• Access Pharmaceuticals Inc., of Dallas, has closed the acquisition of Somanta Pharmaceuticals Inc., of Irvine, Calif., through the issuance of 1.5 million shares of Access Pharmaceuticals' common stock. Some members of Somanta's management team will join the Access team. The two companies came to terms last February in a deal involving about $12.2 million in stock.

• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., reported in a business update that it advanced an RNAi therapeutic development program targeting the Huntington gene for treating Huntington's disease. The program, designated ALN-HTT, to date has yielded preclinical data showing the efficacy of a siRNA targeting the Huntington gene in a mouse model. It is partnered with Minneapolis-based Medtronic Inc. in a 2005 deal that was amended in July to provide for a 50/50 co-development and profit-sharing relationship in the U.S. Medtronic will handle development and commercialization in Europe. (See BioWorld Today, July 31, 2007.)

• Argenta Discovery Ltd., of Harlow, UK, has entered into an alliance with NeuroSolutions Ltd., of Cambridge, UK, to gain preferential access to its specialist electrophysiology and hERG testing services and expertise. The collaboration will enable Argenta to provide its contract research clients with an expanded assay development and screening resource. Financial terms were not disclosed.

• Auriga Laboratories Inc., of Los Angeles, has signed a co-promotion agreement with MiddleBrook Pharmaceuticals Inc., of Germantown, Md., under which Auriga will co-promote Keflex 750-mg capsules (cephalexin capsules, USP), to primary care specialists in the U.S. Cephalexin is the most prescribed oral cephalosporin antibiotic and also is the number-one recommended oral antibiotic therapy for uncomplicated skin and skin structure infections. The co-promotion will begin during the first quarter of 2008. Financial terms were not disclosed.

• BioMimetic Therapeutics Inc., of Franklin, Tenn., has closed on the sale of its dental business to Luitpold Pharmaceuticals Inc., a subsidiary of Tokyo-based Sankyo Co. Ltd. The sale includes the downstream formulation, fill and finish manufacturing rights of GEM 21S. BioMimetic will receive $40 million in cash, plus approximately $4 million in cash from the sale of existing inventory, and royalty payments based on net sales of GEM 21S and future products in the dental and cranio-maxillofacial field. As part of the closing, BioMimetic has received an initial $15 million payment with another $15 million to be paid within 60 days of the closing. Additionally, $6 million will be paid no later than 18 months from close and the remaining $4 million will be paid no later than year-end 2009. (See BioWorld Today, Dec. 18, 2007.)

• Celldex Therapeutics, of Phillipsburg, N.J., said the FDA granted fast-track designation for CDX-110 in the treatment of EGFRvIII expressing glioblastoma multiforme (GBM), the most common and aggressive form of primary brain cancer. CDX-110 is an immunotherapy that targets the tumor-specific growth promoter EGFRvIII that can be expressed by GBM. In a Phase IIa study, GBM patients treated with CDX-110 showed a median survival time of 30 months, more than a 100 percent increase in survival, vs. the historical control's median of 14.5 months. In September, Celldex randomized its first patient into a definitive Phase II/III randomized study of CDX-110 with radiation and temozolomide in patients with newly diagnosed GBM. In October, Celldex signed a definitive merger agreement with Avant Immunotherapeutics Inc., of Needham, Mass.,

• DermTech Inc., of La Jolla, Calif., has entered into an agreement with Stiefel Laboratories Inc., of Coral Gables, Fla., in which the companies will use DermTech's EGIR technology and gene expression assays to identify and further understand the genes involved in causing acne. DermTech will provide Stiefel its EGIR skin sampling technology consisting of adhesives that will be applied to the patients' epidermis. The adhesives will be sent back to DermTech for RNA extraction and gene expression analysis using quantitative reverse transcriptase-polymerase chain reaction techniques. Financial terms were not disclosed.

• Faust Pharmaceuticals SA, of Strasbourg, France, has entered into a research agreement with Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, in which Faust will apply its Neuroclid platform to identify novel drug candidates that target undisclosed G protein-coupled receptors of interest to Takeda. Financial terms were not disclosed.

• Fovea Pharmaceuticals SA, of Paris, said the European Commission granted orphan designation to its recombinant human rod-derived cone viability factor (rh-RdCVF) in retinitis pigmentosa, which would provide the product 10 years of marketing exclusivity upon European approval. Fovea is conducting preclinical studies of RdCVF, which has so far demonstrated efficacy in an animal model of the disease. Clinical trials are expected to start in 2009.

• Jazz Pharmaceuticals Inc., of Palo Alto, Calif., has received orphan drug designation from the FDA for its JZP-8 product candidate for the treatment of recurrent acute repetitive seizures. In December 2007, Jazz dosed the first patient in a Phase II clinical trial of JZP-8. JZP-8 is an intranasal spray formulation incorporating clonazepam, a widely prescribed benzodiazepine.

• Ocera Therapeutics Inc., of San Diego, said the FDA has granted orphan drug designation to AST-120 for the treatment of Pouchitis. Patients with ulcerative colitis often require a resection of the colon and creation of a J-Pouch to reduce the risk of cancer. A J-Pouch collects stool, but the pouch can become inflamed, resulting in a condition known as Pouchitis, which is associated with diarrhea, abdominal cramps, fever and dehydration. AST-120 is an oral agent known to adsorb bile acids and bacterial toxins and to mediate inflammation in the gastrointestinal tract. It currently is being evaluated in a Phase II trial in patients with active Pouchitis.

• Oncolytics Biotech Inc., of Calgary, Alberta, said a research group published results of its work testing the antitumor efficacy and safety of various combinations of reovirus and cyclophosphamide in vivo, which showed that a metronomic dosing regimen was developed that increased survival in mice and demonstrated high levels of reovirus recovered from regressing tumors and levels of neutralizing antibodies that were protective. The company said those data, published in Clinical Cancer Research, supported investigating the use of cyclophosphamide prior to system reovirus administrations in humans to modulate, but not ablate, the immune system.

• Optimer Pharmaceuticals Inc., of San Diego, has been awarded a $1 million annual federal grant, which will be applied to the late-stage development of OPT-80 to treat Clostridium difficile-associated diarrhea. The grant is renewable for up to $3 million total. OPT-80, formerly known as PAR-101 or Difimicin, is a narrow spectrum antibiotic designed to eliminate the infection while preserving the natural balance of flora in the GI tract.

• TransMolecular Inc., of Cambridge, Mass., said the FDA has granted orphan drug designation for the nonradiolabeled version of its anticancer compound, TM601, which is entering clinical trials for the treatment of malignant glioma. The company previously had received orphan designation for the radiolabeled version, 131I-TM601, which recently completed patient enrollment in a Phase II clinical trial in glioma and a Phase I trial in multiple tumor types. TM601 is a synthetic version of chlorotoxin, a naturally occurring peptide derived from scorpion venom, which is highly specific in targeting both primary tumors and metastases.