Pharmaceutical Technology Editors

Hovione announced on Feb. 25, 2022 that Jean-Luc Herbeaux, Hovione’s current chief operating officer (COO), will be their next CEO. Herbeaux will take over for Guy Villax, Hovione’s CEO for the past 25 years, on April 1, 2022.

According to a company press release, Hovione grew tenfold over the course of Villax’s tenure. The company has over 2000 employees and has four production sites in three regions. Going forward, Villax will now serve as a member of the board and shareholder.

“It has been a privilege and honor to lead Hovione over the last decades. I have seen this company, founded by my parents, growing, evolving and constantly re-inventing itself,” said Villax in the press release. “Dr. Herbeaux joined Hovione nearly two years ago as COO and from day [one] brought change and contributed to financial and business successes. We have worked together both on the strategy, which will take Hovione to the next level, and on making this transition smooth.”

Before joining Hovione in 2020, Herbeaux held multiple high-level positions at Evonik.

“I am honored to be entrusted with the role of Hovione’s CEO, and I am deeply motivated to lead this team of talented professionals,” said Herbeaux in the press release. “Building on Guy Villax´s legacy of innovation and customer intimacy, we will continue to work to drive long-term growth for both ourselves and our customers maintaining the Hovione values.”

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Hovione has announced that Jean-Luc Herbeaux will take over for Guy Villax as CEO on April 1, 2022.

Hovione Appoints Jean-Luc Herbeaux as New CEO

UCB, a biopharmaceutical company located in Brussels, announced on Feb. 28, 2022 that it is extending its tender offer to purchase all outstanding shares of common stock of Zogenix, alongside its pending acquisition of Zogenix, until 5:00 p.m., EST on March 4, 2022. The tender offer was previously scheduled to expire on March 1, 2022.

UCB intends to purchase all outstanding shares of Zogenix for a purchase price per share of US$26.00 in cash at closing, plus a contingent value right for a potential cash payment of US$2.00 upon EU approval by Dec. 31, 2023 of Fintepla as an orphan medicine for treatment of Lennox-Gastaut syndrome.

Certain conditions must be met in order to close the tender offer, including the tender of shares representing at least a majority of the total number of Zogenix’s outstanding shares and receipt of required antitrust clearance. The offer may be extended further in accordance with the merger agreement and the applicable rules and regulations of the U.S. Securities and Exchange Commission.

American Stock Transfer & Trust Company, LLC. is the Depositary for the tender offer, and Innisfree M&A Incorporated is the Information Agent. Stockholders who have already tendered their shares do not need to retender or take any other action as a result of the extension of the tender offer.
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UCB has announced that it is extending its tender offer to acquire Zogenix.

UCB Announces Extension of Tender Offer to Acquire Zogenix 

The European Medicines Agency (EMA) has recommended granting a marketing authorization in the European Union (EU) for Kimmtrak (tebentafusp), a monotherapy for the treatment of adult patients with uveal melanoma, a rare type of eye cancer.

Uveal melanoma is a rare and aggressive form of eye cancer where cancer cells form in the tissues of the eye. The cancer can resist treatments and spreads quickly through the body. Many patients survive less than a year after the cancer has spread. According to the EMA, uveal melanoma affects between 5 and 11 patients per million. Surgery, radiation therapy, and removal of the eye are currently the most widely used treatment options for non-metastatic uveal melanoma.

Tebentafusp is a bispecific fusion protein that helps the immune cells get close enough to the cancer cells to attack them. It can be used in adult patients who are human leukocyte antigen (HLA)-A*02:01-positive and have unresectable or metastatic uveal melanoma.

EMA’s Committee for Medicinal Products for Human Use recommended the medicine for marketing authorization under an accelerated timeline to enable faster patient access. The recommendation will be sent to the European Commission for a decision.

EMA has recommended granting a marketing authorization in the EU for Kimmtrak (tebentafusp), a new medicine for a rare type of eye cancer.

EMA Recommends Granting Market Authorization in EU for New Medicine for Rare Type of Eye Cancer

EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting approval of Moderna’s COVID-19 vaccine Spikevax to include use in children aged 6–11. Spikevax is already approved for use in adults and adolescents aged 12 and up.

The CHMP has concluded that the efficacy and safety of Spikevax in children aged 6–11 are also similar to those in adults, and that the benefits of using the vaccine on this age group outweigh the risks. The CHMP will send its recommendation to the European Commission (EC), which will issue a final decision.

The dose of Spikevax in children aged 6–11 will be lower than that used in people aged 12 and above. The most common side effects of the vaccine are similar between children aged 6–11 and adults, some of which include pain, redness and swelling at the injection site, tiredness, headache, and chills. These side effects are usually mild or moderate and improve within a few days.

Ongoing and additional studies are being conducted by the company as well as European authorities to further monitor the safety and efficacy of the vaccine in both children and adults.

EMA has recommended approval of Spikevax for children aged 6 to 11.

EMA Recommends Approval of Spikevax for Children Aged 6 to 11

Johnson & Johnson and Janssen Pharmaceutical Companies confirmed on Feb. 25, 2022 that there is sufficient participation to advance the nationwide opioid settlement agreement to resolve opioid-related claims and litigation by states, cities, counties, and other subdivisions in the United States.

The settlement is designed to directly support state and local efforts to address the opioid crisis in the US. Johnson & Johnson will contribute up to $5 billion to the settlement. The company also no longer sells prescription opioid medications in the US as part of the efforts. According to the company, the settlement agreement is not an admission of any liability or wrongdoing, and the company will continue to defend any litigation that this final settlement agreement does not resolve.

Separate settlement agreements were made between the company and the states of New York, Texas, Nevada, and New Mexico that are consistent with the nationwide settlement agreement. The company also announced a settlement agreement with the federally recognized Tribes. The dollar amounts to be received in these settlement agreements will be deducted from the $5 billion nationwide settlement agreement amount in the form of pro rata shares.

Johnson & Johnson has confirmed advancement of the nationwide opioid settlement agreement.

Johnson & Johnson Confirm Advancement of Nationwide Opioid Settlement Agreement

Pfizer and BioNTech announced on Feb. 24, 2022 that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on the companies’ COVID-19 booster for use in adolescents 12 through 17 years of age. The CHMP recommendation will be reviewed by the European Commission (EC), and a final decision on a variation to the Conditional Marketing Authorization is expected in the near future. If the variation is granted, the decision will immediately apply to all 27 EU member states, which will make booster vaccines available to all individuals 12 years and older.

FDA already granted Emergency Use Authorization (EUA) for the vaccine booster for individuals 12 to 15 years of age in the United States earlier this year. Currently, the Pfizer-BioNTech vaccine is the only COVID-19 vaccine authorized for this age group in the US and Europe.

CHMP based their positive opinion on an evaluation of safety and efficacy data from a clinical trial of a booster dose of the vaccine in those 16 and older, as well as published literature, post authorization data, and real-world evidence from booster doses in young patients in Israel. CHMP deemed the evidence concluded that the booster dose in adolescents would be at least equal to that in adults with no new safety concerns identified.

Pfizer and BioNTech will continue to supply the vaccine under their existing supply agreement with the EC.

Pfizer and BioNTech receive positive opinion for COVID-19 vaccine booster in adolescents 12 through 17 years of age in the EU. 