• 3SBio Inc., of China, saw its shares fall Thursday despite reporting net income of $2.5 million for the fourth quarter of 2007, an increase of 152.2 percent compared with the same quarter in 2006, and net revenues of $6.3 million, an increase of 30 percent. The company reported earnings of 11 cents per American Depository Share, compared to expectations closer to 13 cents per share. The company said net revenue from its flagship injectable recombinant human erythropoietin products marketed under its EPIAO brand increased 14.7 percent to $4.1 million over the fourth quarter. In addition, net revenue from its protein-based therapeutic recombinant human thrombopoietin products marketed under its TPIAO brand increased 99.3 percent to $1.6 million. 3SBio's shares (NASDAQ:SSRX) plummeted 28.3 percent Thursday, or $3.31, to close at $8.39.

• Advanced Cell Technology Inc., of Worcester, Mass., reported a process for generating high-purity hepatocytes for use in regenerative medicine and drug discovery. As reported in Stem Cells, the company's method yielded synchronous populations of hepatocytes generated in clinically preferred conditions with minimum use of serum and cell feeders. Populations of definitive endoderm then were generated from hESCs and induced to differentiate along the hepatic lineage by the sequential addition of inducing factors implicated in physiological hepatogenesis.

• Akorn Inc., of Buffalo Grove, Ill., entered into a deal to market and distribute prefilled syringes and multidose vials of the seasonal influenza vaccine Afluria on behalf of CSL Ltd. Terms were not disclosed. Akorn immediately will begin pre-booking sales for the 2008 flu season.

• Alfacell Corp., of Somerset, N.J., said preclinical data showed that intracellular pathways are affected by Onconase (ranpirnase). The in vitro and in vivo data were presented at 5th Cancer Drug Research & Development Conference in Phoenix. The preclinical data in mice demonstrated the relative potency of chemical conjugates of Onconase, the company said. The work underscored that Onconase works selectively and does not appear to kill cells indiscriminately, the company news release said.

• Cypress Bioscience Inc., of San Diego, and Forest Laboratories Inc., of New York, said the FDA accepted for review the new drug application for milnacipran in fibromyalgia. A decision is expected in October. The drug is a norepinephrine-serotonin-reuptake inhibitor and is sold in about 50 countries outside the U.S. for depression and other nonpain indications. (See BioWorld Today, Jan. 2, 2008.)

• Eurand NV, of Philadelphia, said its new drug application for the porcine-derived, pancreatic enzyme replacement therapy, Zentase (EUR-1008), was accepted for review by the FDA and given priority review status. Based on a December filing, a decision is expected in June.

• Gen-Probe Inc., of San Diego, submitted a supplemental biologics license application to the FDA seeking approval to use its Procleix Ultrio assay to screen donated blood for hepatitis B. The assay currently is approved for HIV-1 and hepatitis C screening and is marketed by Basel, Switzerland-based Novartis AG's Chiron unit.

• GlaxoSmithKline Biologicals plc, of London, said the FDA's Vaccines and Related Biological Products Advisory Committee voted unanimously Wednesday in favor of the firm's data being adequate to support the efficacy of Rotarix (rotavirus vaccine, live, oral) to prevent rotavirus gastroenteritis in infants. In addition, the panel voted 11 to 1 in favor of GSK's data being adequate to support the safety of Rotarix. If approved, Rotarix would allow for completion of the rotavirus vaccination series by 4 months of age and could be integrated into the current vaccine schedule at the 2-month-old and 4-month-old immunization visits. Rotavirus accounts for more than 500,000 deaths worldwide and 2 million hospitalizations each year.

• ImmunoCellular Therapeutics Ltd., of Los Angeles, appointed Manish Singh president and CEO. Formerly Singh was a director of California Technology Ventures, an early stage venture capital firm. In addition, he spent 14 years in various scientific and managerial positions in research, product development, manufacturing and business development.

• Integrated Genomics, of Chicago, said it has published the complete Granulibacter bethesdensis genome sequence, the first organism to be linked to chronic granulomatous disease, an invasive disease resulting from a genetic defect in phagocyte superoxide formation. Complete genome sequencing, annotation and comparative analysis of G. bethesdensis by the scientific team at Integrated Genomics allowed scientists at the National Institutes of Health and the Rocky Mountain Laboratory in Hamilton, Mont., to identify the pathogenic and virulence factors in the genome, the firm said.

• Ipsen SA, of Paris, said the European Committee for Medicinal Products for Human Use provided a positive opinion for Adenuric (febuxostat) 80-mg and 120-mg tablets in chronic hyperuricemia in gout, recommending it for marketing authorization. That opinion will be forwarded to the European Commission for final approval, which typically occurs within 60 days to 90 days. Febuxostat, an oral, once-daily nonpurine selective inhibitor of xanthine oxidase, was licensed to Ipsen in Europe from Tokyo-based Teijin Pharma Ltd.

• Lab21, of Cambridge, UK, said it has obtained a license from Celera, of Alameda, Calif., to access its test for cirrhosis risk in patients with chronic hepatitis C viral infection in the UK and Ireland. The test, known as CRS7, is the first clinical test capable of predicting the likelihood of an HCV patient's risk of progressing to liver fibrosis and cirrhosis.

• MorphoSys AG, of Martinsried-Planegg, Germany, and Astellas Pharma Inc., of Tokyo, said they are extending their March 2007 collaboration until March 2012 under which Astellas has access to MorphoSys' proprietary antibody library HuCAL Gold at its research site in Tsukuba, Japan. The extension includes an option for Astellas to develop and commercialize HuCAL-derived therapeutic antibodies, in which case MorphoSys would receive exclusive license fees, milestone payments and royalties. Under the extended agreement, MorphoSys continues to receive annual user fees for access to its HuCAL platform. Further financial details were not disclosed.

• Neurochem Inc., of Laval, Quebec, is changing its name to Bellus Health and changing the name of its nutraceutical businesses unit to Ovos Natural Health. The company also said its two-year, $60 million credit facility obtained in 2006 has been extended until 2010. In a pipeline update, Neurochem said it plans to initiate a Canadian Phase II trial with NC-503 in Type II diabetes and continue to work with U.S. and European regulatory agencies on Kiacta (eprodisate), which has received two approvable letters for AA amyloidosis and is under review again. Neurochem also reported a net loss of $81.5 million for 2007, and its shares (NASDAQ:NRMX) fell 16 cents, or 9.8 percent, to close at $1.47 on Thursday. (See BioWorld Today, Aug. 11, 2006, and July 19, 2007.)

• NextGen Bioscience Inc., of London, signed a letter of intent with SymbioTec GmbH, of Saarbrücken, Germany, to enter a collaboration based on SymbioTec's cancer drug Oncohist. Oncohist is a genetically engineered derivative of a protein within the innate immune system that selectively targets cancer cells. Financial terms were not disclosed.

• SensiGen LLC, of Ann Arbor, Mich., said the Michigan Economic Development Corp. has approved a 1 percent term loan to be used for expanding the firm's operations in Ann Arbor. The loan will be used to hire workers displaced by the closure of Michigan research facilities owned by Pfizer Inc., of New York. SensiGen said it received an initial investment of $2.6 million from the MEDC in 2004 and has raised an additional $1.4 million in investments from a diverse list of public and private investors from across the nation.

• Sequenom Inc., of San Diego, said preclinical studies examining more than 100 clinical plasma specimens of various ethnicities with partners using the firm's MassARRAY platform and SEQureDx technology indicated that the development-stage Trisomy 21 test is approaching 85 percent ethnic coverage, more than 95 percent sensitivity and close to 99 percent specificity. The Trisomy 21 test is being developed to assess risk of Down syndrome. The test is expected to be commercially available in the first half 2009.

• Sirtris Pharmaceuticals Inc., of Cambridge, Mass., said it will collaborate with the National Cancer Institute to test the anticancer impact of Sirtris' SIRT1 enzyme activators in numerous models of cancer. NCI is providing the resources for the study, accelerating the testing of the compound in both solid and hematological models of cancer, the company said. The study will include SRT501, a proprietary formulation of resveratrol, and multiple compounds from different chemical classes of Sirtris' new chemical entities, which are 1,000 times more potent than resveratrol in in vitro studies, it said.

• StemCyte Inc., of Arcadia, Calif., presented several abstracts at the Bone Marrow Transplant Tandem Meetings regarding its plasma-depleted, cord blood-derived stem cell products. Two studies showed that thalassemia and blood cancer patients receiving plasma-depleted cord blood transplants had lower mortality and better survival than those treated with standard red cell-reduced cord blood. Other data pointed to benefits in reducing chronic graft-vs.-host disease, treating nonmalignant disorders and treating adult malignancies.

• Summit Corp. plc, of Oxford, UK, said its specialist carbohydrate chemistry subsidiary business Dextra Laboratories has signed service contracts with four undisclosed biotechnology firm worth an initial £500,000 (US$981,615), with the value of the deals potentially reaching more than £1 million over the next six months.

• Wyeth Pharmaceuticals Inc., of Philadelphia, said the FDA has approved Xyntha Antihemophilic Factor (recombinant, plasma-/albumin-free) as a therapy for hemophilia A, a rare, hereditary blood-clotting disorder that affects about 15,000 individuals, almost exclusively males, in the U.S. Xyntha is a genetically engineered version of factor VIII, a protein essential for the clotting of blood, which is missing or decreased in patients with hemophilia A. Xyntha is licensed for the control and prevention of bleeding in patients with hemophilia A, which can occur spontaneously or after an accident or injury, and to help prevent surgical bleeding in patients with that condition. Xyntha is made using genes from Chinese hamster ovary cells, which are free from known infectious agents.