Market Place
GSK christens consumer health unit Haleon; witnesses file complaint against BMS for delaying Breyanzi approval process
In this week’s Phispers, we bring you news that GlaxoSmithKline (GSK) has chosen a name for its consumer health unit. Christened Haleon, the unit will debut as a standalone company in mid-2022.
In other significant news, eight unidentified witnesses have detailed “a series of deliberate or reckless acts” by BMS to delay Breyanzi’s approval by the US Food and Drug Administration (FDA) in order to avoid making a US$ 6.4 billion contingent value rights (CVR) payout tied to its big Celgene acquisition.
In a phase 3 trial, AstraZeneca and its Japanese partner Daiichi Sankyo’s breast cancer drug Enhertu helped increase the life span of patients with advanced disease. This is the first HER2-directed therapy to show mortality benefit in HER2-low metastatic breast cancer.
AbbVie has filed for an add-on approval for its antipsychotic drug Vraylar. If the drug bags approval for use in patients with major depressive disorders, AbbVie could clock over US$ 4 billion in peak sales from this drug.
The FDA has issued a complete response letter (CRL) to Irish-American biopharma Mallinckrodt for its kidney drug terlipressin.
In Covid-19 news, Sanofi is back in the vaccine race. It is seeking regulatory approval for its Covid-19 jab, developed along with GSK, which can be used as a booster as well as a standalone two-dose regimen. Meanwhile, FDA has revised its emergency use authorization for Merck’s Covid-19 pill molnupiravir, saying it should be used only as a last line of defense.
In M&A news, Japanese pharma giant Takeda has inked a US$ 2 billion biobucks deal with US-based Code Biotherapeutics to design and develop gene therapies for up to four rare diseases. And Moderna’s Covid-19 vaccine production partner Recipharm has acquired Arranta Bio and Vibalogics in order to strengthen its presence in biologics.
Ahead of spin-off, GSK names consumer healthcare unit Haleon
GlaxoSmithKline’s consumer health unit will be called Haleon when it spins off from the British pharma giant and debuts as a standalone company in mid-2022. GSK said the name of its consumer health unit has been derived from the Old English word “hale” (in good health) and the Greek word “leon” (strength). With Haleon written in all caps and in black, barring the central line of the letter “E” which is in bright green, GSK said the logo embraces vitality.
Haleon will have its headquarters in Weybridge, about 20 miles southwest of central London. Its US$ 162.7 million (£120 million) campus is expected to open in 2024. GSK has named current department head Brian McNamara as the new firm’s CEO designate.
The British pharma giant had announced the demerger of the consumer health unit in June 2021 as part of its plan to separate the prescription drugs and vaccines business from this unit. The consumer health unit generated around US$ 13 billion (£9.6 billion) in sales last year.
GSK’s consumer healthcare business grew by four percent between 2019 and 2021. Pfizer owns a 32 percent stake in the business, which includes popular brands such as Sensodyne toothpaste, arthritis cream Voltaren, pain relievers Panadol and Advil, along with multivitamin Centrum. In December, GSK had rejected Unilever’s US$ 68 billion (£50 billion) takeover bid for the unit.
Astra’s breast cancer drug scores big in phase 3 trial, improves mortality rate
AstraZeneca and its Japanese partner Daiichi Sankyo scored a crucial win for their breast cancer drug Enhertu after a Phase 3 trial helped patients with advanced disease live longer. The trial’s success will help expand treatment options to tackle the most common type of breast cancer in women.
AstraZeneca had paid US$ 6.9 billion in 2019 to Daiichi Sankyo to jointly develop the medicine. The drug, known as an antibody drug conjugate, is currently approved to treat HER2-positive breast cancer after two or more prior anti-HER2-based regimens in the metastatic setting.
Results from the trial showed Enhertu improved the survival rate for breast cancer patients suffering from a type of tumor, known as HER2-low, that couldn’t be removed surgically and whose only treatment option is chemotherapy. This is the first HER2-directed therapy to show mortality benefit in HER2-low metastatic breast cancer.
Soriot becomes highest earning biopharma CEO in Europe: In a year that saw Anglo-Swedish pharma AstraZeneca achieve its highest revenue, thanks to the success of its Covid-19 vaccine, its chief executive Pascal Soriot took home nearly US$ 18.8 million (£13.8 million) — well above Europe’s other top-paid biopharma CEOs. In comparison, Roche CEO Severin Schwan earned just US$ 12.4 million (11.5 million CHF) and Novartis CEO Vas Narasimhan took home US$ 12 million (11.2 million CHF).
‘BMS delayed Breyanzi approval process to avoid US$ 6.4 billion CVR payout’
Last year, Celgene shareholders had filed a case against Bristol Myers Squibb (BMS), accusing it of deliberately slowing down the approval process of cancer cell therapy Breyanzi to avoid paying a US$ 6.4 billion contingent value rights (CVR) tied to its US$ 74 billion Celgene takeover.
Now, in a new filing on Tuesday, eight unidentified witnesses have shared a series of “deliberate or reckless acts” that the drugmaker took in order to slow down the approval.
Some witnesses who worked at the two facilities where the drug was being manufactured said BMS knew the facilities were inadequately prepared prior to the FDA inspection, and the company deliberately did not take necessary action.
During the inspection of the facilities, the regulators had found basic and easily avoidable deficiencies. BMS had to file supplemental regulatory submissions to address these manufacturing deficiencies, but those submissions were also deficient. The FDA even noted that new information was so substantial that it required a major amendment, which one witness — a former executive director at BMS — called a “major blunder.”
As per the CVR, BMS had agreed to pay former Celgene shareholders US$ 6.4 billion if it scored FDA approvals for three new drugs — Zeposia, Breyanzi and Abecma — by pre-determined deadlines. While Zeposia was approved in March 2020, Breyanzi’s FDA approval failed to meet the December 31, 2020 deadline, and the CVR became worthless. Breyanzi was approved just 36 days later. The drug raked in US$ 87 million last year, according to BMS’ last quarter results.
Takeda inks US$ 2 billion biobucks deal with Code Biotherapeutics for rare diseases
Japanese pharma giant Takeda has inked a US$ 2 billion biobucks deal with US-based Code Biotherapeutics to design and develop gene therapies for up to four rare diseases.
As per the agreement, the two companies will use Code’s 3DNA platform to design and develop a targeted gene therapy for a liver-directed rare disease and central nervous system conditions. Takeda has the right to exclusively license four programs. While Takeda and Code will collaborate on research activities up to candidate selection, Takeda will assume responsibility for further development and commercialization of the four candidates.
Code will receive double-digit million dollars in upfront, near-term milestone and research funding payments. It is also eligible to receive future development and commercial milestone payments plus royalties. The total value of the deal could reach up to US$ 2 billion if milestones for all the four programs are achieved.
The Japanese pharma has been on a deal spree. In October, it had bet US$ 3.6 billion on Poseida Therapeutics’ in vivo gene therapies for six to eight programs across liver and hematologic diseases. It also entered into a US$ 1.12 billion deal with Selecta Biosciences for lysosomal storage disorders.
Recipharm acquires Arranta Bio, Vibalogics: Moderna’s Covid-19 vaccine production partner Recipharm is on a global expansion drive since last year. Continuing its M&A run, the Sweden-headquartered contract development and manufacturing organization (CDMO) on Friday announced two acquisitions, just weeks after it acquired GenIbet, a CDMO based in Oeiras, Portugal.
Recipharm has picked up Arranta Bio and Vibalogics to strengthen its presence in biologics. The US-based Arranta specializes in microbiome therapeutic products and messenger RNA clinical production. The deal is expected to close around the end of March.
Its second acquisition, Germany-based virotherapy CDMO Vibalogics, makes live viruses and viral vectors, including herpes, pox viruses and adenoviruses. The company also provides process and analytical development, manufacturing, testing and fill-finish services. Recipharm did not disclose the amount it is paying for the buyouts.
Sanofi, GSK to seek regulatory approval for their Covid vaccine candidate
After meeting several setbacks in the race to launch a Covid-19 vaccine, French drugmaker Sanofi and its British partner GlaxoSmithKline have finally made some headway. The duo is seeking regulatory approval for their Covid-19 vaccine, which is to be used both as a booster as well as a standalone two-dose vaccine.
The two companies plan to submit data to regulators from a late-stage trial of the vaccine, and another trial that tested it as a booster. Full results for both the studies are expected to be published “later this year,” a Reuters report said.
Sanofi-GSK’s vaccine relies on a conventional protein-based approach and uses a technology that is similar to the one used by Sanofi in its seasonal influenza vaccines. It is coupled with GSK's adjuvant, a substance that boosts the effectiveness of a shot. It is also easier to store and transport this vaccine as opposed to other rival shots.
Molnupiravir’s EUA gets revised: The FDA has revised its emergency use authorization (EUA) for Merck’s Covid-19 pill molnupiravir saying it should only be used as a last line of defense. The agency has advised the use of other available treatments, such as Pfizer’s antiviral pill Paxlovid, GlaxoSmithKline’s sotrovimab and Gilead’s Veklury (remdesivir), before turning to molnupiravir.
In December, the FDA had recommended the pill for the treatment of mild-to-moderate Covid-19 in adults and those at high risk.
Mallinckrodt’s rare kidney disease drug gets hit by FDA’s CRL for second time
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to Irish-American biopharma Mallinckrodt for terlipressin, a drug that treats a rare type of progressive kidney failure.
The drugmaker said it had to change to a new packaging and labeling manufacturing facility in the last two weeks, which meant the FDA did not have enough time to conduct inspections of the facility. The company said this was the only issue cited by the FDA in the CRL and no safety or efficacy concerns had been raised.
This is the second time that Mallinckrodt received a CRL for terlipressen. In September 2020, the FDA had denied approval of the drug citing a lack of risk-benefit data.
If approved, terlipressin would treat hepatorenal syndrome (HRS), an acute and life-threatening syndrome involving rapid reduction in kidney function. There are no FDA-approved therapies for HRS, which affects between 30,000 and 40,000 Americans annually.
AbbVie seeks add-on approval for Vraylar in hope to reach US$ 4 billion in sales
AbbVie’s schizophrenia and bipolar drug Vraylar is already a blockbuster that generated over US$ 1.7 billion in 2021. Now, the drugmaker has applied for an add-on approval for the Allergan-acquired drug to treat patients with major depressive disorder (MDD).
The company hopes a green signal from the agency will propel the drug beyond an expected US$ 4 billion in peak sales.
AbbVie’s filing is based on the results of a pair of late-stage studies. In both the studies, Vraylar showed significant improvement in patients against placebos. It also leveraged a third study, which examined the safety and tolerability of Vraylar over 26 weeks. If approved, Vraylar would compete with Johnson & Johnson’s Spravato (esketamine).
Moderna begins late-stage study of RSV vaccine: Moderna has begun a late-stage study of its vaccine for respiratory syncytial virus (RSV) based on the same technology it relied on to develop its Covid-19 vaccine. The data from a phase 2 trial found the vaccine to be safe and tolerable at the selected dose, Moderna said. The drugmaker will now enlist 34,000 adults aged 60 years and older in various countries in the late-stage trial. There is currently no vaccine for RSV. While GlaxoSmithKline recently paused a late-stage trial for an RSV candidate due to a safety concern, Pfizer’s vaccine candidate is in phase 3 trials.
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