surf1944
13 years ago
7:30AM ISTA Pharm reports 'positive', topline results from its Phase 2 clinical trial of BEPOSONE nasal spray for the treatment of symptoms associated with seasonal allergic rhinitis (ISTA) 9.05 : According to the trial findings, BEPOSONE nasal spray showed highly statistically significant improvements compared to placebo in patients' nasal symptoms following exposure to one of the most potent seasonal allergy triggers, Mountain Cedar pollen. These improvements were seen as early as Day 1 of therapy and were sustained through the two-week treatment period. Statistically significant improvement was also seen for BEPOSONE within 15 minutes after dosing in a small subgroup of subjects who frequently evaluated their nasal symptoms for 4 hours after their first nasal spray dose. Further, safety data demonstrated BEPOSONE was well-tolerated as a nasal spray, with an adverse event profile similar to placebo and generally consistent with those observed with bepotastine besilate dosed as a nasal spray in prior clinical trials and with other antihistamine nasal sprays. "Based on these results and the positive Phase 2 results from our single-agent antihistamine nasal spray of bepotastine besilate, BEPOMAX, which were reported last year, we expect to complete some additional Phase 2 studies ahead of our Phase 3 pivotal program covering both products, slated to begin in 2013. BEPOSONE and BEPOMAX represent exciting potential expansions of our prescription allergy product line, currently focused on BEPREVE (bepotastine besilate ophthalmic solution) 1.5% for the treatment of ocular itching associated with allergic conjunctivitis."
mlkrborn
13 years ago
Offer rejected; PPS up!
ISTA Pharm Board of Directors confirms rejection of unsolicited, non-binding proposal from Valeant (VRX) (ISTA) 6.83 +2.86 : Co confirmed today that it had received a letter on November 23, 2011 from Valeant Pharmaceuticals International (VRX) outlining an unsolicited, non-binding proposal to acquire all of the outstanding shares of ISTA for $6.50 per share in cash, subject to due diligence. ISTA also confirmed receipt of a letter from Valeant dated December 16, 2011 reaffirming its non-binding proposal. After careful deliberation, with the assistance of its financial and legal advisors, ISTA's Board of Directors had previously determined on December 13, 2011 that the non-binding proposal was grossly inadequate and not in the best interests of ISTA shareholders.
Kenswift
13 years ago
This is what all that insider buying as about.
Valeant Makes Public Its Interest In Buying ISTA Pharmaceuticals
Valeant Pharmaceuticals International Inc. (VRX) is proposing to acquire Irvine, Calif.-based ISTA Pharmaceuticals Inc. (ISTA), a pharmaceutical company with eye-care and allergy drugs, for $6.50 a share in cash.
Valeant said its proposed offer is worth about $327 million including net debt, and represents a premium of about 67% over ISTA's closing price Thursday of $3.89.
The Mississauga, Ont. drug company said ISTA rebuffed its initial overtures, made in early October, prompting Valeant to make a formal written proposal to ISTA's management on Nov. 23. It later reaffirmed the proposal, but said ISTA rejected it on Dec. 14. That led Valeant to publicly unveil its proposal Friday.
The offer will only remain in effect until Jan. 31, Valeant said.
It's been a busy last few months for Valeant in terms of acquisitions. It's buying Australia's iNova Pharmaceuticals and recently completed the purchase of Calgary's Afexa Life Sciences Inc. Both were friendly deals.
-By Carolyn King, Dow Jones Newswires; 416-306-2100; carolyn.m.king@dowjones.com
mlkrborn
14 years ago
ISTA Pharmaceuticals Reports Second Quarter 2011 Financial Results
Date : 07/28/2011 @ 4:05PM
Source : MarketWire
Stock : ISTA Pharmceuticals (ISTA)
Quote : 4.945 -2.255 (-31.32%) @ 1:50PM
ISTA Pharmaceuticals Reports Second Quarter 2011 Financial Results
Ista Pharmaceuticals, Inc. (MM) (NASDAQ:ISTA)
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ISTA Pharmaceuticals, Inc. (NASDAQ: ISTA), today reported financial results and progress on key milestones for the quarter ended June 30, 2011.
Second Quarter 2011 Highlights
* Second quarter 2011 net revenues were $37.1 million, an increase of 6% over the second quarter of 2010.
* Revenues for ISTA's ophthalmic solution for ocular itching associated with allergic conjunctivitis, BEPREVE® (bepotastine besilate ophthalmic solution) 1.5%, almost doubled over the prior-year quarter, growing from $6.2 million to $12.2 million.
* In April 2011, ISTA announced positive, top-line results from its Phase 2 study of bepotastine besilate nasal spray for allergic rhinitis.
* Under generally accepted accounting principles in the United States (GAAP), net income for the second quarter ended June 30, 2011, was $12.8 million, or $0.25 per share, based on 50.2 million fully diluted shares, impacted primarily by a non-cash warrant valuation gain of $19.0 million resulting from a decrease in the Company's stock price in the quarter. On an adjusted cash basis, ISTA had a net loss of $4.2 million, or loss of $0.11 per share, based on 38.4 million shares outstanding.
"As a company, we consistently record 40% of our net revenues in the first half of the year and 60% in the second half. Our first half net revenues of $73.9 million clearly put us on track to achieve our 2011 annual revenue guidance of $175 million to $190 million," stated Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA Pharmaceuticals. "In the second quarter, as a result of a concentrated sales and marketing campaign during a rather severe spring allergy season, product revenues for BEPREVE, our prescription eye drops for ocular itching associated with allergic conjunctivitis, were up 97% over the prior-year quarter. We have established a solid second position behind the market leader with a product that brings fast, long-lasting relief to ocular allergy sufferers.
"Prior to the allergy season, we successfully converted more than 80% of the bromfenac franchise from twice-daily XIBROMโข to once-daily BROMDAYโข for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extractions. We discontinued XIBROM shipments in late February and refocused our selling efforts on BEPREVE. Midway into the second quarter, a generic competitor to twice-daily XIBROM was approved. While the sales force was dedicated to BEPREVE, our channel and managed care teams were working to strengthen our bromfenac franchise position within the ophthalmic non-steroidal anti-inflammatory drug (NSAID) market. Year-to-date June 2011, as compared to 2010, total prescriptions for ISTA's bromfenac franchise (BROMDAY and XIBROM) increased 6.5% and on a weekly basis, BROMDAY continues to capture share. While revenues for our bromfenac franchise were down in the second quarter over the prior-year quarter, now that the spring allergy season is over, our sales force is fully dedicated to building share with the only once-daily NSAID on the market. Overall, our commercial business has been highly effective this year and with recent managed care contract wins for both BEPREVE and BROMDAY, we have confidence that we can gain share in both the allergic conjunctivitis and NSAID markets in the second half."
Dr. Anido continued, "In terms of progress on our new product pipeline, in April, we announced positive, top-line results from our Phase 2 study of bepotastine besilate nasal spray for allergic rhinitis. We're in discussions with the U.S. Food and Drug Administration (FDA) on the clinical study designs for a bepotastine besilate/steroid combination nasal spray and plan to initiate a Phase 2 trial either during the Mountain Cedar Pollen season later this year or during spring allergy season early next year. Our recently initiated Phase 3 studies for low-concentration BROMDAY are now fully enrolled. We plan to announce results from the low-concentration BROMDAY studies in fourth quarter of this year and launch the product in late 2012 or early 2013.
"In a separate press release today, we reported the preliminary results for the first of two Phase 3 efficacy and short-term safety trials for REMURAโข for dry eye (WEST study), which showed that while REMURA was highly effective in treating a sign and symptom of dry eye versus baseline, it was not statistically significantly better than placebo, a common outcome in dry eye clinical studies. REMURA achieved statistical significance against placebo in the sign of conjunctival staining in a key female patient sub-population with moderate dry eye disease. Armed with this data, we expect to amend the statistical plan to appropriately focus the EAST study. In the fourth quarter of this year, we expect to report the Phase 3 results from the REMURA EAST study, which now is fully enrolled but the database has not been locked. The EAST data will be combined with the results of the WEST study, and the full dataset will determine the next steps for this program."
Financial Results
Net revenues for the second quarter ended June 30, 2011, were $37.1 million, or an increase of 6% over the same period in 2010. Net revenue growth was driven primarily by strong demand for BEPREVE, for ocular itching associated with allergic conjunctivitis, and ISTALOL®, a beta-blocking agent for the treatment of glaucoma.
mlkrborn
14 years ago
ISTA $5.00
July 29, 2011, 10:22 a.m. EDT
Ista plunges 28% on study failure, downgrades
By Val Brickates Kennedy
BOSTON (MarketWatch) -- Shares of Ista Pharmaceuticals /quotes/zigman/89471/quotes/nls/ista ISTA -31.39% plunged 28% to $5.16 early Friday, the day after it released a disappointing quarterly-earnings report and poor preliminary results from a Phase III study for its ophthalmology drug Remura. As a result, Stifel Nicolaus on Friday lowered its rating of the stock to hold. RBC Capital, meanwhile, maintained its outperform rating, but lowered its price target to $12 from $15.
surf1944
14 years ago
ISTA Pharmaceuticals Announces Conference Call and Webcast of Second Quarter 2011 Financial Results
Press Release Source: ISTA Pharmaceuticals On Friday July 15, 2011, 7:30 am EDT
IRVINE, CA--(Marketwire - 07/15/11) - ISTA Pharmaceuticals, Inc. (NASDAQ:ISTA - News) today announced it will release second quarter 2011 financial results after the market closes on July 28, 2011. In conjunction, the Company will host a conference call at 4:30 p.m. Eastern Time to review the Company's commercial operations and provide pipeline updates.
Date: Thursday, July 28, 2011
Time: 4:30 p.m. Eastern Time
Conference call access:
Internet: www.istavision.com
Domestic dial-in: 866.804.6922
International dial-in: 857.350.1668
Passcode: 73568588
To access the 24-hour audio replay, U.S. and Canadian participants may dial 888.286.8010; international participants may dial 617.801.6888. The access code for the replay is 37743515. This conference call also will be webcast live and archived on ISTA's website until September 4, 2011.
surf1944
14 years ago
ISTA Pharmaceuticals Announces Company's Addition to Russell 3000 and NASDAQ Biotechnology Indexes
Press Release Source: ISTA Pharmaceuticals On Thursday June 16, 2011, 7:30 am EDT
IRVINE, CA--(Marketwire - 06/16/11) - ISTA Pharmaceuticals, Inc. (NASDAQ:ISTA - News) has received notification it will join the Russell 3000® Index when Russell Investments reconstitutes its family of U.S. indexes on June 25, 2011.
The Russell Indexes capture the 4,000 largest U.S. stocks as of the end of May, ranking them by total market capitalization to create the Russell 3000® Index and the Russell Microcap® Index. Russell indexes are reconstituted annually and are widely used by investment managers and institutional investors for index funds and as benchmarks for both passive and active investment strategies.
Membership in the Russell 3000, which remains in place for one year, means automatic inclusion in the large-cap Russell 1000® Index or small-cap Russell 2000® Index, as well as the appropriate growth and value style indexes. The Russell 3000 also serves as the U.S. component to the Russell Global Index. Russell determines membership for its equity indexes primarily by objective, market capitalization rankings and style attributes.
In addition, ISTA announced the Company was added to the NASDAQ Biotechnology Index in late May.
surf1944
15 years ago
ISTA Pharmaceuticals Announces Conference Call and Webcast of First Quarter 2010 Financial Results
Press Release Source: ISTA Pharmaceuticals, Inc. On Friday April 16, 2010, 8:00 am EDT
IRVINE, Calif., April 16 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (Nasdaq:ISTA - News), today announced it will release first quarter 2010 financial results before market open on April 30, 2010. In conjunction, the Company will host a conference call at 10:00 a.m. Eastern Time to discuss these results and provide a pipeline update.
Date: Friday, April 30, 2010
Time: 10:00 a.m. Eastern Time
Conference call access:
Internet: www.istavision.com
Domestic dial-in: 800-591-6944
International dial-in: 617-614-4910
Passcode: 68237813
To access the 24-hour audio replay, U.S. and Canadian participants may dial 888-286-8010; international participants may dial 617-801-6888. The access code for the replay is 91982881. This conference call also will be webcast live and archived on ISTA's website until May 30, 2010.
surf1944
15 years ago
ISTA says FDA to review eye drug by Oct. 16
ISTA Pharmaceuticals says FDA to review once-daily eye inflammation treatment by Oct. 16
On Monday March 8, 2010, 5:54 pm EST
IRVINE, Calif. (AP) -- ISTA Pharmaceuticals Inc. said Monday the Food and Drug Administration will make a regulatory decision on the once-daily eye inflammation treatment XiDay by Oct. 16.
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.
XiDay, like Xibrom, is aimed at treating eye inflammation following cataract surgery.
ISTA said the FDA is still considering the company's request for a shorter, six-month, priority review.
ISTA reported Xibrom net sales of $81.1 million for the year ended December 31, 2009.
Shares of ISTA rose 6 cents to $3.89 in after-hours trading after rising 10 cents, or 2.7 percent, to close at $3.83 during the regular trading session.
surf1944
15 years ago
ISTA Pharmaceuticals Announces 2010 Financial Guidance
ISTA Expects 2010 Net Revenue of $147 to $165 Million
Company Anticipates 2010 Operating Income of $8 to $10 Million
Press Release Source: ISTA Pharmaceuticals, Inc. On Tuesday February 9, 2010, 9:00 am
IRVINE, Calif., Feb. 9 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA) today announced financial guidance for the full year 2010. The Company expects net revenue will be approximately $147 to $165 million. In addition, ISTA's management anticipates reporting its first profitable year in 2010, with earnings per share for the full year expected to be at least $0.02, excluding any mark-to-market adjustments relating to warrants.
"2010 will mark ISTA's transition from a young development company to a financially independent commercial organization," stated Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA Pharmaceuticals. "By offering products with differentiated value propositions for both the physician and the patient and building a strong and motivated commercial team, we will have achieved this milestone five years after launching our first product, Istalol, which was closely followed by the launch of our flagship product, Xibrom. As we look to 2010 and beyond, Bepreve, Xibrom, XiDay, bepotastine nasal spray, and bromfenac for dry eye stand out as our long-term growth drivers, and we are excited about ISTA's future."
2010 Financial Outlook in Detail
We expect our net revenue for 2010 will be approximately $147 to $165 million. We continue to assume there will not be a generic competitor to Xibrom in 2010. We expect sales from our Xibrom franchise (including XiDay, assuming U.S. Food and Drug Administration (FDA) approval) to be in the range of $95 to $105 million and anticipate sales from Bepreve will be at least $20 million. As in previous years, our net sales are seasonal, with first quarter net sales typically being the lowest of the year and less than the prior quarter.
We expect our gross margin in 2010 will be in the range of 74% to 76%.
We expect R&D expenses to be approximately 18% to 22% of net revenue, depending upon the progress of our clinical programs. In 2010, we will focus our development activities on our bromfenac formulation as a treatment for dry eye disease and our nasal bepotastine formulation for nasal allergies. During 2010, we anticipate initiating our full-scale Phase 3 clinical program in dry eye disease, as well as the long-term safety study required by the FDA in advance of a New Drug Application (NDA) filing. To maximize our bepotastine franchise, we will complete our formulation work for bepotastine nasal and anticipate initiating the clinical program with this product as a treatment for nasal allergies in 2010.
We expect SG&A expenses for 2010 to be approximately 48% to 52% of net revenue.
We expect our operating income for 2010 will be $8 to $10 million.
We expect our net income for 2010 will be at least $1 million, or earnings per share of $0.02, excluding any mark-to-market adjustments relating to warrants. Once we are profitable, we expect our fully diluted common shares, including our outstanding shares of common stock, warrants and stock options on a treasury stock basis, will be approximately 49 million shares.
We expect our business to generate $6 to $10 million in cash in 2010.
As previously announced on February 1, 2010, the Company will issue full financial results for 2009 after market close on February 23, 2010. In conjunction, ISTA will host a conference call to discuss the 2009 results, as well as review the 2010 guidance and the Company's product development pipeline. Information for the call and webcast are available at www.istavision.com.
Xibrom (bromfenac ophthalmic solution)® 0.09%, Istalol® (timolol maleate ophthalmic solution) 0.5%, Bepreveโข (bepotastine besilate ophthalmic solution) 1.5%, and XiDayโข (bromfenac ophthalmic solution) are trademarks of ISTA Pharmaceuticals.
Full prescribing information for Bepreveโข is available on ISTA Pharmaceuticals' website at http://www.istavision.com/pdf/Bepreve_insert.pdf
Full prescribing information for Xibromโข is available on ISTA Pharmaceuticals' website at www.istavision.com/pdf/XibromPI_XIB553.pdf
Full prescribing information for Istalol® is available on ISTA Pharmaceuticals' website at www.istavision.com/pdf/Istalol_Full_PI-ISL274.pdf
surf1944
15 years ago
ISTA Pharmaceuticals Submits Supplemental New Drug Application to the FDA for Once-Daily XiDay(TM)
Press Release Source: ISTA Pharmaceuticals, Inc. On Thursday December 17, 2009, 4:01 pm
IRVINE, Calif., Dec. 17 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), today announced the Company submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for bromfenac ophthalmic solution dosed once-daily as a treatment for ocular inflammation and pain following cataract surgery. ISTA currently markets Xibromโข (bromfenac ophthalmic solution) 0.09%, which is an eye drop labeled for use twice-daily, beginning 24 hours after cataract surgery. If approved, ISTA plans to market the once-daily product under the brand name XiDayโข.
ISTA filed the XiDay sNDA electronically in eCTD format. Pending FDA validation of the electronic file in the coming days and timely acceptance of the filing by the FDA, ISTA expects a standard review of six months from date of receipt.
Xibromโข (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. Xibrom is the 2009 year-to-date dollar market share leader in the U.S. ophthalmic non-steroidal anti-inflammatory market. ISTA reported Xibrom net sales of $55.1 million for the nine-month period ended September 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 requests the Agency approve a change to bromfenac ophthalmic solution's label to reflect its efficacy as a once-daily treatment in this patient population.
surf1944
15 years ago
7:31AM ISTA Pharm highlights Bepreve clinical data at the 2009 annual meeting of the American College of Allergy, Asthma & Immunology (ISTA) 4.56 : Co announces additional results from their Bepreve 1.5% Phase 3 clinical studies. These results were presented in poster sessions at the 2009 Annual Meeting of the American College of Allergy, Asthma & Immunology in Miami Beach, FL. In a poster presentation titled, "Treatment of Ocular Itching with Bepotastine Besilate Ophthalmic Solution 1.5% for Subjects with More Severe Itching Response in a Conjunctival Allergen Challenge Clinical Model of Allergic Conjunctivitis," integrated results from two Phase 3 studies demonstrated Bepreve 1.5% was as effective in suppressing ocular itching in patients with more severe itching as in patients with all grades of ocular itching. A total of 157 patients were enrolled in two 7-week, masked, randomized, placebo-controlled CAC clinical studies. 113 patients exhibited bilateral ocular itching grades greater than or equal to 3 at screening during study visit 2. Individuals were assessed at 15 minutes, 8 hours, or 16 hours following instillation at study visits spaced 2 weeks apart during the enrollment period. The difference in mean itching grades for the more severely affected subjects was within plus or minus 0.1 unit of the differences for the entire intent-to-treat population