• BioAlliance Pharma SA, of Paris, launched its first drug, Loramyc (miconazole Lauriad), on the French market. The product, an antifungal delivered in a mucoadhesive buccal tablet, was approved in France last year. It was developed specifically for treating oropharyngeal candidiasis in immunodepressed patients. BioAlliance said it is the first biotech company in France to have successfully managed the whole process of bringing an academic innovation out of the lab, through research and development, and onto the market. Par Pharmaceutical Cos. Inc., of Woodcliff, N.J., recently gained exclusive U.S. commercialization rights to the product.

• Celera Group, of Rockville, Md., plans to purchase Berkeley HeartLab, of Burlingame, Calif., for approximately $195 million in cash. BHL is a cardiovascular health care company with a portfolio of CLIA certified tests and disease management services focused on the secondary prevention market. The transaction is expected to close in the second quarter of fiscal 2008. Celera predicts that the acquisition will be accretive to earnings in the second half of fiscal 2008. The company anticipates that BHL's annual revenues will exceed $85 million in calendar 2007 with double-digit year-over-year growth. In calendar 2006, BHL reportedly recorded EBIT margins in excess of 17 percent.

• Celgene International Sàrl, of Boudry, Switzerland, said its oral cancer drug Revlimid (lenalidomide) has been approved by the Swiss Agency for Therapeutic Products for use in combination with dexamethasone as a treatment for patients with multiple myeloma who have received at least one prior therapy. Revlimid has obtained orphan drug designation in the U.S., the EU and Australia for multiple myeloma, is approved for use as an oral treatment in combination with dexamethasone by the European Commission, is approved in the U.S. for multiple myeloma patients who have received at least one prior therapy and for treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

• Eurand NV, of Milan, Italy, said partner GlaxoSmithKline plc, of London, successfully completed a bioequivalence study of an undisclosed GSK compound, triggering a $1.5 million milestone payment to Eurand. The new drug formulation, using Eurand's Microcaps and AdvaTab technologies, is designed to dissolve quickly in the mouth without leaving a sour or bitter taste. Over the course of the collaboration, Eurand could receive up to $42 million in milestones and be entitled to royalties from product sales.

• European ScreeningPort GmbH, of Hamburg, Germany, a new drug discovery service center, has been established with the support of the German Federal Ministry of Education and Research, the Free and Hanseatic City of Hamburg, biotech firm Evotec AG and North German life science agency Norgenta. To date, the venture has raised more than €7 million (US$9.5 million) in financing. Hamburg's European ScreeningPort will build upon research results generated in academia to enable a more systematic and efficient search for promising compounds that can be developed further.

• Fluidigm Corp., of South San Francisco, said SAIC-Frederick Inc., the prime contractor for the National Cancer Institute and a wholly owned subsidiary of Science Applications International Corp. (SAIC), has acquired the BioMark system for use in its core genotyping facility in Gaithersburg, Md. BioMark will allow SAIC-Frederick to simplify its genotyping process to test candidate genes against samples from cancer patients. Financial terms of the deal were not disclosed.

• Geron Corp., of Menlo Park, Calif., said an appeals board of the European Patent Office affirmed the decision to revoke the claims of European Patent 1093381 as granted in 2003 to Pharmexa A/S, of Horsholm, Denmark. The Pharmexa patent had been granted with broad claims covering the use of telomerase peptides and nucleic acids for cancer immunotherapy. Geron filed in opposition requesting that the EPO revoke the patent based, in part, on Geron's earlier patent filings covering telomerase.

• GTC Biotherapeutics Inc., of Framingham, Mass., said the FDA has designated ATryn for fast-track status for the hereditary antithrombin deficiency indication. The FDA also granted GTC permission to submit the associated biologics license application on a rolling basis. GTC anticipates filing the initial sections of the BLA in the fourth quarter and completing the rolling submission after all clinical data are gathered, analyzed and available, which is planned to be by the end of the first quarter 2008. ATryn is a recombinant form of human antithrombin, a protein with anticoagulant and anti-inflammatory properties that normally is present in human plasma. It is in a Phase III comparative study for the treatment of hereditary antithrombin deficiency for patients at risk for developing deep vein thrombosis while undergoing surgical procedures or childbirth. Top-line data from the study is planned to be available late in the fourth quarter.

• Medivir AB, of Stockholm, Sweden, has entered a licensing agreement with the Hainan Noken Pharmaceutical Industry Ltd., of China, for the antiviral compound MIV-210. It is a polymerase inhibitor and belongs to the group of projects administered by subsidiary Medivir HIV Franchise AB. Noken intends to develop MIV-210 to a pharmaceutical for the treatment of hepatitis B virus (HBV). Under the deal, Noken assumes operational and financial responsibility for the clinical trials required for registration of the ultimately developed drug. Noken has marketing rights for MIV-210 in China, Hong Kong, Taiwan, Macao, Singapore, Japan, South Korea and Australia. Medivir retains marketing rights in other parts of the world. During the pharmaceutical development of MIV-210, Medivir may earn $7 million in milestone payments. Medivir is further entitled to a double-digit royalty on Noken's future sales. An estimated 120 million Chinese are chronically infected with HBV and 30 million of those are at risk of the disease escalating to liver cancer and cirrhosis.

• Merck KGaA, of Darmstadt, Germany, submitted an application to the European Medicines Agency for broader use of Erbitux (cetuximab) as a first-line therapy in metastatic colorectal cancer. The application is based in part on data from the CRYSTAL (Cetuximab combined with iRinotecan in first-line therapY for metastatic colorectAL cancer) study, which showed that Erbitux, when added to chemotherapy, significantly increased progression-free survival, response and resection rates. Pending approval, the drug could be available to patients in a first-line indication in the second half of next year. Erbitux was approved in mCRC after irinotecan failure in Europe in 2004, and also is marketed in the U.S. for that indication by New York-based firms ImClone Systems Inc. and Bristol-Myers Squibb Co.

• Metabasis Therapeutics Inc., of San Diego, said a recent publication in the Journal of American Chemical Society describes the integration of quantum mechanics into a method known as free energy perturbation and the use of the resulting QM/molecular mechanics-based FEB method for drug design. The article includes mention of a computer-aided drug design strategy that has been used by Metabasis to calculate the relative inhibitor potencies of several structurally diverse fructose-1, 6-bisphosphatase inhibitors. The company's drug discovery programs focus on the use of those inhibitors for treating Type II diabetes.

• MGI Pharma Inc., of Minneapolis, and partner Helsinn Healthcare SA, of Lugano, Switzerland, said the FDA approved a supplemental new drug application for Aloxi (palonosetron hydrochloride) injection, which includes the removal of a dosing recommendation from the product's label that limited Aloxi use to once per seven-day intervals. Aloxi is approved for the prevention of acute nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic chemotherapy and for prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy. MGI also is seeking approval of Aloxi for postoperative nausea and vomiting, and the PDUFA date for that review is March 4, 2008.

• ThromboGenics NV, of Leuven, Belgium, has completed the technology transfer to Bharat Biotech International Ltd., of Hyderabad, India, for the manufacture of THR-100, a variant of recombinant staphylokinase. THR-100 is a thrombolytic agent developed for treating acute myocardial infarction and other vascular diseases.

• ViaCell Inc., of Cambridge, Mass., has entered into an agreement under which EMD Serono Inc., an affiliate of Merck KGaA, of Darmstadt, Germany, will support the clinical development of ViaCyte, ViaCell's investigational product for the cryopreservation and thawing of human oocytes for use during assisted reproductive technology. EMD Serono will provide quantities of two of its products, Gonal-f RFF Pen (follitropin alfa injection) and Ovidrel Prefilled Syringe (choriogonadotropin alfa injection), for the treatment of patients participating in the ViaCyte study. Financial terms were not disclosed.