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			Real Branding Brand Institute is the premier full-service branding agency dedicated to strategic and innovative brand naming and identity solutions. We strive to exceed the expectations of every client by combining leading-edge market research with the highest levels of client service, integrity and brand management CHIRON REDUCES FLUVIRIN PRODUCTION ESTIMATES, 2005 EARNINGS-PER-SHARE GUIDANCE ------------------------------------------------------------------------------- Chiron Corp. shares fell 6.5 percent after the company reduced the estimated number of Fluvirin influenza vaccines it will produce for the 2005-2006 influenza season and updated its 2005 financial guidance. The company said it now expects to produce between 18 million and 26 million doses of Fluvirin, down from the previous estimate of between 25 million and 30 million, as a result of "delays in start-up procedures for ramping up to full production and normal manufacturing issues inherent to the complexity of influenza vaccine production." "The number of doses Chiron will produce will depend upon the success of its remediation efforts, upon encountering no further adverse manufacturing or regulatory developments and upon the major factors that determine production--volumes, yields and timing," the firm said. Based on this estimate and assuming there is enough demand to allow Chiron to sell the vaccine through the end of November, the firm forecasts its 2005 income from continuing operations will range between $1.20 and $1.45 per share on an adjusted (pro forma) basis and between $0.86 and $1.11 per share on a Generally Accepted Accounting Principles basis. In April, Chiron said it expected 2005 income from continuing operations to range from $1.40 to $1.50 per share on an adjusted (pro forma) basis and between $1.06 and $1.16 per share on a GAAP basis. Excluding items, analysts polled by Thomson Financial expected average earnings of $1.44 per share, Dow Jones Newswires reported. The Food and Drug Administration is expected to conduct a full current good manufacturing practices inspection in July to determine whether previous deficiencies have been resolved. Chiron noted that its failure to adequately address these issues could reduce its ability to market the Fluvirin vaccine. Shares of Chiron closed at $35.47, down $2.48, in heavy trading on the Nasdaq. -=- MYLAN TO CLOSE BERTEK UNIT, OUT-LICENSE NEBIVOLOL ------------------------------------------------------------------------------- Mylan Laboratories Inc. announced the closing of its Bertek subsidiary, the out-licensing of nebivolol, a $1.25 billion share buyback, a $250 million follow-on share repurchase program as well as other plans. The measures are intended to "strike the balance between positioning Mylan for both short- and long-term success while delivering total return to shareholders through share appreciation and our dividend policy," Mylan's Chief Executive Officer Robert Coury said. Specifically, the company plans to close its Mylan Bertek Pharmaceuticals Inc. subsidiary and transfer Bertek product selling responsibilities to Mylan Pharmaceuticals and UDL subsidiaries. "After careful evaluation, we have concluded that the existing Mylan Bertek business is not the type of brand platform that would enable us to fulfill our long stated vision and objective of becoming a more balanced specialty pharmaceutical company," Coury said. "We believe that closing Mylan Bertek will streamline our operations and result in significant cost savings." Moreover, Coury said the company has decided to out-license nebivolol so the company can effectively launch the product with minimal risk and maximal opportunity for shareholders. Commercialization of the product, which received an approvable letter for treating hypertension earlier this month, is then expected to be "cash-efficient and nondilutive," he added. According to CBS MarketWatch, SG Cowen analyst Ian Sanderson said the move could save Mylan between $0.20 and $0.25 per share in annual costs. He added that Johnson & Johnson would be the most likely candidate to license the product, which could achieve peak sales of $800 million per year if it is approved for both hypertension and heart failure. Mylan will begin a modified "Dutch Auction" self-tender Thursday that will enable it to buy up to approximately 48.8 shares or $1 billion. It will pay between $18 to more than $20.50 per share. Once this is completed, Mylan expects to buy back up to an additional $250 million of its common stock on the open market so that, in total, it will have repurchased nearly 25 percent of its outstanding shares. Sanderson said this will move the fair-market value of the stock from $14 to approximately $19 per share. Mylan noted that it continues to believe that financier Carl Icahn's previous offer to acquire Mylan was not serious and that discussions with him are not in the best interest of the company. "If the buyback doesn't completely thwart Icahn, it will take a lot of wind out of his sail. There's also a chance that they could buy out his position, if he chooses to tender," Sanderson said. Mylan also provided financial guidance for fiscal 2006 and 2007. In 2006, the company forecasts adjusted earnings of between $0.92 and $1.15 per diluted share on net revenue ranging from $1.14 billion to $1.34 billion. For fiscal 2007, Mylan expects adjusted earnings of between $1.20 and $1.74 per diluted share and net revenue ranging from $1.25 billion to $1.6 billion. On average, analysts polled by Thomson First Call project 2006 adjusted earnings of $0.81 per share and revenue of $1.36 billion, CBS MarketWatch reported. In 2007, they are estimating $0.97 adjusted earnings per share on $1.47 billion in revenue. The company also said it will increase its annual dividend from $0.12 per share to $0.24 per share effective with its 2006 first-quarter dividend of $0.06 per share payable on July 15 to shareholders of record on June 30. According to The Associated Press, Icahn responded, "We are pleased that Mylan has finally announced actions attempting to enhance shareholder value. However, it is a sad commentary that Mylan needed the strong prodding of its largest shareholder to take the actions that were announced this morning." -=- ROCHE'S XELODA APPROVED AS ADJUVANT THERAPY FOR DUKES' C COLON CANCER ------------------------------------------------------------------------------- The Food and Drug Administration approved F. Hoffmann-La Roche Ltd.'s Xeloda (capecitabine), an orally administered chemotherapy agent, as adjuvant treatment for patients with Dukes' C colon cancer when fluoropyrimidine therapy alone is preferred. The company said the approval was based on results from the X-ACT trial, in which researchers evaluated the comparative effects of Xeloda and intravenous 5-fluorouracil plus leucovorin (5-FU/LV) on disease-free survival. During the trial, three-year disease-free survival rates were 66 percent among Xeloda-treated patients and 62.9 percent among patients treated with 5-FU/LV. Roche noted that 5-FU/LV, also known as the Mayo Clinic Regimen, has been the foundation for the treatment of this type of cancer for 40 years. However, the company added, a need exists for more convenient treatment regimens. Intravenous chemotherapy can require up to 30 clinic visits during 24 weeks of treatment compared with a minimum of eight visits with Xeloda. "What this means is that now thousands of additional colon cancer patients could have the option of using a convenient and effective oral chemotherapy earlier in the treatment of their disease. With Xeloda, they can replace hours of cumbersome intravenous therapy in a clinic with a pill that can be taken at home," said Dr. Howard Burris with the Sarah Cannon Research Institute in Nashville, Tenn. Once ingested, Xeloda is activated by thymidine phosphorylase, a naturally occurring enzyme that is expressed at higher levels in colorectal cancers. Once inside the tumor, Xeloda is transformed into 5-FU, according to Roche. Xeloda is also approved for the treatment of metastatic breast cancer. -=- ANGIOMAX RECEIVES ADDITIONAL APPROVAL TO TREAT PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION ------------------------------------------------------------------------------- The Food and Drug Administration approved The Medicines Co.'s antithrombotic agent, Angiomax (bivalirudin), for use in patients undergoing percutaneous coronary intervention (PCI), or angioplasty. Evidence for the new approval comes from the REPLACE-2 trial, in which researchers evaluated the efficacy and safety of Angiomax plus glycoprotein IIb/IIIa inhibitors (GPIs) in patients undergoing PCI. According to the company, the FDA said in its approval letter that "statistical non-inferiority was not demonstrated for the triple (ischemic) endpoint [death, myocardial infarction, repeat procedures or in-hospital major bleeding] at 30 days," a viewpoint that contradicts that expressed by the REPLACE-2 investigators in an article published in the Feb. 19, 2003 issue of JAMA. However, the agency concluded that Angiomax, "with provisional use of GPI, is safe and effective for anticoagulation during PCI, including placement of intracoronary stents." The updated labeling also contains new dosing recommendations for Angiomax. The prescribing information now recommends a smaller bolus (0.75 mg per kg/body weight) and a smaller infusion (1.75 mg/kg/h), and suggests the infusion be administered throughout the procedure rather than during a four-hour period (as previously specified). The firm said that previous research has shown that this dose "enables streamlined patient care and significantly reduced costs." The company added that it intends to launch promotional programs in the coming weeks as a result of the expanded approval. The Medicines Co. has also filed an additional supplemental New Drug Application for Angiomax for use in patients with heparin-induced thrombocytopenia and thrombosis syndrome (HITTS) in patients undergoing PCI. HITTS is an immune-mediated response to the administration of heparin that results in life-threatening clot formation. The company anticipates an FDA response to this application during the second half of this year. Angiomax is already approved for use in patients undergoing percutaneous transluminal coronary angioplasty, or balloon angioplasty. The Medicines Co. stock closed at $23.77, up $1.32, or 5.9 percent, in heavy trading on the Nasdaq. -=- BMS CREATES NEW POLICY SAYING NO DTC ADVERTISING FOR NEW DRUGS UNTIL ONE YEAR POST-LAUNCH ------------------------------------------------------------------------------- Bristol-Myers Squibb Co. will refrain from direct-to-consumer advertising of any new drug until one year after the launch of the drug, according to a new company policy. During the one-year period, BMS will educate medical professionals regarding the new drug and seek their input regarding their experience prescribing the product. "We have seen research and heard from patients about their concerns about [DTC] advertising. Based on that feedback, and also feedback from medical professionals, we have decided to change our policy," BMS spokesman Tony Plohoros told Reuters. BMS pledged that future DTC ads would include communication of the risks and benefits of the company's products in language that consumers understand and would highlight programs that can improve access to drugs for patients in need. BMS also said it would submit all future DTC advertising materials to the Food and Drug Administration for advisory comments. -=- EXUBERA APPEARS TO BE WELL TOLERATED AMONG PATIENTS WITH DIABETES, STUDIES SUGGEST ------------------------------------------------------------------------------- Pfizer Inc. and sanofi-aventis Group's inhalable insulin Exubera (human insulin powder) was well tolerated for a two-year period among adults with type 2 diabetes, according to data from multiple studies. Researchers conducted a pooled analysis of two Phase III studies involving 304 adults with type 2 diabetes and an analysis of a third study involving 384 patients treated with Exubera during a two-year open-label extension trial. Results showed that patients treated with Exubera maintained glycemic control for the two-year period and experienced no clinically important effects on pulmonary function. In addition, a separate study involving 226 adults with type 1 diabetes showed that Exubera was as well tolerated and effective at achieving tight glycemic control as subcutaneous short-acting insulin. The study results were presented at the American Diabetes Association's annual meeting in San Diego. Exubera has been submitted for regulatory approval in the United States and the European Union for the treatment of type 1 and type 2 diabetes in adults. -=- Real Branding THE NATIONAL LIPID ASSOCIATION ------------------------------------------------------------------------------- The National Lipid Association established a task force that will conduct an extensive safety review of statins and other lipid-modifying drugs. The group's activities will include contributing to an unbiased, published report and conducting a risk-benefit analysis to determine the overall impact of lipid-modifying drugs on public health. The task force received unrestricted grant funding from AstraZeneca Plc, Kos Pharmaceuticals Inc. and Sankyo Pharma Inc. -=- Real Branding ORGANON INTERNATIONAL INC. ------------------------------------------------------------------------------- Organon International Inc. and Fabre-Kramer Pharmaceuticals Inc. reached an agreement whereby Fabre-Kramer will reacquire all rights to Gepirone ER, an investigational treatment for depression. In June 2004, the Food and Drug Administration determined that the New Drug Application for Gepirone ER as a treatment for major depressive disorder was not approvable. However, under the agreement, Organon will receive a milestone payment and royalties if Gepirone ER is approved by the FDA. -=- Real Branding FRESENIUS MEDICAL CARE AG ------------------------------------------------------------------------------- Fresenius Medical Care AG received a second request from the Federal Trade Commission asking for more information regarding the company's proposed acquisition of Renal Care Group Inc. Under the Hart-Scott-Rodino Antitrust Improvements Act, this request extends the waiting period until 30 days after the firms have complied with the request, unless the period is extended by the parties or terminated by the FTC. Fresenius plans to quickly respond and anticipates completing the transaction during the second half of this year. -=- Real Branding CODEXIS INC. ------------------------------------------------------------------------------- Codexis Inc. entered into an agreement with Matrix Laboratories Ltd. for the development and commercialization of active pharmaceutical ingredients designed for a valuable pharmaceutical product. Using a Codexis Thoroughbred biocatalyst, Codexis will use its re-engineering technology platform to create a new synthetic process for the product. The process will then be transferred to Matrix for scale-up and manufacturing, with Matrix retaining exclusive manufacturing and marketing rights. Codexis will receive funding, milestone payments and a royalty on net product sales. -=- Real Branding


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