Entera Bio: Positive Topline EB613 Phase 2 Biomarker Data

 Trial Met Primary Endpoint of Significant Increase in P1NP Based on Final Analysis of 3 Month Data ‒

‒ Final Analysis of 6-Month Data, Including Change in Bone Mineral Density, Expected in Q2:21 ‒

Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of orally delivered large molecule therapeutics, announced the complete 3-month bone biomarker data analysis from the ongoing Phase 2 clinical trial of EB613. EB613 is an orally delivered human parathyroid hormone (1-34), or PTH, positioned to be the first oral bone building (anabolic) product to treat osteoporosis patients. The Phase 2 clinical trial of EB613 is a 6-month, dose-ranging, placebo-controlled, study in postmenopausal female subjects with osteoporosis, or low bone mineral density (BMD), and is being conducted at four leading medical centers in Israel to evaluate the safety of EB613 and identify the best dose(s) for a potential Phase 3 registration trial.

The trial’s primary endpoint was met - the complete 3-month results from the trial showed a significant increase in the P1NP biomarker in the 2.5 mg dose group after 3 months of treatment (P <0.04) as compared to placebo. P1NP is a biomarker that indicates the rate of new bone formation and the change at 3-months is the primary endpoint in this Phase 2 trial.

https://finance.yahoo.com/news/entera-bio-ltd-announces-positive-133000303.html

Takeda: Growth and Emerging Markets Unit Aims at Double-Digit Revenue Growth In 10 Yrs

 

• Aiming for Revenues of JPY 1 Trillion (approximately US$9 Billion2) by FY2030
• Double-Digit Revenue Growth Expected to be Driven by a Balanced and Focused Geographic Presence, Portfolio of 14 Global Brands and Wave 1 Pipeline Assets
• Commitment to Patient Access to Medicines and Addressing Unmet Patient Needs in Emerging Markets Underpin Sustainable Growth

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today outlined its ambition for above-market, double-digit revenue growth of its Growth and Emerging Markets Business Unit (“GEM BU”). The revenue goal of JPY 1 trillion (approximately US$9 billion) by FY2030 represents more than doubling of current revenues in GEM BU. This potential growth will be primarily driven by a balanced geographical focus and targeted portfolio investments in the Company’s highly innovative 14 Global Brands and Wave 1 pipeline assets.

“Building upon Takeda’s global vision to bring long-term value to patients, society and shareholders, we have sharpened our regional strategy to deliver healthcare in geographies that include 85% of the world’s population. As a purpose-led, patient-centric and values-based company, our portfolio combines innovative therapies with the right degree of scale to be competitive. Together with attractive market fundamentals and an executive team equipped to deliver strong business performance, we are committed to delivering sustainable revenue growth while increasing patient access to our life-saving and life-transforming treatments,” said Ricardo Marek, President of Growth & Emerging Markets Business Unit at Takeda.

With 95%3 of GEM BU’s current revenues coming from innovative treatments aligned with the company’s five key business areas, GEM BU has an ambition to outpace forecasted market revenue growth for the region over the next ten years. As a vast geographic area with a combined population of 6.5 billion, the Emerging Markets region presents significant growth opportunities in unmet patient needs across key therapy areas, which we believe can be achieved by a globally-aligned ‘access-first’ strategy.

“Emerging Markets will be a key source of revenue and momentum for Takeda over the next decade, with a strategy aligned to our global innovation focus,” said Costa Saroukos, Takeda chief financial officer. “Through targeted investments in the portfolio and key markets, we expect growth of the GEM BU to outpace the market for specialized, innovative treatments, as we expand our 14 global brands and launch our Wave 1 pipeline assets in the region.”

https://www.streetinsider.com/Business+Wire/Takeda%E2%80%99s+Growth+and+Emerging+Markets+Business+Unit+Aims+to+Deliver+Double-Digit+Revenue+Growth+Over+Next+Decade%C2%B9/18113241.html

Pfizer to consider new production sites only after 'pandemic supply phase'

 Pfizer Inc will consider making its coronavirus vaccine outside the United States and Europe only after the “pandemic supply phase” is over, it said on Thursday, adding it was not currently talking to India over local production.

The comments came after Reuters reported on Wednesday, citing sources, that the U.S. drugmaker had told the Indian government it wanted to produce the shot locally if assured of faster regulatory clearance and freedom on pricing and exports. The sources did not give a timeline.

“At this time we are not in discussions for any additional local manufacturing for this vaccine,” said a spokeswoman for Pfizer, which has developed the vaccine with Germany’s BioNTech SE.

“Once the pandemic supply phase is over and we enter a phase of regular supplies, Pfizer will certainly evaluate all additional opportunities available,” she told Reuters.

BioNTech’s chief executive told Bloomberg News this week the two companies could have the capacity to make 3 billion doses next year, up from their plan to produce at least 2 billion doses this year.

India is the world’s largest vaccine maker, and its companies have deals to make the shots of Oxford University/AstraZeneca, Novavax Inc and Johnson & Johnson, besides several local ones.

Pfizer pulled an application last month seeking emergency approval for its product in India after the drug regulator declined its request to skip a small local safety trial. That has kept the vaccine out of one of the world’s biggest drug markets.

The company declined to comment when exactly it could again seek permission to sell in India, as promised during its withdrawal.

“We remain committed to working towards equitable and affordable access for our COVID-19 vaccine for people around the world including in India, and we welcome opportunities to collaborate with the government to fight COVID-19,” the spokeswoman said in an email.

https://www.reuters.com/article/us-health-coronavirus-india-pfizer/pfizer-to-consider-new-production-sites-only-after-pandemic-supply-phase-idUSKBN2B3169

Europe begins rolling review of Eli Lilly's antibodies for COVID-19

 Europe’s drug regulator said on Thursday it had initiated a rolling review of U.S.-based Eli Lilly’s antibodies to treat COVID-19, days after saying their combination could be used in patients at high risk of progressing to severe illness.

Lilly’s bamlanivimab and etesemivab belong to a class of drugs called monoclonal antibody treatments, which mimic natural antibodies the body generates to fight infection.

This is the latest antibody treatment to earn such a review in the region and follows the European Medicines Agency’s (EMA) evaluation of drugs from South Korea’s Celltrion and U.S.-based Regeneron.

The rolling reviews are aimed at speeding up the approval process by allowing researchers to submit findings in real-time before final trial data is available.

Vir Biotechnology and Britain’s GSK plan to seek emergency use authorization for their experimental antibody therapy after interim data, the companies said on Thursday.

EMA said it was yet to evaluate the full dataset, adding it was too early to draw any conclusions regarding the benefit-risk balance of Lilly’s medicines.

It said the decision to start the review was based on preliminary results from two studies, one testing the ability of the antibodies to treat patients when combined and the other when bamlanivimab is used as a standalone.

So far, vaccines from Pfizer/BioNTech,, Moderna and AstraZeneca/Oxford have been approved in the region, with the verdict on J&J’s single-shot vaccine is expected later in the day.

https://www.reuters.com/article/us-health-coronavirus-europe-eli-lilly/europe-begins-rolling-review-of-eli-lillys-antibodies-for-covid-19-idUSKBN2B313H

EU drugs regulator gives green light to J&J's single-shot COVID-19 vaccine

 The European Union’s drugs regulator on Thursday recommended conditionally approving Johnson & Johnson’s single dose COVID-19 vaccine, as the bloc seeks to speed up a stuttering inoculation campaign and boost its supplies of vaccines.

The COVID-19 shot is the fourth to be endorsed for use in the EU after vaccines from Pfizer-BioNTech, AstraZeneca-Oxford University and Moderna, and is recommended for those over 18 years of age, the European Medicines agency (EMA) said.

The United States, Canada and Bahrain have also approved the shot. South Africa is carrying out an expedited review.

https://www.reuters.com/article/us-health-coronavirus-eu-johnson-johnson/eu-drugs-regulator-gives-green-light-to-jjs-single-shot-covid-19-vaccine-idUSKBN2B31SW

Roche's Actemra fails PhIII Covid-19 Veklury combo trial

 Roche is adding another tally mark to the negative column on Actemra’s mixed record in Covid-19.

The IL-6 drug failed to meet the primary endpoint of REMDACTA, where it was paired with Gilead’s approved antiviral Veklury (remdesivir) for the treatment of patients with severe Covid-19 pneumonia. Adding Actemra didn’t improve time to hospital discharge, the company reported, without breaking down the numbers.

Key secondary endpoints weren’t met, either, including likelihood of death, likelihood of progression to mechanical ventilation or death, and clinical status.

Actemra — which is already on the market for autoimmune conditions such as rheumatoid arthritis and recently racked up a seventh approval in systemic sclerosis-associated interstitial lung disease — has taken investigators and scientists on a bit of a ride as Roche looked to pitch in on the global fight against Covid-19.

Of the two previous Phase III studies evaluating the drug, one met the primary endpoint while the other didn’t. The successful trial, EMPACTA, focused on hospitalized patients with pneumonia and saw Actemra cut the incidence of death or requiring mechanical ventilation by 28. In COVACTA, though, the antibody had failed to differentiate from placebo in terms of improving clinical status for a more severe subgroup.

Since the COVACTA readout came first and alongside similar disappointing news from Regeneron and Sanofi around Kevzara, many had assumed it would spell an end to the idea of repurposing the IL-6 class to fight the immune response and lung damage that can result from a coronavirus infection. But Roche — and CMO Levi Garraway — didn’t give up, and still won’t.

“We continue to believe that the totality of data suggests a potential role for Actemra in treating certain patients with COVID-19, and will discuss the results with health authorities,” he said in a statement.

https://endpts.com/in-the-latest-twist-to-il-6-roller-coaster-roches-actemra-fails-phiii-veklury-combo-trial/

Kroger Health Ups COVID-19 Vaccination Capacity to 1M Doses Per Week

 Kroger Health doubles operational capacity and improves accessibility to vaccine

Kroger Health reissues call to elected officials for earlier vaccination of frontline grocery workers

https://www.prnewswire.com/news-releases/kroger-health-increases-covid-19-vaccination-capacity-to-one-million-doses-per-week-301245510.html