Adams Respiratory Therapeutics Inc., of Chester, N.J., completed its initial public offering of 9.1 million shares of its common stock at $17 each, raising $155.4 million. The offering consisted of 6.9 million shares sold by Adams and 2.25 million shares sold by selling stockholders. Shares are now trading on Nasdaq National Market under the symbol "ARXT." Underwriters included Merrill Lynch & Co., Morgan Stanley, Deutsche Bank Securities and RBC Capital Markets.
Advanced Cell Technology Inc., of Worcester, Mass., entered a collaboration with the Burnham Institute, a California-based non-profit medical research institution, to conduct research that aims to isolate stem cell-specific differentiation markers. Advanced Cell Technology focuses on applying stem cell technology in the field of regenerative medicine.
Alteon Inc., of Parsippany, N.J., said its board adopted an amended and restated stockholder rights agreement to renew and replace the agreement that expired Wednesday. The plan is designed to ensure that all shareholders receive fair and equal treatment in the event of a potential takeover.
Aspreva Pharmaceuticals Corp., of Victoria, British Columbia, said it began patient dosing in the pivotal Phase III trial evaluating CellCept (mycophenolate mofetil) for the treatment of lupus nephritis. The study aims to enroll 358 patients worldwide. Aspreva entered a partnership with F. Hoffmann-La Roche Ltd., of Basel, Switzerland, in 2003 to develop CellCept, Roche's transplant product, in autoimmune diseases.
AutoGenomics Inc., of Carlsbad, Calif., and Targeted Molecular Diagnostics, of Westmont, Ill., formed a three-year partnership to develop cancer biomarkers for oncology performed on the AutoGenomics Infiniti platform. It will be used by pharmaceutical and biotech companies in preclinical and clinical development of targeted therapies. The first assay will be a gene-expression assay associated with tumor response and resistance to compounds targeting the HER1 and HER2 pathways. Future assays will cover specific breast cancer response to therapies, apoptotic response and resistance to chemotherapy.
Biota Holdings Ltd., of Melbourne, Australia, has assessed the damages caused by partner London-based GlaxoSmithKline plc's alleged neglect in supporting the influenza drug, Relenza. It listed in its May 2004 lawsuit losses of between $234 million and $326 million. The assessment accounts for a conservative and a moderate market growth scenario, it said, and assumes Relenza would have achieved a 40 percent market share, instead of the 1 percent worldwide share it now holds.
Cytokinetics Inc., of South San Francisco, said data demonstrated that CK-1213296 activated cardiac myosin by accelerating actin-dependent phosphate release. In cardiac myocytes, it increased contractility without changes in intracellular calcium, and it demonstrated an increase in cardiac contractility and stroke volume in a dog model of heart failure. The data were presented at the 2nd annual symposium of the American Heart Association Council on Basic Cardiovascular Sciences - Targeting Heart Failure: New Science, New Tools, New Strategies, being held in Keystone, Colo.
Dharmacon Inc., of Lafayette, Colo., completed the world's first genome-wide, short-interfering RNA library. It was developed using Dharmacon's SMARTselection and SMARTpool technologies.
DiscoveRx Corp., of Fremont, Calif., launched its new PathHunter cell-based assay platform, a screening technology that uses positional complementation in whole-cells to study cell signaling events based on protein translocation and trafficking. Pathway analysis can reveal important information about off-target effects, compound specificity, and cross-reactivity for drug candidates.
Gentium SpA, of Villa Guardia, Italy, said underwriters of its initial public offering exercised their overallotment option to purchase 300,000 of the company's American depository shares at $9 each, for $2.7 million more in proceeds added to the $21.6 million already raised. Maxim Group LLC and I-Bankers Securities Inc. served as co-managers of the offering. Gentium is focused on developing drugs derived from DNA extracted from natural sources and drugs that are synthetic oligonucleotides to treat vascular diseases and conditions related to cancer and cancer treatments.
Geron Corp., of Menlo Park, Calif., initiated clinical testing of its lead cancer compound, GRN163L, in patients with chronic lymphocytic leukemia. The Phase I/II, dose-escalation trial is designed to demonstrate the safety and tolerability of the drug, an inhibitor of telomerase, administered intravenously on a weekly basis.
Immune Response Corp., of Carlsbad, Calif., said results from a Phase II trial of Remune in HIV patients showed that the drug was effective in delaying virologic failure during antiretroviral treatment interruption. Patients receiving the greatest number of injections showed the longest time to reach a failure endpoint. The study also demonstrated a correlation to the magnitude of HIV-specific immune responses induce in studied patients. The data were presented at the International AIDS Society meeting in Rio de Janeiro, Brazil.
Ivory Capital Corp., of Charlotte, N.C., said its stockholders voted to reincorporate the company in the state of Delaware under the name Chelsea Therapeutics International Ltd. Chelsea Therapeutics Inc. will remain a wholly owned subsidiary. Chelsea acquires and develops technologies to treat rheumatoid arthritis, psoriasis, cancer, and other immunological diseases.
MAP Pharmaceuticals Inc., of Mountain View, Calif., and Elan Corp. plc, of Dublin, Ireland, amended their 2004 agreement to apply Elan's NanoCrystal technology to defined inhalation therapies. The companies have been collaborating to develop a nebulized form of budesonide to treat asthma. The agreement provides additional rights to MAP for the use of NanoCrystal technology to treat multiple respiratory diseases, including asthma.
Morria Biopharmaceuticals plc, of London, said its leading inhaled drug candidate, MRX3, ameliorated asthma symptoms and reduced the levels of several key inflammatory mediators in preclinical trials in animals. Results of the studies appear in the current issue of Thorax.
Paladin Labs Inc., of Montreal, entered into an exclusive agreement with Verus Pharmaceuticals Inc., of San Diego, to commercialize Twinject in Canada. The product is an epinephrine auto-injector indicated for the emergency treatment of severe allergic reactions. It was approved by Health Canada in 2003.
Repligen Corp., of Waltham, Mass., saw it shares (NASDAQ:RGEN) jump 41.6 percent Wednesday, gaining 97 cents to close at $3.30, after the company released its first-quarter earnings for fiscal year 2006. Total revenue for the three months ending June 30 were $4.2 million, compared to revenue of $2.8 million the year before, an increase of 51 percent. The company reported net income of $2.2 million, or 7 cents per share, compared to a net loss 645,000 one year earlier. As of June 30, Repligen had cash and investments totaling $24.9 million.
Schering AG, of Berlin, and AstraZeneca plc, of London, entered a research collaboration and licensing agreement in selective glucocorticoid receptor agonists. The companies will work together up to the end of Phase I trials to identify novel SEGRAs. Under the three-year agreement, AstraZeneca will have an exclusive, worldwide license to develop and market compounds for rheumatoid and respiratory diseases, while Schering will have the same for all other indications. Schering will receive up-front fees, and both parties might benefit from downstream milestone payments and royalties.
Sinovac Biotech Ltd., of Beijing, China, said the State Food and Drug Administration issued a production license for the company's influenza flu vaccine, Anflu. The company received a new drug certificate for Anflu in March, but it now can begin vaccine production, and marketing will begin in late summer. Sinovac markets two other vaccine products in China, including Healive for hepatitis A, and Bilive for hepatitis A and hepatitis B.
StemCell Pharma Inc., of Las Vegas, opened a StemCell Treatment Center at which it will use the placenta/stem cell implant developed by Alfred Sapse to treat patients with multiple sclerosis, early Alzheimer's and retinitis pigmentosa. Clinical trials indicate the implant's effectiveness lasts up to 12 months, compared with two to three months from transplants conducted abroad, the company said.
Tm Bioscience Corp., of Toronto, signed an agreement to supply the University of Miami's Dr. John T. Macdonald Foundation Center for Medical Genetics with reagents for use in its cystic fibrosis and Ashkenazi Jewish panel gene assays. The tools will help researchers screen individuals and populations at risk for DNA variations and mutations, allowing physicians to intervene and prevent serious genetic disorders.
Transkaryotic Therapies Inc., of Cambridge, Mass., and Shire Pharmaceuticals Group plc, of Basingstoke, UK, said shareholders at each company approved the $1.6 billion cash acquisition of TKT by Shire. The acquisition is expected to be completed this week. (See BioWorld Today, April 22, 2005.)
UCB Pharma Inc., of Smyrna, Georgia, the U.S. headquarters of Brussels, Belgium-based UCB, announced positive results for two pivotal Phase III trials of certolizumab pegol for Crohn's disease. The Precise 1 and 2 trials assessed the safety and efficacy of Cimzia, a PEGylated Fab' fragment of a humanized anti-TNF alpha monoclonal antibody, compared to placebo over a 26-week period and in a total of 1,330 patients with active disease. The data will be presented in detail at an upcoming gastroenterology medical meeting.
Wilex AG, of Munich, Germany, said it completed its first Phase I trial of its oral anticancer compound WX-671. The study investigated the oral bioavailability, pharmacokinetics and safety at four dose levels in 16 healthy male volunteers. WX-671 is a second generation serine protease inhibitor targeting the uPA (urokinase Plasminogen Activator) system, which has been shown to play a role in metastasis and primary tumor growth of breast cancer and other solid tumors.
Zonagen Inc., of The Woodlands, Texas, said its contract data management organization completed the final data assessment associated with the Phase Ib trial completed earlier this year on the effects of Proellex on fibroid size. The three-month study included three dose levels of Proellex, as well as a positive control arm (Lucrin/Lupron) and placebo. Patients receiving Proellex saw improvements in symptoms associated with uterine fibroids, namely reduced pain and bleeding, as well as effects on bone retention when compared to Lucrin.