Curtana Pharmaceuticals, Inc.

Few CDMOs have been quite as active as Catalent in the last 18 months, as the company has announced mergers, acquisitions and expansions almost weekly. The company’s next big move is a bit different, as it announced a dive into gummy vitamins on Monday. The New Jersey-based company will buy Bettera Holdings and its four US manufacturing sites for $1 billion, the company said Monday. Bettera specializes in supplements, and is backed by Highlander Partners, a private equity firm. The company is based in Plano, TX and makes gummy, soft-chew and lozenge vitamins. The deal allows Catalent to expand its softgel manufacturing as the market grows. Catalent will pay for the deal through a combination of cash, credit and debt financing, according to a statement. Aris Gennadios “This acquisition is a key strategic move for Catalent’s Consumer Health business, where our leadership in manufacturing technologies and formulation can offer customers more product development opportunities and add manufacturing capacity in this dynamic and fast-growing segment,” Catalent’s Aris Gennadios said in prepared remarks. Gennadios is the company’s president of softgel and oral technologies. The company has about 500 employees, and its 2020 sales totaled around $150 million, according to The Wall Street Journal. Those sales are predicted to grow another 20% this year. That prediction comes after Allied Market Research published a report stating that gummy vitamins are going through a surge in popularity, due to the smoother texture and difficulty many experience swallowing pills. A January WSJ story drew an obvious line: a generation of children who had taken gummy vitamins had grown up. That, coupled with the colors and flavors, offers appeal to Gen Z. In 2018, that market was valued around $5.7 billion. It’s projected to be worth more than $9 billion by 2026. “Introduction of gelatin free, probiotic enriched, and non GMO gummy vitamins is anticipated to create lucrative opportunities for the market expansion in the upcoming future,” the report published in March 2020 says. Bettera was created with the goal of creating a more “enjoyable and convenient” form of nutritional supplements, Highlander Partners CEO Jeff Hull said in a press release. Jeff Hull “Catalent has long had a similar vision, combined with specialized expertise, a history of successful innovation, a wide range of offerings, and the resources to help Bettera continue to grow and meet customer and consumer needs,” he said. “Together, Catalent Consumer Health and Bettera are well positioned to continue Bettera’s mission of serving consumers and participating in the long-term growth of the self-care market.” Bettera’s four manufacturing sites are in Indiana, California, Chantilly, Virginia and New Jersey. In August, Catalent announced it would collaborate with DisperSol to manufacture oncology drugs. Before that Catalent acquired German cell and gene therapy specialist RheinCell Therapeutics, and inked contracts with Denver cannabidiols company JOS Pharmaceuticals and Austin, TX-area preclinical company Curtana Pharmaceuticals, for which it will make CT-170 — a drug therapy for glioblastoma, medulloblastoma and other brain cancers. All of this happened in a little over a month. It also will upgrade its new facility in Anagni, Italy with two new 2,000-liter single-use bioreactors with manufacturing suites.

CDMO Catalent has kept busy with mergers and acquisitions, but Monday, it announced a collaboration with DisperSol to accelerate the manufacturing of the company’s oncology drugs. Catalent will install a commercial-scale KinetiSol line at the oral solids development and manufacturing facility in Somerset, NJ. The platform works to turn molecules with clinical promise into viable medicines, and the KinetiSol technology will be used for all of DisperSol’s pipeline products. That includes a Phase III trial for iron overload disorder and a Phase II trial against prostate cancer. DisperSol will tech transfer its equipment, software and IP to New Jersey, and Catalent will provide the staff needed, including quality control and assurance. “This strategic collaboration with Catalent is integral to our company as we now move into late clinical-stage development and commercial-scale manufacturing of our products,” DisperSol CEO Edward Rudnic said in a press release. “The commercial amorphous solid dispersion manufacturing expertise of Catalent’s team and their globally accredited quality systems make them a perfect partner for DisperSol.” DisperSol’s active programs also include a Phase II trial for DST-8294, which is being studied to treat clotting disorders. The company also has DST-0058 for idiopathic pulmonary fibrosis and DST-5407 for non-squamous non-small cell lung cancer in its pipeline. In a little more than a month, Catalent has acquired a German cell and gene therapy specialist RheinCell Therapeutics, and inked contracts with Denver cannabidiols company JOS Pharmaceuticals, and another Austin, TX-area preclinical company Curtana Pharmaceuticals. With Curtana, the company will make CT-179, a drug therapy for glioblastoma, medulloblastoma and other brain cancers. The company also announced an upgrade to its sleek new facility in Anagni, Italy, the second in the last six months. Two new 2,000 liter single-use bioreactors with new manufacturing suites will support early-phase clinical development and late-stage commercial transfers The project is expected to add 100 new employees, and it should be operational in April 2023. Cytiva drops massive manufacturing investment in home state A Massachusetts-based life sciences company will invest $1.5 billion over the next two years to meet a growing demand for biotech manufacturing. Cytiva, which has headquarters in Marlborough, has already broken ground on a project that includes $600 million for chromatography resins, $400 million for cell culture media, $300 million toward single-use technologies, the Worcester Business Journal reports. In 2020, the company invested $500 million in nearby Shrewsbury, MA and Westborough, MA. Bristol Myers sale of Swiss site to WuXi is complete Bristol Myers Squibb is working on re-evaluating its manufacturing portfolio, and it’s just completed one of its big-name deals of the year. In February, WuXi AppTech’s subsidiary company WuXi STA announced that it planned to acquire the Bristol Myers site in Couvet, Switzerland. That deal was finalized on Tuesday, the drugmaker announced in a press release. It’s not a full departure of Bristol Myers from Switzerland, however. The drugmaker says the country remains an “important strategic location for the company” and says it will keep a presence there, despite no longer having any physical space in the country. The site, based in Neuchâtel, specializes in capsule and tablet dosage.

AUSTIN, TX – July 15, 2021 – Curtana Pharmaceuticals, a privately-held, preclinical stage biopharmaceutical company, today announced that it has signed an agreement with Catalent to support tablet formulation and manufacturing of Curtana’s CT-179, a drug therapy for the treatment of glioblastoma (GBM), medulloblastoma (MB), and other brain cancers. CT-179 is a highly potent and selective small molecule inhibitor of OLIG2, a transcription factor that is essential to normal early brain development but is not actively expressed in most normal adult brain cells or in normal tissues outside the brain. However, it is expressed in all diffuse gliomas and it has been shown that OLIG2 drives tumor initiation, tumor growth, invasion into healthy brain tissue, and resistance to chemotherapy and radiation therapy. Studies to-date have demonstrated the viability of CT-179 to markedly prolong survival in numerous, relevant animal models of GBM, MB and other brain cancers. The drug is orally bioavailable, readily crosses the blood-brain barrier, and achieves high concentrations in the brain. “This is a significant milestone for the company as we move into clinical trials, which are anticipated to commence in the first half of 2022,” said Gregory Stein, M.D., M.B.A. and Chief Executive Officer, Curtana Pharmaceuticals. “GBM is a devastating disease with a poor prognosis and a variety of therapeutic challenges. We are excited to bring this easy-to-use oral therapy with the potential to improve quality of life and prolong survival of patients with GBM and other devastating brain cancers.” Formulation development and CGMP manufacturing of the clinical trial product will take place at Catalent’s 98,000 square-foot facility in San Diego, CA. This facility offers an array of services that support oral and injectable dosage forms that include preformulation testing, formulation and analytical development, CGMP manufacturing, clinical packaging, labeling, and worldwide distribution. “Catalent is proud to partner with Curtana in the pursuit of a treatment for brain cancer,” said Bryan Knox, General Manager of Catalent San Diego. “The Catalent team in San Diego is focused on early-stage development of small molecule and peptide drug candidates, from the bench to the clinic, and our expertise in oral delivery makes us an ideal partner for Curtana on the further development of CT-179.” About CT-179 FDA Orphan Drug designation for the treatment of malignant gliomas, including glioblastoma (GBM), was granted to CT-179 in August 2017. FDA Rare Pediatric Disease Designation for the treatment of medulloblastoma was granted to CT-179 in September 2020. The drug is orally bioavailable, readily crosses the blood-brain barrier, achieves very high concentrations in the brain, and significantly prolongs survival in animal models of brain cancer. CT-179 represents a novel agent which selectively targets OLIG2-expressing brain cancer cells in preclinical studies with great potential as an adjunctive therapy in the treatment of GBM, MB, and other brain cancers. An investigational new drug (IND) application filing is planned for the first half of 2022. About Curtana Pharmaceuticals Curtana Pharmaceuticals, founded in 2013, is a privately held, preclinical-stage biopharmaceutical company headquartered in Austin, Texas. Current investors include Thynk Capital, angelMD, Biosense Global, DEFTA Partners, and other anonymous investors. In 2014, the company was awarded a $7.6 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT). Curtana focuses on the development of novel first-in-class, small molecule therapeutics targeting cancer stem cells in the central nervous system for the treatment of glioblastoma, medulloblastoma, and other brain cancers. For more information, visit . Contact Information Gregory Stein, M.D., M.B.A. Chief Executive Officer gregory.stein@curtanapharma.com