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Cartonet & Gang,
I forwarded the original complaint to Takeda.
Here is the total email exchange....
I think issue should be pursued.
"Dear RVL,
Your complaint, as detailed below, has been forwarded to the Takeda UK QA department to action. Takeda UK are the MA holder for Vitaros in the UK and supply the product from our pre-wholesaler under 2-8° cold chain conditions.
In order for us to investigate this matter further, please can you confirm where you are based, how you ordered the product, who supplied it to you and the batch and expiry details.
I can confirm that this is the first product complaint we have received so far for Vitaros.
I look forward to hearing from you.
Many thanks
Kelly Gomm
QA
-----Original @aol.com]
Sent: 25 June 2014 11:03
To: DSO-UK
Subject: Vitaros
This is a post on the iHub investor website for someone that attempted to buy and use Vitaros.
Name on board is Cartonet. Here is post.....
"I am sorry to say it did NOT work out.
Cold chain version is real trouble.... now I see why Abott not launching in Canada....
the thing got to me in bad shape , also the dispenser I was not that enthusiastic about....the plunger on the accudose did not go smoothly, it was very hard to press
and the liquid content a lot of it got stuck on the wall of th accudose, as I said it lookd like it got in bad shape due to temp issues
this is a major failure I am sorry to say"
My questions are:
Is this typical?
Do you have positive feedback that can be shared?
Sincerely,
A concerned investor/pharmacist
RVL"
Geez, I missed a lot of chatter after Cartonet posted last night. Pharmacy that shipped Vitaros must be "dicey".
This is from CVS website.
Here is how it's done.
Look at meds requiring refrigeration. Much more critical than erectile dysfunction drug.
RVL
Refrigerated Medications
Most Popular Questions
Q. Which medications require refrigeration?
Answer
Refrigerated Medications
Shipping refrigerated prescriptions
Medications requiring refrigeration
Shipping refrigerated prescriptions
We ship all refrigerated medications with gel packs by Express Delivery to ensure they arrive at proper temperature. Packages containing refrigerated medications require the signature of an adult age 21 or over.
Medications requiring refrigeration
While not a complete list, here are the most common medications that require refrigeration.
Actimmune® (interferon gamma 1B)
Amoxil® (amoxicillin) — suspension
Augmentin® (amoxicillin/clavulanic acid) — suspension
Benzamycin® (erythromycin/benzoyl peroxide) — gel
Betaseron® (interferon beta 1B) — vials
Caverject® (alprostadil) — vials
Ceftin® (cefuroxime axetil) — suspension
Cefzil® (cefprozil) — suspension
Cipro® (ciprofloxacin) — suspension
Combipatch® (estradiol/norethindrone)
DDAVP® (desmopressin) — vials
Duricef® (cefadroxil) — suspension
Emcyt® (estramustine phosphate) — capsules
Enbrel® (etanercept) — kits
Epogen® (epoetin alfa)
Fortovase® (saquinavir) — soft gels
Genotropin® (somatropin) — cartridges
Humalog® (insulin lispro)
Humatrope® (somatropin) — vials
Humulin® (insulin)
Iletin® (insulin)
Infergen® (interferon alfacon-1) — vials
Insulin
Kaletra™ (lopinavir/ritonavir) — oral solution
Lantus® (insulin glargine)
Leukeran® (chlorambucil)
Lorabid® (loracarbef) — suspension
Miacalcin® (calcitonin salmon)
Muse® (alprostadil)
Mycostatin® (nystatin) — pastilles
Neupogen® (filgrastim) — vials
Norditropin® (somatropin) — vials
Norvir® (ritonavir) — soft gels
Novolin® (insulin)
Novolog® (insulin aspart)
Procrit® (epoetin alfa)
Rapamune® (sirolimus) — solution
Rebetron™ (ribavirin/interferon alpha 2B)
Regranex® (becaplermin) — gel
Sandostatin® (octreotide)
Suprax® (cefixime)
Thyrolar® (liotrix)
Trimox® (amoxicillin) — suspension
Veetids® (penicillin) — suspension
Velosulin® (insulin)
VePesid® (etoposide) — capsules
Vibramycin® (doxycycline) — suspension
Viroptic® (trifluridine) — eye drops
Xalatan® (latanoprost) — eye drops
Zithromax® (azithromycin) — suspension
U
European Physician education...
Apricus Biosciences Presents Vitaros(R) Poster at the International Symposium on Prostate, Androgens and Men's Sexual Health
20:00 EDT 20 Jun 2013 | Globe Newswire
Home » Syndicated Content » Apricus Biosciences Presents Vitaros(R) Poster at the International Symposium on Prostate, Androgens and Men's Sexual Health
SAN DIEGO, June 21, 2013 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (Nasdaq:APRI) (www.apricusbio.com) announced today that it will present a poster with results of an analysis of existing Phase 3 data for Vitaros®, the Company's lead product candidate for the treatment of erectile dysfunction (ED), at the International Symposium on Prostate, Androgens and Men's Sexual Health. The Symposium is being convened jointly by the European Society of Sexual Medicine ("ESSM") and the International Society for Sexual Medicine ("ISSM"), and is taking place June 21-23, 2013 in Berlin, Germany.
Related Biotechnology, Pharmaceutical and Healthcare News
Apricus Biosciences, Inc.: Apricus Biosciences Announces National Phase Approval for Erectile Dysfunction Cream - Vitaros(R) in Belgium
Apricus Biosciences, Inc.: Apricus Announces National Phase Approval for Erectile Dysfunction Cream - Vitaros(R) in France
Apricus Biosciences' UK partner accepts first shipment of Vitaros
2014 Could Be A Transformative Year For Apricus Biosciences
Recordati to market Apricus' Vitaros in Spain, Russia, Turkey and other global territories
The poster, titled "Comparison of Vitaros® Efficacy and Safety with Short-term and Longer Term Use," (Poster #35) authored by John P. Mulhall, M.D., Director of the Male Sexual and Reproductive Medicine Program at Memorial Sloan-Kettering Cancer Center, is scheduled to be on display June 21-22, 2013 from 9:00 AM to 5:00 PM local time.
"Vitaros® addresses a large population of ED patients who cannot or do not respond well to existing medications due to the systemic effects of PDE5 inhibitors, such as Viagra,"
said Rich Pascoe, Chief Executive Officer of Apricus Bio. "With its innovative, on-demand topical administration, and rapid onset in as little as five minutes, Vitaros® can safely improve erectile function in these patients with both short and longer term use."
This additional analysis of the Phase 3 data looked at the efficacy and safety of Vitaros® for short-term use (12 weeks; n=1,727) compared to longer-term use (n=1,161). The results found that, following 12 weeks of treatment, a statistically significant improvement in erectile function (EF) score was observed for the Vitaros® treatment group (1.6 for the 100 mcg dose group, 2.5 for the 200 mcg dose group, and 2.4 for the 300 mcg dose group) compared to the placebo group (-0.7) (p<0.001). A significantly greater proportion of patients receiving all dose levels of Vitaros® (100 mcg, 200 mcg, 300 mcg) reported improvement (up to 51%) in their erections compared to placebo.
With longer-term exposure, nearly all of the subjects (100%, 100%, and 88.2% in each of the 100mcg, 200mcg, and 300mcg dose groups respectively) had an improvement in EF score, and greater than 90% of the patients reported improvements in their erections. Compared to the end of the 12-week treatment, the mean IIEF score continued to improve for men choosing the 300 mcg dose level. The increased efficacy and the longer term safety evaluated in ED patients repeatedly exposed to Vitaros® illustrated that efficacy does not diminish with longer term use.
The majority of adverse events (AEs) were transient, and mild or moderate in intensity, and the incidence of AE reports decreased with repeated exposure. Relative to 12-week Vitaros® administration, longer term use of Vitaros® resulted in consistent, dose-dependent overall improvement in EF and fewer reports of transient urogenital adverse events.
The Company received approval effective May 31, 2013 of Vitaros® in Europe as a first line treatment for erectile dysfunction. The Company is currently working independently, as well as with its commercialization partners, Sandoz, Takeda, and Bracco, to obtain national phase approvals in France, Germany, Italy, UK, Ireland, Spain, The Netherlands, Sweden, Belgium and Luxembourg in order to make Vitaros® ready to launch in each of these territories across Europe. Vitaros® is also approved in Canada.
SL
No problem
RVL
So, a Dutch Urologist with a twitter account not aware of the dosage form and pharmacokinetic ramifications of a drug approved for usage only in England equals failure?
I want the world to be aware of this drug/stock but geez.
Ask yourself a few questions.
Who should be educating / detailing docs as individuals?
APRI?
Or the company that is selling the drug in the country approved?
Should they be doing this world wide or with physicians that can actually write a prescription for an individual patient?
From the Stockholm European Urology conference in April:
A new paradigm in the treatment of ED - the topical option
Sponsored by APRICUS BIOSCIENCES
Session type:
Symposium
Info:
Friday, 11 April 2014, 16:15 to 17:45, Room K2
Chair(s):J.P. Mulhall, New York (US)
Understanding the ED patient
Duration:16:15 - 16:35
Speaker:Y. Reisman, Amstelveen (NL)
The clinical care pathway in the management of the ED patient
Duration:16:35 - 16:55
Speaker:F. Giuliano, Garches (FR)
Vitaros: A novel strategy for ED management
Duration:16:55 - 17:15
Speaker:E. Kim, Knoxville (US)
Case studies and discussions
Duration:17:15 - 17:45
Speaker:J.P. Mulhall, New York (US)
Cartonet,
You're killing us.
Please use ASAP or I may have a premature blog posting
Daily Mail on Wikipedia:
Between July and December 2013 it had an average daily readership of approximately 3.951 million, of whom approximately 2.503 million were in the ABC1 demographic and 1.448 million in the C2DE demographic.[12] It has over 100 million unique visitors per month to its website.[13]
Again,
Do you have any facts to back up that statement?
Or are you making stuff up?
Sorry, trade at end of trading period, not after hours.
Anyone who follows this stock trade by trade for a period of time knows this stock PPS is being manipulated AND the daily optics of this stock are being manipulated on a daily basis.
1. Whether through "Painting the tape" at end of day
OR
2. low volume trades after hours at levels significantly above or below last trade for no apparent reason,
OR
3. 100 share sales a few cents below last trade immediately following a purchase with increase in PPS.
For the frequent flyers, both pumpers and bashers, we see it every day.
Some on this board refer to #3 as management cashing in the money machine, but I think not.
I agree.
I think the approach of starting by getting information to Urologists, Primary Care, Pharmacists, etc. is absolutely the right approach.
Then next will be the public (I hope), who will ask for and request Vitaros from an informed healthcare provider community.
3 million shares at $79.79 after hours in one trade.
Buy or sell?
Can anyone tell
Want to see a GREAT idea?
From the website
FINALLY!!!!!!!
Requesting a
Sample
of Vitaros®
?If you are a UK registered physician you can request a sample of Vitaros® here.
The Vitaros® ordering portal will open in a new window.
In order to request a sample you will need to enter the following information:
1. Enter your GMC number and press enter or click the disc icon
This will be used to verify that you are qualified to prescribe Vitaros in -the UK.
2. Enter the number of Vitaros® samples required and press enter or click the shopping basket
You can order a maximum of four sample packs at a time, which provide
sixteen doses of Vitaros®.
3. Enter your contact and delivery details, then press enter or click the disc icon
In order to validate your request it is important that you provide your:
first and last name as it appears on the GMC register
registered practice address
telephone number and email so Takeda UK can contact you if there are any problems processing the request
E-signature (initials and today’s date) to confirm you are eligible to receive samples
If you have any questions about requesting a sample then please contact Takeda UK on 01628 537 900.
Wow, thanks for the heads up on website.
website for professionals is very well done.
RVL
Boom.
Gilead Announces Phase 3 Data Showing That the Fixed-Dose Combination of Ledipasvir/Sofosbuvir Achieved 100 Percent Sustained...
To be fair, if I were short, I would be doing everything I could to bash APRI cause I feel a short squeeze coming.
See APRI/Nasdaq website....
SettleDate Short Int. Ave. Daily. Days To Cover
Volume
5/30/2014 2,939,067 127,666 23.021533
5/15/2014 3,025,927 113,521 26.655218
4/30/2014 3,069,652 270,761 11.337128
4/15/2014 3,192,941 200,125 15.954733
3/31/2014 3,281,915 291,771 11.248256
3/14/2014 3,294,969 224,637 14.667971
2/28/2014 3,327,890 315,614 10.544177
2/14/2014 3,366,477 306,869 10.970404
1/31/2014 3,312,989 310,041 10.685648
Read more: http://www.nasdaq.com/symbol/apri/short-interest#ixzz34iozcUzK
Ok, am I the first Pharmacist?
Anyone else out there?
Do you have any facts to back up that statement?
In U.S., Most commonly, there is a wholesaler, (like a McKesson) between Pharmacy and manufacturer of drug.
There are situations where there is a direct link between manufacturer and ordering Pharmacy.
I am Not familiar with process in U.K. And will do homework and share.
The other factor that has major impact on channels of distribution and availability is the Pharmacy/ PBM (Pharmacy Benefits Manager) relationship.
However, I believe Vitaros will be a cash only product for quite sometime. If there is a product that a person will spend there own hard earned dollars, this is it. That is one reason I have invested in APRI.
Of note, for seniors in the US, "Medicare will no longer cover erectile dysfunction (ED) drugs like Viagra, Cialis, Levitra, and Caverject."
We will really get traction with sales when Vitaros is added to a PBM formulary. That positive step can only (I believe) be accomplished with assistance from a big Pharma partner. For example, Cialis is only ED drug on some Blue Cross formularies.
FYI.....
Pharmacy Times June 10
Apricus Biosciences of the USA says that Vitaros, its topically-applied cream formulation of alprostadil, has been approved for erectile dysfunction in 10 European countries.
The green light comes courtesy of the European decentralised procedure and the Netherlands acted as reference member state on behalf of France, Germany, Italy, the UK, Ireland, Spain, Sweden, Belgium and Luxembourg. The active ingredient in Vitaros, alprostadil, is already found in other ED drugs but Takeda, which will market the treatment in the UK, noted that patients have been "deterred by the current methods of administration of other alprostadil-containing medicines", ie pellet or injection.
Richard Pascoe, Apricus Bio chief executive, claimed that Vitaros has "a unique product profile that meets the needs of a large number of patients suffering from ED and who are intolerant to or do not respond to current treatment options". He added that with its "rapid onset of action and "unique topical delivery", the drug could capture a significant share of the $1 billion phosphodiesterase type 5 (PDE-5) inhibitor market in Europe, dominated by Pfizer's Viagra (sildenafil), Eli Lilly's Cialis (tadalafil) and Bayer's Levitra (vardenafil).
As well as Takeda, Apricus Bio has signed up other partners for Europe, such as Sandoz for Germany and Bracco in Italy. Vitaros has also received marketing authorisation in Canada, where it has been licensed to Abbott Laboratories, while US commercial rights are held by Warner Chilcott.
Mr Pascoe added that partnering interest in Vitaros remains strong "and we are actively seeking to secure additional partnerships in the remaining European and global markets". The firm has just completed a $17.1 million financing and the divestiture of "multiple non-core assets".
Female sexual arousal drug
As well as Vitaros, Apricus Bio is also developing Femprox, also an alprostadil-based cream, for female sexual arousal disorder. Seven clinical studies have been successfully completed to date, including one, 98-subject Phase II study in the USA and a nearly 400-subject Phase III trial in China.
There are no approved products for FSAD and Apricus Bio is now hoping to meet with the US Food and Drug Administration shortly to get guidance regarding its next move, regulatory-wise.
Read more at: http://www.pharmatimes.com/Article/13-06-10/New_ED_treatment_from_Apricus_Bio_gets_EU_nod.aspx#ixzz34TMX6qXP
Follow us: @PharmaTimes on Twitter
Eat right and exercise
Agreed,
Femprox is the "prize".
I think not...
Summary
MRK's decision to risk $3.85B of shareholder capital for IDIX "Nuc" assets was driven by its revelation that MK-5172+MK-8742 regimens will require a "Nuc" for activity in GT 2/3.
It is an admission by MRK that its MK-5172+MK-8742 combo is not competitive, relative to GILD's 3rd and 4th-wave regimens.
Immense developmental, clinical, and regulatory risks remain with IDIX "Nucs".
GILD trades at ~25% discount to MRK shares on 2014E and 30% discount on 2015E.
Use any weakness to accumulate GILD ahead of 3 catalysts in 2014.
Co-authored with Dr. Kyle Holloway (Pharm.D)
First and foremost, congratulations to the Idenix (IDIX) team and shareholders, it has been a long, treacherous road the past few years, with many disappointments along the way. With the pleasantries out of the way, the discussion herein will focus on the implications of Merck's (MRK) $3.85B acquisition of IDIX (at a 3.4X premium to Friday's close) on Gilead (GILD).
It is apparent to us that MRK's decision to risk $3.85B of shareholder capital for IDIX "Nuc" assets, including IDX21437 (Phase I/II) and IDX21459 (Phase I study ongoing) was driven by its revelation that MK-5172+MK-8742 regimens will require a "Nuc" for optimal activity in genotypes 2/3. Furthermore, it is an admission by MRK that its MK-5172+MK-8742 combo is not competitive, relative to Gilead's 3rd and 4th-wave regimens with GS-9451, GS-9669, GS-9620, and GS-9857, all of which carry $0 in value in analysts' models, despite 3 of these assets being ahead in the development process than IDIX.
Phase I data showed antiviral activity of mean maximum 4.2-4.3 log10 IU/mL reductions for patients infected with HCV genotype 1, 2, or 3 receiving 300 mg once-daily in a seven-day proof-of-concept portion of a Phase I/II clinical trial, Phase 2 combo to begin mid-2014 with samatasvir will be critical for establishing the initial safety profile for IDIX 21437 over an 8-12 week dosing period, an area where every other HCV Nuc has failed in development.
Using this transaction as a basis for valuing GILD's HCV pipeline would indicate a range of $6-$12B not priced into the stock, given the knee-jerk reaction of GILD's sell-off yesterday. Buy this dip, currently trading ~12x our 2014E, and only 9x 2015E.
(click to enlarge)
Note, GILD trades at a ~25% discount to MRK shares on 2014E, and 30% on 2015E (see charts below, courtesy of Mark Schoenebaum, ISI Group).
(click to enlarge)
(click to enlarge)
(click to enlarge)
Confirmation of this notion that the MRK combo is inferior to GILD's 3rd/4th wave comes from the fact that MRK has initiated several clinical trials in combination with Sovaldi (see snapshot of clinical trial below).
(click to enlarge)
It is unclear if the IDIX combo will become its primary development strategy, or if it's simply a contingency strategy, given that there is only limited evidence of true pan-genotypic activity in genotypes 1-6; recall, IDIX21437's Phase I trial was only 7 days of dosing in 44 treatment-naive patients with genotypes 1-3. While the efficacy was good, we caution that the data is extremely immature and far from being considered robust. While many have noted that there has been no observed pattern of adverse events or laboratory abnormalities, we underscore that only 7 days of dosing data have been seen, far too short to observe many types of toxicity or drug interactions. Yet, analysts conclude, "because MRK paid this exuberant price, somehow MRK knows something they don't, which in effect reduces the risk of failure." We fail to share this flawed logic and conclusion.
To be sure, there are synergies between Merck and Idenix HCV assets, but that said, there is immense development, clinical, and regulatory risk that remains to be nullified with clinical data. Thus, the price paid by MRK emphatically makes GILD's less risky, with more data available that is true pan-genotypic.
Remarkably, analysts believe MRK's purchase of IDIX somehow validates its "Nuc", and analysts have mistakenly concluded that this somehow miraculously reduces the clinical development risk of IDIX21437 and increases its probability of success. Many analysts who have ascribed additional value to MRK's HCV pipeline are failing to apply a fraction of the same generosity to GILD's GS-9451, GS-9669, GS-9620, and GS-9857, all of which carry $0 in models currently, yet GILD is clearly the most competent antiviral company, not MRK. Yet, they give MRK's Phase I/II assets the benefit of the doubt? This is a monumental error, GILD's data sets for Phase I/II assets are already well-characterized for GS-9451 and GS-9669, and we recommend staying ahead of the sell side and taking advantage of weakness in GILD's shares ahead of the Sovaldi/Ledipasvir launch in October 2014, 2Q14 earnings, and the AASLD conference in November, which we expect will be the event when analysts will begin modeling GS-9451 and GS-9669 into their estimates.
MRK's track record in business development in the past has been far from exemplary, with many acquisitions failing to realize their touted potential. While a new business development team was put in place last year, we question why analysts accredit MRK such credibility with such a poor track record of generating returns on shareholder capital. The fundamental takeaway is that MRK only purchased IDIX after the realization that its internal combination regimen required Sovaldi for true pan-genotypic activity, or at least something similar to Sovaldi (IDIX21437). The point we are highlighting is that the market is increasingly valuing these names incongruently, fully ignoring the value of the Phase I/II assets of GILD, the world's top antiviral innovator, while ascribing exorbitant value to the mediocre, more risky Phase I/II assets of MRK/IDIX.
This most certainly creates opportunity, of course, long and short. The Pharma sector is rapidly nearing a fundamental short opportunity as they sell assets and frivolously spend the proceeds; we anticipate this trend to continue throughout 2014, but we also expect history to repeat itself in 2015-2016 with disappointing late-stage clinical results. We reckon that the next 12-18 months will reveal how wise the "wise men" were in large Pharma, but given the fact that MRK and its peers currently trade at a rare premium to large Biotech, the risks are largely skewed to the downside from here, especially given their propensity to spend in an undisciplined manner.
UPDATE YOUR ALERT SUBSCRIPTIONS NOW:
Symbol
Alerts Price Chg % Chg
CGIX
Cancer Genetics, Inc.
11.36 -0.47 -3.97
GILD
Gilead Sciences, Inc.
79.54 +0.54 +0.68
MYGN
Myriad Genetics, Inc.
34.49 -0.06 -0.17
NEPT
Neptune Technologies & Bioresources Inc
2.49 0.00 0.00
PRAN
Prana Biotechnology Ltd
2.03 +0.13 +6.84
TCBI
Texas Capital Bancshares, Inc.
55.39 +0.31 +0.56
VVUS
Vivus, Inc.
5.21 +0.01 +0.19
XOMA
XOMA Ltd.
4.66 -0.17 -3.52
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Pat Geary
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Thank you for a thoughtful article.
10 Jun, 06:08 PMReply! Report AbuseLike4
DoctoRx , Contributor
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Paul, this is another superior article. The technical precision and insights match the stock/business relevance. Kudos!
10 Jun, 06:15 PMReply! Report AbuseLike4
Dr. Paul Nunzio DeSantis, P... , Contributor
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Author’s reply » Thank you kindly, I always try to bring a different angle on things.
10 Jun, 06:51 PMReply! Report AbuseLike3
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From your mouth to Wall Street's ears. Thanks for the info.
10 Jun, 07:25 PMReply! Report AbuseLike1
ajax133
Comments (64)
Well done. Extremely insightful and analytically correct. I believe
that many investors still consider Large Pharma's premium to
Large Cap Biotech as a function of dividend security, rather than
an inverse relationship to innovation.
10 Jun, 07:14 PMReply! Report AbuseLike1
Dr. Paul Nunzio DeSantis, P... , Contributor
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Author’s reply » Good point, dividend security certainly is worth something, and lack of innovation certainly is worth a discount, hence i suppose the ebb and flow?
10 Jun, 07:45 PMReply! Report AbuseLike0
Rasna
Comments (38)
Paul,
Excellent, well thought out and clearly presented article on GILD.
Over the past several months I've spent considerable time trying to analyze and understand an apparent anti-Gilead bias among the analyst community and institutional investors. To date I've not found an answer other than analyst don't seem to grasp the significance of Solvaldi in treating, errr curing HPC. Most of the focus, misplaced and incorrect, has been on the drugs price and ignoring the costs of Summary
MRK's decision to risk $3.85B of shareholder capital for IDIX "Nuc" assets was driven by its revelation that MK-5172+MK-8742 regimens will require a "Nuc" for activity in GT 2/3.
It is an admission by MRK that its MK-5172+MK-8742 combo is not competitive, relative to GILD's 3rd and 4th-wave regimens.
Immense developmental, clinical, and regulatory risks remain with IDIX "Nucs".
GILD trades at ~25% discount to MRK shares on 2014E and 30% discount on 2015E.
Use any weakness to accumulate GILD ahead of 3 catalysts in 2014.
Co-authored with Dr. Kyle Holloway (Pharm.D)
First and foremost, congratulations to the Idenix (IDIX) team and shareholders, it has been a long, treacherous road the past few years, with many disappointments along the way. With the pleasantries out of the way, the discussion herein will focus on the implications of Merck's (MRK) $3.85B acquisition of IDIX (at a 3.4X premium to Friday's close) on Gilead (GILD).
It is apparent to us that MRK's decision to risk $3.85B of shareholder capital for IDIX "Nuc" assets, including IDX21437 (Phase I/II) and IDX21459 (Phase I study ongoing) was driven by its revelation that MK-5172+MK-8742 regimens will require a "Nuc" for optimal activity in genotypes 2/3. Furthermore, it is an admission by MRK that its MK-5172+MK-8742 combo is not competitive, relative to Gilead's 3rd and 4th-wave regimens with GS-9451, GS-9669, GS-9620, and GS-9857, all of which carry $0 in value in analysts' models, despite 3 of these assets being ahead in the development process than IDIX.
Phase I data showed antiviral activity of mean maximum 4.2-4.3 log10 IU/mL reductions for patients infected with HCV genotype 1, 2, or 3 receiving 300 mg once-daily in a seven-day proof-of-concept portion of a Phase I/II clinical trial, Phase 2 combo to begin mid-2014 with samatasvir will be critical for establishing the initial safety profile for IDIX 21437 over an 8-12 week dosing period, an area where every other HCV Nuc has failed in development.
Using this transaction as a basis for valuing GILD's HCV pipeline would indicate a range of $6-$12B not priced into the stock, given the knee-jerk reaction of GILD's sell-off yesterday. Buy this dip, currently trading ~12x our 2014E, and only 9x 2015E.
(click to enlarge)
Note, GILD trades at a ~25% discount to MRK shares on 2014E, and 30% on 2015E (see charts below, courtesy of Mark Schoenebaum, ISI Group).
(click to enlarge)
(click to enlarge)
(click to enlarge)
Confirmation of this notion that the MRK combo is inferior to GILD's 3rd/4th wave comes from the fact that MRK has initiated several clinical trials in combination with Sovaldi (see snapshot of clinical trial below).
(click to enlarge)
It is unclear if the IDIX combo will become its primary development strategy, or if it's simply a contingency strategy, given that there is only limited evidence of true pan-genotypic activity in genotypes 1-6; recall, IDIX21437's Phase I trial was only 7 days of dosing in 44 treatment-naive patients with genotypes 1-3. While the efficacy was good, we caution that the data is extremely immature and far from being considered robust. While many have noted that there has been no observed pattern of adverse events or laboratory abnormalities, we underscore that only 7 days of dosing data have been seen, far too short to observe many types of toxicity or drug interactions. Yet, analysts conclude, "because MRK paid this exuberant price, somehow MRK knows something they don't, which in effect reduces the risk of failure." We fail to share this flawed logic and conclusion.
To be sure, there are synergies between Merck and Idenix HCV assets, but that said, there is immense development, clinical, and regulatory risk that remains to be nullified with clinical data. Thus, the price paid by MRK emphatically makes GILD's less risky, with more data available that is true pan-genotypic.
Remarkably, analysts believe MRK's purchase of IDIX somehow validates its "Nuc", and analysts have mistakenly concluded that this somehow miraculously reduces the clinical development risk of IDIX21437 and increases its probability of success. Many analysts who have ascribed additional value to MRK's HCV pipeline are failing to apply a fraction of the same generosity to GILD's GS-9451, GS-9669, GS-9620, and GS-9857, all of which carry $0 in models currently, yet GILD is clearly the most competent antiviral company, not MRK. Yet, they give MRK's Phase I/II assets the benefit of the doubt? This is a monumental error, GILD's data sets for Phase I/II assets are already well-characterized for GS-9451 and GS-9669, and we recommend staying ahead of the sell side and taking advantage of weakness in GILD's shares ahead of the Sovaldi/Ledipasvir launch in October 2014, 2Q14 earnings, and the AASLD conference in November, which we expect will be the event when analysts will begin modeling GS-9451 and GS-9669 into their estimates.
MRK's track record in business development in the past has been far from exemplary, with many acquisitions failing to realize their touted potential. While a new business development team was put in place last year, we question why analysts accredit MRK such credibility with such a poor track record of generating returns on shareholder capital. The fundamental takeaway is that MRK only purchased IDIX after the realization that its internal combination regimen required Sovaldi for true pan-genotypic activity, or at least something similar to Sovaldi (IDIX21437). The point we are highlighting is that the market is increasingly valuing these names incongruently, fully ignoring the value of the Phase I/II assets of GILD, the world's top antiviral innovator, while ascribing exorbitant value to the mediocre, more risky Phase I/II assets of MRK/IDIX.
This most certainly creates opportunity, of course, long and short. The Pharma sector is rapidly nearing a fundamental short opportunity as they sell assets and frivolously spend the proceeds; we anticipate this trend to continue throughout 2014, but we also expect history to repeat itself in 2015-2016 with disappointing late-stage clinical results. We reckon that the next 12-18 months will reveal how wise the "wise men" were in large Pharma, but given the fact that MRK and its peers currently trade at a rare premium to large Biotech, the risks are largely skewed to the downside from here, especially given their propensity to spend in an undisciplined manner.
No,
there would be no written or unwritten confidentiality regarding results of treatment.
There remains confidentiality with regard to the individual patients identity. (In the U.S. Referred to as HIPPA)
So, I know this has been discussed, but....
Visium's #1 holding at over $450M and it's #1 increased position last quarter is Actavis ahead of the VRX's, MCK's, CVS's......
& now for the first time they put $2.4 M new investment in APRI this quarter.
Look for yourself and think about why an investment firm with this much on the line with ACT would invest in our little APRI that isn't on anyone's radar.
I am feeling much, much, better about the future.
http://www.nasdaq.com/quotes/institutional-portfolio/visium-asset-management-lp-743968
Throw me a frickin' Bone.........................................................
Geez are we desperate for information.
Falling Knife?
On 06/04/14, FELIX BAKER, reported a net BUY trade of SGEN with a net transaction amount of $9,828,093. Net non-zero shares traded: 281963. See below for more information on Seattle Genetics, with symbol SGEN traded on the NasdaqNM. Original SEC Filing Period of Report: 2014-06-02
Heads up.
Anyone have insight?
PITTSBURGH, June 4, 2014 /PRNewswire/ -- Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, announced today the appointment of Richard W. Pascoe as a member of the Company's Board of Directors.
Mr. Pascoe is currently the Chief Executive Officer of Apricus Biosciences, Inc., a pharmaceutical company focused on the development and commercialization of novel therapeutics for men's and women's health. Mr. Pascoe joined Apricus in March of 2013 following the merger of Somaxon Pharmaceuticals with Pernix. At Somaxon Mr. Pascoe held the role of Chief Executive Officer and was responsible for the FDA approval of Somaxon's lead drug Silenor®. Prior to Somaxon, Mr. Pascoe was with ARIAD Pharmaceuticals, Inc., a specialty pharmaceutical company where he most recently acted as Senior Vice President and Chief Operating Officer.
Thankfully, I did.
RVL
Thankfully, I did.
I understand the logic of Actavis acquiring APRI to gain rights to both Femprox world wide and Vitaros in US. I just don't believe APRI Board/management will consider selling with impending first sale of Vitaros in Great Britain. If there is a sale, I believe it will be a fire sale because Vitaros didn't sell well OR a blow out positive because it did. From a pharmacology perspective, the drug works, therefore, I am hoping and betting on the later. I believe more likely, at an early point in Vitaros sales data, a LARGE investment group like Baker Brothers, that follows ALL micro Pharma, will buy a huge stake in APRI. In either scenario, none of us will find it necessary to fret and debate on this Board over the day to day action of a micro cap stock.
SB/DG,
You're arguing over "how high is up".
It's all opinion.
The only thing that matters over short term is sales of Vitaros.
There is no way we sell until sales/response from public for Vitaros is known. APRI won't sell at these bargain basement prices with years of work with Vitaros about to become reality & Big Pharma won't buy off on Acquiring Femprox / APRI until vitaros potential is more certain which drives Femprox potential.
The only good news today is I just picked up a few more shares @ $2.25 in advance of June 16th.
Thanks
RVL
Agreed.
Appears that someone is trying to keep PPS down.
Today is even more obvious than usual.
Absent the comments about Irina and post partum mental status. Which I want to separate myself from.....
I have not been impressed with her level of due diligence.
Seriously, Rayva caused the upgrade to Buy?
Being long, I appreciate the positive reinforcement for PPS, but she is missing the point.
If Vitaros or Femprox are duds, then APRI PPS craters, if Vitaros or Femprox are real, then PPS goes to the Moon. Long term, Rayva's impact will, in either situation, be a rounding error for PPS.
I don't think I am over simplifying situation. Am I ?
RVL
I don't believe the awareness of a drug and resulting ramp up in sales for an erectile dysfunction drug will be adversely impacted by the lack of direct to consumer advertising. Just look at Viagra's growth, BEFORE the widespread utilization &'impact of the internet. Now with the NET, if any of us have any question or issue we all "Google" to get the answer.
Therefore, I agree,with DG, education & detailing of Urologist, PCP's, & PHARMACISTS is the best route to growth, BUT it must be paired with Management of the education of the public via the INTERNET. This could/should result in a more rapid ramp up than Viagra prior to the NET.
RVL
I am out (Thank God)
But I think there is a reason for the struggles that is pretty basic.
See below:
Omega-3 Fatty Acids: Studies Don't Support Heart Benefit
Published: Mar 17, 2014 | Updated: Mar 18, 2014
By Elizabeth DeVita Raeburn, Contributing Writer, MedPage Today
Reviewed by Zalman S. Agus, MD; Emeritus Professor, Perelman School of Medicine at the University of Pennsylvania
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Action Points
A systematic review and meta-analysis was designed to summarize evidence about the associations between fatty acid consumption and coronary disease in light of nutritional guidelines which generally encourage low consumption of saturated fats and high consumption of omega-3 polyunsaturated fatty acids from fish or plant sources.
The review found that current evidence does not clearly support guidelines that encourage high consumption of polyunsaturated fatty acids and low consumption of total saturated fats.
Dietary guidelines that encourage high intake of polyunsaturated fatty acids and low consumption of saturated fats are not clearly supported by research, according to a recent meta-analysis.
When data from 27 randomized controlled trials of fatty acid supplementation was analyzed, the relative risks for coronary disease were 0.97 (95% CI 0.69 to 1.36) with beta-linolenic acid, 0.94 (95% CI 0.86 to 1.03) for long-chain omega-3 polyunsaturated acid, and 0.89 (95% CI 0.71 to 1.12) for omega-6 polyunsaturated fatty acid, Rajiv Chowdhury, MD, PhD, of the University of Cambridge, and his co-authors wrote March 17 in the Annals of Internal Medicine.
Analysis of 32 observational studies found that the relative risks for coronary disease, comparing top and the bottom third of baseline dietary fatty acid intake, were 1.01 (95% CI 0.97 to 1.07) for saturated, 0.99 (95% CI 0.89 to 1.09) for monounsaturated, 0.93 (95% CI 0.84 to 1.02) for long-chain omega-3 polyunsaturated, 1.01 (95% CI 0.96 to 1.07) for omega-6 polyunsaturated, and 1.16 (95% CI 1.06 to 1.27) for trans fatty acids.
Looking at data from 17 studies of circulating fatty acids measured via biomarkers, the relative risks for coronary disease were:
1.06 (95% CI 0.86 to 1.30) for saturated fats
1.06 (95% CI 0.97 to 1.17) for monounsaturated fats
0.84 (95% CI 0.63 to 1.11) for long-chain omega-3 polyunsaturated fats
0.94 (95% CI 0.84 to 1.06) for omega-6 polyunsaturated
1.05 (95% CI 0.76 to 1.44) for trans fatty acids
"The pattern of this analysis did not yield clearly supportive evidence for current cardiovascular guidelines that encourage high consumption of polyunsaturated fatty acids and low consumption of saturated fats," concluded Chowdhury and his co-authors. What's more, they said, "Nutritional guidelines on fatty acids and cardiovascular guidelines may require reappraisal to reflect the current evidence."
The meta-analysis included more than 600,000 participants from 18 countries. All of the studies were published before July 1, 2013. The majority were culled from electronic searches of Medline, Science Citation Index, and the Cochrane Central Register of Controlled Trials. The researchers also looked for relevant studies in the reference lists of identified articles, and for author correspondence related to the studies.
The review "provides a comprehensive systematic synthesis of available evidence," the authors said.
Nutritional guidelines have encouraged low intake of saturated fats, high consumption of omega-3 polyunsaturated fatty acids from fish and plant sources, and avoidance of trans fats, especially partially hydrogenated fat, as a way to improve cardiovascular health, the authors wrote.
But there has been considerable variation, they said, in the international guidelines about the amount and types of fatty acids. "This variation reflects, in part, uncertainties in the available evidence," they authors said.
Interpretation of prospective observational studies has been complicated by potential misclassification in the self-report questionnaires, they said. Early analyses also did not assess the consistency between dietary self-report and biomarker measures of fatty acids in coronary disease, they noted.
Additionally, interpretation of randomized trials of fatty acid supplements has been complicated by the difference in dietary habits of trial populations, the absence, presence, and type of vascular disease in study populations at the beginning of trials, trial duration, composition of supplement regimens, and differences in the efficacy of coronary prevention, the authors said.
Earlier this year, James DiNicolantonio, PharmD, a cardiovascular research scientist at Saint Luke's Mid America Heart Institute in Kansas City, Mo., wrote an editorial in BMJ's Open Heart journal questioning the evidence for guidelines, calling the benefits of a low-fat diet -- especially a diet that replaces saturated fats with carbohydrates or omega-6 polyunsaturated fatty acids -- "severely challenged."
Previous meta-analyses "inappropriately combined trials that were mixed omega-3 and omega-6 and stated that they were omega-6 trials," he said, in an email to MedPage Today. "When looking at the trials that solely replaced saturated fat with omega-6, there was an increase in CHD [coronary heart disease] and CV [cardiovascular] death."
Past meta-analyses also inappropriately excluded the Sydney Diet Heart Study and another study investigating the consumption of corn oil patients with a history of heart disease, both of which showed harm when omega-6 replaced saturated fat, said DiNicolantonio, who believes the high-carb, low-fat diet many followed as a result of the current guidelines has contributed to the obesity epidemic and the rise in diabetes and metabolic syndrome.
Studies like this one should lead to the public eating "real" food, "even if these foods contain high amounts of saturated fat, instead of ingesting industrialized seed oils, particularly corn and safflower oil," says DiNicolantonio.
The authors of this meta-analysis acknowledged limitations to their study. These included a "moderate" amount of available data on some circulating fatty acids and "possible overestimation of associations because of preferential publications of extreme findings or selective reporting of results for particular fatty acids with striking associations," the authors said.
Selective reporting appeared minimal in the randomized trials, they said. But they noted that few observational studies reported on all measured circulating fatty acids. "Therefore it is possible that selective under-reporting may have contributed at least in part to the observational findings in this meta-analysis."
This study was supported by the British Heart Foundation, Medical Research Council, Cambridge National Institute for Health Research Biomedical Research Centre, and Gates Cambridge.
Co-authors disclosed relevant relationships with a number of companies and institutions, including Nestle, Metagenics, Pfizer, Merck Sharp & Dohme, Novartis, Roche Pharmaceuticals, the Medical Research Council, the British Heart Foundation, Cancer Research UK, Quaker Oats, AstraZeneca, UpToDate, GlaxoSmithKline, Merck, the National Heart, Lung and Blood Institute, the National Institute of Neurological Disorders, the Wellcome Trust, and Elsevier (France).
From the American Heart Association:
Clinical Practice Guidelines for Prevention
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Comments
Primary source: Annals of Internal Medicine
Source reference: Chowdhury, R et al "Association of dietary, circulating, and supplement fatty acids with coronary risk" Ann of Intern Med 2014; 160 (6).
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Bottom?
Zman,
Excellent info, thanks for sharing
RVL
Ok what am I missing......dilution?
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