Lannett Company Inc. (fka LCINQ)

[sharkey1]

Also, read the fine print at the bottom of this article

https://www.huffpost.com/entry/dexamethasone-improves-covid-19-survival_n_5ee8d174c5b6add763186a96

Those two HIV, drugs keep showing up

[YJ4LIFE]

Clinical Advancement Of Biosimilar Insulin Glargine, Following FDA Meeting

--Company Anticipates Biosimilar Application to be Submitted By End of Calendar Year 2022--

PHILADELPHIA, June 11, 2020 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today said that representatives from the company spoke with and received guidance from the U.S. Food and Drug Administration (FDA) on the clinical advancement program of its biosimilar insulin glargine partnered product candidate. Insulin glargine is a long-acting insulin used to treat adults with Type 2 diabetes, as well as adults and pediatric patients with Type 1 diabetes, for the control of high blood sugar. Total U.S. sales of the glargine related products, according to IQVIA, were approximately $9.5 billion for the 12 months ending April 2020, although actual biosimilar market values are expected to be lower.

Lannett Logo (PRNewsFoto/Lannett Company, Inc.)
"At the Biosimilar Biological Product Development (BPD) Type II meeting held earlier this week the FDA provided positive feedback on the clinical and CMC (Chemistry, Manufacturing and Controls) advancement of our biosimilar insulin glargine that was consistent with our expectations," said Tim Crew, chief executive officer of Lannett. "Our path forward is clear with regard to what is expected in the planned 351(k) biosimilar application, which we anticipate will be filed in calendar year 2022. We will work with our strategic partner to complete all the necessary development activity, including human clinical trials, in accordance with FDA's guidance."

Crew added, "Biosimilar insulin glargine represents a significant opportunity for Lannett, given the notably large addressable market. Moreover, we believe only a relatively small number of competitors have the technical expertise and requisite resources to develop and manufacture such a complex product."

The company previously announced positive results from the first human study evaluating insulin glargine that Lannett is developing with its strategic alliance partners within the HEC Group of companies (HEC). The trial confirmed that the Lannett/HEC biosimilar insulin glargine was biosimilar to US-approved Lantus® (the reference biologic) in terms of meeting all pharmacokinetics (PK) and pharmacodynamics (PD) safety endpoints in the study.

[NASDAQ2020]

Lannett selling Adderall IR and XR !!!!!!

$1.75 Billion combined market.

[YJ4LIFE]

Lol... welcome back sir. We miss your posts. Have a great weekend!

[Couch]

Gee one day up and the next down.....yawn.

[YJ4LIFE]

Lannett Is Confident After FDA Insulin Glargine Meeting

Longtime generics maker Lannett, of Philadelphia, Pennsylvania, said an FDA meeting this week was positive for its pending insulin glargine biosimilar application.

June 12, 2020

Lannett, a longtime generics manufacturer, emerged with confidence from a June 9, 2020, FDA meeting on the pending Biologics License Application (BLA) for its insulin glargine biosimilar candidate, which would reference the diabetes control product Lantus.

“At the Biosimilar Biological Product Development Type II meeting held earlier this week, the FDA provided positive feedback on the clinical and [chemistry, manufacturing, and controls] advancement of our biosimilar insulin glargine that was consistent with our expectations,” said Tim Crew, CEO of Lannett, in a statement.

A Significant Market

Insulin glargine is a long-acting agent used to manage high blood sugar in adults with type 2 diabetes and adults and pediatric patients with type 1 diabetes. The market for insulin glargine is dominated by large producers and is estimated at $9.5 billion, which makes it an attractive target for Lannett.

“Biosimilar insulin glargine represents a significant opportunity for Lannett, given the notably large addressable market,” Crew said. “Moreover, we believe only a relatively small number of competitors have the technical expertise and requisite resources to develop and manufacture such a complex product.”

Lannett, of Philadelphia, Pennsylvania, intends to file under the 351(k) pathway of the Public Health Service (PHS) Act of the Biologics Price Competition and Innovation Act, which provides for the licensure of biosimilars or interchangeables considered highly similar to FDA-approved originator products.

“Our path forward is clear with regard to what is expected in the planned 351(k) biosimilar application, which we anticipate will be filed in calendar year 2022. We will work with our strategic partner to complete all the necessary development activity, including human clinical trials, in accordance with FDA’s guidance,” Crew said.

As of March 23, certain protein products, including insulin and insulin analogs, human growth hormone, pancreatic enzymes, and reproductive hormones, will be reviewed under the PHS Act, as opposed to the Federal Food, Dug, and Cosmetic Act, the former pathway to approval for these agents.

Regulators hope that the new pathway will remove barriers that have stymied competition in the past and help lower prices for patients, who have faced high out-of-pocket expenses in the past. Many have had to forgo appropriate or regular treatment with insulin because of affordability issues. Recent policy changes, however, have led to caps on insulin out-of-pocket costs that have lessened the burden for patients.

The goal of the FDA meeting was to discuss the design and end point of human studies required for the BLA. The company in December 2019 announced positive results from a pharmacokinetics and pharmacodynamics study of the biosimilar candidate in healthy male adult volunteers.

[YJ4LIFE]

I see. Thanks sharkey1

[sharkey1]

No, they do not make that quinine drug but they do make Lopinavir and Ritonavir, which is part of the new study

[YJ4LIFE]

Does Lannett make hydroxychloroquine? I don’t see it on its website. Can you post the link? TIA

[YJ4LIFE]

It has nothing to do with Elite.

[dr_lowenstein]

so today's pps action tells us how poorly lci is selling elite crapola

[NASDAQ2020]

LCI distributes Elite’s/SunGen products.
They have recently entered A combined market of $1.7 Billion with their 2 new Adderall products.

[Je3232]

I know I’m on the LCI board but does this help Elite? Are they involved at all? Thanks

[YJ4LIFE]

the PPS action of ELITE today tells it all how good Lannette is selling Adderalls. UP UP and AWAY!

[NASDAQ2020]

It’s about to get REAL !!!!

LCI

[sharkey1]

Looks like Elite hired 3 more people, Lannetts partner is cooking a long

https://www.elitepharma.com/careers/

[NASDAQ2020]

June 15th after hours.
It will give a hint how Lannett is doing with both Adderalls.

[NASDAQ2020]

Lannett’s partner ELTP is having financials in a few weeks.
It will give an idea how Lannett is distributing Adderall IR and XR

[sharkey1]

https://www.yahoo.com/news/first-drugs-treat-coronavirus-could-172754714.html


This stock should skyrocket

[Dubster watching]

Sold $6.98

[sharkey1]

It continues, this article is from Hong Kong, just updated, now we are waiting on Joliet

https://www.contagionlive.com/news/phase-2-trial-antiviral-therapy-recovery-covid-19

[Dubster watching]

$6.75seems about right today.

[sharkey1]

Waiting for results

https://www.outlookindia.com/newsscroll/9-hospitals-approved-to-join-whos-solidarity-trial-to-find-treatment-for-covid19/1833456

[Dubster watching]

Unloaded with minimal gains today.
I think we can get better prices this week.

[sharkey1]

A NEW HOPE

https://www.nwherald.com/2020/05/11/joliet-hospital-to-use-new-3-drug-treatment-for-covid-19-cant-obtain-remdesivir-at-this-time/ascuacx/

lannet should be getting some orders

[sharkey1]

6 hours ago, this is a moving target

https://www.healtheuropa.eu/drug-combination-shows-promise-for-treating-covid-19/99874/

[sharkey1]

I wonder if we will hear from Lannett about these latest studies going on

https://medicalxpress.com/news/2020-05-triple-antiviral-drug-combination-early.html

this could be the ticket

[dr_lowenstein]

probably the 20% dip is related to the deal with elite. companies that partner with elite always end up badly

[Dubster watching]

Just realized so many folks I know of here.
GL

[Dubster watching]

Looking to buy this nice dip!

[kennyt 335]

Doesn't matter, a mallet hammer, a ball ping hammer, a sledge hammer, will still make you scream with excitement..

[lowandaway]

Not a very big hammer!

[NASDAQ2020]

It's HammerTime !!!

Lannett To Report Fiscal 2020 Third-Quarter Financial Results, Host Conference Call On Wednesday, May 6 @ 4:30 pm std

PHILADELPHIA, April 29, 2020 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that it will report financial results for its fiscal 2020 third quarter on Wednesday, May 6, 2020, after the market closes. Lannett management will host a conference call that same afternoon at 4:30 p.m. Eastern Time to review the company's performance and answer questions.

The conference call will be available to interested parties by dialing 800-447-0521 from the U.S. or Canada, or 847-413-3238 from international locations, passcode 49654451. The call will be broadcast via the Internet at www.Lannett.com. Listeners are encouraged to visit the website at least 10 minutes prior to the start of the scheduled presentation to register, download and install any necessary audio software. A playback of the call will be archived and accessible on the same website for at least three months.

[NASDAQ2020]

Big Day tomorrow for a Lannett !!!

Enjoy the ride !,,,

LCI

[YJ4LIFE]

I did cashed in BAC today at $25 though.

[YJ4LIFE]

It’s a good day for LCI Nas. I believe the Q in couple weeks will look very awesome. I’m not selling yet. Wait for next week when we pass the teens again. Good luck my friend! Go LCI / ELTP!!!!

[NASDAQ2020]

Thx Sharkey for the link

Looks like our partner Lannett just got some labeling issues cleared up.

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=reportsSearch.process

[NASDAQ2020]

The Monster has launched:

https://www.lannett.com/products/dextroamphetamine-amphetamine-2/

https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=e73cd2b4-1314-4c4d-954c-4f537a0ff627&type=display

[NASDAQ2020]

LCI entering a $1.3 Billion Market

[dr_lowenstein]

perhaps. but nothing to do with adderall

[dr_lowenstein]

nonsense, there is zero data on adderall sales

[NASDAQ2020]

Are whisper #'s moving this ??

LCI

[NASDAQ2020]

The SP churning Adderall XR sales will blow this thing north.

1-2 weeks BlowOut Earnings !!

Government is starting to feed LCI business so they don't have to use Chinese API.

Lannett using non-Chinese API

LCI


HammerTime !!!!!!!!1

[NASDAQ2020]

Any one know Lannett s split ?

[sharkey1]

Could HEC pharma out of Hong Kong be interested in Lannett, I saw a blurb over on TDA
Didn't make sense.

[YJ4LIFE]

What is your guess on the revenue? How much do you think we will get from Adderall XR alone for this next Q? TIA!!!

[NASDAQ2020]

Earnings in a few weeks.

[NASDAQ2020]

Very Savvy !

HammerTime !

LCI

[YJ4LIFE]

Hammer time!

[YJ4LIFE]

LCI has been very good for us this year Nasdaq. It will be even better when we have the next Q in June. I think it will go back to the teens before that. GL on LCI and ELTP as well. Best combo for long term stocks.