This week, SpeakPharma interviews Pete Werth III, the new president of ChemWerth, a company that has been at the forefront of the generic pharmaceutical industry for over four decades.
He shares his vision for ChemWerth, which includes his commitment to strengthening global manufacturing relationships, and enhancing supply chain resilience. Additionally, he highlights the key aspects of a successful drug master file (DMF).
HIGHLIGHTS// Pete Werth III, the new president of ChemWerth/ vision for ChemWerth/ commitment to strengthening global manufacturing relationships/ key aspects of a successful drug master file
Your father,
Peter J. Werth, is recognized as one of the founders of the generic
pharmaceutical industry, having built ChemWerth from the ground up over four
decades ago. How do you view his legacy? As you take the helm, what key lessons
or principles from his leadership do you intend to carry forward?
My father, Peter J. Werth, is a true pioneer in the generic pharmaceutical industry. Over his 42‐year tenure, he not only built ChemWerth from a humble garage startup into a global leader in generic API development but also established standards that many in our industry now take for granted. Under his leadership, we filed our very first DMF in 1987 and have since achieved more than 500 DMF filings. With an average review cycle of just 0.79, we have been far outperforming the industry average of 2.5 cycles.
His focus on quality, regulatory excellence, and a relentless commitment to customers’ success set the foundation for our reputation as a trusted supplier of over 500 APIs sourced from more than 30 cGMP-certified facilities worldwide. Equally inspiring is his dedication to nurture long-term, mutually beneficial relationships with manufacturing partners across the US, Europe, India, and China, as well as his passion for giving back to the community through philanthropic initiatives.
As I take the helm, I intend to build on his guiding principles — sustaining our high standards of quality and compliance while pursuing innovation in regulatory strategy, diversifying our supply chain, and embracing new technologies and approaches to remain competitive in an evolving market.
I will also strive to continue his legacy of
mentorship, ensuring that our company culture remains rooted in integrity and
diligence, with an unyielding focus on making safe, affordable medicines
available worldwide.
HIGHLIGHTS// trusted supplier of over 500 APIs/ 30 cGMP-certified facilities worldwide/ embracing new technologies and approaches to remain competitive
What are your top
priorities as the new president of ChemWerth? How do you plan to strengthen and
expand relationships with manufacturers worldwide?
My immediate priorities as the new president are
twofold: to enhance the value we deliver to our customers and, to deepen our
relationships with our manufacturing partners worldwide.
We will further diversify our supply chain and
broaden our product portfolio. Our expansion plans include upgrading equipment,
and hiring additional highly skilled scientists, engineers, and GMP auditors.
We will also leverage our proprietary product
selection and regulatory submission processes. These processes help us get the
regulatory filing right the first time, and allows us to be approved 44 percent
faster than the industry average. This helps our customers gain a competitive
edge in the market.
In essence, by strengthening operational excellence and expanding our global network, we intend to continue the company’s long-standing commitment to customer success and process innovation.
We plan to reinforce our long-standing relationships with our manufacturers — especially those in strategic markets like China and India — by helping our partners meet the highest standards of regulatory compliance and current good manufacturing practice (cGMP) quality. This balanced approach of strengthening existing partnerships while pioneering new ones is key to maintaining and growing our competitive edge.
HIGHLIGHTS// diversify our supply chain and broaden our product portfolio/ commitment to customer success and process innovation/ filings approved 44 percent faster than the industry average
When ChemWerth
last spoke to PharmaCompass, there
was a mention of investing millions of dollars in expanding manufacturing partnerships in China and India. Can you elaborate on the success of these partnerships, and how have they contributed to ChemWerth’s overall growth?
Our strategic, multimillion-dollar investments in manufacturing partnerships are a cornerstone of our growth strategy. Over the past few years, these joint ventures have proven their worth by diversifying our supply base and mitigating the risk of global supply chain disruptions — a lesson that became all too clear during the Covid-19 pandemic.
These investments are already paying dividends.
They help us support manufacturers producing steroids, hormones, veterinary
products, and large-volume APIs, while also accelerating the development of
small-molecule inhibitors and new generic APIs.
We have ensured that our partners are equipped
with the latest equipment and trained personnel to meet cGMP standards. By
partnering with facilities in these markets, we now have access to
state-of-the-art production capabilities that enable us to produce a wider
range of APIs at competitive costs.
The success of these partnerships is evident in our ability to consistently file DMFs rapidly — often on the first cycle — and deliver affordable, high-quality medicines to patients worldwide. This supports our clients’ growth trajectory and has helped us expand into new markets.
This strategy has reinforced our global footprint — supporting our presence in 38 countries with over 100 products — and positioned us well to capitalize on a global generic drug market projected to grow at a compounded annual growth rate of 5.4 percent from 2022 to 2030, to reach a size of US$ 671 billion by 2030.
HIGHLIGHTS// strategic multimillion-dollar investments/ support manufacturers producing steroid, hormone, veterinary products/ development of small-molecule inhibitors and new generic APIs/ ensured partners are equipped with the latest equipment and trained personnel
ChemWerth has an impressive track record, and an over 40-year relationship with the US Food and Drug Administration (FDA). What are the key aspects of a successful DMF? Are there specific challenges manufacturers face in preparing DMFs, and how does ChemWerth help them overcome these hurdles?
ChemWerth’s record of filing over 500 DMFs in 38 countries reflects our commitment to excellence in regulatory compliance and quality management. A successful DMF is built on comprehensive documentation that rigorously follows cGMP guidelines, robust analytical validation, and detailed tracking of every step.
Every DMF we file meticulously details the entire manufacturing process — from raw material acquisition to final batch production. This comprehensive approach ensures that our submissions meet the rigorous quality, safety, and efficacy standards expected by the FDA.
Our team stays continuously updated on the
evolving guidelines and protocols, which allows us to file DMFs that align with
current FDA practices. We recognize that many manufacturers face challenges
such as complex regulatory requirements, lengthy review cycles, and the need
for precise coordination between various production stages. ChemWerth helps
them overcome these hurdles by offering end-to-end regulatory support, detailed
internal audits, and continuous training on cGMP and FDA requirements.
Our efficiency is a critical competitive
advantage. By receiving approvals 44 percent
faster than the industry average, we help our customers get their products to
market faster, resulting in larger market share and increased profits.
HIGHLIGHTS// over 500 DMFs in 38 countries/ robust analytical validation/ end-to-end regulatory support
What is your
vision for ChemWerth over the next few years? How do you plan to navigate the
challenges and opportunities in the generic pharmaceutical industry?
I plan to continue to add value for our customers, and look for innovative ways to compete in today’s generic pharmaceutical landscape.
At ChemWerth, our vision for the future is rooted
in both our proud legacy and our relentless drive for innovation. We will
further diversify our supply chain and expand our product portfolio. We have
begun leveraging our expertise to supply APIs for biosimilars and new drug
applications (NDAs), while maintaining our reputation for rapid regulatory
approvals.
With unwavering determination, we uphold our “First to Quality. Fast to Market.” approach — delivering high-quality APIs to customers worldwide while leveraging our expertise to give them a competitive edge in their markets.
HIGHLIGHTS// supply APIs for biosimilars and NDAs/ give customers a competitive edge in their markets
This week, we delve into molecular glue degraders (MGDs), one of the most promising frontiers in drug development. MGDs address a vast number of previously “undruggable” disease-causing proteins.Unlike traditional small molecule drugs that require specific
binding pockets, MGDs function by enhancing protein-protein interactions. MGDs
selectively target disease-causing proteins and an enzyme known as E3 ubiquitin
ligase. By creating a binding interface between the two, MGDs destroy the target proteins.Another kind of degraders are proteolysis targeting chimeras (PROTACs) that use a bifunctional approach — one binds the target proteins, and the other binds to an E3 ligases together. These degraders induce the degradation of specific proteins by using the cell’s natural ubiquitin-proteasome system (a process in cells where damaged or unneeded proteins are tagged by a small molecule called ubiquitin and then broken down by a structure called the proteasome so that cells stay healthy and function properly).MGDs constitute a rapidly growing market, where both the targeted
protein degradation technologies and investment in research and development are
witnessing growth.Currently, the most recognized molecular glues are the immunomodulatory imide drugs (IMiDs), such as thalidomide, lenalidomide and pomalidomide, which have been around for some time. According to GlobalData, lenalidomide generated over US$ 6 billion in sales in 2023, thereby
demonstrating the commercial viability of this therapeutic approach.Lilly, AbbVie ink
billion-dollar MGD deals; Biogen partners Neomorph; Pfizer, Triana ink
collaborationThe MGD space has witnessed extraordinary deal-making activity over the recent months, with major pharmaceutical companies committing billions of dollars to secure access to novel MGD platforms and pipelines. This surge in investment reflects the industry’s growing confidence in the therapeutic potential of MGDs to address previously undruggable targets.This year has already seen two landmark deals. In February, Magnet Biomedicine entered into a collaboration
and license agreement with Eli Lilly worth up to US$ 1.29 billion to discover and develop novel MGDs. This partnership leverages Magnet’s TrueGlue discovery platform and approach with Lilly’s expertise in the development of small molecule therapeutics. In January, AbbVie crafted a US$ 1.64 billion deal with molecular glue
biotech Neomorph, combining AbbVie’s oncology and immunology drug development capabilities with Neomorph's leading molecular glue discovery platform.While oncology remains the primary focus, these collaborations are
increasingly expanding into neurodegenerative diseases, immunological
disorders, and other therapeutic areas. For instance, in October, Biogen and Neomorph announced a multi-target research collaboration to discover and develop MGDs for Alzheimer’s, rare neurological, and immunological diseases, potentially worth up to US$ 1.45 billion.October also saw Novartis sign a potential US$ 2.25 billion deal with Monte Rosa Therapeutics. The deal gives Novartis
exclusive worldwide rights to develop, manufacture and commercialize multiple
MGDs (including MRT-6160) for undruggable targets, including in the areas of
immunology and inflammation, metabolism, and genetic diseases.Earlier in October, Triana Biomedicines and Pfizer entered into a research
collaboration to discover novel MGDs for multiple targets across several
disease areas, including oncology, with a total potential value of up to US$ 1.55 billion.And in August 2024, SEED Therapeutics entered into a strategic
research collaboration with Eisai to discover and develop
novel MGDs for neurodegenerative and oncological indications, potentially worth
up to US$ 1.5 billion.BMS leads with three MGDs in late-stage trials; Monte Rosa’s MRT-2359 targets solid tumorsBristol Myers Squibb has established itself as a
leader in the clinical development of MGDs with three products in late-stage
development. These include a next-gen MGD mezigdomide (CC-92480), which is
currently in phase 3 trials in combination with carfilzomib and dexamethasone for relapsed/refractory multiple myeloma.
Another candidate is golcadomide, which is in late-stage clinical trials for high-risk first-line large B-cell lymphoma. And the third MGD in BMS’ portfolio is iberdomide, which has reached phase 3 development for multiple myeloma.Monte Rosa Therapeutics has made significant progress with MRT-2359, an
investigational MGD that is currently in phase 1/2 clinical trials for the
treatment of patients with MYC-driven solid tumors, including non-small cell
lung cancer, small cell lung cancer, and high-grade neuroendocrine cancer.
Myelocytomatosis or MYC is a gene which causes various solid tumors when
overactive.MRT-2359 represents an important advancement in extending the molecular
glue approach beyond hematological malignancies to solid tumors, which have
historically proven more challenging to address with protein degradation
strategies.Other significant early-stage candidates are Nested Therapeutics’ NST-628 and Plexium's PLX-4545. NST-628 relies on
a novel mechanism of action in its category of
RAS-MAPK inhibitors, and overcomes some traditional limitations in the
treatment of cancers.PLX-4545 is Plexium’s first small molecule degrader program to enter clinical development. This potent and selective MGD of a classically undruggable transcription factor, also known as Helios (IKZF2), explores treating solid tumors. Transcription
factors are proteins that regulate gene expression by binding to
specific DNA sequences.Boehringer’s KRAS degrader advances PROTACs approach; Arvinas tests ARV-102 for neurodegenerative diseasesLike MGDs, PROTACs are also witnessing advancements in both R&D and dealmaking. For instance, BridGene Biosciences recently expanded
its strategic collaboration with Galapagos to develop a selective oral
SMARCA2 PROTAC in precision oncology. The SMARCA2 gene provides instructions
for making one piece (subunit) of a group of similar protein complexes known as
SWI/SNF complexes.In the clinical arena, Prelude Therapeutics announced a collaboration with Merck to evaluate PRT3789 in
combination with Keytruda (pembrolizumab) in patients with
SMARCA4-mutated cancers. PRT3789 is a potent and highly selective,
first-in-class SMARCA2 degrader.On the molecular front, ACBI3, a novel pan-KRAS degrader developed through a
collaboration between the University of Dundee and
Boehringer Ingelheim, addresses a critical gap in cancer therapy by targeting 13 out of 17 prevalent KRAS mutants. KRAS mutation is a change in the KRAS gene, a common gene that can cause cancer. ACBI3’s development is a potential breakthrough for millions of cancer patients with KRAS-driven tumors.Vepdegestrant (ARV-471), a collaborative
effort between Arvinas and Pfizer, remains the most advanced
PROTAC candidate to date and has met its primary endpoint in a late-stage study in breast cancer patients with estrogen receptor 1 mutations. Similarly, Arvinas’ ARV-102 became the first PROTAC to be tested in humans for neurodegenerative
diseases, marking a significant
milestone in addressing brain-related disorders.Our viewMGDs offer a new, and groundbreaking approach to treating cancers and various other diseases, thereby attracting substantial investments by major pharmaceutical companies. As clinical trials show encouraging results, we expect investments in the MGDs space to increase even further.
Share
