Silicon Investor - Momenta Pharmaceuticals Inc.

[mopgcw] It has been a long road from 2012 to today, with some swing trades in between bu...

mopgcw — 8/19/2020 10:39:45 AM

It has been a long road from 2012 to today, with some swing trades in between but it is nice when they payout. JnJ got a bargain here imho.

[DewDiligence_on_SI] I think MNTA will ensure that they have at least some interim data from the auto...

DewDiligence_on_SI — 2/13/2018 4:26:20 PM

I think MNTA will ensure that they have at least some interim data from the autoimmune program to report during 2018.

[tuck] Oh? I thought, per the read me first, they were initiating trials, but not repo...

tuck — 2/13/2018 4:08:02 PM

Oh? I thought, per the read me first, they were initiating trials, but not reporting data. You're expecting M230 trial to report this year (M254 data even less likely this year, right)?

TIA & Cheers, Tuck

[DewDiligence_on_SI] Hard to say what could move the stock, but there are some readouts in the autoim...

DewDiligence_on_SI — 2/13/2018 3:34:58 PM

Hard to say what could move the stock, but there are some readouts in the autoimmune program during 2018.

[tuck] And TEVA was too optimistic: 40Mg Glatopa approved and launched. So telegraphed...

tuck — 2/13/2018 2:41:10 PM

And TEVA was too optimistic: 40Mg Glatopa approved and launched. So telegraphed and priced in that there's no reaction. That market will go the way of Lovenox. Have been out of MNTA for several months, and haven't really followed it closely. Will keep on eye on it for its pipe, but at the moment I'm not aware of any readouts that could move the stock in the next year. Anybody?

Cheers, Tuck

[tuck] Teva expects 2nd generic Copaxone circa April. Cheers, Tuck

tuck — 2/8/2018 9:39:09 AM

[Steve Lokness] Same news seems to be moving AKAO this morning

Steve Lokness — 1/30/2018 11:12:29 AM

[nigel bates] CAMBRIDGE, Mass., Jan. 30, 2018 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc...

nigel bates — 1/30/2018 10:30:18 AM

CAMBRIDGE, Mass., Jan. 30, 2018 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that the FDA has classified the outcome of its fourth quarter 2017 reinspection of Pfizer’s McPherson facility as Voluntary Action Indicated (VAI). The Glatopa 40 mg ANDA remains under regulatory review, however, the Company believes the application review could be completed at any time in connection with the change to VAI status.

“We are extremely pleased with this outcome. This past year of uncertainty regarding the resolution of the McPherson facility warning letter has been difficult for Momenta and its shareholders, but with this announced change in status we believe we are well-positioned to gain marketing approval and launch our Glatopa 40 mg in the first half of 2018,” stated Craig Wheeler, Momenta CEO. “We remain committed to our goal of providing patients with relapsing forms of multiple sclerosis a more affordable, high-quality treatment option.”

[tuck] CMS proposals on various topics out today. Of interest to MNTA - should they ev...

tuck — 11/16/2017 7:56:56 PM

CMS proposals on various topics out today. Of interest to MNTA - should they ever launch a biosimilar - is the proposal to categorize them for low income patient subsidies, i.e. as generics. To whit:

"Treatment of Follow-On Biological Products as Generics for Low Income Subsidy (LIS) Cost Sharing and Non-LIS Catastrophic Cost Sharing

This provision would further encourage the use of lower-cost alternatives by classifying follow-on biological products as generics for the purposes of cost-sharing for Part D enrollees who do not receive the LIS and are in the catastrophic portion of the benefit, and for LIS Part D enrollees throughout all phases of the benefit."

CMS proposals

This, of course, has nothing to do with the drug approval process for follow-ons.

Cheers, Tuck

[DewDiligence_on_SI] Musings on value of MNTA's technology: investorshub.advfn.com

DewDiligence_on_SI — 10/7/2017 5:32:53 PM

[DewDiligence_on_SI] Although a 40mg launch is technically "at risk," TEVA's remaining patents on 40m...

DewDiligence_on_SI — 10/4/2017 3:21:42 PM

Although a 40mg launch is technically "at risk," TEVA's remaining patents on 40mg Copaxone will almost certainly be found unenforceable due to double-patenting/obviousness, so MYL is not incurring much risk by launching immediately.

There is no equivocation in MYL's PR about launching immediately—only about the 180-day exclusivity.

[tuck] Wasn't there a bit of patent life left? i.e. if Mylan were to launch this very ...

tuck — 10/4/2017 2:32:56 PM

Wasn't there a bit of patent life left? i.e. if Mylan were to launch this very day, wouldn't they be doing so at risk? Can't remember where we were with that, and wondered if you or anyone knows the answer off the top of their heads. Mylan's PR suggested it might wait and avoid the fight, giving MNTA that much time to get it's fill/finish act together. Regardless, when you say multiple entrants, I assume you mean more than one. So if MNTA did get on the market, Teva would launch the authorized generic. Maybe they will do so first with 20mg dose, since there are now two of those.

Cheers, Tuck

[DewDiligence_on_SI] I'm pretty sure the only issue is whether the FDA approves a 40mg generic from o...

DewDiligence_on_SI — 10/4/2017 2:22:04 PM

I'm pretty sure the only issue is whether the FDA approves a 40mg generic from one of the first-filer applicants (including NVS/MNTA) within six months of yesterday; if they do, all approved 40mg products from first-filers will share the (remaining amount of) 180-day H-W exclusivity.

If the above is true, 180-day H-W exclusivity will end up constraining nobody—unless FDA approves a 40mg generic in the next six months from a non-first-filer applicant, which is highly unlikely, IMO.

Yes, TEVA could (and probably would) launch a 40mg AG if there are multiple approved generics.

[tuck] Any way of handicapping that outcome? And in the best case scenario of shared e...

tuck — 10/4/2017 1:26:00 PM

Any way of handicapping that outcome? And in the best case scenario of shared exclusivity, what happens to the market? Wouldn't Teva do an authorized generic under that scenario?

TIA & Cheers, Tuck

[DewDiligence_on_SI] The damage today is not as bad as it could have been because FDA hasn't yet deci...

DewDiligence_on_SI — 10/4/2017 12:26:05 PM

The damage today is not as bad as it could have been because FDA hasn't yet decided on Hatch-Waxman 180-day exclusivity for 40mg Copaxone (as noted in MYL's PR). MNTA could yet be eligible for shared exclusivity—if they get FDA approval in the next few months.

[tuck] Re Mylan getting 20mg and 40mg before MNTA. Slept in a bit and missed the news ...

tuck — 10/4/2017 12:10:28 PM

Re Mylan getting 20mg and 40mg before MNTA. Slept in a bit and missed the news and opportunity to bail for $15. This stock won't have a significant story for two or three years. Unless they can do better with Humira. But I expect at some point in the near future it will test prices seen in the premarket before the biosimilars generate excitement. Wondering if the Mylan approval is a sign of Gottlieb's influence; maybe it'll help biosimilars, too. Anyway, I'd revisit on said test. Hoping for a dead cat bounce tomorrow, but it may already have had it this morning. Company seems snakebit, to echo rkrw.

I think, in a decade or so, I have a modest (~10%) profit on my current position.

Cheers, Tuck

[DewDiligence_on_SI] Musings re ABBV-AMGN Humira-FoB settlement: investorshub.advfn.com investorshub...

DewDiligence_on_SI — 9/28/2017 5:37:21 PM

Musings re ABBV-AMGN Humira-FoB settlement:

investorshub.advfn.com
investorshub.advfn.com

[DewDiligence_on_SI] MNTA ‘ReadMeFirst’ updated: 2017-2018 news flow; reasons to be optimistic; 1Q...

DewDiligence_on_SI — 5/14/2017 6:31:41 PM

MNTA ‘ReadMeFirst’ updated:

2017-2018 news flow;
reasons to be optimistic;
1Q17 financial results, liquidity, and diluted share count;
transcript of 1Q17 CC;
phase-3 trial of M923 meets FDA draft guidelines for interchange FoBs;
incoming FDA commissioner (Scott Gottlieb) emphasizes interchangeable FoBs;
an interchangeable Humira FoB for US market is badly needed (chart).

investorshub.advfn.com

[hollyhunter] Looks like good entry point here. [graphic]

hollyhunter — 4/7/2017 8:47:33 AM

Looks like good entry point here.

[DewDiligence_on_SI] Bad link in post I'm replying to; for latest MNTA 'ReadMeFirst' (containing many...

DewDiligence_on_SI — 3/13/2017 12:04:50 PM

Bad link in post I'm replying to; for latest MNTA 'ReadMeFirst' (containing many updates), please use:

siliconinvestor.com

[DewDiligence_on_SI] MNTA ‘ReadMeFirst’ updated with many new/revised items on Copaxone, FoBs, and pr...

DewDiligence_on_SI — 3/12/2017 7:41:03 PM

MNTA ‘ReadMeFirst’ updated with many new/revised items on Copaxone, FoBs, and proprietary autoimmune program:

siliconinvestor.com

[DewDiligence_on_SI] MNTA 2017-2018 news flow—updated for delay to 40mg-Glatopa approval and other ma...

DewDiligence_on_SI — 2/17/2017 7:01:19 PM

MNTA 2017-2018 news flow—updated for delay to 40mg-Glatopa approval and other matters:

siliconinvestor.com

Please ignore link in preceding post.

[DewDiligence_on_SI] MNTA 2017-2018 news flow (updated): siliconinvestor.com

DewDiligence_on_SI — 2/17/2017 4:56:58 PM

[mopgcw] Woot!

mopgcw — 1/31/2017 2:27:40 PM

[DewDiligence_on_SI] MNTA's phase-3 trial for Humira FoB had switching arm—consistent with FDA (draft...

DewDiligence_on_SI — 1/18/2017 12:14:40 PM

MNTA's phase-3 trial for Humira FoB had switching arm—consistent with FDA (draft) guidance for interchangeable FoBs:

siliconinvestor.com
siliconinvestor.com
siliconinvestor.com

Note: Humira-FoB program is wholly-owned by MNTA.

[DewDiligence_on_SI] MNTA ‘ReadMeFirst’ updated (mainly wrt M923/M230): siliconinvestor.com

DewDiligence_on_SI — 12/2/2016 7:05:55 PM

[DewDiligence_on_SI] MNTA ‘ReadMeFirst’ updated for 3Q16 results and other items: siliconinvestor.com

DewDiligence_on_SI — 11/4/2016 4:38:57 PM

[DewDiligence_on_SI] MNTA's CEO tells why at-risk launch of 40mg Copaxone likely: siliconinvestor.com

DewDiligence_on_SI — 8/28/2016 1:40:05 PM

[DewDiligence_on_SI] Yes, it does. Handicapping the 40mg-Copaxone market: siliconinvestor.com Regar...

DewDiligence_on_SI — 8/24/2016 8:20:43 PM

Yes, it does.

Handicapping the 40mg-Copaxone market: siliconinvestor.com

Regards, Dew

[mopgcw] Patent office ruling today helps. still holding...

mopgcw — 8/24/2016 7:01:14 PM

[DewDiligence_on_SI] MNTA ‘ReadMeFirst’ updated for 2Q16 results and other info: siliconinvestor.com

DewDiligence_on_SI — 8/5/2016 5:13:26 PM

[DewDiligence_on_SI] MNTA ‘ReadMeFirst’ updated re 40mg-Glatopa & FoB programs: siliconinvestor.com

DewDiligence_on_SI — 5/8/2016 12:17:52 PM

[DewDiligence_on_SI] MNTA 2016-2017 News Flow (updated for 1Q16 CC): siliconinvestor.com

DewDiligence_on_SI — 5/8/2016 12:16:53 PM

[DewDiligence_on_SI] MNTA continues to have strong liquidity: siliconinvestor.com

DewDiligence_on_SI — 5/7/2016 3:27:10 PM

[DewDiligence_on_SI] The most important takeaway from today’s DB webcast is about FoB interchangeabil...

DewDiligence_on_SI — 5/4/2016 12:24:28 PM

The most important takeaway from today’s DB webcast is about FoB interchangeability: twitter.com

[The Ox] Market has now discounted the last 10 years of MNTA's progress (based on the cha...

The Ox — 2/29/2016 1:45:18 PM

Market has now discounted the last 10 years of MNTA's progress (based on the chart). Here's the intermediate version:

[DewDiligence_on_SI] Please use this link instead: siliconinvestor.com

DewDiligence_on_SI — 1/18/2016 7:51:37 PM

[DewDiligence_on_SI] MNTA ‘ReadMeFirst’ primer updated for MYL FoB partnership and other matters: si...

DewDiligence_on_SI — 1/18/2016 6:22:11 PM

MNTA ‘ReadMeFirst’ primer updated for MYL FoB partnership and other matters:

siliconinvestor.com

[DewDiligence_on_SI] MNTA's strong liquidity: siliconinvestor.com

DewDiligence_on_SI — 1/9/2016 2:45:38 PM

[DewDiligence_on_SI] MNTA 2016-2017 news flow (updated for MYL-MNTA FoB partnership): siliconinvestor...

DewDiligence_on_SI — 1/9/2016 2:44:57 PM

MNTA 2016-2017 news flow (updated for MYL-MNTA FoB partnership): siliconinvestor.com

[DewDiligence_on_SI] Why MYL-MNTA FoB partnership does not include Avastin: siliconinvestor.com

DewDiligence_on_SI — 1/9/2016 2:43:44 PM

[DewDiligence_on_SI] MNTA 2015-2017 news flow (updates for Humira FoB and Necupranaib): siliconinves...

DewDiligence_on_SI — 12/21/2015 11:41:27 AM

MNTA 2015-2017 news flow (updates for Humira FoB and Necupranaib):

siliconinvestor.com

[DewDiligence_on_SI] Re: $100M Lovenox bond Please see siliconinvestor.com Regards, Dew

DewDiligence_on_SI — 11/12/2015 5:21:08 PM

[DewDiligence_on_SI] Not sure what happens to the [$100M] bond. Thinking Amphastar collects due to ...

DewDiligence_on_SI — 11/11/2015 7:39:26 PM

Not sure what happens to the [$100M] bond. Thinking Amphastar collects due to non-infringement, but no stock is moving on this, so maybe not.

I don't think anyone collects anything until the case is actually tried by the District Court. Regards, Dew

[DewDiligence_on_SI] MNTA 2015-2017 news flow: siliconinvestor.com

DewDiligence_on_SI — 11/11/2015 7:38:11 PM

[tuck] "Mixed ruling" from CAFC on Lovenox litigation. CAFC mEnox ruling As I underst...

tuck — 11/10/2015 1:44:00 PM

"Mixed ruling" from CAFC on Lovenox litigation.

CAFC mEnox ruling

As I understand it: the CAFC vacates the summary judgement wrt to safe harbor. It finds no infringement of the contested patent, siding with Amphastar regarding tested versus made definitions. The District court had denied Momenta the right to mend the litigation wrt infringement of other patents, but did so on the basis of safe harbor, which the CAFC is vacation. I therefore remands to the District court wrt to litigation of other patents.

I invite the more highly trained legal minds to correct me here, if I'm off. Not sure what happens to the bond. Thinking Amphastar collects due to non-infringement, but no stock is moving on this, so maybe not.

Cheers, Tuck

[DewDiligence_on_SI] Glatopa’s volume share of 20mg Copaxone is 30%, which is “according to plan,” ac...

DewDiligence_on_SI — 10/27/2015 9:56:45 AM

Glatopa’s volume share of 20mg Copaxone is 30%, which is “according to plan,” according to NVS’ 3Q15 CC.

[Robohogs] Not very many beautiful chrts out there, but MNTA has it. It can either hold $20...

Robohogs — 8/28/2015 8:27:25 AM

Not very many beautiful chrts out there, but MNTA has it. It can either hold $20, or stay above downward channel above $18-19. Better to hold above old $20 tops.

Jon

[DewDiligence_on_SI] Appreciate the feedback. Regards, Dew

DewDiligence_on_SI — 8/27/2015 4:36:31 PM

[mopgcw] I concur, which is why I am still holding. fwiw.

mopgcw — 8/27/2015 4:32:25 PM