• Acambis plc, of Cambridge, UK, said that, following discussions with the FDA, it has temporarily withdrawn its Arilvax yellow fever vaccine biologics license application. A BLA can only be considered for review by the FDA if the facility at which the product is manufactured is scheduled for a pre-approval inspection during the 10-month period following BLA submission. The owner and manufacturer of Arilvax, Chiron Vaccines, a division of Chiron Corp., of Emeryville, Calif., is bringing forward its plans to upgrade the areas within its Speke, UK-based plant at which the vaccine is manufactured. Therefore, Chiron's facility will not be ready for the inspection. Acambis said it will work with both the FDA and Chiron to minimize the time to re-submit the BLA. It is expected that Chiron Vaccines' manufacturing facility will be ready for inspection in the first half of 2005, at which time Acambis would re-submit the BLA. The BLA was filed in December. (See BioWorld Today, Dec. 15, 2003.)

• Access Pharmaceuticals Inc., of Dallas, was notified by the FDA that its new drug application for OraDisc has successfully completed the initial review. The initial review, generally known as the completeness review, assesses whether the NDA contains all necessary data and information required for filing. The NDA will now proceed to its formal review by the dermatological division of the FDA. OraDisc is an improved delivery system for amlexanox, the active agreement in Access's Aphthasol, approved for canker sores.

• Affymetrix Inc., of Santa Clara, Calif., completed the GeneChip-brand Smallpox Resequencing Array Set, seven smallpox arrays that will enable resequencing for the entire smallpox genome. Those arrays, developed in collaboration with the Centers for Disease Control and Prevention in Atlanta, contain genomic sequences common to all strains of smallpox, as well as variant DNA from different smallpox isolates.

• Anadys Pharmaceuticals Inc., of San Diego, initiated a clinical trial of ANA971, an orally administered prodrug of isatoribine, to treat chronic hepatitis C. The drug has been administered to 48 patients so far. A recent study showed that intravenous administration was well tolerated and safe at all doses tested. Anadys has exclusive rights to commercialize isatoribine and ANA971 worldwide.

• Astralis Ltd., of Fairfield, N.J., reported the final closing of a private placement from which it received additional gross proceeds of about $1.2 million. The transaction consisted of the sale to accredited investors of units consisting of about 2.3 million shares of stock and warrants to purchase about 2.3 million shares of stock. That brings the total amount of funds raised in the round to about $5.2 million, which the company will use to continue research and development plans, including Phase II trials for its lead product, Psoraxine, for the treatment of psoriasis.

• BioCryst Pharmaceuticals Inc., of Birmingham, Ala., said it completed a $21.4 million registered direct offering of about 3.5 million shares of its common stock to a group of institutional investors. The shares, priced at $6 a share, were registered pursuant to BioCryst's $60 million shelf registration statement that was declared effective by the SEC on Jan. 5. The net proceeds to BioCryst, after payment of placement agency fees and others expenses, were about $20.3 million. Leerink Swann & Co. served as placement agent for the transaction. BioCryst designs, optimizes and develops drugs that block enzymes essential for cancer, cardiovascular and autoimmune diseases, and viral infections. (See BioWorld Today, Feb. 18, 2004.)

• Bioxel Pharma Inc., of Sainte-Foy, Quebec, entered a purchase agreement for cGMP paclitaxel with Cell Therapeutics Inc., of Seattle. The value of the agreement is at least C$1.2 million (US$904,106) for cGMP paclitaxel originating from Bioxel's paclitaxel manufacturing unit. Paclitaxel manufactured under the agreement will be used by Cell Therapeutics for production of Xyotax, which is in Phase III trials for high-risk non-small-cell lung cancer.

• CytoDyn Inc., of Santa Fe, N.M., is registering 890,000 shares for trading on the Over-the-Counter Bulletin Board index. The registration is intended to make a market for the company's shareholders, CytoDyn said. The shares are expected to be about 11 percent of the company's issued stock. CytoDyn is developing monoclonal antibodies to treat HIV/AIDS.

• Exelixis Inc., of South San Francisco, submitted an investigational new drug application for the cancer compound XL647. It intends to begin a Phase I trial in the second quarter. XL647 demonstrates inhibition in vitro against multiple receptor tyrosine kinases that are implicated in tumor proliferation and vascularization.

• Genaissance Pharmaceuticals Inc., of New Haven, Conn., said the SEC declared effective its registration statement for its proposed $19.9 all-stock merger with Lark Technologies Inc., of Houston. A meeting at which Genaissance stockholders will vote on the merger is scheduled for April 1. The merger was made public in December. (See BioWorld Today, Dec. 22, 2003.)

• GeneMax Corp., of Vancouver, British Columbia, said its wholly owned subsidiary, GeneMax Pharmaceuticals Inc., obtained a worldwide exclusive license from the University of British Columbia for a novel assay technology that can be used to screen and select new drugs that regulate immune responses. The technology has relevance to cancers and viral diseases, as well as modulating transplant rejection and autoimmune diseases.

• Genencor International Inc., of Palo Alto, Calif., and the U.S. Army Edgewood Chemical Biological Center reported that they signed an exclusive license to manufacture and sell enzymes to decontaminate certain organophosphate-based nerve agents like sarin. Genencor plans to scale-up and manufacture the enzymes that can be added to water and dispensed in foams, sprays or detergents. The enzymes will be made available to military and first responders. The enzymes are designed to neutralize the chemical agents and have the benefit of being noncorrosive and environmentally friendly.

• Genitope Corp., of Redwood City, Calif., said it will close registration of its Phase III trial (Genitope 2000-03) on March 31. The trial is being conducted at 34 oncology centers in North America to evaluate MyVax Personalized Immunotherapy in previously untreated follicular non-Hodgkin's lymphoma (f-NHL) patients. Opened in November 2000, the trial is designed to test whether active immunotherapy for f-NHL can delay or prevent recurrence of disease in patients in remission following an initial course of chemotherapy. MyVax is manufactured using a tumor-specific marker expressed on the patient's malignant B cells and is intended to stimulate the patient's own immune system to attack cancer cells. The goal of the trial is to demonstrate a significant improvement in the progression-free survival time in those treated with MyVax, compared to the control group. The company expects to complete the patient registration process and then immunize the last patient in March 2005. The first interim analysis would be performed soon after.

• Invitrogen Corp., of Carlsbad, Calif., completed the private placement of $450 million of 1.5 percent senior convertible notes due 2024 to qualified institutional buyers. The initial purchasers hold a 13-day option to purchase up to an additional $67.5 million worth of the notes. The company priced the notes earlier this week. (See BioWorld Today, Feb. 17, 2004.)

• Isotechnika Inc., of Edmonton, Alberta, finalized the manufacturing process for its lead drug, ISA247. The process enables the company to manufacture large-scale batches of the active pharmaceutical ingredient at a lower cost. Process optimization took about one year to complete. In the second half of this year, the company expects to move ISA247, a calcineurin inhibitor, into a Phase III trial for psoriasis and into a Phase IIb trial in kidney transplant patients.

• Micrologix Biotech Inc., of Vancouver, British Columbia, said Canaccord Capital Corp., also of Vancouver, agreed to buy 5 million units at $1 per unit. The underwriter also has an option to purchase up to 2.5 million additional units, which would give the company total proceeds of $7.5 million. Each unit consists of one common share and one-half of one common share purchase warrant. Each whole warrant entitles the holder to purchase one share at $1.25 within two years of the closing date. Micrologix will use the proceeds to fund development of its hepatitis C virus drug candidate, MBI-3253 (celgosivir). The proceeds also will cover other development programs and general corporate purposes, it said.

• Neurocrine Biosciences Inc., of San Diego, reported positive results from its Phase III trial with two doses (5 mg and 10 mg) of the immediate-release formulation of indiplon, achieving statistically significant results in elderly patients with chronic insomnia. Results of the primary endpoint for the study, latency to sleep onset (LSO), was statistically significant for both doses (p<0.02 at 5 mg and p<0.005 at 10 mg), compared to placebo. For LSO, the time to sleep was shortened by more than 27 minutes for both indiplon doses, more than a 40 percent reduction from baseline. Secondary endpoints also were statistically significant. Neurocrine is conducting eight Phase III trials for the drug, and expects to file a new drug application for the two formulations in the first half of 2004 in multiple insomnia indications.

• NexMed Inc., of Robbinsville, N.J., said CJ Corp., a South Korean pharmaceutical company, licensed Femprox. CJ will develop and seek regulatory approval for the drug in South Korea. NexMed will receive royalty payments on sales. Femprox is a cream treatment for female sexual arousal disorder. The product is alprostadil based and incorporates NexMed's NexACT transdermal penetration enhancing technology.

• Nobex Corp., of Research Triangle Park, N.C., said results of an exploratory clinical trial for oral insulin were published in the January 2004 edition of Metabolism. The Phase I/II trial was one of the initial studies to investigate the safety and tolerability of a single oral dose of a modified human insulin in patients with Type I diabetes mellitus. Nobex's lead modified insulin product, known as Hexyl-insulin monoconjugate 2 (HIM2), is an orally active insulin that has reached Phase II development for the treatment of patients with diabetes mellitus.

• Northfield Laboratories Inc., of Evanston, Ill., said that investors in its recent registered direct offering exercised their option to purchase an additional 237,008 shares for proceeds to Northfield of about $1.4 million. Including that option exercise, gross proceeds of the offering total $16.4 million to date. Investors in the offering have the right to purchase up to an additional 409,483 shares of Northfield stock before April 28. The offering was made from a shelf registration statement that became effective July 3. (See BioWorld Today, Jan. 27, 2004.)

• Nuvelo Inc., of Sunnyvale, Calif., plans to offer 4 million shares of its common stock in an underwritten public offering, pursuant to its shelf registration statement on file with the SEC. The underwriters will have an option to purchase up to an additional 600,000 shares to cover overallotments. The 4 million shares is the amount of shares offered after giving effect to a 1-for-3 reverse stock split, which Nuvelo anticipates will become effective on Feb. 23. UBS Securities LLC is acting as the sole book-running manager, with CIBC World Markets Corp., Needham & Co. Inc. and JMP Securities LLC acting as co-managers.

• OpGen Inc., of Madison, Wis., began an optical mapping study of a type of brain tumor called oligodendroglioma. OpGen is working with the Hermelin Brain Tumor Center, a division of the Henry Ford Health System in Detroit, and the inventor of optical mapping, professor David Schwartz of the University of Wisconsin at Madison. The maps are designed to allow researchers to pinpoint and characterize lesions in the genome to determine what is happening at the DNA level and how well a patient will respond to treatment.

• YM BioSciences Inc., of Mississauga, Ontario, received a final receipt from the Ontario Securities Commission for its prospectus. The prospectus qualifies for distribution the common shares and warrants underlying the about 10.9 million special warrants sold to investors for total proceeds of about C$19.1 million (US$14.37 million) by way of its private placement on Dec. 15. The special warrants were deemed exercised at 5 p.m. EST Feb. 19. Trading of the shares issuable upon conversion of the special warrants will commence on Feb. 23 on the Toronto Stock Exchange under the symbol "YM" and on the London Stock Exchange's Alternative Investment Market under the trading symbol "YMBA." YM's lead drug, tesmilifene, is a small-molecule chemopotentiator recently cleared by the FDA for a pivotal Phase III in metastatic breast cancer, an indication for which it has completed a Phase III trial with positive results.