• Acambis plc, of Cambridge, UK, completed its submission of a biologics license application to the FDA for its investigational smallpox vaccine, ACAM2000. It was filed on a rolling basis, with the first portion in January, and it includes data obtained from clinical trials of the fast-track product conducted in more than 3,800 subjects. The company expects the FDA to complete its review before the end of the year.

• ArQule Inc., of Woburn, Mass., received an undisclosed milestone payment from Madison, N.J.-based Wyeth in connection with Wyeth's filing of an investigational new drug application for a compound in development for Alzheimer's disease. ArQule also is entitled to royalty payments.

• Chemokine Therapeutics Corp., of Vancouver, British Columbia, is regaining rights to its compound CTCE-0214 from Pharmaceutical Product Development Inc., of Wilmington, N.C. PPD, which originally licensed those rights three years ago, will retain an interest in the program through potential future milestone payments. Chemokine will pay PPD $100,000 cash on closing, and up to $2.5 million in milestone payments that include $250,000 upon initial Phase III dosing, $250,000 upon filing a new drug application with the FDA, $1 million upon FDA approval for any therapeutic use and 50 percent of the first net sales up to $1 million. The agreement further provides that Chemokine will buy back the 2 million convertible preferred shares held by PPD for 86 cents apiece. In the alternative, at the option of Chemokine, the agreement provides that PPD may convert some or all of those shares into common shares and resell them to a third-party buyer, with Chemokine buying back the preferred shares that are not converted by PPD. The transaction will close on or before May 27.

• Chimerix Inc., of Research Triangle Park, N.C., signed a Cooperative Research and Development Agreement with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) in Fort Detrick, Md., to evaluate its smallpox therapeutic, CMX001, in animal models. The agreement with USAMRIID will allow Chimerix to test CMX001 and other potential drug candidates in USAMRIID's animal models of smallpox and monkey pox infection. The company is developing CMX001 as an oral treatment for smallpox and for complications from the smallpox vaccine.

• Clinuvel Pharmaceuticals Ltd., of Melbourne, Australia, disclosed positive interim results from a Phase II trial with CUV1647 as a prophylactic treatment for patients suffering from moderate to severe polymorphous light eruption, or sun poisoning, confirming results of an earlier trial in Europe last year. The randomized, double-blind clinical trial consisted of two groups of 13 patients receiving either an active or placebo sustained-release implant. Results showed a statistically significant difference (p=0.01) between the active and placebo groups in usage of systemic corticosteroids.

• Corgentech Inc., of South San Francisco, filed a $100 million universal shelf registration statement to permit the company to occasionally issue various securities for proceeds of up to that amount. The terms of any such future offerings and the type of securities to be issued would be determined at the time of any future offering.

• ExonHit Therapeutics SA, of Paris, said a number of its SpliceArray products are available on the Affymetrix microarray platform, in accordance with a supply and provider agreement signed between ExonHit and Santa Clara, Calif.-based Affymetrix Inc. last October.

• InterMune Inc., of Brisbane, Calif., completed patient enrollment in the INSPIRE trial, a pivotal Phase III trial of Actimmune (interferon gamma-1b) in patients with idiopathic pulmonary fibrosis (IPF). The trial is anticipated to conclude in late 2007, with top-line data expected in early 2008. InterMune already markets Actimmune for chronic granulomatous disease and severe, malignant osteopetrosis.

• Isis Pharmaceuticals Inc., of Frederick, Md., granted an exclusive worldwide license to Carlsbad, Calif.-based ImQuest Pharmaceuticals Inc. for ISIS 5320, a phosphorothioate oligonucleotide that has been shown in vitro and in vivo to be a specific inhibitor of HIV. ImQuest plans to develop the product as a topical microbicide therapy for preventing the sexual transmission of HIV, particularly in developing countries, and expects an investigational new drug application for the product to be submitted in the fourth quarter. As part of the agreement, ImQuest will have sole responsibility for development and commercialization, and agreed to pay Isis royalties on any product sales.

• Karo Bio AB, of Huddinge, Sweden, said it developed a new formulation of its drug candidate KB2115, suitable for daily dosing in severe dyslipidemia. The company won approval to conduct a two-week study of the new formulation in healthy volunteers, with a Phase II program expected to start in the fall.

• LAB International Inc., of Laval, Quebec, enrolled the first patient in its LAB CGRP Phase IIa trial, which is expected to completed in the third quarter. LAB CGRP is a 37 amino acid natural neuropeptide produced in the lung in response to allergic stimuli, and the study is investigating its protective efficacy on metacholine induced bronchial hyper-responsiveness in adult patients with mild to moderate asthma, to compare this efficacy to salbutamol and placebo, to evaluate the safety and tolerability of LAB CGRP in asthma patients. The trial is enrolling 12 patients.

• Lorus Therapeutics Inc., of Toronto, said data demonstrated a decreased expression of the molecular target for its antisense drug, GTI-2040, in a Phase II breast cancer trial. A rapid and dramatic reduction in expression of the gene for the R2 component of ribonucleotide reductase was seen in tumor biopsy tissue following treatment with GTI-2040 in combination with capecitabine, and an approximate 25-fold decrease in R2 was seen as early as one day after the start of treatment. The results will be published in the May issue of Oncology Reports.

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., and partner Johnson & Johnson Pharmaceutical Research & Development LLC, a unit of New Brunswick, N.J.-based Johnson & Johnson, started a Phase III trial of Velcade in combination with Rituxan (rituximab) in patients with relapsed or refractory follicular lymphoma, a subtype of non-Hodgkin's lymphoma. Velcade is approved for multiple myeloma patients who have received at least one prior therapy. The approved NHL drug Rituxan is from Genentech Inc., of South San Francisco, and Biogen Idec Inc., of Cambridge, Mass.

• Neurochem Ltd., of Ecublens, Switzerland, a wholly owned subsidiary of Laval, Quebec-based Neurochem Inc., completed the filing of its new drug application for Fibrillex (eprodisate) for amyloid A amyloidosis, and the FDA granted priority review for the application, setting a PDUFA date of Aug. 13. Neurochem began submitting a rolling NDA in August, based on Phase II/III data showing that Fibrillex reduced the risk of renal decline or all-cause mortality to 442 percent relative to placebo. Under a December 2004 collaboration agreement, Neurochem granted Malvern, Pa.-based Centocor Inc. exclusive distribution rights for Fibrillex worldwide, except for Canada, Switzerland, Japan, China, South Korea and Taiwan. (See BioWorld Today, Aug. 23, 2005.)

• Onyx Pharmaceuticals Inc., of Emeryville, Calif., and Bayer Pharmaceuticals Corp., of West Haven, Conn., said Nexavar (sorafenib) tablets has been granted orphan medicinal product status for the treatment of hepatocellular carcinoma by the European Commission. Nexavar previously received orphan drug status in the EU for kidney cancer, and a marketing authorization application was filed in that indication in September. The drug has been approved in kidney cancer in the U.S.

• Palatin Technologies Inc., of Cranbury, N.J., closed its previously announced sale of 11 million units, each consisting of one share of common stock and a warrant to purchase 0.30 shares of common stock, priced at $2.44 per unit. The offering brought in gross proceeds of about $27 million, which will be used for general corporate purposes, including the clinical development of its lead product candidate, bremelanotide, in Phase II trials for both male and female sexual dysfunction. (See BioWorld Today, April 13, 2006.)

• ReNeuron Group plc, of Guildford, UK, signed an agreement with Chemicon International Inc., a subsidiary of Atlanta-based Serologicals Corp., for the manufacture and distribution of two of ReNeuron's ReNcell neural stem cell lines worldwide for research purposes. Under the terms, Chemicon will manufacture and supply ReNcell CX and ReNcell VM cell lines, while ReNeuron will receive up-front and royalty payments. In separate news, ReNeuron entered a further agreement with StemCells Inc., of Palo Alto, Calif., to supply StemCells with cell lines generated using its c-mycER human stem cells immortalization technology, for use in StemCells' areas of therapeutic focus. That agreement builds on the existing cross-license between the two companies signed in July 2005.

• Scolr Pharma Inc., of Bellevue, Wash., obtained commitments to purchase shares of its common stock in a registered direct offering for gross proceeds of about $11.8 million. Under the terms, Scolr expects to sell about 2.4 million shares at $5 per share to a group of institutional investors. The offering is expected to close April 20. Net proceeds from the offering, plus the company's cash and short-term investments of $13.3 million as of Dec. 31, should sustain operations through the end of 2007. Taglich Brothers Inc. and Roth Capital Partners LLC acted as placement agents for the transaction.

• TheraQuest Biosciences Inc., of Blue Bell, Pa., said the FDA granted fast-track designation to the firm's abuse-deterrent Tramadol in an extended-release formulation for the treatment of painful HIV-associated neuropathy.