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FDA clears BMS’ heart drug Camzyos; Biogen CEO steps down after struggling with Alzheimer’s drug
This week, the US Food and Drug Administration (FDA) announced several drug approvals. Bristol Myers Squibb’s Camzyos (mavacamten) became the first-ever cardiac myosin inhibitor to treat an inherited form of heart failure known as obstructive hypertrophic cardiomyopathy (HCM). AbbVie’s immunology drug Rinvoq (upadacitinib) received its fourth approval in five months – the latest one to treat adults with active ankylosing spondylitis (AS).
The agency also expanded the use of Supernus Pharmaceuticals’ once-a-day pill Qelbree for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 18 years and older. And, in a first in 52 years, French rare disease specialist Orphalan’s Cuvrior received approval to treat Wilson’s disease.
This week’s Phispers also has news about Biogen CEO Michel Vounatsos stepping down. The US pharma is planning to “substantially” reduce its commercial infrastructure related to Aduhelm, its Alzheimer’s drug, in order to cut costs and save an additional US$ 500 million, over and above the US$ 500 million cuts announced previously.
After turning down Lilly-Innovent’s cancer drug recently, the FDA issued a complete response letter to Hong Kong-based pharma Hutchmed’s pancreatic cancer drug surufatinib, stating its data from China-only trials are not enough for an approval in the US.
Covid-19 products from Pfizer, Merck and Gilead posted better-than-expected results in the first quarter of 2022, helping the drugmakers post healthy profits. Moderna requested the FDA to authorize its Covid-19 vaccine – Spikevax – for children under six years. An approval will make Spikevax the first shot against the coronavirus for those below five years.
And Gongda Xue, a Chinese citizen and former scientist at the Friedrich Miescher Institute for Biomedical Research (FMI) in Switzerland, became the fifth scientist to be convicted in GSK trade secrets theft case.
With FDA nod in hand, BMS’ Camzyos becomes first drug to treat inherited heart condition
Last week, Bristol Myers Squibb’s Camzyos (mavacamten) became the first-ever cardiac myosin inhibitor to treat a heart failure known as obstructive hypertrophic cardiomyopathy (HCM). This is an inherited disorder where the heart muscle thickens and obstructs blood flow.
This potential blockbuster drug, which received an FDA approval last week, was the centerpiece of the New York pharma’s US$ 13 billion buyout of MyoKardia in 2020. Its approval is based on a study on 251 patients. Those on the drug fared significantly better peak oxygen consumption and improved on a widely used measurement of heart failure as compared to those who received placebos.
Camzyos – to be sold in 2.5 mg, 5 mg, 10 mg and 15 mg dosage capsules – will come with a boxed warning for the risk of heart failure. BMS has fixed the monthly price of Camzyos at US$ 7,356.16, while the annual price is US$ 89,500. Wall Street analysts estimate the drug will add billions to BMS’ kitty, with peak sales estimated at US$ 2.5 billion for 2029.
Biogen CEO steps down post Aduhelm fiasco; to cut costs further by US$ 500 million
Biogen’s struggle with controversial Alzheimer’s drug Aduhelm has culminated in CEO Michel Vounatsos stepping down from his position. The pharma is also planning to “substantially” reduce its commercial infrastructure related to the drug and undertake more cost-cutting measures.
Vounatsos, who became the CEO in 2016, will continue in his role until a successor is appointed, Biogen said.
In addition to the US$ 500 million cost-cutting program it had announced in December, the drugmaker said it plans to save another US$ 500 million a year by trimming the Aduhelm commercial team and undertaking other cost-cutting measures.
The Centers for Medicare & Medicaid Services recently restricted the coverage of the medicine to patients in clinical trials as part of the US government’s Medicare program.
Last month, Biogen decided to withdraw its marketing application for Aduhelm in Europe after it failed to convince the European regulator of the treatment’s benefits. Biogen will retain minimal resources to make Aduhelm available to patients currently taking the drug in the US. It will also continue with the drug’s ongoing redosing study and its upcoming confirmatory trial.
AbbVie’s Rinvoq scores fourth FDA approval in five months
AbbVie’s immunology drug Rinvoq (upadacitinib) is on a roll. Last week, the drug received its fourth approval in five months – the latest one to treat adults with active ankylosing spondylitis (AS), a chronic inflammatory musculoskeletal disease affecting the spine. AS affects about one in every 200 people – or around 1.1 million people – in the US.
The approval is for treating patients who have had intolerance or inadequate response to one or more tumor necrosis factor (TNF) blockers, the same class that AbbVie’s megablockbuster drug Humira belongs to.
The latest FDA approval comes close on the heels of three other approvals – for psoriatic arthritis in December, atopic dermatitis in January and ulcerative colitis in March. It is based on two clinical trials that found patients on Rinvoq displaying significant improvement in symptoms of AS over placebos at week 14.
The nod came on the same day the pharma announced the revenues generated by the drug in the first quarter of this year. While Rinvoq brought in US$ 465 million during this period – a 57 percent increase over the same quarter last year – it fell short of the US$ 490 million that analysts had estimated.
Along with another autoimmune medicine – Skyrizi – the American pharma expects Rinvoq to compensate for Humira’s drop in revenue after it loses its exclusivity in 2023. The company estimates Rinvoq to generate US$ 8 billion in sales by 2025.
Covid-19 products post strong sales, boost Q1 revenues of Pfizer, Merck, Gilead
In our ‘Top Pharma Companies & Drugs in 2021’ article, we carried that the Covid-19 pandemic was the driving force in the pharmaceuticals market, resulting in many drugmakers raking in billions of dollars in sales. As the pharma companies announced their first quarter results of 2022, Covid-19 products continued to bring in healthy sales.
Pfizer, Merck and Gilead posted better-than-expected results in the first quarter of 2022 (Q1), owing to their Covid-19 products, thereby helping the drugmakers post healthy profits.
Driven by strong sales of its Covid-19 vaccine and antiviral pill, Pfizer exceeded Wall Street expectations to grow its profit by 61 percent in Q1.
Its coronavirus vaccine — Comirnaty — brought in US$ 13.2 billion in sales, much above analysts’ estimates of US$ 10.6 billion. And antiviral pill Paxlovid racked up another US$ 1.5 billion. The drugmaker reported US$ 25.66 billion in revenues during the period, beating Wall Street expectations of US$ 24.1 billion.
Pfizer reiterated its 2022 revenue forecast of US$ 98 billion to US$ 102 billion. Of this, it expects Comirnaty to contribute US$ 32 billion, and Paxlovid to chip in another US$ 22 billion.
Similarly, Merck’s Covid-19 antiviral pill Lagevrio (molnupiravir), along with cancer drug Keytruda and Gardasil vaccine, helped Merck post a revenue growth of 50 percent to US$ 15.9 billion in the first quarter.
Gilead, too, got a strong boost from its Covid-19 treatment – Veklury (remdesivir). Sales of the drug rose five percent to US$ 1.5 billion in the first quarter, exceeding estimates of US$ 1.15 billion.
Moderna seeks FDA authorization of its Covid-19 vaccine for use in kids under six years
Moderna has requested the FDA to authorize its Covid-19 vaccine – Spikevax – for children under six years. An approval will make Spikevax the first shot against the coronavirus for those below five years.
Moderna’s request is based on data from a study where children of the age group were administered two 25 mg shots – one-fourth of what is administered to adults. The biotech said its vaccine efficacy against the coronavirus is 51 percent in children younger than two years and 37 percent in children between two and five years.
Canada is also reviewing a request by Moderna to approve its vaccine for children between the ages of six months and five years. The biotech had filed the approval application last week.
FDA expands use of Supernus’ Qelbree for treatment of adults with ADHD
The FDA has approved the expanded use of Supernus Pharmaceuticals’ once-a-day pill Qelbree for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 18 years and older.
This is the first approval in 20 years for a non-stimulant ADHD treatment for adults, after the approval of Eli Lilly’s Strattera in 2002. Qelbree is also the fourth non-controlled ADHD medicine to win FDA approval. It was first approved to treat ADHD in children between the ages of six and 17 years in April last year.
Results from a phase 3 trial in adults proved the drug’s efficacy, tolerability and safety, with no evidence of abuse potential, Supernus said. Non-stimulant ADHD meds don’t cause side effects such as agitation or sleeplessness.
There are around 16 million children, adolescents and adults with ADHD in the US. Supernus has warned the medicine may increase thoughts of suicide and similar actions in the initial months. It has also warned against using the drug with certain antidepressants.
Orphalan’s Wilson’s disease drug gets FDA nod: In a first in 52 years, French rare disease specialist Orphalan’s Cuvrior (trientine tetrahydrochloride) has received FDA approval to treat Wilson’s disease – an inherited disorder that causes copper to accumulate in the liver and brain, leading to organ damage. About 10,000 people in the US suffer from Wilson’s disease.
Orphalan plans to launch Cuvrior in the US early next year. The drug had received an authorization in Europe in 2017.
Six companies are in the fray to develop meds to treat the disease. Some, like ALXN1840 from Alexion (AstraZeneca’s rare disease unit) and Pfizer and Vivet Therapeutics’ gene therapy UX701 have been awarded FDA’s fast-track designation. Alexion’s candidate has also received an orphan drug status in Europe and the US.
After Lilly’s Tyvyt, FDA turns down Hutchmed’s cancer drug due to China-only trial
In March, the FDA had rejected Eli Lilly and its Chinese partner Innovent Biologics’ lung cancer immunotherapy treatment – Tyvyt (sintilimab) – citing a lack of population diversity (the drug’s phase 3 trial was entirely carried out in China). The agency had recommended a multi-regional clinical trial.
This week, the FDA turned down Hutchmed’s pancreatic and extra-pancreatic neuroendocrine tumors drug surufatinib, citing a similar concern. The agency issued a complete response letter (CRL) to the Hong Kong-based pharma stating that its data from two phase 3 trials solely carried out in China, along with a “bridging” trial in the US, are not enough for an approval.
Hutchmed said the agency has asked it to complete a “multi-region” study with participants “more representative of the US patient population” and comparing surufatinib to the standard of care in the country. Inspection scheduling and access issues due to the Covid-19 pandemic also contributed to the rejection, the pharma said. The company is now working with the FDA to evaluate the next steps. Surufatinib is approved in China under the brand name Sulanda.
In a second case, Shanghai-based Junshi Biosciences and its US partner Coherus said the FDA rejected their throat cancer drug, toripalimab, because of a change to the drug’s quality control process and not because of the drug’s China-only trial. The companies said they will be able to complete the changes by mid-summer.
US jury convicts fifth scientist for conspiring in GSK’s trade secrets theft case
Back in 2016, the US had filed an indictment against some scientists working at GlaxoSmithKline (GSK), alleging that they had stolen the British drug behemoth’s trade secrets to benefit a company in China. The conspiracy had come to light post an FBI probe.
Now, the probe has claimed its fifth target – Gongda Xue, a Chinese citizen and former scientist at the Friedrich Miescher Institute for Biomedical Research (FMI) in Switzerland. A federal jury in Philadelphia has found Xue guilty of conspiracy, trade secrets theft and wire fraud. His conviction follows guilty pleas by four other people, including his sister, Yu Xue, a former scientist at GSK. The sentencing has been scheduled for August 15.
According to prosecutors, between 2012 and 2016, Yu Xue and another GSK scientist, Lucy Xi, stole confidential information from GSK about products that were under development to benefit Renopharma, a company in China.
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