XKEM+OTC+mal anderst(der10te)

 

Grrrrrrrrrrrrrrrrrrrrrrrrrrrrrr  

WASHINGTON, Oct. 31 /PRNewswire/ -- Companies in Florida, Georgia and Illinois are exporting equipment and services to a Nigerian pharmaceutical firm to help it in the fight against sickle cell anemia.
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The exports by American Plastics Technologies, Inc., Schiller Park, Ill.; FinancialBridge, Inc., Miami, Fla.; Nitra Group, Aventura, Fla.; and Fischer Scientific Co. LLC, Suwanee, Ga., are being made possible by a $9.3 million loan guarantee from the Export-Import Bank of the United States (Ex-Im Bank). American Plastics Technologies and FinancialBridge both are small businesses.

Xechem Pharmaceuticals Nigeria Limited, Abuja, Nigeria will use the funds to build laboratories and a manufacturing plant in Abuja to develop a variety of herbal-based drugs to combat sickle cell anemia

Ex-Im Bank approved the medium-term loan guarantee under its new $300 million financing facility, allocated among 14 Nigerian banks, to support U.S. exports to Nigeria. The consolidated facility is designed to expedite the processing of short- and medium-term Ex-Im Bank financing for the purchase of U.S. goods and services by Nigerian buyers. This is the third transaction to be supported by the facility.

UPS Capital Business Credit of Hartford, Conn. is the guaranteed lender on the transaction. Two Nigerian banks included in the facility, Diamond Bank Ltd., and Access Bank Nigeria Plc., both of Lagos, are supporting the transaction by providing co-guarantees.

"This transaction will support the development of Nigeria's pharmaceutical infrastructure and at the same time create and sustain U.S. jobs at small and large businesses alike," said Ex-Im Bank Chairman and President James H. Lambright. "We look forward to the continued use of this financing facility to make possible exports to Nigeria that otherwise would not go forward, and to foster growth in Nigeria's banking sector and a wide range of Nigerian industries."

"In the past, European businesses have aggressively used government assisted financing to successfully compete against us, even though their prices are 40-50 percent higher than ours," said American Plastics CEO Dr. Rao K. Murukurthy. "Now with the help of Ex-Im Bank, we are reversing this trend and selling internationally. This project to build a pharmaceutical factory in Nigeria helps us to employ about 25 technicians and engineers for about eight months. It also helps several of our U.S. vendors to employ about 25 workers for six to eight months."

"Helping U.S. companies win global business is important to UPS Capital and in this transaction, four U.S. companies, including two U.S. small businesses, will be supported by the Export-Import Bank of the United States," said Jim Fortsch, head of ECA Finance at UPS Capital. "Since the funds provided by UPS Capital will be used to purchase plant equipment and machinery for a state-of-the art pharmaceutical facility, this project is especially rewarding."

Xechem, a wholly owned international subsidiary of Xechem International, Inc., New Brunswick, N.J., is building the pharmaceutical facilities under an agreement with Nigeria's National Institute for Pharmaceutical Research and Development and Nigeria's Ministry of Health.

U.S. exporters interested in learning more about Ex-Im Bank's Nigerian bank financing facility and how it can be used to support sales of U.S. goods and services to Nigeria may contact the nearest Ex-Im Bank regional office by calling 1-800-565-3946 and selecting option 2. Visit Ex-Im Bank's web site at http://www.exim.gov.

Ex-Im Bank this year marks its 72nd year of helping finance the sale of U.S. exports, primarily to emerging markets throughout the world. The Bank works with commercial lenders to help U.S. companies increase export sales and American jobs and minimize risk by accessing Ex-Im Bank financing and export credit insurance.  

 

Researchers Develop Novel Method for Treatment of Sickle Cell Disease

Newswise — Virginia Commonwealth University researchers have developed a unique anti-sickling agent that may one day be effective in treating sickle cell disease, a painful and debilitating genetic blood disorder that affects approximately 80,000 Americans.

The research team led by Donald Abraham, Ph.D., of Biological and Medicinal Chemistry, in the Department of Medicinal Chemistry in VCU’s School of Pharmacy, has shown that 5-HMF, a pure compound developed by the team, has a high affinity for sickle cell hemoglobin and holds promise for the treatment of sickle cell disease.

“Our findings suggest that this anti-sickling agent may lead to new drug treatments and may one day help those suffering with sickle cell disease. This molecule, 5-HMF, is the most promising molecule to treat sickle cell anemia to come from our research group in more than 30 years,” said Abraham, who is also the director of the Institute of Structural Biology and Drug Discovery.

The United States Patent and Trademark Office recently issued VCU a Notice of Allowance for a patent relating to a method of treating sickle cell disease with 5-HMF compound. A Notice of Allowance is a written notification that a patent application has cleared an internal review and it has been approved for issuance.

Sickle cell disease is caused by an abnormality in the hemoglobin molecule. Normal red blood cells carrying hemoglobin are smooth, round and flexible and can travel easily throughout blood vessels. However, sickle cells are stiff, abnormally shaped, red blood cells that do not flow freely through blood vessels. The sickle cells also may clot together causing a blockage to form which results in pain and potentially dangerous complications that can compromise a patient’s organs.

According to Abraham, the 5-membered, heterocyclic, anti-sickling agent binds to hemoglobin to increase the oxygen affinity of both normal and sickle hemoglobin. In a patient with sickle cell disease, the binding action of 5-HMF would allow sickle cells to move more smoothly throughout the blood vessels of the body and prevent blockages from forming.

Abraham is internationally known for his groundbreaking work discovering and developing drugs that interact with hemoglobin. His research focus is to develop targeted therapeutics in sickle cell anemia, cardiovascular disease, stroke, cancer, Alzheimer’s disease and radiation oncology.

This research was supported in part by a grant from the National Institutes of Health.

Xechem International, Inc., a biopharmaceutical company headquartered in New Brunswick, N.J., has entered into a licensing agreement with VCU Technology Transfer and has the exclusive worldwide rights for the production, sales and marketing of 5-HMF for use to fight sickle cell disease.

A recent grant from the National Heart, Lung and Blood Institute, part of the National Institutes of Health, awarded to Xechem International Inc., will allow researchers to carry out toxicity studies on 5-HMF. The research team will include researchers from VCU and Children’s Hospital of Philadelphia, University of Philadelphia.

Working with Abraham to develop the anti-sickling agent were: Martin K. Safo, Ph.D., Richmond Danso-Danquah, Ph.D., and Gajanan S. Joshi, Ph.D., all researchers in the VCU Department of Medicinal Chemistry.

About VCU and the VCU Medical Center: Virginia Commonwealth University is the largest university in Virginia and ranks among the top 100 universities in the country in sponsored research. Located on two downtown campuses in Richmond, VCU enrolls more than 30,000 students in nearly 200 certificate and degree programs in the arts, sciences and humanities. Sixty-three of the programs are unique in Virginia, many of them crossing the disciplines of VCU’s 15 schools and one college. MCV Hospitals and the health sciences schools of Virginia Commonwealth University compose the VCU Medical Center, one of the nation’s leading academic medical centers. For more, see http://www.vcu.edu.

About Xechem: Xechem International is a development stage biopharmaceutical company working on Sickle Cell Disease (SCD), antimalarials, and antiviral (including AIDS), anticancer, antifungal and antibacterial products from natural sources, including microbial and marine organisms. Its focus is on the development of phyto-pharmaceuticals (Natural Herbal Drugs) and other proprietary technologies, including those used in the treatment of orphan diseases. Xechem’s mission is to bring relief to the millions of people who suffer from these diseases. Its recent focus and resources have been directed primarily toward the development and launch of NICOSAN™ (named HEMOXIN™ in the US and Europe) for the prophylactic management of Sickle Cell Disease (SCD). With the recent Nigerian regulatory approval of NICOSAN™, Xechem is now scaling-up the commercialization of the drug in Nigeria and making preparations for the pursuit of US FDA and European regulatory approval.

 

http://www.newswise.com/articles/view/525035/

 

 

14-Nov-2006

Quarterly Report

Item 2. Management's Discussion and Analysis.

THE FOLLOWING DISCUSSION OF THE RESULTS OF OPERATIONS AND FINANCIAL CONDITION SHOULD BE READ IN CONJUNCTION WITH OUR CONSOLIDATED FINANCIAL STATEMENTS AND THE NOTES THERETO INCLUDED ELSEWHERE IN THIS REPORT.

Overview

Xechem International, Inc., a Delaware corporation, is the holder of all of the capital stock of Xechem, Inc., a development stage biopharmaceutical company engaged in the research, development, and production of niche generic and proprietary drugs from natural sources. Xechem, Inc. was formed in March 1990 to acquire substantially all of the assets of a subsidiary of LyphoMed, Inc. (later known as Fujisawa/LyphoMed, Inc.), a publicly traded company. Xechem Laboratories (formed in 1993), XetaPharm, Inc. (formed in 1996), Xechem (India) Pvt. Ltd. (acquired in 1996), and Xechem UK, Ltd. (formed in 2005) are our subsidiaries. Xechem Pharmaceutical China Ltd., (formed in 2000) is an inactive affiliate. Xechem Pharmaceuticals Nigeria Limited (formed in 2002) is currently owned 100% by us. Xechem's principal product under development is NICOSAN(TM)/HEMOXIN(TM) which has shown efficacy in the treatment of Sickle Cell Disease. The development and production of NICOSAN(TM)/HEMOXIN(TM) is being conducted through Xechem Nigeria. In July 2006, Xechem Nigeria received approval by the National Agency for Food and Drug Administration and Control (NAFDAC), which is Nigeria's drug regulatory agency, for the limited marketing and sale of NICOSAN(TM) in Nigeria, on a limited term basis. The approval was for an initial term of two years, during which time, the Company will work towards completing confirmatory Phase III clinical trials in Nigeria.

We are in the process of expanding our production facility in Nigeria for our Sickle Cell drug, NICOSAN(TM), and preparing for the clinical testing and trials of HEMOXIN(TM) in the United States. We anticipate that expenses will increase, with the expansion of our operations and marketing efforts, as described more fully herein. Our planned activities will require the addition of new personnel, including management, and the development of additional expertise in areas such as preclinical testing, clinical trial management, regulatory affairs, manufacturing and marketing. In order to pursue these activities, we must obtain additional financing, whether in the form of loans or equity infusions. There can be no certainty that we will be able to obtain the financing in the amounts or at the times required.

Results of Operations

The Nine months Ended September 30, 2006 vs. The Nine months Ended September 30, 2005

The following table sets forth certain statement of operations data for the cumulative period from inception (March 15, 1990) to September 30, 2006 and for each of the nine months ended September 30, 2006 and September 30, 2005.

1.         Cumulative
                                                                      Inception
                                              Nine months Ended          to
                                                September 30,       September 30,
                                              2006        2005           2006
                                            --------    --------    -------------
                                                (in thousands)
   Revenue                                  $     81    $      4    $       2,202
   Research and Development Expense         $  1,596    $    665    $      16,248
   General and Administrative Expenses      $  3,608    $  2,240    $      27,860
   Writedown of Inventory And Intangibles   $     --    $     --    $       1,861
   Loss from Operations                     $ (5,123)   $ (2,901)   $     (43,767)
   Other Income (Expense)                   $ (1,451)   $ (3,231)   $     (36,723)
   Net Loss before Income Taxes             $ (6,574)   $ (6,132)   $     (80,490)
   Income Tax Benefit                       $     --    $     --    $       2,636
   Net Loss before Income Taxes             $ (6,574)   $ (6,132)   $     (77,854)
   
   

Revenue

Xechem Nigeria received limited duration approval on July 3, 2006 from Nigeria's drug regulatory authority, the National Agency for Food and Drug Administration and Control (NAFDAC), for the marketing and sale of NICOSAN(TM), for the prophylactic management of Sickle Cell Disease (SCD). The approval is for an initial term of two years, during which time, the Company will work towards completing confirmatory Phase III clinical trials in Nigeria. During the two year term, the company faces no restrictions on its ability to market and sell the drug in Nigeria. However, currently Xechem Nigeria can produce the product only in limited quantities at its pilot-scale facility in Abuja, Nigeria.

We had revenues of $81,000 for the nine months ended September 30, 2006 as compared to $4,000 for the nine months ended September 30, 2005. This represents $78,000 from the sales of NICOSAN(TM) by our subsidiary Xechem Nigeria and $3,000 from the product sales by our subsidiary Xetapharm, Inc for the nine months ended September 30, 2006 as compared to $4,000 from the product sales by our subsidiary Xetapharm, Inc. for the nine months ended September 30, 2005.

Research and Development

Our research and development expenditures have been directed primarily toward the development of our new Sickle Cell treatment drug NICOSAN(TM)/HEMOXIN(TM), which is being developed by our wholly-owned subsidiary, Xechem Nigeria. Our research and development expenditures are also made in conjunction with the development of compounds to make niche generic anticancer, antiviral and antibiotic products that enjoy significant market demand but are no longer subject to patent protection.

In the nine months ended September 30, 2006, our research and development expenditures increased by $931,000 to $1,596,000. In the nine months ended September 30, 2006, our costs associated with the development of our Sickle Cell Disease drug NICOSAN(TM) totaled $1,260,000, an increase of $968,000, as compared to the same period for 2005. Other major expenses for the nine months ended September 30, 2006 were: (a) salaries and wages of our research personnel which were approximately $169,000 for the nine months ended September 30, 2006, as compared to approximately $178,000 for the nine months ended September 30, 2005; (b) repairs and maintenance was $49,000 for the nine months ended September 30, 2006 as compared to $58,000 for the nine months ended September 30, 2005; (c) purchase discount was $0 for the nine months ended September 30, 2006 as compared to $16,000 for the nine months ended September 30, 2005; (d) professional development was $0 for the nine months ended September 30, 2006 as compared to $5,000 for the nine months ended September 30, 2005; (e) depreciation expense was $107,000 for the nine months ended September 30, 2006 as compared to $125,000 for the nine months ended September 30, 2005; (f) consulting fees decreased $8,000 from $10,000 for the nine months ended September 30, 2006 to $2,000 for the nine months ended September 30, 2006; and
(g) other fees decreased $4,000 from $13,000 for the nine months ended September 30, 2005 to $9,000 for the nine months ended September 30, 2006.

We anticipate expenses to increase with the expansion of our production facility in Nigeria for our Sickle Cell drug, NICOSAN(TM), and the clinical testing and trials of HEMOXIN(TM) in the United States. In order to pursue these activities, we must obtain additional financing. There can be no certainty that we will be able to obtain the financing in the amounts or at the times required.

General and Administrative

General and administrative expenses increased by $1,368,000 or 61% to $3,608,000 for the nine months ended September 30, 2006 as compared to the nine months ended September 30, 2005. The increase was primarily due to legal costs of approximately $1,485,000 paid as part of the Xechem, Inc. and Xechem International, Inc. vs. Bristol-Myers Squibb Company, 03 C 1920 lawsuit settlement. In return for Xechem's full release of all claims that were or could have been asserted against BMS in connection with the case, BMS agreed to pay us $4,200,000 and further agreed to release us from all claims BMS could have asserted against us in the case. Legal fees and costs totaled approximately $1,485,000.

The other major expenses for the nine months ended September 30, 2006 were: (a) salaries and wages of approximately $829,000 an increase of approximately $132,000 or 19% as compared to 2005; (b) consulting fees which decreased to $89,000 for the nine months ended September 30, 2006 as compared to $245,000 for the nine months ended September 30, 2005; (c) rent expense increased $10,000 from $134,000 for the nine months ended September 30, 2005 to $144,000 for the nine months ended September 30, 2006; (d) legal fees totaled $315,000 in 2006, as compared to $307,000 in 2005, an increase of $8,000; (e) directors and officers insurance decreased $11,000 from $87,000 for the nine months ended September 30, 2005 to $76,000 for the nine months ended September 30, 2006; (f) medical and property insurance decreased $33,000 from $131,000 for the nine months ended September 30, 2005 to $98,000 for the nine months ended September 30, 2006 ; (g) advertising expense increased approximately $28,000 from $11,000 for 2005 as compared to $39,000 in 2006; (h) private placement cost totaled $0 in 2006, as compared to $177,000 in 2005; (i) accounting fees increased approximately $70,000 from $28,000 in 2005 to $98,000 in 2006; (j) travel expenses increased approximately $14,000 from $143,000 in 2005 to $158,000 in 2006; (k) professional services decreased $13,000 from $37,000 in 2005 to $24,000 in 2006; and (l) other expenses increased $7,000 from $242,000 for the nine months ended September 30, 2005 to $249,000 for the nine months ended September 30, 2006.

Interest expense for non-related parties equaled approximately $5,566,000 for the nine months ended September 30, 2006, an increase of approximately $3,925,000 as compared to the nine months ended September 30, 2005. The increase in expense was the result of additional debt incurred in 2005 and 2006 and approximately $4,128,000 was non-cash in nature due to borrowings evidenced by debentures and notes and the beneficial conversion feature of said debentures. Interest expense for related parties was approximately $90,000 for the nine months ended September 30, 2006 as compared to $67,000 for the nine months ended September 30, 2005 due to increased indebtedness. For the nine months ended September 30, 2006, we had $4,205,000 of other income, as compared of $166,000 of other expense for the nine months ended September 30, 2005, which was a result of Xechem, Inc. and Xechem International, Inc. vs. Bristol-Myers Squibb Company, 03 C 1920 lawsuit settlement. In return for Xechem's full release of all claims that were or could have been asserted against BMS in connection with the case, BMS agreed to pay us $4,200,000 and further agreed to release us from all claims BMS could have asserted against us in the case.

We anticipate expenses to increase for the remainder 2006 with the expansion of our production facility in Nigeria for our Sickle Cell drug, NICOSAN(TM), and the commencement of clinical testing and trials of HEMOXIN(TM) in the United States. We anticipate that general and administrative expenses will increase, with the expansion of our operations and marketing efforts. Our planned activities will require the addition of new personnel, including management, and the development of additional expertise in areas such as preclinical testing, clinical trial management, regulatory affairs, manufacturing and marketing. The exact number and nature of persons hired and our expenses for such persons will depend on many factors, including the capabilities of those persons who seek employment with us and the availability of additional funding to finance these efforts.

We are in the process of expanding our production facility in Nigeria for our Sickle Cell drug, NICOSAN(TM), and preparing for the clinical testing and trials of HEMOXIN(TM) in the United States.

We expect to incur continued costs related to the expansion of our production facility in Nigeria for our Sickle Cell drug, NICOSAN(TM), and the clinical testing and trials of our new drug HEMOXIN(TM) in the United States. In order to pursue these activities, we must obtain additional financing. There can be no certainty that we will be able to obtain the financing in the amounts or at the times required.

Liquidity and Capital Resources; Plan of Operations

On September 30, 2006, we had cash and cash equivalents of $274,000, negative working capital of $5,572,000 and stockholders' deficit of $77,854,000.

As a result of our net losses through December 31, 2005 and accumulated deficit since inception, our accountants, in their report on our financial statements for the year ended December 31, 2005, included an explanatory paragraph indicating there is substantial doubt about our ability to continue as a going concern. This condition has not changed as of September 30, 2006. With respect to NICOSAN(TM)/HEMOXIN(TM), the Company commenced the commercial launch of the drug in Nigeria on a limited basis in the third quarter 2006 and is planning to begin pursuit of the pre-clinical and clinical trials in the United States as required for Food and Drug Administration (FDA) approval. These planned activities are entirely dependent on financings. There can be no assurances that the required funding will be obtained or that the Company will succeed in its efforts to launch the drug in Nigeria or the United States.

In order to meet these cash needs, we have entered into the following recent financing agreements:

(1) On December 13, 2005, we entered into an agreement in principle concerning the settlement of the Xechem, Inc. and Xechem International, Inc. vs. Bristol-Myers Squibb Company, 03 C 1920 lawsuit.

In return for Xechem's full release of all claims that were or could have been asserted against BMS in connection with the case, BMS agreed to pay us $4,200,000 and further agreed to release us from all claims BMS could have asserted against us in the case. Each party agreed to bear their own costs, fees and expenses. Further, BMS agreed to waive the $29,599 fee award granted by the Court on September 7, 2005. BMS made the settlement payment to us in January 2006.

After payment of legal fees, costs, interest due on prior financings and prorations, we received approximately $1,700,000 from this settlement.

(2) The various agreements with Alembic Limited were restructured in December 2005 (See Note 7D). In accordance with the terms of the restructured loan, in January 2006, from the proceeds from the BMS settlement, $1,000,000 of principal and $190,700 of accrued interest was paid to Alembic. The remaining principal balance of $2,000,000 due on the Alembic Promissory Note, together with unpaid interest and certain other fees, is due and payable December 31, 2006.

(3A) On May 31, 2006, Nigeria Export-Import Bank (NEXIM) funded a direct loan to our wholly-owned subsidiary, Xechem Pharmaceuticals Nigeria, Ltd. (Xechem Nigeria).

The loan is in the principal amount of 150,000,000 Naira or approximately One Million Two Hundred Thousand Dollars (US) ($1,200,000). The loan proceeds are being used primarily to facilitate the full-scale commercial production of NICOSAN(TM) through the expansion and integration of existing production facilities at the company's research and production facilities at Sheda Science and Technology Complex, Gwagwalada-Abuja. The loan facility will extend for a period of up to three years, with no principal payments due during the first year. The loan facility bears interest at the rate of 15% per year, payable during the first year in installments in November 2006 and May 2007. Thereafter, the loan facility is to be repaid through four consecutive semi-annual installments of principal and interest with the first repayment (of approximately $400,000 US) occurring on November 29, 2007. The loan facility is secured by: (a) an all assets debenture on the assets of the company which has been incorporated into a trust for all lenders to be managed by Diamond Trustees Company; (b) personal guaranty issued by the CEO, Dr. Ramesh Pandey, backed by a notarized statement of net worth; and (c) promissory notes.

Xechem Nigeria is obligated to pay the following fees: (a) a facility fee of 1% flat on the facility amount or 1,500,000 Naira (approximately $12,500 US); (b) a management fee of 0.5% flat on the principal amount outstanding from time to time, payable annually on the anniversary of the facility; and (c) a monitoring fee of 100,000 Naira (approximately $800 US), payable annually on the anniversary of the facility. Nexim reserves the right to vary the rates as dictated by market realities. Nexim is also entitled to name a director to the Xechem Nigeria board of directors pending the repayment of the facility, but currently has not done so.

(3B) We have been in extended negotiations with UPS Capital Business Credit ("UPS Capital") to obtain financing to cover the cost of acquiring the plant equipment and machinery needed to establish a commercial scale production facility in Nigeria under the U.S. Ex-Im ("Ex-Im") Bank Loan Guarantee Program. Based on the estimated cost of the project, as well as the criteria utilized under Ex-Im's guidelines, the Ex-Im statutory fees, etc., the total amount sought by our subsidiary, Xechem Nigeria from UPS Capital is $9.38 million. In March 2006, we paid a $50,000 non-refundable good faith deposit to UPS Capital. In November 2006, we paid a second non-refundable fees of $190,725 to UPS Capital.

On October 17, 2006, we received notification from UPS Capital that Ex-Im has approved a comprehensive credit guarantee to support UPS Capital's $9.38 million loan to Xechem Nigeria, and that UPS has approved Xechem Nigeria for a $9.38 million credit facility subject to receiving the necessary final commitments from Access Bank and Diamond Bank and on the following principal terms:

(i) Proceeds to be used to fund up to 85% of Xechem Nigeria's cost (i.e, $8,538,542) of the US manufactured equipment and machinery needed for the establishment of a commercial scale pharmaceutical plant in Nigeria, plus certain local costs, fees, etc., for a total credit facility of $9,388,981;

(ii) Principal plus interest at a rate of LIBOR + 2.75% repayable semi-annually in arrears over five years;

(iii) Loan to be supported by a 100% Ex-Im guarantee, which has been approved, together with local bank guarantees from two Nigerian banks, Access Bank, Plc, and Diamond Bank, Plc., which have not yet been obtained;

(iv) Part of UPS Capital loan will be used to cover 100% of the cost of Ex-Im Statutory Exposure Fee of $850,439; and

(v) Total up-front fees payable to UPS Capital are $240,795 of which $50,000 good faith deposit was paid in March 2006. The balance of $190,795 was funded in November 2006.

Upon receipt by UPS Capital of the final commitments from Access Bank and Diamond Bank, the loan documents will be finalized and the proceeds released in accordance with the terms of the loan. Both local Nigerian banks have issued letters of intent to provide the required guarantees, and Xechem Nigeria is in the midst of negotiations regarding the final terms of local Nigerian bank commitments regarding the guarantees. Though there is no certainty that Diamond Bank and Access Bank will issue the final guarantees required to complete the UPS loan. If for any reason such guarantees do not materialize, we will immediately turn to identifying a suitable alternative Nigerian bank or banks to provide the required guarantee(s), though there can be no assurance we would be successful in doing so. If for any reason the UPS loan does not close, including because of the failure to procure the required local bank guarantee(s), and in the absence of alternative capitalization, including possible additional local financing from Nexim Bank in Nigeria, we have not identified alternative sources to fully fund the Nigerian Pharmaceutical Project or our ongoing operations.

If and when the UPS loan closes, there will be additional expenses associated with the completion of the Nigerian facility and start-up of production. We are hopeful that these additional monies will be obtained from potential local financing in Nigeria (debt, equity and/or possible prepayment for product or other product sales) and/or from potential domestic funding sources, although no commitments have been obtained for such funding. In the event all of such financing can be obtained, we have the further risk that cost overruns and/or delays in bringing the product to market could adversely impact execution of our business plan.

(4) In the nine months ended September 30, 2006, holders of Xechem debt converted Xechem debt (in the form of principal and interest) in the aggregate amount of $3,976,000 ($3,761,000 of which is principal and $215,000 of which is interest) into 921,877,000 shares of Xechem's common stock (exercised at conversion rates between $0.0025 - $0.0075 per share). The total conversions in the nine months ended September 30, 2006 represented approximately 66% of Xechem's issued and outstanding stock as of September 30, 2006.

(5) Over the period from February 22, 2006 through May 10, 2006, Marjorie Chassman ("Chassman") infused $780,000 into Xechem. The note will be issued to Chassman in the amount of $780,000, it will bear interest at 8% and is due May 31, 2008. The note is convertible into shares of common stock at $0.005 per share (approximately 156,000,000 shares, excluding interest, which is also convertible into stock at $0.005 per share). The loan has not been documented at this time.

Over the period from June 2, 2006 through June 5, 2006, Chassman infused $200,000 into Xechem. The note will be issued to Chassman in the amount of $200,000, it will bear interest at 8% and is due May 31, 2008. The note is convertible into shares of common stock at $0.01 per share (20,000,000 shares, excluding interest, which is also convertible into stock at $0.01 per share). The loan has not been documented at this time.

Chassman agreed to loan $1,025,000 to Xechem, in two tranches, one in the amount of $500,000 and the other in the amount of $525,000, which were received by June 20, 2006. The note is convertible into shares of common stock at $0.015 per share (approximately 66,666,667 shares, excluding interest). The note bears interest at 8% and is due May 31, 2008. As additional consideration for infusion of the capital, Xechem will issue Chassman 66,666,667 warrants, exercisable at $0.02 per share for a period of 5 years. In addition, Chassman has agreed to extend the due date on all existing notes held by the company to May 31, 2008. The loan has not been documented at this time.

Over the period from August 14, 2006 through September 26, 2006, Chassman infused $300,000 into Xechem. A note will be issued to Chassman in the amount of $300,000, it will bear interest at 8% and is due May 31, 2008. The note will be convertible into shares of common stock at $.03 per share (10,000,000 shares, excluding interest), the loan has not been documented at this time.

(6) In the second quarter 2005, four loans totaling $157,200 and one loan totaling $30,000 were made to the Company by related parties and one unrelated party, respectively. The notes issued for these loans are convertible into shares of common stock at $0.0103 - $0.0125 per share (28,990,093 shares, excluding interest). The terms of these notes range from one month to one year with extensions and interest rates of 10-12%. The individuals also received five year stock options to purchase a total of 14,800,000 shares of common stock at market prices ranging from $0.0103 to $0.0125 per share.

(7) Xechem Nigeria received limited duration approval on July 3, 2006 from Nigeria's drug regulatory authority, the National Agency for Food and Drug Administration and Control (NAFDAC), for the marketing and sale of NICOSAN(TM), for the prophylactic management of Sickle Cell Disease (SCD). The approval is for an initial term of two years, during which time, the Company will work towards completing confirmatory Phase III clinical trials in Nigeria. During the two year term, the company faces no restrictions on its ability to market and sell the drug in Nigeria. Initially it is not anticipated that revenues will be significant but are expected to help in covering a portion of the costs of the operation.

(8) On October 24, 2006, Xechem International, Inc. reached an agreement with Marjorie Chassman ("Chassman") regarding a bridge loan financing, whereby Chassman agreed to loan $500,000 to Xechem, which amount has now been fully funded. The note has been negotiated to convert into shares of our common stock at $0.03 per share (approximately 16,666,667 shares, excluding interest). The note bears interest at 8% and is due May 31, 2008. Xechem may prepay the note any time within six months of receipt of the $500,000 during which six month prepayment period, Chassman agrees not to convert the note. As additional consideration for infusion of the capital and if Xechem does not repay the loan within six months of receipt of the full $500,000, Xechem will issue Chassman an additional 8,333,333 warrants, exercisable at $0.04 per share for a period of 5 years. In addition, Chassman has agreed to extend the due date on all existing notes held by the Company to May 31, 2008. The loan has not been documented at this time.

We expect to continue our development efforts with respect to antifungal, anticancer, antiviral (including anti-AIDS) and anti-inflammatory compounds, as well as anti-aging and memory enhancing compounds. Although we do not expect product revenues from these sources in 2006, we anticipate that these development activities may allow us to enter into more favorable licensing and/or investment arrangements.

We plan to secure financing through various loans and bridge financings, which we feel will meet our current needs, provided the funding of such loans is fully adhered to. We will need to generate funds from operations and/or debt and equity funding sources to enable us to repay such loans and our other outstanding debt.

We are attempting to raise outside financing through the issuance of debt or equity securities or other instruments, although no agreements are currently in place.

In addition, we have issued, and plan to continue issuing equity securities, where possible, to obtain services, without expending cash.

In prior years, we received cash from the sale of our New Jersey net operating losses ("NOLs"), under a program sponsored by the State of New Jersey, which ranged from $300,000 to $500,000 annually. Under new guidelines adopted by the State of New Jersey, Xechem fails to qualify in 2006 for the sale of NOL's because fewer than 75% of our employees, including subsidiaries, are based in New Jersey

Our planned activities will require the addition of new personnel, including management, and the continued development of expertise in areas such as preclinical testing, clinical trial management, regulatory affairs, manufacturing and marketing. Further, if we receive regulatory approval for any of our products in the United States or elsewhere, we will incur substantial expenditures to develop manufacturing, sales and marketing capabilities and/or subcontract or joint venture these activities with others. There can be no . . .

 

 

 

http://biz.yahoo.com/e/070206/xkem.ob8-k.html


müsste doch in den nächsten Wochen richtig losgehen ..............  

 

Ich schau schon Mal gelegentlich auf der Site rein, bis Heute war der Link nicht veröffentlicht,  

http://www.neximbank.com.ng/...o%20support%20Sickel%20Cell%20Drug.htm  

 

Sichelzellenanämie, Sichelzellenkrankheiten, Sichelzellenblutarmut
Definition
                    §
Die Sichelzellenkrankheit, die auch als Sichelzellenanämie bezeichnet wird, ist eine vererbbare Blutkrankheit. Sie ist die auf der Welt am häufigsten vorkommende Hämoglobinopathie, das heißt eine genetisch bedingte Strukturveränderung des Hämoglobinmoleküls. Sie ist der Gruppe der Hämoglobinanomalien zuzuordnen.
Hämoglobin (HB) wird auch als roter Blutfarbstoff bezeichnet und kommt ausschließlich in den roten Blutkörperchen (Erythrozyten) vor. Hämoglobin ist ein so genanntes Chromoprotein, dass zu 94 Prozent aus Globin (einem Eiweiß) und zu 6% aus der eisenhaltigen Gruppe Häm besteht. Hämoglobin wird in den Erythroblasten gebildet, das heißt in kernhaltigen Zellen, die sich durch Teilung und Reifung zu fertigen Erythrozyten (roten Blutkörperchen) entwickeln. Das fertige Hämoglobinmolekül enthält normalerweise insgesamt vier Eiweißketten (Alpha-, Beta-, Gamma- und Deltaketten) mit je einem Häm.
Die Strukturveränderungen des Hämoglobinmoleküls verändern die Form der Erythrozyten; sie nehmen eine gestreckte (sichelartige) Form an. Daher auch der Name Sichelzellenkrankheit.
Das Sichelzellen-Gen wird durch Vererbung an nachfolgende Generationen weitergegeben. Dabei werden zwei Formen der Vererbung in den nachfolgenden Generationen festgestellt: es gibt den heterozygoten Träger ("sickle-cell trait") des Sichelzellen-Gens und den homozygoten Träger des Sichelzellen-Gens. Der Letztere ist von besonderer Bedeutung, da hier das Krankheitsbild entsprechend geprägt ist.
Die Sichelzellenkrankheit (Sichelzellenanämie) kommt fast ausschließlich bei dunkelhäutigen Menschen (oder Mischlingen) in Afrika, Amerika, Arabien, Indien, Vorderasien und im Kaukasus vor. Aufgrund von Einwanderern oder Flüchtlingen aus den betroffenen Regionen ist die Sichelzellenkrankheit heute auch in Deutschland von Bedeutung. Die Erkrankung beginnt meist im Kindesalter, kann aber auch in allen anderen Lebensjahrzehnten auftreten.
20 – 40 Prozent der Bevölkerung im tropischen Afrika und 5 – 10 Prozent der schwarzen Bevölkerung Amerikas sind heterozygote Anlagenträger. Im Rahmen der Sichelzellenanämie erlangen die heterozygoten Patienten eine Resistenz gegen die Krankheit Malaria, die gerade in den Tropen häufig vorkommt.
Die Symptome des Krankheitsbildes treten in ähnlicher Form auch bei anderen Arten einer Anämie auf, welche im Rahmen einer gesicherten Diagnostik ausgeschlossen werden müssen. Hier ist insbesondere eine erworbene hämolytische Anämie zu berücksichtigen.
          
Ursachen§
                    §
Die Ursache der Sichelzellenkrankheit ist eine Strukturanomalie des Hämoglobinmoleküls, deren Veranlagung an nachfolgende Generationen weitervererbt wird. Dabei befindet sich eine einzelne Veränderung (Punktmutation) auf Chromosom 11. Das hat zur Folge, dass in der Beta-Kette des Hämoglobins eine Aminosäure durch eine andere ersetzt wird.
          
Symptome§
                    §
Die Symptomatik ist davon abhängig, welche Form der Sichelzellenkrankheit vorliegt. Die heterozygote Form verläuft in den meisten Fällen ohne jegliche Symptomatik und bedarf in der Regel keiner speziellen Therapie. Bei einem homozygoten Träger der Sichelzellenkrankheit sind die typischen Merkmale einer Anämie (Verminderung des Anteils der Erythrozyten, das heißt der roten Blutkörperchen, der Hämoglobinkonzentration oder des Hämatokrits in der gesamten Blutmenge) schon im Säuglingsalter vorhanden. Die Hautfarbe ist fahl-blass. Dies ist am deutlichsten an den Schleimhäuten und den Handinnenflächen sichtbar. Die körperliche und geistige Leistungsfähigkeit ist reduziert. Oftmals besteht eine Neigung zu Schwindelanfällen und Kopfschmerzen. Bei Belastung treten Atembeschwerden auf und die Anzahl der Atemzüge und Pulsschläge nimmt zu. Es besteht Schlaflosigkeit. Neben den Kennzeichen der Anämie ist eine Vergrößerung der Milz und der Leber (Hepatosplenomegalie) vorhanden. Aufgrund der veränderten Form der Erythrozyten werden die Kapillaren, das heißt die kleinsten Blutgefäße, verstopft. Dies führt zur Infarktbildung in verschiedenen Organen, mit der Folge von Organschäden in Form von Gewebeuntergang. Betroffen davon sind vor allem die Leber, die Lunge, die Milz, die Knochen, die Nieren, die Netzhaut des Auges und das Zentralnervensystem.
Durch die Schädigung der Knochen bestehen Knochen- und Gelenkschmerzen. Schäden der Niere führen zu Blutbeimengungen im Urin und einer eingeschränkten, sich immer mehr verschlechternden Funktion, was auch als Niereninsuffizienz bezeichnet wird. In diesem Stadium hat die Niere ihre Entgiftungsfunktion nahezu eingestellt. Folglich kommt es zur Harnvergiftung des Körpers; es werden lebenserhaltende Maßnahmen notwendig. Das Herz ist vergrößert. Es bestehen Geschwüre im Bereich des Unterschenkels (Ulkus curis), die sich bei einem Großteil der Betroffenen erstmals zwischen dem 13. bis 15. Lebensjahr zeigen. Beginnt die Erkrankung im Kindesalter, ist die körperliche Entwicklung verzögert.
Typisch für den Verlauf dieser Erkrankung ist das Auftreten von so genannten hämolytischen Krisen, das heißt einem plötzlichen Absinken der Menge der roten Blutkörperchen, die einhergeht mit einer hell- bis dunkelgelben Verfärbung der Haut und Fieber. Typischerweise treten bei solchen Krisen Thrombosen in verschiedenen Organen auf. Besonders betroffen sind dabei die Organe des Bauchraumes und die Gelenke. Aufgrund von Thrombosen im Gehirn kann es zu neurologischen Störungen kommen.
Ein weiteres typisches Kennzeichen dieser Erkrankung sind Schmerzkrisen. Diese treten nach Anstrengungen oder Infekten auf und sind für die Betroffenen sehr belastend. Sie sind gekennzeichnet durch Fieber und mehrere Tage dauernde, starke Schmerzen in den Gelenken, Knochen, dem Rücken und dem Bauchraum.
          
Diagnostik§
                    §
Am Anfang der Diagnostik steht das ausführliche Anamnesegespräch, das Fragen nach einer Beschwerdesymptomatik, nach Schwächeerscheinungen, häufigen Infekten, Erkrankungen in der Familie etc. behandelt. Im Anschluss daran werden die Patienten körperlich untersucht. Besteht eine Blutarmut, fällt dem Arzt meist eine bleiche Hautfarbe des Patienten auf. Ist die Milz aufgrund eines vermehrten Abbaus der veränderten Erythrozyten vergrößert, kann man dieses Organ durch die Bauchdecke ertasten. Bei normaler Milzgröße ist dies nicht möglich. Oftmals kommt es dadurch zu Schmerzen im Magen-Darm-Bereich, die sich beim Abtasten verschlimmern können.
Das entscheidende diagnostische Kriterium ist allerdings die Blutuntersuchung. Bei Verdacht auf diese Erkrankung wird der so genannte Sicheltest vorgenommen. Hierbei wird der Blutprobe eine zweiprozentige Natriumsulfid-Lösung zugefügt. Nach dieser Zugabe verformen sich die Zellen und zeigen unter dem Mikroskop die typische Sichelform.
Ein weiteres Verfahren ist die Hämoglobin-Elektrophorese, mit der man den veränderten Hämoglobin-Typ nachweisen kann.
Mittels apparativer Techniken wie Röntgen, Schichtröntgen (CT) sowie Kernspintomographie können eventuelle Organveränderungen dargestellt werden.
          
Auswirkungen§
                    §
Ebenso wie bei der Symptomatik ist auch die Prognose der Erkrankung von der Art des vererbten Sichelzellen-Gens abhängig.
Bei einem heterozygoten Träger des Sichelzellen-Gens besteht in der Regel eine normale Lebenserwartung.
Dagegen ist die Sichelzellenkrankheit bei einem homozygoten Träger des Sichelzellen-Gens als schwere Blutkrankheit zu sehen, die meist zu einer etwas verkürzten Lebenserwartung führt. Durch die Entwicklung in der Medizin können diese Patienten allerdings inzwischen über 60 Jahre alt werden.
          
Therapie§
                    §
Die Ursache dieses angeborenen Defektes kann nicht behoben werden. Zur Schmerzlinderung werden bei Schmerzkrisen Medikamente verabreicht. Weiterhin sind Bluttransfusionen indiziert, die bei kontinuierlicher Anwendung zu einer Verminderung der Schmerzkrisen führen können. Man sollte allerdings im Rahmen der Infusionstherapie ein gewisses Maß nicht überschreiten. Andernfalls können, aufgrund einer Eisenüberladung, schwere Komplikationen entstehen.
Besteht eine Niereninsuffizienz, muss eine so genannte Nierenersatztherapie vorgenommen werden, das heißt die Funktion der erkrankten Niere muss alternativ übernommen werden. Hierzu wird die Dialyse eingesetzt, wobei regelmäßig das Blut des Patienten gereinigt wird.
Bei einer deutlichen Milzvergrößerung wird gegebenenfalls eine Entfernung der Milz (Splenektomie) vorgenommen.
Bestehen Unterschenkelgeschwüre, soll Bettruhe eingehalten und auf ärztliche Anordnung eine Behandlung mit einer entsprechenden Salbe vorgenommen werden. In schweren Fällen kann eine Knochenmarkstransplantation bei geeignetem Spender in Erwägung gezogen werden.
          
Prophylaxe§
                    §
Der Zustand eines Sauerstoffmangels (große Höhe, große Anstrengung) sollte im Rahmen einer Anämie vermieden werden. Kindern sollte ein Schutz vor Infekten durch eine Penicillinprophylaxe bzw. Immunisierung (Impfung) gegen bestehende Erreger verabreicht werden.
Bei Schmerzkrisen sollte neben der medikamentösen Schmerztherapie Flüssigkeit durch Infusionen zugeführt werden, damit die Gefäße besser durchgespült werden und einer weiteren Verstopfung der Gefäße vorgebeugt werden kann.
          
Bemerkungen§
                    §
Leitlinien-Informationen der Fachgesellschaften findet man unter der URL:
http://www.awmf-leitlinien.de/.

Literatur: Die Innere Medizin, Schattauer 2000; Innere Medizin, Urban & Schwarzenberger 1998; Praktische Hämatologie, Thieme 1989; Internistische Differentialdiagnostik, Thieme 1990; Pschyrembel, Klinisches Wörterbuch, de Gryter 1998; Herold, Innere Medizin 2005.
 

also bei wallstreet online gibt es rege unterhaltung und anscheinend stehen sie alle in den startlöchern....was geht da ab  

 

 

 

Xechem Update From The Recent 10th Annual NYSSA Biotech Conference

Xechem International, (Nachrichten) Inc. (OTC BB: XKEM) announced today that Xechem was well received and applauded for Dr. Pandey's work in developing and bringing to market the best treatment in 30 years to relieve the suffering of patients from Sickle Cell Disease (SCD) in Nigeria and throughout the world at the 10th Annual New York Society of Security Analysts Biotech Conference, December 12th/13th, 2006. Some of the highlights given by Dr. Pandey at the conference were: revenues in the first year of full production are estimated to be in the $30 million range, with a 3 to 5 year outlook of $75 - $100 million in Nigeria alone, assuming current pricing and further premised upon Xechem procuring necessary financing, receiving continued regulatory approval from Nigeria and completing construction of the Nigeria manufacturing plant; Worldwide market for Sickle Cell treatment is believed to be 16-18 million patients, with 10 million in Africa; the Nigerian government has raised the priority of Sickle Cell Disease to number two following AIDS at number one. They have also stated that the Nigerian Government will help pay for the treatment of those individuals that cannot pay for NICOSAN™. Dr. Pandey's presentation can be accessed through the Xechem Web Site at www.xechem.com.

Dr. Pandey introduced the new Managing Director for Xechem Pharmaceutical Nigeria, Mr. Iretiolu Oniyide, who comes to the Company with a distinguished career in the banking and pharmaceutical fields for over 30 years.

Xechem is also preparing an IND application to the FDA for US clinical trials to begin on HEMOXINâ„¢ which is the name of NICOSANâ„¢ for the US and Europe. Five US hospitals have agreed to take part in the clinical trials. UMDNJ, Children's Hospital of Philadelphia, SUNY-Brooklyn, Thomas Jefferson and Howard University hospitals. The opening of new Xechem offices in the UK will enable future clinical trials in Europe.

About Xechem

Xechem International is a development stage biopharmaceutical company working on Sickle Cell Disease (SCD), antidiabetics, antimalarials, antiviral (including AIDS), anticancer, antifungal and antibacterial products from natural sources, including microbial and marine organisms. Its primary focus is on the development of proprietary technologies, including those used in the treatment of orphan diseases. Xechem's mission is to bring relief to the millions of people who suffer from these diseases. Its recent focus and resources have been directed primarily toward the development and launch of NICOSANâ„¢ (named HEMOXINâ„¢ for the US and Europe) for the prophylactic management of Sickle Cell Disease (SCD). With the recent limited Nigerian regulatory approval of NICOSANâ„¢, Xechem is now scaling-up the commercialization of the drug in Nigeria and making preparations for the pursuit of US FDA and European regulatory approval. In addition to NICOSANâ„¢, Xechem is also working on another sickle cell compound, 5-HMF, which it has licensed from Virginia Commonwealth University (VCU).  

vieleicht gleicher sprung wie vor 1 jahr  

 

15:38:20    0,028   53.571   408.571
15:37:34 0,028 50.000 355.000
15:36:32 0,028 100.000 305.00  

 

 

XECHEM legte in den letzten 5 Tagen ordentlich d.h. mehr als 60 % zu. Auch heute schon ein schönes Plus. Die Rallye geht wieder los.    

wenn du über die ostertage investiert bleibst kann es passieren das du am Dienstag nur noch 0,017  für die teile bekommst.