454 Life Sciences Corp., of Branford, Conn., said findings published in the July 31, 2005, online issue of Nature detail a new genome sequencing technique 100 times faster than previous technologies. The company's technology, which uses a sequencing technique in microfabricated high-density picoliter reactors, was demonstrated by repeatedly sequencing the bacterial genome Mycoplasma genitalium in four hours, with up to and exceeding 99.99 percent accuracy. 454, a majority owned subsidiary of CuraGen Corp., of New Haven, Conn., said the news represents the first new technology for genome sequencing to be developed and commercialized since Sanger-based DNA sequencing.
Adventrx Pharmaceuticals Inc., of San Diego, closed its previously announced $20 million private placement of common stock and warrants, led by investment funds controlled by Carl Icahn. Those investors, along with New York-based Viking Global Investors LP, will have the right to designate one director to Adventrx's board. The company sold 10.8 million shares of common stock, and issued warrants to purchase an additional 10.8 million shares at an exercise price of $2.26 per share. Proceeds will be used to develop Adventrx's lead product, CoFactor, and broaden its product pipeline in cancer and antiviral treatments.
Aegis Therapeutics LLC, of San Diego, entered a licensing agreement for its patented Intravail drug delivery technology for application to several undisclosed pediatric therapeutics being developed by an unnamed partner focused on that area of medicine. In June, Aegis reported the expansion of its earlier licensing agreement with Intranasal Technologies Inc. to include beta-interferon and low-molecular-weight heparin and has since initiated feasibility studies on a number of additional peptide and protein therapeutics for several pharmaceutical clients.
Amgen Inc., of Thousand Oaks, Calif., and Abgenix Inc., of Fremont, Calif., said the FDA granted fast-track designation for panitumumab, a fully human monoclonal antibody directed against the epidermal growth factor receptor in patients with metastatic colorectal cancer who have failed standard chemotherapy. Fast-track status allows for the submission of a rolling biologics license application and could result in an expedited regulatory review. The companies said they are working toward initiating a BLA submission by the end of the year.
Anadys Pharmaceuticals Inc., of San Diego, filed a preliminary prospectus supplement to its shelf registration statement relating to a proposed underwritten public offering of 4 million shares of its common stock. It is anticipated that the underwriters will be granted an overallotment option for an additional 600,000 shares. All of the shares are being sold by Anadys Pharmaceuticals.
Aptanomics SA, of Lyon, France, entered a collaboration agreement on aptamer-based target validation and drug discovery with Boehringer Ingelheim GmbH, of Ingelheim, Germany. Peptide aptamers are used to interrogate a target for druggable sites and assign and prioritize the biological relevance of the newly revealed sites, and the deal calls for Aptanomics to provide Boehringer with a panel of peptide aptamers and characterize the consequence of binding to therapeutic targets. Financial terms were not disclosed.
Ariad Pharmaceuticals Inc., of Cambridge, Mass., plans to publicly sell 6 million shares of common stock, under an existing shelf registration statement. Underwriters have been granted the option to purchase up to 900,000 shares in overallotments. Lehman Brothers Inc. is acting as sole book-running manager, while Lazard Capital Markets LLC and SG Cowen & Co. LLC are acting as co-managers.
Auxilium Pharmaceuticals Inc., of Malvern, Pa., said top-line findings from a Phase II trial showed that its androgen-replacement product candidate can produce increased serum testosterone levels. The product uses the company's Transmucosal Film Technology to deliver testosterone, and 97 percent of participants rated the transmucosal film either desirable (49 percent) or acceptable (48 percent). The trial evaluated doses of 5, 10 and 15 mg, and results allowed Auxilium to narrow the three tested doses to the lowest dose employed in the study.
Axonyx Inc., of New York, said the FDA approved its investigational new drug application to allow Phase I testing of Posiphen, expected to begin soon in healthy volunteers. Posiphen, which demonstrated in preclinical studies the ability to lower beta amyloid levels in rodents, is in development for the treatment of Alzheimer's disease progression.
BioMarin Pharmaceutical Inc., of Novato, Calif., submitted a new drug application for Orapred ODT, a new formulation of Orapred (prednisolone sodium phosphate oral solution) for inflammatory conditions associated with asthma, arthritis and cancer. The filing comes only weeks after the company cut a large part of its Orapred sales force due to the approval of two generic corticosteroids. (See BioWorld Today, July 7, 2005.)
Biosite Inc., of San Diego, signed an agreement with Banyan Biomarkers Inc., of Alachua, Fla., to review proposed cerebrovascular injury targets discovered with Banyan's animal model of cerebral injury. Biosite may select targets that Banyan nominates and could then make antibodies to those selected targets using the company's antibody development process, which combines immunization of mice and phage display to generate libraries of Omniclonal antibodies. Validated targets would be assessed for potential commercialization. Financial terms were not disclosed.
CureLab Inc., of Boston, was awarded a grant from the National Institutes of Health to continue developing a vaccine against the influenza virus. The award is part of a two-phase grant under the Small Business Innovation Research Bio Defense Program and is expected to total about $7 million. CureLab has developed technology designed to create a vaccine that would work against all flu strains, and also plans to use that technology to create vaccines for AIDS, SARS, Ebola virus, hepatitis C and small pox.
Genentech Inc., of South San Francisco, said its Genentech Foundation for Biomedical Sciences awarded 26 grants worth almost $1.2 million for science programs at educational and community-based organizations in the Bay Area. The grants represent an 11 percent increase over last year's funding, and the new grantees reach hundreds of students in a range of approaches to challenge youth in the world of biotechnology.
Human Genome Sciences Inc., of Rockville, Md., received $7 million in payments from its partner, London-based GlaxoSmithKline plc, related to the achievement of manufacturing and preclinical development milestones for GSK716155 (formerly Albugon), a drug in late-stage preclinical development for the treatment of diabetes. HGS recognized $2 million as revenue in the second quarter, and expects to recognize the remaining $5 million as third-quarter revenue. The agreement, signed in October 2004, allowed GSK to acquire exclusive rights to develop the compound, in exchange for milestone payments that could total up to $183 million, in addition to royalties on any commercialized products. (See BioWorld Today, Oct. 27, 2004.)
Isolagen Inc., of Exton, Pa., said preliminary Phase III results showed that two simultaneous dermal studies of its Isolagen Process for contour deformities met three of four primary endpoints and achieved statistical significance when the results of the two studies were combined. Study B proved to be statistically significant with both patient and physician assessment achieving positive results, while Study A results were mixed with a positive assessment from the patients only. Also, a wide variance in results was reported from site to site across both studies with response rates ranging from 73.3 percent to 7.6 percent, which the company attributed to injection technique.
Large Scale Biology Corp., of Vacaville, Calif., received orphan drug designation for its recombinant human Lysosomal Acid Lipase (LAL) therapeutic. LAL is a naturally occurring human enzyme involved in the metabolism of certain lipids, including cholesteryl esters and triglycerides, and a body's lack of that enzyme can lead to life-threatening accumulations of lipids in major organs. In addition to orphan diseases caused by LAL deficiency, LSBC said its drug also could find use in treating arterial lipid plaque deposits, such as those that occur in atherosclerosis.
Ligand Pharmaceuticals Inc., of San Diego, submitted a request to the Nasdaq Listing Qualifications panel for an additional extension of the deadline for the company to come into full compliance with the Nasdaq requirements for continued listing related to the filing of SEC reports. The company will announce the Nasdaq's decision once it is received.
Nanogen Inc., of San Diego, said that the National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health in Bethesda, Md., awarded the company a grant for $2.5 million over the next five years for a research project to develop a prototype fully integrated diagnostic system for clinical labs to identify infectious agents that cause sepsis and community-acquired pneumonia (CAP). The grant will enable Nanogen to develop improved molecular biological methods, miniaturize those methods and demonstrate the performance of the new molecular diagnostic approach to diagnose sepsis and CAP in a hospital laboratory setting.
Nastech Pharmaceuticals Co. Inc., of Bothell, Wash., plans to offer 1.5 million shares of common stock, pursuant to an effective shelf registration statement. The company intends to grant underwriters an option to purchase an additional 225,000 shares to cover overallotments. New York-based Needham & Co. LLC is acting as sole lead book-running manager, with SunTrust Robinson Humphrey and Delafield Hambrecht Inc. acting as co-managers.
PowderMed Ltd., of Oxford, UK, said that it has advanced its H5N1 avian influenza vaccine program into the final stages of preclinical development. PowerMed said it has produced an H5N1 vaccine by cloning the H5 gene from the current circulating avian flu strain into the company's vaccine "backbone," and now is ready for development.
Samaritan Pharmaceuticals Inc., of Las Vegas, is expanding its business to create a European presence in Athens, Greece, under the moniker Samaritan Europe. The division will be led by Christos Dakas, who also will oversee Samaritan Ireland Pharmaceuticals Ltd. as part of managing all European operations. The company said it decided to expand abroad for easier access to European and developing countries' clinical trial partnerships, European Union development grants and the expansion of its drug discovery and research laboratories.
The Quigley Corp., of Doylestown, Pa., said its wholly owned Quigley Pharma (Ethical Pharmaceuticals) subsidiary obtained results from its continued preclinical research on QR440, botanical broad-spectrum anti-inflammatory compound, which show that QR440 may have disease-modifying potential.