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XKEMQ.PK.

Started by evgeny05, October 04, 2005, 09:09:51 AM

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evgeny05

Hi ! ;D

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.

Forward Looking Statements

This press release contains certain forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended, which are intended to be covered by safe harbors created hereby. Such forward-looking statements involve known and unknown risks and uncertainties.








Good luck.
Evgeny.

mzhou1688

I am in @0.0146 today.
Will hold for long term.

evgeny05

Hi ! ;D



Good luck.
Evgeny.

sebfr

Great find..

Good perpective for long term...

poorman1

Here's the updated chart.  Going logrimithic, baby!  :D


sebfr

Investors are eagerly waiting to see what the future holds in store for Xechem International after witnessing a dramatic upsurge in share prices Wednesday. A gain of over 28%, in combination with an extraordinarily high share volume, surpassing 5.4 million, has many investors stopping to take a closer look at this biotech penny stock. Streetinvesting.com strives to bring true growth opportunities directly to its valued subscribers. Our strength lies in finding these undervalued and under-marketed companies and delivering our research in a timely manner. Streetinvesting.com will be tracking this company attentively for the subsequent weeks and keep interested investors and shareholders posted on any new findings and behind-the-scenes update. For a complimentary and comprehensive report on our current analysis and opinions, please visit www.streetinvesting.com for a free membership subscription.

Xechem Inc., a subsidiary of Xechem International, Inc. is primarily engaged in applying proprietary extraction, isolation, and purification technology towards the production and manufacturing of paclitaxel, AKA "Taxol," a registered trademark of Bristol-Myers Squibb Company. Paclitaxel is a revolutionary new anticancer compound used in the treatment of ovarian, breast, small cell lung cancers and AIDS related Kaposi sarcomas. Recently, Xechem has been successful in isolating pure paclitaxel, receiving a process patent on this technology. Xechem has submitted to the FDA a Drug Master File for the facility and the bulk paclitaxel product. Xechem has already been successful in the acquisition of five U.S. patents on paclitaxel, while its second generation analogs from the U.S. Patent and Trademark Office and over thirty-four international patents are currently pending.

In addition to their focus on the development and production of paclitaxel, Xechem is continuously applying its expertise to the research and development of other niche generic compounds. This is achieved through microbial fermentation or semi-synthesis and on the development of drugs from sources derived from Chinese, Indian and other traditional medicinal plants in the anticancer, anti-fungal, antiviral, including anti-AIDS, anti-inflammatory, anti-aging and memory enhancing areas. Many of these efforts are performed in collaboration with the National Cancer Institute and the National Institutes of Mental Health.

Xechem also has a subsidiary


gmarc66

2005-12-09 06:30:01 
Xechem Expands its Arsenal for Treating Sickle Cell Disease; Licenses New Anti-Sickling Agent from Virginia Commonwealth University (VCU) 


NEW BRUNSWICK, N.J.--(BUSINESS WIRE)--Dec. 9, 2005--
Xechem International, Inc. (OTC BB: XKEM) Xechem
International announced today that it has acquired the exclusive,
worldwide licensing rights to a new five-membered heterocyclic
anti-sickling compound from Virginia Commonwealth University (VCU),
Richmond, VA. Early research has shown this anti-sickling agent to be
a highly effective and relatively non-toxic treatment for Sickle Cell
Disease (SCD). The new compound further expands Xechem's existing
portfolio of products to be used in the fight against Sickle Cell
Disease.
Previously, Xechem International successfully acquired the
exclusive worldwide license from the National Institute for
Pharmaceutical Research and Development ("NIPRD"), Ministry of Health,
Government of Nigeria, for the manufacture, marketing and distribution
of NICOSAN(TM)/HEMOXIN(TM), an all natural, phyto-pharmaceutical
product that has also shown enormous promise for SCD. Both the United
States Food and Drug Administration (FDA) and the European Union's
regulatory body have already granted to Xechem "Orphan Drug" status
for NICOSAN(TM)/HEMOXIN(TM), and the Company is currently in the
process of preparing an Investigational New Drug (IND) Application for
submission to the FDA and applicable EU agencies.
According to Xechem's Chairman and CEO, Dr. Ramesh C. Pandey, "We
know of no existing non-toxic medicines available anywhere in the
world for the effective treatment of Sickle Cell Disease. Between our
existing product, NICOSAN(TM)/HEMOXIN(TM), a non-toxic product that
has shown excellent results in Phase IIA and Phase IIB clinical trials
in Nigeria, and this promising new heterocyclic pharmaceutical agent
being developed in collaboration with VCU, Xechem will be in a truly
unique position to offer viable and efficacious treatments to patients
suffering with this painful and debilitating condition."
Professor Don Abraham of VCU says that "the five membered
heterocyclic compound (5-HMF) is the best potential antisickling agent
in 30 years research to be discovered by our research group. 5-HMF not
only is a natural product with very little if any toxicity, it has a
high affinity for hemoglobin and was very active in genetically
modified mice as shown by our colleagues, Dr. Osheiza Abdulmalik and
Professor Toshio Asakura, the Director of the NHLBI Sickle Cell
Disease Reference Laboratory at The Children's Hospital of
Philadelphia (CHOP), University of Pennsylvania. A number of us,
especially my very close colleagues at VCU, Professors Martin Safo and
Gajanan Joshi, have spent most of our lives searching for a sickle
cell drug and we are hoping that this quest is finally achieved."
Sickle Cell Disease is a genetic blood disorder caused by an
abnormality in the hemoglobin molecule. Patients with this disease
often produce stiff, abnormally shaped cells that do not flow freely
through blood vessels, creating clogs in the vessels, which in turn
cut off the flow of normal hemoglobin and oxygen to the body. In
Nigeria alone, more than 25% of the population are carriers of the SCD
trait and over 4.5 million Nigerians (approximately 5% of the
population) are actually afflicted with the disease. Approximately 12
million people, mostly in sub-Saharan Africa, are believed to suffer
from this disease worldwide.



deadcenter

Looks really strong here!

poorman1

Very, very strong!  Highest volume since October.  Go XKEM.
A strong finish today could set us up for a gap on Monday.  I hope.

poorman1

gmarc66

Wonder if this news will raise the pps some since its been pulling back from its recent high of .029.  This morning bid is sitting at .0184 and ask is at .0191

2005-12-20 06:30:01 
Xechem Settles Antitrust Lawsuit Against Bristol-Meyers Squibb for $4.2 Million 


NEW BRUNSWICK, N.J.--(BUSINESS WIRE)--Dec. 20, 2005--
Xechem International, Inc. (OTC BB: XKEM) Xechem
International announced today that it has settled its antitrust
lawsuit against Bristol-Meyers Squibb Co. for $4.2 million. Court
files reveal that the case against Bristol-Meyers, which was brought
in federal district court in Chicago in 2003, was based on Xechem's
allegations that Bristol-Meyers had engaged in anticompetitive
practices relating to Xechem's efforts to manufacture and bring to
market the drug paclitaxel, a generic equivalent of Bristol's cancer
drug, TAXOL(R). Similar allegations against Bristol had previously
been raised in lawsuits brought by other generic drug companies which
settled out of court. Bristol-Meyers has not admitted to any
wrongdoing as part of the settlement. (For more information regarding
the settlement, please refer to the Company's Form 8-K of public
record.)

Settlement Proceeds Will Further Xechem's Efforts to Launch Sickle
Cell Drug

According to Dr. Ramesh C. Pandey, Xechem's chairman and CEO, the
timing of the settlement was as important to Xechem as the dollars
involved: "The settlement with Bristol-Meyers could not have come at a
better time for Xechem. As people who have been following our company
are aware, we have been working on the development of
NICOSAN(TM)/HEMOXIN(TM), a promising drug to be used in the treatment
of Sickle Cell Disease, a devastating disease that afflicts millions
of people worldwide, mostly in Africa, Greece, Turkey, Italy, the
Arabian Peninsula, India and Latin America, including South America,
Central America and parts of the Caribbean. We hope to bring
NICOSAN(TM) to the Nigerian market in early 2006, and at the same
time, embark on the clinical trials in the US hospitals for FDA
approval through a New Drug Application (NDA) for sale of the drug in
the United States. Xechem has already received Orphan Drug Designation
for NICOSAN(TM) from the US-FDA, which gives Xechem seven years of
marketing exclusivity in the USA. The money from the Bristol
settlement will go a long way to realizing the goal of bringing this
important drug to market." According to Dr. Pandey, the settlement,
which is still being documented, should be completed by year end and
the funds made available to Xechem shortly thereafter.



setravis

It just may.....
I think it is +25.00% in the pre-market
"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

Vipyr

Based on the charts on XKEM, it is poised to finish monday above a penny, as stong accumulation has been going on, as well as massive selling.  People got frightened when it dipped to 0066 on friday... But this one should finish monday above a penny, and over 2 pennies by valentines day.
If you are one of the ones who sold on friday, you will be kicking yourself by the end of the day monday... This one is going to be a nice run. Those whom are still in, enjoy the run coming.. it may run all week long.
In the morning, it may dip a tiny bit more, and then the massive buys will come, and KBOOM!!

joozt

pumping,

looks like raging bull overhere

8)

Wax

Agreed.... I am going in on this one myself today! Chart scan is popping up everywhere too.

joozt

why this big sell-off lately?