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From: John McCarthy2/6/2011 9:03:13 PM
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Alimera Clears Some of the Muddle on Eye Implant Data but Nervousness Still Warranted

Keenly awaited 36-month data for Iluvien achieved exactly what Alimera (ALIM) had hoped. In an analysis taking in two separate trials, the drug-eluting eye implant was significantly better than the standard of care in treating diabetic macular oedema.

However, this does not mean there is nothing to worry about:

the two phase III trials individually failed to show statistical significance at 36 months, with the effect fading after 33 months because of clinical improvements in the control arm of both trials.

Given that the FDA’s first-round rejection of the therapy came because of doubts about the validity of 24-month data, this is bound to raise some concern (Alimera gets unwelcome Christmas message from FDA, December 24, 2010).

What, me worry?

Still, investors do not seem overly perturbed by the news. Shares in Alimera were down 4% to $9.78 in early trading Friday morning, 10% off their April 2010 initial public offering price, while shares in Australian partner pSivida, which makes the implantable device, were down 6% to $4.55.

Given that the implant, which secretes the corticosteroid fluocinolone acetonide, is Alimera’s only clinical-stage candidate, some nervousness is warranted.

The complete response letter inflicted more damage - Alimera lost 9% and pSivida 18% on December 27, the first trading day following the complete response letter.

If there are concerns in Alimera’s offices, its executives are not letting on. In a call with investors, chief executive Daniel Myers said the company is planning on submitting its response to the FDA’s complete response letter by the end of this quarter.

He added that the executive team met recently with FDA staff and were told that regulators were looking only for the 24 month efficacy data.


Lead product

The lead product for both Alimera and pSividia, Iluvien is forecast to sell $409m in 2016, with pSividia forecast to collect $45m in royalties and Alimera $40m from sales outside the US.

These forecasts give the implant a net present value of $980m for Alimera and $217m for pSivida, many times both companies’ market capitalisations.

In rejecting the therapy in December, the agency raised concerns over the data on Iluvien's efficacy in patients who had not undergone cataract surgery before entering the trial.

Note:
This is what Ken is pointing to (I think)

As a group, these patients showed declining effectiveness between months 6 and 18, and development of cataracts was believed to be a cause – some 80% of that patient group underwent surgery before the end of 36 months.

As the implant’s effectiveness for that group had resumed by month 24, the FDA wanted to see if the efficacy could be sustained through 36 months, which it was.

In the pooled analysis at 36 months, 28.7% of Iluvien patients improved their best corrected visual acuity (BCVA) by 15 or more letters from baseline on the early treatment diabetic retinopathy study, compared with 18.9% in the control group, which underwent a sham procedure.

In Trial A, the numbers were 28.4% vs 18.9% and in Trial B they were 29% vs 18.9%.

It is an open question whether the FDA now wants to spend time focusing on the separate data from trials A and B, each of which individually missed statistical significance at the 36 month mark.

Certainly the pooled data set of 561 patients has greater power to find statistical significance, a point the company will choose to focus on.

Improving care

Given that it was the clinical improvements in the patients in the control arm in the final six months that resulted in the lack of statistical significance in the individual trials, the regulator could take the position that over time the standard of care is just as effective.

However, the company also is able to show that the Iluvien patients underwent significantly fewer on-protocol procedures - laser photocoagulation therapy – and off-protocol procedures – Lucentis, Avastin, vitrectomy or intravitreal triamcinolone acetonide – than did the control patients. Thus, the company can demonstrate a benefit in fewer interventions and thus fewer clinical risks.

Predicting the FDA's view on any trial data is difficult at best. While Alimera did a little to clear the doubts about Iluvien, it is clear there remains some worry.

Trial ID NCT00344968

seekingalpha.com

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From: John McCarthy2/16/2011 9:58:35 PM
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pSivida Corp (PSDV) Downgraded by Zacks Investment Research to “Underperform”

Equities research analysts at Zacks Investment Research downgraded shares of pSivida Corp (NASDAQ: PSDV) from a “neutral” rating to an “underperform” rating in a research note to investors on Friday.

pSivida Corp. develops drug delivery products that are administered by implantation, injection or insertion. Once administered, a drug is released on a controlled and level basis for months or years. The Company has two core technology systems, Durasert and BioSilicon. pSivida Corp. has one product candidate for chronic eye disease that has been given Priority Review by the United States Food and Drug Administration (FDA). It has a collaboration with Pfizer, Inc. (Pfizer) to develop additional ophthalmic products. Iluvien, the product candidiate with Priority Review, is designed to provide sustained release treatment for Diabetic Macula Edema (DME). Iluvien is licensed to Alimera Sciences, Inc (Alimera), which is completing fully-recruited Phase III clinical trials.

Shares of pSivida Corp (NASDAQ: PSDV) traded down 5.64% during mid-day trading on Wednesday, hitting $3.85. pSivida Corp has a 52 week low of $3.08 and a 52 week high of $7.22. The stock’s 50-day moving average is $4.74 and its 200-day moving average is $4.71. On average, analysts predict that pSivida Corp will post $-0.16 EPS next quarter. The company has a market cap of $71.3 million and a price-to-earnings ratio of 10.77.

For more information about Zacks Investment Research‘s equity research offerings, visit Zacks.com.

Stay on top of analysts' coverage with American Banking & Market News' daily email newsletter that provides a concise list of analysts’ upgrades, analysts’ downgrades and analysts’ price target changes for each day. Click Here to register.

americanbankingnews.com

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From: John McCarthy5/5/2011 4:37:26 PM
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Company Expects to Submit New Data by May 13, 2011 Addressing All Aspects of the FDA's Complete Response Letter

finance.yahoo.com

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From: John McCarthy5/20/2011 5:36:08 AM
   of 404
 
Slide Show - 2011

phx.corporate-ir.net

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From: John McCarthy6/1/2011 11:26:33 PM
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Alimera Sciences Confirms ILUVIEN NDA Resubmission Has Been Accepted by the FDA

By Louis Bedigian
Benzinga Staff Writer

June 01, 2011 11:41 AMSymbols: PSDV, ALIM

Tags: alimera sciences, ILUVIEN, Alimera, pSivida

Less than one hour before the close yesterday, Benzinga heard positive rumors that the NDA for ILUVIEN, which was resubmitted roughly two weeks ago, had been accepted by the Food and Drug Administration.

The drug, which is a joint venture between pSivida (NASDAQ: PSDV) and Alimera Sciences (NASDAQ: ALIM), was originally rejected by the FDA in January.

This morning, a spokeswoman for Alimera confirmed to Benzinga that the NDA resubmission for ILUVIEN has been accepted by the FDA. The spokeswoman said that Alimera submitted a revised NDA with new data, and that the FDA has until November 12 to examine the revised application.

benzinga.com

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From: John McCarthy6/14/2011 9:42:54 AM
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PSDV and Pfizer start P1 glaucoma trials ...

+++++++++++++++++++++++++++++++++

At that point, Pfizer has an option to take an exclusive, world-wide license to develop and commercialize the product candidate in return for a

$20 million option exercise payment,

double-digit royalty payments on sales of the product and additional development, regulatory

and any sales performance milestone payments of up to $146.5 million.

+++++++++++++++++++++++++++++++++

pSivida Announces Phase I/II Clinical Study Evaluating Bioerodible, Sustained Release Latanoprost Device in Ocular Hypertension and Glaucoma

WATERTOWN, Mass.--(BUSINESS WIRE)-- Drug delivery company pSivida Corp. (NASDAQ:PSDV - News) (ASX:PVA.ax - News) today announced the commencement of a Phase I/II clinical trial studying a new bioerodible drug delivery implant for the treatment of glaucoma and ocular hypertension. The implant is designed to provide long-term, sustained release of latanoprost, the most commonly prescribed agent for reduction of intraocular pressure in patients with ocular hypertension and glaucoma worldwide.

The product candidate is a new, compact drug-delivery implant based on the Company’s DurasertTM technology system. The implant is designed to be administered by an eye care professional in a minimally invasive, outpatient procedure; it is also designed to be injected into the subconjunctival space of the eye and to be bioerodible.

The new study is a dose-escalating study designed to assess the safety and efficacy of the implant in patients with elevated intraocular pressure. If successful, pSivida plans to advance the product into a multi-center Phase II trial.

Dr Paul Ashton, President and CEO of pSivida Corp., said, “We are extremely pleased that this first application of our new bioerodible drug-delivery technology has entered clinical trials. We look forward to advancing this new delivery system both in glaucoma and potentially in other applications as well.”

The insert is being developed under the recently amended Research and Collaboration Agreement with Pfizer Inc. Under the revised agreement, Pfizer will make an initial payment of $2.3 million. pSivida will, with technical assistance from Pfizer, have the right to develop this candidate for the reduction of intraocular pressure in patients with ocular hypertension or glaucoma through Phase II clinical trials.

At that point, Pfizer has an option to take an exclusive, world-wide license to develop and commercialize the product candidate in return for a $20 million option exercise payment, double-digit royalty payments on sales of the product and additional development, regulatory and any sales performance milestone payments of up to $146.5 million.

If Pfizer does not exercise its option, pSivida will retain the right to develop and commercialize the glaucoma product on its own or with a partner. As part of the amended agreement, pSivida regains all rights to its intellectual property in ophthalmic applications previously included in the original Research and Collaboration Agreement, other than those related to the latanoprost product.

finance.yahoo.com

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From: John McCarthy6/14/2011 7:01:41 PM
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Latanoprost = $1.6 billion sales
.
Latanoprost (pronounced la-TA-noe-prost) ophthalmic solution is a topical medication used for controlling the progression of glaucoma or ocular hypertension by reducing intraocular pressure.
.
It is a prostaglandin analogue (more specifically an analogue of Prostaglandin F2a[1]) that works by increasing the outflow of aqueous fluid from the eyes (through the uvealsclearal tract).[2]
.
It is also known by the brand name of Xalatan manufactured by Pfizer. Annual sales are approximately $1.6 billion.
.
The patent for latanoprost expired in March 2011, and at least one generic version (manufactured by Mylan Inc.) is now widely available in the U.S.

Latanoprost was developed by Dr. Carl B. Camras and his research adviser Dr. László Z. Bitó at Columbia University in 1996.[3]
.
en.wikipedia.org

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From: John McCarthy7/5/2011 10:14:54 AM
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Upcoming PDUFA Dates for Sub-$5 Stocks by: Alex Shadunsky July 5, 2011 | about: AIS, ANX, BPAX, CBRX, CORT, PSDV

There are six PDUFA dates on the calendar between now and early next year for sub-$5 stocks trading on one of the three main exchanges. The reason for the focus on sub-$5 stocks is because their prices seem to exhibit the most gains into their respective PDUFA dates, thereby giving the opportunity to buy the stock some months ahead of the PDUFA date, take part in the run-up, and sell shortly before the PDUFA date.

Adventrx (ANX) has a PDUFA date on Sept. 1 for Exelbine (ANX-530) for non-small-cell lung cancer. ANX-530 is the company’s proprietary emulsion formulation of vinorelbine, which is a vesicant and venous irritant; these adverse effects can limit its tolerability. ANX-530 was designed to be bioequivalent to the reference drug while reducing the incidence and severity of vein irritation associated with intravenous delivery of the drug. In a clinical bioequivalence study, ANX 530 and the reference drug were determined to be bioequivalent. The stock was last trading at $3.00.

pSivida (PSDV) has a PDUFA date on Nov. 12 for Iluvien for the treatment of diabetic macular edema (DME), the primary cause of vision loss associated with diabetic retinopathy, a disease affecting the macula (the part of the retina responsible for central vision). Iluvien is an investigational, extended release intravitreal insert for the treatment of DME. Each Iluvien insert is designed to provide a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels of FAc. Iluvien is inserted in the back of the patient's eye to a position that takes advantage of the eye's natural fluid dynamics. The insertion device employs a 25-gauge needle, which allows for a self-sealing wound. The stock was last trading at $4.30.

BioSante Pharmaceuticals (BPAX) has a PDUFA date on Nov. 14 for the Bio-T-Gel NDA. Bio-T-Gel is a testosterone gel for the treatment of male hypogonadism or low testosterone levels. Bio-T-Gel was developed initially by BioSante, and then it was licensed to Teva (TEVA) for late-stage clinical development. Teva is responsible for all Bio-T-Gel's regulatory and marketing activities. BioSante will receive certain milestone payments and royalties upon commercialization. The current U.S. market for male testosterone products is over $1.2 billion. The stock was last trading at $2.91.

Antares Pharma (AIS) has a PDUFA date on Dec. 8 for Anturol Gel in patients with overactive bladder (OAB). Anturol is an oxybutynin gel based on the ATD Gel technology platform, which is a clear, odorless hydroalcoholic gel that provides for delivery of oxybutynin in a non-patch transdermal form. The ATD technology is also used in Elestrin, an FDA-approved product for hormone replacement therapy in postmenopausal women. It has been well recognized that transdermal delivery of drugs including oxybutynin is a safe and effective way of delivering certain drugs that undergo first pass metabolism. By delivering oxybutynin transdermally, first-pass gastric and hepatic metabolism is avoided, which is believed to result in lower anticholinergic side effects such as dry mouth and constipation compared to orally administered treatments. These side effects are believed to account for a significant level of patient non-compliance among existing oral OAB treatments. The stock was last trading at $2.32.

Corcept Therapeutics (CORT) has a PDUFA date on Feb. 17, 2012 for Corlux for Cushing's Syndrome. Corcept's first-generation compound, Corlux, also known as mifepristone, directly blocks the cortisol (GR-II) receptor and the progesterone receptor. Intellectual property protection is in place to protect important methods of use for Corlux. Corcept retains worldwide rights to its intellectual property related to Corlux. The stock was last trading at $3.91.

Columbia Laboratories (CBRX) has a PDUFA date on Feb. 26, 2012 for Prochieve (progesterone gel) for the reduction of risk of preterm birth in women with short uterine cervical length in the mid-trimester of pregnancy. Crinone (progesterone gel) was approved by the FDA in May 1997 for progesterone supplementation or replacement as part of an Assisted Reproductive Technology treatment for infertile women with a progesterone deficiency. Patient preference for Crinone over competing products has been demonstrated in five clinical trials. The product is also available under the trade name Prochieve and available in both 4% and 8% concentrations. Crinone/Prochieve 4% is indicated for the treatment of secondary amenorrhea. The stock was last trading at $3.14.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

seekingalpha.com

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From: John McCarthy7/5/2011 3:02:49 PM
   of 404
 
pSivida on the Cusp of Big Breakthrough

CHARTS
seekingalpha.com


After developing several miniaturized, injectable drug delivery systems for the treatment of niche ocular diseases, pSivida (PSDV) is now at the precipice of several blockbuster indications, including diabetic macular edema (DME), age-related macular degeneration (AMD) and glaucoma, with its next-generation Durasert device.

And in early development is a new generation Tethadur platform that relies on nano-structuring, with the potential for long-term delivery of proteins and antibodies using a highly porous, bio-erodible material to accommodate different molecule sizes to treat multiple diseases.

“We are already a good way along to becoming the world’s leading provider of miniaturized drug delivery systems,” CEO Paul Ashton says in an exclusive interview with BioTuesdays.com. “If we can make something small enough to be injected into the eye, it should be able to be injected into the joint for osteoarthritis, or into the brain, or subcutaneously under the skin.”

There are currently three FDA-approved delivery systems to treat diseases at the back of the eye, and pSivida has developed two of them.

In 1996, marketing partner Chiron (CHIR) launched pSivida’s Vitrasert implant for the treatment of AIDS-related cytomegalovirus retinitis, providing sustained released for six to nine months. In 2005, Bausch & Lomb (BOL) launched pSivida’s Retisert implant for the treatment of posterior uveitis, providing sustained release for two and a half years.

“The big opportunity is not in these niche indications,” Dr. Ashton contends. “In the eye space, the big opportunity is in diseases like DME, AMD and glaucoma.”

Back-of-the-eye diseases affect more than 10 million Americans, of whom 4.4 million have diabetic retinopathy, two million have AMD, and 2.3 million have glaucoma, with an estimated two million more who remain undiagnosed. “So back-of-the-eye diseases represent big commercial opportunities,” he adds.

[Click all to enlarge]


pSivida’s lead development product is Iluvien, an injectable, non-erodible, intravitreal implant to treat patients with DME. It is designed to provide sustained release of fluocinolone acetonide directly into the back of the eye for up to three years after a single injection. Three-year safety and efficacy results from two Phase 3 clinical trials were submitted as part of a new drug application in May 2011, and a decision from the FDA is expected in the fourth quarter of this year.

Iluvien utilizes the company’s third generation Medidur technology. The implant is so small that it can fit down the inside of a needle, Dr. Ashton says, adding that it is injected into the back of the eye with a 25-gauge needle, creating a self-sealing hole. The treatment is similar to intravitreal injections commonly given by retinal specialists.

DME affects almost one million people in the U.S. and is the leading cause of vision loss in people under the age of 65. There are no FDA-approved drug treatments for DME, and laser therapy, involving burning holes in the retina, has limited efficacy, benefitting about 30% of patients. Estimates of the market potential of Iluvien are somewhere between $1.5 billion and $4 billion, Dr. Ashton suggests.

pSivida has licensed Iluvien to Alimera Sciences (ALIM), a company started by the management team of Novartis Ciba Vision, which earlier had launched QLT’s Visudyne drug for the wet form of AMD. Under the accord, pSivida has received $30 million from Alimera since 2008 and Alimera has also covered all R&D costs of Iluvien. On FDA approval, pSivida would receive a further $25 million milestone from Alimera and 20% of the profits on sales of Iluvien.


In the 956-patient Phase 3 studies, nearly 30% of patients experienced vision improvement after 24 months as measured by being able to see an additional three lines on an eye chart, which is the FDA’s gold standard. A three-line improvement in vision corresponds to an almost legally blind patient with 20/100 vision, improving to 20/50, which would render him or her almost legally able to drive a car. “That’s a big improvement in vision,” Dr. Ashton says.

To meet a request from the FDA, pSivida showed that vision improvement also was stable after 36 months. The data were statistically significant through the 33rd month, but statistical significance was lost at 36 months.

pSivida also found that there was a greater improvement in vision in a subgroup of people with chronic DME. These patients, who have had the disease for more than three years, typically have the worst vision. Yet they did significantly better in clinical testing, with 36.4% of patients gaining three or more lines of vision after 30 months, and 34% after 36 months, compared with the laser standard of care group, which improved by 13.2%.

“This was very striking,” Dr. Ashton points out. “And we had strong statistical significance at almost every time point in this subgroup.”

Alimera also is sponsoring Phase 2 clinical trials with Iluvien in patients with wet and dry AMD and retinal vein occlusion.

Earlier this month, pSivida and Pfizer (PFE) amended a 2007 research agreement to focus solely on the development of a long-term, sustained-release implant to deliver Pfizer’s lotanaprost for patients with ocular hypertension and glaucoma, using the Durasert technology which is the basis of Iluvien. The bio-erodible implant is designed to be injected into the white of the eye just below the lower eyelid in a non-invasive, out-patient procedure.

“We’re still in dose escalation Phase 1-2 trials, so when we know the dose, we’ll know how long it can last,” Dr. Ashton says. “But a six-month release device is the target here.”

Annual sales of Pfizer’s Xalatan eye drops, which contain the active ingredient lotanaprost, were approximately $1.5 billion when the compound came off patent in March of this year. Glaucoma affects about 2.5 million Americans and is generally well managed with daily eye drops, but patient compliance is one of the biggest problems.

Under the revised accord, pSivida, with technical assistance from Pfizer, will develop the glaucoma implant through Phase 2 clinical trials. At that point, Pfizer can exercise an option for an exclusive license to complete development and commercialize the implant in return for a $20 million payment, double-digit royalties on any sales and additional development, regulatory and sales performance milestone payments of up to $146.5 million.

If Pfizer, which owns almost 10% of pSivida, doesn’t exercise its option, pSivida has the right to develop and commercialize the glaucoma implant on its own or with a partner. pSivida has already received $10 million in R&D support and a license fee from Pfizer.

In a glaucoma market dominated by eye drops, the big issue for an implant, Dr. Ashton contends, is that until the efficacy is established, it’s difficult to know how many people will use it. He adds, “It could become the treatment of choice ahead of eye drops, or it could be restricted to only people who are not doing well on regular eye drops, which would make it a much smaller market.”

pSivida’s fourth generation Tethadur technology is a system designed to deliver small molecule proteins and antibodies. The highly porous material resembles an array of straws 10 microns in height. “We can control the diameter of the straws that make up the tubes with a very great precision, using nanotechnology,” Dr. Ashton contends.

The company is in preclinical trials to adapt Tethadur to deliver Avastin and Lucentis for the treatment of AMD. “Avastin is the easiest one to work with because all of the antibodies in Avastin are about the same size,” Dr. Ashton says, pointing out that each antibody would occupy one of the fully bio-erodible tubes. The goal is to have the treatment last for about six months and pSivida is hoping to begin human testing in 2012.


While the initial focus is ophthalmology, Dr. Ashton says Tethadur’s applications potentially could be wide-ranging and could include almost any subcutaneously injected protein. “This is potentially a huge opportunity for us.”

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

seekingalpha.com

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To: John McCarthy who wrote (371)9/1/2011 7:34:09 PM
From: Arthur Radley
   of 404
 
msnbc.msn.com

Don't know how this will impact PSDV, but it probably will raise a 'red-flag' for all injectable eye medications. Sure isn't good news for the Avastin users!

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