PoZdroweek 12/2025: Merck acquires Verona Pharma for $10 billion

Merck was responsible for another mega-acquisition in the biopharmaceutical sector. The company will invest $10 billion in Verona Pharma, strengthening its expertise in respiratory diseases. The FDA is proposing a shortened review process for drug candidates for companies that lower their product prices in the US. The idea is controversial. Novartis has the first anti-malaria drug approved for use in newborns and young infants weighing 2 to 5 kg. News of its approval was met with rapid reaction from some African countries.

Another week of symbolic changes in key equity indices that measure the health care sector has passed. The domestic WIGmed index fell 0.4%. The MSCI Europe Health Care (SPYH) fell 0.3%, while the global MSCI World Health Care (XDWH) was the only index to record a marginal gain (+0.1%).

Source: TradingView

Among the global top 20 listed companies in the MSCI World Health Care , Thermo Fisher performed best (+3.9%). Merck was second best (+3.0%), with Eli Lilly, AbbVie, and Danaher tied for third (+2.6%).

Source: own study based on stooq.pl

In Poland, Medicalghoritmics (+18.4%) was the standout. Scope Fluidics (+8.5%) and Captor Therapeutics (+4.7%) also led the pack. Meanwhile, Molecure (-5.6%), NanoGroup (-4.6%), and Celon Pharma (-4.2%) saw significant declines.

Source: own study based on stooq.pl

We're already halfway through the year, and all three healthcare indices discussed have all fallen in the red. WIGmed lost the least, down just over 2%. Its foreign cousins fared much worse. The MSCI World Health Care suffered the most damage, falling by over 12%. However, these results are for indices that are inevitably a function of the baskets of shares that comprise them.

Therefore, it's worth taking a closer look at the stocks of companies that have given their shareholders the most reasons to celebrate, and which have been the source of concern. In the global edition, Novartis (+24.4%), Gilead Sciences (+18.7%), and Abbott (+16.7%) have emerged as the top performers. At the other end of the spectrum in the race for investor attention are UnitedHealth Group (-39.6%), Novo Nordisk (-19.6%), and Thermo Fisher (-16.4%).

In Poland, Medicalghoritmics (+75.1%) earned praise from shareholders. Investors holding Bioton (+44.2%) and Voxel (+36.0%) likely also spoke warmly about their companies. Investments in Molecure (-43.6%), Selvita (-42.4%), and Neuka (-21.6%) were complete flops.

Source: own study based on stooq.pl

Fast-track for companies lowering drug prices in the US

President Donald Trump is employing a carrot-and-stick approach to biopharmaceutical companies. First, he threatened them with import tariffs of up to 200%, which could cripple the industry's American supply chains and, consequently, negatively impact the availability of drugs to patients. Trump indicated that if production of the drugs doesn't arrive in the United States within a year, perhaps even a little longer, he is prepared to impose draconian tariffs.

There's a carrot in all this politics. On Friday, Marty Makary, head of the FDA, revealed that the government agency plans to award a special voucher to companies willing to match the prices of their drugs with lower prices elsewhere in the world. The benefit of this voucher would be to shorten the pre-approval review process for drugs from the typical 10-12 months to just one or two months.

While this isn't a new idea, as it was already discussed last month (the National Priority Review Voucher), Makary's speech on Friday sheds more light on how this tool would work. Companies based in the US and whose work aligns with US national priorities can qualify for the voucher.

In an interview with Bloomberg, Marty Makary admitted that the initiative aims to encourage good market behavior among biopharmaceutical companies, and that priority vouchers are worth a lot of money. The regulator noted that vouchers for priority pediatric review under another program have been sold for over $100 million on secondary markets, although he quickly added that the new national priority vouchers will not be available for sale.

The idea has emerged in the public sphere, that's true. But it raises many ambiguities. It's difficult to say how price equalization would be measured. The plan likely assumes that patients will pay less at the pharmacy counter. However, along the way from the drug manufacturer, there are also a range of intermediaries, such as insurers and pharmacy benefit managers, which the FDA's proposal doesn't address at all.

The criterion that only entities based in the United States would be eligible for the priority voucher smacks of utopia. This is simply unthinkable, and why would it happen anyway? Which rational country would deprive itself of tax revenues and cease employing numerous specialists in-house?

The FDA chief's admission that the deadline has been shortened from 10-12 months to 1-2 months is also problematic. This is essentially an admission that the procedure can be shortened. How, then, does the current process compare to the needs of patients, many of whom eagerly await the fastest possible marketing authorization of the most innovative products, as previously used drugs have failed or have been unable to be treated at all due to a lack of available products.

I know of a painful case involving a friend suffering from a nasty condition who was just a few months away from gaining access to the treatment he longed for. Unfortunately, Scott is no longer with us, perhaps due to bureaucratic inertia.

Merck acquires Verona Pharma for $10 billion

Merck will acquire Verona Pharma for approximately $10 billion. The American company is trying to plug a potential revenue gap due to the upcoming patent expiration of its key cancer drug Keytruda (pembrolizumab).

The transaction will strengthen Merck's respiratory portfolio. Verona Pharma received FDA approval last year for its chronic obstructive pulmonary disease (COPD) drug Ohtuvayre (ensifentrine).

This dual PDE3/4 inhibitor, approved for the maintenance treatment of COPD in adults, generated more than $71 million in sales in the first quarter of this year, significantly exceeding analyst estimates. Experts believe the product could ultimately reach peak annual sales of nearly $4 billion.

Ohtuvayre is an example of inhalation therapy , administered directly to the lungs using a jet nebulizer. Based on this dosing method, Verona Pharma is conducting Phase II clinical trials of ensifentrine for indications in asthma, cystic fibrosis, and non-cystic fibrosis bronchiectasis.

The Verona Pharma transaction was unanimously approved by both boards of directors of the integrating organizations and is expected to close in the fourth quarter of this year. The price Merck offered to Verona Pharma shareholders represented a premium of 23% over Verona's closing share price on July 8.

Source: Verona Pharma

POLAND

Monday (7/7/2025)

Pharmena has entered into an agreement with a specialist company to develop medical device documentation and produce validation batches of a future medical device for use in difficult-to-heal wounds. The products produced in the validation batches will be used for biocompatibility testing and clinical trials to confirm the device's effectiveness.

Following this news, Pharmena shares gained almost 11% during Monday's session.

Medicalgorithmics has signed an agreement with Byteflies to provide the Belgian partner with its DeepRhythmAI (DRAI) artificial intelligence algorithms upon completion of the integration process and obtaining the appropriate regulatory approvals. This is the thirteenth new client acquired by the company, meaning that since the beginning of the year, Medicalgorithmics has signed as many contracts as in all of 2024. The company did not disclose financial details related to the agreement with Byteflies.

- Synektik estimates that in the medical equipment, IT solutions, and services segment, it secured approximately PLN 99 million in medical equipment supply contracts in Q3 2024/2025, representing a 10% improvement compared to the same period of the previous year. During the nine-month period from October 1, 2024, to June 30, 2025, the Synektik capital group secured approximately PLN 246 million in medical equipment supply contracts , compared to PLN 277.3 million a year earlier.

Mercator Medical announced that the District Court in Kraków has repealed the resolution of the general meeting that decided to allocate the profit generated in 2023 to the company's reserve capital. The judgment is not final, and the company will request a court justification of the judgment and, once it receives it, will consider filing an appeal.

On May 28, 2024, the shareholders decided to allocate the entire net profit achieved in 2023 in the amount of approximately PLN 69.8 million to the company's reserve capital.

Wednesday (9/07/2025)

- The Management Board of Pure Biologics set the issue price for series P1 shares at PLN 1. On June 30, this year, the company's general meeting of shareholders decided to increase the share capital through the issue of up to 4,081,572 new shares.

WORLD

Tuesday (8/7/2025)

Novartis has received approval from Swiss regulator Swissmedic for the marketing of its Coartem Baby (artemether/lumefantrine) vaccine. This is the first antimalarial vaccine approved for use in newborns and young infants weighing 2 to 5 kg.

Following regulatory approval, the eight African countries that participated in the evaluation (Burkina Faso, Côte d'Ivoire, Kenya, Malawi, Mozambique, Nigeria, Tanzania, and Uganda) intend to expedite their approvals for Coartem Baby, which will also be marketed under the brand name Riamet Baby in some regions. Novartis intends to make the product available primarily on a not-for-profit basis in malaria-endemic regions.

The soluble formulation, which can be administered with breast milk to facilitate dosing, is indicated for uncomplicated infections due to Plasmodium falciparum or mixed infections including P. falciparum .

The Swiss biopharmaceutical giant noted that, until now, due to the lack of an approved antimalarial drug for children weighing less than 4.5 kg, doctors often had to rely on drugs intended for older children. This approach was associated with, among other things, the risk of overdose.

Wednesday (9/07/2025)

Rhythm Pharmaceuticals announced positive results from a Phase II clinical trial for bivamelagon (LB54640), an orally administered drug candidate for the treatment of a rare form of obesity that occurs after damage to the hypothalamus in the brain. The hypothalamus is responsible for maintaining the body's internal balance, regulating many important functions, including body temperature, thirst, appetite, sleep, emotional behavior, and libido.

In a 14-week Phase II study, bivamelagon was administered to 28 patients aged 12 years or older, none of whom had previously been treated with a GLP-1 agonist. The highest dose cohort (600 mg) achieved a 9.3% reduction in BMI , compared with a 7.7% reduction for the 400 mg dose. The placebo group achieved a 2.2% reduction.

The study's results were evaluated by healthcare industry analysts. Faisal Khurshid, an expert at Leerink Partners, called them utterly impressive, noting that 37.5% of patients in the highest-dose group experienced a ≥10% reduction in BMI.

Stifel analysts were more cautious, noting that bivamelagon is a drug with efficacy that's on par with Imcivree. They believed that bivamelagon would need to demonstrate at least 75% of Imcivree's efficacy , while also providing oral administration and comparable safety profiles, to be considered successful.

Stifel mentioned Imvicree (setmelanotide), which is also being developed by Rhythm Pharmaceuticals. This substance is in Phase III clinical trials and is used as an injectable therapy for patients with acquired obesity following damage to the hypothalamus in the brain. In April 2025, the company reported that the TRANSCEND study demonstrated that administration of the drug reduced placebo-adjusted BMI by 19.8% after one year of dosing.

In response to the clinical reading results, the company's share price rose by almost 37% during Wednesday's session.

Thursday (10/07/2025)

AbbVie announced that it is expanding its offering with a new license agreement valued at over $1.9 billion for a potential first-in-class therapy for cancer and autoimmune diseases. This is the result of an agreement granting exclusive rights to ISB 2001, a trispecific antibody (intended to target three targets simultaneously) being developed by IGI Therapeutics (IGI). The drug candidate is in Phase I clinical trials.

Under the agreement, IGI will receive an upfront payment of $700 million, with the remainder to be paid in potential milestones totaling nearly $1.23 billion. In addition, AbbVie will also pay double-digit royalties on net sales in North America, Europe, Japan, and China, where it will have exclusive rights to develop, manufacture, and commercialize ISB 2001.

IGI reported results from the TRIgnite-1 Phase I clinical trial for ISB 2001 last month at the American Society of Clinical Oncology (ASCO) conference. They showed a 79% overall response rate in patients treated intensively with active doses, with 30% achieving a high complete or stringent complete response.

The FDA has approved Moderna's mRNA-based COVID-19 vaccine for children ages 6 months to 11 years. Spikevax was previously available for pediatric patients under an Emergency Use Authorization granted in 2022. The company said the vaccine will be available for the 2025-2026 season. Shares of the company rose more than 4% in response to the FDA's favorable decision.

Bayer announced that Lynkuet (elinzanetant) , a drug used to treat vasomotor symptoms associated with menopause (commonly known as hot flashes), has received the green light from the UK regulatory authorities (MHRA). A decision on the drug in the US will be made on July 26, 2025.

The British regulator relied on the results of three studies from the OASIS Phase III programme, which involved more than 1,400 women aged 40-65.

The OASIS 1 and 2 studies showed significant reductions in the frequency and severity of hot flashes over 26 weeks, with over 80% of participants achieving a reduction of at least half their frequency by week 26. The OASIS 3 study saw a similar reduction in hot flashes, with the group experiencing approximately 6.7 hot flashes per day at the start of the study, which dropped to a frequency of 1.6 per day after just 12 weeks of treatment.

Bayer revealed that there were no signs of hepatotoxicity even after one year of treatment in OASIS 3.