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Other News To Note
(BioWorld Today) ACE Biosciences A/S, of Odense, Denmark, is collaborating with the Aeras Global TB Vaccine Foundation in Bethesda, Md., on developing second-generation BCG-based vaccines for tuberculosis. ACE is supplying analytical tools for the identification and characterization of antigens expressed by recombinant BCG bacterial strains that provoke a strong immune response. Financial terms were not disclosed.
Actavis Group, of Reykjavik, Iceland, completed the $810 million acquisition of the human generics business of Fort Lee, N.J-based Alpharma Inc. following receipt of regulatory approvals. The deal, along with Actavis' acquisition of New Jersey-based Amide Pharmaceuticals in May, gives Actavis more than 200 products in its development pipeline, and it is expected to file more than 30 abbreviated new drug applications in 2006.
Active Biotech AB, of Lund, Sweden, commenced the second of a planned series of Phase I trials of an orally available investigational compound, 57-57, in development for treatment of systemic lupus erythematosus (SLE). Patients with rheumatoid arthritis also will be included in the study, in addition to those with SLE. Earlier this year, the company reported that 57-57 was well tolerated, at all studied doses, in a Phase I trial involving 30 healthy volunteers. The upcoming study, which will take place at Karolinska University Hospital in Stockholm, the Uppsala University Hospital in Uppsala and the Lund University Hospital in Lund, also will monitor several biological markers in order to evaluate the effect of 57-57 on disease progression.
Amarin Corp. plc., of London, began a Phase III trial of Miraxion in Huntington's disease patients in Europe, three months after dosing began in a U.S. Phase III study. The primary endpoint is a measure of whether Miraxion taken 2 grams per day results in clinically and statistically significant changes in the Total Motor Score-4 subscale of the Unified Huntington's Disease Rating Scale. Both the randomized, double-blinded, placebo-controlled studies are being conducted under a special protocol-assessment procedure, and 240 patients are scheduled for inclusion in Europe and 300 in the U.S. Miraxion has orphan drug designation in the U.S. and in Europe.
Apoxis SA, of Lausanne, Switzerland, acquired exclusive worldwide development and marketing rights to the cancer compound FK866 from Astellas Pharma GmbH, of Munich, Germany. Apoxis said it would begin a series of Phase II studies of the product, re-named as APO866, next year. In exchange, it will make an up-front payment and a series of milestone payments based on successful development and approval of the compound, which selectively depletes a cancer cell's energy and exerts anti-angiogenic activity. Apoxis also will make royalty payments based on net sales. More specific financial terms were not disclosed.
Argenta Discovery Ltd., of Harlow, UK, announced a two-year drug discovery collaboration with Genentech Inc., of South San Francisco, to use Argenta's services to discover new chemical entities against an undisclosed target. Financial terms were not disclosed, but the agreement provides an option to extend the relationship.
Cellectis AS, of Romainville, France, granted AstraZeneca plc, of London, a worldwide nonexclusive license to a patent family related to a process for the specific replacement or insertion of a gene in the receiver genome by homologous recombination. The right is for in vitro and in vivo applications. Financial terms were not disclosed. Also, Cellectis signed a license agreement with Shire Pharmaceuticals, of Basingstoke, UK, granting it a nonexclusive worldwide commercial license to use Cellectis' patented site-directed genome engineering technologies for the creation and development of genetically engineered cells to produce gene-activated biopharmaceuticals. Financial terms of the deal were not disclosed. Shire is concentrating its therapeutic effort on the central nervous system, the gastrointestinal tract and human genetic therapies.
Cerep SA, of Paris, reported that Bristol-Myers Squib Co., of New York, initiated a Phase I trial of a second LFA-1 antagonist discovered through their collaboration, established in 1999. Like the first compound identified in 2003, which is undergoing Phase II trials, the latest one has potential in the treatment of various immuno-inflammatory disorders. The agreement called for Cerep to provide BMS with drug targets in the areas of inflammation and coagulation inhibition, while BMS would pay Cerep research and development funding of $5 million a year, as well as milestones and royalties. The discovery triggered another milestone for Cerep, and the deal has a total potential of $43million to the company.
Crucell NV, of Leiden, the Netherlands, obtained approval from the Belgian authorities to test the safety, tolerability and immunogenicity of its whole-inactivated West Nile virus vaccine in healthy volunteers. The company said it soon will begin a Phase I trial, with recruitment of volunteers under way. In addition, Crucell signed a nonexclusive STAR research license agreement for the production of monoclonal antibodies with Cambridge, Mass.-based Genzyme Corp. Financial terms were not disclosed. The company also reported that Berna Biotech AG, of Berne, Switzerland, requested due diligence information from a third party relating to its proposed acquisition by Crucell. The deal has been recommended by Berna's board. The companies agreed to an all-share takeover in a deal valued at CHF591 million (US$448.6 million), expected to close in February.
Cytos Biotechnology AG, of Zurich, Switzerland, said its open-label Phase IIa trial in 20 patients with allergic rhinoconjunctivitis and asthma due to house dust mite allergies met its primary efficacy endpoint, a median 10-fold increase in allergen tolerance upon conjunctival provocation with house dust mite allergen. After 10 weeks of treatment with 300 micrograms of CYT005-AllQbG10 in conjunction with house dust mite allergen, the median allergen tolerance was increased by at least a factor of 100 (p<0.0001). Post treatment, 17 of the 20 were completely tolerant to the allergen challenge. At the same time, the company said it began another Phase IIa trial of the same Immunodrug candidate to include 36 patients with mild to moderate allergic rhinoconjunctivitis due to grass pollen allergy.
Galapagos NV, of Mechelen, Belgium, said its services division, BioFocus, formed an alliance with Cresset BioMolecular Discovery Ltd., of Hertfordshire, UK, to develop a range of FieldFocus compound libraries using Cresset's molecular fields software. BioFocus also has an option to license the technology for medicinal chemistry projects for itself and third parties. Financial terms were not disclosed.
Genmab A/S, of Copenhagen, Denmark, said its partner F. Hoffmann-La Roche Ltd., of Basel, Switzerland, filed an investigational new drug application with the FDA for a Genmab antibody developed under the companies' collaboration. This is the ninth milestone Genmab has achieved under the agreement, and it will receive a milestone payment from Roche as a result. Roche has selected four Genmab antibodies as clinical candidates for a range of diseases, and this is the first of the four to enter the clinic.
genOway, of Lyon, France, and Invitrogen Corp., of Carlsbad, Calif., signed a co-marketing agreement for RNAi-related services. The deal combines Invitrogen's expertise in RNAi research technologies with genOway's portfolio of transgenesis technologies and RNAi in vivo experience to create a services platform offering RNAi vector design through the creation of RNAi transgenic rodent models. Both companies will share revenues. Specific financial terms were not disclosed.
GPC Biotech AG, of Martinsried, Germany, said an independent data monitoring board for the satraplatin Phase III registrational trial in second-line chemotherapy for hormone-refractory prostate cancer held its third meeting Monday to review safety data from the first 592 patients who had been randomized and had completed at least one cycle of treatment. The board reported that the design and conduct of the trial remain sound and recommended it continue as planned. The interim efficacy analysis is expected to occur by the end of the first quarter of 2006.
GW Pharmaceuticals plc, of Reading, UK, agreed to a European marketing agreement for its cannabis-based painkiller, Sativex, with Almirall, of Barcelona, Spain. Almirall is paying a signing on fee of 12 million (US$21.2 million), followed by milestone payments of up to 34 million on completion of each of the ongoing Phase III trials, regulatory approvals and sales targets. GW said it would receive a significant percentage of sales, also. GW is responsible for completing Phase III trials in multiple sclerosis, neuropathic pain and cancer pain, and the partners will collaborate on the development of Sativex in other indications, with Almirall contributing to the cost. The deal excludes the UK, where Sativex is licensed to Bayer Healthcare.
Iceland Genomics Corp., of Reykjavik, Iceland, said POLYGENE, a consortium including IGC; Bioinformatics ApS, of Denmark; the Department of Statistics and the University of Oxford in the UK; and the Radboud University Nijmegen Medical Center of the Netherlands, received an award from the European Union to study the inherited risk of breast and prostate cancers. The study will seek to discover new genetic causes of the diseases, as well as evaluate combined effects of multiple genes on difference in responses to therapy and disease outcome.
InforSense Ltd., of London, said that AstraZeneca plc, of Cambridge, Mass., strengthened its strategic commitment to InforSense technology across their research and development organization through a multiyear global licensing deal. Scientists at AstraZeneca R&D sites will use InforSense's workflow-based integrative analytics environment to derive research intelligence and enhance productivity in their core drug discovery programs.
MediGene AG, of Martinsried, Germany, issued a nonexclusive license to Glaxo Group Ltd., of London, to develop a therapeutic tumor vaccine using existing patents from MediGene's program, in exchange for a one-time payment from Glaxo. The payment, combined with sales of Eligard, MediGene's prostate cancer drug, aims to ensure that MediGene will reach its previously established 2005 guidance of revenues of 20 million (about US$24 million.) Meanwhile, MediGene said it is postponing the finalization of its Polyphenon E marketing partnership to review new proposals received after the FDA's acceptance of the new drug application for Polyphenon E Ointment for treating genital warts.
MorphoSys AG, of Martinsried, Germany, signed a five-year license agreement with Merck & Co. Inc., of Whitehouse Station, N.J., for the use of MorphoSys's HuCAL Gold and AutoCAL technologies in research and development of human therapeutic antibodies. MorphoSys grants Merck access to its technologies for use in Merck's drug discovery programs.
NicOx SA, of Sophia-Antipolis, initiated a Phase III trial of HCT 3012 in patients with osteoarthritis of the knee. The trial will take place at around 120 sites in the U.S., and patient screening has started with a view to enrolling some 820 subjects by the end of January. The results are expected in the fourth quarter of 2006. HCT 3012 is a nitric oxide-donating derivative of naproxen, which NicOx is developing as a mainline treatment for osteoarthritis, especially in patients who also suffer from arterial hypertension.
Pharmaxis Ltd., of Sydney, Australia, began a Phase III trial of Aridol (mannitol) in patients with suspected asthma to test the product's sensitivity and specificity to identify exercise-induced bronchoconstriction against acknowledged methods for diagnosing airway responsiveness in patients suspected of having asthma. The multicenter, U.S.-based study will enroll 280 subjects. The 15-minute test uses a formulation of mannitol processed into a respirable powder, which is inhaled at increasing doses to cause the airways to narrow and contract. That is detected by measuring the amount of air a person can exhale in one second, and the smaller the dose required to cause contraction, the more severe the diagnosis. People without airway inflammation do not respond to an Aridol challenge test.
Pharmexa A/S, of Hrsholm, Denmark, said the first patients in a Phase II trial of its HER-2 Protein AutoVac breast cancer vaccine had commenced treatment. The vaccine is being administered in combination with the adjuvant QS-21. The study, which is being conducted in centers in Poland, Romania and Russia, will involve 40 patients with HER-2 positive breast cancers.
Proteo Biotech AG, of Kiel, Germany, now a subsidiary of Proteo Inc., of Irvine, Calif., completed a clinical trial of Elafin involving 32 males. The drug is a recombinant human protein and is designed to treat inflammatory diseases. All I.V. doses were well tolerated and no adverse events were recorded.
SciGen Ltd., of Singapore, reported its involvement in a joint venture to establish a manufacturing facility for biopharmaceuticals in China. The facility is expected to produce a range of biopharmaceuticals including SciGen's recombinant human insulin, SciLin and hepatitis B vaccine, Sci-B-Vac.
Serono SA, of Geneva, Switzerland, said one of its U.S. affiliates voluntarily entered a guilty plea, and the company has formally concluded the previously announced settlement of the government investigation into commercial practices related to Serostim (somatropin [rDNA origin] for injection). In October, the company agreed to pay a total of $704 million to resolve criminal charges and civil liabilities in connection with several illegal schemes to promote, market and sell Serostim for AIDS wasting. That money came from a provision of $725 million recorded in the first quarter of 2005 to cover settlement and related costs.
Vernalis plc, of Reading, UK, announced a preclinical development candidate has been selected by Novartis AG, of Basel, Switzerland, under the joint research and development collaboration on heat-shock protein 90, triggering a milestone payment of $1.5 million to Vernalis. The compound is due to enter clinical trials in the second half of 2006.
XTL Biopharmaceuticals Ltd., of Rehovot, Israel, said it is implementing an additional step in its plan for refocusing resources to its lead hepatitis C programs - XTL-6865, which is in Phase I, and XTL-2125, which is set to begin Phase I. The step calls for reducing its staff by 13 employees, or about 25 percent, primarily early-stage research personnel from the company's Rehovot facility.
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