• Basilea Pharmaceutica Ltd., of Basel, Switzerland, submitted a marketing authorization application for oral alitretinoin in severe refractory chronic hand eczema. The application is based on clinical data from nearly 2,000 patients.

• Biothera, of Eagan, Minn., said preclinical research showed that Imprime PGG might increase the efficacy of Erbitux (cetuximab, ImClone Systems Inc.) in the treatment of non-small-cell lung cancer and potentially other cancers that express epidermal growth factor receptor (EGFR) on their cell surface. Imprime PGG is a developmental drug designed to work by engaging innate immune cells to fight cancer. Study results demonstrated that the combination of Imprime PGG and Erbitux significantly improved the long-term survival of xenograft mice implanted with human NSCLC cells - 80 percent survived more than 150 days - while none of the animals treated with Erbitux alone survived past 90 days. Significant reductions in tumor growth also were observed. Data were published in Cancer Research.

• CellCyte Genetics Corp., of Kirkland, Wash., has entered into a collaborative research agreement with the Cleveland Clinic Foundation to investigate the presence and regulation of heart receptors involved in stem cell trafficking in normal and diseased human hearts. CellCyte is developing stem cell enabling products that may increase the number of stem cells delivered to a damaged organ, thereby increasing organ healing. Foundation scientists will analyze heart tissue samples of heart failure patients for the presence of surface receptors that are hypothesized to play an important role in the interaction of stem cells with the heart.

• Competitive Technologies Inc., of Fairfield, Conn., said it presented Palatin Technologies Inc., of Cranbury, N.J., notice of termination of the PT-14 technology license agreement originally signed between the companies in March 1998. The notice alleges Palatin committed a material breach of the contract. CTI, a technology transfer company, is representing the University of Arizona and inventors of the technology, which is believed to have applications in sexual dysfunction and obesity. CTI said it would continue to pursue arbitration and legal processes against Palatin to collect all funds due from earlier alleged violations of the terms of the field-of-use 1998 agreement, and to collect punitive damages and attorney fees.

• Genmab BV, of Utrecht, the Netherlands, extended the use of Guildford, UK-based ID Business Solutions Ltd.'s ActivityBase Xtended Edition within its Hybridoma Discovery department. Genmab initially purchased the program in 2006 to handle the design, capture, storage and retrieval of its plate-based screening data, and ActivityBase XE allows the company to capture, validate and visualize data from antibody screening in a contextually rich environment. Financial terms were not disclosed.

• Merck & Co. Inc., of Whitehouse Station, N.J., has completed the acquisition of San Diego-based NovaCardia Inc., a privately held clinical-stage pharmaceutical company focused on cardiovascular disease. The acquisition adds rolofylline (KW-3902), NovaCardia's investigational Phase III compound for acute heart failure to Merck's pipeline. Merck acquired all the outstanding equity of NovaCardia for a total purchase price of $366.4 million (including $16.4 million of cash and investments on hand at closing), which was paid through the issuance of 7.3 million shares of Merck common stock to the former NovaCardia shareholders. Approximately $325 million of the purchase price will be accounted for as in-process research and development costs, which is expected to result in a charge to Merck's third-quarter earnings of 15 cents per share. (See BioWorld Today, July 26, 2007.)

• NicOx SA, of Sophia Antipolis, France, said Topigen Pharmaceuticals Inc., of Montreal, plans to initiate a Phase II study for the use of its TPI-1020 compound to treat chronic obstructive pulmonary disease. The study, which Topigen expects to launch during the second half of this year, follows promising top-line results from an initial Phase II study with the compound, a respiratory anti-inflammatory treatment licensed from NicOx. (See BioWorld Today, Oct. 28, 2005.)

• Oxford BioMedica, of Oxford, UK, has reached the first development milestone in its collaboration with Sanofi-Aventis, of Paris, for the TroVax cancer immunotherapy, triggering a payment of €9 million (US$12.5 million). The milestone relates to the successful enrollment of 350 patients in the Phase III TRIST study of TroVax in renal cancer. That represents half of the anticipated 700 patients to be enrolled into the trial. In a March 2007 deal, Oxford BioMedica received an initial payment of €29 million, and the current €9 million milestone is part of a potential €19 million in near-term payments linked to the Phase III TRIST study. The company could receive a total of €518 million in initial and milestone payments if development and registration targets are met for defined indications. (See BioWorld Today, March 29, 2007.)

• S*BIO Pte. Ltd., of Singapore, said it is developing an orally administered compound, SB1518, in myeloproliferative disorders (MPD) and certain hematological malignancies. SB1518 is a small-molecule JAK2-selective kinase inhibitor that has shown activity against both the wild-type JAK2 kinase and the JAK2 kinase with the activating V617F mutation that is found frequently among three types of MPD and in some leukemias. It previously showed antiproliferative and antitumor activity, along with good tolerability, in in vitro and in vivo models.

• Senesco Technologies Inc., of New Brunswick, N.J., said the American Stock Exchange accepted the company's plan of compliance and granted Senesco an extension until March 1, 2008, to regain compliance with AMEX's continued listing standards. The company received notice in June indicating that it was below certain standards, due to the fact that its shareholder's equity was less than $4 million and losses from continuing operations and/or net losses were incurred in three of the last four fiscal years.

• SGX Pharmaceuticals Inc., of San Diego, and Novartis AG, of Basel, Switzerland, have amended a previous agreement to give SGX the right to develop and commercialize product candidate SGX393 outside of the collaboration, subject to a reacquisition right of Novartis. In addition, the amendment gives Novartis responsibility for the selection of all future development candidates as well as responsibility for the clinical development of additional compounds from the collaboration. The financial terms of the collaboration agreement remain unchanged. (See BioWorld Today, March 29, 2006.) SGX393, is a potent inhibitor of the T315I mutant (as well as other drug resistant mutants and wild-type BCR-ABL) and has its most likely application in drug-resistant chronic myelogenous leukemia. SGX said the anticipated timeline for filing an investigative new drug application on SGX393 is the first half of 2008, contingent upon successful completion of preclinical studies.

• SkyePharma plc, of London, met with the FDA and agreed on an approach for the additional clinical work required for the asthma drug Flutiform, which will include a further study to provide more efficacy data. Discussions with the FDA are ongoing in relation to the design of the study and will be finalized after submission of supporting chemistry, manufacturing and controls data. The anticipated date for filing of the Flutiform new drug application remains the second half of 2008.

• Theratechnologies Inc., of Montreal, said the FDA declared the firm's tesamorelin (TH9507) clinical development program is moving in the right direction. The agency's Division of Metabolic and Endocrine Drug Products recently requested an update on the status of Theratechnologies' clinical trial program and preliminary results for tesamorelin. Upon review of the documentation, the FDA indicated it was reassured, especially given that thus far there are no signals of glucose intolerance or other safety concerns. With the information known currently, the FDA indicated that it does not anticipate that more trials would be required for the compound, designed for HIV-associated lipodystrophy.