• Accredo Health Inc., of Memphis, Tenn., said that one of its primary divisions, Accredo Therapeutics, has been selected by CoTherix Inc., of South San Francisco, as one of up to three specialty pharmacy providers of Ventavis (iloprost) inhalation solution. Ventavis is approved for pulmonary arterial hypertension (World Health Organization Group I), or PAH, in patients with New York Heart Association Class III or IV symptoms. Ventavis is an inhaled formulation of iloprost, a synthetic compound that is structurally similar to prostacyclins. (See BioWorld Today, Jan. 4, 2005.)

• Alexion Pharmaceuticals Inc., of Cheshire, Conn., priced its private placement of $125 million convertible senior notes due 2012. The notes will bear interest of about 1.4 percent per annum and be convertible into shares of Alexion's stock at an initial conversion rate of about 31.8 shares per $1,000 in notes. Alexion has granted the initial purchasers an option for an additional $25 million in notes. Proceeds will be used to retire Alexion's outstanding 5.75 percent convertible subordinated notes due 2007 and for general corporate purposes.

• Allos Therapeutics Inc., of Westminster, Colo., initiated a Phase I study of its drug PDX (pralatrexate) with vitamin B12 and folic acid supplementation in patients with previously treated (Stage IIIB-IV) non-small-cell lung cancer. The study will enroll six patients per treatment level who have received one prior chemotherapy regimen and might or might not have received an EGFR kinase inhibitor to test the safety, tolerability and pharmacokinetics of escalating doses. PDX is an injectable, small-molecule agent aimed at inhibiting dihydrofolate reductase.

• Antigenics Inc., of New York, priced and entered a definitive agreement to sell $50 million aggregate principal amount of convertible senior notes in a private placement. The sale is expected to close on Jan. 25. Antigenics granted the initial purchasers of the notes a 30-day option to purchase up to an additional $10 million of convertible senior notes. The notes will bear an annual interest rate of 5.25 percent and be initially convertible into Antigenics common stock at a conversion price of about $10.76 per share, as might be adjusted.

• AVI BioPharma Inc., of Portland, Ore., announced a $24 million direct equity placement, entering agreements with several institutional investors for the purchase of 8 million shares of its common stock at $3 per share. Investors also will receive four-year warrants to purchase 1.6 million shares of common stock at an exercise price of $5 per share. The company said proceeds would fund AVI's operations and ongoing clinical programs for treatment of cardiovascular and infectious diseases and cancer. The company's stock rose 103 percent Wednesday to close at $4.14, after it announced it had received a patent covering use of antisense to modulate stem cell maturation. (See BioWorld Today, Jan. 20. 2005.)

• BioDelivery Sciences International Inc., of Newark, N.J., signed a definitive license agreement with Sigma-Tau Industrie Farmaceutiche Riunite SpA for the application of its Bioral nanocochleate delivery technology to formulate up to four pharmaceutical compounds under development by Sigma-Tau, an Italian affiliate of the Sigma-Tau Group. Concurrent with the licensing agreement, Biodelivery entered a stock purchase agreement with Sigma-Tau, and also received an up-front payment of $250,000. The four compounds are new chemical entities and are targeted for use in the fields of oncology, cardiology and immunology.

• Biosignal Ltd., of Sydney, Australia, engaged Dr. Reddy's Laboratories, of Hyderabad, India, to develop a large-scale manufacturing procedure and synthesize quantities of Biosignal's antibacterial furanone compounds. Financial terms were not disclosed.

• Bolder BioTechnology Inc., of Wheat Ridge, Colo., was awarded a $100,000 Phase I Small Business Innovation Research grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. The grant supports research to optimize a human protein to enhance its ability to inhibit formation of new blood vessels.

• CollaGenex Pharmaceuticals Inc., of Newtown, Pa., intends to seek injunctive relief to protect its patent and intellectual property rights following a decision by the U.S. District Court for the District of Columbia. The decision upheld the FDA's classification of Periostat as an antibiotic drug that is not entitled to the patent and exclusivity protection otherwise available under the Hatch-Waxman amendments. Periostat is the registered trademark of CollaGenex's 20-mg tablets of doxycycline hyclate, approved as a systemic adjunct to scaling and root planing for the treatment of adult periodontitis.

• Copernicus Therapeutics Inc., of Cleveland, received an extension to its therapeutics development award from the Cystic Fibrosis Foundation Therapeutics Inc. The $750,000 award was coupled with a $280,000 outstanding payment from the original award to bring the total payment to about $1 million. The extension will support the Phase II advancement of Copernicus' potential genetic therapy for cystic fibrosis.

• Cryptome Pharmaceuticals Ltd., of Melbourne, Australia, said animal studies show that its lead drug, CR001, can reduce the tendency of blood to clot and works within minutes of administration. CR001 is a fragment of a naturally occurring human protein that inhibits the tissue factor-initiated pathway of coagulation. It might offer benefits as an anti-thrombosis treatment, the company said.

• Epigenomics AG, of Berlin, was informed by the majority of its venture capital investors that any sale of shares, which were subject to a six-month lock-up period that expired on Jan. 14, would take place in a jointly executed and coordinated procedure. Morgan Stanley has been appointed to manage the process. The agreement is binding for all investors throughout the year 2005 with opt-out windows every four months.

• Galapagos Genomics NV, of Mechelen, Belgium, stands to receive a milestone payment from Boehringer Ingelheim, of Ingelheim, Germany, which reported it had used Galapagos' SilenceSelect gene knockdown platform to identify a number of genes shown to influence viral replication in human cells. The SilenceSelect collection, offered by Galapagos' genomics services unit, Galadeno, is an adenoviral collection containing siRNA knockdown sequences targeting human druggable transcripts. Under terms of their October 2003 agreement, Galapagos gained up-front technology access fees and is eligible for further option and license fees during the program. Further financial terms were not disclosed.

• GenVec Inc., of Gaithersburg, Md., signed a $1.6 million contract with the Department of Defense to manufacture an adenovector-based malaria vaccine candidate for the U.S. Naval Medical Research Center (NMRC), using GenVec's adenovector technology and 293-ORF6 cell line-based manufacturing process. The vaccine, based on two antigens, is designed to attack multiple stages in the life cycle of the P. falciparum malaria parasite. The NMRC will use materials manufactured under the contract to complete preclinical testing for a planned clinical trial.

• Manhattan Pharmaceuticals Inc., of New York, said the FDA accepted an investigational new drug application for the human clinical testing of its orally administered obesity therapeutic, Oleoyl estrone. The company plans to begin a Phase I trial in Switzerland in the first quarter of 2005. Oleoyl estrone is an oral small molecule shown to cause weight loss without the need for dietary modifications, Manhattan Pharma said. The company's stock (OTC BB:MHTT) rose 37.2 percent Thursday, or 32 cents, to close at $1.18.

• MedImmune Inc., of Gaithersburg, Md., filed an investigational new drug application to begin clinical studies of its respiratory syncytial virus and parainfluenza virus Type 3 candidate vaccine. Preclinical data indicate that the combination vaccine elicited protective immune responses to RSV and PIV-3. MedImmune plans to begin a Phase I trial of the vaccine in healthy adults who have had several years of exposure to wild-type RSV and PIV-3.

• Metabolon Inc., of Research Triangle Park, N.C., agreed to collaborate with the High Q Foundation on a new biomarker study for Huntington's disease. Metabolon will test plasma samples obtained from patients using its metabolomics platform that searches for signatures of HD by measuring the spectrum of biochemical changes, and then mapping those changes to metabolic pathways. Researchers will try to find key biomarkers that will differentiate controls and early- and late-stage disease.

• MorphoSys AG, of Martinsried, Germany, acquired privately held companies, Biogenesis Ltd., of Poole, UK, and its sister company, Brentwood, N.H.-based Biogenesis Inc., for £5.25 million (US$9.8 million), less net debt of £700,000 cash. The two Biogenesis companies will become wholly owned subsidiaries of MorphoSys and will be integrated with MorphoSys' research antibody business unit, Antibodies by Design.

• NicOx SA, of Sophia-Antipolis, France, completed full recruitment in its Phase II trial of NCX 4016 for the treatment of peripheral arterial obstructive disease (PAOD). Four hundred fifty patients with symptomatic PAOD and intermittent claudication have been recruited. The study was designed to evaluate the clinical effects of NCX 4016 on clinical parameters in PAOD, with particular regard to walking distance. The primary endpoint is the change in maximum treadmill walking distance after six months.

• Northfield Laboratories Inc., of Evanston, Ill., filed a prospectus with the SEC for an offering of 3.5 million shares of common stock under an existing shelf registration statement. The company expects to grant underwriters an option for up to 525,000 additional shares to cover overallotments. UBS Investment Bank is the sole book-running manager, and SG Cowen and Harris Nesbit are co-managers. Northfield is developing a blood substitute, PolyHeme, which is in a pivotal Phase III trial.

• Phytopharm plc, of Godmanchester, UK, said a scheduled interim data review for the ongoing Phase II proof-of-principle study of PYM50028 showed no associated safety concerns. The study will continue. Also, the number of subjects will increase from 200 to 238. The compound is an orally active, synthetic, neuroprotective and neuroregenerative product that is under development as a treatment for Alzheimer's disease. The study is being conducted in the UK under the terms of a clinical trial authorization.

• QLT Inc., of Vancouver, British Columbia, reported global Visudyne (verteporfin) sales of about $124 million for the fourth quarter and $448 million for the year 2004. The sales represent a 29.3 percent and a 25.6 percent increase, respectively, over the fourth quarter and for 2003. Visudyne is approved to treat wet age-related macular degeneration and the form of subfoveal choroidal neovascularization that occurs in people 30 and older.

• SurModics Inc., of Eden Prairie, Minn., made an equity investment of €3 million (US$3.9 million) in OctoPlus Technologies BV, of Leiden, Netherlands, as part of an €18.25 million private placement of OctoPlus' preferred stock. In June, SurModics exclusively in-licensed two biodegradable polymer classes from OctoPlus for medical device applications.