The Amylin Europe Ltd. subsidiary of San Diego-based Amylin Pharmaceuticals Inc. submitted marketing authorization applications for Symlin (pramlintide acetate) to the European Agency for the Evaluation of Medicinal Products. Symlin is an analogue of human amylin, a hormone secreted with insulin by the beta cells in the pancreas.
Antisoma plc, of London, has received European orphan drug status for its lead product, pemtumomab (formerly called Theragyn), giving it 10 years of market exclusivity once the product is approved. Pemtumomab, for treating ovarian cancer, also has orphan drug designation in the U.S. It is in Phase III trials and is being developed in collaboration with Abbott Laboratories, of Abbott Park, Ill.
British Biotech plc, of Oxford, UK, said it has begun a Phase I/II study of the tumor-activated prodrug BB-10901, a treatment of small-cell lung cancer (SCLC), which it is developing in collaboration with ImmunoGen Inc., of Cambridge, Mass. The open-label study will first evaluate the maximum tolerated dose and then assess the drug's activity. BB-10901 was created by ImmunoGen by conjugating the cytotoxic drug maytansinoid DM1 with the humanized monoclonal antibody huN901, which binds to a protein found on the surface of SCLC cells. Under an agreement between the two companies signed a year ago, British Biotech is responsible for clinical trials for approval in the U.S., Europe and Japan, and has exclusive rights to BB-10901 in Europe and Japan.
Cytomyx Ltd., of Cambridge, UK, was limited to the lower end of its ambitions, raising £2 million in its listing on London's Alternative Investment Market. The company is the only biotechnology company to have floated in London this year, and CEO Mike Kerins said the response from investors "has been tremendous." However, Cytomyx set out to raise up to £3 million, and £1.45 million was already committed in a prefunding round. The company provides a range of services for early stage drug discovery.
DNA Link Inc., of Seoul, Korea, has agreed to purchase a SNPstream 25K system for industrial-scale single nucleotide polymorphism scoring from Orchid BioSciences Inc., of Princeton, N.J. DNA Link will conduct high-throughput genotyping using the platform and SNPware kits, and will purchase access to Orchid's SNP databases.
Graffinity Pharmaceutical Design GmbH, of Heidelberg, Germany, entered a drug discovery alliance with the pharmaceutical company Aventis Pharma AG, of Frankfurt, Germany. Financial terms were not disclosed. Graffinity validates a large number of small molecules against targets from Aventis. "We form chemical libraries of small molecules in order to discover lead molecules," Graffinity CEO Dirk Vetter told Bioworld International. Such libraries are microarrays of molecules bound covalently on gold-coated chips. If a target interferes with a molecule spot on the gold, it generates surface-plasmon resonance, which gives a detectable optical signal. There is no additional labeling needed for detection of interference. The company calls its proprietary array technology "rapid array-informed structure evolution (RAISE)." Vetter said RAISE is expected to enhance early steps of drug discovery 100-fold. RAISE is Graffinity's core technology.
Gyros AB, of Stockholm, Sweden, and Affibody AB, also of Stockholm, entered a strategic alliance calling for both to allocate resources to develop and commercialize an integrated and automated microfluidics-based protein microarray platform. Gyros said the platform will combine its CD-based microlaboratories with Affibody's high-throughput, high-sensitivity protein microarrays.
Lipha SA, of Lyon, France, and Tripos Inc., of St. Louis, completed the initial phase of their discovery research agreement. At its UK-based chemical research facility, Tripos successfully employed proprietary cheminformatics and discovery technologies in the anticipated timeline to identify and synthesize novel drug candidates against a Lipha target. Under the terms of the contract, Tripos received a technology license fee and payments for its research and discovery services.
Icon Genetics AG, of Munich, Germany, received a DM6.5 million (US$2.85 million) matching grant from the Federal Ministry of Education and Research in Berlin to develop prototypes of its proprietary line conversion technology for wheat and rape seed, two of Europe"s most important crops. The research and development will be done in collaboration with the Institute of Plant Genetics and Crop Plant Research in Gatersleben, Germany. The grant will be leveraged through Icon's own funds and will enable the company to develop the first working prototypes of transgene operating systems for wheat and rape seed.
The Roslin Institute, of Edinburgh, Scotland, announced progress in its cloning collaboration with Geron Corp., of Menlo Park, Calif., with the birth of the first knockout lamb and the cloning of a pig by the nuclear transfer technique that was used to create Dolly, coupled with novel technology for establishing and maintaining pregnancy. The lamb had one copy of the prion protein gene deleted, and was the first cloned knockout mammal other than the mouse. The animal had an untreatable heart defect and was put down at 12 days. The cloned pig is now five months old and appears to be developing normally. The collaboration with Geron, entered in May 1999, aims to use nuclear transfer to make precise genetic modifications to farm animals.
ViaLactia Biosciences Ltd., of Auckland, New Zealand, and Orion Genomics LLC, of St. Louis, entered into a multistage genomics alliance to develop improved varieties of forage plant species for the pastoral agricultural industries, and to develop hardier and higher-yielding crops. Financial terms were not disclosed. Under the terms of the agreement, Orion will use its GeneThresher technology to sequence and identify the complete gene set of a key forage grass species. The two companies will then develop specialized genome research tools, including DNA microchips, genetic markers and sequence databases.
Whatman plc subsidiary Whatman Biosciences Inc. completed the purchase of the assets, except for cash, cash equivalents and marketable securities, of HemaSure Inc., of Marlborough, Mass. The companies signed the sales agreement in February. The transaction consists of a $10 million payment and a reimbursement amount that covers the net change in cash from the ongoing operations of HemaSure's business from Nov. 1, 2000, through the closing date. HemaSure also will get 4 percent royalties of up to $12 million in sales of filtration products using its technology.
Wilex AG, of Munich, Germany, has received an orphan drug designation from the U.S. Food and Drug Administration for a potential drug for treatment of renal cell carcinoma. The designated pharmaceutical is a chimeric (human-murine) G250 IgG monoclonal antibody. It is in a Phase II clinical trial.