Bristol-Myers Squibb, whose billing methods are being probed by U.S. government authorities, said on Tuesday it is investigating its own marketing practices to determine whether it violated anti-kickback laws and cheated state-run Medicaid programs. The world's eighth- biggest drugmaker said its investigation was purely an internal matter, but cautioned that its sales and marketing practices could lead to civil or criminal fines whose size cannot yet be predicted. Its shares ended at $26.26.
Bristol-Myers Squibb Announces Second Quarter and Six Months Sales and Earnings for 2003 Thursday July 24, 8:15 am ET * Company reports fully diluted EPS of $.45 * Company reaffirms full year 2003 earnings guidance * Net Sales increased 22% (including favorable foreign exchange of 4%) to $5.1 billion for the second quarter * ABILIFY(TM) alliance revenue exceeds $100 million for the first six months of 2003 * REYATAZ(TM), company's new HIV/AIDS therapy, approved by U.S. Food and Drug Administration (FDA) * Global sales of key brands including PLAVIX(R), PRAVACHOL(R), AVAPRO(R), PARAPLATIN(R), and SUSTIVA(R) continue to grow
Dow Jones Business News IVAX Gets Tentative Approval For Pravastatin Sodium Friday August 1, 12:48 pm ET MIAMI (Dow Jones)--Ivax Corp. received tentative approval from the Food and Drug Administration (News - Websites) for its pravastatin sodium, in 10-milligram, 20-mg and 40-mg dose strengths. In a press release Friday, the pharmaceutical company said pravastatin sodium is a generic form of Pravachol, which is marketed by Bristol-Myers Squibb Co. (NYSE:BMY - News) and is prescribed for people with high cholesterol or heart disease. Earlier Friday, Ivax said it received final FDA approval for clozapine, a schizophrenia treatment, in a 12.5-milligram dose. That drug a generic form of Novartis AG's (NVS) Clozaril. Ivax's shares traded recently at $17.35, up 20 cents, or 1.2%, on American Stock Exchange volume of 872,200 shares. Average daily volume is 1.2 million shares.
Paclitaxel Combination Improves Survival From Small-Cell Lung Cancer WASHINGTON, DC -- August 6, 2003 -- Combining paclitaxel (Taxol) with two other chemotherapy drugs appears to improve survival in patients with small-cell lung cancer (SCLC) compared with a standard regimen without paclitaxel, according to results from a randomized clinical trial in the August 6 issue of the Journal of the National Cancer Institute. The study found that treatment with paclitaxel, etoposide, and carboplatin yielded better rates of survival and fewer side effects than treatment with carboplatin, etoposide, and vincristine-- one standard chemotherapy regimen. Paclitaxel, both alone and in combination with other chemotherapy drugs, has been associated with high response rates in smaller studies of patients with SCLC, the most aggressive form of lung cancer. Martin Reck, M.D., and Ulrich Gatzemeier, M.D., of the Hospital Grosshansdorf in Hamburg, Germany, and their colleagues conducted a randomized, phase III trial of the two regimens in 614 patients with SCLC. Patients were evaluated for response rate, survival, and toxicities.
Tumor response rates of the two groups were similar. However, patients who received the experimental treatment had a longer median survival time (12.7 months versus 11.7 months) than patients who received standard chemotherapy. The 3-year survival rate of patients in the experimental group was nearly twice that of patients in the standard treatment group (17% versus 9%, respectively). Notably, the improvements in survival were limited to patients with early-stage disease. Patients in the experimental group also experienced a longer median progression-free survival time (8.1 months versus 7.5 months) than patients in the standard treatment group. For each completed chemotherapy cycle, rates of side effects, such as severe anemia and thrombocytopenia, were lower for patients in the experimental group than patients in the standard treatment group. "Our results are the first from a randomized trial to demonstrate a statistically significant increase in median and long-term survival, progression-free survival, and a decrease in drug-related toxicities for patients with SCLC on a paclitaxel-containing regimen compared with standard chemotherapy," the authors write. "The three-drug combination of paclitaxel, etoposide, and carboplatin was effective, safe, and well-tolerated, and therefore we conclude that its use is a reasonable treatment choice for at least some patients with SCLC."
In an accompanying editorial, Janessa Laskin, M.D., of the British Columbia Cancer Research Centre in Vancouver, Canada, and Alan Sandler, M.D., and David H. Johnson, M.D., of the Vanderbilt-Ingram Comprehensive Cancer Center in Nashville, Tenn., point out that despite these encouraging results, the addition of a third drug to etoposide and carboplatin has not been shown in a randomized trial to be better than etoposide and carboplatin alone in the treatment of patients with lung cancer. They say that the future of SCLC treatment lies in targeted therapies, such as drugs that target protein kinases or angiogenesis (the formation of new blood vessels). "Strategies that take advantage of our admittedly limited knowledge of tumor biology are in progress," they say. "It is hoped that one or several of these approaches will prove successful and further enhance our ability to treat this still -too-common and deadly disease." SOURCE: Journal of the National Cancer Institute
BMS284756 (formerly T-3811, a des-fluoroquinolone) potency and spectrum tested against over 10,000 bacterial bloodstream infection isolates from the SENTRY antimicrobial surveillance programme (2000). Gordon KA, Pfaller MA, Jones RN; SENTRY Participants Group. University of Iowa College of Medicine, Iowa City, USA.
BMS284756 is a novel des-F (6)-quinolone, which has a wide range of activity against many species of Gram-positive and -negative organisms. The potency of BMS284756 was compared with that of other quinolones, including ciprofloxacin, gatifloxacin and levofloxacin, and was tested against >10,000 bloodstream isolates from the year 2000 SENTRY antimicrobial surveillance programme. Twelve pathogens accounted for nearly all of the referred isolates and included Staphylococcus aureus, coagulase-negative staphylococci, Escherichia coli, Klebsiella pneumoniae, Enterobacter spp., Serratia spp., Pseudomonas aeruginosa, Acinetobacter spp., Enterococcus spp., Streptococcus pneumoniae and beta-haemolytic or viridans group streptococci. Of the four quinolones tested, BMS284756 was the most active overall against Staphylococcus spp. (MIC(50) < or = 0.03 mg/L) and Streptococcus spp. (MIC(50) 0.06 mg/L). In contrast, BMS284756 was less potent than the other quinolones against the enteric Gram- negative bacilli (MIC(50) < or = 0.03-1 mg/L). With a proposed breakpoint of < or =4 mg/L, BMS284756 may be a therapeutic alternative pending the results of clinical trials.
The Effect on Tumor Response of Adding Sequential Preoperative Docetaxel to Preoperative Doxorubicin and Cyclophosphamide: Preliminary Results From National Surgical Adjuvant Breast and Bowel Project Protocol B-27 Harry D. Bear, Stewart Anderson, Ann Brown, Roy Smith, Eleftherios P. Mamounas, Bernard Fisher, Richard Margolese, Heather Theoret, Atilla Soran, D. Lawrence Wickerham, and Norman Wolmark JCO Nov 15 2003: 4165-4174. First published on Oct 14 2003; 10.1200/JCO.2003.12.005.
Genentech, which is scheduled to report fourth-quarter earnings on Wednesday, saw its shares rise 183 percent in 2003 because of hopes about the company's new cancer therapy, Avastin. In May, Genentech shares leaped 45 percent in a single trading session after the company said Avastin did better than expected in extending the lives of patients with colon cancer. But Avastin has yet to win marketing clearance and therefore hasn't yet generated a dollar in sales. Genentech this year will need to demonstrate that Avastin, which is expected to win the FDA's OK before the end of March, can live up to its billing. "Genentech is going to be the company that everybody is going to be watching," said Tracy DeGregorio, a director with Decision Resources, an industry research firm. "The stock performance was so spectacular, and now the focus will be on whether Genentech can deliver."Avastin is expected to have $124 million in sales this year, rising to $1.1 billion in 2007, according to research firm Datamonitor. With so much riding on Avastin, analysts say any disappointment for the drug could send Genentech shares reeling.
Another cancer therapy, Erbitux from ImClone and pharmaceutical partner Bristol-Myers Squibb (BMY: news, chart, profile), will make headlines again, analysts say. ImClone is still struggling with the taint of an insider-trading scandal involving founder Sam Waksal and his friend Martha Stewart. But some analysts say Erbitux has real promise, and the drug is expected to gain FDA clearance within a month.
Paclitaxel, used in the treatment of refractory ovarian cancer, first-line treatment of ovarian cancer in combination with cisplatin, second-line treatment of AIDS-related Kaposi's Sarcoma, treatment of metastatic breast cancer after failure of combination chemotherapy, adjuvant treatment of node positive breast cancer and in the treatment of non-small cell lung carcinoma with cisplatin. Data exclusivity for TAXOL® in Japan will expire in July 2003 and in the European Union in September 2003. Patents covering various aspects of TAXOL® extend beyond 2003 in Japan and Europe. For a discussion of related litigation, reference is made to Item 3, Legal Proceedings, in Part I of this Form 10-K/A and Note 20, Litigation Matters, to the restated consolidated financial statements.
In addition to taking a $1 billion equity stake in the biotech, Bristol-Myers originally agreed to pay ImClone $1 billion in milestone payments: $200 million at the start of the deal, $300 million at submission of a Biologics License Application, and $500 million upon approval of Erbitux. Instead of the second milestone payment, Bristol-Myers (BMY: Research, Estimates) will now pay $140 million in cash now and $60 million in one year. If Erbitux is approved, Bristol-Myers will also split the third milestone payment, with $250 million upon approval of a first indication and another $250 million upon approval of a second indication. The companies are currently looking for approval for Erbitux to treat colorectal cancer, but are also collecting data on treatment for head and neck cancer. Under the new agreement, ImClone will receive a distribution fee based on a flat rate of 39 percent of North American revenue and the deal will run through 2018.
Reuters Ivax picks Mayne to sell cancer drug in Europe Wednesday February 25, 9:40 am ET NEW YORK, Feb 25 (Reuters) - U.S. generic drugmaker Ivax Corp. (AMEX:IVX - News) on Wednesday said Mayne Group Ltd., a privately held Australian provider of health care services, has agreed to sell Ivax's injectable cancer drug paclitaxel in a dozen European countries. No financial details of the deal were disclosed. The Ivax drug, Paxene, contains the active ingredient of Bristol-Myers Squibb Co.'s (NYSE:BMY - News) Taxol, one of the world's most widely used cancer drugs.