Takeda and Protagonist Announce U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Rusfertide as a Potential First-in-Class Therapy for Polycythemia Vera




Takeda and Protagonist Announce U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Rusfertide as a Potential First-in-Class Therapy for Polycythemia Vera

• Rusfertide Demonstrated Significant Improvements in Hematocrit Control, Phlebotomy Reduction and Patient Reported Outcomes for Patients with Polycythemia Vera in a Pivotal Study
• Submission Primarily Based on Phase 3 VERIFY Study, in Which Rusfertide Plus Standard of Care More Than Doubled Clinical Response Rates, as Well as Four-Year Efficacy and Safety Data from Phase 2 REVIVE/THRIVE Studies
• Prescription Drug User Fee Act (PDUFA) Target Action Date is in the Third Quarter of this Calendar Year

OSAKA, Japan & CAMBRIDGE, Mass. & NEWARK, Calif.–(BUSINESS WIRE)–Takeda (TSE:4502/NYSE:TAK) and Protagonist Therapeutics, Inc. (“Protagonist”) (NASDAQ:PTGX) today announced that the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) and granted Priority Review for rusfertide. Rusfertide is an investigational, first-in-class hepcidin mimetic peptide therapeutic for the treatment of adults with polycythemia vera (PV). The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date in the third quarter of this calendar year. In addition to Priority Review, rusfertide has received Breakthrough Therapy designation, Orphan Drug designation and Fast Track designation from the U.S. FDA.

PV is characterized by the overproduction of red blood cells (erythrocytosis), which increases blood viscosity, or thickness, and can result in life threatening thrombotic events. Hematocrit is the ratio of red blood cells to the total amount of blood in the body. Achieving and maintaining controlled hematocrit levels of <45% is the primary treatment goal in PV to prevent thrombotic events and alleviate burdensome symptoms.

“There is an urgent need for innovative treatment options in polycythemia vera, where patients currently face limited therapeutic choices to control their hematocrit and significant symptom burden,” said Andy Plump, M.D., Ph.D., president of R&D at Takeda. “The FDA’s acceptance of our NDA brings us closer to potentially offering a first-in-class therapy that could meaningfully improve clinical outcomes and quality of life. This milestone is a reflection of our successful partnership with Protagonist and Takeda’s unwavering commitment to advancing innovative treatments in hematologic cancers where significant unmet needs persist.”

The NDA for rusfertide was primarily based on the positive 32-week primary analysis and 52-week results from the Phase 3 global randomized VERIFY study (NCT05210790), as well as four-year efficacy and safety data from the Phase 2 REVIVE study (NCT04057040) and long-term extension THRIVE study (NCT06033586). In the VERIFY study, rusfertide met the primary endpoint and all four key secondary endpoints. Patients receiving rusfertide plus current standard of care demonstrated a higher response rate compared to current standard of care. This included hematocrit control, a reduction in phlebotomy requirements and improvement in pre-specified patient reported outcomes of fatigue and symptom burden. Rusfertide was generally well-tolerated through 52 weeks of treatment. The most common treatment-emergent adverse events (AEs) in rusfertide-treated patients were injection site reactions (47.4%), anemia (25.6%) and fatigue (19.6%), which were mainly grade 1 or 2. Serious AEs occurred in 8.1% of overall rusfertide-treated patients.

“Rusfertide exemplifies Protagonist’s end-to-end expertise, from exploring a novel hepcidin mimetic mechanism to address unmet needs in polycythemia vera to discovering the peptide and driving its clinical development through NDA filing. We are very pleased with the FDA granting rusfertide Priority Review and look forward to its potential approval in 2026,” said Dinesh V. Patel, Ph.D., Protagonist President and CEO. “We have identified a great partner in Takeda as rusfertide progresses toward this milestone, thereby bringing a successful closure to our more than decade-long journey from concept-to-commercialization.”

In January 2024, Protagonist and Takeda entered into a worldwide license and collaboration agreement for rusfertide. Protagonist discovered rusfertide and led its development through Phase 3 studies, with Takeda responsible for implementing the regulatory strategy for the U.S. NDA filing and for leading any future global regulatory filings. Protagonist holds an option to co-commercialize in the U.S. through a 50/50 profit and loss share structure or to opt-out of this structure, providing Takeda with a worldwide license pursuant to the license and collaboration agreement.

About Rusfertide

Rusfertide is a first-in-class investigational subcutaneous treatment that mimics the action of hepcidin, a natural hormone that regulates iron homeostasis and red blood cell production. By targeting the underlying mechanism of iron dysregulation in polycythemia vera, rusfertide aims to reduce excess red blood cell production and help patients achieve sustained hematocrit control. Rusfertide is administered once weekly via subcutaneous self-injection and has been generally well-tolerated in clinical trials to date.

About VERIFY

The Phase 3 VERIFY study (NCT05210790) is an ongoing, three-part, global, randomized, placebo-controlled study evaluating rusfertide in 293 patients with polycythemia vera over a 156-week period, with treatment extension for participants who are continuing to derive benefit from rusfertide beyond the 156-week treatment period. The study is evaluating the efficacy and safety of once-weekly, subcutaneously self-administered rusfertide in patients with uncontrolled hematocrit who are phlebotomy-dependent despite current standard of care treatment, which could include phlebotomy, hydroxyurea, interferon and/or ruxolitinib. The primary endpoint of the study was the proportion of patients achieving a response during Weeks 20-32, which was defined as the absence of “phlebotomy eligibility.” To meet phlebotomy eligibility, patients in the study were required to have: confirmed hematocrit ≥45% that was ≥3% higher than their baseline hematocrit value, or hematocrit ≥48%.

All patients have completed their participation in the randomized, placebo-controlled portion of the study evaluating the efficacy and safety of rusfertide plus current standard of care versus placebo plus current standard of care and are now in the open-label portions of the study.

About REVIVE and THRIVE

The Phase 2 REVIVE study (NCT04057040) evaluated rusfertide in adult patients with polycythemia vera and consisted of three parts, including 70 patients in the dose-finding Part 1 (28 weeks), 59 patients in the blinded, placebo-controlled, randomized withdrawal Part 2 (13 weeks) and 58 patients in the Part 3 open-label expansion (52 weeks). The THRIVE study (NCT06033586) is an ongoing, open-label extension study evaluating the long-term durability of response and safety profile of rusfertide in patients with polycythemia vera. The study includes 46 patients who previously participated in REVIVE. Patients eligible to transition to the THRIVE study completed the open-label extension portion of REVIVE, ≥12 months of rusfertide therapy and had an end-of-treatment visit. THRIVE is designed to further assess the maintenance of hematocrit control, reduction in the need for therapeutic phlebotomy and overall safety of once-weekly, subcutaneous rusfertide over an additional two-year treatment period.

About Polycythemia Vera (PV)

Polycythemia vera (PV) is characterized by the overproduction of red blood cells (erythrocytosis), which increases blood viscosity, or thickness, and can result in life threatening thrombotic events such as stroke, deep vein thrombosis and pulmonary embolism. Hematocrit is the ratio of red blood cells to the total amount of blood in the body. Achieving and maintaining controlled hematocrit levels of <45% is the primary treatment goal in PV to prevent thrombotic events and alleviate burdensome symptoms, including severe fatigue, difficulty in concentrating, night sweats and pruritus.

About Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.

About Protagonist

Protagonist Therapeutics is a discovery through late-stage development biopharmaceutical company. Two novel peptides derived from Protagonist’s proprietary discovery platform are currently in advanced Phase 3 clinical development, with NDAs for both ICOTYDE™ (icotrokinra) and rusfertide under review at the FDA. ICOTYDE is a first-in-class investigational targeted oral peptide that selectively blocks the Interleukin-23 receptor (“IL-23R”), which is licensed to Janssen Biotech, Inc., a Johnson & Johnson company. Following ICOTYDE’s joint discovery by Protagonist and Johnson & Johnson scientists pursuant to the companies’ IL-23R collaboration, Protagonist was primarily responsible for the development of ICOTYDE through Phase 1, with Johnson & Johnson assuming responsibility for development in Phase 2 and beyond.

Rusfertide is a first-in-class hepcidin mimetic peptide that is being co-developed with Takeda Pharmaceuticals pursuant to a worldwide license and collaboration agreement entered in 2024. Protagonist holds an option to co-commercialize rusfertide in the U.S. through a 50/50 profit and loss share structure or can opt-out of this structure. The Company also has a number of preclinical stage drug discovery programs addressing clinically and commercially validated targets including an oral IL-17 peptide antagonist, obesity dual and triple agonists, an oral hepcidin functional mimetic, and the recently announced IL-4 and amylin programs.

More information on Protagonist, its pipeline drug candidates, and clinical studies can be found on the Company’s website at https://www.protagonist-inc.com.

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This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the potential benefits of rusfertide. In some cases, you can identify these statements by forward-looking words such as “anticipate,” “believe,” “may,” “will,” “expect,” or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, our ability to earn milestone payments under our collaboration agreements with Janssen and Takeda, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates. Additional information concerning these and other risk factors affecting our business can be found in our periodic filings with the Securities and Exchange Commission, including under the heading “Risk Factors” contained in our most recently filed periodic reports on Form 10-K and Form 10-Q filed with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition, and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements, whether as a result of new information, future events, or otherwise, after the date of this press release.

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Genentech’s Fenebrutinib Confirms Its Potential as First and Only BTK Inhibitor for Relapsing and Primary Progressive MS in Third Positive Phase III Study (FENhance 1)




Genentech’s Fenebrutinib Confirms Its Potential as First and Only BTK Inhibitor for Relapsing and Primary Progressive MS in Third Positive Phase III Study (FENhance 1)

– FENhance 1 met its primary endpoint, showing investigational fenebrutinib significantly reduced relapses by 51% compared to teriflunomide in relapsing multiple sclerosis (RMS), consistent with FENhance 2 results showing 59% reduction –

– FENhance 1 is the final study readout of the fenebrutinib pivotal clinical development program in MS, following positive results for FENhance 2 in RMS and for FENtrepid in primary progressive multiple sclerosis (PPMS) –

– Fenebrutinib has the potential to become the first and only high-efficacy oral, brain-penetrant treatment for both RMS and PPMS, showing a profound benefit on relapsing and progressive disease biology –

– Totality of data from all three Phase III fenebrutinib studies will be submitted to regulatory authorities –

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the pivotal Phase III study (FENhance 1) of fenebrutinib in RMS met its primary endpoint, showing clinically meaningful and statistically significant results. The study demonstrated that fenebrutinib, an investigational Bruton’s tyrosine kinase (BTK) inhibitor, markedly reduced the annualized relapse rate (ARR) by 51% compared to teriflunomide over a period of at least 96 weeks of treatment, consistent with FENhance 2 results showing a 59% reduction in ARR. Together, these results equate to approximately one relapse every 17 years. Secondary endpoints in both RMS studies show statistically significant and clinically meaningful reductions in brain lesions. Additionally, all progression endpoints show favorable trends for fenebrutinib.

Full data from the FENhance 1 and 2 studies will be shared at the American Academy of Neurology (AAN) Annual Meeting 2026 and submitted to regulatory authorities together with data from the FENtrepid study.

“These pivotal results, together with the earlier data, provide convincing evidence that fenebrutinib can become the first high-efficacy oral treatment for RMS and PPMS,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “Building on a decade of transforming MS treatment, we are committed to advancing innovation to one day allow people with MS to live a life without disability.”

The positive FENhance 1 study follows positive results for FENhance 2 in RMS and for FENtrepid in PPMS, which were both announced in November. The collective positive results across all three pivotal studies demonstrate that fenebrutinib consistently shows a profound benefit on relapsing and progressive disease biology.

In both RMS studies, liver transaminase elevations were comparable with teriflunomide. In the FENhance 1 study, there was one Hy’s Law case in the fenebrutinib arm and one in the teriflunomide arm. Both cases were asymptomatic and resolved after study drug discontinuation. There were no additional Hy’s Law cases across all of the fenebrutinib clinical development program in MS or in other autoimmune diseases.

In the FENhance 1 and 2 studies in RMS, 1 fatal case was reported in the teriflunomide arm and 8 fatal cases with various causes and at different points in treatment in the fenebrutinib arms. Further analyses are ongoing to better understand these findings.

Fenebrutinib targets cells in the immune system known as B cells and microglia. Targeting B cells helps control the acute inflammation that causes relapses, while targeting microglia inside the brain addresses the chronic damage that is thought to drive long-term disability progression. Fenebrutinib, a non-covalent BTK inhibitor, is designed to have high potency, selectivity and reversibility. This design allows it to act throughout the body, and also to cross the blood-brain barrier into the central nervous system (CNS) targeting chronic inflammation.

About the FENhance 1 and 2 studies

FENhance 1 and 2 are two Phase III multicenter, randomized, double-blind, double-dummy, parallel-group studies to evaluate the efficacy and safety of investigational fenebrutinib compared with teriflunomide in a total of 1,497 adult patients with RMS. Eligible participants were randomized 1:1 to receive treatment with either oral fenebrutinib twice a day (and placebo matched to oral teriflunomide once a day) or oral teriflunomide once a day (and placebo matched to oral fenebrutinib twice a day) for at least 96 weeks.

The primary endpoint is annualized relapse rate (ARR). Secondary endpoints include total number of T1-gadolinium-enhancing MRI lesions, total number of new and/or enlarging T2-weighted MRI lesions, time to onset of 12-week composite confirmed disability progression (cCDP12) and 24-week cCDP (cCDP24). cCDP incorporates three measures of disability – total functional disability measured by confirmed disability progression (CDP) based on the Expanded Disability Status Scale (EDSS), walking speed measured by the timed 25-foot walk (T25FW) and upper limb function measured by the nine-hole peg test (9HPT).

Following the double-blind treatment period, patients have the option to enter an open-label extension (OLE) phase, in which all patients receive treatment with fenebrutinib.

About fenebrutinib

Fenebrutinib is an investigational oral, central nervous system (CNS)-penetrant, reversible and non-covalent Bruton’s tyrosine kinase (BTK) inhibitor with an optimized pharmacokinetics (PK) profile. Fenebrutinib can act throughout the body and also cross the blood-brain barrier into the CNS to target chronic inflammation. It is uniquely designed to target relapsing and progressive biology by inhibiting cells in the immune system known as B cells and microglia. Targeting B cells helps control the acute inflammation that causes relapses, while targeting microglia inside the brain addresses the chronic damage that is thought to drive long-term disability progression.

Fenebrutinib is designed to have high potency and reversibility, with a selectivity for BTK 130 times greater than other kinases. This high selectivity highlights fenebrutinib’s potential to bind to its intended target without interfering with other kinases. While most current BTK inhibitors are covalent and irreversible, meaning they form a permanent chemical bond with the enzyme, fenebrutinib is non-covalent and reversible, meaning it binds and then eventually releases the enzyme. These design features may help limit off-target effects.

The fenebrutinib Phase III program includes two similarly designed trials in relapsing multiple sclerosis (RMS) (FENhance 1 and 2) with active comparator teriflunomide and the only trial in primary progressive multiple sclerosis (PPMS) (FENtrepid) in which a BTK inhibitor is being evaluated against Ocrevus.

To date, more than 2,700 patients and healthy volunteers have been treated with fenebrutinib in Phase I, II and III clinical programs across multiple diseases, including multiple sclerosis and other autoimmune disorders.

About multiple sclerosis

Multiple sclerosis is a chronic disease that affects more than 2.9 million people worldwide. People with all forms of multiple sclerosis experience disease progression from the beginning of their disease. Therefore, an important goal of treating multiple sclerosis is to slow, stop and ideally prevent progression as early as possible.

Approximately 85% of people with multiple sclerosis are initially diagnosed with relapsing-remitting multiple sclerosis (RRMS). Relapsing forms of the disease (RMS) include RRMS and active secondary progressive MS, and people with RMS experience relapses and worsening disability over time. Primary progressive multiple sclerosis (PPMS) is a debilitating form of the disease marked by steadily worsening symptoms but typically without distinct relapses or periods of remission. Approximately 15% of people with multiple sclerosis are diagnosed with the primary progressive form of the disease. Until the FDA approval of Ocrevus^®, there had been no FDA-approved treatments for PPMS and Ocrevus is still the only approved treatment for PPMS. Despite the availability of CD20s, 30% of patients remain on low-efficacy oral therapy today. Slowing or stopping progression while simultaneously stopping relapses remains a high unmet need in MS.

About Genentech in neuroscience

Neuroscience is a major focus of research and development at Genentech. Our goal is to pursue groundbreaking science to develop new treatments that help improve the lives of people with chronic and potentially devastating diseases.

Genentech and Roche are investigating more than a dozen medicines for neurological disorders, including multiple sclerosis, spinal muscular atrophy, neuromyelitis optica spectrum disorder, Alzheimer’s disease, Huntington’s disease, Parkinson’s disease and Duchenne muscular dystrophy. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neuroscience today.

About Genentech

Founded 50 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

Indications and Important Safety Information

What is Ocrevus?

Ocrevus is a prescription medicine used to treat:

• Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults
• Primary progressive MS, in adults.

It is not known if Ocrevus is safe and effective in children.

Who should not receive Ocrevus?

Do not receive Ocrevus if you have an active hepatitis B virus (HBV) infection.

Do not receive Ocrevus if you have had a life-threatening allergic reaction to Ocrevus. Tell your healthcare provider if you have had an allergic reaction to Ocrevus or any of its ingredients in the past.

What is the most important information I should know about Ocrevus?

Ocrevus can cause serious side effects, including:

• Infusion reactions: Infusion reactions are a common side effect of Ocrevus, which can be serious and may require you to be hospitalized. You will be monitored during your infusion and for at least 1 hour after each infusion of Ocrevus for signs and symptoms of an infusion reaction. Tell your healthcare provider or nurse if you get any of these symptoms:
  • Itchy skin
  • Rash
  • Hives
  • Tiredness
  • Coughing or wheezing
  • Trouble breathing
  • Throat irritation or pain
  • Feeling faint
  • Fever
  • Redness on your face (flushing)
  • Nausea
  • Headache
  • Swelling of the throat
  • Dizziness
  • Shortness of breath
  • Fatigue
  • Fast heartbeat

These infusion reactions can happen for up to 24 hours after your infusion. It is important that you call your healthcare provider right away if you get any of the signs or symptoms listed above after each infusion.

If you get infusion reactions, your healthcare provider may need to stop or slow down the rate of your infusion.

• Infection:
  • Infections are a common side effect. Ocrevus increases your risk of getting upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes infections. Serious infections can happen with Ocrevus, which can be life-threatening or cause death. Tell your healthcare provider if you have an infection or have any of the following signs of infection including fever, chills, a cough that does not go away, or painful urination. Signs of herpes infection include: cold sores, shingles, genital sores, skin rash, pain, and itching. Signs of more serious herpes infection include: changes in vision, eye redness or eye pain, severe or persistent headache, stiff neck, and confusion. Signs of infection can happen during treatment or after you have received your last dose of Ocrevus. Tell your healthcare provider right away if you have an infection. Your healthcare provider should delay your treatment with Ocrevus until your infection is gone.
  • Hepatitis B virus (HBV) reactivation: Before starting treatment with Ocrevus, your healthcare provider will do blood tests to check for hepatitis B viral infection. If you have ever had hepatitis B virus infection, the hepatitis B virus may become active again during or after treatment with Ocrevus. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure or death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop receiving Ocrevus.
  • Weakened immune system: Ocrevus taken before or after other medicines that weaken the immune system could increase your risk of getting infections.
• Progressive Multifocal Leukoencephalopathy (PML): PML is a rare brain infection that usually leads to death or severe disability and has been reported with Ocrevus. Symptoms of PML get worse over days to weeks. It is important that you call your healthcare provider right away if you have any new or worsening neurologic signs or symptoms that have lasted several days, including problems with:
  • Thinking
  • Eyesight
  • Strength
  • Balance
  • Weakness on 1 side of your body
  • Using your arms or legs
• Decreased immunoglobulins: Ocrevus may cause a decrease in some types of antibodies. Your healthcare provider will do blood tests to check your blood immunoglobulin levels.

Before receiving Ocrevus, tell your healthcare provider about all of your medical conditions, including if you:

• have ever taken, take, or plan to take medicines that affect your immune system, or other treatments for MS.
• have ever had hepatitis B or are a carrier of the hepatitis B virus.
• have a history of inflammatory bowel disease or colitis.
• have a history of liver problems
• have had a recent vaccination or are scheduled to receive any vaccinations.
  • You should receive any required ‘live’ or ‘live-attenuated’ vaccines at least 4 weeks before you start treatment with Ocrevus. You should not receive ‘live’ or ‘live-attenuated’ vaccines while you are being treated with Ocrevus and until your healthcare provider tells you that your immune system is no longer weakened.
  • When possible, you should receive any ‘non-live’ vaccines at least 2 weeks before you start treatment with Ocrevus. If you would like to receive any non-live (inactivated) vaccines, including the seasonal flu vaccine, while you are being treated with Ocrevus, talk to your healthcare provider.
  • If you have a baby and you received Ocrevus during your pregnancy, it is important to tell your baby’s healthcare provider about receiving Ocrevus so they can decide when your baby should be vaccinated.
• are pregnant, think that you might be pregnant, or plan to become pregnant. It is not known if Ocrevus will harm your unborn baby. You should use birth control (contraception) during treatment with Ocrevus and for 6 months after your last infusion of Ocrevus. Talk with your healthcare provider about what birth control method is right for you during this time. Tell your healthcare provider if you become pregnant while receiving Ocrevus.
• are breastfeeding or plan to breastfeed. It is not known if Ocrevus passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Ocrevus.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of Ocrevus?

Ocrevus may cause serious side effects, including:

• Risk of cancers (malignancies) including breast cancer. Follow your healthcare provider’s instructions about standard screening guidelines for breast cancer.
• Inflammation of the colon, or colitis: Tell your healthcare provider if you have any symptoms of colitis, such as:
  • Diarrhea (loose stools) or more frequent bowel movements than usual
  • Stools that are black, tarry, sticky or have blood or mucus
  • Severe stomach-area (abdomen) pain or tenderness
• Liver damage. Ocrevus may cause liver damage. Your healthcare provider will do blood tests to check your liver before you start Ocrevus and while you take Ocrevus if needed. Tell your healthcare provider right away if you have any symptoms of liver damage, such as:
  • yellowing of the skin and eyes (jaundice)
  • nausea
  • vomiting
  • unusual darkening of the urine
  • feeling tired or weak

These are not all the possible side effects of Ocrevus.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Genentech at (888) 835-2555.

For more information, go to https://www.Ocrevus.com or call 1-844-627-3887.

For additional safety information, please see the full Prescribing Information and Medication Guide.

Contacts

Media Contact:

Michelle McCourt, (650) 467-6800

Advocacy Contact:

Lily Rose Atherton, (202) 713-0083

Investor Contacts:

Loren Kalm, (650) 225-3217

Bruno Eschli, +41 61 687 5284

PHCbi Launches LiCellGrow™ Cell Expansion System to Support High-Quality and Efficient Production of Cell and Gene Therapies




PHCbi Launches LiCellGrow™ Cell Expansion System to Support High-Quality and Efficient Production of Cell and Gene Therapies

— Proprietary In-Line Monitoring Technology Enables Seamless Scale-Up from Basic Research to Commercial Manufacturing —

TOKYO–(BUSINESS WIRE)–PHC Corporation’s Biomedical Division (Head Office: Chiyoda-ku, Tokyo; President: Nobuaki Nakamura; hereinafter “PHCbi”), a global provider of laboratory sample storage and cell cultivation solutions and subsidiary of PHC Holdings Corporation (Head Office: Chiyoda-ku, Tokyo), today announced the launch of its new cell expansion system LiCellGrow™ ^(*1) for research use in Japan and other select countries worldwide^(*2). The system is designed to improve quality and efficiency in the production of new advanced therapies by allowing therapy developers to visualize metabolic changes in cells in real time and automatically control culture conditions.

PHCbi will exhibit LiCellGrow™ at the 25th Congress of the Japanese Society for Regenerative Medicine, March 19-20 at the Kobe International Conference Center and Kobe International Exhibition Center in Kobe, Japan.

Cell and gene therapies (CGT), in which cells or genetic material are used to create personalized medical treatments, are rapidly advancing as promising treatment options for hard-to-treat diseases such as genetic disorders and cancer. In the manufacturing of CGT products, however, variations in cell characteristics and complexity of manufacturing are challenges to maintaining a consistent quality product. As a result, therapy developers are faced with reduced production efficiency, lower yields, and increased manufacturing costs compared to conventional therapies. To overcome these challenges, it is essential for therapy developers to be able to identify critical process parameters (CPPs) and critical quality attributes (CQAs) in CGT product manufacturing. The ability to monitor cell status and control culture conditions based on cell status are indispensable to developing quality CGT products at scale efficiently and at a lower cost.

PHCbi developed LiCellGrow™ to address these challenges and support CGT manufacturing at scale by helping to identify optimal culture conditions during the manufacturing process development. The system is equipped with proprietary In-Line monitoring technology that continuously measures, in real time, glucose and lactate concentrations, two key indicators of cell metabolism. It also incorporates culture control technology that adjusts cell culture medium at the optimal time based on these measurements. This technology is built on PHCbi’s proprietary electrochemical measurement platform, cultivated through more than 30 years of blood glucose sensor development. By visualizing the metabolic state of cultured cells, which is traditionally difficult to assess, and enabling precise control of culture conditions, LiCellGrow™ supports improved cell quality and enhanced efficiency as well as lower costs through reduced losses in the manufacturing of CGT products.

Under PHC Group’s Value Creation Plan 2027, which includes a focus on Diagnostics and Life Sciences, PHCbi is developing solutions to enhance efficiency and reduce costs in the manufacturing of CGT products. LiCellGrow™ builds on the In-Line monitoring technology introduced in LiCellMo™ ^(*3), a live cell metabolic analyzer launched in 2024 for research use only. From late 2026 through early 2028, PHCbi plans to expand its product lineup in phases, including culture bags with filtration functions that enhance cell recovery, pH/DO (dissolved oxygen) meter units, and cGMP-compliant dedicated consumables. These enhancements will support seamless scaling of CGT from basic research to commercial manufacturing in products such as CAR-T cell therapy.

[Key Features of the Product]

1. Automated Control and Optimization of Culture Conditions Using In-Line Monitoring Technology

By utilizing In-Line monitoring technology, LiCellGrow™ continuously tracks real-time changes in culture conditions and cell status, and automates medium exchange based on the acquired metabolic data. This enables the culture environment to be consistently maintained in an optimal state, contributing not only to improved cell quality and uniformity but also enhanced manufacturing efficiency. Furthermore, this process control approach aligns with the concept of Quality by Design (QbD) ^(*4), which embeds quality scientifically at the design stage rather than relying solely on final product testing. The system therefore supports the development of scientifically robust and highly reproducible manufacturing processes.

2. Single-Use Design Ensuring Aseptic Conditions and Highly Reproducible Cell Culture

LiCellGrow™ employs easy-to-attach, single-use dedicated culture bags. With automated measurement of culture conditions using In-Line sensors, the sampling tasks previously required to check glucose and lactate concentrations are no longer necessary. This reduces the risk of cross-contamination and enables closed-system cell culture that maintains aseptic conditions. In addition, the device can be placed inside a standard CO₂ incubator commonly used in laboratories, eliminating the need for special facility investments and allowing users to easily establish a reliable and highly reproducible culture environment.

Chikara Takauo, Director of PHC Corporation and Head of the Biomedical Division, commented:

“We are excited to launch LiCellGrow™ and offer therapy developers a new way to solve common challenges in quality, cost, and delivery of cell and gene therapies. Building on the success of our research-use system LiCellMo™, LiCellGrow™ represents an important step forward in making CGT manufacturing efficient, reliable, and scalable. We are committed to expanding our PHCbi offerings to continue to contribute to the adoption of CGT and other advanced therapy options for hard-to-treat conditions.”

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Overview of the 25th Congress of the Japanese Society for Regenerative Medicine

Dates: March 19 – 20, 2026

Venue: Kobe International Exhibition Hall, Building No. 2, 1st Floor (PHCbi Booth No.: T31)

Official Website: The 25th Congress of the Japanese Society for Regenerative Medicine
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(*1) https://www.phchd.com/jp/biomedical/incubation/cell-expansion-system-en
This product is intended for research use only and not for medical or clinical purposes.

(*2) Not available for purchase in the United States. Expected U.S. launch in the summer of 2026.

(*3) Live Cell Metabolic Analyzer | PHCbi
(*4) An approach to quality assurance defined in the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) guidelines (ICH Q8–Q11) and widely adopted in the pharmaceutical field.

About the Biomedical Division of PHC Corporation

Established in 1969, PHC Corporation is a Japanese subsidiary of PHC Holdings Corporation (TSE 6523), a global healthcare company that develops, manufactures, sells, and services solutions across diabetes management, healthcare solutions, life sciences and diagnostics. The Biomedical Division supports the life sciences industry helping researchers and healthcare providers in around 110 countries and regions through its laboratory and equipment and services including CO₂ incubators and ultra-low temperature freezers.

www.phchd.com/global/phc

About PHC Holdings Corporation

PHC Holdings Corporation (TSE 6523) is a global healthcare company with a mission of contributing to the health of society through healthcare solutions that have a positive impact and improve the lives of people. Its subsidiaries include PHC Corporation, Ascensia Diabetes Care, Epredia, LSI Medience Corporation, Wemex Corporation, and Mediford Corporation. Together, these companies develop, manufacture, sell and service solutions across diabetes management, healthcare solutions, diagnostics and life sciences. The consolidated net sales in FY2024 were JPY 361.6 billion with global distribution of products and services in more than 125 countries and regions. PHC Group is a collective term referring to PHC Holdings Corporation and its subsidiaries.

www.phchd.com

Contacts

[Contact for product and service]

Masayo Okada

Marketing Department, Biomedical Division

PHC Corporation

Email: masayo.okada@phchd.com

[Contact for IR and media]

Investor Relations & Corporate Communications Department

PHC Holdings Corporation

Tel: +81-3-6778-5311 Email: phc-pr@gg.phchd.com

Otsuka Medical Devices/Otsuka Pharmaceutical: Paradise Ultrasound Renal Denervation System for the Treatment of Resistant Hypertension, Now Covered by Insurance and Commercially Available in Japan




Otsuka Medical Devices/Otsuka Pharmaceutical: Paradise Ultrasound Renal Denervation System for the Treatment of Resistant Hypertension, Now Covered by Insurance and Commercially Available in Japan

TOKYO–(BUSINESS WIRE)–Otsuka Medical Devices Co., Ltd. (Otsuka Medical Devices) and Otsuka Pharmaceutical Co., Ltd. (Otsuka Pharmaceutical) announce that the Paradise™ Ultrasound Renal Denervation (uRDN) system is covered by National Health Insurance system in Japan, effective March 1. Following the inception of insurance coverage, Otsuka Medical Devices has commenced sales of the system on March 2 and will conduct co-promotion with Otsuka Pharmaceutical.

The Paradise uRDN system was developed by Recor Medical, Inc. (Recor Medical), a U.S.-based subsidiary of Otsuka Medical Devices. This system is indicated for resistant hypertension patients whose blood pressure remains above target despite the use of three antihypertensive medications of different classes, including a diuretic.

Otsuka Medical Devices is introducing ultrasound renal denervation treatment to Japan for the first time. This novel treatment is designed to lower blood pressure by reducing overactivity of the sympathetic nerves surrounding the renal arteries.

With this insurance coverage, Paradise uRDN system becomes available as a new treatment option for resistant hypertension. Under a co-promotion framework, Otsuka Medical Devices and Otsuka Pharmaceutical will leverage Otsuka Pharmaceutical’s established expertise in the cardiovascular and renal fields to supply appropriate treatment options suited to patient conditions. The system will be prescribed by physicians to patients as defined in the guidelines for the proper use of renal denervation systems.

Kazuomi Kario, President of the Japanese Society of Hypertension and Professor of Cardiovascular Medicine at Jichi Medical University, commented, “Resistant hypertension carries an extremely high risk of leading to serious complications, such as cerebrovascular and cardiovascular diseases and renal failure. Being able to provide appropriate treatment opportunities to patients in need through this insurance coverage marks a significant step forward. Furthermore, the Japanese Society of Hypertension, the Japanese Association of Cardiovascular Intervention and Therapeutics, and the Japanese Circulation Society will work together to ensure that proper and safe treatment is delivered based on the facility requirements and patient eligibility criteria outlined in the guidelines for the proper use of renal denervation systems, which were formulated by our three societies.”

Makoto Inoue, President and Representative Director, CEO of Otsuka Holdings Co., Ltd., and President and Representative Director of Otsuka Pharmaceutical stated, “I am delighted that we can provide a new option to address the medical challenge of resistant hypertension by leveraging the know-how cultivated through the Otsuka group’s pharmaceutical business. Moving forward, we will bring together the collective strength of the Otsuka group to deliver optimal solutions for patients and consumers, as we strive to contribute to the total healthcare of every individual.”

“Paradise uRDN system received approval from the U.S. Food and Drug Administration (FDA) in 2023.^* We are extremely pleased that patients in Japan with resistant hypertension now have access to this new treatment option under insurance coverage. We have built a framework with Otsuka Pharmaceutical to ensure this treatment reliably reaches patients in need, and we will continue to contribute to the health of patients and the advancement of medical care.” said Noriko Tojo, President and Representative Director of Otsuka Medical Devices.

Guided by the corporate philosophy of Otsuka-people creating new products for better health worldwide, Otsuka Medical Devices and Otsuka Pharmaceutical will continue to make every effort to deliver new value to address unmet medical needs.

*In the U.S, Paradise uRDN system received FDA approval in November 2023 as an adjunctive treatment option when lifestyle changes and medications have not adequately controlled a patient’s blood pressure.

About Otsuka Medical Devices

https://www.omd.otsuka.com/en/

About Recor Medical

https://www.recormedical.com/

About Otsuka Pharmaceutical

https://www.otsuka.co.jp/en/

Contacts

Otsuka Medical Devices

Inquiry form
+81-3-6361-7459