Acrongenomics Inc., of Athens, Greece, launched its Nano-JETA Real Time PCR Pilot kits for DNA/RNA quantification with the use of beta-globin and Ep-CAM gene, respectively. The Real Time PCR delivers quantitative detection of nucleic acids from the second cycle up to the 13th cycle.
Altana AG, of Bad Homburg, Germany, said its Daxas (roflumilast) collaboration with Pfizer Inc., of New York, was mutually terminated. As a result, Pfizer returned all rights to the phosphodiesterase4 (PDE4)-inhibitor to Altana, which will assume sole responsibility for its development, including ongoing clinical studies. At the same time, Altana said top-line results from a one-year chronic obstructive pulmonary disease (COPD) study showed that the drug significantly improved lung function (FEV1) compared to placebo, the primary endpoint. Specifically, Daxas treatment was associated with 39 +/- 12 ml (p=0.0005) and 48 +/- 9 ml difference from placebo using a full longitudinal data analysis, respectively (p<0.0001). The study included 1,513 patients with severe and very severe COPD. A co-promotion agreement with Pfizer on Detrol will continue under its current terms until the end of next year.
Cephalon Inc., of Frazer, Pa., said underwriters of its previously announced offering of $800 million in aggregate principal amount of 2 percent convertible senior notes due 2015 exercised their full overallotment option to purchase $120 million of additional notes. The total amount of the notes issued comes to $920 million. The notes are convertible prior to maturity into cash and shares of common stock at a conversion price of $46.70 per share. Cephalon intends to use proceeds to purchase its outstanding 2.5 percent notes due 2006 at a price of 97.5 percent of the principal amount. Funds also will be used to repay or repurchase other outstanding debt and for other corporate purposes.
Chronogen Inc., of Montreal, and Inpharzam Richerche, of Taverne, Switzerland, a subsidiary of Zambon SpA, entered a research and development agreement to identify small molecules for the treatment of cardiovascular and metabolic diseases induced by oxidative damage and/or lipids disorders. Chronogen will screen the library of Inpharzam using its in vivo screening assays.
CuraGen Corp., of New Haven, Conn., said preclinical data reported at the International Symposium on Supportive Care in Cancer in Geneva, showed that velafermin (CG53135) might protect the gastrointestinal tract and decrease associated toxicity, including enteritis and diarrhea, following exposure to radiation. More specifically, it was reported that the incidence of enteritis and diarrhea for animals treated with velafermin was reduced up to 50 percent. The product already is in Phase II for the prevention of oral mucositis.
CV Therapeutics Inc., of Palo Alto, Calif., said underwriters exercised their option to purchase an additional $19.5 million in convertible senior notes due 2013 to cover overallotments. The closing of the additional purchase option will increase the surrogate principal amount of 3.25 percent notes to $149.5 million. The company intends to redeem all the outstanding $79.6 million principal amount of its 4.75 percent notes due 2007, and plans to use about $15.2 million to set up an escrow account. Remaining proceeds will go toward general corporate purposes. (See BioWorld Today, June 30, 2005.)
EPIX Pharmaceuticals Inc., of Cambridge, Mass., said the FDA accepted its May submission as a complete response to the approvable letter received from the FDA in January for Vasovist (MS-325). The FDA indicated it would review EPIX's NDA, including the May submission with a target date for an action letter in late November. The FDA also encouraged EPIX to consider a re-read of the images from the Phase III trials to provide additional information about the usefulness of dynamic vs. steady state images, and to schedule a meeting with the FDA to discuss the merits and design of such a study. Vasovist is the first imaging pharmaceutical specifically designed for magnetic resonance imaging, the company said.
Indevus Pharmaceuticals Inc., of Lexington, Mass., closed its previously announced sale of Sanctura marketing rights from Florham Park, N.J.-based Odyssey Pharmaceuticals Inc. to Esprit Pharma Holding Co. Inc. (formerly Saturn Pharmaceuticals Inc.), a recently formed, privately held firm. Sanctura is marketed as a treatment for overactive bladder.
Isolagen Inc., of Exton, Pa., reported positive results from its Phase II dental study to determine the safety and efficacy of the Isolagen Process for the treatment of interdental papillary insufficiency, commonly referred to as "black triangles." The analysis demonstrated that the process was statistically superior to placebo at four months after treatment. Isolagen develops autologous cellular therapies for soft- and hard-tissue regeneration.
Isotechnika Inc., of Edmonton, Alberta, said preliminary data from a Phase III trial of its immunosuppressive compound, ISA247, in psoriasis met its primary endpoint of a two-point reduction in static global assessment scores. The drug also achieved secondary endpoints, including a 75 percent reduction, as measured by the Psoriasis Area and Severity Index. The results were presented at the Canadian Dermatology Association's annual conference in Quebec.
Johnson & Johnson, of New Brunswick, N.J., said its subsidiary, Ortho-McNeil Pharmaceutical Inc., completed the planned acquisition of Alameda, Calif.-based Peninsula Pharmaceuticals Inc. in a $245 million cash-for-stock transaction announced in April. Through the acquisition, J&J will get Peninsula's lead anti-infective compound, doripenem, in Phase III trials to treat nosocomial pneumonia. Last month, Peninsula withdrew its initial public offering of 5.75 million shares with a price range of $12 to $14. (See BioWorld Today, April 20, 2005.)
MerLion Pharmaceuticals Pte. Ltd., of Singapore, and the Institute of Molecular and Cell Biology in Singapore entered a three-year drug discovery and development collaboration in which the institute will provide the company with a series of selected drug targets and projects. MerLion will provide access to its natural products sample collection and apply its screening and natural products chemistry processes to the isolation of new chemical leads and drug candidates. It also will supply its medicinal chemistry in the optimization and preclinical development of active chemical templates. The deal's initial focus will center on identifying potential cancer drug candidates based around the Bcl-2 family of proteins. The partners will work together on lead discovery and optimization and share ownership of the output.
NitroMed Inc., of Lexington, Mass., is launching BiDil (isosorbide dinitrate/hydrazaline hydrochloride), a drug approved last month for the treatment of heart failure in black patients as an adjunct to standard therapies. BiDil will be priced at a wholesale acquisition cost of $1.80 per tablet and supplied to pharmacists in 180-tablet bottles. Since recommended starting dose is three tablets daily, that would translate to $5.40 per day, analyst Jennifer Chao, of New York-base Deutsche Bank Securities, said in a research note. She said that figure is 40 percent higher than earlier estimates of $3.88 per day. Deutsche Bank expects BiDil sales to be $73 million in 2005, $131 million in 2006 and $192 million in 2007. NitroMed's stock (NASDAQ:NTMD) closed at $22.15 Friday, up 14 percent, or $2.70. (See BioWorld Today, June 27, 2005.)
RxKinetix Inc., of Louisville, Colo., said it is one of the 43 recipients of a grant from the Grant Challenges in Global Health Initiative, an international effort supported by a $450 commitment from the Bill and Melinda Gates Foundation, as well as $27.1 from the Wellcome Trust and $4.5 million from the Canadian Institutes for Health Research.
Structural GenomiX Inc., of San Diego, said its New York Structural GenomiX Research Consortium was one of four large-scale centers selected to receive part of $300 million in grants for the Protein Structure Initiative project, funded mostly by the National Institutes of Health. The project is set to begin its second phase to find 3-dimensional shapes of a wide range of proteins. The Joint Center for Structural Genomics, the Midwest Center for Structural Genomics and the Northeast Structural Genomics Consortium also were selected.