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Friday, November 6, 2020

Philips Adds More Targets to 2021-25 Growth Plan

Koninklijke Philips NV said Friday that it has included more targets in its 2021-25 growth plan, building on those announced in October.

The Dutch medical-technology group said it is now targeting accelerated sales growth and an adjusted earnings before interest, taxes, and amortization margin in the high-teens by 2025.

The company said it is also aiming for an extra 400 million euros ($473.2 million) of net savings a year between 2021 and 2025, in an effort to reach extra cumulative net savings of EUR2 billion by the end of that period.

Philips added that it is seeking to achieve mid-to-high-teens organic return on invested capital by 2025.

The company also reiterated the targets it had outlined in its third-quarter earnings on Oct. 19, when it said it was targeting an acceleration in the average annual comparable sales growth to 5%-6%, an adjusted Ebita margin improvement of 60-80 basis points on average annually from 2021 and a free cash flow above EUR2 billion by 2025. 

https://www.marketscreener.com/quote/stock/KONINKLIJKE-PHILIPS-N-V-6289/news/Koninklijke-Philips-N-Philips-Adds-More-Targets-to-2021-25-Growth-Plan-31705313/

Humanigen in COVID-19 drug development agreement with DoD

Humanigen Inc has partnered with the U.S. government to help advance development of its drug candidate as a potential COVID-19 treatment following positive response in hospitalized patients in a late-stage study, the company said on Friday.

Patients receiving the drug, lenzilumab, saw 37% more recovery as compared to current standard of care in the study reut.rs/2U0IPRi, which aims to determine whether the drug can prevent and treat an immune hyper-response called "cytokine storm".

The tie-up with the defense department is part of the U.S. government’s Operation Warp Speed, which has struck deals with several other drugmakers to help speed up the development of a possible COVID-19 treatment.

Humanigen’s shares rose 13% in premarket trading after the company said it plans to file for an emergency use approval (EUA) in the first quarter of 2021, either following interim data at 75% or at study completion.

Lenzilumab has been selected by the National Institutes of Health to be evaluated alongside Gilead Sciences’ COVID-19 drug candidate, remdesivir, which received the U.S. Food and Drug Administration’s approval for treating patients hospitalized with COVID-19.

Lenzilumab belongs to a class of drugs known as monoclonal antibodies, similar to the ones being developed by Regeneron Pharmaceuticals and Eli Lilly for COVID-19. Treatments from Lilly and Regeneron are being considered by the health regulator for EUAs.

Following the recommendation of an independent safety board, Humanigen plans to increase enrollment to the study to ensure higher probability of meeting the main goal.

The next interim data analysis is planned for when the study enrolls about 390 patients, the company said.

The agreement, which is in collaboration with the U.S. Department of Health and Human Services, will support an ongoing late-stage trial of lenzilumab.

https://www.reuters.com/article/us-health-coronavirus-humanigen-dod/humanigen-inks-covid-19-drug-development-agreement-with-u-s-defense-department-idUSKBN27M1JX

Aspirin to be tested as potential COVID-19 drug in UK study

Painkiller aspirin will be evaluated as a possible treatment for COVID-19 in one of Britain’s biggest trials, which will assess whether it might reduce the risk of blood clots in people with the disease.

The scientists behind the RECOVERY trial, which is looking into a range of potential treatments for COVID-19, said it would include the drug, which is commonly used as a blood thinner.

“There is a clear rationale for believing that it (aspirin) might be beneficial, and it is safe, inexpensive and widely available,” said Peter Horby, co-chief investigator of the trial.

Patients infected with the coronavirus are at a higher risk of blood clots because of hyper-reactive platelets, the cell fragments that help stop bleeding. Aspirin is an antiplatelet agent and can reduce the risk of clots, the RECOVERY trial’s website said on Friday.

At least 2,000 patients are expected to randomly get 150 mg of aspirin daily along with the usual regimen. Data from those patients will be compared with at least 2,000 other patients who receive the standard COVID-19 treatment on its own, the website showed.

Small daily doses of aspirin has been found to reduce the risk of certain cancers. As a blood thinner, it increases the risk of internal bleeding, and taking too much over a long period of time has been associated with kidney damage.

Other treatments being tested in the RECOVERY trial include common antibiotic azithromycin and Regeneron’s antibody cocktail that was used to treat U.S. President Donald Trump’s COVID-19 symptoms.

Unlike Gilead’s remdesivir, which has been approved as a COVID-19 treatment in the United States but has shown poor results in a large World Health Organization trial, aspirin is a generic drug, making it much cheaper.

The RECOVERY trial was the first to show that dexamethasone, a steroid which is also cheap and widely available, could save lives of people severely ill with COVID-19.

It also showed that the anti-malarial drug hydroxychloroquine, once touted by Trump, was of no benefit in treating COVID-19 patients.

https://www.reuters.com/article/us-health-coronavirus-recovery-aspirin/aspirin-to-be-tested-as-potential-covid-19-drug-in-uk-study-idUSKBN27M1C0

Novo Nordisk to buyout Emisphere Technologies for $1.8B

  • Novo Nordisk (NYSE:NVO) inks agreement to acquire Emisphere Technologies (OTCPK:EMIS), a drug delivery company with technologies, such as the Eligen SNAC, that enable oral formulations of therapeutics in a debt financed transaction.
  • Under the terms of the agreement, NVO will acquire all outstanding shares of Emisphere for $1.35B and related Eligen SNAC royalty stream obligations owed to MHR Fund Management for $450M, for a total consideration of $1.8B.
  • With these acquisitions, Novo eliminates its future royalty obligations to Emisphere and MHR and obtains full access to the Eligen SNAC technology.
  • Novo and Emisphere have collaborated since 2007 and latter's Eligen SNAC technology is used by Novo under an existing licence agreement in the oral formulation of company's GLP-1 receptor agonist semaglutide, which is marketed and sold under the brand name Rybelsus.
  • https://seekingalpha.com/news/3632958-novo-nordisk-to-buyout-emisphere-technologies-for-1_8b

Novartis comes up empty in study of canakinumab in COVID-19

  • Novartis' (NYSE:NVS) CAN-COVID trial evaluating the efficacy and safety of canakinumab in hospitalized patients with COVID-19 pneumonia and cytokine release syndrome failed to meet endpoints.
  • The ongoing trial did not achieve its primary endpoint showing canakinumab plus standard of care (SoC) failed to demonstrate a significantly greater chance of survival for patients without the need for invasive mechanical ventilation, compared with placebo plus SoC up to Day 29.
  • Survival without the need for mechanical ventilation was 88.8% for canakinumab plus SoC vs 85.7% for placebo plus SoC (P=0.29).
  • Key secondary endpoint of reducing the COVID-19-related death rate during the 4-week period after treatment was also missed.
  • COVID-19-related mortality was 4.9% for canakinumab plus SoC vs 7.2% for placebo plus SoC (P=0.33).
  • Both the primary and key secondary endpoints trended in favor of canakinumab but did not reach statistical significance.
  • The safety profiles of canakinumab plus SoC and placebo plus SoC were comparable.
  • No new safety signals for canakinumab were identified.
  • To further support global pandemic response, in October NVS collaborated with Switzerland-based Molecular Partners to develop two DARPin therapies designed for potential use against COVID-19.
  • In addition, a Phase III trial for ruxolitinib in COVID-19 is ongoing, with preliminary results expected by year end.
  • https://seekingalpha.com/news/3632966-novartis-comes-up-empty-in-study-of-canakinumab-in-covidminus-19

Thermo Fisher, Innoforce in pact for drug manufacturing facility in China

  • Thermo Fisher Scientific (NYSE:TMO) has entered into a joint venture agreement with Innoforce, to establish a new pharma services facility in Hangzhou, China, for integrated biologics and steriles drug development and manufacturing. The new facility is expected to be completed in 2022.
  • Capabilities include drug product development, biologics manufacturing, sterile fill-finish, clinical trials packaging and logistics.
  • Separately, the board has also authorized share repurchase of $2.5B, with no expiration date. This replaces the company's existing repurchase authorization, of which $1B was remaining.
  • https://seekingalpha.com/news/3633010-thermo-fisher-innoforce-in-pact-for-drug-manufacturing-facility-in-china

AstraZeneca's Brilinta OK'd in U.S. for reducing stroke