• Abraxis BioScience Inc., of Los Angeles, said the European Commission has granted marketing approval for Abraxane powder for suspension for infusion (an albumin-bound nanoparticle formulation of paclitaxel) for the treatment of metastatic breast cancer in patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline-containing therapy is not indicated. Phase III clinical trial results demonstrated that Abraxane doubled the response rate and significantly prolonged progression-free survival and overall survival vs. Taxol in the approved indication.

• Alfacell Corp., of Somerset, N.J., has entered into a distribution agreement with BL&H Co. Ltd., of South Korea, for the commercialization of Onconase (ranpirnase) in South Korea, Taiwan and Hong Kong. The compound currently is being evaluated as a treatment for unresectable malignant mesothelioma in a confirmatory Phase IIIb clinical trial. Under the agreement, Alfacell granted BL&H exclusive rights to those areas for marketing, sales and distribution. Alfacell has received an up-front fee of $100,000 and is eligible for milestone payments. Alfacell will also receive 50 percent of all net sales in the territory

• Biovest International Inc., of Tampa, Fla., a majority-owned subsidiary of Accentia Biopharmaceuticals Inc., also of Tampa, has acquired the exclusive worldwide license to autoimmune disease drug Revimmune from Accentia for the treatment and prevention of transplant rejection including rejection following a bone marrow transplant. As an initial indication, the company said it intends to submit an investigational new drug application seeking FDA permission to enter a Phase III clinical trial of Revimmune in bone marrow transplants to treat and possibly cure sickle cell anemia.

• Cardiokine Inc., of Philadelphia, has appointed Manuel Worcel president and CEO. He also will serve as a director of the company. Worcel joins Cardiokine from NitroMed, which he founded in 1993 and where he served as CEO, president and chief medical officer.

• Cardiome Pharma Corp., of Vancouver, British Columbia, and partner Astellas Pharma US Inc., of Deerfield, Ill., said they have been informed by the FDA that a decision has not yet been made regarding the new drug application Kynapid (vernakalant hydrochloride). The FDA did not provide an action letter prior to the PDUFA date of Jan. 19. Vernakalant (iv) is the intravenous formulation of an investigational drug being evaluated for the acute conversion of atrial fibrillation.

• Carigent Therapeutics Inc., of New Haven, Conn., was awarded a six-month $97,000 Phase I Small Business Innovation Research grant from the National Science Foundation to engineer long-circulating nanoparticles that target delivery and enable controlled release of paclitaxel to ovarian cancer tumors. The company's program is based on technology for engineering biodegradable nanoparticles with high-density surface modifications for to target drugs or diagnostic agents to specific tissues and cells.

• Celera Diagnostics, of Alameda, Calif., said it published three studies that demonstrated carriers of the kinesin-like protein 6, or KIF6, gene variant are at a 55 percent increased risk of primary and recurrent coronary heart disease. The studies included more than 30,000 patients, of whom 60 percent are carriers of the risk variant. The studies also showed that the excess risk associated with the KIF6 variant virtually was eliminated by use of Bristol-Myers Squibb Co.'s Pravachol (pravastatin). In addition, high doses of Pfizer Inc.'s Lipitor (atorvastatin) reduced risk in carriers of the KIF6 variant more effectively than moderate doses of Pravachol in patients with acute coronary syndrome, Celera said. The studies, currently available online, will appear in the Jan. 29 issue of the Journal of the American College of Cardiology.

• Exelixis Inc., of South San Francisco, said Bristol-Myers Squibb Co., of New York, has exercised its option to develop and commercialize Exelixis' compound XL139, triggering a $20 million payment to Exelixis. In addition, Exelixis has exercised its option under the January 2007 agreement to co-develop and co-commercialize XL139 in the U.S. Following the transfer of the XL139 development program, BMS will lead all global activities. The parties will co-develop and co-commercialize XL139 in the U.S. and share those profits 50/50. Exelixis will be entitled to receive double-digit royalties on product sales outside of the U.S. Exelixis also said GlaxoSmithKline, of London, has decided not to exercise its option to license XL784, which failed to meet its primary endpoint in a Phase II trial in patients with diabetic nephropathy. Although the data in one subgroup were encouraging, Exelixis said that data from other compounds to which GSK has an option made it unlikely that GSK would use one of its remaining options to choose XL784. As a result, Exelixis has the right to develop and commercialize XL784 either independently or in collaboration with third parties, subject to payment to GSK of a 3 percent royalty on sales of any products incorporating the compound.

• FibroGen Inc., of South San Francisco, said research data on its hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitors (PHI) suggested that endothelial progenitor cells (EPCs) play a significant role in repairing ischemic tissue damage by promoting the formation of new blood vessels at sites of damage and that administration of the company's HIF-PHIFG-6513 product to mice resulted in increased levels of erythropoietin in the circulation and larger populations of both EPC and hematopoietic progenitor cells in the bone marrow. In addition, the ability of FG-6513 to enhance mobilization of EPC from the bone marrow was observed as an increase and in number and percent of EPC in the peripheral blood of mice. Data were reported at the hypoxia conference in Vancouver, British Columbia.

• Genmab A/S, of Copenhagen, Denmark, has reached the second and third development milestones for ofatumumab (HuMax-CD20(R)) under the terms of its collaboration with GlaxoSmithKline, of London. The second milestone payment of DKK87.2 million (US$17 million) was triggered by treatment of the first patient in the Phase II study of ofatumumab in diffuse large B-cell lymphoma in 2007. The third milestone payment of DKK87.2 million was triggered by the first patient receiving treatment in the Phase III rheumatoid arthritis program, which occurred earlier this month.

• Hadasit, the technology transfer company of Hadassah Medical Organization in Jerusalem, and Harvard Medical School and Brigham and Women's Hospital of Boston, said they have partnered to develop a new orally administered combination therapy for autoimmune diseases. The combination therapy is a cocktail of an Anti-CD3 monoclonal antibody in development at Harvard Medical School and a line of glycolipid compounds in development at Hadasit. Clinical data have shown that the glycolipid compounds, which activate specific cells in the immune system when given orally, can be used for all oral applications and without adverse side effects. Preclinical studies demonstrated the same results for the monoclonal antibody, but in animal models.

• ICo Therapeutics Inc., of Vancouver, British Columbia, said it intends to develop iCo-009 under the FDA's 505(b)(2) section, which allows the FDA to reference safety data not developed by the applicant. ICo-009 is an oral reformulation of Amphotericin B for the treatment of systemic fungal infections and visceral leishmaniasis. It is a generic drug that has been in use for approximately 50 years, but is limited in use because it is administered intravenously and has significant infusion related side effects and kidney toxicity.

• ImmunoVaccine Technologies Inc., of Halifax, Nova Scotia, will receive C$3 million from the Atlantic Canada Opportunities Agency under the Atlantic Innovation Fund. The funds will allow IVT to undertake a C$6 million project to develop new potent immune enhancement systems.

• Knopp Neurosciences Inc., of Pittsburgh, has completed a Series B funding round of $10 million, increasing its total capitalization to $20 million. The latest financing involved the exercise of milestone-based callable warrants held by existing investors. The company anticipates making a further Series B call of $10 million following the initiation of Phase II studies of KNS-760704 in amyotrophic lateral sclerosis (ALS). KNS-760704 is a chirally pure, oral formulation of the synthetic amino-benzothiazole (6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazolediamine dihydrochloride monohydrate for the treatment of amyotrophic lateral sclerosis. Like its S(-) optical enantiomer, pramipexole dihydrochloride (Mirapex), KNS-760704 has been shown to be effective in a range of neuroprotective assays.

• Marshall Edwards Inc., of New Canaan, Conn., said triphendiol (previously known as NV-196) has been granted orphan drug status by the FDA for the treatment of pancreatic cancer and for the treatment of cholangiocarcinoma, or bile duct cancer. In the two Phase I clinical studies completed thus far, the investigational drug has demonstrated acceptable pharmacokinetic profiles in healthy human volunteers with no reported side effects.

• Micromet Inc., of Bethesda, Md., announced the publication of a new preclinical study in Cancer Research demonstrating that efficacious doses of a BiTE antibody targeting epithelial cell adhesion molecule (EpCAM or CD326) are well tolerated in two mouse cancer models. BiTE antibodies join cytotoxic T cells with cancer cells for a tightly controlled elimination of cancer cells. EpCAM is one of the most frequently and highly expressed tumor-associated antigens and is found on the majority of colon, lung, breast, prostate, ovarian, gastric, pancreas and on cancer stem cells.

• Palatin Technologies Inc., of Cranbury, N.J., has entered into an agreement to settle all outstanding litigation and disputes with Competitive Technologies Inc., of Fairfield, Conn., related to a license agreement between the companies. Under the terms of the settlement, Palatin retains all rights to bremelanotide, its peptide in clinical development for male erectile dysfunction and female sexual dysfunction, with no obligations for any future payments to Competitive Technologies. Both the pending arbitration initiated by Competitive Technologies and the action in Connecticut Superior Court will be dismissed with prejudice, and the existing license agreement between the two companies has been terminated. Competitive Technologies will receive all rights to a peptide developed at the University of Arizona, called MT-II or PT-14, which Palatin ceased developing in 2000. As part of the settlement, Palatin remitted a one-time payment to Competitive Technologies of $800,000.

• PhytoMedical Technologies Inc., of Princeton, N.J., said that its bisintercalator anticancer compound achieved a 50 percent or greater cancer cell kill rate in new in vitro studies of the DMS 114 strain of human small-lung cancer cells.

• ProtoKinetix Inc., of Vancouver, British Columbia, said repeated tests have confirmed that the addition of AAGP to the cryopreservation process more than doubles the usable inventory of stem cells for research uses. AAGPs (synthetic anti-aging glycoproteins) are the company's products for use in medicine, biotech and cosmetic industries.

• Response Genetics Inc., of Los Angeles, has begun performing the MAGE-A3 gene expression screening assay for GlaxoSmithKline, of London, in its Phase III clinical trial of the investigational MAGE-A3 Antigen-Specific Cancer Immunotherapeutic as adjuvant therapy in MAGE-A3 positive patients with stage IB, II or IIIA Non-Small Cell Lung Cancer. Those assays will be performed in formalin-fixed paraffin-embedded tissue.

• Rubicon Genomics Inc., of Ann Arbor, Mich., has entered into a collaboration with OncoMethylome Sciences, of Liege, Belgium, to identify biomarkers for early detection of cancer. Rubicon will use its MethylPlex platform to carry out the marker identification analysis and granted an option to OncoMethylome to license markers resulting from the collaboration. That is the second such marker identification agreement between the two companies, and OncoMethylome Sciences already has licensed a set of markers from Rubicon. Financial terms were not disclosed.

• Speedel Holding Ltd.. and Novartis AG, both of Basel, Switzerland, said the FDA approved a second product containing SPP100 (aliskiren) for the treatment of hypertension. Novartis, is responsible for commercialization of this first-in-class direct renin inhibitor. Tekturna HCT (aliskiren and hydrochlorothiazide) has been approved as a single-tablet combination of two high blood pressure medicines - Tekturna (aliskiren), the first new type of high blood pressure medicine in more than a decade, and the diuretic hydrochlorothiazide (HCT). That is the first regulatory approval of a single-tablet combination therapy involving Tekturna, known as Rasilez outside the U.S., which has been shown to consistently lower blood pressure for 24 hours and beyond.

• Tibotec Therapeutics, a division of Bridgewater, N.J.-based Ortho Biotech Products LP, said the FDA has approved Intelence (etravirine) tablets for the treatment of HIV infection in adults who have failed treatment with other antiretrovirals. Intelence is a nonnucleoside reverse transcriptase inhibitor that helps to block an enzyme that HIV needs to multiply. The drug, which received a priority review by the FDA, was approved to be used in combination with other anti-HIV medications. It reduces the amount of HIV in the blood and increases white blood cells that help fight off other infections. Intelence also may reduce the risk of death or infections that can occur with a weakened immune system.

• VaxGen Inc., of South San Francisco, said it has not yet determined the record date for the stockholder vote on VaxGen's proposed merger with Raven Biotechnologies Inc., also of South San Francisco. Only stockholders of record as of the record date will be entitled to vote on the merger. Beneficial owners of VaxGen shares held in "street name" as of the record date must follow the instructions of their broker with regard to the voting of shares. The company said it expects that the record date will be Jan. 31.

• VGX Pharmaceuticals, of Blue Bell, Pa., said it has submitted a device master file to the FDA for the firm's Cellectra adaptive constant current electroporation device, which the firm has been developing to deliver its DNA vaccine and therapy products. Preclinical efficacy studies have shown that delivery of DNA-based product candidates with the Cellectra device optimizes DNA uptake and its subsequent expression in the target tissue, and results in enhanced immune responses in animals, VGX said.

• Vical Inc., of San Diego, has entered into a license agreement with The Wistar Institute granting Vical exclusive, worldwide rights to Wistar's Towne strain of cytomegalovirus and related technologies. Financial terms were not disclosed. The Towne strain is an attenuated, or weakened, form of human CMV developed for potential vaccine applications.

• VioQuest Pharmaceuticals, of Basking Ridge, N.J., said preclinical data demonstrated that VQD-002 (triciribine phosphate monohydrate or TCN-P) disrupts a specific signaling pathway associated with chemoresistance and cancer cell survival in ovarian cancer. A specific microRNA (miRNA), known as miR-214, was shown in the study to induce cancer cell survival and cisplatin resistance through activation of the Akt pathway, an important regulator of cell proliferation and survival. Based on those findings, researchers concluded that miRNA molecules play a critical role in inducing treatment resistance and disease progression in ovarian cancer, the firm said.

• Xanthus Pharmaceuticals Inc., of Cambridge, Mass., said the FDA has accepted for review the firm's new drug application for fludarabine phosphate oral tablets for the treatment of relapsed B-cell chronic lymphocytic leukemia (CLL). The FDA granted orphan drug designation for oral fludarabine for B-cell CLL earlier this month. Xanthus licensed the exclusive right to develop and commercialize oral fludarabine in the U.S. from Schering AG, now Bayer Schering Pharma AG, of Leverkusen, Germany, in October 2006.