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...AND what progress has been made toward "herd immunity" through exposure in individuals who did not report symptoms or experienced mild symptoms and have no idea that they have already been exposed.
I personally think this divergence in inflammatory cascade will be our economic saving grace, as I believe we are much further along in immunity development than is currently priced into the market.
Agreed that traction will be hard earned for Prolia, however, there are some serious advantages with the MOA of denosumab compared to bisphosphonates. The oncologists and orthopedists are just beginning to see the risks w zometa, etc re: BRONJ, long bone fractures, and femoral head necrosis.
While bisphosphonates have about a 10yr half-life, Prolia has a half-life of about 25 days (i am speaking from memory here). While BRONJ risk was actually higher for Xgeva vs Zometa on study, the theory is that denosumab (Xgeva, bony cancer) will offer potential of a drug holiday of about 1yr for the activity of osteoclasts to return to baseline. This is not the case w bisphosphonates. There is a very real 3-9% risk of BRONJ post-dental extraction due to lack of bony turnover. While this can be avoided w dental "cancer consults" prior to tx, remaining dentition will be subjected to reduced salivary flow and neglect that often accompanies chemo/radiation therapy.
While I agree that the economics of denosumab uptake will be challenging, I think that Xgeva will eventually eat into Zometa's mkt share. Additionally, I think that oral bisphosphonate use will begin to be limited to <5yrs on drug and then a several yr long drug holiday will be used as the bone is actually maintained very well without add'l dosing. See JAMA study in 2006... 19% fracture rate for this methodology vs 18.9% fracture rate for continuous dosing over 10yrs.
Look for something like Prolia and Reclast to take share away from oral drugs in osteoporosis. Docs get paid for the in-office procedure w both, being IV infusion q12mo w Reclast or subQ w Prolia. There also hasn't been the risk of BRONJ w Reclast like has been seen w Zometa.
TEVA, MNTA: Doesn't the FDA's end of January deadline for a response to TEVA preclude "approval" since the FDA's modus operandi is to keep the sponsor in the dark on exact timing of the approval? Further, if the issue outstanding in the application could be more complicated than immunogenicity, that would imply that final manufacturing inspection has not been conducted.
Painful... Agreed- But if Endo will pay Novartis $85m for the gel formulation of voltaren (which is also expected to have peak sales of $250m), then somebody will step up for territory rights to Dyloject. Rodman estimates $250m peak for Dyloject... so what if it aint as sexy as Voltaren gel in osteoarthritis.
From 3/2008-
Under the terms of the five-year agreement with Novartis, Endo will make an upfront cash payment of $85 million. Novartis is also eligible to receive a one-time milestone payment of $25 million if annual sales exceed $300 million. Novartis will receive royalties on the net sales of Voltaren Gel in the U.S. and will supply the product to Endo. Endo said it expects to commercialize Voltaren Gel as soon as possible, initially using one of its two specialty sales forces, consisting of 160 representatives, prior to executing a full physician launch in late May with an additional 275 contract sales representatives targeting primary care physicians who prescribe NSAIDs and Cox-IIs. Endo estimates U.S. peak annual sales for Voltaren Gel in treating osteoarthritis pain in the range of $250 million to $300 million.
Clark, I'm not saying that the FDA will treat safety in the same manner that I would... Not at all. What I was trying to glean from you concerned any previous investment you had in RPRX and the risk vs reward at that time. I take it you have never held a long position?
In my pov, the safety profile for Proellex is more defined now than ever before. So if risk has gone down, has the reward changed? Is regulatory risk (FDA perceived safetey included) the variable that has gotten more unpredictable? As far as derisking Proellex goes, we have seen the n=6 interim biopsies recently and the 1st round of histology biopsies after 4mo of drug last summer... All without much of a rise in market cap.
Additionally, for some risk vs reward perspective, do you currently hold a long position (options included) in DNDN? As a PREVIOUS holder, I am simply curious...
Clark, have you ever been invested in RPRX? If so, in your opinion what pivotal event, or events, marked the change in the way the FDA handles or views drugs that can be considered partially lifestyle? Was it the Androxal events? Nebido? Since the efficacy and adverse SE risks of Proellex have never been less, I am assuming that regulatory risk is your big hang up.
Make that 11.xx I see. EOM
Great news and the stock is down on 10k shrs traded. I would buy more but I am loaded to the gills after the last spurt in the $8's. Anyone have a supposition as to what is going on here?
My guess: This stock is notoriously late to respond to news. In Dec '06 the run from 5 to $13 was a delayed response to the Ph II results. I guess the fast money funds are busy with other positions right now.
CRTX - wrong... Financial position is strong
From Zacks report 1/14/08:
At September 30, 2007, the company had $34 million in cash and short-term investments. Net cash expenditures in
the third quarter of 2007 were $6.4 million, compared with net cash expenditures of $12.0 million in the third quarter
of 2006 and $5.5 million in the second quarter of 2007. The company had no long term debt sitting on its balance
sheet at September 30, 2007.
We estimate net cash expenditures to be roughly $6 million in 4Q07, and $18 in 2008. Current cash may last
through 2009 in which year the company will achieve profitability.
In addition, DEY has agreed to pay the Company a milestone payment of $5.0 million following the commercial launch of ZYFLO CR. The Company expects to receive this milestone payment in the fourth quarter of 2007.
So likely $33m in cash @ YE 07. They have reduced R&D almost completely and are focused on the lead compounds already ID'd. If they burn $18m in 08 like Zacks projects, then they will have $15m @ YE 08.
CRTX - Critical Therapeutics Reschedules Release of Fourth-Quarter 2007 Financial Results
Wednesday 03/12/2008 5:50 PM ET - BusinessWire
I am loading up because I believe a buyout is probable. CEO Frank Thomas announced he was resigning on March 2nd and the company has been evaluating strategic alternatives for a few months. Whether something is finally in the works or not is the question. Interesting that they cite management turnover and constraints below as the reason for delaying the CC and release but have time to present at Cown & Co. in the next few days. Since they are trading at a slight increase to cash value with Zyflo CR finally showing promise, I am taking the gamble.
Critical Therapeutics, Inc. (Nasdaq: CRTX), a biopharmaceutical company focused on developing and commercializing innovative products for respiratory, inflammatory and critical care diseases, today announced that it has rescheduled the date on which it plans to release its fourth-quarter and year-end 2007 financial results. In light of the Company's ongoing review of strategic alternatives and its recent announcement regarding the transition of management, it has decided to reschedule the announcement of its fourth-quarter and year-end 2007 financial results to the week of March 24, 2008. The Company had previously scheduled the announcement of its fourth-quarter and year-end 2007 financial results and conference call for March 13, 2008.
In addition, the Company filed a Notification of Late Filing on Form 12b-25 with the Securities and Exchange Commission, which would provide the Company an additional 15 calendar days to file its Annual Report on Form 10-K for the year ended December 31, 2007. The current prescribed due date for the Form 10-K is March 17, 2008. Critical Therapeutics intends to file its Form 10-K as soon as practical, but no later than the expiration of the additional 15-day period.
About Critical Therapeutics
Critical Therapeutics, Inc. is developing and commercializing innovative products for respiratory, inflammatory and critical care diseases. The Company owns worldwide rights to two FDA-approved drugs: ZYFLO CR(TM) (zileuton) extended-release tablets and ZYFLO(R) (zileuton tablets). Critical Therapeutics is developing products for acute asthma attacks that lead patients to the emergency room and other urgent care settings. The Company also is developing therapies directed toward the body's inflammatory response. Critical Therapeutics is located in Lexington, Mass. For more information, please visit www.crtx.com.
Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for Critical Therapeutics, Inc., including, without limitation, statements regarding the filing of our Annual Report on Form 10-K for the year ended December 31, 2007, our strategy, future operations, financial position, future revenues, and projected costs; prospects, plans and objectives of management; and all other statements that are not purely historical in nature, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "project," "should," "will," "would" and similar expressions are intended to identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks and uncertainties relating to: our ability to successfully market and sell ZYFLO CR, including the success of our co-promotion arrangement with Dey, L.P. (DEY); our ability to transition our management team effectively; our current review of our business strategy and future operations, and the implementation of changes in our strategy and future operations, if any, approved by our Board of Directors; our ability to develop and maintain the necessary sales, marketing, distribution and manufacturing capabilities to commercialize ZYFLO CR; patient, physician and third-party payor acceptance of ZYFLO CR as a safe and effective therapeutic product; adverse side effects experienced by patients taking ZYFLO CR or ZYFLO; our heavy dependence on the commercial success of ZYFLO CR; our ability to maintain regulatory approvals to market and sell ZYFLO CR; the success of our co-promotion arrangement with DEY for Perforomist(TM) (formoterol fumarate) Inhalation Solution; our ability to successfully enter into additional strategic co-promotion, collaboration or licensing transactions on favorable terms, if at all; conducting clinical trials, including difficulties or delays in the completion of patient enrollment, data collection or data analysis; the results of preclinical studies and clinical trials with respect to our products under development and whether such results will be indicative of results obtained in later clinical trials; our ability to obtain the substantial additional funding required to conduct our development and commercialization activities; our dependence on our strategic collaboration with MedImmune, Inc.; and our ability to obtain, maintain and enforce patent and other intellectual property protection for ZYFLO CR, our discoveries and our drug candidates. These and other risks are described in greater detail in the "Risk Factors" section of our most recent Quarterly Report on Form 10-Q and other filings that we make with the Securities and Exchange Commission. If one or more of these factors materialize, or if any underlying assumptions prove incorrect, our actual results, performance or achievements may vary materially from any future results, performance or achievements expressed or implied by these forward-looking statements.
In addition, the statements in this press release reflect our expectations and beliefs as of the date of this release. We anticipate that subsequent events and developments will cause our expectations and beliefs to change. However, while we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, whether as a result of new information, future events or otherwise. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, business development transactions, joint ventures or investments we may make. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this release.
ZYFLO(R) is a registered trademark of Critical Therapeutics, Inc.
ZYFLO CR(TM) is a trademark of Critical Therapeutics, Inc.
Perforomist(TM) is a trademark of Dey, L.P.
SOURCE: Critical Therapeutics, Inc.
Critical Therapeutics, Inc. Linda S. Lennox, 781-402-5708 Vice President, Investor & Media Relations llennox@crtx.com
"established a Strategic Commercialization and Partnership Committee consisting of members with significant experience in creating partnerships and commercial ventures. The Committee will consist of Directors Peter D. Kiernan III, Neil W. Flanzraich, and Georg Nebgen."
So Kiernan had a window to buy an additional 125k shares last week and he did so because with the creation of the above committee I imagine trading windows will be closed for a few months. Glad i picked up some today at 2.71, only wishing it was a larger purchase.
How did management screw up really badly? They got their first drug over the goal line and had some bad luck with the FDA changing viewpoints on K... Getting a drug approved these days is no small feat, especially your FIRST drug.
Mpower, clearly you have sold. Your posts suddenly have a very negative bias.
#1 the obvious exception is intranasal morphine, sorry.
#2 in the context of when respiratory depression becomes a problem, if ever, it will not be in chronic opioid abusers. Opiate-naive patients are the ones that must be monitored.
Do you view intranasal K as having potential problems with respiratory depression at the dosage given? My point was that the dosage should be a fraction of the anesthetic doesage, hence oxygen sat and other anesthetic limitations such as psychotropic events should not pose a problem.
YMI's fentanyl, belonging to the opioid class, would show respiratory depression/oxygen desaturation due to stim of mu2 receptors in the medullary respiratory centers of the brain. It is also of interest that fentanyl is extremely potent- 80x more potent than morphine. Also, fentanyl PATCHES are contraind. in pts post-surgery due to potential for severe resp. depression. I can only imagine what the risk would be for spray version that is patient-dosed...
Respiratory depression is usually seen with the use of a single, intravenous dose in an opioid-naive patient. In patients taking opioids regularly for pain relief, tolerance to respiratory depression occurs rapidly, so that it is not a clinical problem.
As JAV's products are non-opioid, i would imagine that respiratory depression will be of less risk. However, ketamine does stim opioid mu receptors- but only at high doses that are used to induce anesthesia. It is of interest that ketamine often has effects opposite opioids, ie cardiac output and HR actually increase with anesthetic does of K. As long as none of the patients are allowed to enter stage 2 anesthesia we should be ok :)
What the crap was up with all the Feb 10 call option activity today? Despite being completely covered with calls on ZGEN i started feeling pain today and sold some Feb 10 calls on RPRX @ noon. Thought it would be a decent income generating move. Figures this thing finally takes off in the PM. Maybe i too will be buying into this rally...
Marijuana & perio disease: Not surprising since smoking cigs, diabetes, and plaque and calculus are considered in the literature to be the only significant risk factors in periodontitis (gum disease). A host of other local factors can contribute such as restorative (filling) overhangs, traumatic occlusion, etc. Genetics clearly plays a role in the host-immune response, especially with agressive perio often seen in younger patients of AA descent. The link between perio disease and systemic health is the focus of current research... Is the linkage vertical or lateral???
OT- my freshman yr roommate is the current executive director of SAFER (a division of the pot policy project). He has argued on Fox News, among other media outlets, that marijuana represents a safer choice for recreational use vs alcohol. I guess not from a gum-health perspective, though. Although before i put my foot in my mouth, i should say that alcohol-containing mouthwashes (read Listerine = questionable safety as indicated) are also debateable as far as alcohol's role in drying the oral mucosa and contributing to malignant epithelial lesions often seen in pts who are alcoholic and fancy shots over mixed drinks.
Maybe it was because Brady was constantly getting rushed or knocked on his arse... It's easy to be an armchair quarterback.
What's the ticker.. or do I have to subscribe to your newsletter haha.
DSCO- there could also be questions as to whether or not new FDA reviewers onboard will feel differently NOW about the efficacy results previously submitted... I believe EU regulators may ask for more trial data.
I haven't done much DD on DSCO recently, but it does appear interesting now. I got out after the last go 'round but i see it is now back around my exit point.
They are a "virtual" company, mainly due to the fact that they have licensed the candidates and therefore have no in-house discovery to do. It seems they have finally gotten the drift about contracting some help for articles and publications/presentations on Pro and Androx. So no, a low burn rate doesn't concern me... I guess Joe P doesn't enjoy fine Italian suits the way our fav biotech CEO from Seattle does.
Heck with the $100 bucks! When I am on rotation through our reduced-fee oral surgery clinic, the emergency patients often have impacted molars that need to be extracted IN ADDITION to the bombed out teeth that have been causing them pain and sleeplessness for the last few days. If you told them you would perform all the extractions for free if they would participate in a trial that likely involves IV sedation for the entire procedure... Meaning they won't experience any pain until post-op... vs having some dental students inject 6 cartridges of local and wail on them while they are awake?? That's why it enrolled quickly.
Black Bear/TELK... How exactly is RPRX and Efficacy analogous to Black Bear and TELK? Are you implying that Efficacy is buying recklessly and the end result will be a TELK-like investment return? I've tried to do some research on Efficacy but haven't found much more than a bio for Marke Lappe and the founder. Docbanker on the RPRX board claims to be an acquaintance of the managers. He asserts that they are some of the most diligent investors he knows.
Researching Efficacy Capital... John Faiz Kayyem, Ph.D.
<Mark Lappe is another manager- anybody know more about the firm or the fund? Kayyem owns a Tesla Motors electric sports car and drives a VW Toureg on biodiesel. Interesting. Founded Clinical Micro Sensors and sold it to OMH, i believe.>
Dr. Kayyem is currently a Partner of Efficacy Capital LTD, which manages a biotech public equities fund with $70 million in assets under management.
Dr. Kayyem was born in Los Angeles and attended local schools, graduating from Harvard (now Harvard-Westlake) School in 1981. He then attended Yale University and received his combined Master and Bachelor of Sciences in Molecular Biophysics and Biochemistry in 1985. He went on to graduate school at The California Institute of Technology and received his Ph.D. in Molecular Biology in 1991. He remained at Caltech as a Senior Research Fellow for several years before launching his own venture.
Throughout his education, Dr. Kayyem’s research in molecular and cellular biology, genetics and DNA analysis has been focused on the development of powerful tools for the emerging genomics field. While at the California Institute of Technology, Dr. Kayyem received several research awards including the Beckman Institute Research Fellow in Biology, the Helen G. and Arthur McCallum Fellow and the Office of Naval Research Predoctoral Fellowship.
Dr. Kayyem is a distinguished scientist with many research publications to his credit in such respected journals as the Journal of Organic Chemistry, Journal of American Chemical Society, Journal of Cell Biology, European Journal of Biochemistry, and Chemistry and Biology. Most of these publications address issues of electron flow in organic molecules. His other works have involved the development of new MRI contrast agents and studies of DNA using a novel chemical force microscopy system.
In 1995, Dr. Kayyem founded Clinical Micro Sensors—now an operating subsidiary of Osmetech plc—to commercialize technical innovations he developed while at Caltech. Clinical Micro Sensors uses advanced electronics and biochemistry to create electronic detectors of specific DNA sequences. These “biosensors” have been used in the diagnosis of disease, the detection of environmental pathogens and in monitoring food safety. A novel use for these sensors is emerging in the field of personalized medicine, where these sensors are being used to identify genetic signatures in individual patients that can help in the determination of which drug at what dosage is best for this particular individual.
Clinical Micro Sensors is emerging as an important player in the new field of applied genomics. The company has recently launched its instrument and first test, a carrier screen for Cystic Fibrosis, which received FDA clearance in 2006. This test will be followed shortly by additional tests for clinically relevant mutations and polymorphisms (SNPs).
In 2004, Dr. Kayyem left Clinical Micro Sensors to co-manage the Efficacy Capital family of biotechnology funds. The Efficacy Biotech Fund, which he co-manages, currently has $70 million in assets under management and is becoming a significant institutional investor specializing in micro-cap biotechnology companies.
Since 1997, Dr. Kayyem has been awarded 32 U.S. patents in nucleic acid detection technology, all licensed to or owned by Clinical Micro Sensors. The intellectual property describes the bio-electronic detection of DNA and numerous methods and compositions for detecting and analyzing DNA.
Dr. Kayyem serves on various private company boards, including an AIDS gene-therapy company and a Web 2.0 company developing web-based tools for business and personal presentations. He co-produced a soon-to-be completed feature-length film titled “Nobel Son,” about a “Cal Sciences” Professor and the kidnapping of his son on the eve of the Professor’s receipt of the Nobel Prize in Chemistry. He is also Executive Producer on “The Ground Truth: After the Killing Ends,” a feature-length documentary about the emotional and psychological effects of war on US soldiers. The Ground Truth has been well received by critics and audiences, including those at the Sundance Film Festival. This film also made the “short list” of Oscar potential nominees in 2006.
Dr. Kayyem serves on the Board of Trustees of Caltech and of Polytechnic School, where currently four of his five children attend. He recently served on the Board of Trustees of The Art Center College of Design. Finally, in support of his passion for renewable fuels, he is a founding board member of Green Depot, a non-profit organization supporting sustainable transportation. Green Depot seeks to build alternative fueling stations that will provide much-needed distribution points for biodiesel, ethanol and other renewable fuels and also serve as educational centers for those seeking information about energy, climate, pollution and transportation.
Efficacy's purchase was Mon & Tues, but that is still a good sign. We don't want to see our 14% holder get cold feet.
< If RPRX’s management is not telling investors the whole story about the phase-3 clinical programs and prior clinical data for Proellex>
If there is more to the add'l IND than organizational paperwork, then I will be surprised. Right now the SAME dosage but in an ACUTE indication doesn't bother me. I think this is mountains out of mole hills- and I am not alone... Efficacy Capital bought an additional 120,000 shares Mon & Tues, adding to their 13% stake. Apparently they are OK with it.
Anemia low hanging fruit, yes: to borrow from dewophile's post, "another drug (lupron) has already blazed a path forward for this same indication, but it is flawed..proellex has clear advantages in virtually every facet - faster efficacy (whcih counts for a lot when a patient is bleeding all over herself and a doctor is trying to tune her up for surgery), fewer side effects, more convenient mode of administration."
Plus your chick won't get hairy, etc since she's not on a GnRH agonist! Too bad, i bet women love getting those 3 mo depot injections!
How come you keep asking these types of negative questions?
RPRX- Dew, in the line of your CFO = canary in a coal mine "warning signs for biotech investors" thought process,(which as a previous Big 4 auditor, i never bought into for biotech co's with no earnings) what exactly are you expecting the FDA to balk on concerning the use of Proellex in 50mg and 25mg doses to tx anemia for a total of 3 mo? If you were holding RPRX and people questioned the new IND smelling fishy, IMO you would immediately dismiss it as nonsense since longer durations of dosage in chronic indications had already been granted successful INDs previously... I don't see how anemia is high risk? I'd like YOU to give US some scenarios instead of asking RPRX longs to explain what could easily be a matter of organizational paperwork. Give me some scenarios here, please.
PS - a CFO leaving is a warning sign, but in profitless biotechs there is less pressure to manipulate or cookie jar earnings or accruals. It likely has little to do w financials, and more to do with opportunities elsewhere, unhappy managerial attitudes w/n a co, or a dim outlook clinically (and ultimately financially) IMO.
I believe the reply via telephone is still avail. Website not being updated until i forget when... it's in the PR.
breast cancer- progestins and estrogens together, not so much estrogens alone, have been shown to increase incidence of BC to my knowledge. A SPRM like Proellex would inhibit the breast tissue hyperplasia induced by progestins. Not to mention the co's early proposal of a BC indication for PRo... as for the endometrium... dewophile??
When blood is in the streets, you gotta buy buy buy. Down 26% when this morning was quiet- down only 3% on 30k shares??? You gotta be kiddin me since we are now down 26% and counting. I've been through this shindig before with the hedge fund crowd. They are getting out for the quarter and will be back after YE. Nothing appreciable has changed- so what if Pro needs a large safety database. Who would have thought anything different? Anemia indication alone could be sold for our current market cap w an NDA in a year's time. Give me a break. I'm a buyer
Seconded. I can't believe he even stated OT that he sold and immediately follows w/ some bashing. No sense of decency w/ that one.
"otherwise its' sell the news" Obviously there wouldn't be any risk reduction w/ a positive FDA meeting, I mean it's not like the FDA is being more conservative in this day and age... You are a real a$$ hat.
Does PM150 (nasal ket) have psychotropic/hallucination SE's like traditional ketamine? Or is the dose low enough that this has not presented a problem? We covered it in class in context of a dissociative anesthetic and hallucinations were a major drawback for induction of anyone other than kids or mentally handicapped individuals.
CVS-wise i can see it's great for trauma setting due to inc HR/BP and no opiod resp depression. I guess CI in HTN or epileptic pts though.
Xry, I disagree <majority of dental students and pharmacy students are women. That generally happens when the profit motive is driven out of a profession>
In dentistry at least, the majority of students are NOT women, but men- however the gap is closing. At most schools (that I am familiar w/) the split is approaching 60M/40F or close to it (which is remarkable for a profession that was 90/10 15 years ago. The profit is definitely still there for dentistry, unlike medicine. Until general dentists can no longer get paid more for placing two relatively simple dental implants than an MD can for cardiac surgery, the lifestyle motive alone explains women's entry into these professions (dentistry, pharmacy, etc). MCV's Dental School has seen applications rise from 1100 three years ago to over 3300 so far in this application cycle...
As an aside, the lifestyle and earnings potential are also reasons why Utah students (read Mormons) make up 10-20% of the student body at many US dental schools, but not medical schools.
Will the sunrise tomorrow?
R&R First Take on today's news... Just got in this morning 3.05 - 3.07. Seems like biotechs get pounded on negative news and then great news like this results in a high teen % gain. Curious.
Rodman & Renshaw
First Take
Cortex Pharmaceuticals, Inc.
COR, Price: $2.67 (07/16/07), Market Cap: $107MM (07/16/07)
Rating: Market Outperform, Target Price: $4.50
CX717 Dosing Restriction Was Lifted
• The FDA has lifted the dosing limitation on Cortex’s CX717 (Neurology division)
• Dosing of up to 1,200mg/day is allowed in the currently active Alzheimer’s study
• Cortex anticipates filing an IND for the Division of Psychiatry Products in 3Q07 (ADHD indication)
• Phase IIb ADHD study could get under way in 4Q07
• We believe that the drug is again partnerable and expect a licensing transaction by YE07
o The Alzheimer’s study originally included 200mg, 600mg, and 1,200mg doses of CX717.
However, the FDA’s dosing restriction had previously prevented Cortex from continuing
with the two upper doses. Lifting the restriction permits a return to the original dosing.
o This trial involves mild-to-moderate patients who are either drug-naïve or on
cholinesterase inhibitors at the University of Michigan Medical Center. In animals,
cholinesterase inhibitors like Aricept® and Razadyne® enhanced the effects of CX717.
o Cortex needed to get the green light from the Neurology division on dosing before
submitting its ADHD Phase IIb IND to the Psychiatry division. Since the FDA division that
originally restricted dosing has now deemed CX717 safe at all proposed doses, the
Psychiatry division will be able to make its decision on CX717 in ADHD in that context.
• In the wake of this initial relaxing of the dosing restriction on CX717, we retain our Market
Outperform rating with a target price of $4.50 on Cortex shares.
Re: NVD - As far as Zensana goes, HNAB is stability testing NVD's European formulation. HNAB disclosed in a PR that they believe they have discovered the "root cause of the precipitate after lengthy investigation." As of now, the Euro formulation has surpassed the stability point where the original formulation failed. They are going to sell the licensing rights to a partner who will take the development of Zensana forward to the clinic for another go.
NVD - Anybody buying NovaDel in the $.80's? Seems cheap w/ a $50M mkt cap and approved nitroglycerin oral spray as well as potential for Ambien spray, not to mention old rumors of a collaboration for Viagra oral spray... Here are my points:
New licensing agreement for Zensana is supposed to be announced before Sept.
The PK trial for Zolpidem (Ambien) oral spray was quite a success as expected w/ regard to time of tx onset and PK similarity to 10mg Ambien. Potential for an NDA based on a novel 2.5mg dose for insomnia suffers who awaken in the middle of the night would most likely be funded by a partner, hopefully soon to be announced. NDA to follow in 2H '07 for Zolpidem. I don't believe there are any stability skeletons in the closet aka Zensana, as NVD has 3 commercial scale batches w/ the oldest one 9 mo. out with no reported problems.
Weakness in stock price could be the delay in Sumatriptan spray due to stability or other FDA recomendations. NDA now expected in 1H '08. I have also heard that an ex-CEO of the co. when it was Flemington Pharma is selling some shares to fund a new co., so this may explain the current weakness in PPS. Any thoughts? I nibbled today at .86
KC