On May 6, 2021 Epizyme (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, reported first quarter 2021 financial results (Press release, Epizyme, MAY 6, 2021, View Source [SID1234579373]).

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"Adoption of TAZVERIK has steadily increased as we continue to navigate the unique launch environment presented by COVID-19. We saw month-over-month commercial demand growth, with March 2021 representing our most successful month since launch and we look to build on this momentum as the pandemic-associated challenges begin to ease," said Robert Bazemore, President and Chief Executive Officer of Epizyme. "TAZVERIK net revenues in the first quarter of 2021 increased by 37% from the fourth quarter of 2020, driven primarily by increased adoption in follicular lymphoma. The environment we operated in during the first quarter was not substantially different from the end of last year, however we are beginning to see some encouraging signs that things are slowly beginning to return to normal as vaccine adoption progresses.

"In early March, we hosted a strategic vision call to outline the pipeline-in-a-drug potential we see in TAZVERIK and plans to expand our portfolio starting with the anticipated IND submission for our novel SETD2 inhibitor in mid-2021. We plan to share additional pre-clinical data supporting the advancement of our SETD2 program at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress 2021. During the Vision Call we also shared encouraging preliminary safety and activity data from ongoing combination trials in follicular lymphoma and prostate cancer and look forward to providing a steady stream of data updates from these and our many other planned and ongoing trials over the next few years."

Recent Progress

Commercial Execution: TAZVERIK generated net product revenue in Epithelioid Sarcoma (ES) and Follicular Lymphoma (FL) of $6.2 million in the first quarter of 2021, with March 2021 representing our highest level of commercial demand since launch. Commercial bottle demand growth was 31% in the first quarter compared to the fourth quarter of 2020, while total revenue grew by 37%. New prescribing accounts increased 38% in the first quarter of 2021 compared to the fourth quarter of 2020, including broader adoption among community practice. This is despite the continued negative impact COVID-19 had on patient visits to physicians and new patient starts across all lines of treatment as well as the ability of our field-based teams to fully access physicians treating ES and FL patients.
EZH-302 Phase 1b/3 Confirmatory Study of TAZVERIK in Follicular Lymphoma: The combination of TAZVERIK with R2 (Lenalidomide and Rituximab) is being evaluated in a Phase 1b/3 confirmatory study in relapsed / refractory FL patients. Preliminary safety and activity data of 13 patients from the 400 mg, 600 mg and 800 mg cohorts of the Phase 1b safety run-in were presented during Epizyme’s Vision Call in March showing encouraging initial treatment responses in each dose group, and adverse events that were in line with expectations based on the respective safety profiles of the individual agents. Epizyme plans to submit an update to this safety run-in for presentation at the 2021 ASH (Free ASH Whitepaper) Annual Meeting later this year.

Based on recent discussions with the U.S. Food and Drug Administration (FDA), Epizyme has aligned on an important change to the Phase 3 protocol whereby the second interim analysis will include an efficacy evaluation once 65% of progression free survival (PFS) events have occurred. This allows access to efficacy data earlier than previously expected and may provide an opportunity to stop the study early should the predefined treatment effect be realized. Based on these discussions with FDA, Epizyme has also expanded the Phase 1b portion of the study to include a minimum of 15 patients in the cohorts of 600 mg BID and 800 mg BID to help inform selection of the Phase 3 dose. Enrollment is nearly complete in these two cohorts and patients are being evaluated for follow-up of three months before initiating the Phase 3 randomization portion of the trial.
Additional Ongoing Clinical Trials of Tazemetostat in Follicular Lymphoma: EZH-1401, the Company’s Phase 2 trial evaluating TAZVERIK plus Rituxan in relapsed / refractory FL continues to move forward as planned and is actively enrolling. Patient enrollment also continues in the Lymphoma Study Association (LYSA) trial in front-line FL and Diffuse Large B-cell Lymphoma (DLBCL), as well as other investigator sponsored trials.
EZH-1101 Phase 1b/2 Study of Tazemetostat in Prostate Cancer: The combination of tazemetostat with standard-of-care treatments, enzalutamide or abiraterone, was evaluated in the Phase 1b safety run-in portion of the EZH-1101 trial which enrolled a total of 21 men with metastatic prostate cancer. The Phase 1b protocol allowed patients to enroll who had previously failed enzalutamide, abiraterone, first generation anti-androgen receptor therapies or short course chemotherapy. In the study, patients received either abiraterone plus tazemetostat plus prednisone or enzalutamide plus tazemetostat. Based on encouraging preliminary safety and activity data, particularly in the enzalutamide plus tazemetostat group, Epizyme has initiated enrollment in the Phase 2 efficacy portion of this study which will evaluate enzalutamide plus tazemetostat compared to enzalutamide alone. Epizyme plans to submit an update to the Phase 1b safety run-in for presentation at a medical congress later this year.
EZH-301 Confirmatory Phase 1b/3 Study of TAZVERIK in Epithelioid Sarcoma: The combination of TAZVERIK with doxorubicin compared with doxorubicin plus placebo is being evaluated in a Phase 1b/3 confirmatory study as a front-line treatment for ES patients. We have completed the planned enrollment in the Phase 1b safety run-in portion of the trial and the Phase 3 efficacy expansion portion of the trial remains on track for initiation. Preliminary data from the Phase 1b portion of this study has been accepted as a poster presentation at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting in June.
Tazemetostat Basket Trials in Additional Hematologic Malignancies and Solid Tumors: Epizyme plans to initiate two signal finding basket studies to evaluate tazemetostat safety and efficacy across multiple new types of hematologic malignancies and solid tumors. With this approach, the Company plans to study multiple combinations with standard-of-care therapies and novel mechanisms of action to expand the potential of tazemetostat. Epizyme plans to initiate both basket studies in the second half of 2021.
Planned IND Submission for Epizyme’s Novel SETD2 Inhibitor: Based on the potential of SETD2 inhibition in multiple settings, including high risk t(4;14) multiple myeloma and in other B-cell malignancies such as large-cell lymphoma, as monotherapy and in combination with existing and emerging therapies including tazemetostat, Epizyme is planning to submit an Investigational New Drug (IND) application with the FDA in mid-2021 and expects to initiate a first-in-human clinical trial this year.
First Quarter 2021 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $298.9 million as of March 31, 2021, as compared to $373.6 million as of December 31, 2020.
Revenue: Total revenue for the first quarter of 2021 was $7.6 million, compared to $1.4 million for the first quarter of 2020. Total revenue for the first quarter of 2021 comprised of $6.2 million in net sales of TAZVERIK in the U.S. and $1.4 million in collaboration and other revenue.
Operating Expenses: Total GAAP operating expenses were $72.0 million for the first quarter of 2021 compared to $52.7 million for the first quarter of 2020. Total non-GAAP adjusted operating expenses were $63.7 million for the first quarter of 2021 compared to $45.7 million for the first quarter of 2020.
Cost of revenue: GAAP cost of revenue, which reflects the costs of TAZVERIK units sold, amortization of intangible assets, third-party royalties on net product revenue and costs of tazemetostat API and drug product sold to the Company’s licensees or collaborators, was $2.9 million for the first quarter of 2021 compared to $0.6 million in the first quarter of 2020. Non-GAAP adjusted cost of revenue was $1.8 million for the first quarter of 2021 compared to $0.3 million for the first quarter of 2020.
R&D expenses: GAAP R&D expenses were $32.7 million for the first quarter of 2021 compared to $25.2 million for the first quarter of 2020. Non-GAAP adjusted R&D expenses were $30.3 million for the first quarter of 2021 compared to $22.9 million for the first quarter of 2020.
SG&A expenses: GAAP SG&A expenses were $36.4 million for the first quarter of 2021 compared to $27.0 million for the first quarter of 2020. Non-GAAP adjusted SG&A expenses were $31.5 million for the first quarter of 2021 compared to $22.5 million for the first quarter of 2020.
Net Loss (GAAP): Net loss attributable to common stockholders was $70.3 million, or $0.69 per share, for the first quarter of 2021, compared to $50.9 million, or $0.51 per share, for the first quarter of 2020.
2021 Financial Guidance

Based on its current operating plans, Epizyme expects its current cash runway to extend into 2023. Additionally, the Company expects its non-GAAP adjusted operating expenses for 2021 to be between $235 and $255 million.
A reconciliation of non-GAAP adjusted financial measures directly comparable to GAAP financial measures is presented in the table attached to this press release.
Conference Call Information

Epizyme will host a conference call today, May 6, at 7:30 a.m. ET. To participate in the conference call, please dial (877) 844-6886 (domestic) or (970) 315-0315 (international) and refer to conference ID 4139845. A webcast, as well as supplemental slides to support the webcast, will be available in the investor section of the Company’s website at www.epizyme.com, and will be archived for 60 days following the call.

About Non-GAAP Financial Measures

In addition to financial information prepared in accordance with the U.S. generally accepted accounting principles (GAAP), this press release includes the following non-GAAP financial measures: total non-GAAP adjusted operating expenses on a historical and projected basis, non-GAAP adjusted R&D expenses on a historical basis and non-GAAP adjusted SG&A expenses on a historical basis. Epizyme derives these non-GAAP financial measures by excluding certain expenses and other items from the respective GAAP financial measure, that is most directly comparable to each non-GAAP financial measure. Specifically, the non-GAAP financial measures exclude stock-based compensation expense and depreciation and amortization of intangibles. The company’s management believes that these non-GAAP financial measures are useful to both management and investors in analyzing its ongoing business and operating performance. Management does not intend the presentation of these non-GAAP financial measures to be considered in isolation or as a substitute for results prepared in accordance with GAAP, but as a complement to provide greater transparency. In addition, these non-GAAP financial measures may differ from similarly named measures used by other companies. A quantitative reconciliation of projected non-GAAP adjusted operating expenses to total operating expenses is not available without unreasonable effort primarily due to the company’s inability to predict with reasonable certainty the amount of future stock-based compensation expense.

About TAZVERIK (tazemetostat)

TAZVERIK is a methyltransferase inhibitor indicated for the treatment of:

Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies.
Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.
These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

The most common (≥20%) adverse reactions in patients with epithelioid sarcoma are pain, fatigue, nausea, decreased appetite, vomiting and constipation. The most common (≥20%) adverse reactions in patients with follicular lymphoma are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.

On May 6, 2021 CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported that it will host a conference call and live audio webcast on Thursday, May 13, 2021 at 4:30 p.m. Eastern Time to discuss financial results for the first quarter ended March 31, 2021 and to provide a business update (Press release, CymaBay Therapeutics, MAY 6, 2021, View Source [SID1234579389]).

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Conference Call Details
To access the live conference call, please dial 877-407-0784 from the U.S. and Canada, or 201-689-8560 internationally, Conference ID# 13718350. To access the live and subsequently archived webcast of the conference call, go to the Investors section of the company’s website at View Source

On May 6, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported that it has been selected as the winner of the "Best New Technology Solution for Oncology" award in the fifth annual MedTech Breakthrough Awards program (Press release, Castle Biosciences, MAY 6, 2021, View Source [SID1234579407]). The award recognizes Castle’s DecisionDx-SCC and DecisionDx DiffDx-Melanoma genomic tests, both newly launched in the second half of 2020.

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Castle Biosciences develops and commercializes diagnostic and prognostic tests for dermatologic cancers. The Company’s tests are designed to provide clinically actionable, tumor-specific genomic information to enable more accurate skin cancer treatment plan decisions. Castle believes that the traditional approach to developing a treatment plan for dermatologic cancers using clinical and pathology factors alone can be improved by incorporating personalized genomic information.

In 2020, Castle launched two new genomic tests designed to improve the management of skin cancer, DecisionDx-SCC and DecisionDx DiffDx-Melanoma. DecisionDx-SCC is the Company’s proprietary gene expression profile (GEP) test that is designed to predict the risk of metastasis for patients with cutaneous squamous cell carcinoma who have one or more risk factors. DecisionDx DiffDx-Melanoma is designed to provide a highly accurate, objective result to aid dermatopathologists and dermatologists in characterizing suspicious pigmented lesions. Castle believes these two recently launched tests complement Castle’s GEP test for invasive cutaneous melanoma, DecisionDx-Melanoma, which is a proprietary GEP test that uses an individual patient’s tumor biology to predict risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity independent of traditional staging factors.

The mission of the MedTech Breakthrough Awards is to honor excellence and recognize the innovation, hard work and success in a range of health and medical technology categories, including Robotics, Clinical Administration, Telehealth, Patient Engagement, Electronic Health Records (EHR), mHealth, Medical Devices, Medical Data and many more. This year’s program attracted more than 3,850 nominations from over 17 different countries throughout the world.

"Skin cancers continue to be the most commonly diagnosed cancers, with around 5.5 million new cases diagnosed annually in the U.S., and Castle is addressing this challenge head-on," said James Johnson, managing director, MedTech Breakthrough. "When individualized genomic information is incorporated with traditional clinical and pathology factors used to assess risk, physicians and patients can make more informed treatment decisions, in line with each patient’s risk. Castle is driving innovation in this space, and we are thrilled to recognize Castle in our 2021 MedTech Breakthrough Awards program."

"The approach that physicians traditionally use to determine risk–reviewing clinical and pathological factors like patient history and pathology lab results— is necessary and lifesaving. But adding personalized, precise genomic information to predict the likelihood of any individual’s skin cancer’s future spread or return, or for aiding clinicians with difficult-to-diagnose potential melanoma cases, has the potential to improve patient care," said Derek Maetzold, president and chief executive officer at Castle Biosciences. "We developed DecisionDx-SCC and DecisionDx DiffDx-Melanoma to answer this significant unmet medical need in skin cancer management, and we are thrilled to receive this 2021 MedTech Breakthrough Award in recognition of our innovation in this breakthrough approach and technology to support it."

On May 6, 2021 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, reported financial results for the quarter ended March 31, 2021 and provided recent business highlights (Press release, Aldeyra Therapeutics, MAY 6, 2021, View Source [SID1234579428]).

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"We expect 2021 to be a catalyst-rich year for Aldeyra as we continue to advance reproxalap, our lead program, toward potential commercialization in anterior ocular inflammatory disease," stated President and CEO Todd C. Brady, M.D., Ph.D. "We recently completed the Phase 3 INVIGORATE Trial of reproxalap, achieving statistically significant superiority over vehicle across all assessed signs and symptoms of allergic conjunctivitis, including ocular itching and redness. We look forward to meeting with the U.S. Food and Drug Administration in the second half of this year to discuss the INVIGORATE results and the potential submission of a New Drug Application (NDA). In addition, we remain on track to report top-line results in the second half of this year from the Phase 3 TRANQUILITY and TRANQUILITY-2 clinical trials of reproxalap in dry eye disease.

"We believe we continue to operate from a position of financial strength," Dr. Brady stated. "With the recent follow-on public offering, we expect to have sufficient capital to prepare reproxalap for NDA submission and a potential commercial launch, if approved, while investing in the clinical development of ADX-629, ADX-2191, and other product candidates in retinal and systemic immunological diseases with unmet medical need."

Recent Highlights and Program Updates

Primary, Key Secondary, and All Secondary Endpoints Met in Phase 3 INVIGORATE Allergic Conjunctivitis Clinical Trial: In the first-ever Phase 3 clinical trial of a novel investigational product in an allergen chamber, 0.25% reproxalap ophthalmic solution (reproxalap) demonstrated statistically significant improvement over vehicle for the primary endpoint of ocular itching (p<0.0001), the key secondary endpoint of ocular redness (p<0.0001), and the secondary endpoints of ocular tearing and total ocular severity score (each p<0.0001). The results of INVIGORATE, the second positive Phase 3 trial for reproxalap in allergic conjunctivitis, indicate potential clinical utility before and during exposure to moderate to high levels of pollen.
Phase 3 TRANQUILITY and TRANQUILITY-2 Dry Eye Disease Trial Results Expected in Second Half of 2021: Patient enrollment has begun in the dry eye chamber Phase 3 TRANQUILITY Trial of reproxalap. The primary endpoint of the trial is ocular redness, which was statistically lower (p=0.03) for reproxalap relative to vehicle in the TRANQUILITY run-in cohort results announced in January 2021. Tear RASP (reactive aldehyde species) levels will also be assessed. Approximately 150 dry eye disease patients are expected to be enrolled per arm. Reproxalap will be administered four times the day prior to entry into the dry eye chamber, just before entry into the chamber, and 45 minutes after chamber entry. Enrollment in TRANQUILITY is ongoing, and enrollment in the confirmatory TRANQUILITY-2 Trial is expected to begin in the second quarter of 2021. Aldeyra plans to report top-line results from both trials in the second half of this year.
Phase 2 Clinical Trial Results from ADX-629, an Orally Available RASP Inhibitor, Expected Second Half of 2021: Initial Phase 2 clinical results from ADX-629, a novel orally available RASP inhibitor currently undergoing testing in asthma, psoriasis, and COVID-19, are expected in the second half of 2021. ADX-629 represents a first-in-class systems-based therapeutic approach for an orally administered RASP inhibitor, the potential applicability of which could extend to a myriad of immune-mediated diseases that today are treated with single-target drugs that can lead to serious toxicity.
Public Offering Completed: Aldeyra sold 10,000,000 shares of its common stock at a public offering price of $12.50 per share in an underwritten public offering. The offering generated gross proceeds of $125.0 million and net proceeds of $117.3 million after deducting underwriting discounts, commissions, and estimated offering expenses.
First-Quarter 2021 Financial Summary

Cash and cash equivalents as of March 31, 2021 were $138.4 million. Based on Aldeyra’s current operating plan, the company believes that existing cash and cash equivalents, as of March 31, 2021, together with the net proceeds from the sale of common stock in the underwritten public offering in May 2021, will be sufficient to fund currently projected operating expenses through the end of 2023, including potential NDA submission for reproxalap; initial commercialization of reproxalap, if approved; and continued early and late-stage development of the company’s product candidates in ocular and systemic immune-mediated diseases.

For the quarter ended March 31, 2021, Aldeyra reported a net loss of $11.3 million, compared with a net loss of $9.9 million for the quarter ended March 31, 2020. Net loss per share was $0.25 for the quarter ended March 31, 2021, compared with $0.34 for the same period in 2020. Losses have resulted from the costs of Aldeyra’s clinical trials and research and development programs, as well as from general and administrative expenses.

Research and development (R&D) expenses were $7.7 million for the quarter ended March 31, 2021, compared with $6.6 million for the same period in 2020. The increase of $1.1 million is primarily related to clinical development and manufacturing costs, partially offset by lower personnel related costs and a decrease in preclinical costs.

General and administrative expenses were $3.1 million for the quarter ended March 31, 2021, compared with $3.0 million for the quarter ended March 31, 2020.

For the quarter ended March 31, 2021, total operating expenses were $10.8 million, compared with total operating expenses of $9.6 million for the same period in 2020.

Conference Call & Webcast Information

Aldeyra will host a conference call at 8:00 a.m. ET today to discuss its first-quarter 2021 financial results and recent highlights. The dial-in numbers are (866) 211-4098 for domestic callers and (647) 689-6613 for international callers. The Conference ID number is 6779202. Due to the expected high demand on our conference call provider, please plan to dial in to the call at least 15 minutes prior to the start time.

A live webcast of the conference call will also be available on the Investor Relations page of the company’s website at View Source After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.

On May 6, 2021 Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, and Promethera Biosciences, the leader in advanced therapy development for severe liver diseases, reported that Catalent has acquired Promethera’s cell therapy manufacturing subsidiary, Hepatic Cell Therapy Support SA (HCTS), including its 32,400 square-foot (3,010 square-meter) facility in Gosselies, Belgium (Press release, Catalent, MAY 6, 2021, https://www.catalent.com/catalent-news/catalent-acquires-additional-facility-at-its-gosselies-belgium-campus-for-commercial-scale-plasmid-dna-manufacturing/ [SID1234579491]). The facility will accommodate Catalent’s new commercial-scale plasmid DNA (pDNA) manufacturing and will provide the opportunity for the immediate growth of Catalent’s pDNA service offering, which was recently acquired from Delphi Genetics to support the growing cell and gene therapy pipeline.

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The HCTS facility houses an existing cleanroom infrastructure, process development and quality control laboratories as well as warehouse space, and will be equipped to provide pDNA manufacturing up to a 500-liter scale. This new facility is located on Catalent’s existing campus in Gosselies, adjacent to the Delphi Genetics building. Since the purchase of MaSTherCell in March of 2020, this acquisition is the third that Catalent has made at its Gosselies location, and further expands its cell and gene therapy European Center of Excellence.

Fitting out the facility is expected to begin immediately, and will create more than 200 technical, scientific, and operational new employment positions over the next five years.

Alongside this new expansion in Gosselies, Catalent will also offer commercial-scale pDNA production capabilities at its Rockville, Maryland, facility with the addition of 500-liter scale bioreactor capacity.

"Plasmid DNA manufacturing is a critical component to many biological therapeutics, including viral vectors, mRNA, and cellular therapies. This investment allows Catalent to support these programs from development through to CGMP commercial production, offering the full horizontal supply chain," said Manja Boerman, Ph.D., President, Catalent Cell & Gene Therapy. She added, "The Center of Excellence we have established in Belgium brings critical experience and expertise together on one campus, allowing for key synergies to best support our customers."

"Promethera is thrilled to divest its HCTS facility to Catalent, alongside its new strategy to concentrate activities on its core expertise and breakthrough approach using advanced therapies to restore liver health in patients with life-threatening liver diseases," explained professor Etienne Sokal, President of Promethera.