Momenta Pharmaceuticals, Inc. (MNTA)

[floblu14]

Right to try bill passes. Any implication to MNTA?

This is BULLISH for MNTA's M281and two other NOVEL DRUG programs.

Excerpts:

....would allow people with life-threatening illnesses to bypass the Food and Drug Administration to obtain experimental medications

....designed to give patients an alternative way to obtain drugs not approved by the FDA. Currently, there
are two options for patients seeking experimental medications: enrolling in clinical trials if they are eligible or participating in the FDA's "expanded access" program. The agency has said that it approves almost all such requests to that program.

Patients would be eligible for right-to-try if they had a "life-threatening illness" and had exhausted all available treatment options. The medication itself must have completed early-stage safety testing, called Phase 1 trials, and be in active development with the goal of FDA approval.

Supporters of the bill say charges that the legislation will be harmful or ineffective are "scare tactics." After the House vote, Victor Riches, president and chief executive of the Goldwater Institute, said in a statement that "millions of Americans who have been told they are out of options and it's time to get their affairs in order, are closer to having the opportunity for one last treatment, without having to get permission from the federal government first."

Patients with serious illnesses took to social media Tuesday to urge lawmakers to pass the bill.

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From MNTA's 1Q 2018 CC:

In January, we released positive topline multidose data from our Phase I study of M281 in healthy volunteers, in which the data demonstrated safety and tolerability and confirmed the proof of mechanism for M281. In the multiple ascending dose portion of the study, M281 decreased circulating IgG levels up to 89% with a mean reduction of 84%. In both the SAD and MAD portions of the study, M281 was well tolerated at all dose levels with no serious adverse events or unexpected safety findings observed. We designed the molecule to optimize its ability to reduce IgG levels while minimizing off-target effects and immune activation, and we are very pleased to see this molecules working as designed. We believe M281 has the potential to be a best-in-class molecule for intermittent and chronic use in a broad number of rare immune-mediated disorders with high unmet patient need.

https://seekingalpha.com/article/4171122-momenta-pharmaceuticals-mnta-ceo-craig-wheeler-q1-2018-results-earnings-call-transcript?page=2

I.E.regarding the IVIG shortage -

A. Upgraded Drug Shortages app for Android devices adds alert feature (2018)

The Food and Drug Administration released Drug Shortages 2 mobile application for Android devices. Android device users are able to receive notifications when there is new or updated information about a shortage of a drug product or about a drug within selected therapeutic categories.

Designed for Android devices, Drug Shortages 2 sends alerts when the Agency adds or updates shortage information about a drug product or about a drug within selected therapeutic categories. We are currently working on notifications for the iOS version of the Drug Shortage mobile app, which will be available soon.

https://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm

B. Reasons for IVIG Shortages:

i. There is a global shortage of IVIg, because there are fewer blood donors and more patients who need IVIg

ii. Sometimes temporary shortages are caused by difficulties with production

iii. IVIg is being used to treat an increasing number of diseases and so limited supplies have to go
further.

http://igd.mdsas.com/wp-content/uploads/ivig_patient_guide.pdf