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http://www.today.com/news/government-shutdowns-saddest-photo-goes-viral-8C11377315
On the lighter side, the FDA is on the other side of the fence as we all stand on the gate and look in.....
I have no worries regarding hearing anything today whogo. Monday is a holiday, so I would expect to something Tuesday.
Thanks for picking up the phone and calling Jack, Silvrmoon!
And yes I agree, Jack is a "good guy".
Have a great weekend to all.
That oral drug, tofacitinib, does not have anything to do with the PFE/ATRS deal.
Even better whogo - Along the same lines regarding an insulin product, Sanofi's Lantus (insulin glargine) is another potential, insulin specific drug/pen combo for Pen #1 with TEVA. I think a subQ injection of insulin fits into what we know about Pen 1.
Now back to the my Bears who are getting schooled by your Saints.
Ryman: maybe a new drug in the pipeline for Antares soon could be the drug Levemir, manufactured by Novo Nordisk. And perhaps this could be Pen #1 with TEVA. Levemir is an insulin drug currently delivered subQ.
http://www.drugs.com/availability/generic-levemir.html
I'm thinking this could fit into Antares stating previously that Pen 1 would be an aNDA and its filing probably would trigger a Paragraph IV filing and eventual patent litigation by the original holder.
http://www.novo-pi.com/levemir.pdf (check out the Levemir Flex pen on page 9.)
P.S. Last nite while watching the Northwestern / Ohio State game, a commercial played touting Novo's injector pen for insulin - so this is where this theory comes from.
Saw this on Pfizer web site as well - and wouldn't it be nice for Pfizer to still be the 'official Pain Reliever of the NHL' when the PFE/ATRS product hits the market.....
http://finance.yahoo.com/news/advil-becomes-official-pain-reliever-140000423.html
Advil® Becomes Official Pain Reliever of the National Hockey League and the 30 Team Athletic Trainers
Business WirePress Release: Pfizer, Inc. – Mon, Sep 30, 2013 10:00 AM EDT
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Advil® Becomes Official Pain Reliever of the National Hockey League and the 30 Team Athletic TrainersView Photo
Advil® Becomes Official Pain Reliever of the National Hockey League and the 30 Team Athletic Trainers
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PFE 28.99 +0.1000
NEW YORK--(BUSINESS WIRE)--
Pfizer Consumer Healthcare, a unit of Pfizer, Inc. (PFE) and the maker of Advil®, the #1 selling over-the-counter pain reliever in the United States, and the National Hockey League (NHL) today announced Advil® is an Official Partner and the Official Pain Reliever of the NHL® and the 30 NHL athletic trainers in North America for the 2013-14 season. Under the agreement, Advil® is also an Official Partner and the Official Pain Reliever of the 2014 Bridgestone NHL Winter Classic® and the 2014 Coors Light NHL Stadium Series™.
As an official partner of the NHL, Advil® will receive significant media exposure, including prominent in-ice brand position, camera-visible dasherboards and placement at accompanying fan festivals of League tent-pole events. Advil® will also benefit from custom integration throughout all NHL-controlled media properties including NHL.com, NHL Network™ and NHL Social™, in addition to the League’s U.S. national broadcast partner, NBC Sports Group.
“The Advil® brand has joined the NHL family at a very exciting time,” said Dave Lehanski, Senior Vice President, Integrated Sales, NHL. “With the most ambitious series of big events in League history planned for this season – six outdoor games over 61 days – we are delivering unprecedented fan engagement while offering our partners more opportunities to activate than ever before.”
"The NHL deal provides a terrific platform for driving the launch of our new, fast acting Advil® line,” said Brian Groves, U.S. Chief Marketing Officer at Pfizer Consumer Healthcare. “Advil® is built to be as fast as it is tough. We see the players and the League as embodying the fast acting Advil® promise of fast recovery from tough pain."
About Advil®
Advil® is the number-one selling over-the-counter pain reliever in the United States. Advil® provides relief from multiple aches and pains -- including headaches, backaches, muscle aches and minor arthritis pains. The Advil® line of products also includes Children’s Advil®, Advil® PM, Advil® Cold & Sinus, Advil® Allergy Sinus, and Advil® Congestion Relief and the new fast acting Advil®, available in stores now. Use as directed.
Pfizer Inc.: Working together for a healthier world™
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more, please visit us at www.pfizer.com.
About the NHL
The National Hockey League, founded in 1917, is the second-oldest of the four major professional team sports leagues in North America. Today, the NHL® consists of 30 Member Clubs, each reflecting the League’s international makeup, with players from more than 20 countries represented on team rosters. According to a Simmons Market Research study, NHL fans are younger, more educated, more affluent, and access content through digital means more than any other sport. The NHL entertains more than 250 million fans each season in-arena and through its partners in national television (NBCSN, NBC, TSN, CBC, RDS, RIS, and NHL Network™) and radio (NHL Radio™, Sirius XM Radio). Through the NHL Foundation, the League’s charitable arm, the NHL raises money and awareness for Hockey Fights Cancer™ and NHL Youth Development, and supports the charitable efforts of NHL players. For more information on the NHL, log on to NHL.com.
Photos/Multimedia Gallery Available: http://www.businesswire.com/multimedia/home/20130930005842/en/
MULTIMEDIA AVAILABLE:http://www.businesswire.com/cgi-bin/mmg.cgi?eid=50718545&lang=en
Contact:
Pfizer Inc.
MacKay Jimeson, 212-733-2324
MacKay.Jimeson@pfizer.com
or
NHL
Kerry McGovern, 212-789-2172
kmcgovern@nhl.com
d44, that is simply a trade reconciliation that the market maker has to clear out - its from trades the occurred earlier in the day. The A/H is jumping up, then down with these trades - so probably best to discount them unless we start seeing trade after trade in more of a tight range.
Have a good weekend all!
Sometimes you have those days when you get a utterly nasty tasting brussel sprout in with the good ones, heh chef?
We've hung together this far.....
I did and the result is reflected in my previous comment(s).
Kenasgold, ultimately it will be whatever the FDA approves and the particular name, whatever it is, will be what is used. This issue of Otrexup or Otrexyo or JointJuice (;)) trademark names is a non-issue and has zero bearing on the upcoming PDUFA date.
Perhaps for us retail shareholders - belt AND suspenders approach.
Importantly, I note that the "Suspension Notice" was sent to Antares legal counsel (Ahmed Riaz) on March 20 this year. Also, PFE may never use the trademark that they filed. They could let it die on the vine, resulting in abandonment of their application. Because of the similarity between the two trademarks this suspension notice was sent during the period that pfe has to file a "statement of use" if indeed they intent to use it.
My guess is Antares legal counsel has talked with PFE legal counsel.....
Thanks Ryman, to add to your post, the second link below is THE actual letter.
It looks like the Pfizer filing of similar trademark, Otrexyo) was actually earlier (9/20/12)and Antares filing for Otrexup was 11/2012. They are similar and the USPTO desires to avoid "likelihood of confusion". A suspension letter means you need to wait your turn. This is a procedural issue.
http://tsdr.uspto.gov/documentviewer?caseId=sn85788191&docId=SUL20130320134642#docIndex=0&page=1
http://tsdr.uspto.gov/documentviewer?caseId=sn85788191&docId=SUL20130320#docIndex=0&page=1&tdrlink=
U.S. APPLICATION SERIAL NO. 85788191
MARK: OTREXUP
*85788191*
CORRESPONDENT ADDRESS:
AHMED RIAZ
100 PRNCTN S CORPT CTR STE 300
EWING, NJ 08628-3439
GENERAL TRADEMARK INFORMATION:
http://www.uspto.gov/trademarks/index.jsp
APPLICANT: Antares Pharma Inc.
CORRESPONDENT’S REFERENCE/DOCKET NO:
N/A
CORRESPONDENT E-MAIL ADDRESS:
ariaz@antarespharma.com
SUSPENSION NOTICE: NO RESPONSE NEEDED
ISSUE/MAILING DATE: 3/20/2013
The trademark examining attorney is suspending action on the application for the reason(s) stated below. See 37 C.F.R. §2.67; TMEP §§716 et seq.
The USPTO will periodically conduct a status check of the application to determine whether suspension remains appropriate, and the trademark examining attorney will issue as needed an inquiry letter to applicant regarding the status of the matter on which suspension is based. TMEP §§716.04, 716.05. Applicant will be notified when suspension is no longer appropriate. See TMEP §716.04.
No response to this notice is necessary; however, if applicant wants to respond, applicant should use the “Response to Suspension Inquiry or Letter of Suspension” form online at http://teasroa.uspto.gov/rsi/rsi.
PRIOR-FILED PENDING APPLICATION FOUND: The trademark examining attorney has searched the USPTO’s database of registered and pending marks and has found no similar registered marks that would bar registration under Trademark Act Section 2(d). TMEP §704.02; see 15 U.S.C. §1052(d). However, a mark in a prior-filed pending application may present a bar to registration of applicant’s mark.
The effective filing date of the pending application identified below precedes the filing date of applicant’s application. If the mark in the referenced application registers, applicant’s mark may be refused registration under Section 2(d) because of a likelihood of confusion with that registered mark. See 15 U.S.C. §1052(d); 37 C.F.R. §2.83; TMEP §§1208 et seq. Therefore, action on this application is suspended until the earlier-filed referenced application is either registered or abandoned. 37 C.F.R. §2.83(c).
A copy of information relevant to this referenced application is attached to this suspension notice.
- Application Serial No. 85775440 (OTREXYO for pharmaceutical preparations)
Action on this application is hereby suspended. If applicant has any questions, please contact the examining attorney.
/Elizabeth A. Hughitt/
Examining Attorney
Law Office 111
U.S. Patent and Trademark Office
571 272 9384
beth.hughitt@uspto.gov
PERIODICALLY CHECK THE STATUS OF THE APPLICATION: To ensure that applicant does not miss crucial deadlines or official notices, check the status of the application every three to four months using the Trademark Status and Document Retrieval (TSDR) system at http://tsdr.uspto.gov/. Please keep a copy of the TSDR status screen. If the status shows no change for more than six months, contact the Trademark Assistance Center by e-mail at TrademarkAssistanceCenter@uspto.gov or call 1-800-786-9199. For more information on checking status, see http://www.uspto.gov/trademarks/process/status/.
TO UPDATE CORRESPONDENCE/E-MAIL ADDRESS: Use the Trademark Electronic Application System (TEAS) form at http://www.uspto.gov/trademarks/teas/correspondence.jsp.
silvrmoon, this is the no kill zone and no spin zone. haha back at cha.
So T-minus 3 weeks till the PDUFA date and here we are treading water just above 4 bucks. This trading baffles and surprises me in a way. I'm at the point where I'm thinking we won't see any "exciting" trading until right before the date of expected approval and if this trades anemically up until the FDA determination, then I hope that is what the market is waiting on and waiting for - and only then do we positive market reaction with a decent rise in price.
And the way this is trading, the best scenario I can see is we get a surprise (meaning early) approval, then the volume goes ballistic with a nice rise in price.
And lastly to parrot d44, wtfdik!
Just to reinforce, there is NO offering in the works and this was confirmed when I talked with Jack this morning and his answer to my direct question on the subject was without hesitation, "NO."
Fyi, on a new NE Journal of Medicine study that hit the news wires today:
http://www.bloomberg.com/news/2013-09-11/male-sex-drive-depends-on-both-estrogen-and-testosterone.html
Male Sex Drive Depends on Both Estrogen and Testosterone
By Shannon Pettypiece - Sep 11, 2013 11:00 PM CT
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Estrogen, the main sex hormone in women, plays a bigger role in male libido than previously thought, according to research that may guide development of sex-drive treatments.
The study found that reducing estrogen in men undergoing treatment for low testosterone resulted in a drop in libido and an increase in body fat, even as testosterone levels improved. The research is published in the New England Journal of Medicine.
The finding surprised researchers, who have believed the testosterone caused men to have stronger sex drives than women, said Joel Finkelstein, a study author and endocrinologist at Massachusetts General Hospital. While it’s known that the body converts some testosterone into estrogen and that the hormone declines in men with low testosterone, researchers didn’t fully understand estrogen’s role in male sexual desire.
“What will surprise many people is that loss of sexual desire in men with low testosterone is due to lack of estrogen,” Finkelstein said. “People think estrogen in men makes them very effeminate; they think of it as a female hormone, they think it is testosterone that gives men their sexual desire.”
While there have been clues that estrogen as well as testosterone influence male sex drive there have been few definitive studies until now, Finkelstein said.
Previous Findings
Researchers have found a drop in libido in mice by cutting their estrogen. There also have been anecdotal reports of men undergoing sex changes who see an increase in libido when they start estrogen therapy. In women, it may be the opposite, where testosterone plays a bigger role than estrogen in their sex drive.
“Both sexes require the opposite gender hormone to have adequate libido,” he said.
In the study, researchers looked at more than 300 men ages 20 to 50 that were given treatments to suppress production of all reproductive hormones. Half the men were then given a testosterone-boosting gel or a placebo. The other half received the testosterone gel along with a drug that lowered the production of estrogen.
The researchers found that testosterone was the main hormone involved in lean body mass and muscle strength. Estrogen played a bigger role in fat accumulation. While low testosterone did cause a decline in sexual desire, those getting the estrogen-suppressing drug saw a greater drop-off.
Testosterone Treatments
The finding shouldn’t mean a change in treatment for men with low testosterone. Since the body is able to convert most commercially available testosterone replacement therapies to estrogen, raising testosterone will in turn boost estrogen levels as well. It should, however, discourage drugmakers from trying to develop new forms of testosterone replacements that aren’t able to be converted to estrogen, Finkelstein said.
The U.S. market for testosterone replacement therapies, such as Eli Lilly & Co. (LLY)’s Axiron and AbbVie Inc. (ABBV)’s Angrogel, is almost $2 billion with as many as 13.8 million men older than 45 in the U.S. having low levels of testosterone, according to a 2006 study in the International Journal of Clinical Practice. Lower-than-normal levels can lead to a loss of libido, a decrease in bone and muscle mass, and depression.
Despite, testosterone products being available for decades, Finkelstein said more research is needed into the health benefits and side effects of testosterone, especially in men over 50.
“It is amazing what we don’t know,” said Finkelstein. “Even the most basic things we don’t understand about this drug that has been around for almost 80 years.”
Got it, rph and I agree with you. Very good point!
rph, you wrote: "Another idea that I'll run by everyone... most people I've seen comment seem to think Vibex QS M is scopolamine. Why would they advertise it in their pipeline even though they have not been granted the rights to it yet? Makes no sense for a reputable company to count their chickens before they hatch."
Not sure about what you wrote. Why would they advertise it in their pipeline...? They aren't as far as what I've seen, they only state QS M (neurology). And we won't know what it is until they get this out of preclinical and into the clinical trials.
Also for a clarification is anyone saw my post on ymb (3rd post in a series) when I mentioned the PFE / Antares clinical trial. It looks like very soon after I reviewed the trial for the 5% gel and the latest date of August, they updated the trial date to September. But importantly, they are still in the "enrollment" phase. I expect another payment from Pfizer when enrollment is completed or at least I hope that is the case.
In my opinion, now that the video has been removed and by the person who posted it - "removed by user" it now says, it was a sad attempt by someone to undermine Antares.
No company, NO COMPANY, can market a product (or in this particular case) to put out a video on a product unless the product is approved by the FDA. The FDA cracks down on attempts like this and punishes a company that does attempt these sort of things. This attempt would only serve some sinister person who is shorting the stock or a sinister motive by Antares competition. And I don't think the competition would or could be so incredibly stupid to try such a thing and have it back fire and face SEC and FDA sanctions.
On the bright side, someone is really desperate, plus someone is really dumb.
... it is bogus.
Ryman, perhaps at some point in the future Antares will utilize and embrace more cutting edge communication methods - particularly after securing their in-house branding.
Take a look at Leroux's Linkedin photo which is his most recent photo. Why would Leroux not use his most recent photo in that video but instead what appears to be a younger Leroux. Why would Leroux not say anything or post anything, even in general terms about what was going on in the video.
Too many scammers out there for me to get sucked in to anything anyone posts on a message board. I have Loko on ignore (and I saw from the ymb post from tappy, that he is still calling me out in his posts) as I grew tired of reading his tortured mindless ramblings (he was better when he posted as stockrafter but then still came unraveled).....but given the last two internet "discoveries" of his (as I learned from this board), he needs to be a better researcher and not post for the sake of 'being the first' to find something (but then that does feed his ego I guess or else he is a learned student of stockdaug and following in stockdaugs trading footsteps). He needs to verify first, then post his findings. Verify with Antares first and as a true investor of the company should. If he was worth his salt, he would talk to Antares first - but then maybe that wouldn't fit into his trading plans.
I'm going to bet that the internet message board and SA awareness of the NIH Antares license by Loko was probably not appreciated in that getting that info broadcast to everyone (particularly to the competition)was not well received. I'm thinking the 'official' NIH notification was enough and all that a company on the potential beneficiary receiving would want to have released.
Why would Leroux Jooste (supposedly) post this video and then not type/post anything about what is being done on the video?????? In my book, this video is not legit but a scam by someone. Plus, "Its so easy a kid could do it" is a youtube series.
If one right clicks on the photo and "inspects" the elements, the photo is a "google.jpeg" photo which means the person posting this got the photo from a google search. Why would Leroux have to google for a photo of himself??
Welcome back from your sabbatical, SP1! I was almost getting worried about you.
And nice post!
If I knew the answer to that, I'd be retired on an Island in the Caribbean.
My inclination is not much of a run-up until right before the October PDUFA date which will be speculation of buying a rumor, then with approval a sell off - which will not be a sell off in a negative way but traders who bought the rumor and then eeking out their profit and selling. Antares is not immune to that kind of play.
The company has broadcast for sometime now that this event is key which in my book (for now anyway) puts everything else in second place. The FDA approval of OTREXUP and the ensuing validation of Antares injector platform is a game changer, imo. At this point, I think the investment world has listened to the story, heard the story, knows the story and now says, "okay Antares, prove it."
I'm invested for the beyond OTREXUP PDUFA date, so I'll be an observor.
Thanks Whogo for the input!
whogo:
Regarding your statement: "I've thought about that possibility a few times, but they've sort of mislead investors if it turns out to be true. QSM is supposed to be another internally developed program whereas Copaxone would be a partnered program. I like that idea a whole lot more then Methylcobalamin."
Why couldn't QSM be completely internal at this point? Who's to say it would not develop into something more down the road with TEVA letting them (knowing or unknowingly) take the lead? In the meantime, the trials you mention are or would be or will be conducted. Eventually, a generic Copaxone will be approved I believe and TEVA may see the writing on the wall. I recall maybe a couple years ago, then US TEVA guy, Bill Marth, made the statement that TEVA knows Copaxone is on its last legs or something to that effect.
Just letting the brain dump continue....
Whogo,
At the risk of the absurd, do you think there is any way that QS M could be Copaxone and that Antares has TEVA's blessing and that like Sumatriptan, TEVA will eventually be the supplier of the drug? When would QS M get to market? 2016 - 2017? By then many TEVA copaxone patents will have expired right?
Hi TD and thanks!
The relationship with TEVA, when listening to CEO Wotton talk, seems to have been elevated - there has been some expansion in their collaboration.
I'm not sure about the use of the word "molecule" as sometimes I believe the word molecule in this space can be a catch all in that both methotrexate and testosterone are also considered, "molecules". And at one time these drugs or molecules were all considered by the FDA, a NME (New Molecular Entity) filing, yes? Today, they are not NME's but still molecules or even at some point, "generic".
Along the same lines as your hypothesis, I'm curious about some language Apple used back in March in describing one of the TEVA/Antares pen programs when he stated: "that will be an ANDA filing shortly or, at least, an acceptance of one. And we're looking forward to that moving along. That would typicallyinsert-text-here." Typically??? Usually, it's an "automatic" filing of a potential patent infringement by the branded holder. I'm still trying to figure this one out.
What is rattling around in my head these days is a potential Copaxone future using Antares business model or as Paul put it, Antares Therapeutic Product (ATP) business model. Question is when could this molecule come into that fold? Would Antares wait until a TEVA Copaxone patent expiry? Could they be in a current collaboration regarding Copaxone? (By that I don't mean the current 3TW 40mg dose TEVA program). Could Antares actually be working in concert with TEVA (in Europe) for the 505b2 approach that would tie in with what TEVA's Jeremy Levin said about a "potentially a follow on COPAXONE on May 14." See below.
Could Antares already be in the infancy of developing a Copaxone drug / pen combo - with the blessing of TEVA with favorable financial partnership terms to Antares? TEVA does acknowledge that time is running out and Copaxone is a big revenue producer for them. I remember Apple last March addressing the shift in how TEVA was viewing Antares capabilities - in this case with sumatriptan - see below. Could TEVA want Antares to do the same thing with their Copaxone?
A lot of pure speculation for sure. But at some point, imo, Copaxone will have an Antares footprint on it!
Recent notes from TEVA and Antares CC's and from which produced the above brain dump.
Jon Congleton - Senior Vice President and General Manager, Global CNS
"We know that there is great interest in the efficacy and safety and tolerability of COPAXONE and looking to advance the way that patients can administer it, how they can utilize it.[url][/url][tag]insert-text-here[/tag] It has always been of interest to them. We have always tried to bring improvements to the market.
So we will be prepared for as big of one uptake as can be met by the market. It could be anywhere from a third to a half, based on the research we have right now. I think it's also critical to know what the timing, as Jeremy said, in his statements of an approval early next year, with the planning of potentially a follow on COPAXONE on May 14."[url][/url][tag]insert-text-here[/tag]
Also, : Jeremy Levin - President, Chief Executive Officer
Good morning, everyone, and welcome to Teva's second quarter earnings call.
As you all know, we have had a very busy week. The U.S Federal Court of Appeals confirmed validity of select COPAXONE patents through May 2014, but not others including one patent expiring September 2015. We are disappointed with this part of the Appeals Court decision and we will appeal that decision.
To me this paragraph above may be what Wotton was referencing regarding his Copax comment during the last Healthcare Conference (and I noted this before as well), meaning Copaxone to be another Antares drug to be delivered via their injector platform once it goes off patent.
Robert F. Apple - Chief Financial Officer, Chief Accounting Officer, Executive Vice President, Secretary and President of the Parenteral Products Division
Sure. On the epinephrine program, obviously, we have a date that's been settled between Teva and Myelin and Pfizer, a launch date of June of '15. And we believe we'll hit that target date. And we're hoping to get the approval of our auto-injector, obviously, well before that. With regards to the one of the pen programs, the ANDA, we believe that's very -- that will be an ANDA filing shortly or, at least, an acceptance of one. And we're looking forward to that moving along. That would typically -- once it's filed, it would probably be subject to a 30-month stay, but we'll see where that goes once that filing is made. [url][/url][tag]insert-text-here[/tag]And then as far as the sumatriptan program, we are finishing up our final information that we need to send to the agency to get that approved, and we're hoping that happens as far as the filing next few months. And then it's really up to the FDA as to how quickly they'll review the information that they requested before. It's not like we're back in Q of a review process, but obviously, responding to questions has its own kind of timeline that is unknown to most people.
Paul K. Wotton - Chief Executive Officer, President and Director
Yes. And there's another program with the multi-dose pen as well, which is being spearheaded in Europe, Matt, which will be initially, what I would say, a branded generic 505(b)(2) type of approach. [url][/url][tag]insert-text-here[/tag]And that program is moving along real well, too. So all of our programs actually with Teva have gone extremely well the past few months. And I would say that the relationship with Teva goes all the way up to the top of the company and across the company. And I'm going to tell you this for nothing, it's better than it's ever been before. And I'm very pleased with the amount of progress and the attention we get at Teva now
From March 13, 2013:
Apple to Aaron Hartley, Ladenburg Thalmann. Teva came to us and realized that we've been doing much more insert-text-hereYes, and we're going to be doing all these with the same equipment that were used in methotrexate, that were doing all the methotrexate manufacturing and commercial packaging until there's a real synergy from a capital standpoint to be able to do this
Nice, any agreement with Merck for a drug ($60 million worth over 3 years) at long care nursing home care institutions is a winner!
Speaking of nursing home care, here's a toast to remember, when raising your glasses simply state: "here's to one less day in a nursing home."
Holy schitzkeys Batman! Something new is brewing from the French Quarter and its not Emeril Lagasse, Harry Connick Jr or chef d44.
For those that just don't have the time to read the 10+ page transcript, just for you....can you feel the love??
Earnings Call Aug 7, 2013 my Abstract of the Transcript provided by Seeking Alpha.
This abstract will solely focus on the programs discussed during the call and as such, not the financials which are readily available and clear.
Recap / Intro from CEO Wotton:
• Extremely active 2nd Q
• Update for Otrexup launch – primary focus
o Successfully recruited highly qualified 8 person marketing and sales team resulting in over 100yrs of experience in marketing, launching and selling.
o Engaged 6 national account managers (agreement with Quintiles, largest provider of commercial outsourcing services in the development / commercializing the top 50 selling drugs on the market.
o Already met with 3rd party payers.
o In process of engaging 6 medical science liaison professionals to implement sales force activity w/ approx 25 personnel in 4th Q.
o Grew Board of Directors with recruitment of Marvin Samson (Former Group VP Worldwide Injectables at TEVA, founded Sicor) and Bob Roche Jr., (former Exec VP,Worldwide Pharma Operations Cephalon).
o Recently participated in prestigious European League Against Rheumatism (EULAR)
o Successfully manufactured the validation batches of OTREXUP.
o Conducted positive mid-cycle review with FDA – continue to have positive interactions.
o April saw 1st shipment to TEVA of the Vibex EpiPen and pleased with progress made w/ respect to broad partnership with TEVA
• Intellectual Property
o Over the past 18 months, filed 43 patent application and received 9 new patents.
o In June, USPO issued patent number 8,480,631 (Hazardous Agent Injection System for OTREXUP = 17 years of intellectual property protection for OTREXUP.
o QS device received a new patent no. 8,496,619 (QuickShot device QS T)
? Accelerated development of QS T program
? Expect initial dosing of 1st patients during the 3rd Q
? Continue to plan for a 2016 launch.
? 100% dosage efficiency
“EXPECT TO SEE MUCH MORE SUCH OPPORTUNITIES EMERGING FROM OUR PIPELINE”
Antares Business Model Recap:
o Implemented October 13, 2008, implemented a 5 year strategic plan.
o Refocus the business
o Invest in the pipeline
o Establish position as a specialty pharma co. built on world class injection technology.
o Market cap of $.5billion
o Only US company with comprehensive range of injector platforms.
o ANDA for the 1st multi-dose pens on track.
o FDA (this yr) all 3 device platforms (needle free, VIBEX Medi Jet and multi dose pens) will either been filed and under review or potentially approved for marketing.
o Disciplined approach to screening potential drug device combinations to create novel products.
o Screened approx 200 compounds resulting in 60 interesting candidates.
o 30 compounds deemed feasible.
o 3 to date have been selected (OTREXUP, QS T and QS M)
o Our product process targets already approved molecules.
o Pursuing (always) meaningful clinical benefit with the route switch to SubQ delivery.
o Produce enhanced products with significant revenue potential.
o Antares is an efficient 505(b)(2) machine.
o Entering a new planning cycle.
TEVA:
o EpiPen program, launch date of June 2015, believe that target will be met.
o Approval of the auto-injector well before that date is our belief.
o ANDA program – filing shortly – expect a 30 month stay once filed.
o There is another multi dose pen program as well.
o Spearheaded in Europe
o A branded generic 505(b)(2) type of approach (moving real well)
o TEVA relationship “have gone extremely well the past few months. And I would say the relationship with Teva goes all the way to the top of the company and across the company……it’s better than it’s ever been before.”
I'll say $4.58 close....was I close?? ;)
Transcript link for today's excellent call below.
http://seekingalpha.com/article/1615552-antares-pharma-management-discusses-q2-2013-results-earnings-call-transcript?source=email_rt_article_readmore
Thanks for the link, pepotelargote.
I saw the dual entries and the only thing(s) I can think of to explain the two is for the two indications: one is for RA and the other for Psoriasis.
Hi Tappy, bsav and all,
Bsav is a busy, traveling dude as you know tappy! South America is better off with his presense but the board misses the steadiness and logic of his posts. But it is always good to see a post every now and then when he has the time.
It's now just 3 months, 12 weeks away from the PDUFA date and no news is good news. The incubation period of their baby is as expected and things are looking good to go!
Steady as she goes.
Tappy, the four components of the Antares mafia are alive and well! We debate, dissect, shake it up, challenge, imagine the unimaginable and then take comfort on relying on the unreliable.
Considering those two options:
Management has two choices when they exercise their options. #1. Those options can be converted into shares. #2. They can convert those options into shares & immediately sell them.
#1 contemplates the recipient holding the shares until another time and then convert into shares and sell. Q: So when do they sell having intimate knowledge of the inner workings of the company? Right before or after some significant event they have intimate knowledge of? Risk the SEC crawling up their colons with a magnifying glass?
Point is, if they are executing against their strategic plan and building value for the company, they will have the ability to exercise additional incentive shares options after the fact.
I thought I'd double down and post what I posted on the ymb - my response to a post of yours, ryman.
Happy 4th to all!
But first, how about a paradigm shift to the statement that, "100% about sending a poor message to market". How about "the markets inherent inability to interpret the message correctly."
Thanks ryman.
It would help for investors to not confuse the past history of insiders buying and selling their own shares on the open market and what is going on here (and else) post SEC rule 10b5 along with the Sorbanes Oxley Act of 2003.
Investors hear about and read captions and posts about Executives selling their stock and the knee jerk reaction is 'oh no, something must be wrong.' To me, that's the unfortunate message that is still prevalent today.
In my book, what we are witnessing is not "insider selling" but a rather simple but structured act of the Executives exercising their (ISO's - incentive stock options) that they earned per the BOD (with shareholder approval) of the 2008 Equity Compensation Plan. This is how they can augment their base salary when achieving, meeting and/or exceeding the goals set by the BOD. If they don't meet the specific performance goals - then no options to be had to convert to shares.
Rearview ponders, "what is the motivator ot sell before events which presumably lead to significant upward valuation...." answer is the 10b5 that eliminates or provides an affirmative defense that the Executes where not selling (or buying) when in possession of MNPI's (material nonpublic information). Plus if and when they are awarded these options that are exercisable and they don't use them, what is there value to them? Zero. If I had options that I earned and were available for me to turn into cash and do something with, I would rather have in my pocket the capital than to have it sit there worthless. Plus I could potentially at some point in the future, reinvest it in whatever I choose, even to buy shares in the open market. But then, buying shares in the open market would be tough when you are a CEO (like Wotton) who is the rain maker and almost always in possession of MNPI's.
But, wtfdik
Thanks Ryman - those links provide a wealth of information on the existing RA treatments / therapies, what they do, side effects, cost per month, etc.
My post made it onto Ali's motley fool article, but the same post didn't make it onto AF's article:
http://beta.fool.com/ay97022110/2013/06/30/a-critical-look-at-antares-pharma-in-adams-biotech/38952/
Thanks for this write up Ali. Serves as a much more informed piece on Antares than the AF article.
I tried to post my own (as an admittedly pedestrian retail investor) thoughts in the comment section of AF's article to no avail, so I'll try your venue if you don't mind.
Regarding AF's article I wrote:
Your write up on Antares, while appreciated for the exposure, falls short imo in factual information for this longtime Antares shareholder. I have found much greater transparency and available information regarding the clinical studies along with my Healthcare (Antares) Conference notes (Jefferies, Bank of America, Oppenheimer, Cowen, RBC), etc, conversations with Jack Howarth (Antares VP Corporate Affairs),
Antares 10-k and Antares Investor Presentation(s) available via Antares web site along with the FDA's web site.
You mention in your article a recent discussion with “Antares spokeswoman Elaine Andrecovish”. I’m wondering why your discussion wouldn’t be with Jack Howarth, the in-house go to person for shareholders, retail and institutional alike?
For what it's worth, below is my own 'white paper' summary on Otrexup.
Why Investors should feel confident with an FDA approval of Otrexup.
Pre-NDA / FDA submission studies:
* Human use and human factors usability studies produced positive results.
* Studies showed Otrexup was safe and effective for RA patients w/ moderate to
severe hand function impairment AND self administration of MTX using Antares
Medi-Jet device is ALSO safe and well tolerated with virtually no pain.
* Completed successfully the final and most important clinical study necessary to
support the NDA – study compared the relative systemic abailability of MTXfollowing old method ofadministration to Sub Q self administration of Otrexup and the systemic availability of MTX increased proportionately at every dose, 5, 10, 20 and 25 milligrams.
* Several in place, new patent applications for Otrexup along with filing a trademark application with the USPTO for the brand name Otrexup.
* A Pre-(Otrexup) NDA meeting with the FDA resulted in awareness of an additional treatment option – psoriasis.
* All clinical trials completed with positive results.
* Antares conducted a 4Q12 meeting with the FDA and reconfirmed regulatory pathway.
* Antares is proactive with the Agency.
* Head of the Otrexup program is Leroux Jooste, who previously in 1999, personally brought the DMARD Enbrel to market.
FDA / NDA filing:
* Completed. No refusal to file (RTF) from the FDA. No missing information experienced with the filing.
· Filing was accepted resulting in PDUFA October 14, 2013, no omissions of data or other deficiencies.
· Antares continues proactive FDA communications and Mid-cycle review with the
FDA went “very well.”
· 6 ½ months have past, 3 ½ months left till
approval and “no news (from the Agency) is good news.”
What is Methotrexate (MTX)?
* An already approved and marketed drug.
* Considered the “gold standard” or “foundation of RA treatment.”
* MTX is the most commonly prescribed (DMARD) in use today.
What are clinical trials and how do they relate to drug approval?
1. Whether the drug has the effect it is suppose to have. (Confirmed by
usability studies)
2. How much of the drug to give to a patient and how often. (Confirmed 5, 10,
20 and 25 mg)
3. What side effects are associated with the drug. (Safe and effective)
4. How a drug is broken down in the body and how long it stays in the body.
(Confirmed, safety and efficacy studies)
5. Which foods, drinks, or other drugs can be used at the same time or should
be avoided (contraindicated). (Confirmed, no treatment-emergent serious adverse
events related to MTX)
6. Clinical trials results allow the FDA to make decisions about whether or not a drug should be approved for marketing.
The first five bullet points have been satisfied by the clinical trials conducted by Antares and through the historical documentary on the already approved medicament, methotrexate. The sub Q delivery of the already approved drug, mtx, via Antares Medi-Jet device along with the positive, complete and thorough studies point to FDA approval for Otrexup and its marketing.
Braun, et al (2008): Subcutaneous MTX (15 mg/wk) provided better efficacy than
oral MTX without a higher rate of adverse events (N=375).
• Kremer, et al (2009): Switching from oral to SC MTX resulted in clinical
improvement explained by accumulation of long chain polyglutamated MTX.
• Bakker, et al (2011): Switching from oral to SC MTX resulted in tight control
of RA in an additional 10% to 15% of patients, avoiding the use of a biologic
in those patients (N= 236).
• O’Dell, et al (2011): One-third of patients started on MTX alone had an
"excellent" response that persisted out to two years. Furthermore, patients who started on MTX had radiographic evidence of disease control to those starting on MTX plus a biologic agent (N=766).
• Schipper, et al (2011): Pharmacoeconomic evaluation of costs and efficacy of
starting patients on MTX-alone vs. MTX plus anti-TNF in early RA results in
similar remission rates, favoring an MTX-alone approach.
Fitzpatrick, et al (2011): In a study of resource utilization in RA management, the
authors conclude, “…there is clear evidence that SC MTX, certainly from a cost
perspective, is definitely worthwhile because it reduces cost of treatment
without compromising patientcare.”
Liakos, et al (Eular Conference 2012): Subcutaneous methotrexate is more efficacious and better tolerated than oral methotrexate: The experience of a large group of patients in the rheumatology department of a district general hospital.