Adaptimmune gains full control of late-stage preclinical optimized PRAME TCR; IND-ready in 2023 –
GSK to deliver data from the ongoing Phase 2 / potential registrational trial with lete-cel in sarcoma with final readouts expected in late 2023 –
Adaptimmune will continue to prioritize and focus on its lead MAGE-A4 franchise while determining the optimal development path for complementary PRAME and NY-ESO assets –
Taysha Gene Therapies is an emerging leader in the development of AAV gene therapies; new collaboration aimed at enhancing development of two of Taysha's novel product candidates for rare monogenic central nervous system diseases with serious unmet medical needs -
- Astellas to invest a total of $50 million to acquire 15% of the company and to receive an exclusive option to obtain an exclusive license for TSHA-102 for Rett syndrome and TSHA-120 for giant axonal neuropathy (GAN) -
- Astellas to receive certain rights related to any potential change of control of Taysha -
- Astellas to receive one Board observer seat on the Taysha Board of Directors -
https://finance.yahoo.com/news/astellas-taysha-gene-therapies-announce-233000296.html
-- Diluted EPS of $1.27; Adjusted Diluted EPS of $1.30 --
Total revenues up 11% from the third quarter of 2021 driven by organic Medicaid and Medicare growth.
Health benefits ratio (HBR) of 88.3%, driven by strong Medicare results and inline performance from Medicaid and Commercial.
Value Creation Plan gaining momentum:
4th guidance raise in 2022 totaling a cumulative $0.30, or 5.5%, increase to the mid-point of the 2022 full-year adjusted diluted EPS guidance to a range of $5.65 to $5.75.
Novartis has abandoned development of its drug to treat presbyopia, a common age-related loss of near distance vision, after it failed a phase 2b trial.
The eyedrop formulation of UNR844 (lipoic acid/choline ester chloride) was acquired as part of the group’s buyout of privately-held ophthalmology biotech Encore Vision in 2017, and was designed to work by restoring the elasticity of the eye’s lens that declines with age.
Presbyopia is characterised by a progressive inability to focus on objects nearby, making everyday activities – such as reading – challenging. It is estimated that more than 80% of adults over the age of 45 develop the condition.
Interim results from the phase 2b study in patients aged 45 to 55 years with presbyopia showed that the drug did not achieve a statistically significant dose response three months after starting treatment, missing its primary endpoint.
“Based on these results, Novartis has taken the decision to discontinue the phase 2b study and UNR844 programme,” said the company in its third-quarter results update.
Commercial considerations may also have been at work in arriving at the decision to abandon the project.
At the time of the Encore Vision takeover, there were pharmacological therapies for presbyopia, but that changed last year when AbbVie secured FDA approval for Vuity, a once-daily eyedrop formulation of pilocarpine, as the first drug for the common eye condition.
In trials, Vuity was shown to improve close-up vision within 15 minutes of taking the eyedrops, with a duration effect of around six hours. The drug works by making the pupil contract, mimicking the eye’s natural ability to focus.
The product launched towards the end of 2021 at a price of $80 per month, and AbbVie has been trying to try to persuade people newly diagnosed with mild-to-moderate presbyopia to consider daily eyedrops as an alternative to reading glasses, contact lenses, or laser eye surgery.
So far, sales of the drug haven’t been strong enough to warrant a separate line in AbbVie’s quarterly results statements, despite a television campaign launched in the spring that had attempted to boost uptake. More insight into uptake may be revealed when the company reports its third quarter results later this week.
In April, AbbVie reported positive results of the phase 3 VIRGO trial of twice-daily Vuity, and in June it filed for approval of that new dosing regimen to give an “additional dosing option” to users of the drug.
Meanwhile, pilocarpine-based treatments from Orasis Pharma and Eyenovia, as well as a pilocarpine/phentolamine combination in development at Ocuphire Pharma, all in phase 3, suggest Novartis may have been playing catch-up even if its UNR844 data was stronger.
https://pharmaphorum.com/news/novartis-drops-presbyopia-drug-acquired-with-encore-vision/
Quarterly operating income at Swiss drugmaker Novartis slipped as competition weighed on prescriptions of multiple sclerosis drug Gilenya, but the earnings outlook at generic-drugs unit Sandoz perked up again.
For Novartis, which reports results in dollars, a strong U.S. currency was also a drag on the value of sales generated outside the United States.
Third-quarter group core operating income declined 4% to $4.28 billion, slightly below the average analyst consensus of $4.30 billion.
Quarterly sales slipped 4% to $12.54 billion, falling short of the market view for $12.9 billion
Novartis said it still expected sales and core operating income to grow at a "mid single digit" percentage, when excluding currency swings, but it again lifted its earnings guidance for generic-drugs unit Sandoz, which will be spun off next year.
Driven by sales of cheaper versions of biotechnology drugs that lost patent protection, the division's core operating income is now expected to grow by a "low single digit" percentage. The previous outlook was for earnings at the unit to be broadly flat.
The U.S. Supreme Court last week turned
down
Novartis' bid to block the launch of generic versions of the company's blockbuster multiple sclerosis drug Gilenya, which generated $2.8 billion in sales last year.
Quarterly Gilenya sales fell a currency-adjusted 24% to $507 million, below a consensus of $555 million.
https://finance.yahoo.com/news/1-novartis-earnings-slip-4-053557240.html
AstraZeneca’s IL-5 inhibitor Fasenra is already making blockbuster sales from its use in eosinophilic asthma, but the drugmaker’s efforts to expand its label keep running into difficulties.
Earlier this year, the FDA rejected AZ’s application for Fasenra (benralizumab) as a treatment for chronic rhinosinusitis with nasal polyps (CRSwNP) with a request for more data. Now, the drug has generated mixed results in a phase 3 trial in eosinophilic oesophagitis (EoE), hitting only one of two primary endpoints.
The new results are from the MESSINA study, which involved patients aged 12 or over with EoE, a chronic inflammatory disease driven by type 2 inflammation that damages the oesophagus and can make swallowing even small amounts of food a painful experience, as well as raise the risk of choking.
AZ revealed this morning that Fasenra demonstrated a statistically significant improvement in histological disease remission compared to placebo, but wasn’t able to improve the swallowing problems (dysphagia) that are particularly distressing for EoE patients.
“The results […] confirm that Fasenra achieved near complete depletion of tissue eosinophils, consistent with its mechanism of action However, this did not translate into an improvement in dysphagia symptoms,” said AZ’s head of biopharma R&D, Mene Pangalos.
“We will continue to analyse the complete data set to share with the scientific community,” he added.
When the FDA rejected the CRSwNP filing in March, AZ fell even further behind its main rival in the IL-5 inhibitor class – GSK’s Nucala (mepolizumab) – which is already approved to treat eosinophilic asthma, CRSwNP, eosinophilic granulomatosis with polyangiitis (EGPA), and hypereosinophilic syndrome (HES) and made around $1.5 billion in sales last year.
Nucala isn’t approved for EoE, giving AZ an opportunity to steal a march on its rival if MESSINA had been a success. There are about 160,000 EoE patients in the US who are currently being treated with drugs like corticosteroids and acid suppressants for EoE, more than a quarter of whom have already failed multiple treatments.
However, there is now a heavyweight contender in that disease in the form of Sanofi and Regeneron’s IL-4 and IL-13 inhibitor Dupixent (dupilumab), another drug working to counter type 2 inflammation that became the first and only medicine for EoE in the US when it was cleared by the FDA in May.
Dupixent, meanwhile, is also approved for CRSwNP along with other indications like atopic dermatitis and eosinophilic asthma, which drove it to more than $5 billion in sales last year.
As its competitors get established, the task to grow Fasenra beyond its current stronghold in asthma – which generated $1.26 billion for AZ last year – is looking increasingly difficult.
While it works out whether there is a way forward in EoE, AZ is now waiting for the results of the late-stage NATRON and MANDARA trials in HES and EGPA in the coming months.
https://pharmaphorum.com/news/weak-data-for-fasenra-undermine-azs-ambitions-for-the-drug/
