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    ISIN: US4576601086 · WKN: 899859
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     Ja Nein
      Avatar
      schrieb am 23.03.06 22:37:59
      Beitrag Nr. 1 ()
      Hallo,

      ich möchte diesen Thread eröffnen um Fakten über Insite Vision (WKN: 899859) zu diskutieren. Wird bis dato in D noch kaum gehandelt. http://www.insitevision.com/wt/page/index

      BUSINESS SUMMARY
      InSite Vision Incorporated, an ophthalmic product development company, develops genetically-based technology for the diagnosis, prognosis, and management of glaucoma, ocular infections, and retinal diseases. The company also focuses on ophthalmic pharmaceutical products based on its DuraSite eyedrop-based drug delivery technology. Its principal product, AzaSite, targets infections of the eye. The company has research collaborations and licensing agreements with Societa Industria Farmaceutica Italiana-S.P.A; Quest Diagnostics Incorporated; CIBA Vision Ophthalmics; UC Regents; Columbia Laboratories, Inc.; Global Damon Pharm and Kukje Pharma Ind. Co., Ltd.; and SSP Co., Ltd. InSite Vision was incorporated in 1986 and is based in Alameda, California.

      Gibt es Meinungen zu diesem Wert?

      Gruß Mr.Moose
      Avatar
      schrieb am 28.03.06 14:39:05
      Beitrag Nr. 2 ()
      Insite Vision: March 30, 2006 InSite Vision Announces 4th Quarter, 2005 Earnings Conference Call
      Avatar
      schrieb am 27.04.06 22:26:02
      Beitrag Nr. 3 ()
      Press Release Source: InSite Vision Incorporated


      InSite Vision Meets With the FDA on Pre-NDA Discussions for AzaSite(TM)
      Thursday April 27, 7:00 am ET


      ALAMEDA, Calif.--(BUSINESS WIRE)--April 27, 2006--InSite Vision Incorporated (AMEX:ISV - News) -- an ophthalmic therapeutics, diagnostics and drug-delivery company -- today announced that it had a pre-NDA meeting with representatives of the U.S. Food and Drug Administration (FDA) on Wednesday, April 26, 2006. The purpose of the meeting was to discuss the proposed new drug application (NDA) submission for AzaSite(TM), the Company's ocular anti-infective product. InSite recently announced the successful completion of the second of two required Phase 3 clinical trials to evaluate the safety and efficacy of AzaSite. In this study, patients treated with AzaSite had a significantly higher clinical resolution rate, the trial's primary efficacy end point, and a significantly higher bacterial eradication rate, a secondary end point, than those receiving a placebo. The study showed that AzaSite was safe and well tolerated.
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      "Our pre-NDA meeting with the FDA, in combination with the recent AzaSite Phase 3 clinical trial results, gives us further confidence towards the assembly of our NDA for our lead product AzaSite," said S. Kumar Chandrasekaran, Ph.D., InSite Vision's chief executive officer. "Our discussions with the FDA during this meeting were productive, and will facilitate our full NDA submission which we anticipate could come as early as this quarter."

      InSite Vision was pleased to accept the FDA's offer to participate in the implementation of a new program to provide electronic product labeling. Pending the successful filing of the full NDA and approval from the FDA, the Company expects to commercially launch AzaSite in the U.S. in early 2007.

      About InSite Vision Incorporated

      InSite Vision is an ophthalmic company focused on developing therapies that treat ocular infections, glaucoma and retinal diseases. InSite Vision's lead product is AzaSite, which targets bacterial infections of the eye. AzaSite contains the drug azithromycin, a broad-spectrum antibiotic formulated with DuraSite®, InSite Vision's patented drug-delivery vehicle, which offers the benefit of a low-dosing regimen, attractive to both the eye-care patient and physician. Pending the filing and approval of an NDA with the FDA, InSite Vision currently expects AzaSite to be commercially launched in the United States, while seeking to expand this "technology platform" to include additional product candidates and indications for the worldwide market.

      In the glaucoma area, InSite Vision continues to focus genomic research on the TIGR gene, among other genes in its genomic portfolio. A portion of this research has been incorporated into InSite Vision's commercially available OcuGene® glaucoma genetic test for disease management, which is a prognostic tool designed to detect a genetic marker (mt-1) in the promoter region of the glaucoma-related TIGR gene.

      Additional information can be found at the Company's website, www.insitevision.com.

      This news release contains, among other things, certain statements of a forward-looking nature relating to future events or the future business performance of InSite Vision, such as the timing of filing an NDA with the FDA, the Company's ability to obtain FDA approval of its NDA and the anticipated date of commercialization of AzaSite. Such statements entail a number of risks and uncertainties, including but not limited to: InSite Vision's ability to obtain additional financing, InSite Vision's ability to commence, complete and file an NDA with the U.S. FDA for AzaSite, and receive approval from the FDA for the commercialization of AzaSite; InSite Vision's ability to launch AzaSite and the timing of such a launch; InSite Vision's ability to maintain and develop additional collaborations and commercial agreements with corporate partners, including those with respect to AzaSite and ISV-205; its reliance on third parties for the development, marketing and sale of its products; its ability to adequately protect its intellectual property and to be free to operate with regard to the intellectual property of others, determinations by the FDA, including those with respect to OcuGene, AzaSite and ISV-205. Reference is made to the discussion under the caption "Risk Factors" and elsewhere in InSite Vision's filings with the Securities and Exchange Commission, including its annual report on Form 10-K, and its quarterly reports on Form 10-Q. All forward looking statements in this press release and/or conference call are based on the limited information currently available to InSite Vision, which is subject to change. Although any such projections and the factors influencing them will likely change, InSite Vision undertakes no obligation to update the information. Such information speaks only as of the date of its release. Actual events or results could differ materially and one should not assume that the information provided in this release and/or conference call is still valid at any later date.

      Note to Editors: OcuGene® is written with a "small cap" G; if doing so is not possible, please use an upper case G. InSite Vision Incorporated, InSite Vision, DuraSite® and OcuGene® are trademarks of InSite Vision Incorporated. Other trademarks that may be mentioned in this release are the intellectual property of their respective owners.
      Avatar
      schrieb am 11.05.06 23:14:30
      Beitrag Nr. 4 ()
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      Press Release Source: InSite Vision Incorporated


      InSite Vision Reports First Quarter 2006 Financial Results
      Thursday May 11, 8:00 am ET


      ALAMEDA, Calif.--(BUSINESS WIRE)--May 11, 2006--InSite Vision Incorporated (AMEX:ISV - News) -- an ophthalmic products company currently focused on developing therapies that treat ocular infection, glaucoma, and retinal diseases, today reported financial results for the three months ended March 31, 2006.
      ADVERTISEMENT


      Net loss for the first quarter of 2006 was $5.3 million, or $0.06 per share, including stock option expenses of $128,000 related to the adoption of FAS 123R, compared with a net loss of $3.4 million, or $0.06 per share, for the first quarter of 2005.

      Research and development (R&D) expenses increased to $3.5 million during the first quarter of 2006 from $2.4 million for the first quarter of 2005. The increase in R&D expenses reflects costs associated with the AzaSite(TM) phase 3 clinical trials and with preparation of the related New Drug Application (NDA).

      Selling, general and administrative (SG&A) expenses increased to $1.3 million in the first quarter of 2006 from $1.0 million in the first quarter of 2005.

      InSite Vision had cash and cash equivalents of $3.8 million at March 31, 2006, compared with cash and cash equivalents of $4.0 million at December 31, 2005. The company's current financial position provides sufficient liquidity to fund operations through the middle of July 2006.

      "We are approaching the most important inflection point in our company's history. We have demonstrated exceptional results from our two phase 3 clinical trials for our lead product AzaSite, and we continue on track to submit a NDA for AzaSite with the U.S. Food and Drug Administration (FDA) by the end of the second quarter," said S. Kumar Chandrasekaran, Ph.D., chief executive officer of InSite Vision.

      Recent Company Developments

      On January 13, 2006, InSite Vision announced the completion of enrollment of the second phase 3 clinical trial for AzaSite. The trial was a randomized, double masked, multi-center study that included patients from 1 - 96 years of age. The goal of the second study was to demonstrate superiority of AzaSite as compared to a vehicle (a placebo that does not contain any active drug substance) in the clinical resolution of the bacterial conjunctivitis. Clinical resolution was the primary efficacy endpoint. A secondary endpoint was bacterial eradication. On March 14, 2006, top line results were reported from this second clinical trial. Patients treated with AzaSite had a significantly higher clinical resolution rate, the trial's primary efficacy end point and a significantly higher bacterial eradication rate, a secondary end point, than those receiving the vehicle.

      On April 27, 2006, InSite Vision announced that it had a pre-NDA meeting with representatives of the U.S. Food and Drug Administration (FDA) on Wednesday, April 26, 2006. The purpose of the meeting was to discuss the proposed new drug application (NDA) submission for AzaSite(TM), the Company's ocular anti-infective product. The discussions with the FDA during this meeting were productive, and we believe will facilitate full NDA submission in the second quarter of 2006.

      On May 2, 2006, InSite Vision announced that work by its scientists and collaborators were highlighted in formal presentations and poster presentations at the Association for Research in Vision and Ophthalmology (ARVO) 2006 Annual Meeting in Fort Lauderdale, Florida. Formal presentations at ARVO included a randomized trial assessing microbial eradication and clinical efficacy of 1% azithromycin ophthalmic solution vs. tobramycin in adult subjects with bacterial conjunctivitis and a randomized trial assessing safety and tolerability of 1% azithromycin ophthalmic solution vs. tobramycin in adult and pediatric subjects.

      The results of its phase 3 clinical trial show that the clinical resolution and bacterial eradication rates of AzaSite are equivalent to those of tobramycin even though AzaSite was dosed less frequently, i.e., twice a day for the first 2 days, followed by once a day for the next 3 days versus four times a day for 5 days. In addition, the results demonstrated that AzaSite is as safe and well tolerated in children and adults as tobramycin.
      Avatar
      schrieb am 29.05.06 23:55:29
      Beitrag Nr. 5 ()
      Analyse vom 23.05.2006 | 15:59 23.05.06 15:59
      Update InSite Vision Inc.: Buy
      ThinkEquity

      --------------------------------------------------------------------------------
      Update InSite Vision Inc.: Buy


      Die Analysten von ThinkEquity bewerten in ihrer Analyse vom Dienstag, 23. Mai 2006 die Aktie von InSite Vision Inc. neu mit dem Rating "Buy". Das Kursziel für die Aktie liegt momentan bei 4 $.

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      0,1775EUR -7,07 %
      CEO lässt auf “X” die Bombe platzen!mehr zur Aktie »
      Avatar
      schrieb am 05.07.06 23:33:32
      Beitrag Nr. 6 ()
      23.05.2006 16:07
      Update InSite Vision Inc.: Buy (ThinkEquity)
      Die Analysten von ThinkEquity bewerten in ihrer Analyse vom Dienstag, 23. Mai 2006 die Aktie von InSite Vision Inc. neu mit dem Rating "Buy". Das Kursziel für die Aktie liegt momentan bei 4 $.




      Quelle:Aktiencheck
      Avatar
      schrieb am 05.07.06 23:34:29
      Beitrag Nr. 7 ()
      Press Release Source: InSite Vision Incorporated


      InSite Vision Announces Submission of AzaSite(TM) NDA
      Thursday June 29, 7:00 am ET


      ALAMEDA, Calif.--(BUSINESS WIRE)--June 29, 2006--InSite Vision Incorporated (AMEX:ISV - News) -- an ophthalmic products company currently developing therapies that treat ocular infection, glaucoma, and retinal diseases, today announced it has submitted to the United States Food and Drug Administration (FDA) a New Drug Application (NDA) for AzaSite(TM) for the treatment of bacterial conjunctivitis. AzaSite combines a topical 1% azithromycin formulation with InSite's patented DuraSite® ophthalmic drug-delivery system that increases ocular retention of the drug.
      ADVERTISEMENT


      InSite Vision has completed the compilation and assembly of a hybrid electronic NDA filing in a modified Common Technical Document (CTD) format. This submission incorporates the positive results from the recently completed Phase 3 clinical trials, pre-clinical studies, chemistry, manufacturing and controls. InSite previously announced the completion of these two Phase 3 studies including a vehicle controlled study versus AzaSite and a study comparing 0.3% tobramycin versus AzaSite. The results of these trials showed that AzaSite was safe, well tolerated and efficacious in the treatment of bacterial conjunctivitis.

      Kumar Chandrasekaran, Ph.D., InSite Vision's Chief Executive Officer, stated, "The submission of the AzaSite NDA is a major milestone for InSite Vision and brings our lead product one very significant step further in the FDA approval process. We anticipate the launch of AzaSite in early 2007 as we pursue development of additional products that make up the AzaSite franchise."

      Dr. Chandrasekaran added: "The fundamental characteristics of the AzaSite franchise remain strong and are enhanced by our significant progression announced today in our pursuit to reach commercialization for the product. Furthermore, our corporate partnership discussions are continuing as previously indicated. Our efforts in this matter are designed to ensure that we provide our product franchise with the most effective conduit to the various medical specialties, to maximize patient and physician acceptance, market opportunity and, importantly, shareholder value. Details of the finalized corporate relationships will be provided when available."
      Avatar
      schrieb am 03.08.06 13:48:04
      Beitrag Nr. 8 ()
      InSite Vision Announces $6.3 Million Private Placement
      Thursday August 3, 7:00 am ET
      :laugh::laugh:

      ALAMEDA, Calif.--(BUSINESS WIRE)--Aug. 3, 2006--InSite Vision Incorporated (AMEX:ISV - News) today announced it has entered into definitive agreements for a $6.3 million private placement of common stock and warrants for common stock. Closing of the financing is contingent on approval from the American Stock Exchange, among other standard conditions. The terms of the agreements provide for the sale of approximately 4.8 million newly issued shares of common stock at the five day trailing weighted average price of $1.31 per share, and the issuance of warrants to purchase approximately 1.0 million shares of common stock at an exercise price of $1.51 per share. The warrants have a term of five years, must be exercised in cash and may only be exercised after six months following the closing of the private placement.
      ADVERTISEMENT


      The private placement is to be made to three of InSite Vision's current institutional investors, Balyasny Asset Management, PTV Sciences and a large Boston-based institutional investment management firm. InSite Vision is obligated to file with the U.S. Securities and Exchange Commission a resale registration statement relating to the common stock to be issued in the transaction and the shares of common stock to be issued upon the exercise of the warrants. RBC Capital Markets Corporation acted as placement agent for this transaction.

      This press release does not constitute an offer to sell or the solicitation of an offer to buy the common stock or warrants of InSite Vision. The common stock and warrants to be issued in the private placement have not been registered under the Securities Act of 1933, as amended (the "Act") and may not be offered or sold in the United States absent registration under the Act or an applicable exemption from the registration requirements under the Act.

      The proceeds from this financing, assuming its successful completion, will be used for its general corporate purposes including continued support of InSite Vision's AzaSite(TM) for the treatment of bacterial conjunctivitis, for which InSite submitted a new drug application (NDA) to the Food and Drug Administration (FDA) in June 2006. Additionally, this funding will enable InSite Vision to move forward with the anticipated filing of an investigational new drug application (IND) with the FDA this year for AzaSite Plus(TM), a combination product including AzaSite with an anti-inflammatory steroid.

      S. Kumar Chandrasekaran, Ph.D., InSite Vision's chief executive officer stated, "The proposed financing discussed in today's announcement will provide InSite Vision with adequate liquidity to pursue near-term opportunities that are expected to grow the value of our company. In particular, this financing allows us time to continue pursuing the most compelling corporate partnership for the AzaSite franchise. As I have said all along, we are committed to consummating a partnership or other commercial option that provides our product franchise with the most effective conduit to the various medical specialties, to maximize patient and physician acceptance, market opportunity and, importantly, shareholder value."

      Additional information can be found at the Company's website, www.insitevision.com.

      This news release contains, among other things, certain statements of a forward-looking nature relating to future events or the future business performance of InSite Vision, such as the anticipated closing of the private placement and the proposed use of proceeds therefrom. Such statements entail a number of risks and uncertainties, including but not limited to: InSite Vision's ability to obtain additional financing in the near future, InSite Vision's ability to enroll and complete future clinical trials for AzaSite; the results of InSite Vision's clinical trials, particularly for AzaSite; the ability to complete and file an NDA with the U.S. FDA for AzaSite and its other product candidates, and receive approval from the FDA for the commercialization of AzaSite and its other product candidates; the ability to launch AzaSite and the timing of such a launch; InSite Vision's ability to expand its technology platform to include additional indications and patent options; the effects of its expense control activities on its operations and product development; its ability to obtain regulatory approval and market acceptance of its products and product candidates, including its OcuGene glaucoma genetic test, AzaSite, ISV-205 and ISV-014; InSite Vision's ability to maintain and develop additional collaborations and commercial agreements with corporate partners, including those with respect to AzaSite and ISV-205; its reliance on third parties for the development, marketing and sale of its products; the initiation and results of preclinical and clinical studies; its ability to adequately protect its intellectual property and to be free to operate with regard to the intellectual property of others; determinations by the FDA, including those with respect to OcuGene, AzaSite and ISV-205. Reference is made to the discussion of risk factors detailed in InSite Vision's filings with the Securities and Exchange Commission, including its annual report on Form 10-K and its quarterly reports on Form 10-Q, under the caption "Risk Factors". Any projections in this press release are based on the limited information currently available to InSite Vision, which is subject to change. Although any such projections and the factors influencing them will likely change, InSite Vision undertakes no obligation to update the information. Such information speaks only as of the date of its release. Actual events or results could differ materially and one should not assume that the information provided in this release is still valid at any later date.

      Note to Editors: OcuGene® is written with a "small cap" G; if doing so is not possible, please use an upper case G. InSite Vision Incorporated, InSite Vision, DuraSite® and OcuGene® are trademarks of InSite Vision Incorporated. Other trademarks that may be mentioned in this release are the intellectual property of their respective owners
      Avatar
      schrieb am 03.08.06 16:47:01
      Beitrag Nr. 9 ()
      Alles läuft nach Plan. Kurs +14% in den USA heute :laugh::D:laugh:


      Press Release Source: InSite Vision Incorporated


      InSite Vision to Present Results From Second of Two Pivotal Phase 3 Clinical Trials
      Thursday August 3, 9:00 am ET


      ALAMEDA, Calif.--(BUSINESS WIRE)--Aug. 3, 2006--InSite Vision Incorporated (AMEX:ISV - News), an ophthalmic company focused on ocular infections, glaucoma and retinal diseases, announced today the acceptance of two abstracts related to its second pivotal trial of the topical eye drop antibiotic, AzaSite (1% azithromycin in DuraSite®). The vehicle-controlled, prospective, multi-center, bacterial conjunctivitis trial showed AzaSite was superior to the vehicle in both clinical resolution of the signs and symptoms of bacterial conjunctivitis as well as bacterial eradication. The efficacy and safety data will be presented at the upcoming meeting of the American Academy of Ophthalmology in Las Vegas, Nevada to be held November 11 - 14, 2006. The presentation schedule is as follows:
      Efficacy of Azithromycin 1% Eye Drops vs. Vehicle as First-Line Therapy for Bacterial Conjunctivitis, Mark Abelson, MD, Warren Heller, MD, and the AzaSite Clinical Study Group.
      Safety and Tolerability of 1% Azithromycin Eye Drops as Anti-infective Therapy for Bacterial Conjunctivitis, Warren Heller, MD, Mark Abelson, MD, and the AzaSite Clinical Study Group.
      AzaSite contains 1% azithromycin, a broad-spectrum antibiotic. InSite Vision Inc. has completed two phase 3 studies. The results of these studies were submitted to the FDA on June 28, 2006 as part of the NDA to gain regulatory approval of AzaSite.

      The first phase 3 study was a double-blinded, prospective, active-controlled bacterial conjunctivitis trial. It showed AzaSite dosed twice daily for the first 2 days and once daily for 3 more days was equivalent to tobramycin dosed four times daily for 5 days in resolving clinical signs and symptoms of bacterial conjunctivitis and eradicating offending bacteria. The second phase 3 study was a double-blinded, prospective, vehicle-controlled trial. It showed AzaSite was superior to the vehicle in both clinical resolution of the signs and symptoms of bacterial conjunctivitis and bacterial eradication. Both trials revealed a superior safety profile of AzaSite.

      Kumar Chandrasekaran, Ph.D., InSite Vision's Chief Executive Officer, stated, "These clinical trial results support AzaSite's value proposition of established efficacy and coverage with the convenience and compliance of a once-a-day dosing regimen."

      About InSite Vision Incorporated

      InSite Vision is an ophthalmic company focused on developing therapies that treat ocular infections, glaucoma and retinal diseases. The Company's lead product is AzaSite, which targets infections of the eye. AzaSite contains the drug azithromycin, a broad-spectrum antibiotic formulated with DuraSite, InSite Vision's patented drug-delivery vehicle, which offers the benefit of a low-dosing regimen, attractive to both the eye-care patient and physician. Pending the filing and approval of an NDA with the FDA, the Company currently expects AzaSite to be commercially launched in the United States, while seeking to expand this "technology platform" to include additional product candidates and indications for the worldwide market.

      In the glaucoma area, the Company continues to focus genomic research on the TIGR gene, among other genes in its genomic portfolio. A portion of this research has been incorporated into the Company's commercially available OcuGene® glaucoma genetic test for disease management, which is a prognostic tool designed to detect a genetic marker (mt-1) in the promoter region of the glaucoma-related TIGR gene.

      Additional information can be found at the Company's website, www.insitevision.com.

      This news release contains, among other things, certain statements of a forward-looking nature relating to future events or the future business performance of InSite Vision, such as the anticipated closing of the private placement and the proposed use of proceeds therefrom. Such statements entail a number of risks and uncertainties, including but not limited to: InSite Vision's ability to obtain additional financing in the near future, InSite Vision's ability to enroll and complete future clinical trials for AzaSite; the results of InSite Vision's clinical trials, particularly for AzaSite; the ability to complete and file an NDA with the U.S. FDA for AzaSite and its other product candidates, and receive approval from the FDA for the commercialization of AzaSite and its other product candidates; the ability to launch AzaSite and the timing of such a launch; InSite Vision's ability to expand its technology platform to include additional indications and patent options; the effects of its expense control activities on its operations and product development; its ability to obtain regulatory approval and market acceptance of its products and product candidates, including its OcuGene glaucoma genetic test, AzaSite, ISV-205 and ISV-014; InSite Vision's ability to maintain and develop additional collaborations and commercial agreements with corporate partners, including those with respect to AzaSite and ISV-205; its reliance on third parties for the development, marketing and sale of its products; the initiation and results of preclinical and clinical studies; its ability to adequately protect its intellectual property and to be free to operate with regard to the intellectual property of others; determinations by the FDA, including those with respect to OcuGene, AzaSite and ISV-205. Reference is made to the discussion of risk factors detailed in InSite Vision's filings with the Securities and Exchange Commission, including its annual report on Form 10-K and its quarterly reports on Form 10-Q, under the caption "Risk Factors". Any projections in this press release are based on the limited information currently available to InSite Vision, which is subject to change. Although any such projections and the factors influencing them will likely change, InSite Vision undertakes no obligation to update the information. Such information speaks only as of the date of its release. Actual events or results could differ materially and one should not assume that the information provided in this release is still valid at any later date.

      Note to Editors: OcuGene® is written with a "small cap" G; if doing so is not possible, please use an upper case G. InSite Vision Incorporated, InSite Vision, DuraSite® and OcuGene® are trademarks of InSite Vision Incorporated. Other trademarks that may be mentioned in this release are the intellectual property of their respective owners.



      Contact:
      InSite Vision Incorporated
      S. Kumar Chandrasekaran or Sandra Heine, 510-865-8800
      www.insitevision.com
      or
      Ashton Partners
      888-857-7839 (Investors)
      www.ashtonpartners.com
      Avatar
      schrieb am 08.08.06 10:01:02
      Beitrag Nr. 10 ()
      Anleger werden ernst genommen.;)

      Date: Mon, 07 Aug 2006 08:51:08 -0700

      Dear...

      Thank you for your e-mail of August 3rd.

      There will be a 2nd Quarter, 2006 Earnings conference call on August 14
      at 9:00 EDT.

      If you are interested in listening to the call, you may do so by
      dialing 877-407-0778. A telephone replay will be available for 48 hours
      following the conclusion of the call by dialing 877-660-6853. The
      conference ID is 210914.

      Additionally, the live conference call will be webcast and available on
      the Internet at www.InvestorCalendar.com, as well as on the Company's
      website at www.insitevision.com.

      Regards,
      Kumar Chandrasekaran
      Avatar
      schrieb am 08.08.06 10:28:20
      Beitrag Nr. 11 ()
      Newsflow ist ja wirklich gut
      und der Chart lädt inzwischen auch wieder zum Einsteigen ein,
      nur leider etwas dünnes Volumen,
      aber kann ja noch werden.
      Avatar
      schrieb am 01.09.06 17:14:37
      Beitrag Nr. 12 ()
      Es läuft alles nach Plan......

      InSite Vision Announces FDA Acceptance of New Drug Application for Review
      Monday August 28, 7:00 am ET


      ALAMEDA, Calif.--(BUSINESS WIRE)--Aug. 28, 2006--InSite Vision Incorporated (AMEX:ISV - News) -- an ophthalmic therapeutics, diagnostics and drug delivery company, today announced the U.S. Food and Drug Administration has accepted for filing and comprehensive review, InSite Vision's NDA for AzaSite (azithromycin 1% ophthalmic solution), indicated for the treatment of bacterial conjunctivitis. AzaSite is formulated with "DuraSite," InSite Vision's patented drug delivery vehicle which enhances the retention time of the antibiotic on the surface of the target tissue.

      The NDA contains data from two phase 3 clinical trials in which 698 patients were treated with AzaSite. Data from these studies demonstrated that when AzaSite was administered twice daily on the first two days, then once daily on days 3-5, it provided clinically and statistically significant improvements in clinical resolution of symptoms, and bacterial eradication compared to placebo, and was equivalent in clinical resolution and bacterial eradication when compared to tobramycin administered four times a day.

      S. Kumar Chandrasekaran, Ph.D., InSite Vision's chief executive officer stated, "Today's announcement of the FDA acceptance and review of InSite Vision's NDA is a significant milestone which brings us one step closer to achieving our ultimate goal of the commercialization of our lead AzaSite product in early 2007. We expect a timely review by the FDA and look forward to hearing from them regarding next steps."

      About InSite Vision Incorporated

      InSite Vision is an ophthalmic company focused on developing therapies that treat ocular infections, glaucoma and retinal diseases. InSite Vision's lead product is AzaSite, which targets infections of the eye. AzaSite contains the drug azithromycin, a broad-spectrum antibiotic formulated with DuraSite, InSite Vision's patented drug-delivery vehicle, which offers the benefit of a low-dosing regimen, attractive to both the eye-care patient and physician. Pending the filing and approval of an NDA with the FDA, InSite Vision currently expects AzaSite to be commercially launched in the United States, while seeking to expand this "technology platform" to include additional product candidates and indications for the worldwide market.

      In the glaucoma area, InSite Vision continues to focus genomic research on the TIGR gene, among other genes in its genomic portfolio. A portion of this research has been incorporated into the InSite Vision's commercially available OcuGene® glaucoma genetic test for disease management, which is a prognostic tool designed to detect a genetic marker (mt-1) in the promoter region of the glaucoma-related TIGR gene.
      Avatar
      schrieb am 08.09.06 22:12:08
      Beitrag Nr. 13 ()
      Press Release Source: InSite Vision Incorporated

      InSite Vision, Inc. to Present at ThinkEquity Partners LLC 4th Annual Growth Conference in San Francisco
      Friday September 8, 7:00 am ET

      ALAMEDA, Calif.--(BUSINESS WIRE)--Sept. 8, 2006--InSite Vision Incorporated (AMEX:ISV - News) -- an ophthalmic therapeutics, diagnostics and drug delivery company, has been invited to present at this year's ThinkEquity Partners LLC 4th Annual Growth Conference. This financial conference will take place in San Francisco, September 11 - September 14, 2006.
      ADVERTISEMENT

      InSite Vision's presentation by senior management will include a review of current operations, the progress of the FDA review of InSite Vision's NDA for AzaSite (azithromycin 1% ophthalmic solution), and upcoming plans for the future.

      Commenting on the Company's participation at the Think Equity Conference, S. Kumar Chandrasekaran, President and CEO of InSite Vision, stated, "InSite has had recent success marked by our $6.3 million fund raising and the submission of an NDA to the U.S. Food and Drug Administration for AzaSite. This event will provide InSite Vision with an opportunity to review this success and discuss our plans to achieve commercialization of our lead AzaSite product in early 2007."

      InSite Vision's presentation will be held on Tuesday, September 12, 2006 at 9:30 a.m. (PDT) and will also be available via the Internet at http://www.wsw.com/webcast/tep10/isv/ and on the investor relations section of the Company's Web site at www.insitevision.com. A recording of the presentation will be available for 90 days following the completion of the presentation.

      About InSite Vision Incorporated

      InSite Vision is an ophthalmic company focused on developing therapies that treat ocular infections, glaucoma and retinal diseases. InSite Vision's lead product is AzaSite, which targets infections of the eye. AzaSite contains the drug azithromycin, a broad-spectrum antibiotic formulated with DuraSite, InSite Vision's patented drug-delivery vehicle, which offers the benefit of a low-dosing regimen, attractive to both the eye-care patient and physician. Pending the approval of its NDA with the FDA, InSite Vision currently expects AzaSite to be commercially launched in the United States, while seeking to expand this "technology platform" to include additional product candidates and indications for the worldwide market.

      In the glaucoma area, InSite Vision continues to focus genomic research on the TIGR gene, among other genes in its genomic portfolio. A portion of this research has been incorporated into the InSite Vision's commercially available OcuGene® glaucoma genetic test for disease management, which is a prognostic tool designed to detect a genetic marker (mt-1) in the promoter region of the glaucoma-related TIGR gene.

      Additional information can be found at our website, www.insitevision.com.

      About ThinkEquity Partners LLC

      ThinkEquity Partners LLC is a research-centric institutional investment firm focused on the growth economy. ThinkEquity Partners LLC is dedicated to providing focused insight, advisory services, and capital to institutional investors and corporate constituents in the knowledge economy's key growth verticals, including technology, healthcare, media and consumer business services. For more information about ThinkEquity Partners LLC, please visit www.thinkequity.com. Member NASD and IPC.
      Avatar
      schrieb am 30.10.06 09:59:54
      Beitrag Nr. 14 ()
      War sehr ruhig in letzter Zeit aber jetzt tut sich wieder was. +17% am Freitag in den USA. :laugh:
      Sollte die Genehmigung von AzaSite durch sein? Auch das wird in einen Börsen Blog spekuliert.

      Saturday, October 28, 2006
      Watch Alert: Insite Vision (ISV)

      Shares of Insite Vision (ISV) ended trading on Friday up more than 17%, on more than twice the three month average daily volume.

      No news or media exposure can be detected.

      It is an extremely large jump relative to other stocks that have made it on BHI's watch list. However, such interest in a stock in one day, with no news, warrants attention.

      Insite Vision develops and markets ophthalmic pharmaceutical products, including AzaSite, which is indicated for the treatment of bacterial conjunctivitis.

      On August 28, the company announced that the FDA accepted its NDA for AzaSite for review.

      Friday's action could be a sign of an FDA decision in the near future.

      Insite has made BHI's Watch List.
      Avatar
      schrieb am 14.11.06 20:52:02
      Beitrag Nr. 15 ()
      InSite Trims 3Q Loss
      Tuesday November 14, 10:57 am ET
      InSite Posts Narrower 3rd-Quarter Loss, Cuts Research and Development Costs


      ALAMEDA, Calif. (AP) -- InSite Vision Inc., which makes treatments for eye diseases, said Tuesday it trimmed its loss in the third quarter as research and development expenses fell.
      Losses totaled $3.3 million, or 4 cents per share, compared with a loss of $3.5 million, or 4 cents per share, during the same period last year. InSite had 90.3 million shares outstanding in the period, versus 78.9 million a year earlier.

      Results matched Wall Street's expectations, according to Thomson Financial.

      Revenue was flat year-over-year at $1,000.

      Research and development expenses dropped 32 percent to $1.7 million from $2.5 million a year ago.

      InSite said it believes its current financial position provides sufficient liquidity to fund operations through the end of December 2006, excluding the repayment of secured short-term notes payable of $6.3 million, of which $4.3 million is due December 30, 2006 and $2 million is due January 11, 2007.

      The company applied for FDA approval of AzaSite, a bacterial conjunctivitis treatment, in August.

      Shares of InSite rose 6 cents, or 4.3 percent, to $1.44 in morning trading on the American Stock Exchange. The stock has traded between 69 cents and $2.70 over the past 52 weeks
      Avatar
      schrieb am 15.11.06 22:48:55
      Beitrag Nr. 16 ()
      Star Analysts Get Star Analysts for:

      This is a list of top research analysts based on the accuracy of earnings estimates on ISV, according to StarMine. Analysts that appear here are limited to those covering ISV for a significant period of time. Learn More.

      http://finance.yahoo.com/q/sa?s=isv
      Avatar
      schrieb am 20.11.06 22:51:48
      Beitrag Nr. 17 ()
      Ist zwar bei solchen Werten nicht einfach aber man könnte von Aufwärtstrend mit durchbruch der 38 Tagesline sprechen.
      Avatar
      schrieb am 13.02.07 20:46:24
      Beitrag Nr. 18 ()
      AP
      InSite: AzaSite Plus Well Tolerated
      Tuesday February 13, 12:58 pm ET
      InSite's AzaSite Plus Eye Treatment Found to Be Well Tolerated in Early Stage Clinical Trial


      ALAMEDA, Calif (AP) -- Eye drug developer InSite Vision Inc. said Tuesday its eye treatment candidate AzaSite Plus was well tolerated in early stage clinical trials.
      The company said the combination antibiotic-corticosteroid drug was given to 46 subjects, aged 19 to 67, and that no serious adverse events were reported. The medication uses the company's DuraSite patented eye drop formulation.

      Adverse events were at a minimum and similar in both the AzaSite Plus and placebo groups, the company said.

      InSite hopes to develop the treatment for such eye conditions as blepharitis, or inflammation of the eyelids.
      Avatar
      schrieb am 16.02.07 07:51:38
      Beitrag Nr. 19 ()
      Noch ein Geheimtipp aber bei den Hammer News bestimmt bald nicht mehr....:laugh::laugh:

      InSite Vision Announces Patent Agreement With Pfizer
      Thursday February 15, 4:00 pm ET

      ALAMEDA, Calif.--(BUSINESS WIRE)--InSite Vision Incorporated (AMEX:ISV - News) -- an ophthalmic therapeutics, diagnostics and drug delivery company, today announced that it has entered into a worldwide, exclusive royalty bearing licensing agreement with Pfizer Inc. (NYSE:PFE - News) under Pfizer's Patent family titled "Method of Treating Eye Infections with Azithromycin". Pfizer's granting of this license will enhance the position and marketability of InSite's AzaSite franchise.

      ADVERTISEMENT




      S. Kumar Chandrasekaran, Ph.D., InSite Vision's chief executive officer stated, "The execution of the Pfizer license represents a significant milestone in the development of InSite Vision's AzaSite franchise. Combined with our existing azithromycin and DuraSite drug-delivery patents, this license further broadens InSite Vision's global patent portfolio."

      Under the terms of the agreement, Pfizer will grant InSite a worldwide, exclusive license, including the right to sublicense, to U.S. and all foreign counterparts patents on the parent case titled "Method of Treating Eye Infections with Azithromycin" and patent applications together with any reissues, extensions, or supplementary protection certificates of any of the foregoing for use in connection with InSite's AzaSite franchise products.
      Avatar
      schrieb am 24.02.07 00:23:59
      Beitrag Nr. 20 ()
      Es ist nur noch eine Frage der Zeit bis die Aktie auch in D Aufmerksamkeit bekommt....

      Form 8-K for INSITE VISION INC


      --------------------------------------------------------------------------------

      22-Feb-2007

      Entry into a Material Definitive Agreement, Termination of a Material Definitiv



      Item 1.01. Entry into a Material Definitive Agreement
      Exclusive License Agreement with Pfizer, Inc. and Pfizer Products, Inc.

      On February 15, 2007, InSite Vision Incorporated ("InSite") entered into a worldwide, exclusive, royalty bearing licensing agreement with Pfizer Inc. and Pfizer Products, Inc. (collectively, "Pfizer") under Pfizer's patent family titled "Method of Treating Eye Infections with Azithromycin" for ocular anti-infective product candidates known as AzaSite™ (or ISV-401) and AzaSite™ Plus (or ISV-502) (the "Pfizer License").

      Under the Pfizer License, InSite is required to pay Pfizer a single digit royalty based on net sales of the licensed products and to use reasonable commercial efforts to seek regulatory approval for and market licensed products. The Pfizer License provides InSite the right to grant sublicenses thereunder, subject to Pfizer's prior approval (which approval shall not be unreasonably withheld).

      The Pfizer License also contains payment and reporting terms, representations and warranties, disclaimers of warranties, limitation of liability, patent protection and enforcement, and indemnification provisions.

      The Pfizer License can be terminated by Pfizer due to InSite's uncured material breach, any insolvency event of InSite or if InSite or its sublicensee challenges the validity or enforceability of the licensed patents.

      License Agreement with Inspire Pharmaceuticals, Inc.

      On February 15, 2007, InSite and Inspire Pharmaceuticals, Inc. ("Inspire") entered into a license agreement (the "Inspire License"), under which InSite licensed to Inspire exclusive development and commercialization rights, under InSite's AzaSite™ patent rights and certain know-how, for topical anti-infective products containing azithromycin as the sole active ingredient for human ocular or ophthalmic indications (each a "Subject Product") in the United States and Canada and their respective territories (the "Territory"). The Inspire License also provides for nonexclusive licenses under InSite's DuraSite® patent rights, container patent rights, Columbia patent rights and certain know-how in the same field of use as described above. InSite also grants Inspire an exclusive sublicense under the Pfizer patent rights licensed by InSite under the Pfizer License discussed above. Inspire has the right to grant sublicenses under the terms of the Inspire License.



      --------------------------------------------------------------------------------

      Under the terms of the Inspire License, Inspire has paid InSite an upfront license fee of $13,000,000 and will pay an additional $19,000,000 upon regulatory approval and the approval of an acceptable label for any Subject Product by the U.S. Food and Drug Administration. Inspire will also pay a royalty on net sales of any Subject Product in the Territory, if approved by regulatory authorities. The royalty rate will be 20% on net sales of any Subject Product in the first two years of commercialization and 25% thereafter. Inspire is obligated to pay royalties under the Inspire License for the longer of (i) eleven years from the launch of the first product, and (ii) the period during which a valid claim under a patent licensed from InSite covers a Subject Product. For five years after the first year of commercial sale, Inspire is required to pay InSite the greater of the running royalty discussed above and certain tiered minimum royalties. The royalties discussed above are subject to certain reductions in the event of patent invalidity, third party licenses, generic competition and uncured material breach. Such reductions are cumulative but will in no event fall below a low single digit royalty based on applicable net sales. There are certain permitted offsets against both running royalties and minimum royalties which are not subject to a floor amount. InSite used $7,325,739.60 of the upfront license fee to redeem its senior secured notes issued in December 2005 and January 2006.

      Under the Inspire License, InSite is responsible for obtaining regulatory approval of AzaSite™ in each country in the Territory. No more than 25 days after obtaining regulatory approval for each country in the Territory, InSite will be responsible for transferring regulatory documentation regarding AzaSite™, including the New Drug Application and Canadian equivalent, to Inspire. Thereafter, Inspire will be responsible for all regulatory obligations and strategies relating to the further development and commercialization of products in each country in the Territory. Inspire will also be responsible for all commercialization in the Territory.

      The Inspire License also provides Inspire with an exclusive option to negotiate a license agreement with InSite for AzaSite Plus™, a combination antibiotic/corticosteroid product formulated with DuraSite® technology. If Inspire and InSite enter into a definitive agreement with respect to AzaSite™ Plus or if InSite publicly announces that it is no longer pursuing the development of AzaSite™ Plus, then the AzaSite™ trademark, the AzaSite™ domain names and the AzaSite™ Plus trademark, including all goodwill associated therewith, will be assigned to Inspire in the Territory.

      InSite is obligated to provide to Inspire certain future developments, including know-how and patent rights, developed up to the effective transfer date of regulatory materials in the Territory that are necessary or useful to develop or commercialize any Subject Product for bacterial conjunctivitis in the Territory. Such developments will be provided without additional fees but any Subject Product that includes such developments will be subject to the same royalty rates described above. For certain further developments developed after such regulatory transfer date in the Territory, Inspire has a time-limited exclusive option to license such further developments upon terms and conditions to be separately negotiated.

      The Inspire License also contains representations and warranties, indemnification and patent prosecution and enforcement provisions.

      The Inspire License can be terminated by Inspire for convenience at any time after the earlier of the regulatory approval of the AzaSite™ product in the United States or April 27, 2008. Each party has the right to terminate for uncured material breach or an insolvency event of the other party. If the Inspire License is terminated by Inspire for convenience or by InSite for Inspire's uncured material breach or insolvency, all licenses granted will terminate and all rights therein will revert back to InSite. If the Inspire License is terminated by Inspire for InSite's uncured material breach or insolvency, Inspire will have a 12-month wind-down period to sell products in inventory and the licenses will be terminated after such wind-down period.



      --------------------------------------------------------------------------------

      InSite previously entered into an agreement with Cardinal Health PTS, LLC ("Cardinal") for the manufacture of the finished product AzaSite™. Under the terms of the Inspire License, the parties have agreed to arrangements intended to facilitate Inspire's access to finished product manufactured by Cardinal on an interim basis and to facilitate execution of a longer term arrangement for finished product supply.

      Trademark License Agreement with Inspire Pharmaceuticals, Inc.

      On February 15, 2007, Inspire and InSite also entered into a Trademark License Agreement, under which InSite granted to Inspire an exclusive license to the AzaSite™ trademark and domain name and a nonexclusive license to the DuraSite® trademark in connection with the commercialization of Subject Products in the Territory under the terms of the Inspire License.

      Supply Agreement with Inspire Pharmaceuticals, Inc.

      Inspire and InSite also entered into a supply agreement dated February 15, 2007 (the "Supply Agreement") for the active pharmaceutical ingredient azithromycin. Previously, InSite had entered into a third party supply agreement for the production of such active ingredient. Under the Supply Agreement, InSite has agreed to supply Inspire's requirements of such active ingredient, pursuant to certain forecasting and ordering procedures. The initial term of the Supply Agreement is until 2012, subject to customary termination provisions, such as termination for material breach. Either Inspire or InSite may terminate the Supply Agreement upon 180 days notice to the other party. In addition, Inspire may also terminate the Supply Agreement if InSite's third party supplier moves the location at which the active ingredient is manufactured. After 2012, the Supply Agreement automatically renews for successive three-year periods unless terminated pursuant to the foregoing termination provisions. If InSite is in breach of its supply obligations under the Supply Agreement, Inspire is permitted to qualify a second source supplier, at InSite's expense, and obtain the active ingredient from such second source. InSite is obligated under the Supply Agreement to maintain a minimum quantity of the active ingredient in inventory for Inspire's use in manufacturing such products and to maintain the quality agreement negotiated with its supplier. The Supply Agreement also contains certain provisions regarding the rights and responsibilities of the parties with respect to manufacturing specifications, delivery arrangements, quality assurance, regulatory compliance, product recall, and indemnification, as well as certain other customary matters.



      --------------------------------------------------------------------------------





      Item 1.02. Termination of a Material Definitive Agreement
      Redemption of 2005/2006 Senior Secured Notes

      On February 15, 2007, InSite redeemed and cancelled $6,531,000 in aggregate principal amount of Senior Secured Notes issued on December 30, 2005 and January 11, 2006 (collectively, the "Senior Notes"). InSite paid a total of $780,503.04 in interest under the Senior Notes to the holders thereof. In connection with the redemption and cancellation of the Senior Notes, all liens on InSite's assets, including its intellectual property, were automatically released and all of InSite's obligations to the holders of the Senior Notes under the Amended and Restated Security Agreement, dated as of December 30, 2005, and the Intercreditor and Collateral Agency Agreement, dated as of December 30, 2005, were terminated. Of such Senior Notes redeemed by InSite, $231,000 in aggregate principal amount was held by InSite's Chief Executive Officer. InSite also redeemed and cancelled that certain amended and restated promissory note dated as of December 30, 2005, with an aggregate principal amount of $35,000 that was issued to its Vice President, Finance and Administration.
      Avatar
      schrieb am 20.04.07 20:47:20
      Beitrag Nr. 21 ()
      Die Umsätze in den USA ziehen an.
      Es wird erwartet dass Ende April die Zulassung für AzaSite gegeben wird. :laugh:
      Avatar
      schrieb am 28.04.07 20:49:30
      Beitrag Nr. 22 ()
      :laugh::laugh:

      Das Warten hat sich gelohnt. AzaSite ist approved

      Inspire says US FDA approves AzaSite eye drops

      WASHINGTON, April 27 (Reuters) - Inspire Pharmaceuticals Inc. (ISPH.O: Quote, Profile , Research) said on Friday the U.S. Food and Drug Administration had approved its AzaSite eye drops for treating bacterial conjunctivitis.

      Inspire said it anticipates launching AzaSite in the latter part of the third quarter of 2007 and expects to generate $30 million to $45 million in sales in 2008.

      AzaSite offers patients a reduced dosing regimen compared to other products for bacterial conjunctivitis, the company said.

      Inspire said it acquired exclusive rights to commercialize AzaSite for eye infections in the United States and Canada from InSite Vision Inc. (ISV.A: Quote, Profile , Research) in February.

      :D:D
      Steht auch auf der Inspire Webseite. Montag gibt es einen ConfCall zu dem Approval.

      Nachbörslich Kurs in den USA bei $1.90 = 1.40€:eek:
      Avatar
      schrieb am 02.05.07 20:42:16
      Beitrag Nr. 23 ()
      Approval von AzSite und jetzt evtl. Übernahme zu $2.70
      Dann kommen wir doch noch auf unsere Gewinne :laugh:


      An Eye-Opening Potential Acquisition
      By Mike Havrilla
      May 2, 2007
      As a pharmacist, I know that the easier a drug is for patients to take, the more likely a doctor will prescribe it -- and the greater its chances of financial success. That trend seems to bode well for the latest offering from Inspire (Nasdaq: ISPH). In fact, it might even make sense for the company to acquire its new drug's developer.

      A visionary new drug
      Late Friday, the FDA approved the antibiotic eyedrop AzaSite, developed by InSite Vision (AMEX: ISV) and recently licensed to Inspire for commercialization in the U.S. and Canada. AzaSite is a topical formulation of the popular antibiotic azithromycin -- widely familiar as a five day Z-PAK, originally made by Pfizer (NYSE: PFE). Its less complex treatment regimen could help it capture leading market share for treating pink eye and other eye infections.

      Thanks to InSite'sf proprietary DuraSite technology, AzaSite requires fewer doses than rival products, creating a viscous solution that is better retained in the eyes to eradicate infections more efficiently. According to InSite, the market for these treatments consists largely of children and busy adults -- patients who'll most likely demand convenient dosing from doctors. In addition, AzaSite belongs to the macrolide class of antibiotics; leading competitors Vigamox, from Alcon (NYSE: ACL), and Zymar, from Allergan (NYSE: AGN), are both fluoroquinolones, whose widespread use has reduced their effectiveness amid growing bacterial resistance. Vigamox and Zymar collectively generate roughly $260 million in annual sales.

      AzaSite may also have a leg up on Alcon's Tobradex, a $170 million annual seller that combines antibiotics and steroids to soothe eye infections accompanied by inflammation. AzaSite Plus, a similar combination of medicines currently in clinical trials, would offer the same benefits but require less frequent dosing. AzaSite already reported phase 1 safety data earlier this year, and its combination of previously approved drugs improves its chances for a thumbs-up from the FDA.

      Following the money
      InSite cleared one of the biggest non-regulatory hurdles for its new drug in mid-February. In exchange for agreeing to pay Pfizer a low-single-digit cut of net sales, the company gained exclusive worldwide rights under the patent family "Method of Treating Eye Infections with Azithromycin." The deal includes AzaSite Plus, and InSite can sublicense it to Inspire as well.

      With that issue resolved, InSite wasted no time teaming with Inspire to start selling AzaSite later this year. In exchange, Inspire paid InSite a $13 million upfront license fee, a $19 million milestone payment due upon FDA approval, and a 20% royalty rate for the first two years on the market, with 25% thereafter.

      Let's do the math
      After watching Wall Street basically ignore InSite's shares, even after AzaSite's approval, I believe that a buyout by Inspire could create a combined company much stronger than the sum of its parts. Inspire ended fiscal 2006 with about $100 million in cash and an additional $20 million under an existing loan facility (already earmarked for the $19 million milestone payment Inspire now owes InSite). As $7.25 per share as of Tuesday's closing bell, Inspire's market cap is just over $300 million.

      Currently, InSite has about 93.5 million shares of common stock outstanding, plus warrants outstanding to purchase 16.7 million shares of common stock at a weighted average exercise price of $0.76 per share. That gives it a fully diluted share count of just more than 110 million, based on an S-3 recently filed with the SEC. The company used $7.3 million of Inspire's $13 million up-front fee fully pay back all outstanding debts, leaving it with about $4 million in cash and zero debt after regular quarterly expenses. Based on its closing price of $1.55 on Tuesday, InSite's market cap stands at roughly $170 million -- almost identical to where it started the year, before any of its drugs had been approved!

      If Inspire bought InSite for about $2.70 per share (roughly $300 million on a fully diluted basis), using $100 million of its available cash and approximately 27.5 million common-stock shares for the remainder, I believe that the resulting company would enjoy a premium market cap greater than the firms' combined current $470 million.

      I'm guessing that market would value the combined company in the $7-to-$8-per-share range, where Inspire currently trades. With 70 million shares outstanding, that would add up to a $500 million market cap. Currently, Alcon trades at 8.4 times trailing annual sales, while Allergan receives a trailing price-to-sales ratio of approximately 6. Given Inspire's current revenue projections, and the following conservative sales estimates for AzaSite:

      Year
      Estimated AzaSite Sales*

      2008
      $40 million

      2009
      $80 million

      2010
      $150 million

      *Based on competing products and analysts' estimates.

      ... the combined company's price-to-sales ratio would shrink from a high of 6 in 2008, to 4 in 2009, to less than 3 in 2010.

      A healthy outlook
      I think that's conservative, actually. I'm only accounting for roughly $150 million in peak sales of AzaSite in 2010, without any additional licensing revenues or royalties from international sales. I'm also excluding any sales or out-licensing agreements of either AzaSite Plus or fellow spinoff AzaSite Otic, which lend considerable upside for the combined company. Inspire would also acquire the rights to the valuable DuraSite technology, which could be applied to existing or new drug candidates in the future.

      In conclusion, if Inspire wants to boost revenues, populate its pipeline, increase its market cap, and become profitable, I believe that the company should look toward InSite, with an eye for acquisition.
      Avatar
      schrieb am 10.05.07 08:39:45
      Beitrag Nr. 24 ()
      bizjournals.com
      InSite Vision sees smaller loss in Q1
      Wednesday May 9, 5:43 pm ET


      Eye drug company InSite Vision Inc. reported a loss of $2.6 million for the first quarter, down from a loss of $5.3 million in the first quarter last year.
      Alameda-based InSite (AMEX: ISV - News) cut its research and development costs to $1.8 million for the quarter, down from $3.1 million last year in the same quarter. InSite completed two late-stage clinical trials of its eye infection drug AzaSite, which cut its R&D costs.

      The Food and Drug Administration approved that drug last month -- after the first quarter ended on March 31 -- and the company will begin selling it later this year.

      Published May 9, 2007 by the East Bay Business Times
      Avatar
      schrieb am 15.06.07 12:07:06
      Beitrag Nr. 25 ()
      bizjournals.com
      $190M life science fund launches
      Thursday June 14, 4:42 pm ET

      Austin-based venture capital firm PTV Sciences says it has raised $190 million for a second fund that will invest in life and materials science companies.
      The firm says it already has put some of the money behind several ventures, including endoscopic device maker Apollo Endosurgery Inc., therapeutic peptide specialist BioSurface Engineering Technologies Inc., and biopharmaceutical company ZIOPHARM Oncology, Inc.

      PTV Sciences' first fund was oversubscribed at $66 million and closed in 2004, the company says.

      Fund co-founders Matthew Crawford and Dr. Evan Melrose and their investment team will continue to invest in companies across the country where Texas resources can be leveraged to create disruptive technology and compelling investment opportunities, the company says.

      They invested their first fund in 12 companies, including OsteoBiologics Inc. of San Antonio, which was bought by Smith and Nephew, BioMimetic Therapeutics Inc. of Nashville, InSite Vision Inc. of Alameda, Calif., IDEV Technologies Inc. of Houston, and LDR Spine USA of Austin.

      PTV Sciences also says it has added two venture partners to its investment team: Nancy Chang, formerly president and CEO of Tanox Inc. and Dr. Stephen Slade of the American Academy of Ophthalmology and the American College of Surg
      Avatar
      schrieb am 05.09.07 15:03:13
      Beitrag Nr. 26 ()
      Urlaubsbedingt noch ein paar Nachträge:

      InSite Vision swings to Q2 profit
      Wednesday August 8, 6:14 pm ET


      InSite Vision Inc. reported a $2.2 million profit which it attributed to recognition of deferred revenue related to the licensing of the ophthalmic solution AzaSite to Inspire Pharmaceuticals.
      Alameda-based InSite Vision (AMEX: ISV - News) posted net income of $2.2 million, or 2 cents per share, compared with a net loss of $5.1 million, or a net loss of 6 cents per share, in the second quarter 2006.

      For the first six months of the year, the company reported a loss of $416,000 compared with a loss of $10.5 million for the six months ending June 30, 2006.

      InSite reported cash and cash equivalents of $18.9 million as of June 30, compared with $986,000 as of Dec. 31.

      Published August 8, 2007 by the East Bay Business Times
      Avatar
      schrieb am 05.09.07 15:03:37
      Beitrag Nr. 27 ()
      InSite eye drug goes on sale
      Monday August 13, 1:36 pm ET

      InSite Vision Inc.'s drug AzaSite, a treatment for conjunctivitis, is now on sale in the United States.
      The drug, developed by the Alameda company (AMEX: ISV - News), is being sold by Inspire Pharmaceuticals, which licensed the drug from InSite in February.

      AzaSite was approved by the Food and Drug Administration for bacterial conjunctivitis treatment in April.

      Kumar Chandrasekaran is InSite's CEO and chairman. Christy Shaffer is president and CEO of Inspire (NASDAQ: ISPH - News), which is based in Durham, N.C.

      Published August 13, 2007 by San Francisco Business Times
      Avatar
      schrieb am 05.09.07 15:04:49
      Beitrag Nr. 28 ()
      Unternehmen macht Gewinn und der Verkauf von AzaSite hat begonnen...Eigentlich alles was das Herz begehrt.


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