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Kei, Congratulations on your gain on AEZS!
Re: BPAX diluting 4 times within a year!
I like the potential of LibiGel, and it will be a pretty good run-up play someday. However, they dilute too often, and it sort of reminds me of CTIC. Within the last 12 months, they have been diluting four times: 3/9/10, 6/23/10, 12/27/10, and today 3/4/11. Well, based on this track record, it just can't be a long-term play, IMO.
XNPT: Business Update - PR 2/16/11
http://finance.yahoo.com/news/XenoPort-Reports-Fourth-bw-2998818826.html?x=0&.v=1
XenoPort Reports Fourth Quarter and Year-End 2010 Financial Results <February 16, 2011 04:06 PM Eastern Time >
SANTA CLARA, Calif.--(BUSINESS WIRE)--XenoPort, Inc. (Nasdaq: XNPT) announced today its financial results for the fourth quarter and year ended December 31, 2010. Revenues for the quarter were $1.9 million, compared to $5.8 million for the same period in 2009. Net loss for the fourth quarter was $14.8 million, compared to a net loss of $18.3 million for the same period in 2009. At December 31, 2010, XenoPort had cash and cash equivalents and short-term investments of $108.6 million.
XenoPort Business Updates
Since the beginning of the fourth quarter of 2010, XenoPort:
* Announced that the U.S. Food and Drug Administration (FDA) has accepted for review the GlaxoSmithKline (GSK) response to the FDA Complete Response letter for Horizant™ (gabapentin enacarbil) Extended-Release Tablets (previously known as XP13512). Horizant is under review for the treatment of moderate-to-severe primary restless legs syndrome (RLS). The FDA has designated the new drug application (NDA) resubmission as a Class 2 response and set a new Prescription Drug User Fee Act (PDUFA) date of April 6, 2011.
* Completed a Phase 2b randomized, double-blind, placebo-controlled, clinical trial of arbaclofen placarbil (AP) in patients with gastroesophageal reflux disease (GERD) who experience symptoms in spite of treatment with a proton pump inhibitor (PPI). XenoPort anticipates reporting preliminary top-line results of this clinical trial later in the first quarter of 2011.
* Announced plans to initiate Phase 3 development of AP as a potential treatment of spasticity in multiple sclerosis (MS) patients. Based on discussions with the FDA, XenoPort intends to conduct a single placebo-controlled Phase 3 efficacy clinical trial and an open-label, long-term, safety study of AP in patients with MS. Favorable results from these studies could lead to the filing of an NDA with the FDA under Section 505(b)(2) seeking approval of AP for the treatment of spasticity.
* Initiated a Phase 2 randomized, double-blind, crossover clinical trial in patients with Parkinson’s disease that is designed to evaluate safety, efficacy and pharmacokinetics of XenoPort’s new bi-layer formulation of XP21279 versus Sinemet.
* Received $0.5 million to further fund the development of AP and XP21279 through the Qualifying Therapeutic Discovery Project program under section 48D of the Internal Revenue Code, which was enacted as part of the Patient Protection and Affordable Care Act of 2010.
* Received a $0.2 million grant from The Michael J. Fox Foundation for Parkinson’s Research to support a preclinical study of the efficacy and safety of a novel, orally administered prodrug of acamprosate in reducing L-Dopa-induced dyskinesias (LID) in a pre-clinical model of Parkinson’s disease. The grant was awarded under the Foundation's Therapeutics Development Initiative Fall 2010 Program aimed at supporting preclinical development of Parkinson's disease therapies that have the potential for fundamentally altering disease course and improving treatment of symptoms above and beyond current standards of care.
* Completed a public offering, raising net proceeds of $30.7 million, after deducting underwriting discounts and commissions and other offering expenses.
* Amended and restated its development and commercialization agreement with GSK with respect to Horizant. GSK remains responsible for seeking approval of the NDA for RLS in the United States and for further development and regulatory matters with respect to Horizant for the potential treatment of post-herpetic neuralgia (PHN). Subject to the terms and conditions of the amended agreement, XenoPort has the right to pursue development of Horizant for certain other indications in the United States. GSK remains responsible for commercialization of Horizant in the United States for all indications. In addition, XenoPort has reacquired all rights to XP13512 outside of the United States that were previously granted to GSK (which excludes the Astellas territory). As part of the amended agreement, financial terms, including potential clinical, regulatory and sales milestone payments and profit split/royalty rates, have been modified to reflect the changes in development responsibilities and the reversion of ex-U.S. rights to XenoPort.
Ronald W. Barrett, Ph.D., chief executive officer of XenoPort, stated, “XenoPort met a number of important business objectives since the start of the fourth quarter. We conducted discussions with the FDA regarding our Phase 3 development program for AP as a potential treatment of spasticity in MS patients and hope to begin the Phase 3 efficacy trial by mid-year. In early January, the final subjects completed their participation in our clinical trial of AP in GERD patients who remain symptomatic despite PPI therapy. We anticipate reporting top-line data on this trial later in the quarter. In November, we initiated a Phase 2 clinical trial of XP21279 in patients with Parkinson’s disease.”
Dr. Barrett continued, “Having submitted new information on the benefit/risk of gabapentin enacarbil as an RLS treatment, we await approval decisions from both the FDA in the United States and the PMDA in Japan.”
XNPT: 3 near-term catalysts
(1) Arbaclofen Placarbil (AP) in patients with gastroesophageal reflux disease (GERD): Preliminary top-line results of Phase 2b in the 1st Qtr. '11
(2) Horizant: FDA PDUFA Date = 4/6/11 (GlaxoSmithKline)
(3) Horizant: PMDA in Japan (Astellas)
Re: PLX I was completely caught off guard.
The CRL caused a little more than 20% loss. Well, I treat it as giving away some of my decent profit from DEPO. I am moving onto the next play. I will definitely try to add to my current XNPT position and search for some other plays. Thanks always for your time and efforts in this board. GLTA!
Thanks for the late night post on PLX, colorofmoney!
Great news, indeed! Approval is just around the corner.
Good luck to all on this board and $heff $tation!
http://phx.corporate-ir.net/phoenix.zhtml?c=101161&p=irol-sec
Kei, thanks for your feedback on XNPT.
I'm currently in PLX and have a small position in XNPT. I wanted to see whether or not I should increase my XNPT position after I'm done with PLX this Friday. Good Luck to you and all on this board!
Thank you much, jrbritt!
How do I boardmark "FDA Plays"? Thanks.
Re: XenoPort's Horizant (PDUFA Date 4/6/11)
Hi, cccpmd666, colorofmoney, pcrutch, and kei! I have been following “FDA Plays” board for about 7 months, and I’d like thank all for the solid DD and constructive opinions. I have been investing all my funds into biotech stocks for about a year. And, I’ve been enjoying a great deal. Today, I have decided to post my DD on XenoPort’s Horizant for the first time here on this board and get some feedback. I have noticed that there isn’t any high level of approval sentiment out there even though I feel that it will be approved this time. I thank you all so much in advance for some feedback!
I am quite convinced that XenoPort's Horizant, which has a PDUFA date of 4/6/11, will be approved this time. The most compelling and convincing pieces of evidence are actually in the 2/17/10 CRL itself, which was described in the Form 10-K filed with SEC on 2/26/10. The following is the section of the SEC Form 10-K which contains those pieces of evidence of approval. ( Here is the link: http://phx.corporate-ir.net/phoenix.zhtml?c=187883&p=irol-sec&secCat01.1_rs=91&secCat01.1_rc=10 ) I put numerical references to the 10-K filing to show you the "three" compelling and convincing pieces of evidence:
SEC Filing Form 10-K (Filed on 2/26/2010): Part I, Item 1. Business, Overview
Our lead product candidate, XP13512 (gabapentin enacarbil), is licensed to Astellas Pharma Inc. in Japan and five Asian countries and to Glaxo Group Limited, or GSK, in the United States and all other regions of the world. Astellas has filed a new drug application, or NDA, with the Pharmaceuticals and Medical Device Agency, or PMDA, for approval of XP13512 as a treatment for restless legs syndrome in Japan. Restless legs syndrome is a neurological condition that causes an irresistible urge to move the legs. In January 2009, GSK submitted an NDA to the U.S. Food and Drug Administration, or FDA, for U.S. approval to market XP13512, known in the United States by the trade name Horizant (gabapentin enacarbil) Extended-Release Tablets, for the treatment of moderate-to-severe primary restless legs syndrome, or RLS.
In February 2010, GSK received a Complete Response letter from the FDA regarding the NDA for Horizant for RLS. A Complete Response letter is issued by the FDA's Center of Drug Evaluation and Research when the review of a file is completed and questions remain that preclude the approval of the NDA in its current form. The Horizant Complete Response letter states that the FDA concluded that (1) the NDA provides substantial evidence of effectiveness for Horizant as a treatment for patients with RLS and that (2) the FDA had not identified a clinical safety concern that would prevent approval of the 600 mg dose of Horizant. However, a preclinical signal of pancreatic acinar cell tumors in rats was determined to be of sufficient concern to preclude approval of the Horizant NDA for RLS (3) in its current form. In the Complete Response letter, (3) the FDA acknowledged that similar preclinical findings were known for gabapentin, the parent drug of Horizant, at the time of the FDA's approval of gabapentin for refractory epilepsy, but concluded that the seriousness and severity of refractory epilepsy and the benefit to patients provided by gabapentin justified the potential risk. In the Complete Response letter, (3) the FDA also acknowledged that findings in laboratory animals are not necessarily translatable to risk in humans, and the FDA noted that gabapentin products have been available for over 15 years and do not appear to be associated with a clinical signal for pancreatic cancer.
(1) FDA concluded that Horizant had "Efficacy."
(2) FDA concluded that Horizant had No "Safety" Concern.
(3) FDA acknowledged that preclinical pancreatic acinar cell tumors in rats had been associated with gabapentin. (For apprx. 18 years because Pfizer has marketed gabapentin under the brand name Neurontin since 1993.) FDA also knows that those tumors in rats do not necessarily mean risk in humans. Remember that FDA denied the approval because of the tumors in rats. Here comes the really crucial and game changing fact that we have to know. In order for XenoPort and GlaxoSmithKline to take advantage of all the available nonclinical data related to gabapentin, GSK resubmitted the NDA for Horizant as a 505(b)(2) application in October 2010, and FDA accepted it on November 15, 2010. Now, FDA can consider those "published" data in assessing Horizant, which will clearly work in favor of XenoPort. This was exactly how DepoMed received the approval on Gralise and how Pfizer got the approval on Lyrica. The original NDA was submitted on 1/9/2009 as a 505(b)(1) application which didn't allow FDA to consider the known, historical data. In addition to the amendment, GSK submitted new nonclinical data, two epidemiology studies, and final safety update, all of which should definitely help XenoPort and GSK to get the well-deserved approval.
Lastly, the approval of DepoMed's Gralise on 1/29/2011, which contains gabapentin, gives XenoPort so much better chance of getting the approval on Horizant. On 1/31/2011, Wedbush and RBC Capital said that Horizant will be most likely approved and maintained "outperform" rating. Especially, Wedbush maintained $26 price target.
Hi Zigzagman: My Belief in ANX
Actually, I found your Blog that showed me your opinion on the potential buyout, which I read before. I regularly check your blog on http://www.stock-market-lessons.com/
http://day-trading-the-stock-market.blogspot.com/search?updated-min=2010-02-01T00%3A00%3A00-06%3A00&updated-max=2010-03-01T00%3A00%3A00-06%3A00&max-results=14
Even though a high-profit generating buyout deal doesn't happen soon, I really believe in ANX's future mainly because of the following:
(1) Brian Culley's Ability & Commitment
(2) ANX-530: Bioequivalence has been already established.
(3) ANX-514: Pre-clinical bioequivalence confirmation by President & CEO of Shin Poong Pharma and its commitment to a successful "clinical" bioequivalence study. Shin Poong Pharma has been in business since 1962 and has become a very reputable company in S. Korea with more than 1,500 employees. They believe in emulsion technology. Mr. Kim said on 12-1-2009, "Our independent confirmation of the bioequivalence and comparable overall safety of ANX-514 and Taxotere affirm our belief in both the emulsion platform technology underlying several ADVENTRX product candidates and its application to docetaxel,"
(4) Carl Icahn will make sure that ANX investors and himself will be profitable from this investment.
Good Luck to all sincere investors.
Ultimate Goal of Adventrx:
This is my first post here, and want to share this with all
sincere investors in ANX.
I found this one while trying to research "nano-emulsion technology" which was developed by
Dr. Andrew Chen, Ph.D., the co-founder of SD Pharma that was bought out by ANX in April 2006.
I really wanted to know if ANX has a "patent" on this nano-emulsion technology. I didn't find any definite
answer. It seems like ANX owns the "worldwide intellectual property rights" to some drugs acquired
from SD Pharma. It is patentable, but ANX doesn't own any patent.
The reason why I am sending you this is to let you know about a couple of very fascinating facts in it.
1. Brian Culley's Past Experience:
"Mr. Culley has over 15 years of experience in the biotechnology industry, including deal structure
and negotiation, licensing, due diligence, market and competitive research, and venture funding."
2. TWST: How would you like to see the company evolve over the next couple of years?
Mr. Culley: We’re strongly committed to creating value for ADVENTRX stockholders. That might mean
we will be acquired or will remain as an independent business, and we will make those determinations
as we grow, but we will always make the decision that we believe maximizes our value on a risk-adjusted basis.
We know that focusing on products that are desired by patients and doctors will naturally create a
high-value company, so we are open-minded as to the ultimate outcome. We have and will continue to entertain
credible discussions concerning partnering and acquisition, but in the meantime we will move forward on
the regulatory and commercial plan I’ve described and build the business with both long- and short-term value in mind.
I think we have the answer!!! I'm curious about how you will interpret his response. Here is my interpretation.
This interview was done on Oct. 19, 2009. He made a "No Comment" comment during Jan. 2010 conference
in S.F. I'm sure that THE "ULTIMATE" GOAL OF BRIAN CULLEY AND ANX IS TO SELL THE COMPANY AT THE MAXIMUM
VALUE. That's why ANX brought in Brian Culley who has 15 year experience in "deal structure and negotiation."
And, look at all the recent developments: Icahn's recent moves, Dr. Kostas on ANX board, Dr. Rowinsky on both ANX
and Biogen board, Dr. Kostas & Dr. Rowinsky's prior involvement with ImClone, constant attempt to push down the
stock price, etc. His response to TWST makes me believe that they have had some buyout talks. Doesn't it all make sense?
I just hope that the buyout hope becomes a reality soon.
Good luck to all "sincere" investors!
What are your thoughts on this, Zigzagman?
I always appreciate your insightful posts here.
Here is the link:
http://www.adventrx.com/assets/pdfs/ANX-TWST-Oct09-FINAL.pdf