Indevus Pharmaceuticals Announces Fiscal 2002 Year End and Fourth Quarter Results; Year Highlighted by Success of Phase III Trial With Trospium.Business Editors/Health/Medical Writers LEXINGTON, Mass.--(BUSINESS WIRE)--Dec. 23, 2002 Full Trospium Data to be Presented at American Urological Association Meeting Indevus Pharmaceuticals, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : IDEV IDEV International Development ) today announced its consolidated results of operations for the fiscal year and the three-month period ended September 30, 2002. The Company reported a consolidated net loss of $17,586,000, or $0.38 per share (basic), for fiscal 2002, compared to a consolidated net loss of $1,491,000, or $0.03 per share (basic), for fiscal 2001. For the three-month period ended September 30, 2002, the Company reported a consolidated net loss of $4,817,000, or $0.10 per share (basic), compared to consolidated net income of $7,951,000, or $0.17 per share (basic), for the three-month period ended September 30, 2001. The increased net loss for fiscal 2002 is primarily the result of increased research and development expenses related to the Company's 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 with trospium completed during the fourth quarter of fiscal 2002. In addition, fiscal 2001 results included a product withdrawal credit of $5,582,000. At September 30, 2002, the Company had consolidated cash, cash equivalents and marketable securities Marketable Securities Very liquid securities that can be converted into cash quickly at a reasonable price. Notes: Marketable securities are very liquid as they tend to have maturities less than one year, and the rate at which these securities can be bought or sold has totaling approximately $41,500,000. "Highlighting fiscal year 2002 were the highly positive results of the Company's Phase III clinical trial with trospium for overactive bladder Overactive Bladder Definition Overactive bladder is the leakage of large amounts of urine at unexpected times, including during sleep. Description ," said Glenn L. Cooper, M.D., chairman, president and chief executive officer of Indevus. "The trial met both of its primary endpoints, achieving significantly reduced frequencies of micturition micturition /mic·tu·ri·tion/ (mik?tu-ri´shun) urination. mic·tu·ri·tion n. 1. See urination. 2. The desire to urinate. 3. The frequency of urination. (urination urination Process of excreting urine from the bladder (see urinary system). Nerve centres in the spinal cord, brain stem, and cerebral cortex control it through involuntary and voluntary muscles. The need to void is felt when the bladder holds 3. ) (p less than or equal to 0.01) and urinary incontinence Urinary Incontinence Definition Urinary incontinence is unintentional loss of urine that is sufficient enough in frequency and amount to cause physical and/or emotional distress in the person experiencing it. episodes (p less than or equal to 0.01) among patients treated with trospium compared with patients who received placebo. In addition, the trial met all of its overactive bladder secondary endpoints, and the drug was well tolerated as evidenced by a favorable safety profile. We look forward to presenting the full results of the trial at the American Urological Association meeting, to be held in Chicago from April 26 to May 1, 2003. "As previously announced, we plan to file a New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for trospium with the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) in the second quarter of calendar year 2003, contingent upon discussions with the FDA," said Dr. Cooper. "The NDA for trospium will include the drug's European clinical trial database. This database encompasses over 2,300 patients in multiple double-blind, placebo-controlled studies. "Indevus has exclusive rights to the commercialization of trospium in the U.S.," said Dr. Cooper. "In view of the robust Phase III trial data, we have continued to implement pre-commercialization activities and are evaluating all of our commercialization opportunities for trospium, including a strategic corporate partnership. "Following the return of exclusive, worldwide rights to pagoclone for anxiety disorders Anxiety disorders A group of distinct psychiatric disorders characterized by marked emotional distress and social impairment, including generalized anxiety disorder, panic disorder, obsessive-compulsive disorder, and posttraumatic stress disorder. from Pfizer Inc during the third quarter of fiscal 2002, Indevus is continuing its discussions with several pharmaceutical companies regarding partnering opportunities for this drug," said Dr. Cooper. "A total of six clinical trials have been conducted with pagoclone in generalized anxiety disorder Generalized Anxiety Disorder Definition Generalized anxiety disorder is a condition characterized by "free floating" anxiety or apprehension not linked to a specific cause or situation. and panic disorder Panic Disorder Definition A panic attack is a sudden, intense experience of fear coupled with an overwhelming feeling of danger, accompanied by physical symptoms of anxiety, such as a pounding heart, sweating, and rapid breathing. . Data from these trials, combined with extensive clinical pharmacology, manufacturing process and commercial formulation work completed to date, will represent the basis of future clinical development decisions by Indevus or its prospective partners. "With regard to citicoline, the Company's drug for ischemic stroke, two meta-analyses of clinical trials conducted in both the U.S. and abroad were presented at the 27th International Stroke Conference in February 2002," said Dr. Cooper. "These meta-analyses suggest that treatment with citicoline may reduce infarct infarct /in·farct/ (in´fahrkt) a localized area of ischemic necrosis produced by occlusion of the arterial supply or the venous drainage of the part. growth after stroke and reduce rates of death or disability over a long term. The Company has signed a non-binding memorandum of agreement A memorandum of agreement (MOA) or cooperative agreement is a document written between parties to cooperatively work together on an agreed upon project or meet an agreed upon objective. The purpose of an MOA is to have a written understanding of the agreement between parties. with a privately held biotechnology company to fund the further clinical development of citicoline. The completion of this agreement is contingent upon input from the FDA on the design and clinical endpoints of an additional, large Phase III trial and the negotiation of a definitive contract. "We announced clinical results in December 2002 showing that treatment with IP 751 (previously known as CT-3), a novel anti-inflammatory and analgesic analgesic (ăn'əljē`zĭk), any of a diverse group of drugs used to relieve pain. Analgesic drugs include the nonsteroidal anti-inflammatory drugs (NSAIDs) such as the salicylates, narcotic drugs such as morphine, and synthetic drugs synthetic cannabinoid cannabinoid /can·nab·i·noid/ (kah-nab´i-noid) any of the principles of Cannabis, including tetrahydrocannabinol, cannabinol, and cannabidiol. can·nab·i·noid n. compound, significantly reduced the degree of neuropathic pain in a Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II ," said Dr. Cooper. "In addition, the drug was well tolerated, with no evidence of psychoactive psychoactive /psy·cho·ac·tive/ (-ak´tiv) psychotropic. psy·cho·ac·tive adj. Affecting the mind or mental processes. Used of a drug. properties. "In February 2002, an international collaboration of research groups was awarded a grant of approximately $22.7 million from the U.K.'s Department for International Development (DFID DFID Department For International Development (UK) ) to test the safety and efficacy of vaginal microbicides, including PRO 2000, to prevent HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. transmission," said Dr. Cooper. "The DFID grant will support a broad, five-year program that will include a multi-national, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , double-blind, placebo-controlled Phase III clinical trial of candidate microbicides. In addition to planned testing under this grant, PRO 2000 was previously selected for a European Commission-funded Phase II safety trial in at-risk African women and a Phase II/III pivotal trial in Africa and India sponsored by the National Institutes of Health (NIH "Not invented here." See digispeak. NIH - The United States National Institutes of Health. ). "The Company's early clinical-stage activity included the recent completion of a multi-dose Phase I trial with dersalazine for inflammatory bowel disease inflammatory bowel disease n. Abbr. IBD Any of several incurable and debilitating diseases of the gastrointestinal tract characterized by inflammation and obstruction of parts of the intestine. in Europe," said Dr. Cooper. "We do not believe this early-stage trial met all of its objectives, and we are currently in discussions with the licensor of this compound, J. Uriach, on whether or not to participate in additional clinical testing. "Earlier this month, we announced the successful renegotiation of our licensing agreement with Eli Lilly and Company Eli Lilly and Company (NYSE: LLY) is a global pharmaceutical company and one of the world's largest corporations. Eli Lilly's global headquarters is located in Indianapolis, Indiana, in the United States. related to Sarafem(R) to treat premenstrual dysphoric disorder Premenstrual Dysphoric Disorder Definition Premenstrual dysphoric disorder (PMDD) is a collection of physical and emotional symptoms that occurs 5 to 11 days before a woman's period begins, and goes away once menstruation starts. (PMDD PMDD abbr. premenstrual dysphoric disorder Premenstrual dysphoric disorder (PMDD) Premenstrual syndrome (PMS); symptoms including back and abdominal pain, nervousness and irritability, headache, and breast tenderness )," said Dr. Cooper. "This agreement provides for Indevus to receive an initial payment upon signing, royalty payments based on net sales of Sarafem in the U.S. until the expiration of the Indevus patent covering this product, and other potential milestone payments. These milestone payments will be accelerated and payable upon the completion of Lilly's sale of Sarafem rights to Galen Holdings PLC. "Finally, we strengthened the financial position of the Company during the fiscal year with the completion of a private placement of common stock," said Dr. Cooper. "This financing raised $25 million in gross proceeds and allowed us to end fiscal 2002 with approximately $41,500,000 in cash, cash equivalents and marketable securities." Total consolidated revenues during fiscal 2002 were $4,407,000, compared to revenues of $15,233,000 for fiscal 2001. Fiscal 2002 revenue consisted primarily of royalty revenue of $3,439,000 from Lilly for sales of Sarafem. Fiscal 2001 revenues included $13,000,000 in license fee revenues related to the Company's December 1999 partnership agreement with Takeda Chemical Industries, Ltd. for citicoline. Total consolidated costs and expenses for fiscal 2002 were $22,437,000, compared to costs and expenses of $7,655,000 for fiscal 2001. Research and development expenses in fiscal 2002 totaled $13,309,000, an increase of 151 percent over fiscal 2001, due primarily to increased costs related to the Company's Phase III clinical trial with trospium. Other increased fiscal 2002 expenses included noncash compensation related to stock option grants and pre-marketing costs related to trospium. Included in fiscal 2001 costs and expenses was a product withdrawal credit of $5,582,000. Indevus Pharmaceuticals is engaged in the development and commercialization of a portfolio of products and product candidates, including multiple compounds in late-stage clinical development. The Company's core products under development include trospium for overactive bladder, pagoclone for panic/anxiety disorders, citicoline for ischemic stroke, IP 751 for pain and inflammation, and PRO 2000 for the prevention of infection by HIV and other sexually transmitted pathogens. Except for the descriptions of historical facts contained herein, this press release contains forward-looking statements that involve risks and uncertainties that could cause the Company's actual results and financial condition to differ materially from those anticipated by the forward-looking statements. These risks and uncertainties are set forth in the Company's filings under the Securities Act of 1933 and the Securities Exchange Act of 1934 under "Risk Factors" and elsewhere, and include, but are not limited to: uncertainties relating to clinical trials, regulatory approval and commercialization of our products, particularly trospium; the early stage of products under development; need for additional funds and corporate partners, including for the development of pagoclone and citicoline; history of operating losses and expectation of future losses; product liability and insurance uncertainties; risks relating to the Redux-related litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. ; dependence on third parties for manufacturing and marketing; competition; risks associated with contractual arrangements; limited patent and proprietary rights; and other risks.
INDEVUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
For the three and twelve months ended September 30, 2002 and 2001
(Amounts in thousands except per share amounts)
Three months Twelve months
ended Sept. 30, ended Sept. 30,
2002 2001 2002 2001
Total revenues 552 14,301 4,407 15,233
Costs and expenses:
Cost of revenues 60 498 1,038 698
Research and development 3,352 1,641 13,309 5,301
General and administrative 2,183 1,203 8,090 7,238
Product withdrawal, net - 2,516 - (5,582)
Total costs and expenses 5,595 5,858 22,437 7,655
Income (loss) from operations (5,043) 8,443 (18,030) 7,578
Investment income, net 227 333 987 1,811
Loss on disposition of equity
securities - - - (43)
Impairment of equity securities - (810) (487) (810)
Minority interest (1) (15) (56) (27)
Income (loss) before cumulative
effect of change in
accounting principle (4,817) 7,951 (17,586) 8,509
Cumulative effect of change in
accounting principle - - - (10,000)
Net income (loss) $(4,817) $7,951 $(17,586) $(1,491)
Net income (loss) per common
share:
Basic $(0.10) $0.18 $(0.38) $(0.03)
Diluted $(0.10) $0.17 $(0.38) $(0.03)
Weighted average common shares
outstanding:
Basic 46,827 43,257 45,896 42,948
Diluted 46,827 47,221 45,896 45,628
INDEVUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands)
Sept. 30, Sept. 30,
2002 2001
Cash, cash equivalents and marketable
securities $41,543 $32,171
Other assets 2,388 2,746
Total assets $43,931 $34,917
Liabilities $6,700 $6,160
Minority interest 13 97
Capital 306,097 279,953
Accumulated deficit (268,879) (251,293)
Total stockholders' equity 37,218 28,660
Total liabilities and
stockholders' equity $43,931 $34,917
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