BCRX Awaits FDA Decision, JNJ On Watch, Pfizer/BioNTech’s COVID-19 Vaccine Gets Green Light In UK

Today’s Daily Dose brings you news about the UK authorizing Pfizer/BioNTech’s COVID-19 mRNA vaccine BNT162b2 for emergency use, the anticipated event of BioCryst Pharma, Janssen acquiring rights to investigational gene therapy HMR59, developed by privately-held Hemera Biosciences, and reverse stock split of Nabriva.

Read on…

1. UK Authorizes Pfizer/BioNTech’s COVID-19 Vaccine, FDA AdCom Meeting on Dec.10

Pfizer Inc. (PFE) and BioNTech SE’s (BNTX) COVID-19 mRNA vaccine BNT162b2 has secured Emergency Use Authorization from the UK regulator, Medicines & Healthcare Products Regulatory Agency.

BNT162b2 is based on BioNTech’s proprietary mRNA technology and supported by Pfizer’s global vaccine development and manufacturing capabilities. BNT162b2 is a two-dose vaccine, given 21 days apart.

In a phase III clinical study, BNT162b2 has demonstrated a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective) in each case measured from 7 days after the second dose.

The vaccine will be made available across the UK from next week. The companies have an agreement with the U.K. to supply 40 million doses of the BNT162b2 vaccine. The 40 million doses of the vaccine will be delivered in stages throughout 2020 and 2021.

In the U.S, BNT162b2 is all set to be reviewed by the FDA’s Vaccines and Related Biological Products Advisory Committee on Dec. 10.

The companies have also submitted the final Conditional Marketing Authorization Application following rolling submissions with the European Medicines Agency and several other regulatory agencies around the world.

BioNTech will hold the regulatory authorization in the U.K., and, if the vaccine is approved in the U.S., the EU, Canada and other countries, Pfizer will have the commercialization right worldwide with the exception of China, Germany and Turkey.

Storage & Transport:

Specially designed shippers for BNT162b2, which can maintain a temperature of minus 70 degrees Celsius for extended periods of time without any additional equipment but dry ice have been developed. The shipper can maintain temperature for 10 days unopened which allows for transportation to markets globally.

Once open, a vaccination center may use the specially designed shippers as a temporary storage solution to maintain the recommended storage conditions (-70°C ±10°C) up to 30 days with re-icing every five days in accordance with the handling instructions. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment 24 hours a day, seven days a week.

After thawing, the vaccine vial can be stored for up to five days at standard refrigerated conditions of 2 to 8 degrees Celsius.

BNTX closed Wednesday’s trading at $121.09, up 6.21%.

2. What awaits BioCryst Pharmaceuticals?

The FDA decision on BioCryst Pharmaceuticals Inc.’s (BCRX) investigational drug Orladeyo, an oral, once-daily treatment for prevention of Hereditary Angioedema attacks, is expected to be announced on December 3.

Hereditary angioedema (HAE) is a rare disease characterized by unpredictable, potentially life-threatening recurrent swelling attacks most commonly affecting the extremities, face, abdomen, and larynx.

Currently, 7 products have secured FDA approval for preventing and treating HAE attacks and all these drugs are delivered intravenously or administered subcutaneously.

Berinert, Firazyr, Kalbitor and Ruconest are approved for treating HAE attacks while Cinryze, Haegarda, and Takhzyro are approved for preventing HAE attacks. (Source: US HAEA).

Orladeyo, if approved, will become the first oral treatment for preventing Hereditary Angioedema attacks. This drug candidate is also under review in Japan and Europe, with a decision expected this month and March, respectively.

BCRX closed Wednesday’s trading at $5.04, up 3.49%.

3. Janssen Secures rights to eye disorder gene therapy from Hemera

Johnson & Johnson’s (JNJ) subsidiary Janssen Pharmaceuticals Inc. has acquired the rights to investigational gene therapy HMR59, developed by privately-held Hemera Biosciences LLC., for undisclosed terms.

HMR59, administered as a onetime, outpatient, intravitreal injection is designed to help preserve vision in patients with geographic atrophy, a late-stage and severe form of age-related macular degeneration.

Geographic atrophy, a leading cause of blindness in people over 50 years of age, is said to affect an estimated 5 million people globally. There are currently no available therapies for geographic atrophy.

A phase I study of HMR59 for patients with geographic atrophy has been completed. A second phase I study exploring HMR59 in patients with wet-AMD is currently ongoing.

In other news, the company’s COVID-19 vaccine candidate Ad26.COV2.S has been taken up for rolling review process by the European Medicines Agency. The rolling review process of the vaccine candidate was initiated by the EMA’s human medicines committee based on preliminary results from laboratory studies and early clinical studies in adults.

Ad26.COV2.S is currently under a phase III study, dubbed ENSEMBLE, which is designed to evaluate the safety and efficacy of a single vaccine dose versus placebo in up to 60,000 adults of age 8 years and older, with participants in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa and the United States.

JNJ closed Wednesday’s trading at $148.14, up 0.47%.

4. Nabriva Implements Reverse stock Split

Nabriva Therapeutics plc (NBRV) has implemented a 1-for-10 reverse stock split of its outstanding ordinary shares, which will be effective from December 3.

The reverse stock split is being done in order to be in compliance with the $1.00 per share minimum closing bid price requirement for continued listing on the Nasdaq.

NBRV closed Wednesday’s trading at $0.39, down 10.50%.

5. Stocks That Hit New Highs/Lows

Fate Therapeutics Inc. (FATE) closed Wednesday’s trading at an all-time high of $60.53, up 0.51%.

Generation Bio Co. (GBIO) closed at an all-time high of $51.61, up 6.59%.

Amicus Therapeutics Inc. (FOLD) closed at an all-time high of $23.23, up 2.65.

Viveve Medical Inc. (VIVE) closed at an all-time low of $4.80, down 6.10%.

Histogen Inc. (HSTO) closed at an all-time low of $1.27, down 3.05%.

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