¿ Acambis plc, of Cambridge, UK, said its U.S. subsidiary, Acambis Inc., of Cambridge, Mass., was awarded a second contract by the U.S. Centers for Disease Control and Prevention to produce smallpox vaccine. This contract is to produce 155 million doses of smallpox vaccine within the next 12 months at a fixed price of $428 million. Acambis has teamed up with Baxter BioScience, the biotechnology business of Baxter Healthcare Corp., of Deerfield, Ill., to contribute toward manufacturing. The contract includes the funding of an accelerated clinical development plan with the objective of obtaining FDA approval of the vaccine as rapidly as possible. Approval application is expected in mid-2003 and funding for this plan will be spread over 2002 and 2003. The first clinical trials of Acambis¿ vaccine are scheduled to start early in 2002. Acambis¿ stock (NASDAQ:ACAM) gained $7.30 Thursday, or 20 percent, to close at $45.
¿ Alliance Pharmaceutical Corp., of San Diego, said as a result of a successful pre-approval inspection of its manufacturing facility, the company received a letter stating the Los Angeles District Office of the FDA is recommending approval for Imavist (AFO150), an ultrasound contrast agent. The recommendation has been submitted to the FDA¿s Center for Drug Evaluation and Research, and any final approval will come from that office. Imavist is intended to increase the diagnostic value of echocardiography by providing more detailed images of the heart than can be achieved with standard (non-contrast) ultrasound imaging.
¿ Amerimmune Pharmaceuticals Inc., of Woodland Hills, Calif., completed a Phase Ia human safety trial for an intravenous formulation of its murine monoclonal antibody. The study, conducted in 13 subjects suffering from HIV/AIDS, found Cytolin to be safe and well tolerated across a narrow dose range. The initial study consisted of two single escalating doses of 0.05mg/kg and 0.1mg/kg body weight.
¿ Angiogene Inc., of Montreal, enrolled the first patients into Beta-Impact, its Phase I/II trial for the prevention of restenosis following balloon angioplasty. This open-label trial is aimed at assessing the safety, tolerability and efficacy of delivering the Angiogene Oliglow radiotherapeutic compound locally into the coronary wall. Oliglow is a beta-emitter source that has demonstrated in preclinical studies optimal retention properties in the arterial wall, and has shown effectiveness in inhibiting smooth muscle cell proliferation, a key cause of restenosis.
¿ Cell Therapeutics Inc., of Seattle, said its cancer drug treatment, Trisenox (arsenic trioxide) injection, was granted orphan drug designation for the treatment of both chronic myeloid and acute myelocytic leukemias by the FDA. CTI is in the process of studying Trisenox as a single agent and in combination with Gleevec (imatinib mesylate) for chronic myeloid leukemia in chronic, accelerated and blast crises. Additionally, the National Cancer Institute is sponsoring several clinical trials that are in Phase II for acute myelocytic leukemia.
¿ Cellegy Pharmaceuticals Inc., of South San Francisco, acquired Vaxis Therapeutics Corp., of Kingston, Ontario. The transaction is valued at less than $4 million payable primarily in Cellegy stock plus potential earnout payments over a seven-year period. The acquisition of privately held Vaxis provides Cellegy with issued U.S. patents covering nitroglycerin and other nitric oxide donors for the treatment of female sexual dysfunction (FSD) as well as a number of other conditions. In addition to the FSD indication, the Vaxis pipeline and patents consist of nitroglycerin and other nitric oxide donors for the treatment of peripheral vascular disorders, including Raynaud¿s disease.
¿ Celsion Corp., of Columbia, Md., said it completed treatment of all 160 patients required in its pivotal benign prostatic hyperplasia Phase II trial. Also, it submitted to the FDA two of the three required modules necessary to complete the premarket approval application. Celsion focuses on medical treatment systems for cancer and other diseases, using targeted heat technology delivered by microwave technology.
¿ Cepheid Inc., of Sunnyvale, Calif., announced a two-year Cooperative Research and Development Agreement with the U.S. Department of Agriculture to develop DNA tests for rapid field diagnosis of plant diseases threatening major cash crops. The tests will be developed and optimized for use on Cepheid¿s portable Smart Cycler TD and its next-generation GeneXpert systems. USDA scientists will design DNA primers and probes to detect organisms response for several diseases, including citrus canker, Karnal bunt of wheat, Pierce¿s disease in grape vines and plum pox in stone fruits. Cepheid retains first rights to license resulting diagnostic tests for commercial use on its systems.
¿ Cytogen Corp., of Princeton, N.J., received notification from the state of New Jersey that it may sell $1.26 million in tax benefits for the current tax year under the state¿s technology tax certificate transfer program. The benefits may be sold for not less than 75 cents on the dollar. Cytogen is arranging for the sale of the credits and anticipates concluding the transaction for net proceeds of about $1.1 million this quarter.
¿ DeCode genetics Inc., of Reykjavik, Iceland, and Roche Ltd., of Basel, Switzerland, reported that DeCode scientists mapped the first gene with genome-wide significant linkage to rheumatoid arthritis outside the MHC region. The companies will use the discovery for further research and development in both diagnostics and therapeutics. DeCode receives milestone payments for this discovery under the companies¿ 1998 gene and drug development alliance. The findings, combined with existing knowledge on the links between variations in the MHC and rheumatoid arthritis, provide genetic markers that predict an increased risk. DeCode¿s stock (NASDAQ:DCGN) rose $1.85 Thursday, or 23 percent, to close at $9.90.
¿ Emisphere Technologies Inc., of New York, announced the results of the initial Phase I study evaluating the oral delivery of cromolyn sodium, a nonsteroidal anti-allergy medication, with one of the company¿s proprietary drug delivery agents. The study consisted of cromolyn sodium administration with an Emisphere carrier in an oral capsule formulation to 10 healthy human volunteers, who received either four treatments of the cromolyn sodium/carrier combination or one treatment of cromolyn and one of the carrier alone. Results of the study showed effective absorption from the gastrointestinal tract. The oral dose produced maximum mean plasma cromolyn concentrations as high as 46 ng/mL, which is higher than those obtained from the current, non-oral methods of administration, such as nebulized liquid or inhaled aerosol formulations.
¿ Endovasc Ltd., of Montgomery, Texas, responded to the Office of Orphan Products Development in a letter which further clarifies the patient population for Liprostin. Correspondence from OOPD suggested clarification was required regarding the patient population to obtain approval for an application submitted by the company in August for treatment of patients with critical limb ischemia.
¿ Epimmune Inc., of San Diego, and Bavarian Nordic A/S, of Copenhagen, Denmark, entered a collaboration agreement to combine their technologies to develop vaccines for the treatment or prevention of HIV infection. The companies will combine Epimmune¿s technology and expertise in the fields of T-cell epitope (protein fragment) identification and vaccine design with Bavarian Nordic¿s vaccine delivery technology, Modified Vaccinia Ankara, and its development and manufacturing expertise to design and develop both therapeutic and prophylactic HIV vaccines.
¿ Exelixis Inc., of South San Francisco, delivered four crop protection targets to Dow AgroSciences LLC, of Indianapolis, under the companies¿ year-old collaboration that could lead to the development of more effective products to control weeds and fungal diseases of plants. The discoveries were made through Exelixis¿ Mechanism of Action technology, which identifies the molecular target of biologically active compounds, in this case herbicidal and fungicidal compounds provided by Dow. The identification of these targets triggered undisclosed milestone payments to Exelixis. Separately, Exelixis began its exchange offer for common stock shares of gene analysis software company Genomica Corp., of Boulder, Colo. Exelixis announced the acquisition, valued at $110 million, on Nov. 19.
¿ Genset SA, of Paris, received confirmation from the French securities regulatory authority (COB) that the financing structure considered by its new agreement with Sociiti Ginirale meets the COB¿s requirements as they have been specified to date for this type of financing structure. Under the two-year agreement, Sociiti Ginirale will purchase shares of Genset stock at times determined by Genset. The new issuance of shares to Sociiti Ginirale will be based on reference periods of five consecutive trading days selected by Genset. Depending on the volumes traded and share prices on the Nouveau Marchi during the reference periods, Sociiti Ginirale will purchase between 5,000 and 125,000 Genset shares at the end of each period. As long as the price of Genset¿s shares on the final day of the five-day period exceeds the average trading price over the five-day period, Sociiti Ginirale will purchase beween 7.5 percent and 15 percent of the number of Genset¿s shares traded on the Nouveau Marchi during the reference period.
¿ Inhale Therapeutic Systems Inc., of San Carlos, Calif., said it saw positive results from a study of inhaleable leuprolide, its peptide analogue used to treat prostate cancer and endometriosis. Results showed a powdered formulation of leuprolide developed with Inhale¿s Inhance pulmonary delivery technology delivered the drug with a bioavailability of 18 percent, compared to injectable systemic delivery. The results of the 12-person study suggest clinical doses of leuprolide could be given as once-daily single inhalations.
¿ Geron Corp., of Menlo Park, Calif., reported publication of research results that demonstrate that the company can differentiate human embryonic stem cells (hESCs) into populations of neural precursors and mature, functional neurons, including dopaminergic neurons that have the potential for use in treating Parkinson¿s disease. Published in next month¿s issue of Experimental Neurology, in the studies hESCs were maintained in feeder-free conditions for over 100 population doublings and were subsequently differentiated into populations of cells highly enriched (70 percent to 90 percent) of proliferating neural precursor cells. These progenitor populations were further differentiated into mature neurons that showed similar functional characteristics to human fetal-derived neurons. The hESC-derived neurons expressed the relevant biochemical markers and showed appropriate functional activity measured by electrophysiological techniques.
¿ Neoprobe Corp., of Dublin, Ohio, reported an agreement with Fusion Capital Fund II LLC, a Chicago-based institutional investor, for Fusion to buy up to $10 million of Neoprobe¿s common stock over 40 months. The price and number of shares purchased will be based upon the stock¿s market price at the time of sale without any fixed discount. Proceeds from the funding will be used for general corporate and working capital purposes, but are primarily intended to support expansion and development of new products. Neoprobe has the right to decrease or suspend purchases of common stock and to terminate the common stock purchase agreement at any time.
¿ Oncolytics Biotech Inc., of Calgary, Alberta, completed enrollment for its Phase I trial of Reolysin, a human reovirus-based product, for the treatment of various cancers. Interim safety and efficacy information will be reported before the end of the quarter. The trial is designed to determine the safety and tolerance of Reolysin when administered by injection directly into the tumor in late-stage cancer patients. As secondary endpoints, the company is measuring tumor response for both the treated lesion, as well as remote tumors.
¿ Pambec Laboratories Inc., of Loveland, Colo., released an AIDS drug, Aidfarel, which it said shows great promise in permanently stopping the human immunodeficiency virus-1 that causes AIDS. The drug, soon to be delivered to the National Cancer Institute for final cellular testing, works differently from all other AIDS drugs, whether synthesized or found in nature. Clinical trials will begin once the cellular test data have been reviewed by the FDA. Aidfarel inhibits both the replication and transcription of the integrated viral DNA known as a provirus by using the Binary Molecular DNA Clamp.
¿ Pharmasset Inc., of Atlanta, was awarded a Phase I Small Business Innovation Research Program grant of $148,000. The National Institute of Allergy and Infectious Disease will fund research on antivirals against hepatitis B virus. The objective is to further characterize a number of novel Pharmasset nucleoside compounds that have demonstrated antiviral activity against HBV. Pharmasset will continue the preclinical evaluation of compounds that have the potential to suppress HBV and greatly minimize the likelihood of the development of resistance.
¿ Ribozyme Pharmaceuticals Inc., of Boulder, Colo., raised $9.5 million through the sale of nearly 2.3 newly issued shares of common stock and five-year warrants to purchase 226,191 additional newly issued shares of its common stock at an exercise price of $5 per share. ABN AMRO Inc. served as financial adviser and placement agent of the offering. Ribozyme said the proceeds will provide it with additional resources to be used to fund and expand clinical development programs in cancer and hepatitis together with the development of Ribozyme¿s diagnostic and pharmacogenomic technology platform based on the use of Allosteric ribozymes. Ribozyme¿s anti-hepatitis C virus ribozyme, Heptazyme, is in Phase II development.
¿ Scion Pharmaceuticals Inc., of Medford, Mass., entered into an agreement with CeNeS Pharmaceuticals Inc., of Norwood, Mass., to acquire CeNeS¿ chemical libraries and associated intellectual property rights in the areas of sodium and calcium ion channels, as well as glutamate and sigma receptors. Scion also is acquiring various other assets and equipment from CeNeS, and it may acquire a Small Business Innovation Research grant from the National Institutes of Health. Scion will own and have worldwide exclusive rights to the compound portfolio and all of its associated intellectual property. Scion will pay CeNeS $800,000 in staged payments and up to $2 million in milestone payments.
¿ Stressgen Biotechnologies Corp., of Victoria, British Columbia, released Phase II trial results involving its lead fusion product, HspE7, a novel immunotherapeutic for the treatment of diseases caused by human papillomavirus. Final results of the high-dose study in patients with high-grade anal dysplasia at six months demonstrated a 75 percent reduction from high-grade dysplasia, a precursor to anal cancer, to low-grade dysplasia, potentially avoiding the need for surgery in these patients. At 18 months in the follow-up registry, 50 percent were in complete remission. Final results of the high-dose study in patients with genital warts at six months demonstrated a 53 percent median reduction of wart area vs. 16 percent with placebo. Similar results had been seen in six-month data. Further follow-up of the same retrospectively reviewed patients showed a 73 percent complete remission rate for those patients followed 18 months.
¿ Third Wave Technologies Inc., of Madison, Wis., said its board of directors approved the adoption of a shareholder rights plan. The plan is designed to enable all Third Wave stockholders to realize the full value of their investment and to provide for fair and equal treatment of all stockholders in the event that an unsolicited attempt is made to acquire the company. Stockholders of record at the close of business on Dec. 20 will receive one right to purchase a fractional share of Third Wave preferred stock. The rights will be issued as a non-taxable dividend and will expire 10 years from the date of the adoption of the rights plan, unless earlier redeemed or exchanged.
¿ Transkaryotic Therapies Inc., of Cambridge, Mass., said the U.S. District Court of Delaware issued an opinion favorably construing the claims of U.S. Patent No. 5,356,804 in an infringement suit Genzyme Corp., of Cambridge, Mass., and Mount Sinai School of Medicine brought against it. Next week, TKT plans to move for summary judgment that Replagal does not infringe on this patent. In July 2000, the two entities sued TKT over Replagal (agalsidase alfa), an enzyme replacement therapy for Fabry disease, saying that it infringed on the patent. Separately, Genzyme said it also would seek summary judgment of infringement of its patent ¿based upon TKT¿s own admissions¿ during the hearing. TKT¿s stock (NASDAQ: TKTX) rose $4.33, or 11.6 percent, on Thursday to close at $41.55.
¿ Vivus Inc., of Mountain View, Calif., said it saw positive results from a Phase II study of Alista, its topical formulation of alprostadil for the treatment of female sexual dysfunction. The double-blind, placebo-controlled crossover-design trial evaluated patient responses to doses of Alista administered in the clinic in conjunction with visual sexual stimulation. Seventy-nine patients were treated at six sites.