Market Place
Kodak’s US$ 765 million loan put on hold; Digital health sees its biggest deal as Teladoc buys Livongo
This week, Phispers brings you news about the world’s first Covid-19 vaccine bagging clearance in Russia, even though its clinical trials are far from over.
Expectedly, experts are skeptical about its safety and efficacy. Digital health saw its biggest health deal yet, with Teladoc buying Livongo for US$ 18.5 billion.
Trump administration in the US issued another executive order that tasks the FDA to drive the purchase of only America-made drugs.
The US government’s US$ 765 million loan granted to Kodak, to increase America’s self-sufficiency in producing drugs, has been put on hold as SEC probes the extraordinary growth in its stock and allegations of insider trading.
And, both Pfizer and Hikma said they will be manufacturing Gilead’s remdesivir, a drug that has been proven effective against the novel coronavirus.
Kodak’s US$ 765 million loan put on hold as SEC probes insider trading concerns
A fortnight back, we had reported on how former photography giant, Eastman Kodak, had received a US$ 765 million government loan in a bid to increase America’s self-sufficiency in producing drugs to treat several medical conditions.
Last week, the loan to Kodak was put on hold after senior Democratic lawmakers asked the US Securities and Exchange Commission (SEC) to investigate securities transactions made by the company and its executives around the time it learned it could receive the government loan.
The loan was announced on July 28. However, the shares had already rallied by around 25 percent the previous day.
US lawmakers said they had “serious concerns” and have asked SEC to probe their concerns pertaining to insider trading. As a result, the US International Development Finance Corp (DFC) has put its US$ 765 million loan on hold.
DFC said in a tweet: “On July 28, we signed a Letter of Interest with Eastman Kodak. Recent allegations of wrongdoing raise serious concerns. We will not proceed any further unless these allegations are cleared.”
DFC had earlier said the loan was provided “at the direction of President Donald J Trump” (who said he was “proud” when the letter of intent was signed). Trump has since sought to distance himself from the deal, saying he wasn’t involved.
Trump issues executive order that tasks FDA to drive purchase of America-made essential drugs
Last week, the US President Donald Trump finally signed an executive order that tasks the US Food and Drug Administration (FDA) to drive the purchase of America-made essential drugs and devices.
With this executive order, aimed at onshoring the production of essential drugs, medical devices and critical inputs, the US hopes to reduce the country’s reliance on foreign manufacturing. It also hopes to promote federal procurement of domestic goods.
“We cannot rely on China and other nations across the globe that could one day deny us products at a time of need,” Trump said.
The order, which Trump signed while visiting a Whirlpool manufacturing plant in Clyde, Ohio, instructs the government to develop a list of “essential” medicines.
In consultation with FDA, federal agencies have 90 days under the order to “develop and implement procurement strategies, including long-term contracts,” to boost domestic manufacturing. The FDA has an even tighter deadline of just 30 days to develop an initial list of essential medicines, medical countermeasures and critical inputs and 90 days to finalize the list.
Additionally, FDA has been instructed to accelerate the approval or clearance of domestically manufactured products and inputs.
However, the order provides several workarounds for agencies to procure essential products internationally if domestic procurement would not be in public interest; if the products are not made in the US or are not available from domestic sources in sufficient quantity or quality; or if costs would rise by more than 25 percent unless a higher percentage is otherwise required by law.
Expectedly, the move faced flak from the industry. Pharmaceutical Research and Manufacturers of America’s (PhRMA) president, Stephen Ubl, said the order, and Trump’s recent executive orders aimed at drug pricing, “contradict and undermine each other.”
Two weeks back, Trump had signed an executive order — “Lowering Drug Prices By Putting America First”. However, the White House is still to release the text of the order. After Trump signed the drug pricing order, drug industry representatives had refused a White House meeting on the issue. Numerous CEOs have also criticized Trump’s plan in conference calls with analysts.
Several experts said the move appeared to be either posturing by Trump before the presidential election in November, or to be targeting China.
Trump’s executive order has come on the heels of government deals with Kodak and Phlow to produce pharmaceutical ingredients in the US, under Operation Warp Speed (a public-private partnership, initiated by the Trump administration, to facilitate and accelerate the development, manufacturing, and distribution of Covid-19 vaccines, therapeutics, and diagnostics). The deal with Kodak was criticized by Teva’s CEO, Kåre Schultz, who said he doesn't “see how it’s plausible” for Kodak to be competitive in the drug ingredients field, even with a US$ 765 million loan from the US government.
Teladoc announces biggest digital health deal; to buy Livongo for US$ 18.5 billion
Two digital health powerhouses — Teladoc and Livongo — have announced their merger, thereby giving rise to the largest digital health entity worth US$ 38 billion.
Teladoc has purchased Livongo for US$ 18.5 billion. This merger signals the beginning of a new era in digital health. It is much larger than deals like Amazon’s acquisition of PillPack and Google’s US$ 2.1 billion bid for FitBit.
Both Teladoc and Livongo have been in acquisition mode in recent years, acquiring smaller startups. Last month, Teladoc announced it was buying InTouch; and in 2019, Livongo had acquired myStrength. Both companies have been incredibly successful amid the pandemic. The combined telehealth company will continue with the name Teladoc Health.
The combined entity will enable their clients, including healthcare providers, health insurers and employers, to offer a much broader set of services and capabilities.
While Teladoc leads with a focus on virtual care, Livongo focuses on proactive patient engagement.
The mega deal took place two days after Siemens Healthineers announced a US$ 16.4 billion offer for the cancer radiotherapy player Varian Medical Systems.
Blackstone to buy Ancestry: Last month, we had reported on how Blackstone had launched a fund for life sciences, known as Blackstone Life Sciences. Soon after forming the fund, the investment firm announced it was buying a majority stake in the direct-to-consumer genetics company, Ancestry, from its former equity holders for US$ 4.7 billion.
Vaccine update: Russia clears first Covid-19 vaccine; experts skeptical about its efficacy
On Tuesday, the President of Russia, Vladimir Putin, said the country has cleared the world’s first Covid-19 vaccine — Sputnik V — for use. Putin said it is an effective protection against SARS CoV-2, and that one of his own daughters has already received it.
Even though the clinical trials on the vaccine are far from over, the move clears the way for widespread use of the vaccine among Russia’s population. Production of Sputnik V will begin next month. According to deputy prime minister, Tatyana Golikova, Russia plans to begin inoculating medical staff in August. Health minister, Mikhail Murashko, said a course of two shots would provide immunity for up to two years.
The speed at which Russia has cleared the vaccine raises concerns that geopolitics may have been given priority over science.
“This is a political decision by Putin so he can claim that Russia was the first in the race to develop a Covid-19 vaccine,” said Svetlana Zavidova, executive director of Russia’s Association of Clinical Trials Organizations.
Scott Gottlieb, former commissioner of the US Food and Drug Administration (FDA), has urged caution over Russia’s Covid-19 vaccine.
“I think it’s a ridiculous publicity stunt. If it’s supposed to make Russia look like some sort of biotechnology powerhouse, then as far as I’m concerned it does the opposite,” said medicinal chemist Derek Lowe in his blog — ‘In the Pipeline’ — published in the Science Magazine.
In fact, the rushed registration has drawn criticism the world over, with a local association of multinational pharmaceutical companies calling it dangerous. No data has yet been published by the researchers.
Moscow’s Gamaleya Institute and the Russian Direct Investment Fund (RDIF), which is developing the vaccine, said it is undergoing Phase 3 trials. However, a World Health Organization (WHO) database lists the vaccine as still being in Phase 1 testing. Last week, WHO had urged Russia to follow international guidelines for producing a vaccine against Covid-19.
RDIF plans to conduct Phase 3 clinical trials in Saudi Arabia, the United Arab Emirates, Brazil, India and the Philippines. Mass production is lined up in India, South Korea, Brazil, Saudi Arabia, Turkey and Cuba. At least 20 countries have evinced interest in obtaining supplies.
The Russian candidate is a viral vector vaccine based on a human adenovirus — a common cold virus — fused with the spike protein of SARS CoV-2 to stimulate an immune response and is similar to one developed by China’s CanSino Biologics.
US government, Moderna reach US$ 1.5 billion deal: On Tuesday, Moderna said it had reached an agreement with the US government to supply millions of doses of its Covid-19 vaccine candidate — mRNA-1273.
The award of up to US$ 1.525 billion is for manufacturing and delivering 100 million doses of the vaccine, including incentive payments for timely delivery. The deal also includes an option to purchase an additional 400 million doses.
The agreement is on top of a previous award of up to US$ 955 million from the US government towards supporting development of the vaccine, including a recent commitment of up to US$ 472 million from the Biomedical Advanced Research and Development Authority (BARDA).
The US has entered into supply agreements with Pfizer-BioNTech (for 100 million doses at the cost of US$ 19.50 per dose), AstraZeneca-Oxford (for 300 million doses at US$ 4 per dose), Sanofi-GSK (for 100 million doses, around US$ 10.50 per dose), Novavax (100 million doses at US$ 16 per dose) and J&J (for 100 million doses at US$ 10 per dose).
Pfizer, Hikma to manufacture Gilead’s remdesivir
Last week, drug behemoth Pfizer Inc said it has signed a multi-year agreement to make Covid-19 treatment - remdesivir for developer Gilead Sciences Inc, as the latter is under tremendous pressure to increase tight supplies of the antiviral drug.
Gilead is targeting to manufacture enough remdesivir by 2020-end to treat over 2 million Covid-19 patients. It has also agreed to send nearly all of its remdesivir supply to the US until September.
Last week, Britain’s Hikma Pharmaceuticals Plc also said it has started manufacturing remdesivir at its Portugal plant. Hikma’s CEO, Sigurdur Olafsson, said the company will start supplying batches of the drug “soon,” and Gilead is expected to distribute it.
Remdesivir has demonstrated an ability to help hospitalized Covid-19 patients during formal clinical trials. However, hospital staff and politicians have complained about difficulties in gaining access to the drug. Even outside of the US, there are fears of shortages.
In order to add capacity, Gilead has expanded its manufacturing network for the drug to over 40 companies in North America, Europe and Asia.
Pfizer will provide contract manufacturing services through its McPherson (Kansas) plant, the drugmaker said. Pfizer has helped other drugmakers manufacture their products — for instance, it makes Epipen emergency allergy treatments through its Meridian Medical Technologies business and also operates a contract manufacturer called Center One.
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