3SOF

now @ +28.91%.....Volume @ 46,281,407

Volume Alert...Vol Hits all-time high today!!

Re-post news;
Xechem's Orphan Drug Status Approved for Its Sickle Cell Medicine in the European Union
Tuesday October 4, 8:30 am ET


NEW BRUNSWICK, N.J.--(BUSINESS WIRE)--Oct. 4, 2005--Xechem International, Inc. (OTC BB: XKEM - News) Xechem International announced today that its wholly owned subsidiary, Xechem UK Ltd., has received Orphan Drug designation from the European Medicine Evaluation Agency (EMEA) for NIPRISAN (now known as NICOSAN(TM)/HEMOXIN(TM)), a phytopharmaceutical product that has shown efficacy in the treatment of Sickle Cell Disease. The designation covers all 25 countries that comprise the European Union. Similar Orphan Drug status was previously granted to Xechem by the U.S. Food and Drug Administration.
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Dr. Ramesh Pandey, Xechem's Chairman & CEO said, "Obtaining Orphan Drug status for our Sickle Cell Disease product in both the European Union and the United States brings to Xechem substantial advantages and incentives which will help facilitate approval of the drug and make it easier for us to bring this important medicine to market. To have received these coveted designations from both the FDA and EMEA for a natural, herb-based product such as ours is particularly gratifying."

Significance of Orphan Drug Designation

The EMEA regulation on orphan medicinal products is designed to encourage companies to develop and market treatments for rare, life threatening medical conditions that affect less than five people in every 10,000 in the EU. In addition to granting the license holder protection from direct or generic competition for a period of ten years within the EU following drug approval, orphan drug status allows for regulatory assistance, reduced regulatory fees associated with applying for marketing approval, protocol assistance and scientific advice. Similar incentives, including seven years of marketing exclusivity, tax credits, and access to potential grant funding for non-clinical and clinical research, accompany orphan drug status in the U.S.

According to Dr. Pandey, "Given the virtual lack of commercially viable treatments for SCD in the United States and the EU, the multi-year exclusivity for NICOSAN(TM)/HEMOXIN(TM) could create a significant revenue producing opportunity for Xechem."

About Sickle Cell Disease

Sickle Cell Disease (SCD) is a devastating hereditary blood disorder, caused by an abnormal Hemoglobin called Sickle Hemoglobin, and is characterized by acute painful crises, organ damage, anemia and early death. SCD is particularly prevalent among people from sub-Saharan Africa. In Nigeria alone over 4 million people are afflicted with the disease and another 26 million are believed to be carriers of the sickle cell trait. It is estimated that more than one out of seven persons living on the African continent carry the sickle cell trait and over 18 million actually suffer with the disease worldwide.

About Xechem

Xechem International, Inc., is a development stage biopharmaceutical company focusing on anticancer, antiviral (including AIDS), antifungal, Sickle Cell Disease (SCD), antimalarial and antibacterial products from natural sources, including microbial and marine organisms. Xechem's mission is to bring relief to the millions of people who suffer from these diseases. Its primary focus is on the development of phytopharmaceuticals and other proprietary technologies including those used in the treatment of orphan diseases. Nearly all of Xechem's attention and resources are currently being directed toward the development and commercial launch of NICOSAN(TM)/HEMOXIN(TM), which has shown efficacy in the treatment of SCD.

It's 11:45: Huge Volume 126m,
price:    .0154,20%up

With the Brytsol-Myers suit out of the way they can go forward with its paclitaxel drug?...... a generic equivalent of Bristol's cancer drug, TAXOL(R).

Xechem International, Inc. is engaged primarily in applying its proprietary extraction, isolation and purification technology to the production and manufacture of paclitaxel. Paclitaxel is an anticancer compound used for the treatment of ovarian, breast, small cell lung cancers and AIDS related Kaposi sarcomas. The Company has successfully isolated pure paclitaxel and has received a process patent on this technology. The Company has submitted to the FDA a Drug Master File for the facility and the bulk paclitaxel product. The Company has been issued five U.S. patents on paclitaxel and its second generation analogs from the U.S. Patent and Trademark Office and over thirty-four international patents are pending.

Quote from: brucey on February 27, 2006, 12:46:56 PM
It's 11:45: Huge Volume 126m,
price:    .0154,20%up

Monster in the making with Bristol-Myers out of the way and their money in our pockets...Somebody know something with the huge volume we are seeing and with buyers on every dip we have had! I expect we hear something soon based on the volume and heck, the entire float will be changing hands and setting higher lows as we go!

30mil shares traded in this range..Lows looking higher all the time...Looking for strong EOD run...GLTA

Xkem doesn't look good after 12:00.with volume going up fast,price going down fast too....strong selling....now .013

667+ Million shares traded in last 7 days...Setting higher lows as trade the float near these levels... look for a GAP tomorrow with the buying at the end of today! We very well could break .03 in next few days with this volumeand .07 in 1-2 weeks....Somebody keeps on buying and today was a great day as we got rid of a lot of weak hands and traded 209mil.... GLTA

Back with charts tonight but They will be bullish with positive close and so many shares traded here and above us now.....Looking good!

I got my head handed to me today on this one, but did not sell.  Hopefully we gap and I can break even.  That is my hope.

Xechem Locations

Corporate Headquarters

Xechem International, Inc.
New Brunswick Technology Center
100 Jersey Avenue
Building B, Suite 310
New Brunswick, NJ 08901
USA

(Xechem, Inc., Xechem Laboratories, Inc., and XetaPharm, Inc. are also located at the above address)
Tel: (732) 247-3300
Fax: (732) 247-4090
E-Mail: [email protected]

Regional Office

Xechem/XetaPharm, Inc.
12106 Pawnee Drive
Gaithersburg, MD 20878
USA Tel: (301) 330-5098
Fax: (301) 330 5098
E-Mail: [email protected]

Xechem Nigeria

Xechem Pharmaceuticals Nigeria Ltd.
Sheda Science and Technology Complex
Technology Park, Gwagwalada
Federal Capital Territory, Abuja
NIGERIA Tel: 234-9-671-8379
E-Mail: [email protected]



Xechem U.K.

Xechem U.K., Ltd.
The White House
2 Meadrow
Godalming
Surrey GU7 3HN
UK Tel: 44 (0) 1483 424 269
Fax: 44 (0) 1483 424 310



Xechem India

Xechem (India) Pvt. Ltd.
B-3/17, Safdarjung Enclave
New Delhi 110029
INDIA Tel: 011-91-11-2-618-4293
Tel: 011-91-11-2-618-4294
Fax: 011-91-11-2-618-4295
Email: [email protected]

Sickle Cell Research, Efficacy, Awareness and Marketing Advisory Board

The Company established the Sickle Cell Research, Efficacy, Awareness and Marketing Advisory Board (the "Sickle Cell Advisory Board"), which consists of distinguished individuals from the fields of pharmaceutical sales and marketing, urban marketing, international consulting, professional networking, entertainment, academia and business to assist the Company's management in creating public awareness of its efforts to bring an effective treatment for Sickle Cell Disease to market in the United States and globally.  The following are the current members of the Sickle Cell Advisory Board:

Vincent A. Carter , MBA
Desiree V. Delgado
George C. Fraser, Ph.D.
Glenda Baskin Glover,
Ph.D., CPA, JD
Marcellus Grace, Ph.D..
Nadine B. Hack, MPA, MALS
J. Wayman Henry III
Wallye Inese Holloway
Stephen H. Kolison, Jr., Ph.D.
Kofi Lomotey, Ph.D.
Tamara New, M.D.
Dakota Pippins, MBA

For personal information on the board please visit the website:
http://www.xechem.com/aboutxechem.html

Company Drugs:
http://www.xechem.com/drugs.html

HEMOXIN™/NICOSAN™ (Sickle Cell Disease, SCD)

In July, 2002, Xechem acquired an exclusive, worldwide license to develop NICOSAN™ (HEMOXIN™ in the US) from the Nigerian government and, subsequently, received U.S. orphan drug status for HEMOXIN™ from the FDA in August, 2003. The product is made from four botanical species indigenous to Nigeria. NICOSAN™ is produced there today by Xechem. The Company expects to launch NICOSAN™ in Nigeria's 4,000,000 SCD patient market, the world's largest SCD market, in 2005.   SCD, a devastating hereditary blood disorder characterized by acute painful crisis, organ damage, anemia and early death, affects over 80,000 African Americans in the U.S. alone. Based on published data and human experience, the Company believes the successful clinical development of HEMOXIN™ represents an unusually low risk. In phase II human studies in Nigeria, published in Phytomedecine, HEMOXIN™ was shown to be safe in all patients and effective in approximately 80% of patients. As published in the May 2003 issue of the British Journal of Hematology, Asakura and colleagues from Children's Hospital of Philadelphia (CHOP) and the University of Pennsylvania demonstrated the anti-sickling effects of HEMOXIN™ in transgenic mice. This lends significant credibility to the Nigerian human experience to initiate clinical trials in the U.S.

PAXETOL™ Brand of Paclitaxel

Currently, our PAXETOL™ brand of paclitaxel for injection is being prepared for marketing, via strategic manufacturing, distribution, sales and alliances in Domestic and International markets

On June 3, 1996, Xechem announced the findings of a comparison study between TAXOL™ (a registered trademark of Bristol-Myers Squibb) and PAXETOL™ for antitumor activity in vitro and in vivo.


Proprietary Drugs

Our expertise in drug development started with our first project: the successful launch of vancomycin in a remarkably short time - within 3 and 1/2 years, from culture in the test tube through final active drug substance to the finished dosage form marketed with FDA approval. This occurred when Xechem was affiliated with the LyphoMed Pharmaceutical Company.

An emphasis is now on our PAXETOL™ brand of paclitaxel for treating refractory ovarian and breast cancer.


Generic Drugs

The generic drugs produced include:

Vancomycin
Paclitaxel (PAXETOL™)
Bleomycin

450 million shares Volume last 3 days...Something big is coming IMO... We now have 3 generic cancer drugs... Paclitaxel (PAXETOL™) alone could make this company...

When I had cancer I took Bleomycin, but I believe it wasn't the generic form... but the gemeric form will save healthcare so much money...and now we have rights to Paclitaxel (PAXETOL™)...that will cut into Bristol-Myers profits... I wouldn't be surprised to see a buyout in the works...GLTY

Quote from: oicpecnoc on February 27, 2006, 05:52:14 PM
I got my head handed to me today on this one, but did not sell.  Hopefully we gap and I can break even.  That is my hope.

XetaPharm (Xechem Nutraceutical Subsidiary)

Nutraceutical Products With Pharmaceutical Quality Standards

Over the past several years there has been a growing awareness of alternative medicines. This was recognized by the U.S. Federal government and an Office of Alternative Medicine was established within the National Institute of Health (NIH).

The Gold Leaf is our symbol for purity, quality and reliability.

Based upon the analytical and technological strengths of Xechem in the areas of natural products, our XetaPharm subsidiary, formed in 1996, is producing over the counter (OTC) natural products such as Melatonin, DHEA, GinsengOnce®, GinkgoOnce®, GarlicOnce®, Gugulon™, Co-Enzyme Q-10 and other life enhancing nutritionals from China, Mexico, South America, India and other places around the world.

The same exacting quality standards apply for botanicals, herbals and nutritional supplements as for pharmaceuticals. Products are standardized, with potency and purity verifiable by an outside independent laboratory. Products contain pharmaceutical grade-active ingredients (United States Pharmacopoeia [USP] grade when applicable). Finished products are tested for potency, purity, weight variation, disintegration, and dissolution as per USP.

To directly link to our separate XetaPharm website, click below to transfer:
www.XetaPharm.com