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Regardless, as I understand things, the profit share MNTA receives still changes from 45% to 10-12%.
"Amphastar is currently preparing for launch and anticipates launching its Enoxaparin Sodium Injection product in the fourth quarter of 2011."
http://finance.yahoo.com/news/Watson-Pharmaceuticals-prnews-1917936964.html?x=0&.v=1
"Amphastar is currently preparing for launch and anticipates launching its Enoxaparin Sodium Injection product in the fourth quarter of 2011."
http://finance.yahoo.com/news/Watson-Pharmaceuticals-prnews-1917936964.html?x=0&.v=1
Assuming Sanofi launches a generic Lovenox (sL) of their own and dividing up the estimated total sales revenue equally among 4 (Branded Lovenox, sL, mL, & now aL), I estimate MNTA to generate $11.7 Million/quarter with an EPS of -$0.23
**Note - NVS if I recall, will now pay back MNTA some of the original R&D cost in MNTA's efforts to develop mL. I would imagine this is a one time payment to MNTA.
"Separately, the change in timing of Teva's Enoxaparin launch raised our EPS estimate for 2011 - 2012 by $1.51/$0.14, respectively."
Launch of tL?? Seriously, considering the FDA has yet to approve tL and MNTA suing Teva for patent infringement scheduled for February 2013, how can these guys be so arrogant in projecting as such??? Heck, TEVA hasn't even forecasted earnings for tL.
"UBS chipped in cutting the price from $20 to $17"
Was there any explaination by UBS for the adjustment as you cited? TIA
Quote
"MYL’s Copaxone ANDA is unlikely to be approved by the FDA, IMO"
Given you are a man of odds, what odds would you currently place on MYL Copaxone ANDA getting FDA approval?
Have your odds for MNTA's ANDA Copaxone changed since you last shared with us your thoughts? Not really much has changed in the landscape from my perspective and the updates from Wheeler/Shea have been consistent these last 8 months.
TIA
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Management
No offense but I truly think you have exhausted this subject matter here and we all know where you stand.
Thank you for providing clarity. Apropos the timing element of a pending FDA approval.....is it appropriate to suggest that there has to be "some" amount of pressure on the FDA for getting mC approved...if only for the purpose of helping relieve some of the financial pressure/cost associated with purchasing the Teva Branded Copaxone? With TEVA's price increases these last few years, patients have to be really feeling a pinch.
OT somewhat
"The FDA often extends an action date by three months."
Back in early March there was a general impression that MNTA was going to conduct a mCopaxone bio-equivelence trial small in number (<30) that may supplement their mC ANDA.
That being the case, would MNTA also expect the FDA to extend an action date by three months as well for mC? My thinking is if the study was completed, written up and presented to the FDA by the end of June, perhaps we "could" hope to here something from MNTA/FDA by the end of September. That would be month 38 that the FDA had the mC ANDA in their hands. Comments? TIA
From what I see, PRICE T ROWE decreased their holdings buy 19,000 shares. They still hold 3,686,647 shares.
Hi jbog,
Aren't you concerned about missing a big "pop" when the FDA approves mC? Or do you hold a core position in addition to trading MNTA? I see your point on selling and buying MNTA. Those that purchased MNTA in February at $13/share are pleased. And those that purchased last week in the $15's are pleased as well. I personally just don't have the aptitude to buy and sell short term. TIA
Quote "GILD has too much cash for its own good" .......
Then they should buy MNTA for 3 Billion in cash!
Half way through Q3, roughly another $32 Million in profits added to the balance sheet. Goofy analysts!!
Daily Lovenox-Exclusivity Count = 389
Hi Floblu14,
Thank you. Appreciate your efforts in keeping this a fun and interesting place to read and comment.
Have a great week everyone!
Deal in Place for Inspecting Foreign Drugs
http://www.nytimes.com/2011/08/13/science/13drug.html
By GARDINER HARRIS
Published: August 13, 2011
More than 80 percent of the active ingredients for drugs sold in the United States are made abroad, mostly in a shadowy network of facilities in China and India that are rarely visited by government inspectors, who sometimes cannot even find the plants.
But after decades of failed attempts, the federal government and the generic drug industry have reached an agreement that is almost certain to pass Congress and that will lead to routine inspections of these overseas plants, potentially transforming the enormous global medicine trade.
Under the landmark agreement, expected to be completed within weeks, generic drug companies — which make 75 percent of the prescription medicines sold in the United States — would pay $299 million in annual fees to underwrite inspections of foreign manufacturing plants every two years, the same frequency required of domestic plants.
Self-interest helped drive the agreement because the industry will not only get speedier approvals of new products as part of the deal but also may avoid scandals involving tainted medicines, which tend to hurt confidence in the entire industry.
At its present pace, the Food and Drug Administration would need more than 13 years to inspect every foreign drug plant exporting to the United States. Some plants have never been inspected, which saves them huge sums in cleanup and other compliance costs — an important reason that drug manufacturing is disappearing from the United States and that tainted-drug scandals occur.
In one infamous case, Chinese manufacturers deliberately substituted a cheap fake for the dried pig intestines used to make the blood-thinning drug heparin. The tainted drug was linked to 81 deaths and exposed tens of thousands of people to danger. The F.D.A. never inspected the plants making the crucial ingredients, a larger problem that only now, more than three years later, may be fixed.
“This agreement is epoch-making,” said Guy Villax, chief executive of Hovione, a generic drug maker with plants in New Jersey, Europe and China. Supply chains for many generic drugs often contain dozens of middlemen and “are highly susceptible to being infiltrated by falsified” drugs, Mr. Villax said.
Dr. Margaret Hamburg, commissioner of the F.D.A., said she was pleased with the generic drug fee proposals. “If a program along the lines of what the parties are working on is enacted by Congress, it would represent a real breakthrough,” Dr. Hamburg said. “F.D.A.’s entire generic drug program would be placed on a much more stable footing.”
The agreement will not affect the making of over-the-counter medicines or vitamins, whose global supply chains are even more vulnerable to tampering since government inspectors almost never visit their makers. Aspirin and vitamin C supplements, among others, are now made almost entirely in uninspected plants in China.
Nor will the agreement change the F.D.A.’s oversight of name-brand prescription medicines. Although branded drugs usually have more secure supply chains than those of generics, major pharmaceutical companies have moved aggressively into China in recent years and often rely on rarely inspected suppliers.
Federal officials for years have expressed concerns about the nation’s growing reliance on sometimes mysterious foreign drug suppliers, but they had largely despaired of fixing the problem. Congress has never given the F.D.A. the money needed to inspect these plants, and for nearly two decades the generic drug industry resisted proposals to pay inspection fees.
The industry changed its stance for several reasons. First, the heparin scandal scared everyone. The fake ingredient was good enough to pass a sophisticated test, so the conspirators probably knew that deaths would result, reflecting a callous level of greed. And the Chinese government refused to allow the F.D.A. to investigate, suggesting that the perpetrators were not only smart but politically well connected.
Second, the generic drug industry is no longer a motley collection of struggling mom-and-pop companies. Years of consolidation have created giants like Israel-based Teva Pharmaceuticals that understand that their businesses depend on winning the confidence of patients and regulators alike, and they can afford to pay the fees needed to achieve that confidence.
Third, the industry finally gave up hope that Congress would appropriate enough money for the F.D.A. to perform the job. The agency’s oversight of generics has floundered so badly that new applications to sell generics take a median of 31 months to be approved, and there are now 2,458 applications awaiting approval, up from 2,361 at the end of last year. The new fees are expected to underwrite the hiring of enough reviewers to bring approval times down to 10 months and sharply cut the application backlog — providing cheaper and better drugs to patients.
The fourth reason is Heather Bresch. Ms. Bresch, 42, is the president of Mylan Inc., a generics giant, and the daughter of Senator Joe Manchin III, Democrat of West Virginia. For years, Mylan’s sole drug plant was in Morgantown, W.Va., and the facility is so huge — it produces 22 billion tablets and capsules a year — that the F.D.A. stationed an employee there almost full time. But in 2007, Mylan bought two foreign companies with plants on nearly every continent. When Ms. Bresch visited these and other foreign plants, she was shocked to learn that many had not been visited by an inspector in almost a decade.
“As a mother of four children, I want to know the drugs I’m giving them are safe,” Ms. Bresch said. “And as an American businesswoman, I want to keep jobs here, and that means making sure foreign drug plants have to meet the same standards as domestic ones.”
Last year, she wrote an ambitious proposal to tax the industry $300 million annually so the F.D.A. could do a better job. Agency officials initially reacted skeptically since the industry had repeatedly rejected earlier, far more modest fee proposals. But Ms. Bresch lobbied aggressively, according to several participants, and her proposal was soon largely adopted, although a few small details remain to be negotiated.
Generic drug fees will be included in a package of industry fees — including those for branded drugs and medical devices — in legislation the Obama administration is expected to send Congress in January. Such fees were first approved in 1992 and have become a vital source of F.D.A. financing, although some consumer groups say they have led the agency to become too cozy with those it regulates.
Legislation must pass before October 2012, or numerous F.D.A. functions will halt, imperiling patients and creating chaos in the drug and medical device industries. Since such an outcome is unthinkable to government officials and industry executives alike, most predict that the legislation will pass early and easily. But defaulting on the nation’s debts was once seen as unthinkable and nearly happened this summer, so worries abound.
MNTA
My forecasted 2011 EPS now exceeds the PE Ratio at today's market price. EPS of $4.80 vrs PE Ratio of 3.14
One amazingly great buying opportunity IMHO.
Daily Lovenox-Exclusivity Count = 383
In light of all the “news” this last week in general, just to reiterate to those of us that are invested in MNTA future or considering to invest, according to my simplistic calculations, MNTA has earned another $26 Million and change to their balance sheet since the start of Q3. Happy weekend and enjoy the though of being invested in an AAA+ rated Biotech company. JMHO
Great question. February's lows of $12.66? Never would have imagined we would be back in this range while maintaining sole generic status of Lovenox. Totally clueless.
Quote
think some who would not consider an investment in biotech will begin to take a 2nd look @ MNTA
As an investment vehicle or did you mean as a buyout potential? TIA
One time change in the royalty rates (low double digits estimated to be 11-12% up from 9% (the 20-25% referenced in the CC). ***If another generic Lovenox ever enters the market place (new information as noted by go seek)
Quote "Prediction: by 11:45 am, at least one class-action lawsuit will be filed against Mitch Gold and the Board Members of Dendreon alleging something or other. "
Kahn Swick & Foti, LLC Announces Investigation into Dendreon Corp.
http://finance.yahoo.com/news/Kahn-Swick-Foti-LLC-Announces-bw-1641890231.html?x=0
Didn't take long........
Can you imagine the markets reaction "if" mC was approved later this afternoon??????? TEVA would have peeps bailing left and right.
Daily Lovenox-Exclusivity Count = 374
ROTFLMFAO
Noted and will conform. My apologies.
Daily Lovenox-Exclusivity Count = 370
Daily Lovenox-Exclusivity Count = 369
Bill Marth seriously must be "very disappointed"...... TEVA is still no where to be found with it's own version of generic enoxaparin.
My guess is it won't be mentioned during the upcoming earnings conference call TEVA has scheduled unless some analyst inquires....
Daily Lovenox-Exclusivity Count = 366
Daily Lovenox-Exclusivity Count = 366
Quote
"Anything special happen at a year?"
An anniversary milestone payment of $2.5 Million (estimated) for sole generic status.
Daily Lovenox-Exclusivity Count = 364
Daily Lovenox-Exclusivity Count = 364
Daily Lovenox-Exclusivity Count = 363
Daily Lovenox-Exclusivity Count = 363
My fancy word is "gnormous". Very impressive. Now all we need is mC to get the FDA approval. 36 months and counting?