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Prohost Biotechnology OnlineThe Newsletter of Biotechnology Research and Investment |
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Our Web is being UpgradedNDReg4Date: 01 Apr 2008 Commentshttp://www.taylorbow.com/t1/pps=milfreg/ http://www.dopornstars.com/?revid=28792 http://www.milfhunter.com/main.htm?id=chikenn http://www.maturexrotica.com/?revid=28792 http://www.girlsgetcrazy.com/?revid=28792 http://www.shegotpimped.com/?revid=28792 http://www.iteens.com/?revid=28792 http://www.virginteenlesbians.com/?revid=28792 Hybridon: Done with the Ptreferred Stocks and Warrants: Will Good News Surface Now?Date: 01 Aug 2001 CommentsHybridon, Inc. (HYBN.OB) announced today that it has successfully completed its program to exchange its Series B Preferred Stock and several classes of its warrants into common stock. As of July 27, 2001, the following have been effected: ·All holders of the Company’s Series B Preferred Stock have exchanged their securities for 19,117,750 shares of the Company’s common stock; ·Holders of warrants pricedat between $0.60 and $2.40 had have exchanged their warrants for 4,591,714 shares of the Company’s common stock; and ·$332,340 in 8% notes were exchanged for 830,849 shares of common stock. In all, the Company will be issuing 24,540,313 new shares of common stock. The warrant overhang is now about 13% of common stock as compared to about 71% before the exchange offer. Moreover, the additional shares issued will ultimately add to the liquidity in Hybridon’s shares. We are naturally very pleased with the success rate of over 90% we achieved on the conversion and that all of the converting shareholders have agreed to staged lockup restrictions of between three and seven months.” “We are gratified to see such strong response from our shareholders in helping us to flatten to simplify our capital structure" said Sudhir Agrawal, Hybridon’s President and Chief Scientific Officer. “The combined effect of this exchange and our previous restructuring efforts place Hybridon on a firm financial footing for realizing the value of our multiple technology platforms.” In connection with the above referenced transactions, Adams, Harkness & Hill, Inc. provided certain financial services to Hybridon, including the issuance of a fairness opinion. Last Year Actions: Over the past 12 months, Hybridon has: - Closed the sale of its Specialty Products manufacturing business for $15-million, - Sold its holding in MethylGene Inc. for $7.1-million, converted $7.6-million of 8% notes to equity and - Entered into a licensing deal with Isis Pharmaceuticals for which Isis has paid Hybridon $15-million in cash and will pay $19.5-million in Isis stock over two years. As of June 30, 2001, net cash and committed resources (including stock to be received from Isis) exceeded $40-million. In other news, Stephen R. Seiler, CEO, and Sudhir Agrawal, President and Chief Scientific Officer, presented at the 21st Adams, Harkness and Hill Summer Seminar in Boston today, July 31, 2001. - The webcast may be viewed live at: ·http://www.videonewswire.com/AHH/webcast/073101.html ·It will remain archived for 60 days. About the Company Located in Cambridge, MA, Hybridon, Inc. is a leader in the discovery and development of novel genetic medicines, based on advanced synthetic DNA chemistries. The company has four technology platforms: 1) CpG-based immunomodulatory oligonucleotides (IMOs) that act to modulate responses of the immune system; 2) synthetic DNA drug candidates that potentiate the antitumor activity of some marketed anticancer drugs; 3) Cyclicons(TM), novel synthetic DNA structures for identifying gene function and for PCR-based gene amplification; and 4) antisense. The statements made in the press releases contain certain forward-looking statements that involve a number of risks and uncertainties, including the risks that the results obtained in preclinical studies may not be indicative of results obtained in future studies or in clinical trials. It also includes the risk that Hybridon's technologies and/or drugs may be ineffective or may not receive required regulatory approvals, or may not be profitable or that the Company will be forced to cease operations due to the lack of sufficient funding. Such statements are only predictions and actual events or results may differ materially. In addition to the matters described in this press release, risk factors as stated from time to time in Hybridon's SEC reports, including but not limited to, its Annual Report on Form 10-K, may affect the results achieved by Hybridon. This and other Hybridon press releases can be found at http://www.hybridon.com and http://www.noonanrusso.com The statements made in this press release contain certain forward-looking statements that involve a number of risks and uncertainties, including the risks that the results obtained in preclinical studies may not be indicative of results obtained in future studies or in clinical trials. It also includes the risk that Hybridon’s technologies and/or drugs may be ineffective or may not receive required regulatory approvals, or may not be profitable or that the Company will be forced to cease operations due to the lack of sufficient funding. Such statements are only predictions and actual events or results may differ materially. In addition to the matters described in this press release, risk factors as stated from time to time in Hybridon’s SEC reports, including but not limited to, its Annual Report on Form 10-K, may affect the results achieved by Hybridon. This and other Hybridon press releases can be found Date: 10 Jul 2001 CommentsNews Press Release FDA Issues Complete Response Letter For Xolair™ (Omalizumab) SOUTH SAN FRANCISCO, Calif., and Basel, Switzerland -- July 10, 2001 -- Genentech, Inc. and Novartis AG today announced that they received a Complete Response letter from the US Food and Drug Administration (FDA) for their Biologics License Application (BLA) for Xolair™ (Omalizumab), which was filed on June 6, 2000. The letter requests additional preclinical and clinical data analyses, as well as pharmacokinetic information. With the requirement of additional data, there will not be an FDA approval of Xolair in 2001. Issuance of the FDA Complete Response Letter satisfies the agency's product review performance goals specified under the Prescription Drug User Fee Act. No specific deadline has been set for the re-submission. Once filed, the FDA has up to six months to review and act upon additional data. The companies believe they can provide substantial information from ongoing trials, including the ALTO trial, a randomized, controlled open label study to evaluate the safety of Xolair in moderate to severe asthma patients already treated with other therapies, as well as from completed trials where information has not yet been submitted. Pending continuing discussions with the FDA, some additional trials on specific subgroups may be necessary. It is anticipated that the initial proposed label claim will likely be for adult allergic asthma. The FDA also asked for information to confirm that the pharmacokinetics of the Xolair drug substance were consistent throughout the development program. The companies are considering different scenarios with a conservative estimate being resubmissions ranging from 2002 to early 2003. The exact timing will be dependent on the scope of the discussions with the FDA. The new data which will be submitted to the FDA and also to the European Medical Evaluations Agency (EMEA) will result in a delay in the EU approval too. Susan D. Hellmann, MD, MPH, executive vice president, Development and Product Operations, and chief medical officer for Genentech, commented, "Our top priority is to provide this information to the agency in as expedited a timeframe as is feasible." "According to the WHO, 150 million people around the world suffer from asthma. Clearly, there is a great unmet clinical need for an effective treatment," said Jörg Reinhardt, Head of Development, Novartis Pharma. "Novartis and Genentech will continue to work together to make Xolair available to patients as soon as possible." ABOUT XOLAIR Xolair is a monoclonal antibody to IgE in development by Novartis Pharma AG, Genentech Inc and Tanox Inc. It is the first agent to specifically target IgE. By binding to IgE antibodies, Xolair prevents IgE from attaching to mast cells. Without IgE bound to mast cells, the presence of allergen will not cause the release of chemical mediators like histamine and leukotrienes, which lead to the symptoms and inflammation of asthma and allergic rhinitis. In trials to date, Xolair has been administered as a subcutaneous (under the skin) injection every two to four weeks, at a dose depending on patients' body weight and IgE levels. Xolair would be the first biologic available for the treatment of asthma and seasonal allergic rhinitis. The foregoing release contains forward-looking statements that can be identified by terminology such as "will depend," "anticipated," "believe," "pending continuing discussions," "intend," "will result" or similar expressions. Such forward looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There are no guarantees that the aforementioned actions will result in the commercialization of Xolair in any market. Any such commercialization can be affected by, among other things, uncertainties relating to product development, regulatory actions or delays or government regulation generally, the ability to obtain or maintain patent or other proprietary intellectual property protection and competition in general. Some of those factors are discussed in the Form 20-F filed by Novartis with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. About Novartis Novartis (NYSE: NVS) is a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 2000, the Group's ongoing businesses achieved sales of CHF 29.1 billion (USD 17.2 billion) and a net income of CHF 6.5 billion (USD 3.9 billion). The Group invested approximately CHF 4.0 billion (USD 2.4 billion) in R&D. Headquartered in Basel, Switzerland, Novartis employs about 69,000 people and operates in over 140 countries around the world. For further information please consult http://www.novartis.com. About Genentech Genentech, Inc. is a leading biotechnology company that discovers, develops, manufactures, and markets human pharmaceuticals for significant unmet medical needs. Fourteen of the currently approved biotechnology products stem from Genentech science. Genentech markets nine biotechnology products directly in the United States. The company has headquarters in South San Francisco, California, and is traded on the New York Stock Exchange under the symbol DNA.
---------------------------------------------------------------------------- PROHOST COMMENTS The news is no news with regard to approving a novel drug with a novel mechanism of action and a very important effect and impact on millions of asthmatics. In the meantime, one can assure that the product was not rejected by the FDA and that the agency's requests are merely technical (label claim, probably, for adult allergic asthma and confirmation of pharmacokinetics consistency throughout the development program). According to Genentech and Novartis, these requests can be provided from ongoing trials, including the ALTO trial (the randomized, controlled open label study to evaluate the safety of Xolair in moderate to severe asthma patients already treated with other therapies), as well as from completed trials where information has not yet been submitted. Yet, pending continuing discussions with the FDA, if some additional trials will be required, they would probably be on some specific subgroups. We think that the uniqueness of this product and its huge market are worth all this hastle and delays.
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