Element Materials Technology | January 15, 2022
Element Materials Technology (Element) completed its sixth life sciences-focused acquisition of 2021, with the formal completion of the acquisition of JMI Laboratories. Element has now built out its expertise and capability for pharmaceutical and biopharmaceutical customers, expanding to a team of more than 1,000 experts in 23 facilities across North America and Europe.
This significant step change in pharmaceutical and medical testing capabilities from Element forms part of its broader strategic shift to increase its global presence in Life Sciences and Connected Technologies.
“Our expansion into life sciences and connected technologies over the last two years has seen us gain a leadership position in these strategically important end-markets. As we celebrate 10 years of being a standalone Element business, we see more and more opportunities to work closely with our customers throughout their product and testing lifecycles.”
Jo Wetz, Element CEO
Cherie Gudz, Vice President, Life Sciences Americas, said: “In a world still dealing with a pandemic, the life sciences sector has never been more vital. The six acquisitions this past year alone cements Element’s commitment to continue to build a scale business in this vital sector, which now forms our largest global end-market. We are thrilled to have JMI’s team and expertise join the Element family”.
Based in North Liberty, Iowa, JMI is a market leader in antimicrobial resistance monitoring studies utilized for US-FDA regulatory and new drug application submissions, through their proprietary SENTRY Antimicrobial Surveillance Program. It offers microbiology and molecular testing services to assist in the development of new antimicrobials and clinical trial support. The Company is CLIA accredited and able to test under GLP conditions. The business is notable for its team of highly scientific and well-published industry recognized experts in the field, including 10 MD/PhDs with extensive knowledge of microbiology and antimicrobials, and can consult on a broad range of scientific topics covering epidemiology, mechanisms of resistance in bacterial and fungal organisms, microbiology diagnostics and susceptibility testing methods.
Aprecia Pharmaceuticals | October 21, 2021
Kyle Smith has been named President and Chief Operating Officer of Aprecia Pharmaceuticals, LLC, effective immediately. Mr. Smith is a 10-year veteran with Aprecia and has served as Vice President of Operations for the past 3 years. As President and Chief Operating Officer, Mr. Smith will be responsible for leading day-to-day business activities.
Aprecia has further strengthened its leadership team by promoting Patrick Staudt to Vice President of Operations, effective immediately. A 14-year veteran of Aprecia, Mr. Staudt has led the East Windsor, NJ manufacturing operations for more than 10 years and has demonstrated the talent and experience to lead expected, expansive growth through multiple technology platforms.
Mr. Smith and Mr. Staudt have been cornerstones of Aprecia's history of technology and manufacturing innovation. They have been key contributors in establishing the company as the leader in the development and manufacturing of pharmaceutical products through 3D-Printing. Their experiences with Aprecia have helped craft the company culture and 3DP pharmaceutical manufacturing innovation, and their contributions have created a momentum which continues to accelerate through important partnerships and novel products.
"As Aprecia's technology platforms expand and industry partnerships advance, Aprecia requires additional talent and resources to meet these growing demands, We are fortunate to have these seasoned technology experts and corporate leaders to promote and guide the organizational growth well into the future."
Chris Gilmore, Aprecia's Chief Executive Officer
Mr. Kyle Smith holds a Master of Business Administration degree from Miami University, and a Bachelor of Science in Chemical Engineering from Georgia Institute of Technology.
Mr. Patrick Staudt holds a Bachelor of Science degree in Biomedical/Medical Engineering from Drexel University.
Founded in 2004, Aprecia received the first and only FDA approved three-dimensionally-printed (3DP) pharmaceutical product approval in 2015. Aprecia uses its ZipDose® Technology to create rapidly disintegrating oral dosage forms that are easy to take and easy to administer. Without compression during the 3DP manufacturing process, engineered and coated particles such as taste masking and modified release are possible on large dose products (over a 1000mg). Aprecia directly owns a patent estate for novel 3DP machines and pharmaceutical 3DP applications. It licenses its exclusive technology platform to pharmaceutical partners as a means to extend product lines, improve patient reach and experience, and address FDA requirements as a pediatric delivery form.
Ipsen | January 24, 2022
Ipsen announced the Health Canada approval of Sohonos, an oral selective retinoic-acid receptor gamma agonist indicated to reduce the formation of heterotopic ossification in adults and children aged 8 years and above for females and 10 years and above for males with fibrodysplasia ossificans progressiva.1 Sohonos is approved for the treatment of patients with FOP for both chronic use, and for flare-ups, in these patient populations. This decision marks the first approval for Sohonos worldwide.
“FOP is a progressive and debilitating condition which has such a profound impact on patients, and their families. Until today, there was no approved medicine, and we are proud to bring this important new medicine to the FOP community.”
Dr. Howard Mayer, Executive Vice President and Head of Research and Development, Ipsen
FOP is characterized by new bone formation outside of the normal skeletal system, like in soft connective tissues, a process known as heterotopic ossification,2 which can be preceded by painful soft tissue swelling or “flare-ups.”2 Flare-up episodes are common and are a substantial contributor to the formation of new bone, however bone can also form in the absence of a flare-up. Once formed, it is irreversible and leads to loss of mobility and shortened life expectancy.2 It is an ultra-rare genetic disorder with an estimated prevalence of 1.36 per million individuals; however, the number of confirmed cases varies by country.3,4.
As part of the ongoing commitment to the FOP and rare disease community, Ipsen plans to file in the US in H1 2022 and is in discussions with other regulatory authorities around the world.
About the MOVE clinical program
This approval is based on data from the ongoing MOVE trial, the first global multi-center Phase III trial in FOP. MOVE is an open-label, single-arm trial, evaluating the efficacy and safety of a chronic/flare-up dosing regimen of palovarotene in decreasing new annualized HO volume in patients with FOP.
Sohonos is an oral, selective RARγ agonist developed as a treatment for people living with the debilitating ultra-rare genetic disorder, FOP. The treatment was acquired by Ipsen through the acquisition of Clementia Pharmaceuticals in April 2019. It is a member of the retinoid class of drugs that is associated with birth defects in humans. Sohonos must not be used by patients who are, or intend to become, pregnant due to the risk of teratogenicity. To minimize fetal exposure, Sohonos is to be administered only if all conditions for pregnancy prevention are met. Sohonos has been shown to cause premature physeal closure in growing children with FOP; periodic monitoring is recommended.
Ipsen is a global, mid-sized biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease and Neuroscience; it also has a well-established Consumer Healthcare business. With total sales of over €2.5bn in FY 2020, Ipsen sells more than 20 medicines in over 115 countries, with a direct commercial presence in more than 30 countries. The Company’s research and development efforts are focused on its innovative and differentiated technological platforms located in the heart of leading biotechnological and life-science hubs: Paris-Saclay, France; Oxford, U.K.; Cambridge, U.S.; Shanghai, China. Ipsen has around 5,700 colleagues worldwide and is listed in Paris and in the U.S. through a Sponsored Level I American Depositary Receipt program.