Moderna locks up Spikevax name in Europe, joins Pfizer Comirnaty in wait for US brand approval

 Spikevax it is. Moderna has earned European Medicine Association approval for the brand name of its COVID-19 vaccine, even as it awaits an FDA decision.

With last week's official nod in the EU, Moderna's Spikevax joins Pfizer and BioNTech’s Comirnaty and AstraZeneca’s Vaxzevria with European brand-name approvals. None of the names is approved in the U.S., though, because the vaccines are still under emergency use authorization rather than bearing full FDA approval.

Still, it's likely the companies are fielding the same brand names in their vaccine applications filed or soon-to-be-filed with the FDA.

Spikevax is unique not only among the already approved vaccine names, but also among typically long and tongue-tying drug names in general. Its simple two-syllable name is a combination referring to the spike protein of the coronavirus and the shorthand word for vaccine.

“At two syllables with a vax suffix, that’s considered a big win from a branding standpoint in the pharma and vaccine industry,” Scott Piergrossi, Brand Institute president of operations and communications, said.

Brand Institute developed the Spikevax moniker, as well as the Comirnaty and Vaxzevria brand names.

The fourth vaccine—from Johnson & Johnson, approved for emergency use in the U.S. and Europe—is still simply called the Janssen COVID-19 vaccine, referring to J&J's drug development unit.

J&J filed for trademark protection in October on names that could be potential candidates, including Jcovden, Jcovav and Evcoyan. They were filed as names for vaccines, but without more specific details. More recently, J&J filed Jycovson, Jcovsen and Jycovden in March also as vaccine names.

“The uniqueness of each of the (EU-approved) names and the distinctiveness when compared to each other really shows how each project team is different,” Piergrossi said, adding that each name reflects “individual styles, preferences and personalities.”

Spikevax is the most straightforward, while Comirnaty combines several concepts. Two high-priority ideas the team wanted were COVID immunization and mRNA technology. Pfizer and BioNTech decided on community as an image and association they wanted to elicit.

The name Comirnaty then breaks down to the Co- prefix, followed by the mRNA in the middle, and ending with the -ty suffix, which nods to both community and immunity.

In the case of Vaxzevria, AstraZeneca did not offer an analysis of the name, but the first syllable refers again to the shorthand for vaccine.

Many consumers, of course, still refer to the vaccines by their pharma company maker. But the Brand Institute believes the brand names will eventually catch on. Just look at how quickly the media and consumers have picked up on the World Health Organization's new Greek alphabet naming system for COVID variants.

Piergrossi acknowledged that “it’s going to take some time for the vaccine brand names to establish traction, understanding and awareness in the market.”

With booster shots looking imminent, though, repetition of the brands over months and even years would help spur adoption.

https://www.fiercepharma.com/marketing/moderna-secures-spikevax-name-europe-joins-pfizer-s-comirnaty-awaiting-official-name-and

Allogene Gets FDA Fast Track Designation for T Cell Therapy for Multiple Myeloma

 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) therapies for cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ALLO-605, the Company’s next-generation AlloCAR T therapy targeting BCMA for the treatment of relapsed or refractory multiple myeloma. The FDA granted Fast Track designation based on the potential of ALLO-605 to address the unmet need for patients who have failed other standard multiple myeloma therapies. The Phase 1 dose escalation portion of the IGNITE trial evaluating ALLO-605 was initiated in Q2 2021.

ALLO-605 is the Company’s first TurboCAR™ clinical candidate. TurboCAR is a proprietary, next generation platform technology based upon programmable cytokine signaling designed to improve the function and potency of AlloCAR T™ cells. These properties may also enable CAR T therapy to succeed in solid tumors and increase efficacy in hematologic malignancies. Preclinical results from the ALLO-605 study were presented in a poster session at the American Society of Hematology (ASH) annual meeting in December of 2020.

https://finance.yahoo.com/news/allogene-therapeutics-granted-fda-fast-123000096.html

CVRx, Inc. Announces Upsized IPO Pricing

 CVRx, Inc. (“CVRx”), a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative and minimally invasive neuromodulation solutions for patients with cardiovascular diseases, announced today the upsize and pricing of its initial public offering of 7,000,000 shares of its common stock at a public offering price of $18.00 per share. In connection with the offering, CVRx has granted the underwriters a 30-day option to purchase up to an additional 1,050,000 shares of common stock at the initial public offering price, less the underwriting discount. The shares are expected to begin trading on the Nasdaq Global Select Market on June 30, 2021 under the ticker symbol “CVRX.” The gross proceeds from the offering, before deducting the underwriting discount and other offering expenses payable by CVRx, are expected to be approximately $126.0 million, excluding any exercise of the underwriters’ option to purchase additional shares. The closing of the offering is expected to occur on July 2, 2021, subject to the satisfaction of customary closing conditions.

J.P. Morgan, Piper Sandler and William Blair acted as joint book-running managers and as representatives of the underwriters for the offering. Canaccord Genuity acted as a lead manager for the offering.

https://www.globenewswire.com/news-release/2021/06/30/2255257/0/en/CVRx-Inc-Announces-Upsized-Pricing-of-Initial-Public-Offering.html

Indivior lifts outlook on strong sales of addiction treatments

 

Indivior Plc on Wednesday raised its annual revenue and profit forecast, encouraged by strong sales of its opioid addiction treatments in the first half of the year as patients resumed routine visits to clinics and hospitals, sending its shares 10.5% higher in early trade.

The London-listed drugmaker now expects full-year net revenue between $705 million and $740 million, to account for growth in its injectable opioid addiction treatment, Sublocade, and steady sales of its top-selling medicine, Suboxone.

In February, Indivior forecast sales of up to $625 million on the upside that COVID-19 restrictions, which kept patients away from hospitals and limited access to medicines, would be lifted in the second half of the year.

Opioid addiction has been a crisis in the United States, Indivior's biggest market. The U.S. Centers for Disease Control and Prevention has said nearly 500,000 people died from opioid overdoses in the United States from 1999 to 2019.

The company also expects Sublocade sales to be in a range of $210 million to $230 million, from $185 million to $210 million estimated earlier, after it received a large order from an unnamed customer in the criminal justice system.

Indivior, spun off from Reckitt in 2014, has been focusing on growing newer treatments including Sublocade, and Perseris for schizophrenia to boost its fortunes. Earlier this month, it expanded into treatments for cannabis-related disorders.

The drugmaker, which was grappling with drawn-out legal challenges and competition even before the coronavirus outbreak hammered the healthcare sector, will report interim results on July 29.

https://www.marketscreener.com/quote/stock/INDIVIOR-PLC-19344116/news/Indivior-nbsp-lifts-outlook-on-strong-sales-of-addiction-treatments-35750507/

Alpine Immune Sciences in Collaboration With Merck for Keytruda

 Alpine Immune Sciences Inc. said it is in a clinical trial collaboration and supply agreement with Merck.

The company said the collaboration will evaluate the safety and efficacy of Alpine's ALPN-202, a first-in-class conditional CD28 costimulator and dual checkpoint inhibitor, in combination with Merck's anti-PD-1 therapy Keytruda pembrolizumab.

The clinical trial began dosing study participants in June.

Keytruda is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc.

https://www.marketscreener.com/quote/stock/ALPINE-IMMUNE-SCIENCES-I-37230832/news/Alpine-Immune-Sciences-in-Collaboration-With-Merck-for-Keytruda-35755169/

Atea Pharma: Encouraging Results From Study of Covid-19 Treatment

 Atea Pharmaceuticals Inc. reported positive interim results from the global Phase 2 study evaluating AT-527 in hospitalized patients with mild-to-moderate Covid-19.

Roche Holding AG and Atea are jointly developing AT-527, an oral direct-acting antiviral agent derived from Atea's purine nucleotide prodrug platform.

The biopharmaceutical company said the interim analysis of the Phase 2 study included data from 70 hospitalized, high-risk patients with Covid-19, of which data from 62 patients were evaluable for virology analysis.

Interim virology results indicated that AT-527 rapidly reduced viral load levels. At Day 2, patients receiving AT-527 experienced an 80% greater mean reduction from baseline viral load as compared with placebo. A sustained difference in viral load reduction was maintained through Day 8, the company said.

By Day 14, the last viral sampling study day, 47% of patients in the AT-527 arm and 22% in the placebo arm had no detectable RNA virus. Nasopharyngeal swabs were measured in a reverse transcription polymerase chain reaction test for the quantitative detection of nucleic acid from SARS-CoV-2, the company said.

Consistent with previous studies, AT-527 was generally safe and well tolerated, the company said.

In this study, there were no drug-related serious adverse events. Nonserious adverse events were equally distributed across treatment arms. Most were mild-to-moderate in severity and assessed as not related to the study drug. No safety concerns or newly determined risks were identified, the company said.

https://www.marketscreener.com/quote/stock/ATEA-PHARMACEUTICALS-INC-114338425/news/Atea-Pharma-Reports-Encouraging-Results-From-Study-of-Covid-19-Treatment-35752897/

Coronavirus: early signs Sinovac’s jab is safe and effective in children

 

• Chinese company says initial studies indicate that CoronaVac induced antibodies in more than 96 per cent of trial participants
• Immune responses among children and teenagers were higher than adults assessed in previous studies, researchers say
• https://www.scmp.com/news/china/science/article/3139078/early-signs-sinovacs-covid-19-jab-safe-and-effective-children