2021 H1 TOP10 "Overturn" Incidents of Overseas Pharmaceutical Companies

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In a COVID-19 raid, hundreds of companies around the world quickly built vaccine/new drug pipelines for the new coronavirus

Vaccine CDMO that cannot be saved by PR-Emergent BioSolutions

At the beginning of the COVID-19 pandemic, Emergent's signal to the outside world seemed to have done everything

Under the media reports, Emergent BioSolutions has also benefited from this and its success is boundless

Unfortunately, not long after, an FDA inspector discovered problems with training, recording, and testing procedures at his Baltimore plant

Judging from Emergent's response to the media, the company has taken remedial measures to correct the error

The CEO's irreversible cooperation-Gilead & Galapagos

Although the "Hope of the People" Remdesivir once made Gilead popular for a while, this highlight does not seem to last until this year

For example, the rheumatoid arthritis drug filgotinib previously developed by Gilead and Galapagos has little hope of obtaining FDA approval; in February this year, it had to terminate another cooperative drug ziritaxestat III in patients with idiopathic pulmonary fibrosis (IPF).

Some people in the industry said that the reasons for the failure of the two drug candidates were mainly related to the management's strategy

The mRNA company that is unwilling to "stop losses"-CureVac

The German company CureVac was one of the earliest companies that announced that it would develop an mRNA new crown vaccine, and from the very beginning, it has declared how good its technology is

In June 2021, CureVac announced the second interim data of the key phase II/III clinical trial HERALD (NCT04652102) of its mRNA vaccine CVnCoV to prevent new coronavirus infection

After the news came out, CureVac's stock price fell sharply

In a relatively loose public opinion regulatory environment, a certain concept can cause stock prices to take off at any time, and even investors will most likely never be able to judge the truth

Research and development of the next "bad start" leader-Vertex

In October 2020, after Vertex's drug VX-814 for the treatment of α-1 antitrypsin deficiency (AATD) was declared unsuccessful, the company's stock price fell by 20%, and its market value evaporated by nearly US$14 billion

In June of this year, Forte Pharmaceuticals, another AATD drug, VX-864, fell short of expectations.

Two drugs, VX-814 and VX-864, have successively announced failures in the development of AATD, while rival Arrowhead Pharmaceuticals is advancing in this field, and finding the next explosive drug has become a top priority for Vertex

The "player" who withdrew from the new crown track-Merck

Former Merck CEO Fowitzer once said that developing a new vaccine is not a child's play

Merck thought that it was late to join the new crown track, and announced at the beginning of the year that it would abandon the development of two new crown vaccines and focus its firepower on antiviral therapies
.

In April, Merck announced the termination of the further development of the immunomodulator MK-7110 (previously known as CD24Fc) for the treatment of COVID-19; at the same time, the termination of oral antiviral drug molnupiravir (EIDD-2801/MK-4482) in severely ill hospitalized patients The Phase II/III study is reserved to advance the Phase III study of molnupiravir in mild to moderate outpatients
.

"Waterloo" ophthalmic gene therapy-XIRIUS

Speaking of Biogen, everyone's first reaction may be that Aduhelm, a new Alzheimer's disease drug approved by the FDA not long ago, has forgotten that the company "paid the bill" for the failure of ophthalmic gene therapy in the first half of the year
.

In May of this year, Biogen announced that the Phase II/III clinical trial code-named XIRIUS for the treatment of X-linked retinitis pigmentosa failed to improve the vision of patients and the trial failed
.
The gene therapy uses AAV8 as a delivery vector to deliver the correct version of the RPGR gene to the retina through subretinal injection, replace the mutant gene, and express the RPGR protein, thereby slowing or preventing the further loss of vision in patients with X-linked retinitis pigmentosa
.

Biogen had previously placed high hopes on the gene therapy, hoping to solve the X-linked retinitis pigmentosa problem with one treatment.
Then, in this phase II/III clinical trial, compared with placebo, the patients received gene therapy for 12 months.
The patient's vision did not improve significantly
.
The gene therapy came from Biogen's acquisition of Nightstar Therapeutics, an eye disease gene therapy company, for US$877 million in 2019
.

The failure of this gene therapy clinical trial is not only a blow to Biogen's previous huge acquisition, but also may shake its information in gene therapy
.
Next, let’s look at the performance of another gene therapy for the treatment of choroidal disease
.

Unlucky R&D head-Hal Barron

Hal Barron, head of GSK research and development, plans to terminate two studies earlier this year, the phase III of feladilimab (GSK3359609) for ALS, and an agonist for inducing T cell costimulation (ICOS)
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In February, the failure of bintrafusp alfa caused various questions about Hal Barron's oncology strategy in the industry
.

GSK CEO Emma Walmsley hired Barron for the purpose of inspiring the troubled pharmaceutical giant, but Barron is always attacked by investors
.
Some people even think, but if Barron behaves more convincingly, will the company get to this point?

The new crown antibody that was "raided" by the variant-bamlanivimab

In November last year, the FDA authorized the emergency use of the monoclonal antibody drug bamlanivimab, which became the first new coronavirus antibody drug under development to obtain the EUA of the US regulatory agency
.

In April of this year, because of the increase of mutant viruses that are resistant to bamlanivimab, the use of only the drug to treat patients with new coronary pneumonia caused "the risk of treatment failure is increasing
.
" Therefore, as a single treatment drug, the risk of using this drug has exceeded the possible curative effect, and there is no need to give EUA
.

However, the lessons learned by Eli Lilly in the development of bamlanivimab may be a gain for Regeneron and Vir/GSK
.

Clinically frustrated NASH player-NGM

Investors had high hopes for GM's NASH drug Aldafermin (R&D code: NGM282)
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However, like other NASH drug development companies before it, NGM has also now discovered that positive biomarker results may not translate into improved histological results
.

Aldafermin is an engineered FGF-19 analogue
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Previously published clinical data showed that compared to placebo, Aldafermin can significantly inhibit bile acid synthesis, reduce liver fibrosis, inflammation and steatosis, and can maintain a 24 week long-lasting response, with good tolerability and safety
.

In May of this year, the latest phase IIb clinical ALPINE 2/3 study failed to reach its primary endpoint, and NGM subsequently cancelled the phase III clinical advancement plan for the product
.
As a result of this news, NGM's share price fell 40.
8% on the day the news was announced
.

The expelled R&D boss-Moncef Slaoui

Moncef Slaoui, 61, is a well-known figure in the biopharmaceutical industry
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He previously worked at GlaxoSmithKline for nearly 30 years, served as the director of medical research and development and head of the vaccine department, and retired in 2017
.

He is better known in the market as the chief adviser of the vaccine "Operation Warp Speed" (OWS) during the Trump administration, and announced his resignation before Biden's new administration took office
.

GlaxoSmithKline (GSK) issued an open letter on March 25, after confirming the complaint of related misconduct, it decided to immediately expel Moncef Slaoui, the chairman of the board of directors of the subsidiary Galvani Bioelectronics
.

Reference: The top10 pipeline blowups, setbacks and snafus for H1 2021