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ISTA Pharmaceuticals Highlights Bepreve(TM) Clinical Data at the American College of Clinical Pharmacy (ACCP) 2009 Annual Meeting
Press Release
Source: ISTA Pharmaceuticals, Inc.
On 4:01 pm EDT, Wednesday October 21, 2009
Companies:ISTA Pharmaceuticals Inc.
ANAHEIM, Calif., Oct. 21 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA - News) today announced poster presentations of results from the Company's Bepreve(TM) (bepotastine besilate ophthalmic solution) 1.5% Phase 3 clinical studies in allergic conjunctivitis. The studies demonstrated Bepreve was safe and well-tolerated when given twice daily for six weeks in a healthy pediatric population as young as three years of age. The clinical findings were presented at the American College of Clinical Pharmacy (ACCP) 2009 Annual Meeting in Anaheim, CA, and were encore presentations from earlier meetings in 2009.
In a poster previously presented at the American Academy of Allergy Asthma & Immunology 2009 Annual Meeting titled, "The Ocular Comfort and Safety of the Novel Anti-Histamine Bepotastine Besilate Ophthalmic Solution 1.5% in a Healthy Pediatric Population", ISTA presented results from a 6-week, multi-center, randomized, double-masked, placebo-controlled, parallel-group safety study. The study enrolled 861 individuals, of whom approximately 15% (127 subjects) were pediatric subjects. Subjects were randomized to receive either Bepreve or placebo twice daily. Following test drop instillation for each eye at study visit 2 (one week of dosing) and visit 3 (three weeks of dosing), the overall comfort of the investigational product was graded using a quantitative scale. The study showed there was no clinically or statistically significant difference in the ocular comfort of Bepreve and placebo among pediatric subjects, either immediately after or five minutes following instillation.
In a separate poster previously presented at the Association for Research in Vision and Ophthalmology 2009 Annual Meeting titled, "The Safety of the Anti-Histamine Bepotastine Besilate Ophthalmic Solution in a Healthy Pediatric Population from Ten to Seventeen Years of Age", ISTA presented subpopulation data from the 6-week, placebo-controlled, parallel-group safety study. The proportion of pediatric subjects in this age group instilling Bepreve and with an adverse event (22.5%) was similar to that seen for subjects 10-17 years of age instilling placebo (20.0%).
No severe adverse events were reported during the 6-week safety trial and all pediatric patients completed the trial.
In addition, ISTA presented additional efficacy results from placebo-controlled conjunctival allergen challenge (CAC) clinical trials with Bepreve 1.0% and 1.5%. The positive results for some non-ocular symptoms considered secondary endpoints in the CAC trials were presented in the following encore poster presentations:
Bepotastine Besilate Ophthalmic Solution Reduces Nasal Symptoms in the Conjunctival Allergan Challenge (CAC) Clinical Model
Authors: G.L. Torkildsen, P.J. Gomes, J.I. Williams, J.A. Gow, M.B. Abelson, T.R. McNamara
Bepotastine Besilate Ophthalmic Solution 1% Reduces Ear or Palate Pruritus with Rapid Onset in a Clinical Model of Allergic Conjunctivitis
Authors: G.L. Torkildsen, P.J. Gomes, J.I. Williams, J.A. Gow, M.B. Abelson, T.R. McNamara
Abstracts are available on the ACCP Journal website at http://www.pharmacotherapy.org.
About Bepreve(TM) (bepotastine besilate ophthalmic solution) 1.5%
Bepreve is a non-sedating, highly selective antagonist of the histamine (H1) receptor. It has a stabilizing effect on mast cells, and it suppresses the migration of eosinophils into inflamed tissues. The compound's primary mechanisms of action are believed to make it an effective treatment against ocular itching associated with allergic conjunctivitis.
Bepotastine was approved in Japan for use as a systemic drug in the treatment of allergic rhinitis and urticaria/pruritus in July 2000 and January 2002, respectively, and is marketed by Mitsubishi Tanabe Pharma Corporation (formerly Tanabe Seiyaku Co., Ltd.) under the brand name TALION®. TALION was co-developed by Tanabe Seiyaku and Ube Industries, Ltd., who discovered bepotastine. In 2001, Tanabe Seiyaku granted Senju Pharmaceutical Co., Ltd., exclusive worldwide rights, with the exception of certain Asian countries, to develop, manufacture and market bepotastine for ophthalmic use. In 2006, ISTA licensed the exclusive North American rights from Senju to an eye drop formulation of bepotastine for the treatment of allergic conjunctivitis. In 2007, ISTA licensed exclusive North American rights to nasal dosage forms of bepotastine from Tanabe Seiyaku and obtained a future right to negotiate for a North American license to oral dosage forms of bepotastine for allergy treatment.
Full prescribing information for Bepreve(TM) is available on ISTA Pharmaceuticals' website at http://www.istavision.com/pdf/Bepreve_insert.pdf
Healthcare Takeover Talk Continues
http://seekingalpha.com/article/164070-healthcare-takeover-talk-continues?source=yahoo
ISTA Pharmaceuticals, Inc. (ISTA), who won unanimous support for the approval of their Bepreve drug for the treatment of itchy eyes from the FDA closed as one of the sector's biggest gainers, up to $4.53 +0.28 (6.59%) after a nice write-up in the Motley Fool. The company has more approvals coming down the pipeline and it's investors are feeling very bullish. ISTA is the fourth largest branded ophthalmic pharmaceutical business in the U.S. ISTA’s four marketed products plus its product candidates include therapies for inflammation, ocular pain, glaucoma, allergy, and dry eye.
Anyone else buying call options in ISTA? I have the Oct 5's and the Oct 7.50's, as well as owning some stock. What share price are you anticipating with FDA approval hopefully forthcoming very, very soon?
ISTA Pharmaceuticals' Bepreve(TM) Receives FDA Approval for the Treatment of Ocular Itching Due to Allergies
Company Increases 2009 Net Revenue Guidance
Press Release
Source: ISTA Pharmaceuticals, Inc.
On Tuesday September 8, 2009, 7:45 pm EDT
Companies:ISTA Pharmaceuticals Inc.
IRVINE, Calif., Sept. 8 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA - News) today announced the U.S. Food and Drug Administration (FDA) has approved Bepreve(TM) (bepotastine besilate ophthalmic solution) 1.5% as a twice-daily prescription eye drop treatment for ocular itching associated with allergic conjunctivitis in patients two years of age and older.
"Bepreve offers a new, safe and effective way to treat the itching caused by ocular allergies. We expect to have Bepreve available to ophthalmologists and patients in the United States in the fourth quarter of 2009," stated Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA. "Because of the timing of this approval and the strength of our underlying business, we will accelerate all of the launch activities immediately, including the scale-up of the sales force. This will allow us not only to finish this year very strongly but also enter next year with an expanded sales force in place. Bepreve and Xibrom will share the top spot on our promotional activities, but we will continue to devote time and energy to Istalol, too."
ISTA conducted multiple clinical studies, evaluating the safety, efficacy, onset and duration of effect of Bepreve. Two Phase 3 double-masked, placebo-controlled, conjunctival allergen challenge (CAC) studies demonstrated Bepreve significantly reduced ocular itching. In addition, the studies achieved statistical significance and demonstrated Bepreve's rapid onset of action in providing relief to persons with ocular itching associated with allergic conjunctivitis.
"Patients who experience ocular itching due to allergies want comfortable, quick and long-lasting relief for their eyes. Bepreve is the first truly new treatment for allergic conjunctivitis approved in several years. Allergic conjunctivitis, not to be confused with viral or bacterial conjunctivitis or pink eye, is an eye allergy that often results in ocular itching, and I am excited patients will have this new treatment option," commented Gregg J. Berdy, M.D., Assistant Professor of Clinical Ophthalmology, Washington University School of Medicine.
Dr. Anido concluded, "As we are accelerating our launch timing to the fourth quarter and are expanding our sales force, we now expect to be able to recognize Bepreve revenue this year. In addition, Xibrom and Istalol are performing particularly well year to date, giving us confidence to increase our full-year 2009 net product revenue guidance for our four marketed products to $101 million to $104 million. Our total net revenue for full-year 2009, including net product revenue and $2.9 million from the one-time recognition of deferred revenue resulting from our previously disclosed modification of our partnership with Otsuka, is now expected to be $104 million to $107 million. We also are reiterating our guidance that ISTA will be operating income neutral in 2009, as our increased net revenue will offset the costs associated with launching Bepreve and expanding our sales force."
About the U.S. Ocular Allergy Market
Approximately 60 to 90 million Americans suffer from ocular allergy. Allergic conjunctivitis, the most common allergy affecting the eyes, is caused by exposure to certain allergens such as pollen from trees, grass and plants, animal dander, feathers, dust mites and molds. Ocular itching is the most common symptom of ocular allergy, reported by more than 75% of allergy patients. Current treatments for allergic conjunctivitis include antihistamines, mast cell stabilizers and anti-inflammatories. Based on data from IMS Health, in 2008 approximately 6.6 million prescriptions were filled for ocular allergy treatments, resulting in sales of approximately $560 million.
About Bepreve(TM) (bepotastine besilate ophthalmic solution) 1.5%
Bepreve is a non-sedating, highly selective antagonist of the histamine (H1) receptor. It has a stabilizing effect on mast cells, and it suppresses the migration of eosinophils into inflamed tissues. The compound's primary mechanisms of action are believed to make it an effective treatment against ocular itching associated with allergic conjunctivitis.
Bepotastine was approved in Japan for use as a systemic drug in the treatment of allergic rhinitis and urticaria/pruritus in July 2000 and January 2002, respectively, and is marketed by Mitsubishi Tanabe Pharma Corporation (formerly Tanabe Seiyaku Co., Ltd.) under the brand name TALION®. TALION was co-developed by Tanabe Seiyaku and Ube Industries, Ltd., who discovered bepotastine. In 2001, Tanabe Seiyaku granted Senju Pharmaceutical Co., Ltd., exclusive worldwide rights, with the exception of certain Asian countries, to develop, manufacture and market bepotastine for ophthalmic use. In 2006, ISTA licensed the exclusive North American rights from Senju to an eye drop formulation of bepotastine for the treatment of allergic conjunctivitis. In 2007, ISTA licensed exclusive North American rights to nasal dosage forms of bepotastine from Tanabe Seiyaku and obtained a future right to negotiate for a North American license to oral dosage forms of bepotastine for allergy treatment.
INDICATIONS AND USAGE
Bepreve(TM) (bepotastine besilate ophthalmic solution) 1.5% is a histamine H1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis.
DOSAGE AND ADMINISTRATION
Instill one drop of Bepreve(TM) into the affected eye(s) twice a day (BID).
CONTRAINDICATIONS
None.
Reasons why this go
DD:
#1 -
Super low float for such a market this bio tech company captures in Ocular medicines. 33.22MIL only.
#2- very profitable company already, fundamentals and balance sheet is good and will be in green easily early next year. Especially for a biotech, most biotechs are in DEEP DEEP RED of debt, not ISTA, no dilution here with actually making money. Added to that by end of this year yet another filing for approval, a pipeline of Ocular medicines coming. check 2008 vs 2009 net revenues and data in their first half of 2009 filing:
Ended June 30,
2009 2008 % Change
Xibrom $ 18.1 $ 13.6 33 %
Istalol 4.3 2.8 54 %
Vitrase 1.5 1.3 15 %
Other 0.1 0.1 0 %
Total Net Revenue $ 24.0 $ 17.8 35 %
At June 30, 2009, based on available external and internal data, we believe the amount of average wholesaler inventories was reduced by approximately half a month from the first quarter of 2009.
Gross margin and cost of products sold. Gross margin for the three months ended June 30, 2009 was 74% of net revenue, or $17.7 million, as compared to 73% of net revenue, or $13.0 million, for the three months ended June 30, 2008.
Cost of products sold was $6.2 million for the three months ended June 30, 2009, as compared to $4.8 million for the three months ended June 30, 2008. Cost of products sold for the three months ended June 30, 2009 and 2008 consisted primarily of standard costs for each of our commercial products, distribution costs, royalties, inventory reserves and other costs of products sold. The increase in cost of products sold is primarily the result of increased net product sales. The increase in gross margin for the three months ended June 30, 2009 as compared to the three months ended June 30, 2008 is primarily the result of increased growth in prescription levels and market share, particularly for Xibrom, our highest gross margin product.
#2 -
Expecting to file for another FDA approval:
IRVINE, Calif. (AP) -- ISTA Pharmaceuticals Inc. on Wednesday reported successful late-stage clinical trial results for Xibrom QD, a new once-per-day eye drug.
The company said Xibrom QD eye drops were significantly better than a placebo at eliminating eye inflammation 15 days after cataract surgery. The drug also achieved a secondary goal of eliminating eye pain one day after surgery. The drug is a once-per-day version of Xibrom, a drug that is already on the market but is intended to be used twice a day.
The trial included 299 patients who had cataract surgery on one eye.
ISTA said it expects to file for Food and Drug Administration approval of Xibrom QD by the end of the year. In late 2008, the FDA asked ISTA to run a third late-stage study of the drug to confirm results from previous trials.
ISTA acquired the U.S. marketing rights to Xibrom in 2002 and launched the product in 2005. The company said sales in the first half of 2009 were $33.8 million, making the drug the best selling anti-inflammatory eye drops in the U.S.
http://finance.yahoo.com/news/ISTA-says-daily-Xibrom-eye-apf-1324395409.html?x=0&.v=2
#3-
Wall St. Journal article below says ISTA to get likely approval
UPDATE: FDA: ISTA Eye Drop Effective; Concern On Rejena
WASHINGTON (Dow Jones)--The Food and Drug Administration said Wednesday that ISTA Pharmaceutical Inc.'s (ISTA) Bepreve eye drops were effective at treating eye-itching associated with allergies.
However, the agency questioned data involving another proposed eye drop, Rejena, by privately held River Plate Biotechnology Inc. for the treatment of dry-eye disease. If approved, Rejena would be marketed by Alcon Inc. (ACL).
Both Bepreve and Rejena will be reviewed Friday by the FDA's Dermatologic and Ophthalmic Drugs Advisory Committee. Bepreve and Rejena are considered a new chemical entity, and all such products are routinely reviewed by FDA advisory panels.
ISTA is seeking FDA approval to market Bepreve to people with conjunctivitis, or pink eye, caused by allergies.
The FDA posted a review of Bepreve on its Web site Wednesday. The agency said there were no serious safety issues seen in clinical trials of Bepreve. The most common side-effect was a distorted sense of taste after receiving the drops, which 20% of the patients reported.
The advisory panel will be asked to vote on whether it thinks Bepreve is safe and effective. Given the positive FDA review of the product, panel endorsement is likely. The FDA usually follows its panels' advice, but it isn't required to do so.
ISTA said it expects the FDA to make a final decision on whether to approve Bepreve by Sept. 12.
In the review of Rejena, the FDA said one study showed a "lack of robust treatment effect" and questioned the interpretation of data in another study that suggested the treatment worked better than a placebo.
The FDA said it didn't see serious side-effects in clinical studies of Rejena, which is marketed as Vismed in Europe.
The FDA panel also will be asked to vote on whether Rejena's clinical data show whether the product is safe and effective.
River Plate said that, in documents also posted to the FDA's Web site, the clinical data along with post-marketing experience are "supportive of a favorable risk-benefit profile" for FDA approval of the product.
By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com http://online.wsj.com/article/BT-CO-20090624-708999.html
ISTA says daily Xibrom eye drops met goal in study
ISTA Pharma says Xibrom QD eliminated eye inflammation and eye pain after cataract surgery
On Wednesday August 26, 2009, 7:31 am EDT
Companies:ISTA Pharmaceuticals Inc.
IRVINE, Calif. (AP) -- ISTA Pharmaceuticals Inc. on Wednesday reported successful late-stage clinical trial results for Xibrom QD, a new once-per-day eye drug.
The company said Xibrom QD eye drops were significantly better than a placebo at eliminating eye inflammation 15 days after cataract surgery. The drug also achieved a secondary goal of eliminating eye pain one day after surgery. The drug is a once-per-day version of Xibrom, a drug that is already on the market but is intended to be used twice a day.
The trial included 299 patients who had cataract surgery on one eye.
ISTA said it expects to file for Food and Drug Administration approval of Xibrom QD by the end of the year. In late 2008, the FDA asked ISTA to run a third late-stage study of the drug to confirm results from previous trials.
ISTA acquired the U.S. marketing rights to Xibrom in 2002 and launched the product in 2005. The company said sales in the first half of 2009 were $33.8 million, making the drug the best selling anti-inflammatory eye drops in the U.S.
ISTA Pharmaceuticals Announces Positive Preliminary Phase 3 Clinical Results to Support sNDA Filing for Once-Daily Xibrom(TM) 0.09%
Press Release
Source: ISTA Pharmaceuticals, Inc.
On Tuesday August 25, 2009, 4:00 pm EDT
Companies:ISTA Pharmaceuticals Inc.
IRVINE, Calif., Aug. 25 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA - News), today announced positive preliminary Phase 3 results from the Company's Xibrom((TM)) (bromfenac ophthalmic solution) 0.09% QD (once-daily) confirmatory clinical study. Xibrom 0.09% QD achieved statistical significance in the study's primary endpoint, the absence of ocular inflammation 15 days following cataract surgery, and the secondary efficacy endpoint, the elimination of ocular pain one day post surgery. During the study, no serious ocular or systemic adverse events occurred, and the safety profile is consistent with ISTA's currently marketed Xibrom twice-daily formulation.
The confirmatory Phase 3 study was a multi-center, randomized, double-masked, parallel-group study in 299 patients who underwent cataract surgery in one eye. Patients were assigned randomly (1:1) to receive either Xibrom once daily or placebo. Dosing began one day before cataract surgery and continued for 14 days following surgery. The proportion of patients experiencing no pain was assessed at Day 1 post surgery, and the proportion of patients with complete absence of ocular inflammation was assessed at Day 15 post surgery. Ocular inflammation was evaluated using a summed ocular inflammation score (SOIS) and was measured by an assessment of immune cells in the anterior chamber of the eye ("cells") and cellular debris ("flare"). The secondary efficacy endpoint was evaluated via a pain score from the Ocular Comfort Grading Assessment recorded in a diary. Patients also graded their symptoms at each office visit, which included photophobia, the chief symptomatic complaint following cataract surgery.
In December 2008, ISTA announced integrated results from two Phase 3 studies with Xibrom 0.09% QD. Based on the results of the studies, the U.S. Food and Drug Administration (FDA) required ISTA to conduct an additional confirmatory study with Xibrom 0.09% QD. The current study confirms the efficacy and safety of Xibrom 0.09% QD which was previously demonstrated in an identical Phase 3 clinical trial in 2008. Once the Company completes its analysis of the full dataset, ISTA expects to file a supplemental New Drug Application (sNDA) with the FDA prior to the end of 2009, seeking approval of the Xibrom 0.09% formulation for once-daily treatment for the inflammation and pain following cataract surgery.
Xibrom((TM)) (bromfenac ophthalmic solution)
Xibrom is a topical non-steroidal anti-inflammatory compound for the treatment of ocular inflammation and pain following cataract surgery. Xibrom, under a different trade name but identical formulation, was launched in Japan in 2000 by Senju Pharmaceuticals Co. Ltd. ISTA acquired U.S. marketing rights for Xibrom in 2002 and launched the product in the U.S. in 2005. According to IMS data, Xibrom is the 2009 dollar market share leader in the U.S. ophthalmic nonsteroidal anti-inflammatory market, with net sales of $33.8 million for the six-month period ended June 30, 2009.
Xibrom currently is labeled as an eye drop used twice-daily beginning 24 hours after cataract surgery. Xibrom has not been approved by the FDA as a once-daily treatment. ISTA's sNDA filing will request the Agency to approve a change to the drug's label to reflect Xibrom's efficacy as a once-daily treatment in this patient population.
ISTA Pharmaceuticals Announces Conference Call and Webcast of Second Quarter 2009 Financial Results
Press Release
Source: ISTA Pharmaceuticals, Inc.
On Wednesday July 29, 2009, 11:28 am EDT
Companies:Ista pharmaceuticals inc.
IRVINE, Calif., July 29 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA - News), today announced it will release second quarter 2009 financial results after market close on August 5, 2009. In conjunction, the Company will host a conference call at 5:00 p.m. Eastern Time to discuss these results and provide a pipeline update.
Date: Wednesday, August 5, 2009
Time: 5:00 p.m. Eastern Time
Conference call access:
Internet: www.istavision.com
Domestic dial-in: 866-700-7441
International dial-in: 617-213-8839
INTRA day chart straight shows straight decline.. what is going on/?
Dermatologic and Ophthalmic Drugs Advisory Committee Unanimously Recommends Bepreve(TM) for the Treatment of Ocular Itching Associated with Allergic Conjunctivitis
Press Release
Source: ISTA Pharmaceuticals, Inc.
On Friday June 26, 2009, 10:28 am EDT
Companies:Ista pharmaceuticals inc.
IRVINE, Calif., June 26 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA - News) today announced the Dermatologic and Ophthalmic Drugs Advisory Committee appointed by the U.S. Food and Drug Administration (FDA) recommended the approval of Bepreve(TM) (bepotastine besilate ophthalmic solution) 1.5% as an eye drop treatment for ocular itching associated with allergic conjunctivitis. The Committee voted unanimously 7 to 0 in favor of approving Bepreve after reviewing comprehensive safety and efficacy data from ISTA's clinical program.
"The Committee's vote supports our belief that Bepreve provides a safe and effective treatment for ocular itching associated with allergic conjunctivitis. We will continue to work closely with the FDA as we approach the September 12th action date," stated Vicente Anido Jr., Ph.D., President and Chief Executive Officer of ISTA Pharmaceuticals.
Although the FDA is not required to follow the Committee's guidance, the Agency usually considers the Committee's recommendation when evaluating pending applications. The FDA has assigned a Prescription Drug User Fee Action Date of September 12, 2009.
About Bepreve (bepotastine besilate ophthalmic solution) 1.5%
Bepreve is a non-sedating, highly selective antagonist of the histamine (H1) receptor. It has a stabilizing effect on mast cells, and it suppresses the migration of eosinophils into inflamed tissues. The compound's primary mechanisms of action are believed to make it an effective treatment against ocular itching associated with allergic conjunctivitis.
Bepotastine was approved in Japan for use as a systemic drug in the treatment of allergic rhinitis and urticaria/pruritus in July 2000 and January 2002, respectively, and is marketed by Mitsubishi Tanabe Pharma Corporation (formerly Tanabe Seiyaku Co., Ltd.) under the brand name TALION®. TALION was co-developed by Tanabe Seiyaku and Ube Industries, Ltd., who discovered bepotastine. In 2001, Tanabe Seiyaku granted Senju Pharmaceutical Co., Ltd., exclusive worldwide rights, with the exception of certain Asian countries, to develop, manufacture and market bepotastine for ophthalmic use. In 2006, ISTA licensed the exclusive North American rights from Senju to an eye drop formulation of bepotastine for the treatment of allergic conjunctivitis.
ISTA halted...T1, news pending...
UPDATE 1-US FDA staff: No big safety issues with Ista drug
Wed Jun 24, 2009 9:17am EDT
* Drug under review for treating allergy-related eye itch
* Advisory panel meets Friday to evaluate data
WASHINGTON, June 24 (Reuters) - No serious safety problems were reported in studies of Ista Pharmaceuticals Inc's (ISTA.O) proposed eye drops for allergy-related itching, U.S. drug reviewers said in documents released on Wednesday.
In one study that evaluated risks, 25 percent of patients treated with the drug reported a taste-related event such as a bitter taste or aftertaste, said staff in the Food and Drug Administration division that reviews eye drugs.
The analysis from FDA staff was prepared for an advisory panel that meets Friday to consider if adequate safety and effectiveness has been shown for the drug, called Bepreve. (Reporting by Lisa Richwine; Editing by Lisa Von Ahn)
A Look at ISTA's Strong Pipeline
ISTA is a California-based company which has emerged over the past several years to become the fourth largest prescription ophthalmic (visual pathway) firm in the $5 billion U.S. market.
The company currently has three products on the market-
1) Xibrom (twice daily)- for the treatment of inflammation after cataract surgery
2) Istatol- for the treatment of glaucoma
3) Vitrase- which is used as a spreading agent.
Combined these three products accounted for $83 million in revenue in 2008 with $63 million from Xibrom, $15 million from Istatol and $5 million from Vitrase. The company is operating with significant although declining losses as the company has spent approximately $32 million on R&D in each of the past two years. It has been working on several new products in larger potential markets in the ophthalmology space.
The most likely near-term product for the company is Bepreve, which is a treatment for ocular allergies, which has already been approved in the Japanese market (licensed by Senju).
The market in the U.S. for ocular allergies is estimated to be over $600 million per year which could be a major catalyst for this $125 million market capitalization company looking forward. Bepreve has a scheduled PDUFA date in front of the FDA of 9/12/09 although they will first be meeting in front of an advisory committee on 6/26/09. Based on strong clinical results and the existence of the product in Japan without major safety issues the odds of an approval appear to be very high.
Other current products under development by ISTA include a once-daily version of Xibrom and T-Pred, which is a topical anti-inflammatory treatment ($700M market) which are both in Phase III.
The company has two products in the dry eye space ($400M+ market) under review including a lower dosage version of Xibrom and ecabet sodiun. Finally, the company has a nasal allergy product ($2B+ market) also under development.
As with all younger biotechnology and pharmaceutical companies there are significant risks inherent such as with financing (the company has $104 million in debt although half is not due for at least 3 years and the company has $52 million in cash); a history of operating losses (although losses are steadily declining) and regulatory uncertainty with the FDA.
Based on the approval of Bepreve in the fall of 2009 and potential additional approvals for the company in 2010, my models show the company with positive operating income in the late part of 2009 and positive net income in 2010. At a share price of $3.50, (an under $120 million market cap) the risk/reward for the company looks very attractive for speculative investors.
Disclosure: Author is long ISTA
http://seekingalpha.com/article/143645-a-look-at-ista-s-strong-pipeline?source=yahoo
ISTA Pharma (NASDAQ:ISTA): On 6/1/09, ISTA announced the Dermatologic and Ophthalmic Drugs Advisory Committee will review ISTA's New Drug Application (NDA) for Bepreve(TM) (bepotastine ophthalmic solution) on June 26, 2009. On 11/13/08, ISTA announced it had filed its NDA with the FDA for Bepreve as an eye drop treatment for ocular itching associated with allergic conjunctivitis. As bepotastine is a new chemical entity in the U.S., ISTA expected an Advisory Committee would be convened for Bepreve. ISTA continues to expect a standard review of ten months and has been given a PDUFA decision date of 9/12/09 for the FDA to complete its review of the pending NDA.
http://seekingalpha.com/article/143425-fda-calendar-18-hot-summer-trades
10-Jun-09 Sun Trust Rbsn Humphrey Initiated ISTA with a Buy rating
ISTA Pharmaceuticals Announces Positive Results for Phase 2 Study of Low-Dose Bromfenac in Dry Eye Disease
On Monday June 8, 2009, 4:01 pm EDT
IRVINE, Calif., June 8 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA - News), today announced positive results from a proof-of-concept Phase 2 clinical study in subjects with dry eye disease (keratoconjuctivitis sicca) using a new, proprietary, low-dose formulation of bromfenac, the active ingredient in Xibrom® (bromfenac ophthalmic solution) 0.09%. The study achieved statistical significance in the primary endpoint of the objective sign of conjunctival staining (Lissamine Green test) as compared to baseline. The study also achieved statistical significance on the objective sign of corneal staining (Fluorescein test) as compared to baseline. Patients also achieved statistically significant improvements in subjective symptoms measured by the Ocular Surface Disease Index (OSDI) and improvement in patients' most bothersome ocular symptoms.
"The strong clinical results from this proof-of-concept study further support our belief that a modified, low-dose formulation of bromfenac has the potential ability to effectively and conveniently treat signs and symptoms of dry eye disease and provide fast and sustainable relief for patients. Bromfenac's strong safety profile should support long-term treatment, which would be necessitated due to the chronic inflammatory nature of dry eye disease," stated Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA Pharmaceuticals.
"ISTA is strongly committed to focusing on dry eye disease. The results of this study may help identify patients that would be most suitable for a larger, placebo-controlled study. These data come on the heels of our recently announced positive ecabet sodium Phase 2b study results in ISTA's dry eye franchise. We will analyze the data from both programs to determine which product candidate or candidates to move into further advanced studies, which could begin as early as 2010."
ISTA's proof-of-concept, Phase 2 bromfenac study enrolled 38 patients who exhibited signs and symptoms consistent with moderate dry eye disease. All patients received low-dose bromfenac bilaterally twice a day for 42 days. Patient baseline scores were recorded prior to the first treatment with low-dose bromfenac and were compared to baseline at Day 14, Day 42 and Day 52. The study was designed to investigate the effects of low-dose bromfenac compared to baseline on the objective signs of conjunctival staining (Lissamine Green test) and corneal staining (Fluorescein test), as well as subjective symptoms (OSDI and patient's most bothersome ocular symptoms), when administered under normal environmental conditions.
Results of the Lissamine Green test in the Phase 2 study revealed statistical significance for low-dose bromfenac versus the patients' baseline scores starting as early as Day 14 and sustained through Day 52, ten days post treatment. Lissamine Green, a validated staining technique that stains the entire ocular surface, allows analysis of dry eye damage on the conjunctiva to determine the severity of dry eye disease. Adverse events were uncommon, and there were no serious ocular or systemic adverse events.
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http://www.istavision.com/
http://finance.yahoo.com/q/ks?s=ISTA
ISTA Pharmaceuticals, Inc., an ophthalmic pharmaceutical company, discovers, develops, and markets therapies for inflammation, ocular pain, glaucoma, allergy, and dry eye in the United States. The company offers Xibrom for the treatment of inflammation and pain following cataract surgery; Istalol for the treatment of glaucoma; and Vitrase for use as a spreading agent. Its developing products include Bepotastine ophthalmic solution for allergic conjunctivitis; T-Pred, a Phase III clinical trial product candidate for the treatment of steroid-responsive inflammatory ocular conditions; Ecabet Sodium, a Phase IIb clinical trial product, for the treatment of dry eye syndrome; and Bepotastine nasal for the treatment of allergic rhinitis. The company's products developing products also include a steroid product candidate to treat ocular inflammation; iganidipine to enhance ocular nerve blood flow; and a formulation of latanoprost for the treatment of glaucoma. It sells its products primarily to drug wholesalers, retailers, and distributors, including chain drug stores, hospitals, clinics, government agencies, and managed healthcare providers. ISTA Pharmaceuticals was formerly known as Advanced Corneal Systems, Inc. and changed its name to ISTA Pharmaceuticals, Inc. in March 2000. The company was founded in 1992 and is headquartered in Irvine, California.
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