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INSV NEWS!!
InSite Vision Establishes Scientific Advisory Board
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Insite Vision (OTCBB:INSV)
Intraday Stock Chart
Today : Thursday 15 September 2011
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InSite Vision Incorporated (OTCBB:INSV) today announced the appointment of a new Scientific Advisory Board (SAB) to help guide and shape its research programs in the development of novel ophthalmic medicines. Members of InSite’s SAB represent leaders in ophthalmic research, treatment and clinical drug development, including Richard Lindstrom, M.D., Gary Foulks, M.D., Michael Lemp, M.D., and Kelly Nichols, O.D., M.P.H., Ph.D. The SAB will be led by InSite’s Chief Medical Officer, Kamran Hosseini, M.D., Ph.D. and Brian Levy, O.D., a member of InSite’s Board of Directors, will also participate in all SAB meetings.
“We are very pleased to bring together these key eye care thought leaders to establish the InSite Vision Scientific Advisory Board. Their deep insight into the etiology of important ocular diseases will be instrumental in advancing our therapeutic programs,” said Dr. Hosseini. “The interest and direct participation of these world-class medical professionals on our SAB reflects the progress InSite is achieving in the development of ocular medicines. Our SAB members have already made significant contributions to our current clinical development programs, providing input on trial protocols and endpoint design. We look forward to future contributions in the same vein.”
Richard Lindstrom, M.D., founder and attending surgeon of the Minnesota Eye Consultants and Adjunct Professor Emeritus at the University of Minnesota Department of Ophthalmology, is a board certified ophthalmologist and internationally recognized leader in ocular surgery. He has been at the forefront of ophthalmology’s evolutionary changes throughout his career as a recognized researcher, teacher, inventor, writer, lecturer and highly acclaimed physician and surgeon. He is Chief Medical Editor of the USA and International editions of Ocular Surgery News. Dr. Lindstrom is past President of the American Society of Cataract and Refractive Surgeons (ASCRS). He serves on the ASCRS Executive Committee and is the Chair of the ASCRS Foundation. Dr. Lindstrom is also past President of the International Society of Refractive Surgery, the International Intraocular Implant Club, and the International Refractive Surgery Club. He is also the Global Education Liaison of the International Society of Refractive Surgery of the American Academy of Ophthalmology. Prior to joining the SAB, Dr. Lindstrom provided valuable guidance to InSite Vision on the protocol for the Phase 3 DOUBle clinical study for AzaSite Plus™ (ISV-502) and DexaSite™ (ISV-305).
Gary Foulks, M.D., is Emeritus Professor of Ophthalmology at the University of Louisville School of Medicine Department of Ophthalmology and Visual Sciences and is former Assistant Dean for Clinical Trial Research at the University of Louisville School of Medicine. Dr. Foulks has authored more than a hundred publications regarding his research in a wide variety of ophthalmologic areas and he is currently active in clinical trial research in ocular surface disease, dry eye and contact lens wear. Dr. Foulks presently is Editor-in-Chief of The Ocular Surface and is on the editorial boards of Cornea and the Eye and Contact Lenses (formerly the CLAO Journal). Before becoming an SAB member, Dr. Foulks consulted with InSite Vision on the DOUBle study protocol, as well as on the trial design for the company’s Phase 1/2 clinical trial of ISV-101 for the treatment of dry eye.
Michael Lemp, M.D., is a corneal specialist with a major research focus in dry eye and ocular surface disease where his work stands as the worldwide standard for the design of clinical trials for dry eye. He has served as Professor and Chairman of the Department of Ophthalmology at Georgetown University, as an officer and board member of many national and international ophthalmic organizations, member of the Food and Drug Administration (FDA) Ophthalmic Devices Advisory Board, and National Institutes of Health (NIH) Study Sections and advisory committees. Dr. Lemp has authored over 200 scientific articles and five books, and has served on national, international and government advisory boards. He is the Founding Editor-in-Chief of The Ocular Surface. He is currently Clinical Professor of Ophthalmology at Georgetown and George Washington Universities and is the Chief Medical Officer of Tearlab Inc.
Kelly Nichols, O.D., M.P.H., Ph.D., is a Professor at the University of Houston College of Optometry where she currently has an NIH grant to study dry eye in postmenopausal women. Dr. Nichols received a Doctor of Optometry degree from U.C. Berkeley and an M.P.H. and Ph.D. from Ohio State University. She serves as a medical advisor to the Sjogren’s Syndrome Foundation and sits on the governing board of the Tear Film and Ocular Surface Society and the Ocular Surface Society of Optometry. She participates as a reviewer for NIH Study Sections and is a member of several prominent ophthalmic journal editorial boards. Dr. Nichols has served as principal investigator or participated in numerous industry-sponsored studies in dry eye and Meibomian Gland Dysfunction (MGD), and recently served as the chair of the International Workshop on MGD. Dr. Nichols lectures and writes on dry eye, contact lenses, diabetes and public health, and women’s health issues.
Dr. Brian Levy, O.D., joined the Board of Directors with more than thirty years of industry experience. He is currently the Chief Scientific Officer of Nexis Vision, which is developing a novel refractive surgery technology. Among his many accomplishments, he oversaw the development of Besivance®, an InSite Vision-licensed drug, while serving as a Corporate Vice President and Chief Medical Officer of Bausch & Lomb.
About InSite Vision
InSite Vision is advancing new and superior ophthalmologic products for unmet eye care needs. The company’s product portfolio utilizes InSite Vision’s proven DuraSite® bioadhesive polymer core technology, an innovative platform that extends the duration of drug retention on the surface of the eye, thereby reducing frequency of treatment and improving the efficacy of topically delivered drugs. The DuraSite platform is currently leveraged in two commercial products for the treatment of bacterial eye infections, AzaSite® (azithromycin ophthalmic solution) 1%, marketed in the U.S. by Merck, and Besivance® (besifloxacin ophthalmic suspension) 0.6%, marketed by Bausch & Lomb and their partner Pfizer Inc. InSite Vision’s clinical-stage ophthalmic product pipeline includes AzaSite Plus™ (ISV-502) and DexaSite™ (ISV-305) for the treatment of eye infections, BromSite™ (ISV-303) for pain and swelling associated with ocular surgery, and ISV-101 for the treatment of dry eye disease. For further information on InSite Vision, please visit www.insitevision.com.
this company have great future if continue on this path and accelerate
, the dr
From the latest filing-- BOD asking for: (5) the approval of a contingent amendment to Article 4 of the Company’s Restated Certificate of Incorporation to effect a contingent reverse stock split of the Company’s outstanding common stock.
ANYBODY WHO DOESN'T SELL AT .55 TO .60 CENTS A SHARE' WILL LOOSE ALL HIS OR HERS MONEY...NUFF SAID
Must be too boring for people just sits here like a rock that doesn't move....hoping for the best for you here.
the MA200 on the weekly is at .60, phase 3 will begin in 2011, 17m in cash = future big runner
the revenues are improving
InSite Vision Reports Third Quarter 2010 Financial Results
-- AzaSite® Royalty Revenues Up 16 Percent Over Second Quarter 2010 --
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Companies:Insite Vision Inc.
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INSV.OB 0.35 0.00
Press Release Source: InSite Vision Incorporated On Thursday November 4, 2010, 4:01 pm EDT
ALAMEDA, Calif.--(BUSINESS WIRE)-- InSite Vision Incorporated (OTCBB:INSV.ob - News) today reported operating and financial results for the quarter ended September 30, 2010. Total revenue for the third quarter of 2010 was $3.2 million with an operating income of $0.2 million and a net loss of $2.3 million. As of September 30, 2010, cash, cash equivalents and marketable securities totaled $17.6 million.
Corporate and Commercial Updates
In August 2010, InSite Vision commenced a Phase 1/2 clinical trial of ISV-303 for the treatment of pain and swelling associated with ocular surgery. ISV-303 is a topical anti-inflammatory and pain product candidate that combines a low concentration of bromfenac with InSite Vision’s proprietary DuraSite® technology to extend and improve the topical delivery of medication to the eye.
InSite Vision is working with the U.S. Food and Drug Administration (FDA) to obtain a Special Protocol Assessment (SPA) for the Phase 3 development program of ISV-502 and ISV-305 for the treatment of blepharitis, an ocular disease characterized by inflammation of the eyelids. ISV-502 and ISV-305 each leverage InSite’s proprietary DuraSite technology. ISV-502 combines azithromycin and dexamethasone in DuraSite, and ISV-305 incorporates dexamethasone in DuraSite.
Prescriptions of AzaSite® (azithromycin ophthalmic solution) 1%, for the treatment of bacterial conjunctivitis, increased by 15 percent in the third quarter of 2010 from the second quarter of 2010 and by 45 percent compared to the third quarter of 2009. AzaSite is marketed by Inspire Pharmaceuticals in the United States.
In October 2010, InSite was informed that it will receive a Therapeutic Discovery Project Grant of $489,000 from the U.S Government for the clinical development of ISV-502 and ISV-303.
InSite Vision will be presenting a corporate update at the upcoming Wall Street Analyst Forum financial conference on November 11th, 2010 in New York City.
“We are making excellent progress in 2010 in advancing our therapeutic pipeline of DuraSite-enabled products. During the quarter we announced commencement of a Phase 1/2 clinical trial of ISV-303. We also are making good progress for an SPA with the FDA for our planned Phase 3 clinical study of ISV-502 and ISV-305,” said Louis Drapeau, InSite Vision’s Chief Executive Officer.
Third Quarter 2010 Results Summary
Revenues in the third quarter of 2010 were $3.2 million compared to $2.2 million for the third quarter of 2009. Third quarter 2010 revenues included royalties from Inspire Pharmaceuticals of $2.8 million for sales of AzaSite compared to $2.2 million in the third quarter of 2009. Of note, for the first time royalties received from product sales of AzaSite in the third quarter of 2010 exceeded the combined required loan interest and Pfizer royalty payments. InSite Vision also received royalties from global net product sales of Besivance® (besifloxacin ophthalmic suspension) 0.6% by Bausch & Lomb. Both AzaSite and Besivance utilize InSite Vision’s proprietary DuraSite drug delivery technology.
Research and development (R&D) expenses for the third quarter 2010 were $1.4 million compared to $1.0 million in the third quarter 2009. The increase in R&D expenses was primarily driven by the initiation of the ISV-303 Phase 1/2 clinical trial in the third quarter of 2010.
General and administrative (G&A) expenses were $1.0 million for the quarter ended September 30, 2010 compared to $1.4 million in the same quarter in 2009. G&A expenses in 2010 were lower due to lower personnel expenses in 2010 due to the company’s 2009 corporate restructuring.
Net loss for the quarter ended September 30, 2010 was $2.3 million, or $0.02 per share, compared to a net loss of $3.1 million, or $0.03 per share, in the same quarter of 2009.
InSite Vision had cash, cash equivalents and short-term investments of $17.6 million at September 30, 2010. Total cash usage in the third quarter 2010 was $2.6 million.
Thanks for that site...The holding patents here alone are at $1.50 if sold individually....
Very bullish chart here...Something is brewing and I can't wait....
There is a new CEO at Inspire. The guy came from Sepracor, he seems to have a history of working for buyout targets.
Have some shares in an IRA, most boring stock on the planet, but price should be higher so I hang on to them.
Rain, you still in this??
What is everyone's take on the Q3 financial statement?
no, no relation, even though I have met him... Funny story though - My dad was at the opening game this year and got to go to the parents lunch before the game (we are good friends with one fo the guys on the team) and everyone kept asking him if he was Justin's dad and he said yes.
I also followed Joe over and have reaped the benefits up to this point, I am up around 180% on my investment in just over 6 weeks.
Hook em
Hey justin,
Any relation to the UT kicker? Thought from your profile that you may have followed joe over from OB (which I did as well).
Anyway, hookem...
and OU sucks!
It's about time! I've been waiting FOREVER! Go INSV!
Could be gearing up for a great earnings release next week... stock is starting to heat up
shouldn't the quarter earning come out early November?
Uh, not $.14 buyout ferchrissake. How about $1.40?
tired of waiting and sold enough at $.43 to have only free share now. Bring on he $.140 buyout
this was me.. had a nice return 23% and will keep a close watch on it still own the majority of my shares.
absolutely not related at all.
Just a number of small biotechs got a nudge today after that news came out.
Maybe only attention to the overall sector. . .except there was an inordinate volume on two days last week and today's price action was interesting. The close was no biggie, but the bid/ask mid-day was jumping around quite a bit.
I asked Rain what news there could possibly be to ever move this stock forward--I can't really think of anything.
Buyout at $1.25--I'm all in on that!
robj
...how is that in anyway relevant to ophthalmology.
This might explain the volume and push today:
here is the article if full - it has been moved -
Production of H1n1 Vaccine for Coming Weeks Is Delayed, CDC Says
Share | Email | Print | A A A
By Bruce Rule
Oct. 16 (Bloomberg) -- Swine flu vaccine production has been delayed, so monthly estimates won’t be met, Anne Schuchat, head of the National Center for Immunization and Respiratory Diseases at the U.S. Centers for Disease Control and Prevention, said on a conference call today.
She did not give a reason for the delay.
Rain, what do you make of the volume during a couple of days this week? Not so much price appreciation when you look at only the closes, but most shares are being traded at the ask lately.
Even being an ownedr, I don't know what the catalyst would be to drive this stock to even the $.60s
robj
Besivance was approved by the U.S. Food and Drug Administration in the second quarter 2009 and is being marketed by Bausch & Lomb and Pfizer Inc...
When either of those two catalysts speak, instantaneous eruption will be the effect..
That's the loan they got against future Inspire AzaSite royalties. The value for the Azasite deal came in at 120m, INSV got a 60m loan against this. By the end of this year Inspire royalties paid to INSV will cover the interest payments for the loan.
Are we not soon to come upon some recs by Piper about strategic planning. The only one I'm interested in is an outright sale of this company, ferchrissake a buck looks like the Eldorado Gold mine right now.
Rainmaker, am I reading this right?
$60 Million in debt? Who do they owe this to?
Ferchrissake, if that's accurate number, no wonder we're sitting at $.40
Wonder what a person thinks will happen to make it go up?
I can't think of anything. Rainmaker?
Finally! A wopping 10,000 shares traded!
lol does anybody know what this means, cause i have no freaking clue
Not one single trade in the morning!
the calm before the storm.
just don't know if it's acid rain or marshmallows with rainbows, yet.
Sorry can't help you out, got the info from one of the CC's. If you're not sure call IR or the company.
i'm sorry i don't want to sound like a hassle, but I looked all over, and all I can find is that INSV says they're working with piper and Jaffery, not that there are 6 possible choices being examined. Do you mind showing me the link and quote?
From their earnings CC's. Never gave the names of the 6, you can find the link to the CC's on INSV's website.
I'm really curious where you got the information that Piper Jaffery has found 6 potential deals for INSV to consider. I would really like some sources, and if you know what the 6 deals are, that would be even better=d
I'm trying to gauge if I should buy more share or not
thanks~Steve
I'm excited and own several thousand shares!
Wow!
Not a single trade in the first 1.5 hours.
Wow, wow!
Could there be any less interest here?
Up nicely yesterday on good volume. Alright, who' hiding the news, eh?
Release the hounds!
NEWS (a repeat) --
Sep 17, 2009 (Close-Up Media via COMTEX) -- InSite Vision Inc. has announced
that Inspire Pharmaceuticals, its commercial partner for AzaSite (azithromycin
ophthalmic solution) 1 percent in the U.S and Canada, has committ ed to
increasing production of AzaSite in response to the manufacturing supply
shortage of erythromycin ophthalmic ointment (0.5 percent).
Erythromycin ophthalmic ointment is approved for prophylaxis of ophthalmia
neonatorum, a form of bacterial conjunctivitis that may be contracted by
newborns during delivery. The Company said that it is the only product approved
for this indication commercially available in the United States. Recently, the
U.S. Food and Drug Administration (FDA) placed erythromycin ophthalmic ointment
on the FDA's Drug Shortage list. The Centers for Disease Control and Prevention
(CDC), the U.S. Department of Health and Human Services, the American Academy of
Ophthalmology and the FDA all recommend that existing supplies of erythromycin
ophthalmic ointment be reserved for the treatment of neonatal prophylaxis use.
According to the Company, these organizations are encouraging healthcare
professionals to use alt ernative drugs, including AzaSite, for the treatment of
superficial ocular infections involving the conjunctiva and/or cornea caused by
organisms susceptible to erythromycin, as well as for treatment of post-surgical
and posttraumatic events. In addition, the CDC has recommended AzaSite as an
acceptable substitute for neonatal prophylaxis use where erythromycin ophthalmic
ointment is not available. AzaSite has not been approved by the FDA for the
treatment of prophylaxis of ophthalmia neonatorum and no clinical trials have
been conducted using AzaSite in this population. This recommendation was based
on available AzaSite data on pharmacology and gonococcal microbiologic
sensitivity.
((Comments on this story may be sent to health@closeupmedia.com))
Copyright Close-Up Media, Inc. 2009. All Rights reserved
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INDUSTRY KEYWORD: Health_And_Beauty_Close-up
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InSite Vision is committed to advancing new and superior ophthalmologic products for unmet eye care needs. Our mission is to develop and facilitate market entry for novel products worldwide that preserve and improve vision.
Our lead product, AzaSite® (azithromycin ophthalmic solution) 1%, is approved by the United States Food and Drug Administration (FDA) and the Therapeutic Products Directorate (TPD) of Health Canada for the treatment of bacterial conjunctivitis. AzaSite is formulated with our proprietary DuraSite® technology, which extends the residence time of the antibiotic azithromycin on the eye for several hours, thereby reducing the need for the frequent dosing regimen related to conventional anti-infective eye drops. AzaSite was launched in the U.S. in August 2007 by Inspire Pharmaceuticals, InSite’s commercial partner for the U.S. and Canada and will be marketed by international partners in Japan, Europe, South Korea, select countries in South America, Turkey and China upon approval in those countries. InSite will also pursue partnerships with companies who share our commitment to bringing innovative ophthalmic products such as AzaSite to patients worldwide.
AzaSite Plus (ISV-502), another product candidate in the AzaSite family, is currently in late-stage development for the treatment of eyelid infection and inflammation, specifically for the indication of blepharitis.
Our strategy includes maximizing AzaSite sales in the U.S. and abroad through close collaboration with marketing partners, seeking development partners for our DuraSite-enabled early-stage product candidates, and applying our expertise in ophthalmology to identify, in-license, or acquire promising new product candidates or technologies.
http://www.insitevision.com/partners
Commercial partnerships: InSite Vision receives royalty payments from our two commercial products, AzaSite® (azithromycin ophthalmic solution) 1% and Besivance™ (besifloxacin ophthalmic suspension) 0.6%. AzaSite is approved in the United States and Canada and marketed by InSite Vision’s partner, Inspire Pharmaceuticals. InSite Vision has also formed multiple strategic licensing and distribution agreements with partners to market AzaSite in select countries in Europe, Asia and South America upon regulatory approval in those regions. Besivance was approved by the U.S. Food and Drug Administration in 2009 and is being commercialized by Bausch & Lomb and Pfizer Inc. We work closely with our partners to support and extend product sales.
http://www.insitevision.com/product_pipeline
Phase Chart
Authorized Shares (AS) = 240 million
Outstanding Shares (OS) = 94.74 million
Restricted Shares = 21.73 million
Float = 73.01 million
http://finance.yahoo.com/q/ks?s=INSV.OB
INSV News
http://finance.yahoo.com/q/h?s=INSV.OB
INSV SEC Filings
http://finance.yahoo.com/q/sec?s=INSV.OB
INSV Management
· Louis Drapeau
Chief Executive Officer, Vice President and Chief Financial Officer
· Lyle M. Bowman, Ph.D.
Vice President, Development
· David Heniges
Vice President and General Manager, Commercial Opportunities
· Kamran Hosseini, M.D., Ph.D.
Vice President, Clinical Affairs and Chief Medical Officer
· Surendra Patel
Vice President, Operations and Quality
INSV Contact Information
http://finance.yahoo.com/q/pr?s=INSV.OB
Insite Vision Inc.
965 Atlantic Avenue
Alameda, CA 94501
United States - Map
Phone: 510-865-8800
Fax: 510-865-5700
Web Site: http://www.insitevision.com
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