With $16 Price Target
Wednesday, August 31, 2022
FDA authorizes Moderna, Pfizer/BioNTech vaccine boosters retooled for Omicron
The U.S. Food and Drug Administration on Wednesday authorized the retooled COVID-19 booster shots of both Moderna and Pfizer/BioNTech that target the currently dominant BA.4/BA.5 Omicron subvariants of the coronavirus.
Both updated vaccines also include the original version of the virus targeted by all previous COVID shots, as the country prepares for another broad vaccination campaign in the fall.
Armed with $570M war chest, Arcutis launches psoriasis cream in the US
Arcutis Biotherapeutics has spent the weeks since the FDA approval of its topical plaque psoriasis cream Zoryve strengthening its cash position, drawing down $125 million from its loan facility and raising $162 million via a stock offering. That done, the biotech has launched the PDE4 inhibitor in the U.S.
The product, branded Zoryve, is a topical formulation of the active ingredient found in AstraZeneca’s oral chronic obstructive pulmonary disease treatment Daliresp. Formulating the molecule into a steroid-free cream resulted in a treatment that achieved investigator-assessed treatment success in around 40% of patients at Week 8 in a pair of late-phase trials and a side effect profile that looks competitive.
Securing approval enabled Arcutis to draw down $125 million from its loan facility. On the same day, the biotech priced a public stock offering to bring in a further $161.7 million. The actions leave Arcutis with around $570 million to support the commercialization of Zoryve and its pipeline programs.
Patients can now access the therapy. Arcutis recently made the topical cream available for ordering at pharmacies nationwide, expanding beyond an initial launch focused on Zoryve Direct pharmacies. The Zoryve Direct pharmacies are contracted pharmacy partners that help commercially insured individuals access the therapy, including by supporting them as they navigate the payer process.
Arcutis has priced Zoryve with the goal of achieving broad, high-quality coverage. Zoryve’s wholesale acquisition cost is $825 per 60-g tube, compared to the $1,325-per-tube list price of Dermavant’s rival psoriasis cream Vtama.
“We strongly believe that meaningful innovation must extend beyond product development, and include a commitment to ensuring our products are accessible to the individuals who need them. With this in mind, we are executing a responsible pricing and go-to-market strategy for Zoryve as yet another way to deliver innovative solutions for those living with plaque psoriasis,” Arcutis CEO Frank Watanabe said in a statement.
https://www.fiercepharma.com/pharma/armed-570m-warchest-arcutis-launches-psoriasis-cream-us
Aquestive approval stalled by orphan drug priority
Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing medicines to solve patients' problems with current standards of care and provide transformative products to improve their lives, announced today that the U.S. Food & Drug Administration (FDA) has granted tentative approval for Libervant™ (diazepam) Buccal Film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 12 years of age and older.
"Tentative approval" means the FDA has concluded that Libervant has met all required quality, safety, and efficacy standards for approval but, due to an existing FDA regulatory grant of orphan drug market exclusivity for Valtoco®, a diazepam nasal spray product, Libervant is not yet eligible for marketing in the United States. As a result of the FDA determination, the Agency cannot give final approval for Libervant until the expiration or inapplicability of the orphan drug market exclusivity, including, for example, by court order, a selective waiver of the orphan drug exclusivity, or a reversal of the FDA’s decision and determination that Libervant is “clinically superior” to Valtoco.
Novartis hit with Entresto patent suit from universities amid legal fight with generics makers
Novartis is already suing a long list of generics producers that aim to bring copycats of the company's popular heart failure drug Entresto to market. Now, the Swiss pharma itself has become target in a patent infringement lawsuit.
Entresto infringes a co-crystal patent held by the University of Michigan and the University of South Florida, the two institutions alleged in a complaint filed Monday in the U.S. District Court for the Northern District of California.
The universities are seeking a jury trial and damages to compensate for the alleged patent infringement. Since Entresto is a blockbuster that generated $3.55 billion worldwide last year, the damages, if awarded, could wind up being significant.
Entresto is a combination of sacubitril and valsartan. Thanks to an expanded FDA nod in 2021 to treat patients with heart failure with preserved ejection fraction (HFpEF), Entresto saw sales jump 37% at constant currencies in the first half of 2022 to $2.22 billion. Novartis has said the combo therapy could reach $5 billion in peak sales.
At the center of the new lawsuit is U.S. Patent No. 10,633,344, which was awarded in April 2020. It covers a technology of making multicomponent solid drugs with “improved drug solubility, dissolution rate, stability and bioavailability,” according to the complaint.
The Entresto co-crystals of sacubitril and valsartan comprise “supramolecular synthons,” which touched on the patented supramolecular technology, the universities argue.
Novartis didn't immediately respond to a request for comment on the lawsuit.
The new suit against Novartis comes as the Swiss pharma is trying to fend off several Entresto generic contenders, including Teva, Viatris, Aurobindo and Lupin, among others. In the U.S., Entresto boasts patents protecting various aspects of its formulation into as late as 2036. For example, Novartis in December sued Torrent Pharma for infringing on an Entresto dosage regimen patent, which expires in May 2036.
In late 2021, Novartis also filed a citizen petition asking the FDA not to approve any Entresto copycats until at least February 2024. The timeline was drawn from an additional three-year exclusivity period that came with the HFpEF nod in 2021. Greenlighting any generic before 2024 would go against FDA’s “same labeling” standards for generics, the company argued.
At that time, Novartis noted at least 18 drugmakers had submitted applications seeking approval of a generic Entresto product. Those companies are looking to bring their copycat versions to the market in July 2023, when a regulatory stay that prevents the FDA from granting final generic approvals lifts.
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