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Daily Lovenox-Exclusivity Count = 362
Daily Lovenox-Exclusivity Count = 361
Daily Lovenox-Exclusivity Count = 361
Daily Lovenox-Exclusivity Count = 360
Daily Lovenox-Exclusivity Count = 360
Daily Lovenox-Exclusivity Count = 358
Daily Lovenox-Exclusivity Count = 358
Daily Lovenox-Exclusivity Count = 357
At $262M, I estimate $80.3 M mL revenue, operating expenses of $24.2M (including an R&D adjustment that Rick Shea mentioned would impact income/revenue for Q2-2011), shares outstanding of 50.7 M with a resulting earnings of $1.11.
I throw out a swag of $262M
Daily Lovenox-Exclusivity Count = 356
Daily Lovenox-Exclusivity Count = 356
Daily Lovenox-Exclusivity Count = 352
Nitpick....would have preferred a graph with a labeled x-axis (date - timeline). Back from my college days.....
Quote
"the difference in script volume between May and June"
I may be way off base here, but something that would be interesting to consider is the seasonality of conditions (DVT, etc…) as a functionality of warmer weather versus colder weather. Is it possible that warmer weather resulting in significantly increased outside activity thus lowering incidences of DVT and related conditions because the population is on the move so to speak? In the absence of physical activity, is it more likely that blood stagnates causing various health events that require medical treatment? Just a though here….. as one looks at these numbers in an attempt to explain the slight (or not so slight*) downturn in prescripts from May to June. Is it possible to get more historical data going back 3-5 years to look for this type of occurrence?
TIA
And today marks the end of Q2-2011 sole generic mL status!!!
Bill Marth must be very disappointed where ever he may be.
News for 'MNTA' - (Committee Leaders Expand Investigation Into Tainted Heparin, Seek Assistance & Cooperation From Industry Leaders Three Years After U.S. Deaths and Serious Complications, Chinese Government and FDA Still Have Not Identified Culprit or Contamination Source)
Jun 30, 2011 (Congressional Documents and Publications/ContentWorks via COMTEX)
-- WASHINGTON, DC - House Energy and Commerce Committee leaders are further expanding their investigation of the now 3-year unsolved case of toxic and sometimes lethal contaminated heparin supplies that were imported from China and given to U.S. patients. Committee Chairman Fred Upton (R-MI), Chairman Emeritus Joe Barton (R-TX), Health Subcommittee Chairman Joe Pitts (R-PA), Health Subcommittee Vice Chairman Dr. Michael Burgess (R-TX), and Oversight and Investigations Subcommittee Chairman Cliff Stearns (R-FL) are reaching out to 10 companies because documents provided by the FDA indicate that they have information related to the Chinese heparin industry and Chinese heparin supply chains.
The leaders are seeking documents and information from Amphastar Pharmaceuticals, Momenta Pharmaceuticals, Siegfried USA, Inc., Sagent Pharmaceutical, APP Pharmaceuticals, Sanofi Aventis, Drug Source Company LLC, Global Pharma Sourcing LLC, Pacific Rainbow International, and Sandoz.
The committee leaders write, "We believe there is substantial public interest in solving this case. More than 80 percent of the U.S. unfractionated heparin supply is sourced from China and more than 16 percent of U.S. pharmaceutical ingredients are imported from China. There is reason to believe all or some of the individuals responsible for the adulteration are still actively engaged in the Chinese pharmaceutical supply chain and pose a continuing threat to pharmaceutical products imported to the U.S. How the heparin came to be contaminated and the exact nature of the contaminant remain unknown. It is important to determine how the adulteration happened so that industry and government can take more effective proactive measures to reduce the risk of such adulteration in the future."
The leaders firmly believe discovering the root cause of the heparin crisis is an urgent matter of public health and that the public deserves long-overdue answers about the contamination of this widely used blood-thinning drug in order to prevent similar dangers in the future.
Dating back to 2008, committee Republicans have been pressing the FDA for answers about the agency's handling of the investigation into the contaminated heparin. The U.S. Government Accountability Office also faulted some of the FDA's efforts, including the decision to continue allowing drugs to be imported from Chinese facilities that refused to allow inspections. In February, Committee leaders called on the Food and Drug Administration to release documents related to its response to the unsolved case.
A copy of the letter can be found HERE
http://energycommerce.house.gov/news/PRArticle.aspx?NewsID=8767 .
Read this original document at:
http://republicans.energycommerce.house.gov/news/PRArticle.aspx?NewsID=8768
Copyright (C) 2011 Federal Information & News Dispatch, Inc.
News for 'MNTA' - (Committee Leaders Expand Investigation Into Tainted Heparin, Seek Assistance & Cooperation From Industry Leaders Three Years After U.S. Deaths and Serious Complications, Chinese Government and FDA Still Have Not Identified Culprit or Contamination Source)
Jun 30, 2011 (Congressional Documents and Publications/ContentWorks via COMTEX)
-- WASHINGTON, DC - House Energy and Commerce Committee leaders are further expanding their investigation of the now 3-year unsolved case of toxic and sometimes lethal contaminated heparin supplies that were imported from China and given to U.S. patients. Committee Chairman Fred Upton (R-MI), Chairman Emeritus Joe Barton (R-TX), Health Subcommittee Chairman Joe Pitts (R-PA), Health Subcommittee Vice Chairman Dr. Michael Burgess (R-TX), and Oversight and Investigations Subcommittee Chairman Cliff Stearns (R-FL) are reaching out to 10 companies because documents provided by the FDA indicate that they have information related to the Chinese heparin industry and Chinese heparin supply chains.
The leaders are seeking documents and information from Amphastar Pharmaceuticals, Momenta Pharmaceuticals, Siegfried USA, Inc., Sagent Pharmaceutical, APP Pharmaceuticals, Sanofi Aventis, Drug Source Company LLC, Global Pharma Sourcing LLC, Pacific Rainbow International, and Sandoz.
The committee leaders write, "We believe there is substantial public interest in solving this case. More than 80 percent of the U.S. unfractionated heparin supply is sourced from China and more than 16 percent of U.S. pharmaceutical ingredients are imported from China. There is reason to believe all or some of the individuals responsible for the adulteration are still actively engaged in the Chinese pharmaceutical supply chain and pose a continuing threat to pharmaceutical products imported to the U.S. How the heparin came to be contaminated and the exact nature of the contaminant remain unknown. It is important to determine how the adulteration happened so that industry and government can take more effective proactive measures to reduce the risk of such adulteration in the future."
The leaders firmly believe discovering the root cause of the heparin crisis is an urgent matter of public health and that the public deserves long-overdue answers about the contamination of this widely used blood-thinning drug in order to prevent similar dangers in the future.
Dating back to 2008, committee Republicans have been pressing the FDA for answers about the agency's handling of the investigation into the contaminated heparin. The U.S. Government Accountability Office also faulted some of the FDA's efforts, including the decision to continue allowing drugs to be imported from Chinese facilities that refused to allow inspections. In February, Committee leaders called on the Food and Drug Administration to release documents related to its response to the unsolved case.
A copy of the letter can be found HERE
http://energycommerce.house.gov/news/PRArticle.aspx?NewsID=8767 .
Read this original document at:
http://republicans.energycommerce.house.gov/news/PRArticle.aspx?NewsID=8768
Copyright (C) 2011 Federal Information & News Dispatch, Inc.
LOL. Not sure it will bounce. Hope I don't offend anyone.
I've added recently in the mid $18's.....I feel MNTA has a lot going for them including continued sole mL status. I don't see TEVA getting approval in the next 18-24 months if ever. Remember, they don't control the manufacturing of the product presented to the FDA in their ANDA. Add in mC, potential FOB partnerships....I still think this is a STRONG BUY.
Just my 2 cents.
"IF you can create a drug by a process, obtain a COM patent and only after it expires disclose the process (or even claim improvements to the process), file new process patents and thus double or more the TERM of patent protection for the invention, you have abused the patent system unlawfully. JMHO
(I am not a patent lawyer - so I may be missing something important. There are a couple of them here that may be able to correct me if this is wrong and I am still learning.)
The argument I have just made could be coupled with misrepresentations in the patenting process to support the inequitable conduct theory for a win. Or it could be viewed as a statutory violation and invalidated on that basis.
I do think obviousness/double patenting is the most probable basis for invalidation. "
Zip....do you still feel this way? Have your coworkers that are patent lawyers given you helpful insight that is consistent with your original statement from last November?
TIA
Rich
IG,
IMHO.....The pending FDA approval of mC (ANDA) is a separate issue from the legal patent case. Why do you believe FDA approval of mC is tied to the legal case between TEVA and MNTA?
Perhaps a silly question, but can you provide to me how you find out such information like this please? TIA
Totally speechless. Just amazing that TEVA cannot be honest……
Do you think MNTA would solicit a 'wink and a nod' from NVS prior to signing any FoB deal?
I do not myself. Nothing would be gained from showing your cards to a potential buyout candidate as I view it.
Positive news would be fun right now.
Does one penny above $20 count? LOL
Congrats Go seek! Wish I could add here myself.....but I have to practice some common sense.
My last purchase was Thursday May 19th......got a good chunk more at $18.40. Fun to watch it continue to rise...... For now though I think I'll just sit and watch....LOL.
"MNTA hiring like there's a bright future."
Urche...great to hear from you! Funny you mention this as I've been mulling over the same thoughts. Leaves you wondering what MNTA will do after mC is approved and they sign with an FOB partner.
Maybe if our moderator is up to it, we should all take the survey again within 3-6 more months. I have a feeling I would change my vote as well.
Cheers!
"The more relevant point is that there are no settlement discussions in progress."
Frankly I view this as a "positive" for MNTA. When the FDA eventually approves mC, TEVA finally will have to face the music and will no longer be able to "spin" their own music.
"Signals that the planets are correctly aligned, $20 will fall." Maybe this week for $20????
OT Planets Align in the Morning Sky
by Dr. Tony Phillips
Science@NASA
Huntsville AL (SPX) May 10, 2011
Have you ever woken up at the crack of dawn, shuffled to the kitchen counter for your first cup of joe, only to discover that you're out of coffee beans? Cruel. This week it's not a problem, because there's something to open your eyes even better than coffee. Four bright planets are aligning in the morning sky.
Look out any east-facing window about a half hour before sunrise. If you have a clear view of the horizon, you'll see Mercury, Venus, Mars and Jupiter clustered together in a patch of sky less than 10o wide. If you wanted to, you could hide them all behind your outstretched hand-but don't. The view is too good.
The best morning is May 11th, when Venus and Jupiter converge to form a tight pair only 1/2o apart. (Now you can hide them using no more than one finger.) Venus and Jupiter are so bright you might think you've witnessed a double supernova beaming through the morning twilight. But, no, it's just the two brightest planets in our own solar system.
Keep an eye on Venus in particular. As the sun rises and the sky fills with morning blue, the Goddess of Love does not fade away. You can actually see Venus in broad daylight if you know where to look.
May 11th is just the beginning. Throughout the month, the quartet of worlds will rearrange themselves on a daily basis, forming different shapes in the pre-dawn sky.
On May 13th, for instance, Mercury, Venus and Jupiter form a bright celestial triangle--almost equilateral. It's a geometry lesson before breakfast. On May 20th, a new triangle will appear. This time the vertices are Mars, Venus, and Mercury. Observing tip: Mars is not as bright as the others. Binoculars may be required to help you find and fully appreciate the red planet in morning twilight.
The show comes to an end on May 30th when an exquisite crescent Moon joins the four planets for a Grand Finale--five heavenly lights dotting the eastern sky all at once.
What a way to begin the day.
I see according to your link that since Mr. Jim Cramer made his “Sell” call recommendation on March 25th, MNTA share price has increased by some 29.3%. Too funny if you ask me.
Zipjet......what know facts? TEVA is the only party IMHO that truly might have an inclination as to the probability of tL getting approval in the next 2 years if ever. I remain in the "camp" that strongly believes that tL won't get FDA approval for thier ANDA for their product. As others have shared, TEVA also has zero IP on the analytics required to analyze Lovenox and neither does ItalFarmaco.
IMHO, as far as MNTA being in the teens, it is my perception that the MNTA/TEVA story is too complex for most to digest and delineate the information surrounding this mL/tL story. The investment community is either too lazy or too busy to spend the necessary time required to understand the situation and put out decent coverage (report) on MNTA. Just my 2 cents.
QUOTE
I'm estimating conservatively that $20-25 million was overstocking and Momenta will have between $65-70 million in Q2 mL profit share and EPS of $0.85-1.00/share.
Thank you for sharing your estimates. Did you include in your Q2 projections the R&D adjustment that Rick Shea mentioned during the CC that would impact income/revenue for Q2-2011? My thinking is along the lines of $2-3 Million.
Amen. (eom)
Thank you for your insight. I'm thinking (could be wrong) that NVS/MNTA will take their chances in court. As you previously have pointed out, NVS/MNTA patent lawyers I'm sure feel very confident they will succeed in court. Why settle out of court giving TEVA all the Copaxone sales when NVS/MNTA is prepared to launch? Best to all.
Hi Dew,
This scenario being the case, would MNTA be compensated for agreeing to hold off with the introduction of mC into the market place?
TIA
This IMHO is a great story playing out in front of us all. Twists and turns in a great book...the only difference being some of us own a very small piece of the book. Truly fascinating!!!
IMHO......anyone selling here needs their head examined!
Total agree with your assessment.