News – Life Sciences Voice

China forces insulin price cuts resulting in pullback for global pharma players

Editorial Team — Mon, 24 Jan 2022 15:44:23 +0000

Xinhua, a Chinese news channel, commented on the price cut on insulin which was brought on by China’s volume-based procurement (VBP) program. An over 45% discount on insulin products had to be given by companies to find a place in Chinese public hospitals, which is projected to save China over a billion in medical expenses next year.

The VBP scheme provides large contracts to Chinese public hospitals for insulin companies that adhere to price cuts. The procurement scheme has cover until 2022, amounting to over 200 million doses.

Healthcare groups have divided the insulin drug into four categories which include insulin analogs, basal, and quick-acting.

As China forces price cuts on insulin, international companies like Sanofi, Eli Lilly, and Novo Nordisk saw a decline in their revenues as a result of their respective insulin products; Lantus, Humalog, and Novolog. These three companies held over 70% of the 120 million patients in the Chinese market before this scheme. Insulins are the top drug for diabetes in the country.

Of the three companies, Eli Lily cut its insulin prices the most and lost no market share as a result. The company had to reduce its insulin price by about 75% in this process and price of Humalog Mix25 is now $2.96.

Lantus and Humalog were able to hold onto their respective market shares as well, after an over 65% price cut was implemented by their companies.

Novo Nordisk also cut its insulin cost, however, it was not enough to retain its top position in the Chinese market and it expects to see a 3% drop in global sales.

As the price cut on insulin is enforced in China, domestic companies are expected to benefit by gaining a collective market position of close to 30%.

The VBP scheme has affected Big Pharma significantly and it is expected that other drugs, such as antibody medicine, may be the next to come under the VBP umbrella. While the scheme was tested first in 2018, large molecule medicine had not been targeted before this.

Danish company Novo has seen significant success in China with growth in insulin sales over 10% amounting to almost $1.5 billion. The company is currently hard at work bringing GLP-1 drugs to the Chinese market this year.

The U.S. has also seen lower prices of insulin after heavy public outcry.

Aussie pharma CSL in talks to buy Swiss firm Vifor Pharma for USD 7B

Editorial Team — Mon, 17 Jan 2022 15:29:53 +0000

CSL, the Australian giant, is in talks to buy Vifor Pharma in a deal that is valued at $7B, or A$10B. Vifor Pharma is a Swiss pharma company.
Analysts predict that as CSL buys Vifor Pharma it will be able to expand on its current portfolio to include manufacturing of drugs for kidney and heart disease. Currently, CSL pharmaceutical company is the largest manufacturer of blood plasma treatments.
The deal has been in the works since early 2021, but as the talks have become serious, Vifor Pharma’s shares have risen by almost a fifth, closing in at a 21% increase in the Swiss index.
CSL pharmaceutical company had seen a dip in collections for plasma due to COVID-19 pandemic restrictions. This is due to the fact that it is dependent on people coming for blood to be purchased by the company.
As CSL buys Vifor pharma, they will gain the ability to expand on their kidney transplant franchise, which is currently in its infancy stage. However, this will be a step away from their focus on the therapeutic area of medicine. Both companies have stated that they will not be commenting on the deal.

Sanofi to acquire Origimm Biotechnology in a bid to expand vaccine pipeline

Editorial Team — Mon, 10 Jan 2022 15:25:16 +0000

Sanofi will acquire Origimm Biotechnology as per an agreement signed by the two healthcare companies. The deal is expected to be finalized within the month but has not revealed any financials, so far.

One of the goals of the agreement is to grow Sanofi’s vaccine pipeline.

Austria’s Origimm Biotechnology focuses on the manufacturing of microbiome treatments as well as antigens against skin diseases caused by bacteria, and they have been in the process of manufacturing an acne vulgaris vaccine.

Sanofi will be adding the developing vaccine for acne vulgaris into its vaccine pipeline through the agreement with Origimm Biotechnology.

The acne vulgaris vaccine is named ORI-001, and has entered the clinical study stage this year. As Sanofi acquires Origimm Biotechnology, it will also develop its mRNA platform which is an antigen. Its Ph1/2 trials are expected to start in a little over a year.

Sanofi’s vaccine pipeline is to broaden through ORI-001- having the potential to be a first in the market vaccine for acne. Acne is a common skin condition among teenagers. However, acne also affects adults and regardless of the age group, has the ability to cause significant distress in affected individuals. In moderate and severe cases the Cutibacterium acnes bacterium is often the culprit which can be treated, as per Sanofi claims.

Austrian Origimm Biotechnology hopes that along with Sanofi they can create solutions for a myriad of microbiome-related skin diseases and illnesses with success and revolutionize the treatment of such illnesses.

Is Biogen’s Alzheimer’s drug worth $56K? Experts say $8400 and raise questions about efficacy

Editorial Team — Tue, 27 Jul 2021 14:10:43 +0000

Aduhelm, Biogen’s new drug for Alzheimer’s disease, which was approved by FDA contentiously last month, continues to face criticism since then. The FDA now says it should be investigated independently. Out of this criticism, some insurers have refused to pay for the drug, some hospitals have denied its administration and hence, more experts are of the view that the drug has no proven benefit and the cost of it is too high to be $56,000 for yearly supply.
Institute for Clinical and Economic Review (ICER), a non-profit organization, called in a meeting of medical experts. The panel disapproved by 15 to 0 votes, saying that the drug doesn’t seem to provide any clinical benefit to the patients.
The persistence of the viewpoint regarding Aduhelm was seen among the members of discussion panel for FDA, consisting of expert advisors, who also voted unanimously against FDA approval, last November. Ten out of eleven advisors voted against it, with the remaining one as “uncertain”.
The FDA, regardless of the negative feedback given by the panelists, approved the drug on June 7, igniting the fire of criticism. In an exception, FDA revised its recommendations for the recipients of the drug, narrowing the pool from all Alzheimer’s patients to patients with mild symptoms, which was an unusual step taken by the agency.
Things got odd when Janet Woodcock, acting Commissioner FDA, declared that she was going to call for the Office of Inspector General, to look into the matter. The ongoing concern over FDA’s compassion with Biogen could “undermine public’s confidence in the FDA’s decision,” she wrote to acting IG Christi Grimm.
The doctors, hospitals and the insurers, who already had refused paying for the drug or to administer it, are no longer interested in knowing the outcome of the investigation. Mount Sinai’s Health System and Cleveland Clinic have both refused to administer the drug, as reported by New York Times. Furthermore, six affiliates of Blue Cross and Blue Shield in Pennsylvania, North Carolina, Florida, New York and Michigan refused to cover the drug saying that it was “experimental” or “investigational”, Boston Globe said.
According to the ICER’s last month report, the latest cost-effectiveness analysis for Aduhelm computed the yearly price to be $3,000 to $8,400 at max, reducing the current cost up to 85-95%.
Biogen’s top medical officer, Maha Radhakrishnan, told the panel at the ICER meeting that the company “regrets that the ICER assessment missed the mark” for the drug evaluation. Radhakrishnan asserted that to assess the drug “innovative thinking” and a new framework are required.

AstraZeneca and FibroGen hit FDA committee’s safety data firewall for roxadustat

Editorial Team — Mon, 26 Jul 2021 06:59:18 +0000

Two roxadustat partners AstraZeneca and FibroGen have received objections regarding safety concerns of their drug from the FDA after which the two companies headed into a high-stakes meeting with the FDA staffers. The daylong session didn’t have a fruitful response, rather, their application faced even more uncertainty.
The meeting was held to discuss the drug’s safety profile and efficacy in both non- dialysis patients and patients having dialysis and their enrollment criteria for clinical research ̶ a potential post-marketing study.
FDA committee panelists disapproved the use of the said drug for treating anemia in chronic kidney disease non-dialysis patients by 13 to 1 vote. The committee raised questions about the entirety of the safety data provided by the companies. The panelists were unsure about the post-marketing study proposed by the partner company to learn about drug’s heart safety profile.
The only vote in their favour was of Dr. Susan Crowley from Veterans Health Administration, who said that it would be fair for patients and providers to share the responsibilities of decision-making under a risk-mitigation program.
The panelists voted 2 to 12 against the approval for patients with dialysis, and this particular vote, other than Crowley’s, which turned to “yes” in this matter, was of Dr. Ravi Thadani, from Mass General Brigham. He was with the viewpoint that some people could get benefit from the treatment and also that he was “convinced” by the efforts put in by AstraZeneca and FibroGen for taking safety concerns seriously.
The center of discussion throughout the meeting was the drug’s safety and data provided by the companies. The panelists concluded that the companies must provide more safety data before the drug becomes commercially available.
The vote from the FDA’s advisory committee sets up high-stakes FDA review for the drug. The agency isn’t bound to adhere to the recommendations of its committee, but it usually does.
Talking particularly about roxadustat, AstraZeneca FDA had scheduled its decision regarding the drug back in December, 2020, but later extended its decision to March, 2021. Then in March, the agency further delayed the process by saying that an advisory committee meeting must be convened.
In addition to back-to-back delays, the two companies hit another setback in April when one of the partners, FibroGen, declared that it had modified the criteria for analysing heart safety data for roxadustat to be more convenient.
The drug is already commercially available in China and Japan.
The industry watchers have already believed that the drug would be a blockbuster beating standard erythropoiesis stimulating agents in the race with an additional benefit of treating non-dialysis patients.

NRx Pharmaceuticals signs deal for clinical trials of Israel’s homegrown Covid-19 vaccine

Editorial Team — Tue, 20 Jul 2021 22:34:56 +0000

Israel Institute for Biological Research (IIBR), an institute run by Israel’s Defense Ministry, has signed a memorandum of understanding (MoU) with the NRx Pharmaceuticals. According to which Israel’s domestic COVID-19 vaccine will undergo clinical trials as revealed by a statement.

Brilife, the said vaccine, will be driven to complete its third-stage clinical trials by the NRx Pharmaceuticals. Tens of thousands of volunteers belonging to Ukraine, Georgia and Israel will take part for the said cause after which the company will work up the commercialization of the vaccine. The Israeli vaccine is currently undergoing its second-stage trials after the fruitful attainment of first one in December, 2020 by IIBR.

The Defense Minister of Israel, Benny Gantz, applauded this covenant considering it “an excellent news”. In one of his statements Gantz narrates, “I anticipate that with this agreement, we will be able to complete the development of the vaccine and enable Israel to produce vaccines independently, because as we have seen recently – the coronavirus is not going anywhere”.

Pharma manufacturers lawsuits against payers and benefit managers preferred drugs are on FTC’s radar

Editorial Team — Mon, 12 Jul 2021 21:40:43 +0000

The attention of federal antitrust regulators has been drawn to a slew of lawsuits filed by pharmaceutical companies, challenging the “preferred” medicine list of payers and benefit managers.

Pfizer, Sanofi, and other healthcare companies are suing their rival companies for allegedly giving rebates to the insurance companies and Pharmacy benefit managers in exchange for their drugs being added to the preferred formulary list.

The FTC (Federal Trade Commission) told Congress in May that lawsuits contending that such exclusive discounts restrict competition and might create constitutional theories that the agency will follow.

According to Industry observers, these suits as well as FTC’s evaluation of them could set the tone for how pharmaceutical rebates are governed, potentially changing the means of reaching hundreds of pharmaceuticals to the consumers.

However, this intricate sector is based on treaties with precise terms and unique connections, and plaintiffs are finding it very hard to apply antitrust legislation to fact-specific cases, which could impact authorities’ decisions to enforce or impel changes.

“The FTC may use the losses in private cases as evidence that the current interpretations or applications of antitrust laws are inadequate, and maybe as an argument that the laws need to be changed,” said Barbara Sicalides, a partner at Troutman Pepper LLP.
PBMs (Pharmacy Benefit Managers) are used by insurers to bargain with the drug makers for reduced prices. Pharmaceutical manufacturers pay kickbacks to be included on the PBM formulary list, which often includes the terms to exclude rival’s products from the list. Competitors who seek to promote their products to PBMs’ customers face a “rebate wall” as a result of the practice.

According to a 2020 report by Xcenda, AmerisourceBergen’s healthcare consultancy firm, this rebate practice has been unregulated even though the PBMs have unified in past years.

The three top PBMs CVS Caremark, a CVS Health Inc. subsidiary, OptumRX, a part of Optimum Inc., and Express Scripts, a company of Cigna group, now hold about 70% of the prescriptions in the United States, according to a report.

Roche to lay off 300 to 400 employees in product development jobs

Editorial Team — Mon, 05 Jul 2021 22:26:21 +0000

Roche’s executives, including CMO (Chief Medical Officer) Levi Garraway, claimed in a recorded video conference with staff acquired by Swiss Newspaper Blick, that the company is planning to slash 300 to 400 jobs at PD (Product Development) locations, this year.

Roche has a global workforce of 101,000 employees. The Basel-based corporation has acknowledged the video conversation and stated that the company will cooperate with all the staff members and assist them to cope with the loss of their jobs.

The company operates product development locations in Switzerland, United Kingdom, China, United States, and Canada, and other locations, where personnel’s responsibilities include clinical investigations for potential pharmaceuticals developed under many research programs.

Project delivery, project management, coaching, learning and development, administrative support, and business management are among the jobs that are affected as a result of employees cut down, stated by Roche’s manager in a video conference.

From August through October, workers who are about to lose their jobs will be notified, with British employees being notified first then the workers in other locations. In the Video, an HR (Human Resources) manager claimed that their duties will end in early November.

“This is the hardest thing I’ve had to do since I’ve been in Roche,” Head of global drug safety, Felix Arellano, said on the recording.
In 2020, Roche reported a net profit of $16.3 billion (15.1 billion Swiss francs), boosted by pandemic diagnostics that helped to overcome the declining medicine sales

Activist investor Elliott Management asks for new board and CEO to reapply

Editorial Team — Mon, 05 Jul 2021 22:22:41 +0000

Before the splitting of GlaxoSmithKline’s consumer healthcare sector next year, Elliot Management, an activist US investor, has effectively requested that Dame Emma Walmsley should apply again for her post as the CEO of GSK.

The New York hedge fund, which has acquired a “significant” share in GSK in April, issued a public letter to the board and chairman of GSK, outlining a series of proposals to regain the reputation of GSK following “years of disappointing performance” according to the letter. It is the first public remark of Elliot following the company’s investment.

Elliot had demanded that GSK should hire new members of the board of directors who have extensive knowledge in pharmaceutical and consumer health sectors, as well as introduce a method to appoint “the best executive leadership” for the vaccine and pharmaceutical division, also including the consumer health sector, which includes products such as Nicorette and Sensodyne. This would compel Walmsley to apply again for her job, who is intended to lead the business through its reorganization and becoming the CEO of the new GSK.

On Thursday, GSK’s shares rose 1.3% to £14.38

This letter puts higher pressure on Walmsley, who managed the consumer health business before taking over as the CEO of GSK four years ago from Sir Andrew Witty. As she does not have any scientific knowledge, several investors are skeptical that she is the ideal person to manage the new GSK. On an investor day last week, she responded to the critics by calling herself a “change agent”.

Elliot slammed GSK’s ten-year poor performance, its “overly bureaucratic” research procedures, and erratic strategy. It highlighted the selling of Witty’s cancer division to Novartis in 2015, accompanied by Walmsley’s return to oncology in 2018.

Elliot proposed that executive incentives should be tied to more aspirational goals, such as achieving a 32% operational profit rate by 2026 and meeting R&D (Research and Development) objectives. It also advised GSK to look into the possibility of selling the consumer division before the separation.

GSK has outlined the sales target for vaccines and pharmaceutical products division of £33 billion by 2021, which is nearly equal to £34 billion earned by the entire firm and consumer health sector last year. The shares of the company have surged in the days following the update, with City experts praising the targets, and Royal London Asset Management, expressing its support.

GSK spokesperson said: “The legacy issues that Elliott identifies in its letter are not new.” The spokesperson added that shareholders were supportive of GSK’s plan to “deliver a step-change in performance” and were “focused on GSK executing on it without distraction or delay. This is our clear priority”.

Vertex scores FDA nod for kids’ cystic fibrosis drug Trikafta

Editorial Team — Thu, 17 Jun 2021 02:22:32 +0000

Trikafta was approved by FDA for the treatment of Cystic Fibrosis in patients aged 6 to 11 years, after receiving approval to be used in patients of ages 12 and up.

The FDA has authorized Vertex Pharmaceuticals to manufacture Trikafta for the treatment of Cystic Fibrosis in patients of ages 6 to 11 years.

This authorization is only for the children who have at least one F508del mutation in CFTR (Cystic Fibrosis Transmembrane Conductance) gene or a CFTR gene mutation that reacts to the treatment depending on its in-vitro studies.

Trikafta was approved by FDA in 2019 for the treatment of cystic fibrosis patients of ages 12 and up. It has also received authorization in countries such as Australia, Europe, and United Kingdom.

The drug is a combination of three APIs, elaxacaftor, ivacaftor, and tezacaftor. According to the manufacturer, the medication is now available in a new dose as a result of the approval.

Vertex Pharmaceuticals CEO and president Reshma Kewalramani said: “Today’s approval is a critical milestone in our efforts to deliver medicines that help treat the underlying cause of this devastating disease as early in life as possible.”
In phase 3, open-label, multi-center clinical trial, the firm evaluated the effectiveness, safety, and pharmacokinetic properties of the drug in 66 children of ages 6 to 11 years, for 24 weeks.
Two F508del mutant variants or one F508del mutant variant and one reduced functionality mutation were present in the patients.

The data obtained from the previous drug studies in individuals of ages 12 and up have shown similar safety data and well-tolerated treatment schedules for Trikafta.

The detailed findings of phase 3 clinical trial were published in the American Journal of Respiratory and Critical Care Medicine by Vertex Pharmaceuticals.

The legislative approval of Trikafta as Kaftrio is being sought by the company in the United Kingdom and Europe for the treatment of cystic fibrosis in patients of ages 6 to 11 years.

This year, the company will also seek approval in Australia, Switzerland, and Israel.