King Pharmaceuticals announces exclusive license for papillomavirus vaccines with Novavax.King Pharmaceuticals, Inc. (Bristol, TN; 423-989-8077) announced that it has obtained an exclusive license from Novavax, Inc. (301-854-3900) to use its proprietary cell line to develop and potentially commercialize recombinant human papillomavirus human papillomavirus (HPV), any of a family of more than 60 viruses that cause various growths, including plantar warts and genital warts, a sexually transmitted disease. Detectable warts can be or removed, usually by chemicals, freezing, or laser, but often recur. virus-like particle vaccines. Novavax and King are currently working together on manufacturing HPV-16 virus-like particle vaccines being evaluated by the National Cancer Institute in clinical trials. The vaccines are designed to prevent and/or treat HPV-16 infection and associated cervical cancer Cervical Cancer Definition Cervical cancer is a disease in which the cells of the cervix become abnormal and start to grow uncontrollably, forming tumors. . The recombinant HPV-16 virus-like particle vaccines were developed originally by Drs. Douglas Lowy and John Schiller of the Laboratory of Cellular Oncology at the NCI See Liberate. . The HPV-16 virus-like particle vaccines were developed further and manufactured as experimental clinical vaccines by Dr. Robin Robinson of Novavax's Biomedical bi·o·med·i·cal adj. 1. Of or relating to biomedicine. 2. Of, relating to, or involving biological, medical, and physical sciences. Service Division. In September 2000, Novavax received a contract from the NCI to manufacture the HPV-16 L1 virus-like particle vaccine for a large-scale clinical efficacy trial. The NCI will fund the initial planned related Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the which is expected to commence during mid-2001. The product will be manufactured at King's Parkedale facility in Michigan utilizing Novavax and Parkedale personnel. Pursuant to the license agreement, King has an exclusive worldwide license to develop, manufacture and market HPV-16 virus-like particle vaccines for the prevention and/or treatment of human papillomavirus infection, except that Novavax retains the right to co-market any such product in the United States, including Puerto Rico. King will pay Novavax during the term of the license a royalty based on 17% of any net sales Net Sales The amount a seller receives from the buyer after costs associated with the sale are deducted. Notes: This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight , less cost of goods, of any human papillomavirus product successfully developed under the license agreement. The term of King's license shall continue for so long as Novavax's related cell line technology remains proprietary to Novavax, including pursuant to any existing patent or patent protection that must be sought under the terms of the license agreement. As part of the transaction, King has agreed to make a $25 million convertible debenture Convertible Debenture Any type of debenture that can be converted into some other security. Notes: For example, a convertible bond can be converted into stock. investment in Novavax. The note is convertible into Novavax common stock at $10.00 per share, an 18% premium to a 20 day trading Day trading Establishing and liquidating the same position or positions within one day's trading. average prior to closing. The note carries a 4% coupon payable semi-annually in cash and stock. Novavax received $20 million on December 19, 2000, and will receive an additional $5 million when Novavax files a New Drug Application for its topical transdermal estrogen replacement therapy estrogen replacement therapy n. Abbr. ERT The administration of estrogen, especially in postmenopausal women, to relieve symptoms and conditions associated with estrogen deficiency, such as hot flashes and osteoporosis. , ESTRASORB, expected to be filed in the first half of 2001. John A. Spears, president and chief executive officer of Novavax, stated, "We are very pleased that King is making an investment in Novavax at this time. We have collaborated with King on several projects over the last several years and they have been an excellent corporate partner. This transaction confirms my belief that it has been and will continue to be, a mutually beneficial relationship. This is the first significant investment in Novavax by a major pharmaceutical company." John M. Gregory, chairman and chief executive officer of King, stated, "We are excited to officially join forces with Novavax in the development of human papillomavirus vaccines which, if successful, could provide an important breakthrough in the prevention and/or treatment of human papillomavirus-induced cervical cancer. The Centers for Disease Control and Prevention Centers for Disease Control and Prevention (CDC), agency of the U.S. Public Health Service since 1973, with headquarters in Atlanta; it was established in 1946 as the Communicable Disease Center. recently reported that nearly 18% of American women and 8% of American men carry this strain of human papillomavirus which causes approximately half of all cases of cervical cancer." Novavax is a biopharmaceutical drug delivery company engaged in the research and development of differentiated drug products primarily in the fields of women's health Women's Health Definition Women's health is the effect of gender on disease and health that encompasses a broad range of biological and psychosocial issues. and infectious diseases. The company is applying its proprietary lipid vesicle vesicle /ves·i·cle/ (ves´i-k'l) 1. a small bladder or sac containing liquid. 2. a small circumscribed elevation of the epidermis containing a serous fluid; a small blister. encapsulation technologies, including Novasome lipid vesicles and micellar nanoparticles, to develop product candidates for the topical and oral delivery of generic and non-generic drugs, peptides, proteins and oligonucleotides. The company's Novasome technology is also being developed as an adjuvant adjuvant /ad·ju·vant/ (aj?dbobr-vant) (a-joo´vant) 1. assisting or aiding. 2. a substance that aids another, such as an auxiliary remedy. 3. delivery system for enhanced vaccine efficacy. Novavax's Biomedical Services Division is engaged in contract research and development and Phase I/II vaccine manufacturing of human vaccines for government laboratories and other vaccine companies. King is a vertically integrated pharmaceutical company that manufactures, markets, and sells primarily branded prescription pharmaceutical products. King seeks to capitalize on niche opportunities in the pharmaceutical industry created by cost containment initiatives and consolidation among large global pharmaceutical companies. King's strategy is to acquire branded pharmaceutical products and to increase their sales by focused promotion and marketing and through product life cycle management. |
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