Today’s Daily Dose brings you news about the buyout offer received by Aptevo, updated efficacy data of Pfizer/BioNTech’s COVID-19 vaccine candidate, Corcept receiving a favorable ruling from Patent Trial & Appeal Board related to the U.S. Patent ‘214 covering Korlym, Aquestive’s Type A meeting with FDA, and regulatory update related to CorMedix’ Defencath.
1. Aquestive Completes Type A Meeting With FDA
Aquestive Therapeutics Inc. (AQST) has completed a Type A meeting with the FDA confirming a pathway for resubmission for approval of its lead drug candidate Libervant.
Libervant Buccal Film, proposed for the rapid treatment of acute uncontrolled seizures in refractory patients with epilepsy on stable anti-epileptic drugs, was refused approval by the FDA in September this year.
In its Complete Response Letter, issued on September 25, the FDA had cited that certain weight groups showed a lower drug exposure level than desired. No clinical safety issues or non-clinical Chemistry, Manufacturing and Controls (CMC) issues were identified then.
AQST closed Wednesday’s trading at $6.27, up 1.13%.
2. Aptevo Gets Buyout Proposal from Tang Capital
Shares of Aptevo Therapeutics Inc. (APVO) were up more than 35% in extended trading Wednesday, following Tang Capital Partners’ proposal to acquire the remaining common stock of the company it does not already own for a price of $50.00 per share in cash. Tang Capital Partners already owns 54.4% stake in Aptevo.
The company’s lead drug candidate APVO436 is under a Phase 1/1b trial in acute myeloid leukemia and myelodysplastic syndrome patients. Dosing in cohorts 1 through 7 of the phase 1/1b trial has been completed, and enrollment in cohort 8 has commenced.
Early this month, the company revealed that out of the total nine patients in cohort 6, two patients have achieved clinical remission, one patient is exhibiting stable disease status while in six patients the disease had progressed.
APVO was trading around $2 when we alerted readers to it on November 6, 2017, in our report titled “Flying under the radar…”.
The stock closed Wednesday’s trading at $35.39, down 14.87%. However, in after-hours, the stock was up 35.07% at $47.80.
3. CorMedix’ Defencath To Skip FDA Panel Review
The FDA has notified CorMedix Inc. (CRMD) that the Advisory Committee meeting tentatively scheduled for January 14, 2021 to review the company’s New Drug Application for Defencath stands cancelled.
Defencath is a novel, antibacterial and antifungal solution designed to prevent costly and life-threatening bloodstream infections associated with the use of central venous catheters in patients undergoing chronic hemodialysis.
Based on the regulatory agency’s ongoing dialogue with the company, the FDA has come to a conclusion that an advisory committee review is not needed. The FDA’s decision is scheduled to be announced on February 28, 2021, and it remains unchanged.
CRMD closed Wednesday’s trading at $6.50, up 7.97%.
4. Patent Trial & Appeal Board Rules In Favor Of Corcept
The Patent Trial & Appeal Board has upheld the validity of all claims of Corcept Therapeutics Inc. (CORT) related to the U.S. Patent ‘214 covering Korlym.
Korlym, which is used to treat high blood sugar (hyperglycemia) in adults with Cushing’s syndrome who also have type 2 diabetes mellitus or glucose intolerance has been marketed since April 2012, and it is protected by 13 patents, which are said to have expiration dates ranging from 2028 to 2037.
The ‘214 patent covers a method of co-administering dose-adjusted Mifepristone, a glucocorticoid receptor antagonist, which is the active ingredient in Korlym, along with medications known as strong CYP3A inhibitors, including commonly-prescribed antiviral, antibiotic, antifungal and antidepressant medications.
Teva Pharmaceuticals (TEVA) and Sun Pharmaceuticals are seeking to sell their generic versions of Korlym even before the expiration of the patents covering the drug. Last May, Teva had petitioned the Patent Trial and Appeals Board (PTAB) challenging the validity of the ‘214 patent covering Korlym.
Now, with the PTAB upholding the claims of Corcept, ‘214 patent will expire only in 2037.
CORT closed Wednesday’s trading at $18.66, up 3.44%. In after-hours, the stock gained 19.24% and was at $22.25.
5. Pfizer/BioNTech’s COVID-19 Vaccine Candidate 95% Effective
Pfizer Inc. (PFE) and BioNTech SE’s (BNTX) mRNA-based COVID-19 vaccine candidate, BNT162b2, has demonstrated a vaccine efficacy rate of 95% in their ongoing phase III study, as per the results of final efficacy analysis.
The phase III global study, which is testing BNT162b2 at a 30 micrograms (mcg) dose level in a two-dose regimen, given 21 days apart, has enrolled 43,661 healthy participants to date and 41,135 of them have received a second dose of the vaccine candidate as of November 13.
As per the updated results, there were 162 cases of COVID-19 in the placebo group compared to only 8 cases in the BNT162b2 group. Totally 10 severe cases of COVID-19 were observed in the trial, with nine of the cases occurring in the placebo group and one in the BNT162b2 vaccinated group.
In the first interim efficacy analysis of the phase III trial, conducted on November 8, BNT162b2 was found to be more than 90% effective in preventing COVID-19.
The vaccine has been found to be well tolerated – with no reports of serious safety concerns. The trial will continue to collect efficacy and safety data in participants for an additional two years.
Pfizer and BioNTech plan to seek emergency approval for BNT162b2 in the coming days. The European Medicines Agency and Health Canada have already begun rolling review of BNT162b2.
As for the challenges that have been widely discussed regarding the transportation and storage of BNT162b2, Pfizer and BioNTech are confident of overcoming the same.
The companies noted that they have developed specially designed, temperature-controlled thermal shippers utilizing dry ice to maintain temperature conditions of minus 70°C±10°C. They can be used be as temporary storage units for 15 days by refilling with dry ice. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment across their pre-set routes leveraging Pfizer’s broad distribution network.
The companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021.
PFE closed Wednesday’s trading at $36.32, up 0.78%. BNTX closed the day’s trading at $90.44, up 4.04%.
6. Stocks Hitting New Highs/Lows
Kazia Therapeutics Ltd. (KZIA) closed Wednesday’s trading at a new 52-week high of $13.47, up 36.34%.
Prelude Therapeutics Inc. (PRLD) closed at a new high of $52.90, up 2.32%.
Kodiak Sciences Inc. (KOD) closed at a new high of $127.01, up 11.18%.
GoodRx Holdings Inc. (GDRX) closed at a new low of $33.76, down 6.77%.
Codiak BioSciences Inc. (CDAK) closed at a new low of $7.90, down 9.51%.
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