• A&G Pharmaceutical Inc., of Columbia, Md., closed a convertible debt financing, resulting in gross proceeds of $750,000. The financing was provided by New England Partners, with follow-on financing by the Maryland Department of Business and Economic Development and ASM Resources Inc. A&G issued a secured convertible debenture with a face amount of $750,000 that bears interest at 8 percent per annum and is due December 2006. Participants in the bridge loan will convert their investment into an equity position in A&G's Series B round of funding and might participate with additional capital. A&G is focused on developing monoclonal antibodies to disease-specific antigens for both therapeutic and diagnostic products.

• Adenosine Therapeutics LLC, of Charlottesville, Va., and Bristol-Myers Squibb Medical Imaging, of N. Billerica, Mass., began Phase II trials of BMS068645, a selective A2a adenosine receptor agonist for use in cardiac perfusion imaging studies. In April 2000, Adenosine granted a worldwide license to Bristol-Myers covering the development and use of the product for the diagnosis and prognosis of coronary artery disease. Bristol Myers is conducting and funding all trials in cardiac imaging and licensing select data back to Adenosine for use outside the cardiac imaging field.

• Adherex Technologies Inc., of Ottawa, Ontario, received orphan drug designation for sodium thiosulfate from the FDA. The designation was granted for the prevention of platinum-induced ototoxicity in pediatric patients. Adherex has a portfolio of drugs under development, including Exherin, its lead cadherin antagonist compound, and STS, a drug designed to protect against severe hearing loss that often is produced by platinum-based anticancer agents.

• AnorMED Inc., of Vancouver, British Columbia, said that Swedish authorities have granted the first European regulatory approval for Fosrenol (lanthanum carbonate). Fosrenol is a new medicine that helps control phosphate levels in patients who require dialysis for severe kidney disease. Sweden will be the reference member state in the EU Mutual Recognition Procedure for Fosrenol. AnorMED's worldwide exclusive licensee Shire Pharmaceuticals Group plc, of Basingstoke, UK, expects Fosrenol to be available in other countries in the European Union during the second half of the year. Separately, QRxPharma Pty. Ltd., of Brisbane, Australia, said it signed a development agreement with Shire Laboratories Inc., under which Shire will develop extended-release formulations of QRx's opioid product, Q8003. Q8003 is under development for the treatment of moderate to severe pain and is expected to be ready for Phase III trials later this year.

• BioSpecifics Technologies Corp., of Lynbrook, N.Y., received on March 22 notice from Nasdaq that its stock was delisted from the Nasdaq SmallCap Market, effective with the open of business March 24. The delisting was based on BioSpecific's failure to satisfy the $2.5 million shareholders' equity requirement as of Dec. 31. The company's securities were immediately eligible for quotation on the Over-the-Counter Bulletin Board. BioSpecifics said it intends to pursue a review of the decision before the Nasdaq Listing and Hearing Review Council. BioSpecifics is focused on products for wound healing and tissue remodeling.

• Cold Spring Harbor Laboratory, of Cold Spring Harbor, N.Y., said a paper published in Nature describes the creation of the first library of human RNA interference clones, which will provide users with the ability to shut off every gene in the human genome. The library is the first DNA vector-based, human genome-wide RNAi library that is sequence verified. Several leading pharmaceutical companies are licensing nonexclusive rights to the library for target identification and validation purposes. Greg Hannon, lead scientist in the development of the new library, helped develop the short-hairpin method for triggering RNAi. The sequence-validated library of short-hairpin RNA molecules targets each one of more than 10,000 different human genes with three different gene-specific interfering RNAs.

• Connetics Corp., of Palo Alto, Calif., said Phase III data of Velac to treat acne vulgaris showed a statistically superior treatment effect for Velac, compared with other therapies. The two Phase III trials included more than 2,200 patients treated at 37 centers for 12 weeks. The trials compared Velac with clindamycin gel, tretinoin gel and placebo gel. The proportion of patients achieving treatment success were 37 percent with Velac, 27 percent with clindamycin gel, 25 percent with tretinoin gel and 14 percent with placebo. The mean reduction in total lesion counts was 49 percent, 38 percent, 40 percent and 23 percent, respectively. Connetics expects to file a new drug application in the third quarter. Velac, which is approved in Europe, is a once-daily treatment combination of clindamycin and tretinoin in an aqueous gel. In May 2002, Connetics licensed rights from Yamanouchi Europe BV, a unit of Yamanouchi Pharmaceutical Co. Ltd., of Tokyo, to develop and commercialize Velac exclusively in the U.S. and Canada, and nonexclusively in Mexico.

• Crucell NV, of Leiden, the Netherlands, and the Aeras Global TB Vaccine Foundation in Bethesda, Md., reported a new collaboration on the preclinical and clinical development of candidate tuberculosis vaccines. Aeras agreed to provide Crucell up to $2.9 million contingent upon meeting certain development milestones, for development of TB vaccine candidates. The Crucell-Aeras TB vaccine program will focus on improvement of the only currently available TB vaccine, Bacillus Calmette-Guerin, using Crucell's PER.C6 and AdVac technologies. With the collaboration, Crucell's early stage TB vaccine development is fully funded up to entering the clinic, it said.

• Cubist Pharmaceuticals Inc., of Lexington, Mass., said that since the U.S. launch in November of Cubicin in complicated skin and skin-structure infections, the company expects that the drug "can reasonably achieve" sales in the range of $40 million to $50 million in 2004. Cubicin (daptomycin for injection) is meant for infections caused by certain Gram-positive organisms.

• Dragon Pharmaceutical Inc., of Vancouver, British Columbia, entered a letter of intent to merge with Oriental Wave Holding Ltd., of the British Virgin Islands. Dragon shareholders would own about 31.7 percent of the new entity, while Oriental Wave shareholders would own about 68.3 percent. Oriental Wave, a sole shareholder of a China-based pharmaceutical company focused on generic drugs, had consolidated revenues of $26 million in 2003. Once the merger is completed, Dragon's rHu Erythropoietin business and production facility in Nanjing, China, will become the core foundation of the biotech division of the combined company. The companies expect the merger to be completed in the third quarter.

• Enhance Biotech Inc., of New York, appointed Covance Inc., of Princeton, N.J., to conduct trials on the development of LI 313 through their UK-based facilities. LI 313 is in Phase I trials and is derived from natural sources. Chemical modifications to the product have allowed it to act as a T-cell mediator in topical applications, it said.

• Enzon Pharmaceuticals Inc., of Bridgewater, N.J., launched CLEAR II, a multicenter registry developed for clinicians to share and exchange information regarding the clinical course of invasive fungal infections and clinical experience with Enzon's marketed antifungal Abelcet and other antifungal agents. CLEAR II will add to Enzon's CLEAR (Collaborative Exchange of Antifungal Research) database, completed in 2000, which includes data from 3,514 patient records. The registry was built using La Jolla, Calif.-based ProSanos Corp.'s simultaneous secure electronic entry and reporting web-based system.

• Exten Industries Inc., of Warwick, R.I., said its board voted to merge its wholly owned subsidiary, MultiCell Technologies, into the parent company and to change the company name from Exten Industries to MultiCell Technologies Inc. The chairman and CEO said the name change more accurately reflects the company's current business focus. MultiCell Technologies provides hepatic cells and cell lines to pharmaceutical companies for drug discovery and toxicity tests and is developing cell-based toxicological and drug screening tests and biologics for use in diagnostic and therapeutic applications.

• InterMune Inc., of Brisbane, Calif., said pirfenidone was granted orphan drug designation by the FDA for the treatment of idiopathic pulmonary fibrosis. Pirfenidone is an orally active small molecule that shows a range of biologic activity, the company said. In vitro evidence has shown that it inhibits collagen synthesis, down-regulates pro-fibrotic cytokines and decreases fibroblast proliferation.

• Jazz Pharmaceuticals Inc., of Palo Alto, Calif., completed a $250 million financing with private equity and venture capital investors. Jazz, which raised $15 million in its Series A round in April, is focused on developing and commercializing drugs that treat neurologic and psychiatric disorders by improving and expanding the uses of known compounds. The financing enables the company to build its portfolio. The financing was led by an affiliate of Kohlberg Kravis Roberts & Co. Other investors were Prospect Venture Partners, Versant Ventures, Beecken Petty O'Keefe & Co., Golden Gate Capital, Thoma Cressey Equity Partners, Adams Street Partners, EGS Healthcare Capital Partners, Lehman Brothers Healthcare Fund and an entity associated with the Oak Hill investment group.

• Organon Pharmaceuticals USA Inc., of Roseland, N.J., said the FDA approved Follistim AQ Cartridge (follitropin-beta injection). It is the first follicle-stimulating hormone treatment available in a pre-filled, pre-mixed solution, approved in the U.S., the company said. The cartridge is designed to be used with Follistim Pen, a pen device that is designed to facilitate accurate delivery of individualized doses of pre-mixed follitropin-beta injection, a prescription fertility medication made from recombinant DNA technology. Follistim AQ Cartridge is prescribed for women undergoing assisted reproductive treatment such as in vitro fertilization and for the induction of ovulation to achieve pregnancy.

• Penwest Pharmaceuticals Co., of Danbury, Conn., said its hypertension product PW2101 met its primary endpoints in a pivotal efficacy study. The company plans to submit a new drug application by the end of the year, seeking approval for the higher strengths of the product. Penwest is seeking a marketing partner for the product, and it plans to complete additional work to support a manufacturing site change prior to the NDA submission. The study compared PW2101 to placebo in 163 subjects. All strengths of PW2101 were statistically significant, and all adverse events were mild and transient in nature, except for one moderate adverse event. Penwest expects to begin a clinical trial for a low-dose version of the product in the second quarter.

• RegeneRx Biopharmaceuticals Inc., of Bethesda, Md., said new data indicate that Thymosin Beta-4 prevents apoptosis in human corneal epithelial cells exposed to ethanol in vitro. The research was published in the April 2004 issue of Investigative Ophthalmology and Visual Science. Ethanol is used during Lasik (laser-assisted subepithelial keratectomy) surgery to correct refractive disorders of the eye. Gabriel Sosne and his colleagues at Wayne State University School of Medicine and Kresge Eye Institute in Detroit conducted the study. TB4 is a naturally occurring 43-amino-acid peptide present in virtually all human cells.

• Vicuron Pharmaceuticals Inc., of King of Prussia, Pa., said Phase III data of anidulafungin in combination with liposomal amphotericin B showed the two treatments could be used together to treat invasive aspergillosis infections without increasing side effects. The data provide evidence that the combination is well tolerated as a first-line therapy. The trial enrolled 30 patients with probable or proven invasive aspergillosis. Anidulafungin is a naturally occurring molecule improved through chemical modification. Vicuron filed a new drug application for anidulafungin to treat esophageal candidiasis in April. (See BioWorld Today, April 29, 2003.)