AdipoGenix Inc., of Boston, named Ed Cannon president and CEO. He was the founding president and CEO of Elixir Pharmaceuticals Inc., of Cambridge, Mass., and is replacing Tom Vogel, who joined AdipoGenix as president and CEO in 2002. He will continue as an advisor and member of the board at the company, which is developing products that treat obesity and its co-morbidities.
Albany Molecular Research Inc., of Albany, N.Y., agreed to a two-year collaboration with Alcon Research Ltd., of Fort Worth, Texas, to discover and develop ophthalmic pharmaceuticals. AMRI will screen samples from its natural product collections to identify and develop compounds and provide custom chemical synthesis services. AMRI said it could receive possible milestone payments and royalty payments on net sales of commercial products. Financial terms were not disclosed.
Atherogenics Inc., of Atlanta, announced pricing of $175 million aggregate principal amount of its convertible notes due 2012 in a private placement. The notes will bear a 1.5 percent annual interest rate and be convertible into shares of common stock at an initial rate of about 38.6 shares per $1,000 principal amount of notes, subject to adjustment. Atherogenics said it expects proceeds to fund costs of its ARISE trial for AGI-1067, other research and development, clinical trials and general corporate purposes.
Crucell NV, of Leiden, the Netherlands, said its STAR technology is being evaluated by Genentech Inc., of South San Francisco, for the production of antibodies and other proteins. In a joint evaluation program that is funded by Genentech, the companies are investigating whether STAR can increase the production yields of Genentech's systems. If successful, Genentech has an option to sign a nonexclusive license agreement to the technology.
DFB Pharmaceuticals Inc., of Fort Worth, Texas, acquired the wound-management activities of EpiSource SA, a subsidiary of Lausanne, Switzerland-based IsoTis OrthoBiologics Co. Financial details were not disclosed. DFB said initial focus will be on Allox, EpiSource's spray delivery platform using live human cells.
DOR BioPharma Inc., of Miami, entered an agreement whereby a subsidiary of Cambrex Corp., of East Rutherford, N.J., will provide process development and current Good Manufacturing Processes production services for DOR's ricin vaccine, RiVax. They will work together pursuant to DOR's recently awarded $5.2 million grant from the National Institutes of Health in Bethesda, Md., for ricin vaccine development.
Elan Corp. plc, of Dublin, Ireland, agreed to more broadly license its NanoCrystal technology to F. Hoffmann-La Roche Ltd., of Basel, Switzerland. The deal gives Roche the right to apply the technology, which is designed to improve the clinical performance of poorly water-soluble drugs by transforming them into nanometer-sized particles, to a number of its drug candidates. Elan will receive development milestones and royalties on sales of any product incorporating the use of the technology, though specific financial terms were not disclosed.
Elite Pharmaceuticals Inc., of Northvale, N.J., said its subsidiary, Elite Laboratories Inc. reported results from its clinical program testing the company's abuse resistant technology (ART) for narcotic analgesics, using naltrexone as a narcotic antagonist. The company said studies, involving 12 volunteers, showed that unaltered naltrexone formulated with ART would not be absorbed into the patients' blood. Elite Labs said it plans to continue with the clinical program.
Erasmus Medical Center in Rotterdam, the Netherlands, said The Lancet published results from a large international study showing that peginterferon alfa-2b produced sustained responses in patients with chronic hepatitis B. The study showed that patients with chronic hepatitis B responded to peginterferon alfa-2b, and achieved higher sustained response rates than is typically seen with any other antiviral treatment.
GlycoGenesys Inc., of Boston, received notification from Nasdaq that it has evidenced compliance with the bid price requirement and all other requirements necessary to continue its listing on The Nasdaq SmallCap Market. Accordingly, a hearing scheduled later this month to determine its listing status has been canceled and the hearing file will be closed. The company is focused on carbohydrate-based drug development.
ID Biomedical Corp., of Vancouver, British Columbia, received FDA clearance to begin immediate clinical testing of its influenza vaccine, Fluviral, in the U.S. The company intends to ship product to the U.S. and begin enrollment before the end of this month. The Fluviral vaccine to be tested was produced using a terminal sterile filtration step, a modification to the production process that is an FDA requirement for flu vaccines entering the U.S. market. The study will involve about 300 healthy adults between 18 and 64. The company also said it completed enrollment of a similar clinical trial of Fluviral in Canada. It enrolled 658 people and is designed to compare Fluviral's safety and immunogenicity of using the new production process vs. a comparator flu vaccine. The Canadian trial is being conducted in adults in two age groups, 50 to 64 and more than 64 years of age.
Inhibitex Inc., of Atlanta, completed enrollment in its Phase II trial of Aurexis in 60 patients with documented Staphylococcus aureus bloodstream infections. The company added that enrollment in its ongoing Phase III trial of Veronate for the prevention of hospital-associated infections in very low-birth-weight infants has outpaced initial expectations as it has more than one-third of the 2,000 patients intended for inclusion. At the same time, an independent Data Safety Monitoring Board unanimously recommended that the trial proceed as designed without modification after reviewing safety and other data available from the first 500 patients.
Ligand Pharmaceuticals Inc., of San Diego, exercised the first option under its November 2004 agreement with Indianapolis-based Eli Lilly and Co. to buy down a portion of the royalties payable to Lilly on U.S. sales of Ligand's cancer drug Ontak. Ligand will make a one-time cash payment of $20 million to Lilly in exchange for elimination of the Ontak royalties due in 2005, and a reduced reverse-tiered royalty scale on net sales in the U.S. thereafter above a certain threshold. Ligand recorded sales of $34.3 million for Ontak in 2003, and $25.9 million in the first three quarters of 2004. (See BioWorld Today, Nov. 10, 2004.)
Nabi Biopharmaceuticals, of Rockville, Md., initiated a U.S. StaphVax immunogenicity study in orthopedic surgery patients with implanted devices. The trial will evaluate a total of 120 patients undergoing orthopedic surgery that involves the implantation of synthetic material. The objective of the study is to evaluate safety and antibody levels over a six-month period. Results are expected by the end of the third quarter.
Neurogen Corp., of Branford, Conn., appointed Craig Saxton chairman of the company's board. Saxton, 62, is a former executive of Pfizer Inc., where he oversaw global drug development. He has served on Neurogen's board since January 2002 and succeeds Frank Carlucci, who remains on the board as chairman emeritus.
Paradigm Therapeutics Ltd., of Cambridge, UK, completed the acquisition of Amedis Pharmaceuticals Ltd., also of Cambridge. At the point of merger, the company reported cash reserves of £11 million (US$20.6 million), about half of which is new investment. Focused on identifying targets and compounds in the areas of CNS, pain, endocrinology and metabolism, the company has two programs in late-stage preclinical development.
ProtoKinetix Inc., of Vancouver, British Columbia, received their first report on the safety of the initial series of newly synthesized antifreeze glycoproteins (AFGPs) from France's National Institute of Chemistry. The in vitro assays performed on KB cells showed that the new chemical structures are totally lacking cytotoxicity even in very high doses. Natural AFGPs have been shown to enable the preservation of cells and tissues for an extended period of time at low temperatures.
Schering AG, of Berlin, said the FDA issued an approvable letter for Bonefos (clodronate), an oral non-amino bisphosphonate intended to reduce the occurrence of bone metastases in the post-surgical treatment of breast cancer patients. Schering's U.S. affiliate, Berlex Laboratories Inc., of Montville, N.J., plans to request a meeting with the FDA to discuss the information needed to obtain final approval.
SemBioSys Genetics Inc., of Calgary, Alberta, said the underwriters of its initial public offering have exercised the entire overallotment option and purchased an additional 525,000 common shares and 262,500 warrants, resulting in gross proceeds of about C$2.6 million (US$2.1 million). In total, the company, which is developing protein-based pharmaceutical and non-pharmaceutical products, received about C$20.1 million in gross proceeds from the IPO and the exercise of the overallotment. A syndicate of investment dealers co-led by Orion Securities Inc. and Dlouhy Merchant Group Inc., and including First Associates and Raymond James Ltd., participated in last month's financing. (See BioWorld Today, Dec. 8, 2004.)
The American Society of Hematology in Washington said research published in the Jan. 15, 2005, issue of Blood showed that stem cell transplantation is a viable option for select patients with HIV-associated lymphoma. It has become the standard of care for patients with relapsed lymphoma, but not for patients who suffer from that disease and HIV.
Ziopharm Inc., of New Haven, Conn., agreed to a two-year collaboration with Southern Research Institute, of Birmingham, Ala., to develop a series of IPM (isophosphoramide mustard) analogues. Ziopharm also signed a two-year option agreement for exclusive worldwide rights for the alkylating agents and said a patent covering those analogues has been issued in the U.S. In November, the company announced it secured exclusive global rights to a form of IPM (Z10-201) from DEKK-Tec Inc. of New Orleans.