
The competition mainly uses outdated blood. They try and clean it up, cross link it, etc. to create artificial blood. Another problem is that there is not enough outdated blood in the world to produce enough for 60 million transfusions let alone 120-180 million transfusions/per year.
Dr. Drees, author and noted expert, who lectures 2-3 times a year in the field, had prophesied from the beginning that the competitors would have problems. And problems they have had. There were about a dozen companies in blood substitutes about 10 years ago. Here's what is going on with some of the few survivors.
1. Baxter: In a 100 person trial, 40 people died (in the U.S.A.). European trials have also been stopped.
2. Alliance: Used fluorocarbons like Sanguine does but a different form. Had strategic alliance with Johnson & Johnson and the German company Hoescht. Both companies canceled their funding.
3. Somatogen: Uses recombinant DNA. Had agreement with Eli Lilly. Eli Lilly canceled agreement. Baxter has recently acquired Somatogen.
4. Biopure: Had contract with Upjohn. Upjohn canceled contract. Biopure uses cow's blood.
The good thing is that the competition has had numerous troubles. The bad thing is that this gives the product line a negative image. Remember that Sanguine's technology is different from the competitors. Sanguine's technology does not use outdated blood, cow's blood,etc. Also, Sanguine's technology is second generation, i.e. there was a successful 1st generation, but it was dropped by Japanese drug company, Green Cross Corp., due to false dates. Green Cross Corp. had no patents, so Sanguine patent application is effective.
Sanguine and Dr. Drees phone number: 626-405-0079 |
