| To: tuck who wrote (155) | 7/25/2006 1:15:08 PM | | From: kenhott | | | | | In this stock, some people seem to think they will know when news are coming. And some people seem to think they know who knows when news are coming. Of course I continue to know nothing which is quite unfair. Regardless I am standing by my principle about their previous selective disclosures. But as my friend would tell me, you may have your principle, but you can't live off the interest. |
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| To: Robohogs who wrote (156) | 7/25/2006 2:26:16 PM | | From: Rocky9 | | | | | Me - I sold some some Sept 20 calls for ~2.20 on 1/3 the position. Looks good now, but I would have been better to sell outright probably. Wish there had been Aug 20s and 22.50s. Bought back the July 12.50 puts for a big loss last Friday. wish I had kept the stock now. Oh well. Let's just hope that it stays over 15. No wonder the options are priced through the roof. |
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| To: rkrw who wrote (153) | 7/31/2006 9:20:28 AM | | From: dr.praveen | | | | Momenta Pharmaceuticals Files Investigational New Drug Application for Novel Anticoagulant for Acute Coronary Syndromes
Monday July 31, 7:50 am ET
Novel Compound Designed Using Momenta's Proprietary Technology
CAMBRIDGE, Mass., July 31 /PRNewswire-FirstCall/ -- Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA - News), a biotechnology company specializing in the characterization and engineering of complex drugs, announced today that it has submitted an electronic Investigational New Drug (IND) application to the U.S. Food and Drug Administration to begin a Phase I human clinical study of M118, the Company's lead novel development candidate. M118 is an anticoagulant designed specifically to treat acute coronary syndromes (ACS).
Momenta developed M118 using its proprietary technology for the detailed analysis and design of complex sugar therapeutics. By isolating, characterizing and engineering the key sugar structures within heparin that contribute to anticoagulation, Momenta designed a proprietary compound that it believes could provide baseline anticoagulant therapy to treat ACS patients who require a coronary intervention, as well as those ACS patients who are medically managed, or do not require intervention in order to treat their coronary attack. M118 is designed to be a reversible and monitorable anticoagulant that has a pharmacokinetic profile similar to a low molecular weight heparin. Thus, M118 is designed to be a therapeutic option that can be used across a variety of ACS treatment paths.
"M118 has the potential to be a significant future advancement in the treatment and management of ACS," said Alan Crane, CEO of Momenta. "We are very encouraged by our preclinical studies which show that M118 could be a potent agent that provides consistent, flexible and reversible anticoagulant therapy. We look forward to continuing to advance M118 into Phase I clinical trials in the coming months."
"M118 illustrates the potential of our technology, particularly our ability to leverage analytics and engineering to create novel drug candidates," continued Mr. Crane. "The filing of the M118 IND also demonstrates our technology's capability to generate a large number of product opportunities as we add and advance both complex generic and novel products to our growing pipeline."
Background on M118
M118 directly leverages Momenta's technology for characterizing complex mixtures, correlating specific chemical structures to biological activity, and applying these structure-function relationships to design therapies with improved clinical properties. This "rational" engineering process has resulted in a product design that we believe combines in one molecule, the best attributes of existing anticoagulants.
A key unmet need in ACS is the lack of a flexible anticoagulant agent that can be used regardless of whether a patient requires coronary intervention or is treated medically with pharmacological agents. We believe M118 can directly overcome this challenge as it combines the advantageous properties of unfractionated heparin, a preferred agent in ACS because of its ability to be reversed and monitored, with the convenience and predictable pharmacokinetic properties of low molecular weight heparins.
Based on preclinical studies, M118 has been shown to be at least as effective in inhibiting clot formation as unfractionated heparin without causing increased bleeding complications. Moreover, preclinical studies found that M118's anticoagulant activity was reversible by protamine sulfate, unlike currently marketed low molecular weight heparins or direct thrombin inhibitors. Finally, the preclinical studies also demonstrated that the level of anticoagulation provided by M118 can be readily monitored using standard point-of-care coagulation assays.
Background on Acute Coronary Syndromes
ACS is characteristically used to describe patients experiencing an acute myocardial infarction, or heart attack, as well as patients who present at hospitals with unstable angina, a transient blockage of a coronary artery. According to the National Hospital Discharge Survey, each year, there are more than 1.9 million occurrences of either unstable angina or myocardial infarction requiring medical treatment across the U.S. As part of the treatment of ACS, anticoagulant agents are routinely administered to prevent the accumulation and formation of blood clots which can lead to serious, life-threatening complications.
About Momenta
Momenta Pharmaceuticals is a biotechnology company specializing in the detailed characterization and engineering of complex sugars. Momenta is applying its technology to create technology-enabled generic versions of sugar-based and other complex drug products, develop improved versions of existing drugs, and discover novel drugs and new biological processes. The Company's most advanced product candidate is M-Enoxaparin, a technology-enabled generic version of Lovenox®. In accordance with its collaboration with Sandoz, the generics business of Novartis AG, an ANDA was submitted to the FDA for M-Enoxaparin in August 2005. Momenta has multiple technology-enabled generic products in its pipeline. Momenta's first novel drug candidate is M118. The Company is developing other novel drug candidates through its discovery effort focused on understanding sugar-based biological processes. Momenta was founded in 2001 based on technology initially developed at Massachusetts Institute of Technology and is headquartered in Cambridge, MA.
To receive additional information about Momenta, please visit the website at momentapharma.com, which does not form a part of this press release. |
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| To: dr.praveen who wrote (161) | 7/31/2006 9:43:24 AM | | From: tuck | | | | From the S-1:
>>M118 is currently in preclinical development. We intend to file an investigational new drug application, or IND, prior to the end of the first quarter of 2005 and begin Phase I clinical trials shortly thereafter.<<
Only a year and a half behind schedule. They were only a bit behind with the M-Enoxaparin ANDA. I hope this isn't a trend.
Cheers, Tuck |
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| 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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