• AbD Serotec, of Martinsried, Germany, a division of MorphoSys AG, said its customer, Frederick, Md.-based Integrated BioTherapeutics Inc. received a five-year National Institutes of Health grant to develop human antibody therapeutics against staphylococcal enterotoxin B, a bacterial-derived toxin from Staphylococcus aureus. The amount of the award was not disclosed. The project is a continuation of a biodefense-related project started in September 2006 by USAMRIID using AbD Serotec's custom monoclonal antibody services. Under the terms, IBT will use a selection of HuCAL-based antibodies generated by AbD Serotec against staphylococcal enterotoxin B in in vitro and in vivo experiments to identify lead candidates.

• Acusphere Inc., of Watertown, Mass., received notice from Nasdaq that it has failed to regain compliance with minimum bid price requirements since its warning in January. The company plans to request a hearing and may conduct a reverse stock split afterward if necessary. The company's lead cardiovascular ultrasound imaging agent Imagify (perflubutaine polymer microspheres for injectable suspension) is under FDA review.

• Alfacell Corp., of Somerset, N.J., signed a deal with Raanana, Israel-based Megapharm Ltd. for distribution of Onconase (ranpirnase) in Israel. Alfacell will manufacture and supply the product to Megapharm, which will manage regulatory and commercial activities. The companies will share profits equally. Onconase failed to improve survival in a Phase IIIb trial for unresectable malignant mesothelioma, but the company reported survival benefits in a second-line subset and plans to continue its rolling new drug application. (See BioWorld Today, May 30, 2008.)

• Amsterdam Molecular Therapeutics BV, of Amsterdam, the Netherlands, entered a collaboration with St. Jude Children's Research Hospital in Memphis, Tenn. AMT will sponsor research at St. Jude's on a gene therapy treatment for hemophilia B and will retain rights to the compound. Specific terms were not disclosed.

• Clinical Data Inc., of Newton, Mass., said that its Cogenics division has entered into a scientific research and development agreement with H. Lundbeck AS, of Copenhagen, Denmark, to support its clinical studies with genotyping solutions on a global basis. Under the agreement, Cogenics will use its clinical genotyping platforms and expertise to support Lundbeck's clinical studies worldwide, initially focusing on Lundbeck's Phase I studies. The term of the agreement is open-ended, and the parties intend to collaborate on multiple projects going forward.

• DOR BioPharma Inc., of Ewing, N.J., said that it has executed a definitive collaborative agreement with IDIS Ltd., of Weybridge, UK, for the supply and distribution within the European Union of the company's investigational drug orBec (oral beclomethasone dipropionate) for the treatment of gastrointestinal graft-vs.-host disease via a named patient program.

• Dyax Corp., of Cambridge, Mass., said that the company has entered an exclusive negotiation period ending on Sept. 30 with Dompé Farmaceutici SpA, of Milan, Italy, for a European license to DX-88 in angioedema indications, including hereditary angioedema, for which the company recently completed its second Phase III trial. As a condition for the exclusive negotiation rights, Dompé entered a securities sale agreement with Dyax to purchase 2 million shares of Dyax common stock in a private placement at $4.98 per share, which represents a 57 percent premium over the closing price on July 10. The offering, which represents a total investment of $10 million, is expected to close July 17.

• Jerini AG, of Berlin, said that the European Commission has granted marketing authorization for Firazyr (icatibant) for the treatment of acute attacks of hereditary angioedema, a rare, potentially life-threatening genetic disorder caused by a deficiency of C1 inhibitor, a human plasma protein. The commission's approval makes Firazyr the first product to be approved in all EU countries for the treatment of HAE. Firazyr, a synthetic peptidomimetic that works by blocking the B2 receptor as an antagonist to the peptide-hormone bradykinin, which has been shown to be elevated in HAE patients and responsible for edema formation during HAE attacks, has been granted orphan drug status for the treatment of angioedema by the European Medicines Agency and the FDA.

• MediGene AG, of Martinsried, Germany, said that an initial investigation of the recent death of a Phase I clinical trial volunteer in Scotland indicated that the individual in question died from acute myocardial re-infarction arising from coronary thrombosis. The patient had suffered several small infarctions in the past, and the autopsy revealed pre-existing coronary arteriosclerosis and myocardial hypertrophy. MediGene said the evidence indicated that a causal connection between the death and the action of its investigational rheumatoid arthritis drug RhuDex "is unlikely." The trial protocol included a comprehensive analysis of participants' cardiac and vital functions both prior to and following administration of the trial medication, the company said, but that minor, asymptomatic infarctions can go undetected. The trial will remain on hold until the investigation is finalized.

• Perlegen Sciences Inc., of Mountain View, Calif., said it has opened a portfolio of patented technologies that together enable whole genome association studies capable of assessing a person's predisposition to specific disease risks and treatment outcomes. The firm said that the family of six complementary patents covers methods of genetic analysis used to detect markers for multifactorial traits. Those methods range from identification of tightly linked haplotype blocks and multiloci markers to optimal matching of patient cases and controls and methods for managing the massive data sets that accompany the analyses.

• Sun Pharmaceutical Industries Ltd., of Mumbai, India, said its subsidiary, Alkaloida Chemical Co. Exclusive Group Ltd., has extended the expiration date of the tender offer for purchase of all outstanding ordinary shares of Taro Pharmaceutical Industries Ltd., of Hawthorne, N.Y., to 5 p.m. EDT, Sept. 2. The extension was recommended by Judge Michal Agmon-Gonen J. of the Tel-Aviv District Court to allow the court to rule on the merits of the litigation filed against Alkaloida and its affiliates by Taro about the applicability of the special tender offer rules under the Israeli Companies Law. The offer was commenced on June 30 to comply with the terms of the option agreement between Alkaloida and the controlling shareholders of Taro. Alkaloida exercised its options to acquire shares of Taro from the controlling shareholders on June 25.