Novo Obesity Drugs Have $33 Billion Potential, JPMorgan Says

 

• Analyst boosts Novo price target by 25%, raises estimates
• Shares have soared on the success of Ozempic and Wegovy drugs

Novo Nordisk A/S can capture almost half of the rapidly growing global market for obesity drugs, equating to potential sales of around $33 billion by 2030, according to JPMorgan Chase & Co.

The Danish drugmaker — which is now Europe’s biggest company after the success of its Ozempic and Wegovy injectable drugs — will be a big beneficiary from a shift in the way that obesity and cardiovascular disease are treated, analysts led by Richard Vosser wrote in a note. They doubled their estimate for the overall obesity drug market to $71 billion in sales by 2032, and expect Novo and Eli Lilly & Co. to share the overwhelming majority of that.

https://www.bloomberg.com/news/articles/2023-09-07/novo-obesity-drugs-are-33-billion-opportunity-jpmorgan-says

Asensus Surgical Announces Collaboration with NVIDIA

 Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™, today announced a collaboration with NVIDIA to accelerate the development of Asensus’s Intelligent Surgical Unit™ (ISU™) and improve its ability to deliver novel clinical intelligence to surgeons.

Asensus will utilize a broad suite of NVIDIA tools to enhance the augmented intelligence capabilities of its ISU. Asensus’s ISU is built with NVIDIA accelerated computing technology and has been bringing real-time augmented intelligent features — such as digital tags, 3D measurement, and enhanced camera control — to surgeons since 2021.

https://finance.yahoo.com/news/asensus-surgical-announces-collaboration-nvidia-105500968.html

Pfizer, Valneva say 'positive' result for Lyme disease vaccine candidate booster

 Pfizer and French pharmaceutical peer Valneva announced on Thursday that a phase 2 study for its VLA15 Lyme disease vaccine candidate showed a "strong immune response" in both children and adolescents a month after a booster shoot.

"The Phase 2 booster results emphasize the vaccine candidate’s potential to provide immunity against Lyme disease in paediatric and adolescent populations," the two companies said in a statement.

"VLA15 well-tolerated in all age groups following booster dose."

Pfizer says it intends to submit regulatory applications for VLA15, which Valneva presents as being "the most advanced Lyme disease vaccine candidate currently in clinical development", to both the European Medicines Agency and U.S. Food and Drug Administration by 2026 if the phase 3 clinical trial, launched last year, gives positive results.

The New-York-based drug giant previously said it aimed to file for regulatory authorisations by 2025.

In February, Pfizer and Valneva announced they had to end VLA15 trials for a significant amount of U.S. participants due to "violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator".

https://finance.yahoo.com/news/1-pfizer-valneva-positive-result-054050964.html

Beam Launches Early-Stage Study of Allogeneic, Base-Edited CAR-T Therapy

 Beam Therapeutics on Tuesday announced it had dosed its first patient in the Phase I/II clinical trial of BEAM-201, an investigational allogeneic quadruplex-edited allogeneic CAR-T cell therapy.

The Massachusetts-based biotech is testing BEAM-201 in relapsed or refractory T-cell acute lymphoblastic leukemia/T-cell lymphoblastic lymphoma (T-ALL/T-LL), a typically challenging cancer to treat with limited treatment options, and for which allogeneic CAR-T therapies could make a “substantial impact,” Beam CEO John Evans said in a statement.

“We believe that the full therapeutic potential of CAR-T therapies, including the ability to utilize an allogeneic source of T cells, will only be unlocked through higher levels of cellular engineering enabled by multiple simultaneous genetic edits,” Evans said in Tuesday’s announcement, noting that the company’s base editing approach is “well-suited” for this application.

Base editing is an emerging precision medicine approach that works by precisely triggering mutations at a single nucleotide base. Unlike typical gene editing therapies, base editors do not introduce double-stranded breaks into the DNA, which lets them avoid unintended off-target effects associated with other gene therapies including induced mutations at other loci, which can lead to safety concerns and toxicities.

Beam’s base editors follow this principle and chemically transform one nucleotide base into another. BEAM-201 makes use of multiplex base editing to simultaneously silence several genes in a donor-derived T-cell, thereby producing a CAR-T therapy that is universally compatible and that can sidestep host rejection and immunosuppression.

Despite its huge clinical potential, the base editing approach has run into several regulatory roadblocks. In July 2022, the FDA put BEAM-201 under clinical hold and in a subsequent SEC filing the company revealed that this regulatory pause was due to the need for additional control data from the candidate’s genomic rearrangement studies. The FDA had also requested further analyses of BEAM-201’s off-target editing experiments.

The regulator released the clinical hold in December 2022 after Beam successfully addressed the FDA’s concerns.

Fellow Massachusetts biotech Verve Therapeutics also ran into an FDA pause in November 2022, when its investigational editor VERVE-101 was put on clinical hold. A month later, the regulator asked for more data on the candidate, which Verve is developing for heterozygous familial hypercholesterolemia. Trials in New Zealand and the U.K. are ongoing.

https://www.biospace.com/article/beam-launches-early-stage-study-of-allogeneic-base-edited-car-t-therapy/

Amneal gets OK for FDA shortage product

 Amneal Pharmaceuticals, Inc. (NYSE: AMRX) ("Amneal" or the "Company") today announced it has received Abbreviated New Drug Application ("ANDA") approval from the U.S. Food and Drug Administration ("FDA") for calcium gluconate in sodium chloride injection, 1000 mg/50 mL and 2000 mg/100 mL. This injectable product is currently on the U.S. FDA shortage product list.

The product approval received the FDA’s Competitive Generic Therapy ("CGT") designation with 180-day exclusivity. Amneal has the highest number of CGT approvals in the U.S. Generics industry.

Calcium gluconate in sodium chloride injection is a small volume parenteral bag indicated for the treatment of acute symptomatic hypocalcemia in pediatric and adult patients. Key Warning: Concomitant use of ceftriaxone and Calcium Gluconate in Sodium Chloride Injection is contraindicated in neonates (28 days of age or younger.) For full prescribing information, see package insert located here.

https://finance.yahoo.com/news/amneal-receives-u-fda-approval-200000568.html

Novartis updates on Sandoz finances ahead of spin-off

 Novartis confirmed this morning that it expects to complete the separation of its generic and biosimilar medicines unit Sandoz into an independent company on or around 4th October – and provided more financial details ahead of the transaction.

It said Sandoz made sales of $4.8 billion in the first half of the year, up 8% at constant currencies, with operating profit up 3% to $1 billion. The revenue gains were mainly derived from increased volumes in Europe, driven by biosimilars and a strong cough and cold season, and partly offset by negative price effects.

Novartis also confirmed its full-year financial predictions for Sandoz, including mid-single-digit net sales growth and margins of 18% to 19% in 2023 that it expects to rise to 24% to 26% in the mid-term.

Sandoz's management has previously told investors that it expects to add $3 billion in annual sales from the launch of new products after the separation, mostly from biosimilars and complex generics, and it has been building biologics manufacturing capacity in preparation.

The Swiss pharma group is following many of its rivals in the pharma sphere in narrowing its focus on higher-value, innovative medicines and exiting categories like generics and consumer health products that offer lower margins.

Other examples include Pfizer's spin-out of its Upjohn generics business in 2020 – to be combined with Mylan to form Viatris – as well as several consumer health sell-offs in recent years, for Novartis as well as Johnson & Johnson, GSK, and Pfizer. Novartis also spun out its Acon eyecare business in 2019.

Novartis will hold an extraordinary general meeting (EGM) of its shareholders on 15th September to seek final approval for the spin-off. Shareholders stand to receive a Sandoz share for every five Novartis shares or American Depositary Receipts (ADRs) they hold. Novartis' board unanimously voted in favour of separating Sandoz last month.

In addition to shareholder approval, Novartis will also need to get the green light from regulators for the listing of Sandoz shares on the SIX Swiss exchange and for an ADR programme in the US.

Novartis started a strategic review of Sandoz in 2021, after the subsidiary had been suffering from pressure on sales and operating profits for several years due mainly to pricing pressures, which were then compounded by the pandemic.

It has said that the spin-off will allow investors to "participate fully in the potential future upside of both Sandoz and Novartis."

The generics and biosimilars market was worth about $208 billion in gross sales before discounts and rebates in 2022 and is forecast to grow at about 8% annually over the next decade.

https://pharmaphorum.com/news/novartis-updates-sandoz-finances-ahead-spin

J&J pulls out of Idorsia deal for hypertension drug

 Idorsia has lost Johnson & Johnson's Janssen Biotech unit as the partner for its aprocitentan candidate for resistant hypertension, following a likely delay in the FDA's review of the drug.

The Swiss biotech said it has reacquired rights to the orally active, dual endothelin receptor antagonist with a payment of CHF 306 million ($343 million) due to Janssen if it gets approved by the FDA or EMA in the EU. 

Janssen licensed rights to aprocitentan and any derivatives in 2017 for a one-time payment of $230 million plus royalties on sales. It has retained one use of aprocitentan however, in pulmonary hypertension, and will receive 30% of any fee received by Idorsia if it out-licenses the drug to another partner.

The timing of Janssen's exit is interesting, given that aprocitentan is currently under review by the FDA with a decision due by 19th December, although Idorsia chief executive Jean-Paul Clozel said this morning that it is likely to face a three-month delay due to an FDA request for more materials to support a risk evaluation and mitigation strategy (REMS) for the drug.

When Idorsia filed aprocitentan with the US regulator last December, analysts at Jefferies were predicting that it had the potential to become a $2.5 billion blockbuster due to the urgent need for new therapies for people with hypertension that cannot be controlled using current drugs.

It is thought that around 10% of the 1.3 billion people with hypertension around the world struggle to control their blood pressure using the current main classes of antihypertensive, namely diuretics, calcium channel blockers, and renin-angiotensin system-targeting drugs.

In the phase 3 PRECISION trial, aprocitentan met its main objective of reducing systemic blood pressure compared to placebo, with an overall reduction of 3.8 mmHg with a daily dose of 12.5 mg aprocitentan at four weeks.

In its statement, Idorsia said that it is "initiating activities to determine the best approach to maximise the value of aprocitentan…the first anti-hypertensive therapy which works via a new mechanism of action in 30 years."

The revised agreement also cancels a revenue-sharing deal between Idorsia and Janssen relating to oral multiple sclerosis therapy Ponvory (ponesimod), which was approved for marketing in 2021.

The Swiss company's chief financial officer André Muller said that if aprocitentan is approved in the US and Europe "as expected, Idorsia would have an additional product in its portfolio giving the company more strategic flexibility."

https://pharmaphorum.com/news/jj-pulls-out-idorsia-deal-hypertension-drug