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Monday, August 31, 2020

Akcea up as Ionis acquires remaining stake for $500M; positive vupanorsen data

Akcea Therapeutics (NASDAQ:AKCA), a majority-owned affiliate of Ionis Pharmaceuticals (NASDAQ:IONS) presents data from the Phase 2 clinical trial of vupanorsen (AKCEA-ANGPTL3-LRx) at the ESC Congress 2020.

Vupanorsen, an investigational antisense therapy being developed using Ionis’ Ligand Conjugated Antisense technology platform to reduce the production of angiopoietin-like 3 (ANGPTL3) protein from the liver which is a key regulator of triglyceride and cholesterol metabolism is used to treat patients with certain cardiovascular diseases.

In the Phase 2 study, vupanorsen met the primary endpoint of significant reductions in triglyceride (TG) levels and multiple secondary endpoints compared to placebo, with a favorable safety and tolerability profile.

A total of 105 patients with hypertriglyceridemia (fasting plasma TG levels >150 mg/dL), type 2 diabetes and non-alcoholic fatty liver disease were randomized to three dosing cohorts in a 3:1 ratio (vupanorsen:placebo) within each cohort and treated for six months.

Statistically significant dose-dependent reductions in fasting TGs at all dose levels, with the highest mean reduction of 53% at 80 mg every four weeks (44% mean reduction compared to placebo, P<0.0001).

Statistically significant dose-dependent reductions compared to placebo in ANGPTL3 (62%), very low-density lipoprotein (VLDL) cholesterol (38%), total cholesterol (19%), and non-high-density lipoprotein (non-HDL) cholesterol (18%) (mean reductions achieved with the 80 mg every four-week dose).

No effect on glycemic parameters and no decrease in hepatic steatosis and a favorable tolerability and safety profile was observed.

Also, IONS and AKCA have entered into a definitive agreement under which Ionis will acquire all of the outstanding shares of Akcea common stock, not already owned, ~24%, for $18.15/share in cash, for the total transaction value of ~$500M.

As on June 2020, AKCA had a total 101.5M common shares outstanding. 


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CorMedix up on FDA acceptance for filing and priority review of Defencath

FDA has accepted CorMedix (NYSEMKT:CRMD) +7% filing of new drug application for Defencath its product candidate to be used as a catheter lock solution in hemodialysis patients for the prevention of catheter related blood stream infections.

The FDA had previously granted a rolling submission and review, which the Company completed at the end of June.

FDA also granted priority review and set a Prescription Drug User Fee Act date of February 28, 2021 for the completion of its review for approval of the NDA.

Source: Press Release


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Novavax inks deal to supply 76M doses of COVID-19 vaccine to Canada

Novavax (NASDAQ:NVAX) has reached an agreement in principle with the Canadian government to supply up to 76M doses of COVID-19 vaccine, NVX-CoV2373, if approved.

Shipments may start as early as Q2 2021, subject to licensure.

The advance purchase agreement should be finalized shortly.


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Blow to Philips earnings as U.S. cancels ventilator order

Philips (NYSE:PHG) has cut its 2020 earnings outlook after the U.S. government scrapped the bulk of an order for 43,000 ventilators.

It will now deliver just 12,300 hospital ventilators by the end of the year, though a spokesman said he expected Philips will find other buyers for the 30,700 excess devices.

The termination follows a July report by the U.S. Congress House Subcommittee on Economic and Consumer Policy that found the White House had overpaid Philips by at least $500M. The firm denied any profiteering.

Back in July, Philips said that a surge in orders for medical equipment would enable it to achieve an “adjusted EBITA margin improvement” in 2020, but it now expects “to deliver modest comparable sales growth with an adjusted EBITA margin of around the level of last year.”


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Arrowhead reports encouraging data on cardiometabolic candidates

Arrowhead Pharmaceuticals (NASDAQ:ARWR) announces positive new Phase 1/2 clinical data on two RNAi-based cardiometabolic candidates, ARO-APOC3 targeting apolipoprotein C-III (APOC3) being developed as a treatment for patients with hypertriglyceridemia, and ARO-ANG3 targeting angiopoietin like protein 3 (ANGPTL3) for treatment for mixed dyslipidemias.

The data were presented at the European Society of Cardiology (ESC) Congress 2020.

In normal volunteers, repeat doses of ARO-APOC3 resulted in reduction in APOC3.

Maximal mean fasting lipid, lipoprotein, and apolipoprotein changes of: -75% for triglycerides (TG), -25% for low-density lipoprotein cholesterol (LDL-C), -33% for apolipoprotein B (ApoB) and +75% for high-density lipoprotein cholesterol (HDL-C).

ARO-APOC3 had a favorable safety and tolerability profile.

ARO-ANG3 Presentation Details:

Dose-dependent reduction in fasting ANGPTL3;

Maximal mean reductions in fasting lipid, lipoprotein, and apolipoprotein concentrations of: -71% in TG, -50% in LDL-C, -42% in ApoB, -34% in non-HDL-C and -47% in HDL-C.

Lipid, lipoprotein, and apolipoprotein reductions sustained to week 16.

ANGPTL3 inhibition has the potential to treat mixed dyslipidemia and decrease residual risk in patients with cardiovascular disease on guideline-recommended standard of care.

See other Companies presenting at ESC 2020 Conference: MyoKardia (NASDAQ:MYOK), Johnson & Johnson (NYSE:JNJ), Amarin (NASDAQ:AMRN), LivaNova (NASDAQ:LIVN), Philips (NYSE:PHG), Innovent Biologics (OTCPK:IVBIY).


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Nestle to buy Aimmune Therapeutics for $2.6B

Nestle’s (OTCPK:NSRGY) Health Science division (NHSc) has entered into a definitive agreement to acquire peanut allergy treatment maker Aimmune Therapeutics (NASDAQ:AIMT).

Under the terms of the merger agreement, Nestle’s wholly owned subsidiary, Société des Produits Nestlé S.A. (SPN), will commence a cash tender offer to acquire all outstanding common shares of Aimmune that are not already owned by NHSc for $34.50/share in cash (174% premium to closing price of $12.60 as on August 28), representing a total enterprise value of ~2.6B.

NHSc currently has a total investment of $473M in Aimmune, an approximately 25.6% equity ownership stake. Initial investment of $145M was made in November 2016, followed by further investments of $30M in February 2018, $98M in November 2018 and $200M in January 2020.

The transaction is expected to close in Q4.


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FDA to fast-track COVID-19 vaccine

The chief of the FDA is willing to bypass the full federal approval process in order to make a COVID-19 vaccine available as soon as possible.

However, the move is not intended to please President Donald Trump, said FDA Commissioner Stephen Hahn. An emergency authorization could be appropriate before Phase Three clinical trials are completed “if the benefits outweigh the risks,” he added.

“It is up to the [vaccine developer] to apply for authorization or approval, and we make an adjudication of their application,” Hahn told the Financial Times. “If they do that before the end of phase three, we may find that appropriate. We may find that inappropriate, we will make a determination.”


Already, China and Russia have each approved vaccines without waiting for the completion of phase three trials, which come with the most rigorous testing for a potential new drug. Public health officials in the U.S. and elsewhere have warned that the move could be unsafe.

“Our emergency use authorisation is not the same as a full approval,” Dr. Hahn said. He insisted that he would not rush a vaccine to please the president, amid reports that Mr. Trump wants a vaccine to be available before November’s election to help improve his chance of victory.

Selected tickers: Kamada (NASDAQ:KMDA), Grifols (NASDAQ:GRFS), XBiotech (NASDAQ:XBIT), Cerus (NASDAQ:CERS), ADMA Biologics (NASDAQ:ADMA).


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