Viatris Q2 Earnings Beat Estimates, Multiple Sclerosis Therapy Accepted For FDA Review

 Viatris Inc 

VTRS+3.87%+ Free Alerts

 reported Q2 FY23 sales of $3.91 billion, up 2% on a divestiture-adjusted operational basis, marginally higher the consensus of $3.89 billion.

Brands performed in line with expectations, reflecting strong year-over-year performance in key brands, including Yupelri and sales from Tyrvaya.

Complex generics performed in line with expectations.

The company generated approximately $124 million in new product revenues in Q2, primarily driven by lenalidomide in the U.S., and is on track to achieve approximately $500 million in new product revenues in 2023.

Generics, which include diversified product forms such as oral solids, injectables, transdermals, and topicals, performed ahead of expectations due to strong performance across broader Developed and Emerging Markets portfolios.

It reported an adjusted EPS of $0.75, better than the consensus of $0.71. The company reported an adjusted profit of $905.4 million, down from $1.01 billion

Adjusted EBITDA reached $1.31 billion compared to $1.48 billion a year ago.

Guidance: Viatris reaffirms FY23 revenue guidance of $15.5-$16 billion versus the consensus of $15.6 billion.

It expects adjusted EBITDA of $5.0-$5.4 billion and free cash flow of $2.3-$2.7 billion.

Concurrently, the FDA accepted for review Viatris and Mapi Pharma's recently submitted New Drug Application for GA Depot 40 mg. 

The product is a long-acting glatiramer acetate being investigated as a once-monthly injection for relapsing forms of multiple sclerosis, with a PDUFA action date of March 8, 2024.

https://www.benzinga.com/general/biotech/23/08/33600035/viatris-q2-earnings-beat-estimates-multiple-sclerosis-therapy-accepted-for-fda-review

Rejection of Sage/Biogen's Zuranolone Boosts Prospects for Axsome's Auvelity: Blair

 Axsome Therapeutics Inc 

AXSM-3.49%+ Free Alerts

 reported Q2 sales of $46.7 million, beating the consensus of $40.19 million. 

The company reported a Q2 EPS loss of $(1.54), missing the consensus of $(1.24).

Sales from Auvelity, a prescription oral medicine used to treat adults with major depressive disorder (MDD), reached $27.6 million, up 76% sequentially. There were no Auvelity sales in the comparable 2022 period as the product was launched in October 2022.

Approximately 53,000 prescriptions were reported for Auvelity in Q2, up 72% sequentially.

Sunosi's revenue was $19.1 million, consisting of $18.4 million in net product sales and $0.7 million in royalty revenue associated with Sunosi sales in out-licensed territories. Sunosi's revenue to Axsome for the comparable period in 2022 was $8.8 million.

Q2 U.S. Sunosi total prescriptions increased by 15% Y/Y and 8% sequentially.

Based on the current operating plan, cash and cash equivalents of $437.1 million is sufficient to fund anticipated operations into cash flow positivity.

William Blair notes FDA rejection for Sage Therapeutics Inc 

SAGE-53.6%+ Free Alerts

 and Biogen Inc's 

BIIB+0.86%+ Free Alerts

 zuranolone for MDD.

Analysts Myles Minter, Sarah Schram, and Tiffany Marchell say this bodes well competitively for Auvelity in the early launch as a novel-acting branded antidepressant, following a string of other notable misses outside zuranolone including the ARIA trial of PRAX-114 from Praxis 

PRAX-3.85%+ Free Alerts

 and RELIANCE III study of Relmada's 

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 of REL-1017.

The analysts see Auvelity as an effective antidepressant therapy with a branded therapy competitive moat currently that should garner increasing traction as commercial coverage continues to come online.

https://www.benzinga.com/analyst-ratings/analyst-color/23/08/33601230/fdas-rejection-of-sagebiogens-zuranolone-boosts-prospects-for-axsomes-auvelity-anal

Poseida Gets Strategic Investment by Astellas and Provides Business Update

 -Poseida Therapeutics, Inc.  (Nasdaq: PSTX), a clinical-stage cell and gene therapy company advancing a new class of treatments for patients with cancer and rare diseases, today announced a $50 million strategic investment by Astellas Pharma US, Inc. which is comprised of the purchase of 8,333,333 shares of common stock at $3.00 per share for an aggregate purchase price of $25 million and an additional $25 million one-time payment for certain strategic rights, and provided a business update.

"We are excited to announce a strategic investment by Astellas, a premier global pharmaceutical company that shares our strategic vision for the future of genetic engineering and cell and gene therapies. This investment further validates our technology and approach and also reflects our broad strategic options in progressing the business," said Mark Gergen, Poseida's Chief Executive Officer. "Based on this investment and cost control measures implemented in the business, we are extending our cash runway guidance as we remain focused on being good stewards of capital. As we look towards the future, we are taking recent learnings from our allogeneic programs and implementing improvements across our clinical trials. Based on these findings, we are adjusting guidance on data updates and look forward to sharing clinical data highlighting some of these enhancements at a medical meeting later this year, with plans for a more robust clinical update to follow in mid-2024."

Allogeneic CAR-T Program Updates & Clinical Trial Learnings

"We are continuing to advance the Phase 1 trials for both P-BCMA-ALLO1 and P-MUC1C-ALLO1 and the data we have generated has led us to find improvements that we believe have the potential to greatly benefit our allogeneic portfolio," added Kristin Yarema, Ph.D., President of Cell Therapy at Poseida. "We have implemented a number of these already in our clinical-stage programs, as we continue steady progress in dose-ranging and explore approaches such as raising conditioning lymphodepletion to emerging industry norms and exploring additional dosing and administration options.  We are also improving our manufacturing process in ways that will further increase product yield, and are encouraged by the early signals we are seeing in this area also. Overall, we remain highly excited about the potential of our allogeneic platform and our ongoing opportunities for continuous improvement."

P-BCMA-ALLO1

P-BCMA-ALLO1 is an allogeneic CAR-T product candidate being developed to target relapsed/refractory multiple myeloma (R/R MM) in partnership with Roche. The Company is currently evaluating P-BCMA-ALLO1 in a Phase 1 clinical trial and expects to present a clinical update for the program at a medical meeting in 2023, subject to clearance with Roche. Given the implementation of new dosing regimens, the Company expects that there will be a limited number of patients available for evaluation in newer cohorts. Poseida plans to provide a further clinical update in mid-2024.

P-MUC1C-ALLO1

P-MUC1C-ALLO1 is an allogeneic CAR-T product candidate targeting solid tumors derived from epithelial cells, including breast and ovarian cancers. The Company is currently evaluating P-MUC1C-ALLO1 in a Phase 1 clinical trial. The Company expects to present clinical updates for the program at a medical meeting in 2023. Given the implementation of new dosing regimens, the Company expects that there will be a limited number of patients available for evaluation in newer cohorts. Poseida plans to provide a further clinical update in mid-2024.

P-CD19CD20-ALLO1

P-CD19CD20-ALLO1 is an allogeneic CAR-T product being developed to target B-cell malignancies in partnership with Roche. P-CD19CD20-ALLO1 is the Company's first dual CAR program and contains two fully functional CAR molecules to target cells that express either CD19 or CD20. The Company believes that by targeting both CD19 and CD20, there is potential to overcome antigen escape that has been observed by others. In June 2023 Poseida received IND clearance from the FDA for P-CD19CD20-ALLO1, which the Company believes is the first allogeneic dual CAR-T therapy targeting CD19 and CD20 antigens that has received such clearance, and has initiated site start-up for this program. Poseida expects to dose the first patient with P-CD19CD20-ALLO1 in early 2024.

https://www.biospace.com/article/releases/poseida-therapeutics-announces-strategic-investment-by-astellas-and-provides-business-update/

EU Pulls Authorization of Novartis’ Sickle Cell Disease Drug

 The European Commission has formally revoked its conditional marketing authorization for Novartis’ sickle cell disease therapy Adakveo (crizanlizumab), the Swiss pharma company announced Friday.

The decision comes after the Committee on Medicinal Products for Human Use (CHMP) recommended in May 2023 to pull the approval following a review of additional Phase III data. The EC’s decision is legally binding, forcing Novartis to withdraw Adakveo from all 27 territories covered by the Commission, including Germany, Sweden and Spain, as well as Iceland, Norway and Liechtenstein, which are part of the European Economic Area.

Patients in these territories should discuss alternative treatment options with their doctors and healthcare providers, Novartis said in its announcement.

Adakveo is a humanized IgG2 monoclonal antibody that works by binding to the cell adhesion molecule P-selectin, which is found on the surface of platelets and blood vessel endothelium, while disrupting its interaction with its corresponding ligands. In turn, this mechanism of action allows Adakveo to prevent vaso-occlusion in sickle cell disease (SCD).

The FDA approved Adakveo in November 2019 as a treatment to lower the frequency of vaso-occlusive crises in SCD patients aged 16 years and above. Nearly a year later, in October 2020, the European Medicines Agency signed off on a conditional approval for the SCD therapeutic and its conversion to standard authorization was contingent on further evidence to validate the efficacy and safety of the product.

Novartis ran the Phase III STAND trial to support Adakveo’s full approval in the EU, but in January of this year the company reported that the late-stage study was unable to replicate previous efficacy findings. A preliminary analysis of STAND showed that Adakveo was unable to significantly distinguish itself from placebo in terms of lowering the annualized rates of vaso-occlusive events in SCD patients.

The CHMP flagged this and launched its own review of Adakveo, confirming in May 2023 that Novartis’ treatment “did not reduce the number of painful crises leading to a healthcare visit” as compared with placebo.

The European regulator also looked at past studies of Adakveo, a managed access program and real-world performance data, noting that these studies “had several limitations, such as the lack of a comparator, and could not be used to show the effect of Adakveo or counterbalance the negative results of the STAND study.”

Despite the lack of significant evidence of therapeutic benefit, Novartis pointed out that STAND did not document new safety concerns with Adakveo, and its adverse event profile remains consistent with what had been established in prior trials.

Still, the CHMP noted that STAND “showed a higher rate of severe and serious treatment-related side effects,” therefore concluding that Adakveo’s benefits do not outweigh its risks.

https://www.biospace.com/article/eu-pulls-authorization-of-novartis-sickle-cell-disease-drug-adakveo/