This week, SpeakPharma interviews Michael
Kallelis, CEO of Mikart, a leading contract development and manufacturing organization (CDMO) celebrating its 50th anniversary in the pharmaceutical industry. Based in the United States, Mikart has built a reputation for technical expertise, flexible business terms, and specialized capabilities in pharmaceutical development services.
In this exclusive interview, Kallelis
discusses how Mikart maintains its competitive edge through its Pharmaceutical
Development Services team, quality control framework, and commitment to
customized business solutions. Kallelis also explores the company's focus on
liquid suspensions manufacturing, driven by growing demand from aging
populations and pediatric patients, and explains how Mikart balances
traditional family business values with modern innovation.
HIGHLIGHTS// celebrating
its 50th anniversary/ reputation for technical expertise/ how Mikart
maintains its competitive edge
Mikart is celebrating 50 years in business this year — what are some of the major milestones that have shaped the company's journey?
Over our 50-year history, we've celebrated many memorable milestones, but one of the most significant in recent years has been achieving our growth objectives. This success was driven by the strategic expansion of our Pharmaceutical Development Services team, the completion of full aggregate serialization in our packaging department, modernization of our IT systems, enhanced productivity, and our ability to attract both new and returning customers.
HIGHLIGHTS// expansion of our Pharmaceutical Development Services team/ completion of
full aggregate serialization/ attract both new and returning customers
How has Mikart
maintained its competitive edge in a constantly evolving pharmaceutical
landscape?
Our customers
consistently tell us that what sets us apart is our technical expertise, high
service level, and flexible, customized business terms. At the core of our
competitiveness is our focus on Pharmaceutical Development Services (PDS).
Mikart's PDS opinion
leaders are actively engaged in business development and form early,
collaborative relationships with our customers' technical teams. From the
outset, our prospects and clients work directly with Mikart's experienced
formulation chemists, analytical method developers, and process-oriented
engineers to design robust, reproducible, and efficient processes.
This hands-on
development approach is supported by a comprehensive quality control testing framework — covering raw material testing, in-process checks, on-site microbiological testing, and in-house stability studies. Oversight is provided by our robust Quality Management System, managed by a dedicated Quality Assurance and Regulatory Affairs team.
The result is
disciplined problem-solving, timely FDA submissions, and a
"right-first-time" philosophy that accelerates time-to-market. We
operate with a strong sense of urgency and consistently deliver a high level of
customer satisfaction.
What truly
differentiates Mikart is our commitment to customized business terms that
eliminate common roadblocks seen with other CDMOs. Our secret sauce is our
exceptional service and flexibility in helping our customers bring innovative
medicines to patients.
HIGHLIGHTS// technical expertise, high service level/ flexible, customized business
terms/ comprehensive quality control testing framework/
dedicated Quality Assurance and
Regulatory Affairs team/ timely FDA submissions/ accelerates time-to-market
What capabilities
or services does Mikart offer today that didn't exist 10 or 20 years ago?
Mikart was an early
leader in serialization, implementing full capabilities well ahead of the
industry timeline. This proactive approach has kept our packaging team in high
demand. We also upgraded our tablet compression equipment to enhance both speed
and reliability.
To support growing
development needs, we invested in new lab-scale development equipment, unit
dose cup filling, sachet packaging, low-humidity suites, and a brand-new suite
dedicated to closed-system manufacturing of liquids and suspensions.
Most recently, we
launched a multi-million dollar expansion of our packaging lines to support
higher-speed tablet filling, powder-in-bottle formats, and new liquid fill
capabilities.
HIGHLIGHTS// early leader in serialization/ upgraded our tablet compression equipment/
multi-million dollar expansion of our packaging lines
Why are liquid
suspensions becoming such a key focus, and how is Mikart positioned?
Formulating suspensions is a complex process that requires specialized expertise and equipment. According to our customers, few mid-market CDMOs do it well — and Mikart is one of them.
There is growing
industry demand for high-quality suspension manufacturing, driven by the needs
of the aging baby boomer population and pediatric patients. For both groups,
swallowing tablets or capsules can be difficult, making oral liquid suspensions
a more practical alternative.
In addition to being easier to administer, suspensions offer pharmacological advantages and can improve dosing compliance. Enhanced flavoring techniques further improve the patient experience — especially for children and infants — by making medicines more palatable.
HIGHLIGHTS// growing industry demand for high-quality suspension manufacturing/ suspensions
offer pharmacological advantages/ improve dosing compliance
How does Mikart
balance tradition with innovation to meet modern customer demands?
At Mikart, we work hard to preserve the values of a traditional family business, even as we continue to modernize. Our goal is to make every customer feel like they are our top priority.
Each customer is
supported by a dedicated project manager who serves as their primary point of
contact, along with direct access to key team members across departments. This
structure ensures our customers are never isolated from our subject matter
experts and can get timely, accurate answers to their questions.
We're also mindful of the "technology trap" — the tendency to pursue every new innovation at the expense of focus and efficiency. Instead, we rely on market data and customer trends to guide our investments, enabling us to concentrate our resources and capital on technologies that meet real market needs.
HIGHLIGHTS// customer is supported by a dedicated project manager/ customers are
never isolated from our subject matter experts/ we rely on market data and
customer trends to guide our investments/ meet real market needs
Looking ahead,
what's in store for Mikart in the next 5-10 years?
Mikart's strategic
plan is now in full motion, and with the momentum we've built, 50 percent
growth is within reach. This projection is backed by a strong pipeline of
annual FDA filings, a growing customer base, and a robust portfolio of active
Pharmaceutical Development Services projects.
As we grow, we remain
committed to delivering exceptional service and continuously evolving to meet
the changing needs of our customers. With renewed
political emphasis on domestic manufacturing for the US market, we are ideally
positioned to support the rapid, cost-effective development and production of
high-quality medicines here at
home.
As we approach our
50th anniversary in the CDMO industry, we celebrate our legacy and look forward
with optimism to the opportunities ahead in the next 5 to 10 years.
HIGHLIGHTS// 50 percent growth is within reach/ strong pipeline of annual FDA filings
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It has been a turbulent year for the US
Food and Drug Administration (FDA), marked by reductions in both staff and budget, shake-ups at the top and a reduction in inspections. This upheaval has clearly impacted the functioning of the agency, with
reports of missed deadlines and reduced
responsiveness.
This disruption resulted in a slowdown in
new drug approvals in the first half of 2025 (H1 2025), as opposed to the same
period last year. Incidentally, drug approvals in H1 2024 were also down by 19 percent compared to H1 2023.
FDA’s Center for Drug Evaluation and Research (CDER) approved 16 novel drugs in H1 2025, down from 21 in H1 2024, a
decline of nearly 24 percent. Of these, nine were small molecules and seven
were biologics. The period saw eight first-in-class therapies get CDER’s approval, as opposed to 17 in H1 2024.
FDA’s Center for Biologics Evaluation and Research (CBER) approved seven biologics in H1 2025, compared
to eight in the same period last year.
In comparison, both Health Canada and the European
Medicines Agency (EMA) reported a strong rebound in approvals and
authorizations, respectively. Health Canada approved 20 drugs in H1 2025, as opposed to
10 in H1 2024. Similarly, EMA authorized 19 new therapies in H1 2025, compared to 15 in H1 2024. Notably, EMA’s pending decisions increased to 25 in H1
2025, from 14 in the same period last
year, while conditional authorizations remained static at five. This underscores EMA’s active regulatory pipeline, suggesting that more drugs could be approved in Europe soon.
View New Drug Approvals in H1 2025 with Estimated Sales (Free Excel Available)
Vertex’s non-opioid painkiller, GSK’s antibiotic for UTI, Merck’s RSV antibody bag FDA nods
Oncology remained the single largest category in H1 2025 with seven new drugs being approved by
the FDA, followed by four rare diseases and disorders and as many infections and infective diseases.
The eight drugs that were designated first-in-class in H1
2025 are: Journavx (Suzetrigine), Imaavy
(nipocalimab), Emrelis (telisotuzumab vedotin), Blujepa (gepotidacin mesylate), Qfitlia (fitusiran), Avmapki Fakzynja
Co-Pack (avutometinib potassium/defactinib hydrochloride), Tryptyr (acoltremon), and Andembry (garadacimab).
In January, a
new class of non-opioid pain therapy made a debut — FDA approved Vertex Pharmaceuticals’ Journavx (suzetrigine). This
first-in-class oral analgesic could bring in US$ 2.9 billion in sales for Vertex
by 2030.
The half year also saw a new oral antibiotic — GSK’s Blujepa (gepotidacin) — for treating uncomplicated urinary tract infections (uUTIs) bag
FDA approval. This is the first new antibiotic for
uUTIs in nearly three decades. It treats infections caused by resistant pathogens such as E. coli and K. pneumoniae.
In June, Merck’s Enflonsia
(clesrovimab), a long-acting monoclonal antibody, won FDA approval to prevent
respiratory syncytial virus (RSV) lower respiratory tract disease in neonates
and infants entering their first RSV season. A single 105 mg dose provides
protection for about five months, the length of a typical RSV season. Enflonsia
could bring in US$844 million in annual sales by
2030.
View New Drug Approvals in H1 2025 with Estimated Sales (Free Excel Available)
FDA approves four meds for rare diseases, including SpringWorks’ Gomekli, Novartis’ Vanrafia
In H1 2024, rare genetic diseases had witnessed some significant
approvals. The trend continued in H1 2025. In February, Gomekli (mirdametinib), developed by SpringWorks Therapeutics, became the first approved therapy for
neurofibromatosis type 1 (a genetic disorder that causes tumors to grow on
nerve tissues) in adult and pediatric patients who have symptomatic plexiform
neurofibromas (benign,
complex nerve tumors) not amenable to complete resection. Analysts expect peak sales of around US$ 0.8 billion by 2030. Post this approval,
SpringWorks got acquired by Merck KGaA for approximately
US$ 3.9 billion.
The same month, Ono
Pharma-owned Deciphera’s Romvimza (vimseltinib) became the first
oral therapy approved for another rare disease
known as symptomatic tenosynovial giant
cell tumor. This is a benign but aggressive growth that can be painful. This new drug offers patients an
option beyond surgery.
In March, Sanofi’s Qfitlia (fitusiran) was approved for routine prophylaxis in
hemophilia A or B, with or without inhibitors. And in April, Novartis’ Vanrafia (atrasentan) was granted accelerated approval for IgA nephropathy
(a chronic autoimmune kidney disease), which is at the risk of rapid
progression. Vanrafia could bring in sales of over US$ 735 million by 2030.
Johnson & Johnson secured approval for Imaavy (nipocalimab-aahu) for generalized myasthenia gravis (a chronic autoimmune disease that causes muscle weakness) in adults and adolescents. Imaavy’s sales could cross US$1.17 billion by 2030.
Rare diseases continue to attract regulatory attention, with the trend carrying into the current quarter. July witnessed two noteworthy rare-disease approvals — Ekterly (garadacimab), CSL’s once-monthly
prophylactic treatment for hereditary
angioedema (a genetic disorder that causes recurrent episodes of swellings),
and Sephience (pegvaliase-abcx), BioMarin’s new therapy for phenylketonuria (a rare metabolic disorder).
View New Drug Approvals in H1 2025 with Estimated Sales (Free Excel Available)
FDA greenlights new oncology therapies, including Astra’s Datroway, AbbVie’s Emrelis
The field of oncology saw some notable new drug approvals. In January, Datroway (datopotamab deruxtecan), an antibody-drug conjugate (ADC) developed by AstraZeneca and Daiichi Sankyo, was granted approval for adults with unresectable or metastatic, hormone receptor-positive, HER2-negative breast cancer. Later, in June, the FDA granted accelerated approval to AstraZeneca;s Datroway for adults with locally advanced or metastatic, EGFR-mutated non-small cell lung cancer. The drug’s peak annual sales are projected at about US$ 4.2 billion by 2030. In May, Emrelis (telisotuzumab
vedotin-tllv), AbbVie’s ADC was granted FDA’s accelerated approval. Emrelis treats
locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC)
characterized by significantly increased levels of the c-Met protein in cancer
cells. FDA also approved a companion diagnostic test — Roche's Ventana — in May to determine the c-Met protein biomarker status in order to identify patients eligible for Emrelis.
The same month, FDA also granted accelerated
approval to Verastem’s Avmapki Fakzynja Co-pack, a dual oral therapy for adults with KRAS‑mutated recurrent low‑grade serous ovarian cancer (LGSOC). This novel regimen combines two inhibitors — avutometinib and defactinib — to disrupt critical signaling pathways that fuel tumor growth.
In ophthalmology, Alcon re-entered the
prescription pharmaceutical market with Tryptry (acoltremon), a first-in-class
TRPM8 agonist for dry eye disease, which stimulates corneal nerves to increase
tear production.
View New Drug Approvals in H1 2025 with Estimated Sales (Free Excel Available)
Our view
The
changes in the FDA are clearly having a far-reaching impact on the global
pharmaceutical industry. There have been reports of drugmakers losing confidence in the FDA, which has been a gold standard for drug regulation. Some American biotechs are shifting early trials outside of the US. With EMA and Health Canada authorizing/approving a larger number of drugs in H1 2025, we do see some changes underway that may eventually reshape drug development.
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