September 23th, 2010 by BiotechInvest
After negative Biodel comments need something positive. I picked ISTA because it’s very simple story with predictable happy end.
ISTA “new” product Bromday (old name XiDay™) contains 0.18% of active agent bromfenac (non- steroidal anti-inflammatory agent). Currently marketed XIBROM™ contains 0.09% of bromfenac. XIBROM ophthalmic solution is indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction. For the treatment of postoperative inflammation in patients who have undergone cataract extraction, one drop of XIBROM ophthalmic solution should be applied to the affected eye(s) two times daily beginning 24 hours after cataract surgery and continuing through the first 2 weeks of the postoperative period. New formulation Bromday is a once-daily version of Xibrom.
In April 01, 2008 ISTA reported topline results of a clinical trial of Xibrom(TM) (bromfenac sodium ophthalmic solution) QD (once-daily) 0.18% formulation, a new formulation of ISTA's ocular, non- steroidal anti-inflammatory agent. The findings demonstrated equivalence between the 0.18% formulation and ISTA's 0.09% formulation of Xibrom given once daily in achieving the primary efficacy endpoint of absence of ocular inflammation 15 days following surgery. The data also showed no statistically significant difference between the two formulations in achieving the secondary efficacy endpoints of elimination of ocular pain and mean reduction of markers of inflammation (inflammatory cells and flare). In addition, the results indicated both formulations of bromfenac produced a low overall incidence of ocular adverse events. In December 2009 ISTA filed a sNDA with the FDA seeking approval of the Bromday formulation for once-daily treatment for the inflammation and pain following cataract surgery. Prescription Drug User Fee Act, or PDUFA, is October 16th, 2010.
Bromday is protected by US patent # US2007/0287749 A1 granted in December 13, 2007.
Actually that’s all story. ISTA expects sales from its Xibrom in the range of $95 million to $105 million, so Bromday sales will be in the same range. There are no any problem with new formulation safety because it actually same formulation with 2 times increased concentration of active component bromfenac.
Probability of FDA approval is close to 100%. So risk is very low and reward is moderate. Last ISTA earning release gave average 20-25% gain, so FDA approval may push ISTA price another 25-30% to $4.5-5 range.
Disclosure: no positions of ISTA, will add this week.
October 17, 2010 by BiotechInvest
"IRVINE, Calif., Oct. 16 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (Nasdaq:ISTA - News), today announced the U.S. Food and Drug Administration (FDA) has approved the Company's supplemental New Drug Application (sNDA) for BROMDAY™ (bromfenac ophthalmic solution) 0.09% as a once-daily prescription eye drop for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction. ISTA expects to launch BROMDAY (formerly referred to as XiDay) prior to the end of 2010."
It seems like that finally FDA gave approval for BROMDAY. But BROMDAY is just same old XIBROM™ that contains 0.09% of bromfenac. Only now patients will use it once-daily.
We know that "the only patent applicable to Xibrom expired in January 2009". So, practically Xibrom can already generic drug.
"But now, after BROMDAY approval "since the BROMDAY approval process required additional clinical investigations beyond those conducted for the original approval of XIBROM™ 0.09%, we are seeking a three-year exclusivity period under the Drug Price Competition and Patent Term Restoration Act, commonly known as the Hatch-Waxman Act."
Well, since ISTA expects sales from its Xibrom franchise will be in the range of $95 million to $105 million sales of BROMDAY should at least the same.
ISTA closed at Friday at $4.48. What growth should we wait in Monday? I will say 15-20% i.e. $5-5.50 will be reasonable. But don't forget about ISTA Pharmaceuticals, Inc. Earnings Conference Call (Q3 2010) scheduled to start Tue, Nov 2, 2010, 4:30 pm Eastern. http://biz.yahoo.com/cc/9/117539.html
Usually ISTA reports very good earning results and it gives another 15-20% pps increasing (unfortunately only for short time). Will ISTA pps grows during these two next weeks? May be...
Recommendations: daily monitor ISTA price, sell it if it go down after approval spike.
October 18th, 2010 by BiotechInvest
Well, ISTA behaves as usually: price decreases after any positive news. If you keep it you lose significant amount of gain. Very predictable. So, next spike should be earning release. Will monitor ISTA and buy it several days before Nov. 2th.
October 22, 2010 by BiotechInvest
A couple words about ISTA future... Don't forget about this:
"ISTA recently announced the Company has initiated its REMURA Phase 3 clinical study program. Two Phase 3 studies to evaluate the efficacy and safety of REMURA are being conducted under a Special Protocol Assessment (SPA) agreed upon with the U.S. Food and Drug Administration (FDA), and two remaining Phase 3 safety studies are the subject of additional SPAs currently under review by the FDA. ISTA anticipates starting the remaining safety studies later this year and reporting results for the first two Phase 3 efficacy and safety studies in the middle of 2011."
REMURA is a bromfenac ophthalmic solution for dry eye. Actually it's already approved by FDA Xibrom (or Bromday now). The starting phase III study is also produce some price spike. SPA is also good news.