The orginal release:
CVM : CEL-SCI CORP (AMEX)
CEL-SCI Corporation And TAKEDA CHEMICAL INDUSTRIES,LTD. Enter Worldwide Collaboration To Develop And Commercialize Multikine(TM) Agreement For A Potential Cancer Cure
VIENNA ,VA, AND TOKYO, JAPAN, Jun 10, 2002 (INTERNET WIRE from COMTEX) --
CEL-SCI Corporation (AMEX: CVM chart, msgs) and TAKEDA CHEMICAL INDUSTRIES,LTD. (TSE 4502) announced today that they have entered into an agreement to jointly develop and commercialize Multikine(TM). Multikine is an immunotherapy drug, is manufactured using the Company's proprietary cell culture technologies. It is a combination, or "cocktail," of natural human interleukin-2 (IL-2) and certain lymphokines and cytokines. It is designed to break tumor tolerance and produce a memory immune response against the cancer. Multikine is a copy of a healthy person's immune response. Clinical studies have shown discernible tumor reductions in cancer patients treated with Multikine with minimal side effects.
Multikine has been tested in over 150 patients in clinical trials conducted in the United States, Canada, Europe and Israel. Most of these patients were head and neck cancer patients, but some studies were also conducted in prostate cancer patients and HIV-infected patients with cervical cancer. The Company expects that in the treatment of head and neck cancer Multikine may be used in combination with existing therapies in the early stages of cancer with the goal of increasing cure rates.
Currently,the 5-year relative survival rate for all cancers combined is 60%. CVM is currently treating patients in two head & neck cancer studies and one cervical cancer study.
Using only the Multikine regimen, of the 10 patients, seven had regression in tumour size, with one of the patients showing a complete disappearance of the tumour. In addition, patients had a resolution of tumour ulceration, increased tongue mobility and reduction or elimination of local pain. There were no tumour progressions or adverse local changes, nor evidence of toxicity from Multikine. Recovery after operation and wound healing were normal. Additionally, microscopic evaluation of the surgical specimens showed evidence of cellular immune reaction against the tumours and destruction of tumour cells.
The trial is conducted in patients with newly diagnosed advanced head and neck cancer (Stage II-IV) with Multikine given before surgery and/or radiation, the normal treatments of choice. Multikine therapy is given during the first two weeks, with surgery or radiation to follow after week three. Dr. Feinmesser intends to expand the trial by another 10 patients at a higher dose level of Multikine. A similar trial involving 21 patients is currently ongoing in Canada.
The success of this drug regimen will ultimately be measured by its effects on the overall recurrence rate in these patients and its effects on patient quality of life. Currently, about 50 percent of advanced head and neck cancer patients have a recurrence of the cancer and the prognosis for these patients is poor.
Head and neck cancer is the sixth most frequently occurring cancer world-wide, with an incidence of 500,000 cases annually. Recent statistics show no reduction in head and neck cancer mortality, but rather a dramatic increase of the disease in certain segments of the population. It mostly occurs in men in their 50's or early 60's with a history of smoking and alcohol consumption. Conventional treatments consist of either surgery, which can be extremely disfiguring, or radiation therapy and chemotherapy, both of which can be associated with severe side effects.
"Developing innovative products to help patients with cancer live longer is a primary goal for CEL-SCI, and we believe Multikine is one of the most promising late stage investigational oncology compounds currently under study," said Maximilian de Clara, President of CEL-SCI Corporation. "This is a highly significant collaboration for TAKEDA , as Multikine is at the leading edge of innovative, targeted cancer therapy. One of our clear objectives for achieving sales growth in the coming years is the in-licensing of late-stage development compounds with significant commercial potential, and this agreement is a tangible example of that commitment."
Under the terms of the agreement, CEL-SCI and Takeda will jointly develop and co-market Multikine in the United States , and Takeda will have exclusive development and marketing rights to the compound in all countries outside of the U.S. CEL-SCI will retain responsibility for global manufacturing and for regulatory filings within the U.S., while Takeda will assume all regulatory responsibilities outside the U.S. Joint management teams, including representatives from both partners, will oversee the Alliance.
Collectively, this agreement will provide up to $520 million in cash, equity, milestones and convertible debt to CEL-SCI. In addition, Takeda will fund 75 percent of all future NDA-directed development costs in the U.S., and 100 percent of all other development, marketing, and sales costs within the U.S. and elsewhere. CEL-SCI will also receive royalties on all worldwide sales of Multikine. CEL-SCI will receive a total of $175 million in initial and near- term payments consisting of $10 million cash as a licensing fee and $40 million cash as development fees, $50 million in convertible debt, and $75 million pursuant to an equity investment upon achievement of a near-term clinical milestone. CEL-SCI will receive an additional $280 million in cash, and $65 million in convertible notes, pursuant to achievement of clinical and regulatory milestones.
CEL-SCI Corporation is a developer of novel immune therapy products for cancers and infectious diseases. Formed as a Colorado corporation in 1983, CEL-SCI is involved in the research and development of certain drugs and vaccines primarily focused in the treatment of cancer. CEL-SCI manufactures its most advanced product, Multikine(TM), using proprietary cell culture technologies, which involve a combination, or "cocktail", of natural human interleukin-2 and certain other cytokines. Multikine is being developed as a potential treatment for Human Papilloma Virus (HPV) induced cervical dysplasia (the precursor stage before the development of cervical cancer) in HIV infected women and for head and neck cancer. Multikine has been tested in over 160 patients and is currently in a Phase II head & neck cancer trial in Europe, as well as a Phase I clinical trial in HIV-infected women with HPV-induced cervical dysplasia being conducted at the Institute for Human Virology (IHV) in Baltimore.
In addition, the Company's platform technology, L.E.A.P.S.(TM) (Ligand Epitope Antigen Presentation System), is being evaluated in 8 R&D collaborations including NIH/NCI, Johns Hopkins University and the Naval Medical Research Center (NMRC) of the U.S. Navy. L.E.A.P.S. is a T-cell modulation technology that CEL-SCI is testing as potential treatments and/or preventive vaccines against various diseases. Present target diseases are AIDS, chronic genital and oral herpes, malaria, colon cancer, breast cancer and autoimmune myocarditis. Most of the L.E.A.P.S. research and development is supported by grants.
please visit our website at: www.cel-sci.com
TAKEDA CHEMICAL INDUSTRIES ,LTD
Message from the President
To contribute to better health and quality of life for people throughout the world - that is Takeda's foremost mission. To accomplish this, we work constantly to create a supply of innovative products.
We are now making major strides in this process. Our anti-ulcer agent Prevacid (lansoprazole) and prostate cancer treatment Lupron Depot (leuprolide acetate) are already major global products, and we recently introduced two new drugs that we expect to become our next blockbusters: an anti-hypertensive agent Blopress (candesartan cilexetil), which is now marketed in 51 countries, and an anti-diabetic agent Actos (pioglitazone hydrochloride), which was launched in the United States and Japan in 1999, and in Europe in 2000. Original Takeda products such as these are playing an increasingly important role in improving the health and quality of life of people worldwide, a trend that should further boost our global presence.
Such products were made possible by Takeda's technologically advanced research laboratories and world-class researchers. In addition to the product launches mentioned above, we are looking forward to the fruits of the unique basic research being conducted by our scientists. Based on research in the area of human genetics, we are investigating orphan receptors, or receptors whose functions are currently unknown. Our technology for efficiently identifying the binding "keys" for these receptors is leading to a stream of successes such as the discovery of eight novel ligands or receptors. These successes demonstrate Takeda's strength in basic research, which will be the driving force behind the Company's future growth.
Takeda is also devoting efforts to expanding its global operations. We conduct effective pharmaceutical clinical trials with development operations centered in the United States, Europe and Japan and have established a network for marketing our own brands in all major countries. In the United States, the world's largest market for pharmaceuticals, we established TAP Pharmaceuticals Inc. (now TAP Pharmaceutical Products Inc.) in 1985 as a joint venture with Abbott Laboratories to develop and market Takeda's innovative products. With sales now surpassing $3.5 billion a year, TAP is one of the fastest-growing pharmaceutical companies in the United States. Furthermore, in May 1998, we established a wholly owned U.S. marketing subsidiary, Takeda Pharmaceuticals North America, Inc., which began marketing Actos, a treatment for type 2 diabetes, in August 1999. The creation of an independent marketing network demonstrates Takeda's firm commitment to deepening its presence in the crucial U.S. market.
As a member of society, Takeda obviously must comply with all laws and regulations. However, we also consider it our duty, as a company dealing with products that directly affect human life, to conduct all our business activities in accordance with the highest ethical standards. To ensure thoroughness in this area, we have instituted the Takeda Compliance Program, which incorporates the Takeda Charter of Business Conduct and the Takeda Code of Compliance Standards. Observance of the program's principles by all employees will enable us to fulfill our social responsibilities as a good corporate citizen.
Over the long run, Takeda has made steady progress as a leading pharmaceutical firm in Japan, and I am confident that our commitment to our corporate philosophy will increase the value of Takeda for patients, shareholders and the community and will be the driving force behind Takeda's continued growth in the 21st century.
please visit: www.takeda.com
The statements contained in this press release that are not historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the expectations, beliefs, intentions or strategies regarding the future. Without limiting the foregoing, the words "anticipates," "believes," "expects," "intends," "may" and "plans" and similar expressions are intended to identify forward-looking statements. The Companies intend that all forward-looking statements be subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect the Companies' views as of the date they are made with respect to future events, but are subject to many risks and uncertainties, which could cause the actual results of the Companies to differ materially from any future results expressed or implied by such forward-looking statements. For example, the results obtained in pre-clinical or clinical studies may not be indicative of results that will be obtained in future clinical trials, delays in the initiation or completion of clinical trials may occur as a result of many factors, and clinical trials may not yield results that are suitable for regulatory approvals. Further examples of such risks and uncertainties also include, but are not limited to: the obtaining of sufficient financing to maintain the Companies planned operations; timely development, receipt of necessary regulatory approvals, and acceptance of new products; the successful application of the Companies' technology to produce new products; the obtaining of proprietary protection for any such technology and products; the impact of competitive products and pricing and reimbursement policies; governmental approvals of the agreements; and changing market conditions. The Companies do not undertake to update forward-looking statements. Although the Companies believe that the forward- looking statements contained herein are reasonable, they can give no assurances that the Companies' expectations are correct. All forward looking statements are expressly qualified in their entirety by this cautionary statement and other factors detailed in both Companies' reports as filed with the Securities and Exchange Commission.
CONTACT: Alexander G Esterhazy
Cel-Sci Corp
703-506-9460
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