Citius Pharma (CTXR) Enters an Agreement with Dr. Reddy’s to Acquire Investigational Anti-Cancer Agent E7777

Citius Pharma (CTXR) Enters an Agreement with Dr. Reddy’s to Acquire Investigational Anti-Cancer Agent E7777

Citius Pharmaceutical (CTXR) Confirms Their Agreement to Acquire Anti-Cancer Agent E777 From Dr. Reddy’s

Good day everyone,

We are updating our coverage of Citius Pharmaceuticals, Inc. (NASDAQ: CTXR), a late-stage pharmaceutical company developing a pipeline of critical care products, stem-cell therapy, and oncology products.

Current price $2.20/share (as of 10:00 AM EDT September 7, 2021)

CTXR shares gapped at the open to start today’s session at $2.15/share and had traded as high as $2.27 presumably based on today’s big news. Trading volume is brisk with over 2.1M shares traded in the first 30 minutes today.

I cannot stress enough how big this new development is for CTXR

CTXR released the news this morning about their acquisition of E7777 from Dr. Reddy’s and here is what they had to say:

Citius expands late-stage pipeline with the acquisition of Dr. Reddy’s exclusive license rights to E7777, an improved formulation of previously FDA-approved ONTAK®; the exclusive license is with Eisai Co. Ltd

Patient enrollment has been completed in the Pivotal Phase 3 trial for the treatment of relapsed or refractory cutaneous T-cell lymphoma (CTCL) with a BLA filing expected by the end of 2022; if approved, the BLA will provide regulatory exclusivity for 12 years; E7777 has been granted orphan drug designation by the FDA for the treatment of CTCL

Citius’s exclusive license of E7777 is for all markets excluding certain parts of Asia and Japan; E7777 was approved in Japan for the treatment of CTCL and PTCL in 2021

Citius plans to explore the potential of E7777 to treat larger patient populations with additional indications in PTCL and immuno-oncology

I am more excited this morning than I was before this press release. CTXR plans to file for a Biologics License Application (BLA) which is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce, within 16 months. That is huge and it means that E7777 is more developed than I initially thought it was.

We also found out this morning that Eisai (the Tokyo company originally developing E777) will be responsible for completing the current CTCL clinical trial, and chemistry, manufacturing, and controls (CMC) activities through the filing of the BLA with the FDA. Citius will be responsible for development costs associated with potential additional indications.

That fact makes this pending deal even sweeter as CTXR may have no additional development costs for the CTCL indication until the BLA next year and can focus on studies for other indications. Nice. According to CTXR, “the addition of E7777 will allow us to accelerate serving cancer patients with critical unmet needs and provide us with a substantial near-term revenue opportunity in CTCL.”

If you’ve watched CTXR over time like I have, the news doesn’t come much bigger than this. E777 could be the springboard that launches the company into a major pharma player. Stay tuned, there’s a lot more to discuss about the potential with this development.

We will have more on CTXR soon.

The Traders News Source
original report below

Citius Pharma (CTXR) Enters an Agreement with Dr. Reddy’s to Acquire Investigational Anti-Cancer Agent E7777

Good day everyone,

We have been wondering what Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) might end up doing with the huge cash hoard of $115M I’ve been telling you about the past couple months and the answer is now apparent.

Current price $2.10/share (at market close Friday, September 3, 2020)

CTXR just entered into an agreement with Dr. Reddy’s (NYSE: RDY), to buy all its rights (excluding Asia) to E7777, an engineered IL-2-diphtheria toxin fusion protein and certain related assets used in the oncology sector as an anti-cancer agent.

Under the terms of agreement, Dr. Reddy’s will receive $40 million upfront upon the closing of the transaction, followed by approval milestone payments of up to $40 million related to the CTCL (cutaneous T-cell lymphoma) indication approval and up to $70 million for additional indication approvals. Further, Dr. Reddy’s will receive certain sales-based milestones and tiered earn-out payments.

Entry into the oncology sector with a viable anti-cancer agent could be a major catalyst for CTXR

Why invest in E7777?

First, we need to recognize that the CTXR management, board of directors, and scientific advisory boards are made up of some of the best minds in medicine and would give significant due diligence and careful consideration to an investment of this magnitude.

E7777 has significant potential as an important component of systemic therapy for CTCL (cutaneous T-cell lymphoma) and other cancers. It’s an established anti-cancer agent that has been the subject of clinical trials and pre-clinical studies both as a monotherapy and a combination therapy. In both situations E7777 has produced positive results.

I want to note that Dr. Reddy’s negotiated $70M in additional payments as E7777 is approved for other indication approvals beyond CTCL.

E7777 began clinical trials when it was being developed by Eisai Co. Ltd, a Tokyo company. Eisai sold E7777 to Dr. Reddy’s in 2016, excluding rights to Asia. A phase 2 trial was initiated by Eisai in March of 2016 and was completed in 2019.

More recently, in November 2020, Dr. Reddy’s did a poster presentation at SITC with pre-clinical data indicating that both E7777 and Anti-PD-1 both reduced tumors as monotherapies, but got substantially better results when combined.

The consummation of the RDY agreement will place CTXR solidly on the up-and-coming pharma companies list. Both Eisai (mc $24.3B) and Dr. Reddy’s (mc $11.1B) are significant players in pharma and E7777 I is an established anti-cancer agent. Both Eisai and Dr. Reddy’s invested in E777.

Eisai conducted positive monotherapy human trials before they sold to Dr. Reddy’s and decided to retain the rights in Japan and Asia. Dr. Reddy’s conducted pre-clinical combination studies and presented data at a major oncology conference before this transfer to CTXR.

We won’t know CTXR’s plans for this anti-cancer agent until they announce it, but the possibilities are exciting. I think the acquisition of E7777 may be a major catalyst for the company both in the near and mid-term. The addition of E7777 to the CTXR pipeline could make the company more interesting to institutional investors also.

I am writing this report over the holiday weekend and CTXR hasn’t released the news of this agreement yet. All the information above is generated from Dr. Reddy’s press release and other publications. I will update you immediately when CTXR makes an announcement.

Stay tuned and stay informed. We will be updating this exciting development at CTXR.

For our newer members:

About Citius Pharmaceuticals, Inc.

Citius is a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, with a focus on anti-infectives in adjunct cancer care, unique prescription products, and stem cell therapy. The Company’s lead product candidate, Mino-Lok®, an antibiotic lock solution for the treatment of patients with catheter-related bloodstream infections (CRBSIs), is currently enrolling patients in a Phase 3 pivotal superiority trial. Mino-Lok® was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). Through its subsidiary, NoveCite, Inc., Citius is developing a novel proprietary mesenchymal stem cell treatment derived from induced pluripotent stem cells (iPSCs) for acute respiratory conditions, with a near-term focus on acute respiratory distress syndrome (ARDS) associated with COVID-19.

More on CTXR coming soon.

The Traders News Group

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