License Agreement for TLANDO® Franchise in the U.S. and Canada

[madman]

Lipocine and Verity Pharma Enter into License Agreement for TLANDO® Franchise in the U.S. and Canada

/PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, Gordon Silver Limited and...

www.prnewswire.com

SALT LAKE CITY, Jan. 18, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, Gordon Silver Limited and Verity Pharmaceuticals, Inc. (Verity Pharma) today announced that they have entered into an exclusive licensing agreement under which Verity Pharma will market TLANDO® in the United States and, if approved, in Canada. TLANDO is the first and only oral testosterone replacement therapy (TRT) option approved by the US Food and Drug Administration (FDA) that does not require dose titration. The agreement also provides Verity Pharma with the U.S. and Canadian rights to develop and commercialize LPCN 1111 (TLANDO XR), a next-generation, once-daily oral product candidate for TRT.

Under the terms of the agreement, Lipocine will receive from Verity Pharma a license fee of $11 million with an initial payment of $2.5 million which was received on the signing of the License Agreement, $5 million to be paid on February 1, 2024, $2.5 million to be paid no later than January 1, 2025, and $1 million to be paid no later than January 1, 2026. Lipocine will be entitled to receive up to $259 million in development and sales-based commercial milestone payments, as well as tiered royalty payments at rates ranging from 12% up to 18% on net sales of TLANDO franchise products. Under the agreement, Verity Pharma will be responsible for regulatory and marketing obligations in the U.S. and Canada, and all further development. Lipocine retains all rights to the TLANDO franchise for territories outside the U.S. and Canada, and all rights to non-TRT indications globally.

"We are very pleased to enter this license agreement with Verity Pharma. Men's health is one of Verity Pharma's areas of focus and Verity Pharma's sales force has existing relationships with men's health prescribers. Verity Pharma is highly motivated and has the capabilities and expertise to successfully grow the TLANDO franchise without interruption in patient access to TLANDO," said Dr. Mahesh Patel, President and Chief Executive Officer of Lipocine. "This transaction will further enable Lipocine's strategy to focus on developing treatments for CNS disorders and to add value to our non-core assets."

TRT is a large and growing market with ~8M annual prescriptions in the U.S. and ~650,000 in Canada.

Raymond James acted as financial advisor to Lipocine on this transaction.

 

[madman]

This is great news for Canadians!

TLANDO XR (testosterone tridecanoate) is coming!


*Gordon Silver Limited and Verity Pharmaceuticals, Inc. (Verity Pharma) today announced that they have entered into an exclusive licensing agreement under which Verity Pharma will market TLANDO® in the United States and, if approved, in Canada. TLANDO is the first and only oral testosterone replacement therapy (TRT) option approved by the US Food and Drug Administration (FDA) that does not require dose titration. The agreement also provides Verity Pharma with the U.S. and Canadian rights to develop and commercialize LPCN 1111 (TLANDO XR), a next-generation, once-daily oral product candidate for TRT.



About TLANDO XR

*TLANDO XR (also known as LPCN 1111) is a next-generation, novel ester prodrug of testosterone comprised of testosterone tridecanoate (TT) which uses Lipocine's proprietary delivery technology to enhance solubility and improve systemic absorption. Lipocine has successfully completed a Phase 2b dose-finding study in hypogonadal men. Results suggested that the primary objectives were met, including identifying the dose expected to be tested in a planned Phase 3 study that would be required for FDA approval.

 

[RotnGun]

So how long do the legalities of these things take to clear up before they are officially available on the shelfs in Canada?

 

[madman]

So how long do the legalities of these things take to clear up before they are officially available on the shelfs in Canada?

Going to be a while.

They still need to conduct a Phase 3 study.


*Lipocine has successfully completed a Phase 2b dose-finding study in hypogonadal men. Results suggested that the primary objectives were met, including identifying the dose expected to be tested in a planned Phase 3 study that would be required for FDA approval.

Your only options as of now seeing as the granddaddy of oral TU Andriol (manufactured by Merck) was discontinued in 2018 would be the two generics Taro-Testosterone (manufactured by Taro Pharmaceuticals Inc.) or pms-TESTOSTERONE ( manufactured by PHARMASCIENCE INC.).

Taro Taro RX product details | Pharmaceutical Industries Ltd.

www.taro.ca

Pharmascience | Nous prenons soin des patients dans le monde

Pharmascience est à l'avant-plan du marché des médicaments génériques, prenant en charge des patients à travers le monde.

www.pharmascience.com

 

[RotnGun]

I can't believe it. These PDFs say that oral testostetone undecanoate is only 7 percent bioavailable once ingested .
@Systemlord I know you take Jatenzo. What are your thoughts on oral Jatenzo so far?

 

[Systemlord]

These PDFs say that oral testostetone undecanoate is only 7 percent bioavailable once ingested .
@Systemlord I know you take Jatenzo. What are your thoughts on oral Jatenzo so far?

Jatenzo at 7% bioavailability, 237 mg twice daily = 474 mg daily = 3318 mg per week.

My response and results speaks for itself. I have endless energy, from morning till bedtime.

My HGBA1C is now 5.8%, so close to a normal level, down from 9.5%. I’m 6’ foot, 200 lbs, 32” waist now, lost 4 inches off my waist total, and it’s not going to stop there!

I building muscle and will be 52 years old in 2 months. I met this 22 year old women at the gym who is crazy about me, we workout 4 times a week. I have multiple women scoping me out, who were all competing against each other.

The way women are looking at me, every day, is noticeably different, whether at work, in public or at the gym.

Those are the results, and I couldn’t have done it without Jatenzo.

Life is good!

 

[madman]

I can't believe it. These PDFs say that oral testostetone undecanoate is only 7 percent bioavailable once ingested .
@Systemlord I know you take Jatenzo. What are your thoughts on oral Jatenzo so far?

Oral TU is around 7%.

Transdermal T (standard application) is around 9-13%.

Keep in mind the average secretion rate of T in a healthy young male is 5-7 mg/day.

Oral TU (Jatenzo, Tlando, Kyzatrex) is dosed twice daily.

Transdermal T gel standard application is once daily.

Need to pay attention to the daily doses used!

Do the math.

 

[RotnGun]

Jatenzo at 7% bioavailability, 237 mg twice daily = 474 mg daily = 3318 mg per week.

My response and results speaks for itself. I have endless energy, from morning till bedtime.

My HGBA1C is now 5.8%, so close to a normal level, down from 9.5%. I’m 6’ foot, 200 lbs, 32” waist now, lost 4 inches off my waist total, and it’s not going to stop there!

I building muscle and will be 52 years old in 2 months. I met this 22 year old women at the gym who is crazy about me, we workout 4 times a week. I have multiple women scoping me out, who were all competing against each other.

The way women are looking at me, every day, is noticeably different, whether at work, in public or at the gym.

Those are the results, and I couldn’t have done it without Jatenzo.

Life is good!

That's an impressive improvement in A1C level .
How long did it take you to get from 9.5% to 5.8% while on TRT?
How long have you been on TRT?

 

[Systemlord]

That's an impressive improvement in A1C level .
How long did it take you to get from 9.5% to 5.8% while on TRT?

I’ve been on the same dosage of Jatenzo for two years. The first year I was vitamin D and iron deficient, because I was forced to get monthly phlebotomies all of 2022, which kept my ferritin levels low.

Then my doctor told me I didn’t have to get phlebotomized anymore.

For half of 2023, I hadn’t figured out how much iron supplement to take yet, not until 6 months ago.

So six months with no deficiencies and this is the timeline where improvements accelerated for me!

How long have you been on TRT?

Since 2017, but I had treatment failure on topicals and injections. I only respond to a rapid release formulations of TRT.

My body prefers a large surge in androgens, frequently and also declining quickly.

 

[madman]

Lipocine Announces Continued Commercialization of TLANDO® through Verity Pharmaceuticals

/PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, today announced that...

www.prnewswire.com

SALT LAKE CITY, Feb. 2, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, today announced that commercialization of TLANDO® in the U.S. has been transitioned to its licensee Verity Pharma, effective February 1, 2024, enabling the continuity of patient access to TLANDO. TLANDO is the first and only oral testosterone replacement therapy (TRT) option approved by the US Food and Drug Administration (FDA) that does not require dose titration.

In January 2024, Lipocine and Gordon Silver Limited entered into an exclusive license agreement under which Verity Pharma will market TLANDO® in the United States and, if approved, in Canada. Under the terms of the license agreement, Lipocine has received the second tranche of the $11 million license fee, $5 million. In addition, per the license agreement, Gordon Silver Limited is to make license fee payments of $2.5 million and $1 million no later than January 1, 2025, and January 1, 2026, respectively.

Home :: TLANDO

www.tlando.com

 

[madman]

U.S. - Products | Verity Corporate

veritypharma.com

 

[madman]

Manufactured for Verity Pharmaceuticals, Inc.
Ewing, NJ 08628
Manufactured in the United Kingdom

TLANDO® and its design are registered trademarks of Verity Pharmaceuticals Inc.Verity Pharmaceuticals, Verity Pharma, and their designs are trademarks of Verity Pharmaceuticals, Inc. © 2024 Verity Pharmaceuticals Inc. All rights reserved.

 

[madman]

Marius Pharmaceuticals Submits KYZATREX® (Testosterone Undecanoate) CIII Capsules for Approval to Health Canada

It was just a matter of time! F**king A! Looks like they may have beat out Verity Pharmaceuticals Oral Tlando dibs on the Canadian market! RALEIGH, N.C., July 30, 2024 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, a patient-centric healthcare company focused on developing innovative...

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