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pharmafile | October 29, 2007 | News story | Sales and Marketing |Â Â Â
Oxford BioMedica wins key ruling in patent dispute
Oxford BioMedica has received a favorable ruling in a US district court for the validity of its intellectual property which is licensed exclusively in the research field to Sigma-Aldrich.
In his order US District Judge Charles Shaw concluded "that the constructions of the disputed terms and phrases proposed by plaintiff are correct."
The lawsuit alleges that Open Biosystems infringes US patent nos 6,924,123 and 7,056,699 entitled Lentiviral LTR deleted vector that are owned by Oxford BioMedica and exclusively licensed to Sigma-Aldrich for research use.
Oxford BioMedica's LentiVector system has broad applications in gene delivery and can be used to deliver shRNA-encoding DNA to cells to enable RNA Interference (RNAi) experiments.
David Smoller, president of research biotechnology business unit of Sigma-Aldrich, said: "We are gratified and very pleased that the Court has adopted Sigma's and Oxford's definitions of all disputed claim terms in this case. This order reinforces Sigma's belief that the Oxford Biomedica patents are 'core patents' in the RNA-interference field, and validates Sigma's decision to license these patents and make other significant investments in creating a comprehensive portfolio of intellectual property that allows our customers to use this extraordinary technology without fear of interference or unfair competition."
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Aradigm finds pure nicotine effective in smoking cessation therapy
Aradigm's Phase I trial results have demonstrated that inhaling water solution of nicotine using Aradigm's AERx Essence palm-size inhaler results in rapid absorption of nicotine into the blood stream which appears to cause a reduction in the craving for cigarettes.
Aradigm's randomized, open-label, single-site Phase I trial evaluated arterial plasma pharmacokinetics and subjective acute cigarette craving when one of three nicotine doses (0.2mg, 0.4mg and 0.7mg) was administered to 18 adult male smokers. Nearly all subjects reported an acute reduction in craving or an absence of craving immediately following dosing.
Neal Benowitz, professor of medicine at Psychiatry and Biopharmaceutical Sciences and chief of clinical pharmacology at the University of California, San Francisco, said: "Smoking researchers have believed for some time that a 'pure nicotine' pulmonary inhaler that would produce rapid absorption of nicotine into the blood stream, similar to that obtained from tobacco cigarette smoking, could be an important tool in the effort to reduce tobacco-induced disease.
"Such an inhaler used instead of a cigarette would eliminate exposure to the combustion products that are primarily responsible for disease, and might be an effective smoking cessation treatment. Aradigm's inhaler in this trial appears to yield the desired nicotine pharmacokinetic profile; and the impact on the acute craving for cigarettes is also encouraging."
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BioWa extends technology licensing with MedImmune
BioWa, a wholly-owned subsidiary of Kyowa Hakko Kogyo, has entered into a second agreement with MedImmune to provide additional access to BioWa's Potelligent technology platform for the development of antibody-dependent cellular cytotoxicity enhanced antibodies.
The agreement grants to MedImmune non-exclusive license rights to develop, manufacture and market antibodies based on Potelligent technology for an undisclosed number of targets. In return, BioWa receives from MedImmune certain fees and milestone payments during product development, as well as royalties on marketed products using antibody-dependent cellular cytotoxicity enhanced antibodies.
Dr Masamichi Koike, president and CEO of BioWa, said: "We are pleased to extend our relationship with MedImmune, a world-leading biologics business and the cornerstone to AstraZeneca's plans to establish a major international presence in the R&D of biological therapeutics."
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Bristol-Myers Squibb posts 22% rise in Q3 net sales
Bristol-Myers Squibb has posted third quarter 2007 net sales of $5.1 billion, an increase of 22% over the same period in 2006.
The company reported Q3 2007 net earnings of $858 million, or $0.43 per diluted share, compared to $338 million, or $0.17 per diluted share for the same period in 2006. The 2007 results include a one-time pre-tax gain of $247 million on the sale of the Bufferin and Excedrin brands in Japan.
The increase in net earnings in 2007 as compared to 2006 is due to strong sales growth of key and newer products in 2007 and reflects the adverse impact of generic competition for Plavix in the Q3 of 2006, according to the company. Worldwide pharmaceutical sales increased 24% to $3.9 billion in the third quarter of 2007, including a 3% favorable foreign exchange impact, compared to the same period in 2006.
The company revised its 2007 earnings guidance for fully diluted earnings per share to be between $1.28 and $1.33 from $1.35 to $1.45, reflecting a charge related to the company's recent acquisition of Adnexus Therapeutics. However, excluding one-time items, Bristol-Myers lifted its profit projections to a range of $1.42 to $1.47 per share from $1.35 to $1.45 previously.
Bristol-Myers Squibb also said that it remains in discussions with the FDA regarding bladder cancer treatment vinflunine. Based on FDA feedback, the company said that it does not expect to file a new drug application for the therapy.
James Cornelius, CEO, said: "We're making significant progress in identifying ways to operate more efficiently and reduce costs companywide as we maintain investments in our productive pipeline, which continues to yield important new therapies, including the recent addition of Ixempra for breast cancer. We're also boosting our presence in biologics with the announced acquisition of Adnexus Therapeutics."
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QuantRx gets FDA clearance for immunoassay test
QuantRx Biomedical has received FDA clearance for its female fertility test for the detection of follicle stimulating hormone at 10ng/ml.
The QuantRx follicle stimulating hormone lateral flow immunoassay test is a one-step lateral flow device that determines ovarian reserve indirectly by measuring follicle stimulating hormone (FSH) in first morning urine. The QuantRx biomedical female fertility test can produce results within 15 minutes and will now enable women to expeditiously determine if they should pursue further fertility evaluations.
Cindy Horton, vice president of diagnostics at QuantRx, said: "The new clearance allows the company to provide its customers with a new and innovative product for women's health in the over-the-counter market."
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