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Back in 2003, Antares and Eli Lilly had an agreement for Diabetes / Obesity. Just trying to see if there is any connection still.....
First, from one year ago:
"Transition Therapeutics Inc. announced the results of a single ascending dose escalation study of TT-401, a type 2 diabetes drug candidate. TT-401 is a once-weekly administered peptide being studied for its potential to lower blood glucose levels in patients with type 2 diabetes and accompanying obesity. TT-401 is a dual agonist of the GLP-1 (glucagon-like peptide-1) receptor and a second metabolic target.
The Phase 1, double-blind, placebo-controlled randomized study enrolled 48 non-diabetic obese subjects in six cohorts evaluating six escalating subcutaneous single doses[url][/url][tag]insert-text-here[/tag] of TT-401. TT-401 demonstrated an acceptable safety and tolerability profile in non-diabetic obese subjects in the study. TT-401 exhibited the expected pharmacological effect on glucose and pharmacodynamic biomarkers at doses that were safe and tolerable. The pharmacokinetic profile, assessed over 28 days, demonstrated a half-life consistent with once-weekly dosing.
As the study results have met expectations, Transition and its development partner, Eli Lilly and Company have jointly decided that the next development step will be a multiple ascending dose study of TT-401 in obese subjects with type 2 diabetes.
In March 2010, Transition entered into a licensing and collaboration agreement with Lilly, where Transition acquired the rights to a series of pre-clinical Lilly compounds, including TT-401 for the treatment of type 2 diabetes.
Date: June 18, 2012"
Today's news has Lilly taking over all development rights for this sub Q diabetes drug candidate: [url][/url][tag]insert-text-here[/tag]
"Transition Therapeutics Inc. recently announced that Eli Lilly and Company has exercised its option to assume all development and commercialization rights to type 2 diabetes drug candidate TT-401. In conjunction with this assumption of rights, Transition will receive a $7-million milestone payment.
Lilly and Transition have amended their agreement to address future development of TT-401 and associated financial arrangements. Lilly will assume all costs and perform all future development and commercialization activities of TT-401. Transition will contribute payment of $14 million to Lilly in three separate installments during the Phase II clinical study. If TT-401 is successfully commercialized, Transition will be eligible to receive approximately $240 million in additional milestone payments. Transition will also be eligible to receive a double-digit royalty on sales of TT-401 products and a low single-digit royalty on related compounds.
"We are encouraged by the early data seen to date with TT-401, and are pleased by the efficient and thorough process by which Transition Therapeutics conducted the Phase I studies," said David Moller, Vice President of Endocrine and Cardiovascular Research and Clinical Investigation for Lilly. "We look forward to continuing the development of TT-401, as it supports our strategy of offering a broad portfolio of therapies for people with diabetes."
"We are very pleased with Lilly's commitment to the development of TT-401. The Phase II efficacy study and parallel product development work will be performed by Lilly's world-class clinical development team. Our additional financial contribution secures a greater vested interest for Transition, and we welcome the opportunity to invest in this drug candidate that has shown encouraging data in the recently announced human proof-of-concept study," added Dr. Tony Cruz, Chairman and Chief Executive Officer of Transition.
TT-401 is a dual agonist of the GLP-1 (Glucagon-Like Peptide-1) and glucagon receptors, which is being developed to treat type 2 diabetes and accompanying obesity. In March 2010, Transition entered into a licensing and collaboration agreement with Eli Lilly and Company, where Transition acquired the rights to a series of preclinical compounds from Lilly, including TT-401 for the treatment of type 2 diabetes.
Transition is a biopharmaceutical company, developing novel therapeutics for disease indications with large markets. The company's lead CNS drug candidate is ELND005 for the treatment of Alzheimer's disease and bipolar disorder. Transition's lead metabolic drug candidate is TT-401 for the treatment of type 2 diabetes and accompanying obesity. For more information, visit www.transitiontherapeutics.com."
"Five patients (10.2 percent) had a treatment-emergent adverse event; one patient in the oral MTX group experienced mild and transient nausea. Some patients in the delivery device group had slight to barely perceptible erythema at the injection site after administration."
It is not crystal clear but I'm guessing the break down is as you guess.
Out of the five, one in the oral group reported a TEAE (mild and transient nausea - typical kind of treatment-emergent adverse event for oral delivery) and the rest or "some patients" in the sub Q group reported the slight to barely perceptible erythema at the injection site.
I agree the reported TEAE's are not a real concern and as the report notes: "No patients experienced bleeding, ecchymosis, or hematoma at the injection site or required countermeasures during the study. No patients discontinued the study because of an injection site reaction."
OT:
BLACKHAWKS WIN THE STANLEY CUP!!!! What an ending to the game!
BSAV88 and I now get to get stop emailing each other when they play and get back to 'other' venues at night! ;)
Here's my white paper on why the FDA will approve 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 MTX following old method of administration 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 (oh, by the way!) 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?
• Whether the drug has the effect it is suppose to have. (Confirmed by usability studies)
• How much of the drug to give to a patient and how often. (Confirmed 5, 10, 20 and 25 mg)
• What side effects are associated with the drug. (Safe and effective)
• How a drug is broken down in the body and how long it stays in the body. (Confirmed, safety and efficacy studies)
• 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)
• 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.
Eli Lilly's drug forteo. Nice find Ryman! Looks like another future drug for Antares to bring into the fold. From what I could find, the patent(s) on Forteo start to expire in 2018.
So today for grins and giggles, I followed up and called the Pfizer 1 800 call center number. Its a recording and you leave your name, phone number, email, the study your calling about, etc. So in my message I said I was interested in Study ID B3491010? for the Chicago area, thinking because I live in the 'far' suburban of about 25 miles from downtown Chitown and listed the city previously that I was excluded because I was maybe too far and this would help answer that question. The reply today was:
"Unfortunately, the study you are interested in is not being conducted in your area. Please keep checking the website. If you find a trial you are interested in that becomes available in or near Chicago, please call the Pfizer ClinicalTrials.gov call center at 1-800-718-1021."
So, I'm thinking that maybe the enrollment must not be all that large since they are not including an area like the Chicago area. Or, the areas that will be included have enough of us "weekend warriors" to capture whatever enrollment is required.
ATRS held up quite well today given the beating the market took! Where were all the ATRS shorts the past two days??? One would think we would see more downside like most other stocks. There's resilience being demonstrated and I view that as a plus going forward!
Good points rph. I wonder if during the screening process for all applicants, if they address on a questionaire any involvement in "XYZ" company. But then, if someone is an Antares investor, the argument is "so what, this is a Pfizer trial, I didn't see anything about Antares."
Then also, how does one screen against competitors (plants so to speak) coming in and signing up to do exactly as you note??
I believe it was that space age cartoon character George Jetson that said, "JANE! STOP THIS CRAZY THING!!"
Ryman, when convenient, please delete the duplicated posts....it twasn't moi.
Director Chase also sold 53,000 shares less than a year ago. The least he could do is buy back 10k ;)
Nov 27, 2012 CHASE ANTHONY R
Director
8,900 Direct Sale at $28.17 - $30.21 per share. 260,0002
Nov 26, 2012 CHASE ANTHONY R
Director
1,100 Direct Sale at $29.04 per share. 31,944
Nov 13, 2012 CHASE ANTHONY R
Director
10,000 Direct Sale at $25.65 - $26.26 per share. 260,0002
Sep 6, 2012 CHASE ANTHONY R
Director
33,000 Direct Sale at $13.95 - $14.79 per share. 474,0002
Also, after thinking about this and re-reading my notes from the June 6, 2012 conference - I recall something about a statement that Pfizer had previously completed or conducted P1 & P2 studies a number of years ago. If I recall correctly, then that explains what CEO Wotton said about a P 3 "later this year".
Meaning that did not happen and its 6 months off or 6 months later. And I'm guessing at this point, but guessing that when Pfizer re-approached the Agency, the FDA wanted some of the pre P 3 studies done that we now know have been completed.
This P1 study:
http://www.clinicaltrials.gov/ct2/show/NCT01771822?term=5%25+gel&lead=Pfizer&rank=1
and this P1 study:
http://www.clinicaltrials.gov/ct2/show?term=5%25+gel&lead=Pfizer&rank=3
and now the latest P3 filing:
http://www.clinicaltrials.gov/ct2/show?term=5%25+gel&lead=Pfizer&rank=2
Also, after thinking about this and re-reading my notes from the June 6, 2012 conference - I recall something about a statement that Pfizer had previously completed or conducted P1 & P2 studies a number of years ago. If I recall correctly, then that explains what CEO Wotton said about a P 3 "later this year".
Meaning that did not happen and its 6 months off or 6 months later. And I'm guessing at this point, but guessing that when Pfizer re-approached the Agency, the FDA wanted some of the pre P 3 studies done that we now know have been completed.
This P1 study:
http://www.clinicaltrials.gov/ct2/show/NCT01771822?term=5%25+gel&lead=Pfizer&rank=1
and this P1 study:
http://www.clinicaltrials.gov/ct2/show?term=5%25+gel&lead=Pfizer&rank=3
and now the latest P3 filing:
http://www.clinicaltrials.gov/ct2/show?term=5%25+gel&lead=Pfizer&rank=2
What I remember is that it was Bob Apple that stated, the deal with Pfizer would be disclosed (or discovered) via a filing by Pfizer of a clinical trial. And I recall he said something like, to paraphrase, "probably someone will be find it on clinical trials . gov.
And I just found some notes from the June 6, 2012 Jefferies Conference, see bold faced bullet point below:
"These are my notes from the Jefferies Global Healthcare Conference.
These are specific to slide 7, “Diverse and Advanced Product Pipeline” and what CEO Wotton said of each.
• Three lauched and marketed products (as we all know), TevTropin/Zomajet, Elestrin with Jazz and Gelnique 3% with Watson (US) Daewoong (SK)
• TEVA/VIBEX EPI – launch June 22, 2015
• TEVA/VIBEX 2, filed ANDA – Paul did not mention a specific update other than in reference to the two TEVA pens with filed ANDA's.
• Antares Vibex MTX – NDA to be filed in next 9 months or so, recruiting is ahead of schedule!
• Antares Vibex QS T – a once weekly dose to compete with the gels.
• TEVA Pen 1 – ANDA to be filed in the U.S. by TEVA in 4th Q 2012 – a paragraph 4 filing
• TEVA Pen 2 – a 505b2 U.S. filing, most likely will be filed in Europe ahead of U.S. given the more refined pathway to the market
• Population Council NestraGel – looking for potential partnering opportunity right now.
• Pfizer (undisclosed) – a product going into Ph3 later this year and product will be unveiled when filed on clinicaltrials.gov, but its actually a significant opportunity.
[url][/url][tag]insert-text-here[/tag]
Regarding Paul’s commentary to the two TEVA Pens (1&2), he stated the following:
These are multi dose pens. These pens are typically carried around for like a month and patients such as diabetics use them to inject their medication every day.
Regarding Antares' two proprietary programs, MTX and QST, he stated, 'our own programs, this is where the value, I think, for the company in the future is going to be.'
There was no Q&A session at the end as there was a 'breakout session planned in advance."
Jab9
Whogo, when did you hear that about Antares being the party that would or could reveal once P 3 started? My understanding is whether and when the specific delivery method is revealed, it is in Pfizer's court given they are funding this $20-$30 million trial.
This afternoon, I tried to sign up for the trial from the web site. Not sure why the study doesn't include the Chicago area, unless the study center needs to be within "X" number of miles from the location one plugs in, within the on-line form. Maybe I'll call the number.
"Good afternoon,
You have reached a Pfizer email /call center that processes inquiries made on Pfizer studies posted to the Clinical Trials gov web site.
Unfortunately, the study you are interested in is not being conducted in your area. Please keep checking the website. If you find a trial you are interested in that becomes available in or near ******, IL, please call the Pfizer Clinical Trials gov call center at 1-800-718-1021.
Best Regards,
Pfizer ClinicalTrials gov Call Center"
Chef, I have not looked at AVNR. I could and did just a while ago, but I cannot at this point say much about it. I would need to really dig into it. Sorry!
FWIW on this TEVA acquisition below. I recall the new CEO Jeremy Levin talk about his building of a "constellation" of companies that are strategic to the 'new' TEVA. It was interesting, at least to me, to read about this 'drug delivery'company TEVA is acquiring.
http://www.rttnews.com/story.aspx?ID=2136936
6/17/2013 9:38 AM ET
Teva Pharmaceutical Industries Ltd. (TEVA: Quote) announced it has entered into a definitive agreement to acquire MicroDose Therapeutx, a privately-held pharmaceutical and drug delivery company focused on inhalation technologies and products. Teva will acquire all of MicroDose's outstanding shares for a payment at closing of $40 million, additional payments of up to $125 million upon achievement of regulatory and development milestones, plus sales-based milestones and tiered royalty payments upon commercialization of MDT-637 and an earlier stage Asthma/COPD medicine.
Teva said it will now have access to MicroDose's proprietary technology including its multi-dose dry powder nebulizer device, which requires no preparation and can be administered in under 30 seconds.
yahoo is lousy in that they are apparently so inept with providing any oversight. Hopefully it will get better as we get closer to the PDUFA date in October.
Go Blackhawks and best wishes to JrDeLane!
Tappy,
I believe what you state "and I 'work' for ATRS" is a good philosophy to have when you are an investor and shareholder and I know what you mean. It's a win-win situation for all the right reasons.
And the thoughts about mgmt actually engaging on message boards is a waste. They don't and wouldn't as you note. The only person that sometimes reads the ymb that I know of is Jack and he does so when he has a conversation with a poster (once they reveal themselves and he always trys to get a name up front and if not then he notes that - and the legitimate message board posters state up front who the are and what there alias is) and then Jack will monitor the board to see if that person has posted and/or represented their conversation appropriately. And he does this because he cares.
So getting back to the philosophy of "and I work for ATRS", I guess my own example is when I saw a ymb poster, "nthnsh" post that he talked with Jack and after reading what he wrote, his post didn't make sense and I called Jack and also sent him the post by nthnsh. The poster never called Jack, the poster was lying. And as we all know, that board has a host of liars. Then the poster stated it was 4-6 wks ago that he called. Never happened said Jack again. You see, Jack apparently is very thorough in what he does. He keeps a detailed phone log of all calls he gets and the subject matter. Jack even knows I have a copy cat on the ymb. So, in calling out this poster, I work for my investment, ATRS. Also, as you know, Antares mgmt loves the retail investor. Now there are subgroups of retail investors - you can be a short, a day trader, a flipper, and a long term investor. They love the long term retail investors who gets it. The others are a detriment to the value of the stock.
That's my weekend brain dump!
Have a good rest of the weekend!!
One of the potential drugs - device delivery that has been talked about.
Teva's Lonquex Recommended For Approval In EU - Quick Facts
6/3/2013 1:12 AM ET
Teva Pharmaceutical Industries Ltd. (TEVA: Quote) reported that the Committee for Medicinal Products for Human Use or CHMP has urged that a Marketing Authorization may be issued in the European Union for Lonquex for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy. The CHMP positive opinion opens the way to a final approval decision from the European Commission anticipated within the next few months.
Lonquex is a long-acting recombinant granulocyte colony-stimulating factor based on novel GlycoPEGylation technology. Lipegfilgrastim is a novel, pegylated and glycosylated long-acting form of filgrastim, intended for once-per-cycle fixed dose, subcutaneous injection for neutrophil support in patients receiving myelosuppressive chemotherapy with the exception of chronic myeloid leukemia and myelodysplastic syndromes.
Michael Hayden, Teva's President of Global R&D and Chief Scientific Officer, said: "Effective prophylaxis against neutropenia and febrile neutropenia is a high priority for patients undergoing cytotoxic chemotherapy. This chemotherapy attacks rapidly dividing bone marrow cells and dramatically reduces the ability to fight off infection, which can have serious consequences for patients. Loquenex reduces the neutropenia that can lead to these consequences. We look forward to receiving final approval and being able to offer this medication to patients."
http://yahoo.brand.edgar-online.com/displayfilinginfo.aspx?FilingID=9321740-1191-17428&type=sect&TabIndex=2&companyid=7335&ppu=%252fdefault.aspx%253fcik%253d1016169
fyi on proxy voting results and incentive bonus(es).
Hope everyone had a very good Memorial Day weekend!
Got your email and sorry for not getting back to you promptly! Working on some stuff here.
No, not going to make it. My bro in Lancaster, PA is coming out this way during that time whereas I thought I'd hole up at his place for a few and make the short trip to Phily for the meet and greet. Plus at the same time, my niece (UofC Davis Vet school) student and 2nd yr MD resident nephew will also be in town close by - so family comes first plus I already voted by shares.
Next year, I'm for sure going to make the trip just because! I want to maybe break some bread with Howarth and a few Antares investors!
probably don't need to do this but you all knew what I meant - but I can be a perfectionist!
The other "thing" - not "think".
Not much to add tdp, my friend. I believe Wotton provided just a little more color on the midcycle FDA review in that to paraphrase, "we were satisfied with our dialogue and status with the agency" or something to that effect. The other think that stuck out for me was during the Q&A with the BoA moderator was his question about Copaxone and the adaptability with Antares pen injector and Wotton responded matter of factually of the Antares pen capable of delivering that molecule and also commented or eluded to his own knowledge of the most recent 3TW regimen.
The devil is in the details - of which we know very little to next to nothing.
All in all, Antares is confident in their position(s) on many fronts and I see no reason to cast any doubt otherwise!!
And what about that vacation SP1?? ;).
The end of the beginning is perhaps underway!
http://seekingalpha.com/article/1440871-antares-reiteration-of-my-buy-recommendation?source=email_rt_article_title
From SA author Smith on Stocks.
bsav - good to hear from you!
The "non growth" and grain of salt concerning investor malaise and lackluster with the pps as you put it Grukf, is by past design that is working its way through the system. At least that's my interpretation of what you are saying.
The only thing or item I'll argue that does not belong in the "split of the current revs" is Tev-Tropin. That has been a winner after TEVA converted the Antares pen. This one is not stagnant nor declining and guess what, its an injector and not a gel. And guess what they are now focused on as the lead rev driver - a home grown injector that will deliver at home methotrexate. New products do have to gain market share with incentives, etc as you state. But the subcutaneous in home injectable MTX is a different animal, isn't it. New ballgame. To me, the worry you note, will be in the rear view mirror and much less of a factor moving forward.
I think investors in Antares today, either get the story or they don't. Either they understand the shift from partnership royal based revenues to high margin home grown organic revs or not. Then there are the investors who do know this but are driven to play the stock in this transition period - in an attempt make a few pennies, nickels and dimes while time still yet permits. I firmly believe, that window of "opportunity" is soon coming to an end. That last sentence pertains to the trading scenarios we have been experiencing lately.
Btw, speaking of gels, I asked Jack about a Pop Council male birth control gel, his reply was, if they are working on a male birth control gel, they are doing it on their own.
The only gel I'm excited about right now is Ibuprofen gel. The one that is in clinical trials by Pfizer. Ibuprofen is the only over the counter medicine in its class today and the only Ibuprofen is Advil which has a market saturation that is envious. There is NO Advil gel currently available OTC. This will be the first and it will be using Antares delivery method.
Good post Grukf - thanks for stimulating my thoughts! Lastly, to go back to your very first sentence - "ATRS, current and future revenues" - to me any correlation between current and what future revs will be is or will be like apples to oranges. No comparison. Current revs generate a modest, non profit generating revs. Future revenues (while yet to be realized obviously) are being structured, modeled, formulated and ultimately marketed to exact extraction from what we are experiencing today and just as you have noted!
Have a great weekend all.
A few notes / highlights:
*had mid cycle review with the FDA regarding Otrexup and are confident of its success in achieving the advertised PDUFA date in October.
*exhibiting "highly controlled spending" as they ramp up for Otrexup launch
*First user study has been completed for QS T - similar path as Otrexup.
*in position to "DOMINATE the subcutaneous space" with the Vibex technology combination products platform. I really liked this statement!
*QS M (Neurologic) - intellectual property is being worked on and once all this is in place, the drug will be announced.
Otherwise, the main focus was on their injector platform, everything else is ancillary and not surprising, at least to me, as they have been clearly broadcasting this directive for some time now.
Nothing new here but the article just bolsters the future multi MTX DMARD use of Antares Vibex pen.
A future/potential Vibex pen use MTX with add on DMARD.
Back on Feb 16, 2013 I posted this on the ymb:
Formula: MTX + Medi-Jet = ATRS (+TNF alpha) = ATRS delivery of Biologics for the treatment of DMARD’s
MTX = methotrexate
Medi-Jet = Antares delivery device
TNF alpha = tumor necrosis factor (Currently available biologic agents act as inhibitors of the cytokines IL-1 or TNF. Cytokines are messenger molecules made by many of the body's cells that act to excite other immune system cells. Interleukin-1 (L-1) and tumor necrosis factor (TNF) are made in large amounts in rheumatoid arthritis and other forms of inflammation)
DMARD = Disease Modifying antirheumatic drugs
MTX is considered the first line therapy for the treatment of rheumatoid arthritis (RA) and a top line therapy for poly-articular-course juvenile RA and moderate to severe psoriasis.
Antares has the first and only Subcutaneous, MTX single use, once weekly disposable device (the Medi-Jet) capable of administering MTX doses from 10, 15, 20 to 25 mg.
I’m going to argue, this avenue of MTX delivery by Antares is unique, forward thinking and a potential “trend setter” for the delivery of future biologics when used in combination with MTX.
From today’s GaBi online (whogo, you are familiar with this publication):
Development of biosimilars for rheumatologyPosted 03/05/2013
http://gabionline.net/Biosimilars/Research/Development-of-biosimilars-for-rheumatology?utm_source=GONL2&utm_campaign=712902ae0d-GONL+V13E03E05&utm_medium=email&utm_term=0_e096b353ae-712902ae0d-309520813
In 2012, worldwide sales for the top three selling tumour necrosis factor (TNF) inhibitors reached US$20 billion. These biological treatments for arthritis are costing patients between US$10,000–US$30,000 per year making the need for lower cost biosimilars clear [1].
There are currently no biosimilar monoclonal antibodies (mAbs) or soluble receptor constructs (cepts—large, intricate proteins with unique tertiary and quaternary structures that are inherently difficult to replicate) approved by EMA or FDA for treatment of rheumatic diseases, although randomized controlled trials are complete or ongoing, see Table 4 [1]. EMA is, however, reviewing two applications for marketing authorization of infliximab biosimilars, one of which is thought to come from South Korean biotechnology company Celltrion, which has already received approval for its product for rheumatoid arthritis and autoimmune diseases from the regulatory authorities in Korea [2].
Biosimilars, as with all biologicals, are complex molecules to produce, and uncertainties surrounding the exact regulatory requirements have led some companies to suspend their development. This, however, has not put off others and, with patent expiries looming, rheumatologist should expect biosimilars to be with them very soon.
Rituximab (marketed as Rituxan) Information
Rituxan is a prescription medicine used to treat:
• Non-Hodgkin’s Lymphoma (NHL): alone or with other chemotherapy medicines
• Chronic Lymphocytic Leukemia (CLL): with the chemotherapy medicines fludarabine and cyclophosphamide
• Rheumatoid Arthritis (RA): with another prescription medicine called methotrexate, to reduce the signs and symptoms of moderate to severe active RA in adults, after treatment with at least one other medicine called a Tumor Necrosis Factor (TNF) antagonist has been used and did not work well enough
• Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA): with glucocorticoids, to treat GPA and MPA
I don't know what Jack Howarth would be able to say about this gel. And the might not be communicating much of anything given next week is the earnings release and call.
I had to chuckle about your Ph II recent completion - if you count 5 years as recent, comment. Chuckle because when you look at Ali's title, "Challenger emerging against 400 yr old condom", one could argue 5 years ago is recent!
I thought it was another good article by Ali but decidedly, more out of his wheel house of financial modeling as this article involves more speculation at this point given where things currently are. His article also served as an opportunity to draw attention to the timing of the ENDO-2012 event last year when the stock price took off ("In the 10 trading days following the original presentation ATRS share price went parabolically higher jumping from $3.54 to a high of $5.25.")and to point out the 2013 event is just around the corner as well....."This year's presentation might create a similar excitement"
Tappy, I posted this on the ymb and thought I'd follow up here given the ymb is getting overrun this morning by impersonators, fakes and renegade posters.
"I agree with your post. But having said that, I'm curious on your opposing sentiment for LibiGel vs Male Birth control. Libigel represents a 'lottery ticket' but male contraceptive "is highly improbable". I trust you read Ali's article. Are you labeling the male bc improbable because of no fda trials to date?
I'm personally viewing both of those 'gels' as a lottery ticket for us."
jab9
New article just out by Ali Yasar. And Ali is one of those SA writers, along with Smith on Stocks, that actually call the company to discuss - (per Jack H).
http://seekingalpha.com/article/1371571-seizing-the-blockbuster-opportunity-buried-in-conservative-modeling-at-antares-pharma?source=email_rt_article_title
Cato,
I'm not sure about Antares own rules or more importantly the Incorporation rules of the State of New Jersey. But typically, there has to be a shareholder vote and the best time for a shareholder vote is once a year when other issues need shareholder votes and approval. I say votes and approval because the Board of Directors has already 'unanimously recommended' for approval the 6 items. In this case, the BOD weighs in with their recommendation then the shareholder vote occurs. If they did not do this now, the next 'convenient' time would be one year from now OR if something came up between now and then, then there would need to be a special call for a shareholder vote.
Again and as I noted prior, I believe this is the company acting in a manner of prudence. When I think of what they are doing and what I think they will do and where they are headed, I'm reminded of the famous Chicago Architect Daniel Burnham who is quoted to say, "make no small plans". And I don't think CEO Wotton has plans for mediocrity. I see Otrexup (its particular injection platform) as the tip of the iceberg in the delivery of drugs and the delivery of methotrexate, then testosterone, then the Neurologic drug as Antares just getting warmed up and ramping up. After all they have identified between 40-60 drugs. Here's a wild thought when thinking of the quote, 'make no small plans', what if they decide to pursue a biologic for delivery with their existing platform? That will take $$$ to execute that business plan - alternatively, what if they go upfront 50/50 with TEVA on a biologic for 50/50 back end deal? Or and as previously noted, what if and in connection with the existing TEVA partnership, TEVA wants Antares to not only provide the injectors but to have them do the manufacturing in house - TEVA provides the drug in a prefilled syringe (just as in the new agreement with TEVA and sumatriptan)and Antares does the rest in house. Big bucks upfront with big bucks back end profit.
To me, they are making big plans and are preparing upfront for those big plans and that does not scare me, I applaud it.
"Atlas Snuggled" great id - of course I immediately thought of "Ayn Rands, Atlas Shrugged"
Cato,
Its late but I will respond to your post tomorrow.
Catokart:
Thanks. Not sure yet if I'll be available to attend that game but soon as I know, I'll give you a heads up.
Shadowplay: I agree with your post (and the consensus) that the ymb is trash - a "broken arrow". I haven't posted for awhile now and don't plan on posting there but only on a select basis to reach other serious posters that don't participate here. In fact I haven't read any of the posts but only look for the names of serious regulars.
TD: Thanks for your reply.
FWIW category, I haven't changed my bullish thoughts about Antares as I have seen/heard/witnessed no reason to adopt any other view. Sure, this rut we've been stuck in gets old. Some call this rut - basing action, consolidation, a floor etc., but whatever your flavor, I look at it as a bottom base with a daily battle between the bears and the bulls and the end result is a draw as each day closes. I'm sure we will break out of this and I lean to the upside because and again, no reason to believe the opposite and would be unsubstantiated.
Finally, like others, I have exercised my right as a shareholder and voted my proxy shares as I saw fit. As I told Jack last time we chatted, I'm not sure yet if I'll be there. The only reason I'd go is to meet Jack, Paul and others that I already know but only via email / phone contact (and some of the message board attendees).
TD, I always look forward to reading your keystrokes and I know what you are saying TD and I don't disagree.
On the flip side, it could also be said that the shareholders (that don't understand), need to educate THEMSELVES as that would also take only about 10 seconds. After all, they are shareholders right? Any investor who needs to be spoon fed by any publicly traded company, will need for the company to devote someone or even a group of people for that effort.
In Antares' case, all someone has to do is pick up the phone and inquire.
It sounds like you are asking or wanting (as we all would like to know) more specifics (other than what's stated in the Schedule 14A), so that we can gain their trust with increasing the authorized share count - after all - its not dilution until they bring to market whatever or how many authorized shares they have. You know this, but I want to make it clear that voting for authorization to increase the sharecount and having that approved - does not automatically trigger stock dilution. If item 3 (increasing the number of authorized share is approved) it does not mean, the next trading day the value or pps share has effected. And even (assuming approval), would the "dilution" be done in a manner that is reckless or is it to better the companies future growth and ultimately in the best interest of the shareholder?
This is not the first publicly traded company to proposed such a thing.
It would be fun, to be able to have these kind of conversations with you and many others here, siting around a table, eye ball to eye ball and debate to debate and agree or agree to disagree.
I hope you and the rest here have a great weekend!
P.S. In the Chicago area this morning, running out in the car, it was snowing! No accumulation, but snowflakes nonetheless.
I suspect you all have maybe seen this by SM. Below is the link, fwiw. Some good follow on comments, Loko gives his par usual detailed points with links as well.
http://seekingalpha.com/article/1349331-thursday-s-biopharma-trade-movers?source=yahoo
Cato:
Here's some brainstorming I've been doing and it's a tie into my April 5 post on this board. I'll post a portion of that post in a moment.
Braindump questions:
1) What if they gain approval of increasing the 'authorized' shares from 150M to 200M AND then they actually issue a portion of the additional 50M shares sooner[url][/url][tag]insert-text-here[/tag] rather than later. (In another post I mentioned my thought was that they are just trying to be prudent and to have the authority 'in place' as a contingency plan for future / potential use if the need arises.
2) Why would they pull the trigger sooner and bring some of the newly authorized shares to market? What good reason could be behind that?
Let's review Wotton's business model - here's his latest statement from the March Earning Call and we have been hearing this alot:
"However, the bigger picture is the progress we've made on our internal pipeline as we shift this company towards a specialty pharmaceutical company that controls its own development destiny with products such as OTREXUP and QS T." He has also put it this way - to paraphrase him: 'a shift from a royalty driven company to a revenue driven specialty pharma company.'
With that, on to my April 5th post which highlights some comments from an Antares employee who seems to be able to fly under the radar - Bob Apple.
A subject worth revisiting from the 4th Q yr end CC (from SA transcripts) read just how TEVA is talked about.
Aaron Hartley
If you don't mind, we have another one for you. Could you give us a little more detail on the new sumatriptan agreement?
Apple:
Yes, I think sumatriptan was originally VIBEX 2. And what -- Teva came to us and realized that we've been doing much more on our owninsert-text-here And so what the agreement is currently is that Teva will make the sumatriptan in a prefilled syringe and send that to our manufacturers where we will make the device, assemble the device with the prefilled syringe and do the final packaging, all on our equipment. And so it's truly taking us all the way down to the commercial supply of the product, which is very different than our other agreements with Teva where we typically just supply them with the devices and then they do everything after that. So we felt that was a real positive step in our relationship in providing them the flexibility to have us complete the product development for them
Then Paul chimes in:
"Yes. I think it's also a reflection of how far we've come as a company because as a result of our taking charge of our own destinyinsert-text-here
The only good reason to issue newly authorized shares sooner rather than later would be as reflected in the above highlighted sections from Apple and Wotton focused on TEVA. We know TEVA has made big changes to their business model - particular in how they are looking at acquisitions and steering away from the "big" pharma M & A and looking at smaller acquisitions with companies that will make up their new order (or more accurately, new "Constellation") per new CEO Jeremy Levin. But acquisitions aside, I think TEVA may rely on, need and want exactly what a company like Antares can deliver. Right now, they are using third party manufacturing for perhaps both the epi-pen and Vibex for Sumtriptan and I suspect TEVA is paying / funding this directly or perhaps is just a pass-through from the manufacturers - to Antares-to TEVA.
There are other TEVA / Antares pen programs in the pipeline. How is Antares going to handle these programs? How much more control does Wotton want on Antares destiny and revenue generating side of the business model in bringing to market TEVA's programs and needs? Why not control, not only Antares own pen programs, but also TEVA's from the manufacturing side or as Apple said, 'more of the development work downstream.'
You guys follow me? Does it make any sense?
This dude abides td!
I'm viewing item number 3 as a 'contingency' plan. But given the BOD approves of this, along with the other items AND given the quality people running the company, I personally have no reason to not vote for. I trust them until they prove to me that I should not.