Business Insights, PHARMACY MARKET
Businesswire | August 03, 2023
MedinCell During today’s Q2 earnings call, Richard Francis, President and CEO of Teva, and Eric Hughes, Executive Vice President, Global R&D & Chief Medical Officer, commented the US launch of UZEDY since May 2023 and the olanzapine Long-Acting Injectable (LAI).
About UZEDY
Richard Francis said1
“We are actually right on plan or slightly ahead of our market access strategy targets and we are very happy with the launch.”
“The newest member of our innovative family is said risperidone, our long-acting treatment for schizophrenia. Now, to remind everybody, this is a $4 billion market and we've only just launched UZEDY, but we're very pleased with the feedback we're getting from healthcare professionals. And they're confirming that the product profile that we have is unique and advantageous. Now we're seeing this in the fact that our NBRX2 is 40%, so already we're getting 40% of the risperidone long-acting market. We're also seeing hospitals look to use our free samples and free trial requests, and we're having good discussions with our payers. So once again, I think excitement around UZEDY early days, but initial feedback is very positive.”
UZEDY, a long-acting injectable (LAI) risperidone for the treatment of schizophrenia in adults, is the first FDA-approved product based on MedinCell’s BEPO technology. MedinCell is eligible for up to $105m commercial milestones and for royalties on net sales.
About LAI olanzapine (mdc-TJK), initiated in January 2023
Eric Hughes said1
“Our Olanzapine Phase 3 study is actually enrolling very quickly.”
“Olanzapine as an oral agent account for 20% of the patients being treated today, but only less than 1% of patients on the long-acting form are being using that product. And that's primarily because of the safety profile3.”
Richard Francis, said1
“With olanzapine, I've already highlighted the fact that it's a $4 billion market. But if we do manage to bring this to the market with a favorable safety profile, I think we have a real opportunity to have a significant product on our hands here.”
mdc-TJK is an investigational long-acting injectable olanzapine also based on BEPO technology. If approved, it could be the first olanzapine LAI with a favorable safety profile offering a valued treatment option as a complement to UZEDY for severe schizophrenia patients. MedinCell is eligible for $12m left out of $17m of development milestones, for up to $105m commercial milestones and for royalties on net sales.
About MedinCell
MedinCell is a commercial-stage technology pharmaceutical company developing long-acting injectable drugs in many therapeutic areas. Our innovative treatments aim to guarantee compliance with medical prescriptions, to improve the effectiveness and accessibility of medicines, and to reduce their environmental footprint. They combine already known and used active ingredients with our proprietary BEPO® technology which controls the delivery of a drug at a therapeutic level for several days, weeks or months from the subcutaneous or local injection of a simple deposit of a few millimeters, entirely bioresorbable. The first treatment based on BEPO technology, intended for the treatment of schizophrenia, was approved by the FDA in April 2023, and is now distributed in the United States by Teva under the name UZEDY™.
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Pharmacy Market
PRNewswire | July 21, 2023
Catalyst Clinical Research an industry-leading provider of specialized clinical development solutions, announced today it has acquired Genpro Research ("Genpro"), a Massachusetts-based global clinical research organization with staff in the US, India, and Ireland.
Genpro is a next generation services and technology partner for the pharmaceutical, biotechnology, and medical devices industry with expertise in biometrics, medical writing, RWE, and AI enabled automation product development. Genpro will continue to be led by Dr. Sachin Marulkar and the existing management team.
Commenting on the announcement, Catalyst CEO Nick Dyer said, "We are hugely enthusiastic about the addition of Genpro to our family. We share the opportunity to expand our global footprint, broaden and deepen our services, and to use the AI platform to create value for ourselves and customers in a range of labor-intensive document creation processes. In addition, our approach to prioritizing culture and treating our teams like family are similar and will act as a critical foundation for our combined company as we move forward."
Genpro CEO Dr. Sachin Marulkar added, "By joining Catalyst, we will continue to expand our biometrics, scientific reporting and technology offerings, have access to more opportunities globally, and provide our clients with additional products and services. We are excited to utilize the synergies in advancing our AI/ML technology platform to create beneficial new tools and improve the efficiency of clinical research. Catalyst is highly aligned with our purpose, values, and our relationship-driven focus. We look forward to stepping into these opportunities while still acting with the speed and flexibility our customers value and maintaining the collaborative culture that is so important to our employees."
This acquisition adds more than 120 team members in India with expertise in biometrics and medical writing further bolstering Catalyst's robust functional service offerings. This further enables biopharma, MedTech and CRO clients (current and future) to access Catalyst's specialized clinical research services, along with broader expertise in global time zones, new solutions, and early access to innovative automation platforms.
Melissa Church, Senior Vice President, Strategy at Catalyst, expressed the strategic significance of the acquisition, emphasizing its importance in advancing Catalyst's commitment to providing top-notch specialized clinical development solutions. She stated, "Catalyst is extremely intentional in its acquisition approach, ensuring we choose organizations that are additive to our capabilities and match well with our people-first culture. In Genpro we are gaining a very talented team delivering function specific biometrics and medical writing services which fits squarely in our strategic growth plan supporting both our Catalyst Flex and Catalyst Oncology solutions. This creates more value for our customers, collaborators, partners and investors long term."
Highlighting scientific and innovation focus of the deal, Kapil Khambholja, Genpro's CSO and Practice Head of Medical Writing, Real-World Evidence, and Health Economics and Outcomes Research (RWE & HEOR) emphasised both company's shared commitment for advancing therapies beyond milestones to transforming lives. Dr Kapil stated, "This partnership will propel Genpro's automation roadmap forward, aligning strategically with Catalyst's interests. We are also thrilled to see Genpro's scientific initiatives gaining momentum, and we eagerly anticipate collaborating with Catalyst's dedicated team to inspire advancements of breakthrough therapies touching lives."
About Catalyst Clinical Research
Catalyst is a clinical research organization (CRO) that provides highly customizable solutions to the global biopharmaceutical industry through two established, branded solutions: Catalyst Oncology and Catalyst Flex. The company provides full-service oncology CRO offerings through Catalyst Oncology and multi-therapeutic Client- or Catalyst-managed functional services through Catalyst Flex. With around 1000 staff and offices in the United States, Europe, and Asia-Pacific regions, Catalyst's flexible service model is built from more than a decade of listening to customers, devising customer-centric solutions, and helping customers drive breakthrough clinical studies by leveraging expert teams and innovative technologies.
Catalyst is a portfolio company of QHP Capital, a leading healthcare and life sciences investment firm.
About Genpro Research
Genpro Research is a technology and services partner dedicated to serving the pharmaceutical, biotechnology, and medical devices industries. By providing expertise in biostatistics, data sciences, medical writing & evidence synthesis, the focus has been on thoughtful service execution on clinical studies. And, as an experienced technology provider, Genpro uses Artificial Intelligence, Machine Learning, and Natural Language Processing algorithms for clinical development and post-launch activities, Genpro's central commercial platform called MaiA is used for Evidence Generation and Study Report Automation that brings depth and clarity to enable informed decision making.
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PHARMACY MARKET, PHARMA TECH
Businesswire | July 12, 2023
Kindeva Drug Delivery, a global leader in contract drug delivery development and manufacturing services and technology, and H&T Presspart (a division of the Heitkamp & Thumann Group), a market leader in respiratory drug delivery systems design, development, and manufacturing, are partnering with Chiesi Group, an international research-focused biopharmaceutical and healthcare group, for the installation of a production line for dose counter (DC) and dose indicator (DI) devices. Combining the specific expertise of each partner, H&T Presspart will manufacture Kindeva Drug Delivery’s dose counters under license for Chiesi Group for their pressurized metered-dose inhaler (pMDI) portfolio.
This partnership is a continuation of the agreement signed in 2014 between Kindeva Drug Delivery and H&T Presspart to accelerate the growth of Kindeva Drug Delivery’s dose counter technology. This technology enhances patient safety by providing real-time information on the remaining doses in inhalers, preventing unexpected shortages. H&T Presspart will expand the cleanroom facilities at their Marsberg, Germany, site to support the dose counter production. As part of this strategic partnership, Chiesi Group will use dose counters in their innovative carbon minimal pMDI portfolio, which uses a low Global Warming Potential (GWP) propellant to minimize the climate impact of the inhalers, while maintaining all the therapeutic options that patients suffering from respiratory diseases need.
David Stevens, global chief commercial officer of Kindeva Drug Delivery, stated: “Kindeva is pleased to extend this strategic partnership as it solidifies our core objective of improving the lives of patients around the world. Kindeva embraces the responsibility it has in ensuring that patients who depend upon our device technology are reliably supplied, and we believe that this innovative supply chain collaboration further underscores this commitment.”
Roberto Della Valle, head of global direct procurement of Chiesi Group, added: “Chiesi, with its patient-centric approach, is dedicated to delivering therapeutic solutions that enhance patients’ health and quality of life. Collaborating with Kindeva and H&T Presspart exemplifies this commitment, and we are thrilled to take this step forward. By providing an inhaler that reassures patients about the remaining dose count, we aim to enhance their safety and confidence.”
Christian Kraetzig, president of H&T Presspart, commented: “With our expertise in device industrialization and manufacturing, this agreement marks another step in our journey to becoming a leading development and contract manufacturing partner in drug delivery devices.”
About Kindeva Drug Delivery
Kindeva Drug Delivery is a global contract development manufacturing organization focused on drug-device combination products. Kindeva Drug Delivery develops and manufactures products across a broad range of complex drug-delivery formats, including injectables (autoinjector, intradermal, microneedle), pulmonary & nasal, and transdermal patches. Its service offering spans early-stage feasibility through commercial scale drug product fill-finish, container closure system manufacturing, and drug-device product assembly. Kindeva Drug Delivery serves a global client base from its nine manufacturing and research and development facilities located in the U.S. and U.K.
About Chiesi Group
Chiesi is an international, research-focused biopharmaceuticals group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company’s mission is to improve people’s quality of life and act responsibly towards both the community and the environment. By changing its legal status to a Benefit Corporation in Italy, the US, and France, Chiesi’s commitment to create shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, we’re part of a global community of businesses that meet high standards of social and environmental impact. The company aims to reach Net-Zero greenhouse gases (GHG) emissions by 2035. With over 85 years of experience, Chiesi is headquartered in Parma (Italy), operates in 31 countries, and counts more than 6,500 employees.
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