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MARKET INTEL by PharmaCompass
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By PharmaCompass
2022-09-15
Impressions: 1839
In pharma news this week, Bristol Myers Squibb’s oral drug Sotyktu (deucravacitinib) has been approved by the US Food and Drug Administration (FDA) as a treatment for patients with moderate-to-severe plaque psoriasis. Sotyktu, a drug that BMS had acquired through its US$ 74 billion buyout of Celgene, is the only TYK2 inhibitor in the world to be approved for this condition.
In other approval news, the FDA has given a thumbs up to Revance Therapeutics’ anti-wrinkle injection Daxxify (daxibotulinumtoxinA). The drug will now compete against market leader, AbbVie’s Botox, which has long dominated the aesthetic market. According to data from late-stage studies, while the effect of a Botox injection lasts for around three months, a single dose of Daxxify is effective for almost six months, and in some patients, can last up to nine months.
This week, US President Joe Biden signed an executive order, pledging to invest over US$ 2 billion to boost the biotech supply chain and make the US drug industry less reliant on foreign manufacturing.
Novartis said its blockbuster anti-inflammatory drug Cosentyx provided rapid and sustained relief to patients suffering from moderate-to-severe hidradenitis suppurativa (HS) in two late-stage clinical trials. HS is a painful, lump-forming skin condition that affects about 1 percent of the population and is difficult to diagnose. Meanwhile, Novartis is investing US$ 300 million to bolster development and manufacturing operations that will help it move towards early technical development of biologics.
In regulatory news, the FDA has issued a Form 483 with two observations to Indian drugmaker Ajanta Pharma’s formulation facility at Dahej in Gujarat (India). The agency had carried out an inspection of the facility between September 5 and 9. The FDA has also issued a Form 483 with eight observations to Panacea Biotec’s manufacturing unit at Baddi in the Indian state of Himachal Pradesh. The agency had inspected the facility from May 30 to June 8.
BMS’ Sotyktu wins first FDA nod in moderate-to-severe plaque psoriasis
The FDA has approved Bristol Myers Squibb’s oral drug Sotyktu (deucravacitinib) as a treatment for patients with moderate-to-severe plaque psoriasis. Sotyktu, which BMS had acquired following its US$ 74 billion buyout of Celgene, is the only TYK2 inhibitor in the world to be approved for this condition.
FDA’s nod is based on two phase 3 trials, where the drug outperformed both the placebo as well as Amgen’s Otezla on two commonly used measures to assess skin clearing: psoriasis area and severity index (PASI) and static physician’s global assessment (sPGA).
Sotyktu works by inhibiting TYK2, which belongs to a family of proteins known as Janus kinases or JAK. Last year, the FDA had made it mandatory for JAK inhibitors like Pfizer’s Xeljanz and AbbVie’s Rinvoq to carry black box warnings on their labels after they were linked to cardiovascular complications and cancer. However, unlike other JAK inhibitors, Sotyktu will not have to carry any warning, as the FDA has agreed that Sotyktu “is a new class” of drug.
BMS is planning to launch Sotyktu in the market this month. The New York-based pharma is investigating the drug’s potential in other indications such as systemic lupus erythematosus. The drug is also being reviewed by the European and Japanese regulatory authorities.
Meanwhile, Nimbus Therapeutics has raised US$ 125 million for the development of its lead candidate, which it hopes will be able to compete against BMS’ Sotyktu as a med for plaque psoriasis. The experimental drug is currently undergoing phase 2 trials.
Revance’s anti-wrinkle drug Daxxify bags FDA nod, to take on AbbVie’s Botox
Last week, the FDA approved Revance Therapeutics’ anti-wrinkle injection Daxxify (daxibotulinumtoxinA), setting up a rival to market leader AbbVie’s Botox that has long dominated the market.
Daxxify’s approval is based on efficacy data from phase 3 clinical studies conducted on more than 2,700 patients. Just like Botox, Revance’s injection temporarily removes moderate-to-severe frown lines, also known as glabellar lines. While the effect of Botox injections last for around three months, a single dose of Daxxify is effective for almost double that time – that is six months – and in some patients can last up to nine months.
Revance is yet to disclose the price of Daxxify. The pharma is also evaluating the drug in mid-stage studies for the upper face, forehead lines and crow’s feet, along with two therapeutic indications — cervical dystonia and adult upper limb spasticity.
US pledges US$ 2 billion to boost biotech supply chains, reduce reliance on China
This week, US President Joe Biden signed an executive order, pledging to invest over US$ 2 billion to boost the biotech supply chain and make the US drug industry less reliant on foreign manufacturing. The executive order is being viewed as part of the government’s strategy to reduce America’s reliance on China for pharmaceuticals and manufacturing of biotech products.
As part of the initiative, the Department of Defense (DoD) and the United States Department of Health and Human Services (HHS) will invest US$ 1 billion over the next five years to boost domestic biomanufacturing infrastructure and help both private and public firms expand manufacturing capacities and boost supply chains. The DoD plans to provide US$ 200 million to enhance biosecurity and cybersecurity measures for those facilities.
Another US$ 40 million has been earmarked to expand production of active pharmaceutical ingredients (APIs), antibiotics and key starting materials for essential medications needed for responding to pandemics.
The agencies will provide US$ 270 million to launch a program that will accelerate research for new products as well as support the creation of bio-based materials for defense supply chains.
The HHS also plans to fund the development of FDA’s research programs for more advanced manufacturing technologies and support the development of an Advanced Manufacturing Innovation Hub. It will also support the development of the FDA’s Center for Advancement of Manufacturing Pharmaceuticals and Biopharmaceuticals to create more science and regulatory policies. The agency will also fund several programs related to gene and cell therapy manufacturing.
Novartis’ Cosentyx succeeds in treating painful skin condition in late-stage trials
Novartis said its anti-inflammatory drug Cosentyx was successful in providing rapid and sustained relief to patients suffering from moderate-to-severe hidradenitis suppurativa (HS) in two late-stage clinical trials. HS is a painful, lump-forming skin condition that affects about 1 percent of the population and is difficult to diagnose. Cosentyx also proved to be superior to placebo in reducing skin pain.
Novartis has submitted the phase 3 trial results to authorities in Europe and plans to submit them to the US regulators this year to seek approval for the indication. The Swiss pharma will publish long-term follow-up trial data next year.
The blockbuster drug is already approved for conditions like psoriasis and arthritis. Along with heart failure drug Entresto, Cosentyx is among Novartis’ major revenue growth drivers. The drug generated US$ 2.4 billion in sales in the first half of 2022. If approved, Cosentyx will challenge AbbVie’s Humira, which is the only drug approved to treat the condition.
To invest US$ 300 million in early-stage biologics: Novartis plans to invest US$ 300 million to bolster development and manufacturing operations that will help it move towards early technical development of biologics.
The Swiss pharma will spend US$ 110 million to ramp up clinical manufacturing and technical development at its facility in Mengeš, Slovenia. It will invest another US$ 60 million to expand and upgrade capacity at its site in Schaftenau, Austria. Additionally, the pharma is putting aside US$ 100 million to set up a biologics hub at its Basel (Switzerland) campus to complement the existing Novartis Institutes for BioMedical Research.
Takeda invests US$ 300 million at Belgium site: Takeda is investing about € 300 million (US$ 300 million) to build a new manufacturing plant for plasma-derived therapies and a new carbon net-zero emissions warehouse at its existing site in Lessines, Belgium. The new plant will have higher output and will be “even more data and digital driven” compared to the existing facility, the Japanese drugmaker said. The 50-year-old Lessines site, which employs 1,200, produces plasma-based therapies that can treat over 300,000 patients with rare and chronic diseases every year.
Indian drugmakers Ajanta Pharma, Panacea Biotec hit by FDA’s Form 483s
The FDA has issued a Form 483 with two observations to Indian drugmaker Ajanta Pharma’s formulation facility at Dahej in Gujarat. The drugmaker said the FDA had carried out an inspection of the facility between September 5 and 9.
The company said the two observations are procedural in nature. Ajanta Pharma said it is in the process of responding to the FDA, and intends to do so within the stipulated time.
Meanwhile, the FDA has also issued a Form 483 with eight observations to Panacea Biotec’s manufacturing unit at Baddi in the Indian state of Himachal Pradesh. The agency had inspected the facility from May 30 to June 8.
Panacea Biotec said it has received a communication from the FDA indicating the inspection classification as Official Action Indicated (OAI). The OAI classification implies that the FDA expects further corrective actions and may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved. The observations are related to improvements in existing procedures and are addressable, the company said.
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