b00n hat am 04.03.2013 - 20:35 folgendes geschrieben:
nach einiger Zeit auf watch, heute paar gekauft. 1.14
Das ist schon mal für s erste durch:
Thursday, 6 Dec 2012 07:00am EST
DURECT Corp announced the pricing of an underwritten public offering of 14 million shares of its common stock, offered at a price of $0.90 per share to the public. The gross proceeds to DURECT from this offering are expected to be approximately $12.6 million, before deducting underwriting discounts and commissions, and other estimated offering expenses payable by DURECT. All of the shares in the offering are to be sold by DURECT. The offering is expected to close on or about December 11, 2012.
In March 2013, we expect Durect to file a new drug application (NDA) for Posidur, to be submitted under the 505(smiley(2) pathway, meaning the FDA should make a decision roughly twelve months later. The market has written off Posidur, but we think the odds of a first-cycle approval are clearly greater than 0%, which could lead to upside in Durect shares later in 2013 as investors start to come back to the story.
Posidur notwithstanding, a key driver for Durect stock is Remoxy. We’ve been telling people that Durect stock is undervalued since September 2012. At the time, we believed visibility on Remoxy was improving based on optimistic comments from commercialization partner Pfizer (PFE)
"Following our pre-NDA communications with the FDA this summer, we are preparing to submit a new drug application for POSIDUR in the first quarter of 2013," stated James E. Brown, D.V.M., President and CEO of DURECT. "Pfizer has initiated a confirmatory bioavailability study to assess the pharmacokinetic profile of modified REMOXY formulation compositions, with a data read out expected early in 2013. We also are pleased that Zogenix has been actively enrolling in the Phase I clinical trial for Relday."
Remoxy A Blockbuster
The market opportunity for an abuse-resistant oxycodone is enormous in our view. Quite simply, the market for oxycodone-ER (OxyContin) is enormous in itself, with Purdue booking over $3 billion in sales in the U.S. in 2012. The growth of prescription opioid use over the past decade is astonishing. From 1997 to 2007, the milligram per person use of prescription opioids in the U.S. increased from 74 milligrams to 369 milligrams, an increase of 402%.
Durect is entitled to 6.0% to 11.5% royalties on worldwide sales of Remoxy.
We expect in sales of Remoxy at Pfizer. Our assumptions assume that Pfizer will re-file the NDA in September 2013 and launch the product mid 2014. We model Pfizer taking 30% of the OxyContin market. Using a 15% discount rate, and then a 50% reduction based on probability of approval, we see the potential royalty stream from Remoxy alone worth roughly $1.75 per share. We believe the potential for Remoxy alone makes Durect a very attractive investment.
ALZET and LACTLE
Durect currently manufactures and distributes ALZET miniature implantable osmotic pumps and accessories used for experimental research in mice, rats, and other laboratory animals. The company controls the rights to these products on a worldwide basis. Durect markets the ALZET product line through a direct sales force in the U.S. and through a network of distributors outside the U.S.
ALZET pumps continuously deliver drugs, hormones and other test agents at controlled rates from one day to four weeks without the need for external connections, frequent handling, or repeated dosing. In laboratory research, these infusion pumps can be used for systemic administration when implanted under the skin or in the body. They can be attached to a catheter for intravenous, intracerebral, or intraarterial infusion or for targeted delivery, where the effects of a drug or test agent are localized in a particular tissue or organ. Durect acquired the ALZET product line from ALZA in April 2000. For 2012, we estimate ALZET at $7.5 million. We model similar amounts for 2013 and 2014.
- REMOXY® (oxycodone) Extended-Release Capsules CII. Pfizer has efforts underway to resolve the issues raised in the REMOXY Complete Response Letter and stated in their quarterly earnings call on November 1, 2012 that they have initiated a confirmatory bioavailability study to assess the pharmacokinetic profile of modified REMOXY formulation compositions, with data expected in early 2013. Pfizer expects that the results of this study will provide greater clarity on Pfizer's ability to adequately address the questions raised in the Complete Response Letter, and Pfizer is targeting a meeting with the FDA in late March to discuss these outputs. Based on feedback Pfizer receives from the FDA at the meeting, Pfizer will subsequently determine the next steps and/or required timing to respond to the Complete Response Letter.
REMOXY, an investigational drug, is a unique long acting oral formulation of oxycodone intended to treat moderate to severe pain. Based on DURECT's ORADUR® technology, which is covered by issued patents and pending patent applications owned by us, REMOXY is designed to discourage common methods of tampering associated with prescription opioid analgesic misuse and abuse.
- POSIDUR™ (SABER®-Bupivacaine) Post-Operative Pain Relief Depot. Following our pre-NDA communications during the summer with the FDA regarding POSIDUR, we intend to submit a new drug application (NDA) under 505(smiley(2) with the FDA in the first quarter of 2013.
POSIDUR is our investigational post-operative pain relief depot that utilizes our patented SABER technology to deliver bupivacaine to provide up to three days of pain relief after surgery. We currently hold worldwide commercialization rights to POSIDUR.
- Transdermal Development Candidates. DURECT has two transdermal products that are in mid- to late-stage development with features that may be superior to currently available patches. TRANSDUR™-Sufentanil is our proprietary transdermal patch intended to deliver sufentanil to chronic pain sufferers for a period of up to 7 days from a single application; this compares favorably against existing fentanyl patches which are substantially larger and typically effective for 2-3 days. ELADUR, for topical neuropathic conditions such as post-herpetic neuralgia (PHN), is our proprietary transdermal patch intended to deliver bupivacaine for a period of up to three days from a single application; existing lidocaine patches for this condition can be worn for 12 hours with a rest period of 12 hours during which time many patients experience breakthrough pain. We are in discussions with potential partners regarding licensing development and commercialization rights to these two transdermal programs to which we hold worldwide rights.
- ORADUR-ADHD Program. We are developing a drug candidate (ORADUR-ADHD) based on DURECT's ORADUR Technology for the treatment of Attention Deficit Hyperactivity Disorder. This drug candidate is intended to provide once-a-day dosing with added tamper resistant characteristics to address common methods of abuse and misuse of these types of drugs. We and Orient Pharmahave completed several Phase I pharmacokinetic studies with multiple formulations, and we are continuing to refine our lead formulations. Orient Pharma is our licensee for certain Asian and South Pacific countries, while we retain the rights to the rest of the world.
- Relday™ (Risperidone Program). In July 2011, we signed a development and license agreement with Zogenix to develop Relday, a product candidate targeting the antipsychotic market. In July 2012, Zogenix announced that it had initiated its first Phase I clinical trial for Relday in patients. This study is a single-center, open-label, safety and pharmacokinetic (PK) trial that will enroll 30 patients with chronic, stable schizophrenia or schizoaffective disorder. We understand that Zogenix expects that the study will be completed by the end of 2012. Relday is a proprietary, long-acting (once-monthly) injectable formulation of 0.5 mL of risperidone using DURECT's SABER controlled-release formulation technology in combination withZogenix's DosePro® needle-free, subcutaneous drug delivery system. The existing long-acting injectable risperidone product, which achieved $1.6 billion in global net sales in 2011, requires twice-monthly, 2 mL intramuscular injections with a 21 gauge or larger needle.
- Feasibility Projects and Other Activities. During the third quarter of 2012, we continued work on several feasibility projects as a means of demonstrating that our technologies can achieve the drug delivery objectives set forth by our collaborators and are worthy of further development. The Zogenix program, described above, was one such project which has matured into a development and license agreement.
- Business Development Activities. We have multiple programs that may potentially be licensed over the next 12-18 months. These include POSIDUR, TRANSDUR-Sufentanil, ELADUR, ORADUR-ADHD (territories outside certain Asian and South Pacific markets), as well as various other programs which we have not described publicly in detail.
DRRX after hour 1.41 in den zusammenhang auch PTIE kukn. (Remoxy partner)