• Arpida Ltd., of Basel, Switzerland, closed its acquisition of TLT Medical Ltd., of Reinach, Switzerland. The deal entails an up-front payment to TLT as well as potential milestone payments that together could total up to CHF57 million (US$47.3 million). The stock-and-cash deal was announced last month. Shares issued in connection with the closing represent less than 0.3 percent of those outstanding. TLT is developing a therapy to treat onychomycosis, or fungal infections of the nails of the fingers and toes.

• BioMarin Pharmaceutical Inc., of Novato, Calif., said AnGes MG Inc., of Osaka, Japan, submitted a biologics license application for Naglazyme (galsulfase) with the Japanese Ministry of Health, Labor and Welfare. AnGes is seeking approval of the product for treating MPS VI (also known as Maroteaux-Lamy syndrome). The product already is approved the U.S. and Europe. AnGes got Japanese marketing rights through a December 2006 deal.

• Caliper Life Sciences Inc., of Hopkinton, Mass., granted a multiyear license on its noninvasive optical imaging methods to Novartis AG, of Basel, Switzerland. The technology is designed to allow scientists to visualize, track and quantify biological processes at the molecular level in living animals with high throughput and relatively low cost, Caliper said. Terms of the deal were not disclosed.

• Cangene Corp., of Winnipeg, Manitoba, said it met all the regulatory and manufacturing requirements for the "usable product" milestone on contracts with the U.S. government for products to treat botulism and inhalational anthrax. The contracts, signed last year, are managed by the U.S. Biomedical Advanced Research and Development Authority within the Department of Health and Human Services. The usable product designation means the company has met specific regulatory and manufacturing requirements that allow it to deliver the products to the U.S. Strategic National Stockpile and begin invoicing once delivery has been accepted. The company said it anticipates that delivery is imminent. It said initial payments are expected to be in the range of $18 million to $22 million, for reimbursable development costs and payment for the initial product delivery. The combined total value over the terms of the contracts is about $505 million, excluding options. (See BioWorld Today, June 2, 2006, and July 31, 2006.)

• Carrington Laboratories Inc., of Irving, Texas, said its DelSite Biotechnologies Inc. subsidiary entered into an agreement to provide high-molecular-weight GelSite polymer to a U.S. company for testing a novel technique for cardiac tissue repair. The GelSite mucoadhesive properties in the application may create a molecular anchor to slow or prevent the dispersion of active ingredients away from specific tissue. The technology enables controlled release of injected systemic drugs. Terms of the deal were not disclosed.

• Cipher Pharmaceuticals Inc., of Mississauga, Ontario, said the FDA through a letter agreed with the Division of Dermatology and Dental Products' view that an additional clinical study is needed to further demonstrate the safety of CIP-Isotretinoin, its formulation of the acne drug. The response was to a formal dispute resolution request from Cipher. The company said it is reviewing the response to determine the most appropriate path forward to achieve approval.

• GeneNews Ltd., of Toronto, said it signed an agreement with an Asian biomedical consortium to develop blood-based biomarkers for the detection and management of prostate diseases. The consortium will provide $2 million to GeneNews to conduct the work required to identify and validate biomarkers related to prostate disease using its Sentinel Principle and Discovery Funnel technologies. If a biomarker panel were successfully validated, GeneNews then would develop and commercialize a prostate disease test. The consortium would be entitled to certain royalties from commercial sales.

• Genta Inc., of Berkeley Heights, N.J., launched and began sales of its oncology product Genasense (oblimersen sodium) on a named-patient/compassionate-use basis outside the U.S. That designation refers to the distribution or sale of a product to a specific health care professional for the treatment of an individual patient. In most countries, the program provides for full cost recovery for drugs that either are pending regulatory approval or are in late-stage trials intended to lead to formal regulatory approval, Genta said. Until now, the company had been supplying Genasense at no charge.

• GeoPharma Inc., of Largo, Fla., said its shareholders approved the proposed merger with Dynamic Health Products Inc. Closing of the merger is expected around Aug. 31. GeoPharma specializes in the manufacturing and distribution of over-the-counter, nutritional, generic drug and functional food products. DHP is a distributor of sports nutrition products.

• Indevus Pharmaceuticals Inc., of Lexington, Mass., said it received a $49.9 million milestone payment from co-promotion partner Esprit Pharma Inc., of East Brunswick, N.J. The payment follows the Aug. 3 FDA approval of Sanctura XR (trospium chloride extended-release capsules), a once-daily formulation of Sanctura, for treating overactive bladder. Indevus said the milestone payment was based on the total costs to develop Sanctura XR, including clinical development, as well as manufacturing development costs.

• Inspire Pharmaceuticals Inc., of Durham, N.C., announced the U.S. launch and commercial availability of AzaSite (azithromycin ophthalmic solution) 1 percent for the treatment of bacterial conjunctivitis. Inspire's 98 sales representatives have begun product education outreach to physicians. The product is formulated with the DuraSite ocular drug delivery system developed by InSite Vision Inc., of Alameda, Calif. Inspire licensed from InSite in February rights to commercialize AzaSite for ocular infections in the U.S. and Canada. It estimated AzaSite sales revenues will be $30 million to $45 million in the U.S. in 2008. It was approved in late April. (See BioWorld Today, Feb. 20, 2007, and May 1, 2007.)

• LifeCycle Pharma A/S, of Horsholm, Denmark, and Sciele Pharma Inc., of Atlanta, said the FDA approved a formulation of fenofibrate in 120-mg and 40-mg dosage strengths for the treatment of hyperlipidemia and hypertriglyceridemia. The fenofibrate product uses LifeCycle Pharma's Meltdose technology, which is designed to provide enhanced absorption and greater bioavailability. It will be marketed by Sciele. LifeCycle gets a $4 million milestone payment for the approval, and could get payments of up to $8 million more if certain sales targets are met. It also will receive tiered royalty payments on product sales.

• Marshall Edwards Inc., of Washington, said a study published in the current issue of BMC Neuroscience showed phenoxodiol also might have the potential to be used in conjunction with cisplatin chemotherapy to prevent induction of platinum-induced neuropathy. The product is being developed as a therapy for late-stage, chemo-resistant prostate, ovarian and cervical cancers. Study results showed the addition of phenoxodiol produced no cytotoxicity at low doses and blocked the cisplatin-induced neurite toxicity, a result that could allow for more intensive cisplatin therapy. The combination is being tested in the ongoing Phase III OVATURE trial in ovarian cancer.

• Sloning BioTechnology GmbH, of Puchheim, Germany, said it will carry out a feasibility study with bioMerieux, of Paris, to generate gene variants of an essential enzyme to be used in diagnostic applications. Sloning will use its Slonomics industrial-scale gene synthesis technology to provide a gene library with a full set of ratio-controlled mutants. Successful completion would enable bioMerieux to identify an enzyme with enhanced characteristics. Terms of the deal were not disclosed.