- TOFIDENCE (BIIB800) becomes the first tocilizumab biosimilar to gain FDA approval in the United States
- FDA approval is based on a robust analytical, non-clinical and clinical data package comparing TOFIDENCE to the reference product ACTEMRA
Friday, September 29, 2023
FDA Approves Biogen’s TOFIDENCE™ (tocilizumab-bavi), a Biosimilar Referencing ACTEMRA
MSD eyes March FDA decision on PAH drug sotatercept
MSD has been granted a priority review by the FDA for its pulmonary arterial hypertension (PAH) candidate sotatercept, setting up a decision on the would-be blockbuster by 26th March next year.
The company – known as Merck & Co in North America - said the activin receptor type IIA-Fc (ActRIIA-Fc) fusion protein has the potential to be a first-in-class therapy for PAH, a life-threatening disease caused by the narrowing of blood vessels in the lungs.
MSD filed the drug for approval on the back of results from the STELLAR trial, which showed that sotatercept achieved a significant increase in exercise capacity, measured using the six-minute walking test in PAH patients when added to stable background therapy.
Patients who received sotatercept also had an 84% lower risk of death or worsening of their condition compared with patients on standard therapy, and overall the drug hit eight of nine secondary endpoints in the study, all save one looking at the emotional and cognitive impact of PAH on patients.
“Despite advances in the treatment of PAH over the last two decades, there is still a significant need to improve outcomes for patients,” said Dr Joerg Koglin, senior vice president, of global clinical development, at Merck Research Laboratories (main picture).
“Based on the profound improvements across primary and secondary outcome measures in the phase 3 STELLAR trial, we believe sotatercept has the potential to transform the treatment of patients with PAH,” he added.
Sotatercept was acquired as part of MSD’s $11.5 billion takeover of Acceleron Pharma in 2021, and is a key component of the pharma group’s strategy to generate $10 billion in cardiovascular disease therapy sales in the 2030s. It is also one of the drugs that could help MSD prepare for the loss of patent protection on cancer blockbuster Keytruda (pembrolizumab) later this decade.
The drugmaker reckons sotatercept has the potential to become a $3 billion product at peak for PAH, thanks to its potential to become the first drug for PAH that addresses the underlying disease process, rather than simply dilating blood vessels to reduce pressure.
Sotatercept is thought to work by blocking abnormal signalling between cells in the pulmonary blood vessels, which might lead to a partial reversal of the disease process.
In addition to STELLAR, MSD is running the phase 3 HYPERION trial of sotatercept in newly diagnosed intermediate- and high-risk PAH patients, seeking to move it up the treatment pathway, as well as the phase 2 CADENCE study in pulmonary hypertension due to left heart disease.
https://pharmaphorum.com/news/msd-eyes-march-fda-decision-pah-drug-sotatercept
Biogen shuts digital health unit and exits Apple alliance
Biogen has decided to close down its digital health unit, formed just two years ago, as part of a major cost-reduction drive that has already claimed thousands of jobs.
The decision – first reported by Stat citing Biogen’s head of corporate development, Adam Keeney – is not an exit from the digital health category, but an acknowledgement that Biogen will rely more heavily on external partnerships to fulfil its objectives in this area.
Among the immediate consequences of the retreat is the abandonment of a partnership with Apple set up in 2021 to develop digital biomarkers of cognitive health based on sensors in the Apple Watch and iPhone, according to the report.
The collaboration has revolved around the 23,000-subject Intuition study, which measured cognitive function using the Apple devices and just generated two-year data that was reported at this week’s DTx in Boston.
The study had been billed as a key element in Biogen’s push to improve the treatment of Alzheimer’s disease, tied to the recent approval of its Eisai-partnered therapy Leqembi (lecanemab), which needs to be given to people in the early stages of the disease.
Biogen’s head of cognitive & mental health sciences, Richard Hughes, gave an update at the meeting that showed the biomarkers were able to identify people developing cognitive symptoms, promising that plenty more insights from the data would be forthcoming.
A recent update on the clinicaltrials.gov database suggests that the study was completed on 19th September, a few days ahead of the Biogen announcement.
Biogen Digital Health was created in 2021 with a wide-ranging and ambitious remit to use digital technologies to transform the company and its interactions with health systems, with three locations in Boston, Zurich, and Paris employing around 150 team members.
The unit’s work spans four main areas, including the use of technology to improve R&D, developing digital tools for clinicians as well as patient-facing apps and wearables and digital therapeutics.
The dismantling of the unit is part of a much wider restructuring at Biogen that saw two major rounds of job cuts in 2022 and 2023, following the launch of Leqembi’s ill-fated predecessor Aduhelm (aducanumab), which was scuppered by reimbursement restrictions.
Aduhelm’s demise, and an expected slow take-up of Leqembi, came as the company’s longstanding multiple sclerosis franchise is being hit hard by generic competition and spinal muscular atrophy (SMA) treatment Spinraza (nusinersen), which has seen its growth stalled by rival therapies entering the market.
It is also in the midst of a planned $7.3 billion takeover of Reata Pharma, aimed at bolstering its product portfolio and pipeline.
https://pharmaphorum.com/news/biogen-shuts-digital-health-unit-and-exits-apple-alliance
Oragenics Enters into Agreement with Lantern Bioworks for Replacement-Therapy Assets
Oragenics, Inc. (NYSE American: OGEN) ("Oragenics" or the "Company") and Lantern Bioworks announce a groundbreaking partnership, marked by the formalization of a materials transfer agreement. This milestone follows rigorous testing and validation of Oragenics’ biological samples, which are poised to potentially revolutionize dental caries prevention by replacing harmful bacterial strains with non-pathogenic counterparts.
Under this agreement, Oragenics has received a cash payment of $50,000 alongside an enticing opportunity to acquire one million shares of Lantern Bioworks’ equity. Additionally, Lantern Bioworks has committed to pay Oragenics a ten percent (10%) royalty on the net income generated from any products stemming from the transferred assets. The royalty payments span a ten (10)-year term.
https://finance.yahoo.com/news/oragenics-enters-agreement-lantern-bioworks-200000918.html
Drugmakers face down deadline on Medicare price negotiations
The deadline for drugmakers to sign agreements to negotiate with Medicare on pricing is fast approaching. Major drugmakers have until Sunday to sign an agreement to participate in the program or potentially face heavy taxes and lose their ability to sell through Medicare.
With courts yet to impose an injunction in a spate of pending lawsuits, several of the companies producing the 10 drugs selected for Medicare negotiations appear ready to move ahead with negotiations
Merck, whose diabetes treatment Januvia was selected, made it known it will sign an agreement with the Centers for Medicare & Medicaid Services (CMS) “under protest.”
“While we disagree on both legal and policy grounds with the IRA’s new program, withdrawing all of the company’s products from Medicare and Medicaid would have devastating consequences for the millions of Americans who rely on our innovative medicines, and it is not tenable for any manufacturer to abandon nearly half of the U.S. prescription drug market,” Merck said in a statement.
A spokesperson for Bristol Myers Squibb (BMS), which has a hand in two products on the Medicare list, similarly said it had “no choice other than to sign the ‘agreement.’”
“If we did not sign, we’d be required to pay impossibly high penalties unless we withdraw all of our medicines from Medicare and Medicaid. That is not a real choice,” the company’s spokesperson told The Hill in a statement.
BMS and Merck have filed lawsuits against the Department of Health and Human Services (HHS) to block the bargaining program, accusing the federal government of unconstitutional actions and exceeding its authority.
Under the rules established by the Inflation Reduction Act, manufacturers that don’t want to take part in negotiations can withdraw all of their products from coverage under Medicare and Medicaid, losing a highly lucrative income source.
The alternative is an excise tax on a selected product’s sales in the U.S., with the rate starting at 65 percent and potentially going all the way up to 95 percent. Plaintiffs suing to stop the negotiations have said no company could afford to pay the tax. Drugmakers can avoid the penalty by giving at least 30 days of notice before it goes into effect, saying they will terminate their relationships with Medicare and Medicaid.
During recent oral arguments between the Chamber of Commerce and the federal government, attorneys representing the administration argued there is nothing compelling companies to keep their drugs covered under Medicare and Medicaid. They further argued the risk of financial harm as a result of ending relationships with the CMS, which they acknowledged could occur, does not amount to a coercive action.
“There are decades of settled precedents from across the country that collectively established that Medicare providers have no vested interest in future Medicare participation at all, let alone under particular terms, because Medicare is a voluntary program,” the government argued.
Sunday has dual importance as the Chamber of Commerce in its lawsuit has requested a preliminary injunction on the Medicare Drug Price Negotiation Program, saying “irreparable harm” would occur if the process is allowed to continue.
U.S. District Judge Michael J. Newman has said he is working as quickly as he can to provide a decision on the matter. At the time of writing, no ruling has been issued.
Other drugmakers whose products have been chosen gave more conciliatory statements when speaking on their intent to engage with the CMS.
AstraZeneca said it was “proud” of the role its drug Farxiga has played in the lives of people in the U.S. living with Type 2 diabetes.
“We remain committed to ensuring patients have access to FARXIGA and plan to participate in the process outlined by CMS to communicate the value of FARXIGA to people covered by Medicare,” the company said.
Boehringer Ingelheim’s diabetes medication Jardiance was also chosen. The company said in a statement it was “committed to engaging in open and transparent conversations with CMS.”
“We look forward to sharing detailed information with CMS on the value of Jardiance and to reinforce the need to invest in scientific medical innovation for the patients we serve,” it added.
Some companies were less definitive when asked about their intentions.
Novo Nordisk, the maker of NovoLog, said it “supports policies to ensure patients can afford their medicines, including insulin. Unfortunately, we have seen CMS take aggressive steps to carry out unilateral price setting without consideration for the impact on patients living with chronic disease or the overall healthcare system.”
“We continue to explore all options that allow us to drive change for people that need it and strive to continue to bring innovative medicines to the market while helping increase access for those that need them,” Novo Nordisk added.
Other companies whose products have been named — including Johnson & Johnson, Novartis, Immunex Corporation and Pharmacyclics — did not immediately respond when reached for comment by The Hill.
Regardless of the vocal resistance to negotiating, experts have said drug manufacturers were always likely to take part in the process because of the ever-present possibility that their lawsuits could fail.
Adlai Nortye Ltd. Announces Pricing of Initial Public Offering
Adlai Nortye Ltd. (NASDAQ: ANL) (the “Company” or “Adlai Nortye”), a clinical-stage biotechnology company focused on the development of innovative cancer therapies, today announced the pricing of its initial public offering of 2,500,000 American depositary shares (“ADSs”), or 2,875,000 ADSs if the underwriters exercise their over-allotment option in full, each representing three Class A ordinary shares, at a public offering price of US$23.00 per ADS. All of the ADSs were offered by Adlai Nortye. In addition, an investor will acquire a total of 5,217,391 Class A ordinary shares from Adlai Nortye in a private placement concurrent with the closing of the public offering at the same per share purchase price. Adlai Nortye expects to receive aggregate gross proceeds of US$97.5 million, including US$57.5 million from the public offering (before deducting underwriting discounts and commissions and offering expenses, and not taking into account potential exercise of the underwriters’ over-allotment option) and US$40.0 million from the concurrent private placement. Assuming the over-allotment option is exercised in full, the aggregate gross proceeds to be received by Adlai Nortye may reach up to approximately US$106.1 million.
The ADSs are expected to begin trading on the Nasdaq Global Market on September 29, 2023 under the ticker symbol “ANL”. The offering is expected to close on October 3, 2023, subject to the completion of customary closing conditions.
Cantor Fitzgerald & Co. is acting as sole book-running manager for the public offering.
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