Biotech Stocks Day-in-Review: BioCryst Begins Pivotal Trial of Fodosine

by: Centient Biotech Investor
BioCryst (NASDAQ:BCRX) moved its lead oncology drug, Fodosine, into a pivotal trial for relapsed or refractory T-cell leukemia/lymphoma. Due to the event, BioCryst is now due a $5 million milestone from Munidpharma. The endpoint of the trial will be the percentage of complete remissions caused by Fodosine.

Advanced Cell Technology (ACTC), the controversial company that made news in 2006 for developing stem cells without destroying embryos, received a $200,000 NIH grant to differentiate stem cells using phage displayed ligands. Advanced Cell is working in conjunction with the Burnham Institute on the project. Because it is a federal grant, the project will use NIH-approved stem cell lines.

DOV Pharmaceuticals
(DOVP) out-licensed the world-wide rights for Bicifadine, a serotonin and norepinephrine reuptake inhibitor, to XTL Biopharmaceuticals Ltd (NASDAQ:XTLB). XLT will develop Bicifadine for neuropathic pain. XLT will make a $7.5 million upfront payment and another $126.5 available for milestone payments. The drug, which DOV licensed from Wyeth (WYE), has been extensively studied, but the results were often disappointing. XLT will use its extensive safety record and apply the drug to this proven market for serotonin/norepinephrine reuptake inhibitors, giving XLT immediate access to a late-stage drug.

Novovax (NASDAQ:NVAX) has increased the quality and purity of its virus-like particle [VLP] vaccine for HIV/AIDS. The VLP has a structure similar to the virus, but lacks the DNA to replicate or infect the host, allowing it to cause an immune response without risk. Novovax is making plans to put the improved vaccine in a Phase I trial.

BioMarin (NASDAQ:BMRN) reported positive data from a Phase III study of Phenoptin in patients with phenylketonuria [PKU]. The study, which built on an earlier successful Phase III trial of the drug, allowed the 4-12 year-old patients a less-restricted diet. BioMarin expects to file an NDA for the drug in Q2 of 2007. Its partner, Merck Serono (SRA-OLD), plans to file for European approval in Q3 of 2007.

Nabi Biopharmaceuticals (NASDAQ:NABI) has put Civacir, a hepatitis C immune globulin (human) in a Phase II trial. The drug is aimed at preventing liver disease in patients who receive liver transplants and are receiving immunosuppressive drugs. Nabi predicts that the drug could generate $400 million in revenue.

Dendreon (NASDAQ:DNDN) received priority review for Provenge, its therapeutic vaccine for hormone refractory prostate cancer. The upshot of priority review is that the FDA will rule on approval for Provenge by May 15, 2007.

Neurobiological Technologies (OTCPK:NTII) received its final $4 million installment payment from Celtic Pharma for Xerecept, a drug targeting peritumoral brain edema, currently in Phase III trials. Neurobiological could receive $15 million in regulatory milestones in addition to the $33 million in guaranteed payments.

Hollis-Eden (HEPH) reported positive preclinical data on HE3286, an oral synthetic hormone that treats type 2 diabetes. Hollis-Eden says the drug candidate, which is a novel insulin sensitizer, significantly lowered glucose levels in mice.

Lilly (NYSE:LLY) and its Japanese partner Daiichi Sankyo have completed enrollment in a pivotal Phase III trial that pits prasugrel against Plavix in patients with acute coronary syndrome undergoing percutaneous coronary intervention [PCI].

The FDA accepted a new drug application for Somatuline Autogel, a drug being developed by Tercica (TRCA) and its European partner Ipsen for acromegaly. The FDA is expected to complete its review of the drug by August 30, 2007.

Merck Serono [SRA] has completed enrollment in a Phase III trial of an oral formulation of cladribine for relapsing forms of multiple sclerosis. The drug has fast track and priority review status in the US.

Watson Pharma (WPI) reported positive results from two Phase III trials of silodosin, a drug aimed at benign prostatic hyperplasia. Although specific data were not released, the company said the drug produced a statistically significant improvement in both endpoints, which were an improvement in International Prostate Symptom Score-1 and improvements in maximum urine flow. Watson will release more data at an upcoming scientific conference.

Genizon BioSciences out-licensed to Pfizer (NYSE:PFE) the diagnostic rights for use of genetic discoveries made in three diseases: Alzheimer’s, attention deficit hyperactivity disorder and endometriosis. Genizon will retain the therapeutic rights to its discoveries, which are genetic variations associated with the diseases. Financial details were not disclosed, but Pfizer will pay an upfront fee, underwrite research, and make an equity investment in Genizon.

Hana Biosciences (HNAB) was given orphan drug designation for Mariqibo, a treatment for acute lymphoblastic leukemia. In December, Hana reached an agreement with the FDA for a special protocol assessment for the drug, covering a pivotal trial that Hana will begin in the first half of 2007. Marquibo is a formulation of vincristine, a standard chemotherapy, encapsulated in a rigid lipid bilayer of sphingomyelin that causes the drug to be leaked out slowly.

Biotech resumed its upward movement after the three-day weekend. The Centient Biotech 200™ rose 17 points to end at 4095, a gain of .42%. The broad market did not fare as well, with the S&P 500 up only .08% and Nasdaq lower by .20%.

Disclosure: none.