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branding IdentityBrand 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 PR PHARMACEUTICALS' INVESTIGATIONAL PAH INJECTION GRANTED ORPHAN DRUG DESIGNATION ------------------------------------------------------------------------------- PR Pharmaceuticals Inc. (PRP), a private biopharmaceutical company, said its lead compound, PulmoLAR (2-methoxyestradiol), was granted orphan drug status by the Food and Drug Administration for the treatment of pulmonary arterial hypertension (PAH).During preclinical and in vitro studies, PulmoLAR addressed "many of the pathological processes associated with PAH," the company said. PulmoLAR significantly reduced levels of endothelin-1 and increased the synthesis of prostacyclin in endothelial cell cultures, PRP noted, adding that data from cell cultures showed the injectable drug to be a "potent inhibitor of vascular smooth muscle and endothelial cell proliferation." Animal models of PAH demonstrated that PulmoLAR reduced right ventricular hypertrophy, vascular remodeling, pulmonary hypertension and inflammatory cell infiltration in lung tissues. According to Dr. Stevan Tofovic, principal investigator of the animal studies, PulmoLAR "markedly" reduces damage to lung arteries that can lead to right ventricular failure. "The net effect is reduced severity of disease, resulting in improved survival," he said. PRP anticipates filing an Investigational New Drug application and beginning Phase I studies this year. "The orphan drug designation for PulmoLAR for PAH is an important step in our development efforts," said Dr. Claude Piche, the company's vice president of clinical development and regulatory affairs. "In addition to recognizing the potential the drug offers for this indication, orphan drug designation offers benefits in terms of regulatory exclusivity, assistance with clinical development and a waiver of [Prescription Drug User Fee Act] filing fees," he noted. -=- CEPHALON TO BUY PRIVATELY HELD ONCOLOGY DRUG COMPANY FOR APPROXIMATELY $160 MILLION CASH ------------------------------------------------------------------------------- Cephalon Inc. signed a definitive merger agreement to acquire all outstanding capital shares of Salmedix Inc., a private, San Diego-based company that specializes in the development of compounds to treat hematologic malignancies. Cephalon will pay approximately $160 million in cash for the stock. Upon the achievement of certain regulatory milestones, Cephalon will be required to pay an additional $40 million in cash. At the close of the transaction, Cephalon said it expects Salmedix, which will become a wholly owned subsidiary, to have cash in hand of approximately $25 million, net of expenses related to the transaction. The transaction is expected to close in the second quarter. Treanda (bendamustine hydrochloride) is Salmedix's most advanced product and is currently in Phase II trials for the treatment of indolent non-Hodgkin's lymphoma (NHL). As a single agent, Treanda has demonstrated high response rates in patients with relapsed, indolent NHL who were refractory to treatment with Genentech Inc. and Biogen Idec Inc.'s Rituxan (rituximab). "We are excited about Treanda and its addition to our oncology portfolio," said Frank Baldino Jr., chief executive officer of Cephalon. "This acquisition, along with encouraging data from our ongoing studies of CEP-701 in acute myelogenous leukemia, gives us the opportunity to advance our entry into the oncology marketplace with multiple product candidates." CEP-701 is Cephalon's lead tyrosine kinase inhibitor; it is being tested as a treatment for AML and for prostate cancer. Through the acquisition of Salmedix, Cephalon will obtain exclusive rights to market Treanda in the United States and Canada. Cephalon said it expects the transaction to dilute its 2005 earnings by $0.10 to 0.15 per share. The company plans to issue a revised guidance after the acquisition closes. -=- CURAGEN ANNOUNCES NEW CEO, TWO RESEARCH AGREEMENTS; SHARES UP ------------------------------------------------------------------------------- CuraGen Corp. appointed board member Patrick Zenner, who was formerly president and chief executive officer of Hoffmann-La Roche Inc., as its new chairman and interim CEO; the company will continue its search for a new CEO. Zenner will be taking over for CuraGen's founder and CEO, Jonathan Rothberg, who will serve as chairman of CuraGen's majority-owned subsidiary, 454 Life Sciences Corp. Rothberg will also continue to serve on CuraGen's board of directors. Christopher McLeod, executive vice president of CuraGen, has been named 454 Life Sciences' president and CEO. CuraGen also announced that, along with TopoTarget A/S, it entered into a cooperative research and development agreement with the National Cancer Institute's Division of Cancer Treatment and Diagnosis regarding their histone deacetylase inhibitor, PXD101. The drug, which is being co-developed by Curagen and TopoTarget to treat patients with solid and hematologic cancers, is currently in Phase II testing for the treatment of advanced multiple myeloma. In separate news, 454 Life Sciences and F. Hoffman-La Roche Ltd. entered into an exclusive, five-year, worldwide agreement for the promotion, sale and distribution of 454 Life Sciences' nanotechnology-based Genome Sequencing Systems. According to the companies, 454's proprietary technology enables researchers "to sequence up to 100 times faster than current commercial platforms." CuraGen shares closed at $3.85, up $0.32, or 9.1 percent, in heavy trading on the Nasdaq. -=- IMCLONE TO DISCONTINUE SMALL MOLECULE PROGRAM, CLOSE FACILITY, CUT WORKFORCE ------------------------------------------------------------------------------- ImClone Systems Inc., maker of colon cancer drug Erbitux (cetuximab), intends to discontinue development of its small molecule cancer drugs by mid-July and will cut its workforce by approximately 5 percent. The company said its "pipeline and research heritage is in the development of antibodies" and that pursuing these avenues will offer "greater potential in the short- and long-term." The decision came after the company considered how long it would take to realize commercial benefits from the small molecule program. ImClone plans to shut down a chemistry facility in Brooklyn, N.Y., and eliminate 40 to 50 jobs. As a result, the company anticipates recording pre-tax charges of approximately $2 million in the second quarter related to severance costs. In addition, the company is considering writing off "long-lived" assets of its small molecule group, which would result in a charge for the value of the assets of approximately $5.5 million. While the severance costs will be a cash payment, the disposition of assets would involve a non-cash charge. ImClone expects to reduce its operating expense savings over the balance of the year, resulting from the program's discontinuation. -=- MYLAN'S Q4, FULL-YEAR EARNINGS, REVENUE FALL; FAILED KING ACQUISITION, WEAKER SALES TO BLAME ------------------------------------------------------------------------------- After failing to acquire King Pharmaceuticals Inc., Mylan Laboratories Inc.'s net earnings and net revenue fell in the fourth quarter ended March 31 and for the full 2005 fiscal year. For the fourth quarter, Mylan reported net earnings of $38.1 million, or $0.14 per diluted share, compared with net earnings of $74.9 million, or $0.27 per diluted share, in the prior-year's fourth quarter. Mylan said this quarter's earnings include approximately $0.06 per share in costs related to its planned acquisition of King, which was terminated in February when the companies were unable to agree on terms for the controversial transaction valued at approximately $4 billion. On average, analysts polled by Reuters Estimates had expected the company to report a profit of $0.17 per share for the quarter. Net revenue for the fourth quarter fell from $333.4 million in 2004 to $316.4 million in 2005. Mylan attributed the decline to "price erosion as a result of increased competition." For the fiscal year 2005, the company earned $203.6 million, or $0.74 per diluted share, compared with $334.6 million, or $1.21 per diluted share, in the previous fiscal year. Mylan reported net revenue of $1.25 billion for the full year compared with net revenue of $1.37 billion in fiscal year 2004. In March, Mylan said it expected to earn between $0.75 and $0.80 per share for fiscal 2005, but this guidance excluded charges related to the failed acquisition. Mylan shares closed at $16.07, down $0.29, or 1.8 percent, in moderate trading on the New York Stock Exchange. -=- TEVA'S COPAXONE PROVIDES SIGNIFICANT REDUCTIONS IN MS RELAPSE RATES AS COMPARED WITH INTERFERON DRUGS, NEW STUDY SHOWS ------------------------------------------------------------------------------- Treatment with Teva Pharmaceutical Industries Ltd.'s Copaxone (glatiramer acetate) appears to provide significantly greater reductions in multiple sclerosis relapse rates and results in significantly lower rates of discontinuation as compared with interferon drug therapy. A total of 308 patients with relapsing-remitting MS were included in the study. For six months, all subjects were treated with Copaxone, Biogen Idec Inc.'s Avonex (interferon beta-1a), Chiron Corp.'s Betaseron (interferon beta-1b) or Serono SA's Rebif (interferon beta-1a). The authors compared the drugs' treatment effects for an additional 24 months following the treatment period. After the initial six months of treatment, all groups demonstrated similar reductions in relapse rates. This treatment effect was sustained for the 24-month follow-up period. None of the interferon drugs showed superiority in reducing relapse rates at 12 and 24 months. However, as compared with the interferon drugs, Copaxone resulted in significantly higher rates of relapse reduction. Furthermore, a significantly lower rate of treatment discontinuation was observed among the Copaxone-treated patients than among those treated with interferon drugs. "[T]he results provide helpful clinical information regarding the efficacy of immunomodulatory therapies in early stages of [relapsing-remitting] MS patients in a clinical setting," the authors concluded. The study was published in the June edition of the European Journal of Neurology. -=- branding Identity BIOMARIN PHARMACEUTICAL INC. ------------------------------------------------------------------------------- BioMarin Pharmaceutical Inc.'s board of directors named Jean-Jacques Bienaime as the company's new chief executive officer effective immediately. Bienaime will also serve as a board member. Previously, Bienaime was chairman, president and CEO of Genencor International Inc. Bienaime replaces BioMarin's interim CEO, Louis Drapeau, who held the position since August, when Fredric Price resigned for personal reasons. BioMarin shares closed at $6.98, up $0.52, or 8.1 percent, in heavy trading on the Nasdaq. -=- branding Identity STRUCTURAL GENOMIX INC. ------------------------------------------------------------------------------- Structural GenomiX Inc. said its lead product candidate, Troxatyl (troxacitabine), received orphan drug designation from the Food and Drug Administration for the treatment of acute myelogenous leukemia (AML). The drug, a nucleoside analog, is being evaluated in separate Phase I/II trials as a treatment for relapsed AML and for treating solid tumors. The company plans to move into Phase II testing for the drug in relapsed and/or refractory AML in adult patients by mid-2005. -=- branding Identity ADHEREX TECHNOLOGIES INC. ------------------------------------------------------------------------------- Adherex Technologies Inc. initiated a Phase Ib/II clinical trial of Exherin, a targeted anticancer therapy also known as ADH-1, in advanced cancer patients with tumors expressing the molecular target N-cadherin. This second Phase Ib/II study will assess the drug's safety, tolerability and anti-tumor activity using ascending doses in a "daily x 5" schedule (daily dosing Monday through Friday) every three weeks. Adherex is also evaluating the drug in a Phase Ib/II trial in Europe and a Phase II trial in Canada. -=- branding Identity HANA BIOSCIENCES INC. ------------------------------------------------------------------------------- Hana Biosciences Inc. initiated a Phase I/II clinical study of anticancer agent talotrexin, also referred to as PT-523, as a monotherapy for relapsed or refractory acute lymphoblastic leukemia (ALL) in adults. The Phase I portion of the study will determine the drug's dosing, safety, tolerability and pharmacokinetics in patients with refractory leukemia; the Phase II portion will focus on talotrexin's efficacy in treating relapsed or refractory ALL. The company is also currently finishing Phase I testing of the drug in patients with advanced solid tumors and is beginning Phase I/II testing as a treatment for non-small cell lung cancer. Hana plans to test talotrexin in patients with cervical cancer, as well. -=- branding Identity
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