In order to reflect the transition of the company's primary focus which was a drug discovery and early-stage licensing firm to one focused on drug development and late-stage product candidates in important viral diseases, management renamed Biota Pharmaceuticals (BOTA) to Aviragen Therapeutics (NASDAQ:AVIR) on April 11, 2016. The firm's common stock began trading on the NASDAQ Stock Exchange under the new ticker AVIR on April 13, 2016.
Subsequent to our last update on Aviragen Therapeutics, the company has been busy attending and presenting at industry conferences. In March 2016, the company sold certain assets (related to early stage antibiotics) to a newly formed subsidiary of Spero Therapeutics, LLC, a Cambridge-based biopharmaceutical company that develops novel therapies for the treatment of bacterial infections. As the company's core product offering are antiviral products, the sale of a noncore product is a strategic move by management. Financial terms of the transaction were not disclosed.
In February 2016, the company received positive news from the FDA. By recognizing BTA585's potential to address the unmet medical need to treat RSV infections, the FDA granted Fast Track designation status for the development program of BTA585 that is being developed to treat RSV infections.
The Fast Track program was put into place under the FDA Modernization Act of 1997. The Fast Track designation allows expedited review of new drugs that are intended to treat serious conditions as well as demonstrate the potential to address an unmet medical need. The designation allows AVIR to have a rolling review with the FDA during the submission process and this is because the Fast Track designation allows the following:
Frequent communication (written/in-person meeting) with the FDA to discuss the clinical development plan and trial design for the drug
Relaying relevant data to support drug approval
Eligibility for an accelerated approval and priority review, including the submission of a New Drug Application (NDA) on a rolling basis.
This implies that AVIR can submit those sections of an NDA that are completed, to be reviewed by the FDA, instead of waiting to complete every section and then submit the entire application for review. Since no treatment for RSV infections currently exists, the Fast Track program will be beneficial for AVIR since the frequent communication between the FDA and AVIR s management will be required to ensure proper execution of clinical trials so that relevant data that the FDA deems important for gaining approval can be collected.
With positive trial results from SAD and MAD studies and the recent Fast Track designation by the FDA, management initiated the Phase 2a RSV challenge efficacy study in the beginning of April 2016, as anticipated. The Phase 2a trial is a double-blind, placebo-controlled study is designed to evaluate the safety, pharmacokinetics, and antiviral activity of orally dosed BTA585 in healthy volunteers challenged intranasally with RSV. Following a positive test for RSV or five days after challenge, approximately 60 healthy adults will be randomized to receive either BTA585 or placebo. Subjects will be dosed twice daily for seven days and monitored for 28 days. The topline data from this Phase 2a trial is expected during 2H 2016. If trial results are favorable, the firm will plan for a Phase 2b natural exposure trial shortly after.
On April 25, 2016 AVIR inked a royalty agreement with HealthCare Royalty Partners. The transaction yielded net proceeds of $20 million to AVIR in exchange for an undisclosed portion of the firm's royalty rights to Inavir. With the closing of this transaction, the company's cash position is expected to be in the $75- $80 million range. This cash raise is in line with AVIR s strategy of generating non-dilutive financing by monetizing royalty assets, which relieves burden on shareholders.
The current transaction with HealthCare Royalty Partners who have offered $20 million at the outset, gives AVIR a large influx of cash that will allow the company to spur the development of the next generation of direct-acting antivirals to treat infectious diseases as well as accelerate their clinical trial programs. At the same time, retaining a portion of the royalty will allow AVIR to benefit from the potential growth and anticipated future revenues of Inavir.
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