On April 25, 2022 ERYTECH Pharma (Euronext Paris: ERYP—Nasdaq: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported the sale of its U.S. manufacturing facility to Catalent, a leading contract development and manufacturing organization (CDMO) in advanced therapies (Press release, ERYtech Pharma, APR 25, 2022, View Source [SID1234612901]).

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Under the terms of an asset purchase agreement between ERYTECH and Catalent (the "APA"), Catalent agreed to acquire ERYTECH’s state-of-the-art commercial-scale cell therapy manufacturing facility in Princeton, New Jersey, for a total consideration of $44.5 million. ERYTECH’s current staff at the site of approximately 40 people will be offered Catalent’s employment.

The parties will also enter into a long-term supply agreement, under which Catalent will manufacture ERYTECH’s lead product candidate eryaspase (GRASPA) for clinical and commercial supply in the United States. ERYTECH has a Phase 1 trial in first-line pancreatic cancer ongoing in the United States and is in a continued dialogue with the U.S. FDA regarding a potential BLA submission for GRASPA in hypersensititve ALL, now targeted in the third quarter of 2022, subject to FDA agreement on remaining outstanding information requests.

Catalent will also offer their expertise in late-stage and commercial manufacturing of advanced therapy medicinal products with respect to product characterization, commercial production, regulatory inspections, and approvals.

ERYTECH’s Princeton facility is a 30,900 sqft cutting edge manufacturing facility, designed with the flexibility to expand to support various cell therapy production requirements and capacities. Catalent intends to expand the Princeton site and leverage ERYTECH’s experienced staff to manufacture a broader portfolio of cell therapies. ERYTECH will retain its manufacturing site in Lyon, France and its expertise and capabilities in manufacturing process science to continue innovating in cell therapy manufacturing.

"In Catalent we have found a great partner for the manufacturing of our innovative red blood cell derived products, and we believe that this strategic partnership will meet our long-term manufacturing needs in the United States," commented Gil Beyen, Chief Executive Officer of ERYTECH, "As we are turning this important page for ERYTECH, I wish to thank our entire Princeton team very much for their talent and dedication in building and developing our flagship facility since its inception in 2018. ERYTECH will now further focus capital resources on the development of potentially transformative therapeutics for serious diseases. We are also continuing to evaluate further strategic options for the company, including additional partnerships and addition of complementary assets, through which we can leverage our ERYCAPS platform and our development and manufacturing capabilities."

"This acquisition is strategically important to Catalent’s commitment to support the development, clinical, and commercial supply of cell therapies to meet rapidly growing demand," said Manja Boerman, Ph.D., President, Catalent Cell & Gene Therapy. "The talented and experienced staff already employed at the facility, the capabilities it has in place, and the opportunity to quickly add further capacity on the same site, allows Catalent to expand rapidly to create a U.S. campus and center of excellence for cell therapy development and manufacturing that will serve customers around the world."

ERYTECH reported cash and cash equivalents of €33.7 million ($38.1 million) as of December 31, 2021. Upon closing of the transaction, ERYTECH’s cash and cash equivalents are expected to be approximately €55 million ($60 million) with the addition of the $44.5 million (€40.8 million) purchase price payment. With a reduction in yearly cash disbursements of approximately $7.5 million related to running costs of the Princeton facility, this cash position is expected to fund ERYTECH’s operations under its current configuration to mid-2024.

KEY TRANSACTION TERMS

In connection with the transaction, ERYTECH’s board of directors has established an ad hoc committee in order to review the indications of interests received by ERYTECH and to issue a recommendation to its board of directors. After having assessed the transaction and potential strategic alternatives, ERYTECH’s board of directors has unanimously approved it on the basis, inter alia, of the recommendation of the ad hoc committee and the opinion of its works council.

Pursuant to the APA, Catalent paid a total consideration of $44.5 million to ERYTECH.

Pursuant to the APA, ERYTECH has made certain representations and warranties on the transferred assets. ERYTECH has also agreed to certain customary covenants and restrictions with respect to assets and liabilities comprising the transaction consistent with a transaction of this nature.

The parties will also enter into a long-term supply agreement for the manufacturing and supply of the lead product candidate eryaspase (GRASPA) by Catalent to ERYTECH.

Duane Morris is serving as legal counsel to Catalent. Cooley LLP and Gide Loyrette Nouel A.A.R.P.I. are serving as legal counsel to ERYTECH. Torreya Capital LLC is serving as exclusive financial advisor to ERYTECH.

On April 25, 2022 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company) a leader in the development of targeted radiotherapies for patients with unmet needs reported that highlighted data from full patient enrollment in the pivotal Phase 3 SIERRA trial of Iomab-B was presented in an oral presentation at the upcoming Transplantation & Cellular Therapy (TCT) Tandem Meetings of ASTCT and CIBMTR, the combined annual meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR) being held April 23 – 26, 2022 virtually and in Salt Lake City, Utah (Press release, Actinium Pharmaceuticals, APR 25, 2022, View Source [SID1234612918]).

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Highlights of the SIERRA data presentation includes:

Greater than 5-times increase in Bone Marrow Transplant access for Iomab-B versus control arm and universal engraftment in patients receiving Iomab-B

100% of patients (66/66) receiving Iomab-B were able to proceed to a bone marrow transplant (BMT) and all achieved engraftment compared to only 18% of patients (14/77) on the control arm who received physician’s choice of therapy including targeted agents such as Venetoclax (Bcl-2), FLT3 and IDH1/2 inhibitors with 1 patient having a graft failure.
At full enrollment, 82% of patients (63/77) on the control arm are failures for the primary endpoint of durable Complete Remission (dCR) of 6 months having never achieved a Complete Remission (CR)
Including patients who crossed over to receive Iomab-B after not achieving a CR with control arm therapies, 71% of patients (106/150) were able to access a BMT on the SIERRA trial.
Lower rates of non-relapse transplant related mortality at day 100 and adverse events in patients receiving Iomab-B

Non-relapse transplant related mortality (TRM) 100 days post BMT was 9% (6/65) in the Iomab-B arm compared to 14% (2/14) in the control arm
Rates of sepsis were statistically significantly lower in the Iomab-B arm (p=0.002) with 5% of patients (4/75) experiencing grade 3 or greater sepsis compared to 24% of patients (18/76) in the control arm.
Rates of febrile neutropenia were 34% lower in patients on the Iomab-B arm (25/75) compared to the control arm (34/76)
Five times greater percentage of patients potentially evaluable for the primary endpoint consistently seen throughout the SIERRA trial

At full enrollment, 78% of patients (59/76) on the Iomab-B arm are potentially evaluable for the dCR primary endpoint compared to 16% (12/77) after taking into account rates of 100-day TRM
The approximate five times difference has been consistent at interim analyses at 25%, 50%, 75% and now 100% enrollment
Dr. Avinash Desai, Actinium’s Chief Medical Officer, said, "These data from the SIERRA trial were very well received by the transplant community at TCT and there is clear enthusiasm from physicians for the potential of Iomab-B. Currently, patients with active, relapsed or refractory AML have limited access to BMT, as seen in the SIERRA control arm, and thus poor survival outcomes of only 2-4 months. Even with the approval of multiple targeted therapies for patients with AML, which were used in about half of the patients in the control arm of SIERRA, they have no meaningful impact in improving BMT access or engraftment. Iomab-B is the only targeted radiotherapy being developed for this patient population and it simultaneously delivers high amounts of radiation to the patient’s radiosensitive cancer cells and to their bone marrow to achieve induction and conditioning. We are excited to be able to highlight 100% BMT access and engraftment and strong safety data to the transplant community at TCT and now look ahead to delivering strong topline data in the third quarter of this year."

SIERRA Trial Patient Characteristics:

Iomab-B Arm

(N=76)

Control Arm

(N=77)

Cross-Over Patients

(N=40)

Median Age

65.0

66.1

64.6

Molecular and
Cytogenetic Risk

Favorable: 5.3%

Intermediate: 32.9%

Adverse: 60.5%

Favorable: 3.9%

Intermediate: 33.8%

Adverse: 62.3%

Favorable: 5%

Intermediate: 35%

Adverse: 60%

Median Blast %
at Randomization

30%

19.5%

35%

Sandesh Seth, Actinium’s Chairman and CEO, stated, "We have always had confidence in Iomab-B given the strong BMT access, engraftment, safety and outcomes data that existed prior to the SIERRA trial. With patient enrollment in the multi-center, randomized SIERRA trial complete, it is incredibly exciting to see the consistency in the data across hundreds of patients who have been treated with Iomab-B. We intend to transform BMT conditioning with Iomab-B, not only for patients with active, relapsed or refractory AML, but across multiple blood cancer indications. Positive topline data from the SIERRA trial will be a major catalyst in allowing us to achieve that goal and even expand beyond BMT to conditioning for cell and gene therapies. We look forward to continuing to advance targeted radiotherapies and work to bring them to patients underserved by current therapies to improve patient outcomes."

About the Tandem Meetings

The Tandem Meetings I Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR are the combined annual meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR). Administrators, clinicians, data manager / clinical research professionals, fellows-in-training, investigators, laboratory technicians, MD/PhDs, nurses, nurse practitioners, pharmacists, physician assistants, and other allied health professional attendees benefit from a full scientific program that addresses the most timely issues in hematopoietic cell transplantation and cellular therapy.

About Iomab-B

Iomab-B (I-131 apamistamab), via the monoclonal antibody apamistamab, targets CD45, an antigen widely expressed on leukemia and lymphoma cancer cells, immune cells and bone marrow stem cells. Apamistamab is linked to the radioisotope iodine-131 (I-131) and once attached to its target cells emits energy that travels about 100 cell lengths, destroying a patient’s cancer cells and ablating their bone marrow. By carrying iodine-131 directly to the bone marrow in a targeted manner, Iomab-B may avoid the side effects of non-targeted chemotherapy and external radiation on most healthy tissues while effectively killing the patient’s cancer (induction) and marrow cells (myeloablation) including those in bone marrow niches due to the "crossfire" effect enabled by the I-131 radioisotope.

Iomab-B was licensed from the Fred Hutchinson Cancer Research Center where it was studied in nearly 300 patients, in multiple clinical trials in 6 blood cancer indications. Iomab-B is being studied in the pivotal Phase 3 SIERRA (Study of Iomab-B in Relapsed or Refractory AML) trial, a 150-patient, randomized controlled clinical trial in patients with active, relapsed or refractory Acute Myeloid Leukemia (AML) who are age 55 and above. If granted approval, Iomab-B is intended to prepare and condition patients for a bone marrow transplant, also referred to as a hematopoietic stem cell transplant, in a potentially more efficacious manner and with a more beneficial safety profile than the non-targeted intensive chemotherapy conditioning that is the current standard of care in bone marrow transplant conditioning. A bone marrow transplant is often considered the only potential cure for patients with certain blood-borne cancers and blood disorders. Iomab-B has been granted Orphan Drug Designation from the U.S. FDA and the European Medicines Agency (EMA). Iomab-B also has patent terms extending to at least 2036/2037 in the US and EU. In addition, Actinium received positive Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the EMA indicating that the Phase 3 SIERRA trial design, primary endpoint and planned statistical analysis are acceptable as the basis for a Marketing Authorization Application.

About the SIERRA Phase 3 Trial

The SIERRA trial is a 150-patient, randomized clinical trial, studying Iomab-B compared to physician’s choice of salvage therapy in patients with active, relapsed or refractory acute myeloid leukemia (r/r AML) age 55 and above. The SIERRA trial completed enrollment in the third quarter of 2021 with the last patient receiving a BMT in the fourth quarter of 2021. Topline data from the SIERRA trial is expected in the third quarter of 2022. In SIERRA, patients receiving Iomab-B, those achieving a remission after salvage therapy or those patients not achieving remission after salvage therapy that crossed over to receive Iomab-B were offered a BMT, which is the only treatment option with curative potential for patients with active r/r AML. The SIERRA trial is the only randomized Phase 3 trial to offer BMT to this patient population. The control arm of SIERRA included over 20 single agents or combination treatment options based on physician’s choice, including salvage chemotherapy and recently approved targeted agents including Bcl-2 inhibitor (Venetoclax), FLT3 inhibitors and IDH 1/2 inhibitors as there is no standard of care for this patient population. The SIERRA trial enrolled patients at 24 leading transplant centers in the United States and Canada.

On April 25, 2022 Group reported that sales increase 11%1 at constant exchange rates (CER) and 10% in Swiss francs Pharmaceuticals Division sales up 6%; continued strong sales of new medicines for severe diseases (Press release, Hoffmann-La Roche, APR 25, 2022, View Source [SID1234612938]). Impact of biosimilars decreases as expected.

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Diagnostics Division sales grow 24% due to good momentum in base business and continued high demand for COVID-19 tests. After a strong first quarter, significant decline in COVID-19-related testing expected.
Highlights in the first quarter:
FDA approval of Vabysmo (severe eye diseases); CHMP recommends EU approval of Polivy combination (aggressive form of blood cancer), Tecentriq (early-stage non-small cell lung cancer) and mosunetuzumab (follicular lymphoma)
Positive long-term data for Evrysdi (spinal muscular atrophy) and for Vabysmo and Susvimo (severe eye diseases)
Roche provides molecular testing solutions to identify and differentiate SARS-CoV-2 Omicron variants

Outlook for 2022 confirmed
Commenting on the Group’s sales, Roche CEO Severin Schwan said: "As expected, we started the year with strong demand for our diagnostics base business, our broad portfolio of COVID-19 tests and our new medicines. I am particularly pleased about the progress we are making in developing our product pipeline, including positive new data in neurology as well as in severe eye diseases. Based on our current assessment of the development of the COVID-19 pandemic, we confirm the outlook for the full year."

*Asia-Pacific, CEETRIS (Central Eastern Europe, Turkey, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others

Outlook confirmed for 2022
Sales are expected to be stable or grow in the low-single digits (at constant exchange rates). Core earnings per share are targeted to grow in the low- to mid-single digit range (at constant exchange rates), including the accretive effect of the 2021 share repurchase. Roche expects to increase its dividend in Swiss francs further.

Roche anticipates sales of COVID-19 medicines and diagnostics to decrease by approximately CHF 2 billion to around CHF 5 billion, and sales losses to biosimilars in the current year to be roughly CHF 2.5 billion. Excluding those effects, Group sales are expected to grow in the high-single digit range.

Group results
In the first quarter of the year, Group sales rose by 11% (10% in CHF) to CHF 16.4 billion.

Pharmaceuticals Division sales increased by 6% to CHF 11.2 billion. Newly launched medicines to treat severe diseases continued their strong growth, including Ronapreve (COVID-19; mainly in Japan), Ocrevus (multiple sclerosis), Hemlibra (haemophilia), Evrysdi (spinal muscular atrophy) and Phesgo (breast cancer).

The impact of competition from biosimilars for the established cancer medicines Avastin, MabThera/Rituxan and Herceptin has further slowed down as expected (combined CHF 568 million of sales reduction).

In the United States, sales increased by 2%. Ocrevus, Hemlibra, Actemra/RoActemra, Tecentriq and Phesgo were the main growth drivers. This was partly offset by the expected impact of biosimilars.

In Europe, sales decreased by 1%. Growth of Ocrevus, Phesgo and Evrysdi and other innovative medicines was offset by the biosimilars impact and lower Ronapreve sales.

Sales in Japan significantly increased (+69%), driven by the high demand for Ronapreve and other innovative medicines, such as Polivy and Evrysdi.

Sales in the International region were stable. Sales growth of Perjeta, Ronapreve, Alecensa, Evrysdi, Hemlibra and Ocrevus was neutralised by the impact of biosimilars. In China, sales declined by 9% due to strong biosimilars competition; excluding China, sales increased by 5%.

The Diagnostics Division reported strong sales growth of 24% to CHF 5.3 billion. The division’s base business showed good momentum (+10%), especially in the immunodiagnostics business, with cardiac tests as key contributor.

Roche’s leading portfolio of COVID-19 tests remained a major sales driver, with increased demand for point-of-care and PCR tests. The portfolio contributed significantly to the division’s overall sales growth with a total of CHF 1.9 billion (CHF 1.2 billion in the first quarter of 2021).

Sales grew across all regions, driven by North America (59%) and Asia-Pacific (34%). Latin America reported a plus of 9%; Europe, Middle East and Africa (EMEA) grew 2%.

Pharmaceuticals: key development milestones in the first quarter of 2022

Ophthalmology
In January 2022, the FDA approved Vabysmo for the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular oedema (DME). In March, approval was granted in Japan. Neovascular AMD and DME are two leading causes of vision loss, together affecting around 40 million people worldwide.

In February, Roche presented promising longer-term data from its phase III studies of Vabysmo and Susvimo (nAMD). These results further reinforce the potential of both eye medicines to offer durable vision outcomes with fewer eye injections than the current standard of care, thus reducing the treatment burden for people with these conditions.

Oncology
In March, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the approval of Polivy combination therapy for the treatment of previously untreated diffuse large B-cell lymphoma (DLBCL). This is the most common form of non-Hodgkin lymphoma. The Polivy regimen is the first therapy in more than 20 years to significantly improve outcomes in this aggressive form of blood cancer.

Also in March, Roche announced that the phase III SKYSCRAPER-02 study, evaluating the investigational anti-TIGIT immunotherapy tiragolumab plus Tecentriq and chemotherapy as an initial treatment for people with extensive-stage small cell lung cancer (ES-SCLC), did not meet its co-primary endpoint of progression-free survival. The broad tiragolumab programme in other cancer types will be continued with high priority.

In April, the phase II acelERA trial on giredestrant did not meet its primary endpoint of progression-free survival in people with a certain form of advanced breast cancer. However, efficacy data were encouraging with a more pronounced benefit in patients with higher dependence on estrogen receptor activity. Overall survival data are still immature. The acelERA trial is the second randomized trial following the phase II coopERA trial in the neoadjuvant setting where giredestrant demonstrated improved efficacy and good safety. Giredestrant is being investigated in further clinical trials for patients with 1st line metastatic breast cancer and early breast cancer. Results from the acelERA trial will be presented at a medical meeting later this year.

Also in April, the CHMP recommended EU approvals of Tecentriq as adjuvant treatment for certain people with early-stage non-small cell lung cancer (eNSCLC) and of mosunetuzumab for the treatment of relapsed or refractory follicular lymphoma (FL).

If approved, Tecentriq will be the first and only cancer immunotherapy available for certain people with early-stage NSCLC in Europe, and mosunetuzumab will be the first CD20xCD3 T-cell engaging bispecific antibody available to treat FL offering a new, off-the-shelf, fixed-duration treatment option.

Neurosciences
At two neurology conferences (the Muscular Dystrophy Association Clinical and Scientific Conference and the American Academy of Neurology Annual Meeting), Roche presented new data from its growing neuroscience portfolio, including multiple sclerosis (MS), spinal muscular atrophy (SMA), neuromyelitis optica spectrum disorder (NMOSD), Alzheimer’s disease (AD) and Duchenne muscular dystrophy (DMD).

The new data underlined the longer-term efficacy and safety for Roche’s new medicines Ocrevus (MS), Evrysdi (SMA) and Enspryng (NMOSD).

New data for Ocrevus showed benefit in disability progression and cognitive decline in both secondary progressive and primary progressive MS. Roche is also focusing on making its clinical trials more inclusive: A separate analysis included findings from underrepresented populations, such as Black and Hispanic/Latino-American MS patients.
New data for Evrysdi (pivotal SUNFISH study) confirmed that increases in motor function were sustained at three years while adverse events decreased over the same period.
In addition, Roche and its partner Sarepta announced details of the phase III pivotal study (EMBARK) of delandistrogene moxeparvovec (SRP-9001), an investigational gene therapy for boys living with DMD.

Roche also presented baseline characteristics of its Alzheimer’s disease (AD) clinical programme with gantenerumab, a late-stage investigational subcutaneously administered monoclonal antibody. Data from the pivotal GRADUATE trials are expected in the fourth quarter of 2022.

COVID-19
The high rate of unvaccinated people will continue to put a strain on hospitals and healthcare systems around the world, furthering the need for effective COVID-19 treatments.

In April, the FDA granted priority review to Actemra/RoActemra for the treatment of COVID-19 in hospitalised adults. More than one million people with severe or critical COVID-19 have already been treated with Actemra/RoActemra worldwide, demonstrating the important role of this medicine in the fight against the pandemic. Roche has established a comprehensive access approach to improve the availability of its COVID-19 medicines around the world, such as implementing an international differential pricing strategy, specifically designed to address the needs during this pandemic.

Pharmaceuticals: Key development milestones in the first quarter of 2022

Compound Indication Milestone
Regulatory

Polivy combination Previously untreated diffuse large B-cell lymphoma CHMP recommendation of EU approval
Actemra/RoActemra COVID-19 in hospitalised adults FDA priority review; EU filing; WHO prequalification
Vabysmo Neovascular age-related macular degeneration (nAMD) and diabetic macular oedema (DME) US and Japan approval; EU filing
Tecentriq Adjuvant treatment for certain people with early-stage non-small cell lung cancer (eNSCLC) CHMP recommendation of EU approval
mosunetuzumab Relapsed or refractory follicular lymphoma (FL) CHMP recommendation of EU approval
Phase III / pivotal and other key readouts

Vabysmo Diabetic macular oedema (DME)

Phase III YOSEMITE and RHINE
(2-year data)
Susvimo Neovascular or ‘wet’ age-related macular degeneration (nAMD) Phase III Archway
(2-year data)
Ocrevus Complete spectrum multiple sclerosis (MS): SPMS and PPMS Phase III CONSONANCE
(1-year data)
Evrysdi SMA type 2 or 3: Long-term efficacy and safety in people aged 2–25 years Phase III
SUNFISH part 1 and 2
(3-year data)
Evrysdi Presymptomatic infants with SMA Phase II RAINBOWFISH ad interim data
Enspryng Neuromyelitis optica spectrum disorder (NMOSD): Long-term efficacy and safety Phase III SAkuraSky and SAkuraStar
tiragolumab + Tecentriq + chemotherapy First-line treatment of extensive-stage small cell lung cancer (ES-SCLC) Phase III
SKYSCRAPER-02: co-primary endpoint not met
delandistrogene moxeparvovec (SRP-9001) gene therapy Duchenne muscular dystrophy (DMD) Phase III study design, EMBARK
giredestrant ER-positive, HER2-negative locally advanced or metastatic breast cancer Phase II acelERA: primary endpoint not met
Diagnostics: key milestones in the first quarter 2022
In March, Roche and its subsidiary, TIB Molbiol, confirmed that they have molecular testing solutions to identify and differentiate SARS-CoV-2 Omicron variants of concern. It is critical to quickly and accurately identify variants to inform ongoing research and development of therapeutics and vaccines. This can potentially stop or slow down the advancement of the disease. In addition, differentiated testing helps public health professionals to plan and implement the necessary measures.

Also in March, Roche announced a collaboration with Bristol Myers Squibb to advance personalised healthcare through digital pathology solutions. This collaboration is among the first examples where artificial intelligence (AI) technology and digital pathology applications are playing a role in developing treatments for patients.

Pharmaceuticals sales

*Asia-Pacific, CEETRIS (Central Eastern Europe, Turkey, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others

Top-selling pharmaceuticals

*Asia-Pacific, CEETRIS (Central Eastern Europe, Turkey, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others

Pharmaceuticals sales: Selected top-selling and new medicines

Ocrevus (first approved in 2017; CHF 1.4 billion, +18%). Relapsing and primary progressive forms of multiple sclerosis; two-hour only infusion. The demand for this treatment in both indications remained strong, mainly in the United States, while the pandemic still had a certain negative impact. Sales growth in Europe across most countries, notably in Germany, Italy and UK.

Perjeta (first approved in 2012; CHF 993 million, +1%). HER2-positive breast cancer. Sales increased mostly due to high demand in China in both early and metastatic breast cancer settings. Sales growth in the International region (mainly China) was partly offset by sales decline in Europe due to the launch of Phesgo in 2020.

Hemlibra (first approved in 2017; CHF 853 million, +30%). Haemophilia A with and without factor VIII inhibitors; only prophylactic treatment that can be administered subcutaneously once weekly, every two or every four weeks. Sales continued to show an impressive uptake, especially in the United States and Europe.

Tecentriq (first approved in 2016; CHF 825 million, +8%). Cancer immunotherapy (either alone or in combinations) for various types of cancer, e.g. lung, bladder, breast and liver cancer. Sales increased mostly due to high demand in the United States and Europe. Sales in Japan decreased, primarily due to governmental price cuts.

Actemra/RoActemra2 (CHF 792 million, +3%). Rheumatoid arthritis, forms of juvenile idiopathic arthritis and giant cell arteritis, CAR T cell-induced severe or life-threatening cytokine release syndrome and COVID-19 pneumonia. The inclusion of this medicine in treatment guidelines for severe COVID-19-associated pneumonia by a number of countries drove sales growth, with the United States as a major contributor.

Herceptin2 (CHF 607 million, -19%). HER2-positive breast cancer and HER2-positive metastatic gastric cancer. The sales decrease was mainly due to biosimilar uptake in various countries.

Ronapreve (first approved in 2021; CHF 587 million, +272%). Antibody combination for the prevention and treatment of recently diagnosed high-risk patients with mild to moderate COVID-19. Roche is responsible for distribution in Europe and other countries outside the United States, its partner Regeneron is responsible for the United States. The sales growth in Japan was partly offset by the sales decline in Europe.

Avastin2 (CHF 581 million, -32%). Advanced colorectal, breast, lung, kidney, cervical and ovarian cancer, relapsed glioblastoma (a type of brain tumour) and liver cancer in combination with Tecentriq. Sales were heavily impacted by the uptake of biosimilars, mainly in the United States.

MabThera/Rituxan2 (CHF 564 million, -21%). Forms of blood cancer, rheumatoid arthritis and certain types of vasculitis. Sales further decreased due to the biosimilar erosion, notably in the United States.

Kadcyla (first approved in 2013; CHF 511 million, +9%). HER2-positive breast cancer. Sales growth was driven by the usage of Kadcyla in the early breast cancer setting. Sales benefited from patients switching to this new standard of treatment.

Xolair2 (CHF 456 million, +9%, United States only). Chronic spontaneous urticaria and allergic asthma. Steady sales growth in the chronic spontaneous urticaria indication. Xolair remains the market leader in the larger allergic asthma indication.

Alecensa (first approved in 2015; CHF 361 million, +23%). ALK-positive non-small-cell lung cancer. The global uptake continued with sales growth across all regions.

Lucentis2 (CHF 256 million, -26%, United States only). Eye conditions, including ‘wet’ age-related macular degeneration.

TNKase/Activase2 (CHF 247 million, -20%). Acute myocardial infarction (AMI).

Esbriet (first approved in 2014; CHF 241 million, -6%). Idiopathic pulmonary fibrosis (IPF).

Evrysdi (first approved in 2020; CHF 226 million, +189%). Spinal muscular atrophy (SMA) in adults and children two months of age and older. Evrysdi helps infants to survive without permanent ventilation. It is the first and only medicine for SMA that can be administered at home. Evrysdi continued to show a strong uptake across all regions, mainly in Europe.

Gazyva/Gazyvaro (first approved in 2013; CHF 165 million, +7%). Chronic lymphocytic leukaemia, rituximab-refractory follicular lymphoma and previously untreated advanced follicular lymphoma. Approved as a shorter duration infusion time of 90 minutes, compared to the standard infusion of 3-4 hours.

Phesgo (first approved in 2020; CHF 146 million, +410%). Early and metastatic HER2-positive breast cancer (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection). Offers faster administration in just minutes, compared to hours with standard intravenous administration. Sales continued to show a considerable uptake, especially in Europe and the United States.

Polivy (first approved in 2019; CHF 81 million, +89%). Relapsed or refractory diffuse large B-cell lymphoma; part of combination therapy; a fixed-duration treatment option for people with this aggressive form of blood cancer.

Enspryng (first approved in 2020; CHF 41 million, +216%). Rare autoimmune disease of the central nervous system (neuromyelitis optica spectrum disorder; NMOSD); first subcutaneous NMOSD treatment that can be self- or carer-administered at home. Enspryng has continued to show a very good uptake, with over 1,000 people with this rare disease treated to date (including newly diagnosed and previously treated patients).

Vabysmo (first approved in 2022; CHF 21 million3). Neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular oedema (DME), two leading causes of vision loss. Sales of this new eye medicine showed a good uptake.

Rozlytrek (first approved in 2019; CHF 16 million, +78%). Specific form of non-small cell lung cancer (NSCLC); solid tumours expressing a specific gene fusion; ROS1-positive, advanced NSCLC.

Susvimo (first approved in 2021; CHF 1 million3). Eye implant with continuous drug delivery for neovascular or ‘wet’ age-related macular degeneration (nAMD) treatment.

Diagnostics sales

Core Lab. Focuses on central labs; provides diagnostics solutions in the areas of immunoassays, clinical chemistry and custom biotech. Sales increased by 8% due to its immunodiagnostics business, with cardiac tests as main contributors. Sales grew across all regions, mostly in Asia-Pacific and EMEA. The US Core Lab business (excluding custom biotech) grew 10%.

Point of Care. Focuses on diagnostics solutions in emergency rooms, medical practices or directly with patients; includes SARS-CoV-2 rapid tests, blood gas and electrolyte tests. Continued significant sales growth of 84%. The SARS-CoV-2 Rapid Antigen test was the main growth driver, especially in North America.

Molecular Lab. Focuses on molecular labs; provides diagnostics solutions for pathogen detection and monitoring, donor screening, sexual health and genomics. Sales grew 21%, led by the virology business, mainly in EMEA and Asia-Pacific.

Diabetes Care. Focuses on integrated personalised diabetes management for people with diabetes and healthcare professionals. Sales decreased by 7%, as a result of the continued contraction of the blood glucose monitoring market due to people switching to continuous glucose monitoring systems. This was partly offset by higher demand in emerging markets. Excluding the base effect of the resolution of a rebate dispute in the first quarter of 2021, sales increased by 1%.

Pathology Lab. Focuses on pathology labs; provides diagnostics solutions for tissue biopsies and companion diagnostics. These targeted diagnostics support the specific therapy decisions for each patient. Sales increased by 14%, especially in North America and Asia-Pacific. This was mainly due to growth in the advanced staining business.

First Quarter Sales 2022 Webinar
There will be a live webinar for investors and analysts today, Monday, 25 April at 2:00 pm CEST. To access the webinar, please click here.

On April 25, 2022 OncoC4, Inc., a clinical stage biopharma company developing novel immunotherapies for cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ONC-392, the Company’s next-gen anti-CTLA-4 monoclonal antibody (mAb) that preserves the CTLA-4 immune checkpoint function, as a single agent for the treatment of patients with metastatic non-small cell lung carcinoma (NSCLC) who have had disease progression on prior anti-PD-(L)1 therapy (Press release, BioNTech, APR 25, 2022, View Source [SID1234655987]).

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"We are grateful for the Fast Track designation for ONC-392, which underscores the unmet need for new treatment options for patients with PD(L)-1-resistant NSCLC," said Yang Liu, PhD, co-founder, CEO and Chief Scientific Officer of OncoC4. "We look forward to more frequent interactions with the FDA to accelerate our clinical development path as we seek to bring this promising drug candidate to patients as expeditiously as possible. Our Phase 1b dose expansion study is ongoing for multiple indications, including PD(L)1-resistant NSCLC, with pivotal studies being planned in the near term."

Fast Track designation is intended to facilitate the development and expedite the review of new therapeutics for the treatment of serious or life-threatening conditions where there is an unmet medical need. The ONC-392 program may be eligible for more frequent meetings with the FDA to discuss the drug’s development plan ensuring collection of appropriate data needed to support approval, and more frequent written communications with the FDA regarding topics such as the design of the proposed clinical trials. Fast Track programs also have eligibility for rolling review as well as eligibility for Accelerated Approval and Priority Review if relevant criteria are met.

ONC-392 is currently in Phase 1 clinical testing to evaluate safety, pharmacokinetics, and efficacy as monotherapy and in combination with anti-PD-1 standard of care in advanced solid tumors and NSCLC (PRESERVE-001; NCT04140526). In recently completed Parts A and B of the study, OncoC4 observed promising clinical activity of ONC-392 in PD(L)1-resistant cancer, including NSCLC.

About NSCLC: Lung cancer, of which 84% are NSCLC, accounts for 25% of all cancer deaths, more than any other cancer, in the United States. Immunotherapy targeting PD(L)1 has been transformative for NSCLC in terms of lives saved. Unfortunately, most lung cancer remains resistant to PD(L)1-targeting therapy, and PD(L)1-resistant NSCLC is one of the biggest challenges for cancer immunotherapy and a huge unmet medical need. CTLA-4 is another clinically validated target although no CTLA-4-targeting drug has been approved as monotherapy for lung cancer.

About ONC-392: Based on decades of research led by OncoC4 co-founders, Drs. Yang Liu and Pan Zheng, OncoC4 is developing ONC-392, a nextgen anti-CTLA-4 mAb that most effectively and selectively eliminates regulatory T cells, a major culprit of immune evasion, in the tumor microenvironment. Unlike traditional anti-CTLA-4 antibodies, ONC-392 does not cause lysosomal degradation of CTLA-4 and thus preserves the immune tolerance checkpoint function of CTLA-4 in the rest of the body. As a result, ONC-392 has a much-improved therapeutic index compared to other CTLA-4-targeting drugs.

About the PRESERVE-001 Trial (NCT04140526): The trial is conducted to assess the safety, pharmacokinetics, and efficacy of ONC-392 as a single agent in advanced solid tumors and in combination with anti-PD(L)1 standard of care in Non- Small Cell Lung Cancer and other solid tumors. The study consists of three linked parts: Part A is a dose-finding rapid titration study of ONC-392 as a single agent in patients with advanced solid tumors of various histologies to define the recommended Phase II dose for ONC-392 monotherapy (RP2D-M); Part B is dose-finding for combination with standard dose of pembrolizumab (Part B) to define the Recommended Phase II dose for ONC-392 combination therapy (RP2D-C); and Part C comprises expansion cohorts of ONC-392 in monotherapy and in combination therapy with pembrolizumab to determine safety and initial efficacy.

On April 25, 2022 F. Hoffmann-La Roche Ltd. (hereafter "Roche") [Head Office: Basel, Switzerland. CEO: Severin Schwan] reported its first quarter sales 2022 (January 1 – March 31, 2022) (Press release, Hoffmann-La Roche, APR 25, 2022, View Source [SID1234612868]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Roche owns 59.89% of Chugai’s outstanding shares (61.16% of voting rights) as of the end of December 2021.

Its investor update and presentation materials can be found on its website (View Source).
Chugai’s performance for the period of January 1 to March 31, 2022 is included in the announced Roche Group’s results.