| To: tuck who wrote (162) | 7/31/2006 12:19:40 PM | | From: dr.praveen | | | | I agree tuck. They r not that good on deadlines. I don't know what their problems are...:-( :-) I feel M118 is a very big opportunity for Momenta which is behind schedule. Also they didn't give out the time frame for the filing of their mystery generic.
Having said all that, I will be very patient on them.
Regards,
Praveen |
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| To: tuck who wrote (162) | 7/31/2006 12:56:32 PM | | From: rkrw | | | | Lovenox filing they guided to mid 05 and they filed in August 05. So less so late than stressful to shareholders since it wasn't June or July.
118 they reguided to filing mid this year not long after the ipo. See below.
This is complex stuff, characterizing and reverse engineering the mfg process and making sure you can replicate to scale, so I think it's a lot harder than typical to guide.
Not that I like missed timelines less than anyone else. But I'm happy they got it into the clinic since I think there's sound basis for why it should work and become one of the major unpartnered biotech programs. But it's cv, will take a lot of time and money!
Recent Developments
Nov 2004:
<<M118, the Company’s preclinical novel low molecular weight heparin candidate targeted for acute coronary syndromes, is currently in preclinical development. The Company has made a strategic decision to develop an alternate manufacturing process for M118 now rather than waiting until a later stage in the product’s clinical development. This process development effort is intended to result in a more efficient and reproducible process for manufacturing the drug substance required for future clinical and commercial programs and has the potential to reduce near-term development costs for M118. Development of the alternate manufacturing process is anticipated to cause a six to twelve month delay in the filing of the IND for M118 from the Company’s previously disclosed target filing date of June 2005.>>
Well, 6-12 month delay turned out to be 13. Not too too bad :-) |
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| To: rkrw who wrote (164) | 7/31/2006 1:30:50 PM | | From: tuck | | | | Ah, thanks for that dig; I feel a little better now. Market, as usual, remembers only the time to launch and the burn to get there. I wrote some calls a few days ago. I might end up buying them back. Sort of nice to have tradeable, volatile days again with this one.
Cheers, Tuck |
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| To: rkrw who wrote (164) | 8/5/2006 2:20:15 AM | | From: dr.praveen | | | | FDA pressed to clarify how biotech drugs are OK'd
Governors seek speedy approval for generics
By Diedtra Henderson, Globe Staff | August 4, 2006
WASHINGTON -- The governors of four states yesterday petitioned the Food and Drug Administration in an attempt to force the agency to quickly clarify how generic versions of two drugs made from living organisms can be brought to market.
Biotechnology companies -- including such Cambridge firms as Biogen Idec Inc. , Genzyme Corp. , and Momenta Pharmaceuticals Inc. -- are anxiously awaiting a resolution to the seven-year-old FDA regulatory dilemma. In the next three years, biologic drugs worth $50 billion in sales are scheduled to lose patent protection, opening the door to generic competitors that can lower prices.
According to IMS Health, sales of branded biologic drugs rose to $32.8 billion in 2005 , 17.2 percent higher than in the previous year.
Taken alone, the governors' petition is unlikely to speed FDA action, said Kenneth Kaitin , director of the Tufts Center for the Study of Drug Development in Boston. But it does add to the enormous political pressure on the FDA to issue guidelines for a process to approve generic biotechnology drugs .
``There simply is no excuse -- scientific, legal or otherwise -- for FDA to continue to delay the release of these guidance documents," Representative Henry Waxman , Democrat of California, and Senator Orrin Hatch , Republican of Utah, wrote the FDA in February.
Under pressure from a federal judge, the FDA in late May finally did approve a relatively simple generic biotechnology drug -- a human growth hormone by made a unit of the Swiss drug maker Novartis AG. But the agency stopped short of resolving how it will approve more complex generic biologic products.
The FDA in 2002 drafted guidance documents that outline approval requirements for generic versions of insulin and human growth hormone . But it has not released the information, the governors of Kansas , Minnesota , Vermont , and Wisconsin wrote in their 10-page petition. They seek prompt FDA publication of the drug-specific guidance documents and a commitment to work with manufacturers to speed treatments to market that can be substituted for any other approved human growth hormone or insulin.
``These products raise complicated scientific issues and we continue to work on them internally," said FDA spokeswoman Susan Bro. The agency will ``review the governors' concerns carefully and respond accordingly," she said.
The governors' interest is simple: money.
Market competition for both products ``could save the American healthcare system hundreds of millions of dollars annually," they wrote.
Americans spend about $1.5 billion each year on insulin products to treat diabetes and $433 million on human growth hormone, which treats such conditions as growth deficiencies and AIDS.
In Massachusetts , which is not yet part of the petition, 292,000 diabetics spent $60.9 million on insulin in 2004 alone, according to the Centers for Disease Control and Prevention .
Providing cheaper versions of biologic drugs, however, should not come at the expense of lowering the FDA's standards for approval, said Alan Crane , Momenta chief executive. The Cambridge firm uses sophisticated technology to ensure that generic versions of complex biotech drugs are equivalent to their brand-name counterparts, he said.
``It's our very strong position that FDA require the same quality standards," Crane said, ``not to compromise the safety and efficacy, not to compromise the quality of the products."
Biogen Idec entered the biogeneric debate early, providing ideas on such topics as how much clinical data would be needed to support approval. But even with FDA road maps, generic competitors would still face staggering capital costs -- $400 million to $600 million to construct a manufacturing plant -- and tough competition from branded products already proven effective.
``The best offense for a biopharmaceutical company is a good defense. And a good defense is having a better molecule," said James D. Green , Biogen Idec senior vice president of preclinical and clinical development sciences.
Diedtra Henderson can be reached at dhenderson@globe.com.
boston.com |
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| To: rkrw who wrote (164) | 8/8/2006 12:29:20 PM | | From: tuck | | | | Momenta hasn't put any kind of guidance in their earnings PRs; have they given it anywhere else? They beat on revenues, but missed on EPS, which tells me analysts' models of expenses suck, probably for lack of info. I haven't listened to the CC yet, but the stock is being pummeled on EPS (unless there was some other negative new disclosure I missed), which shouldn't matter that much. If I wasn't so heavily loaded I might consider buying more.
Cheers, Tuck |
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| To: tuck who wrote (167) | 8/8/2006 2:02:16 PM | | From: IRWIN JAMES FRANKEL | | | | Just listened to the CC on replay to see if there was something there to account for the sell-off.
Answer - no. :-) Unless the comments about the Sandos deal needing Scott Hart Rodino clearence surprised the market. My guess is that this is just a formality.
A few points:
- M356 is the descriptor being used for Copaxone, I think
- Trial of the Teva/Amphistar matter will be bifurcated with a Phase I trial of the inequitable conduct charge. Inferentially this will happen this year and sooner than December. Judge Oranna Bumgarner Felter will try the case. (DC Dist Ct)
- M118 had some very promising findings in a dog study
- Q&A answer suggested IND to NDA at under 30 months
If anyone else sees a reason for the sell-off I would like to know.
:-)
ij |
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| To: IRWIN JAMES FRANKEL who wrote (169) | 8/8/2006 2:33:41 PM | | From: rkrw | | | | Only negatives I saw, burn rate now at higher end of $30-40M range but that doesn't account for the nvs deal and is the two part trial negative since if they fail to overturn on phase I, it takes longer to get through phase II?
Hypothetical non lawyer questions. Same inequitable conduct issue as before, same judge who ruled the first time, same appeals court, what and how will the inequitable conduct outcome (and reversal) change? If it's all the same info as before and the judge places a higher burden of proof, is she likely to rule no on inequitable conduct?
Hard to imagine why the deal wouldn't pass Scott Hart Rodino. But I've noticed Crane enjoys explaining the downside risks more than other bio ceo's. |
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| To: rkrw who wrote (170) | 8/8/2006 3:00:30 PM | | From: IRWIN JAMES FRANKEL | | | | >>if they fail to overturn on phase I, it takes longer to get through phase II?
True but the inequitable conduct is likely to win.
>>Same inequitable conduct issue as before, same judge who ruled the first time, same appeals court, what and how will the inequitable conduct outcome (and reversal) change? If it's all the same info as before and the judge places a higher burden of proof, is she likely to rule no on inequitable conduct?
It seems to me that not getting summary judgment (which uses a very high standard) does not suggest that the VERY SAME evidence in a trial would be insufficient to win at trial. Even under the elevated standard for summary judgment, inequitable conduct was established. But motive was not sufficiently proved for the summary judgment. I think the same facts in a trial with the lower standard of proof (guessing it would be clear and convincing) would result in a finding of motive to deceive. That would result in a win for Teva/Ampha.
I suspect that the court will grant a partial sj establishing the necessary facts other than evidence going to motive. If that happens it could be a pretty short trial even for the well paid patent bar. :-)
ij |
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