On October 31, 2019 The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) granted Shreis Scalene Sciences (Shreis), in Gaithersburg, MD, ‘Breakthrough Device Designation’ for the CYTOTRON – a CE marked, whole-body therapeutic medical device (Press release, Shreis Scalene Sciences, OCT 31, 2019, View Source [SID1234550159]). "We are confident that the FDA will continue to interact with Shreis under the premises of the recent guidance (Breakthrough Devices Program), to enable the marketing submission, with the clinical datasets needed to support it," said Prof. Meena Augustus, Co-Founder CEO & CSO of Shreis. The company’s designation request stated that "The Cytotron is intended to be used to cause degeneration of uncontrolled growth of tissues. It is indicated for treating protein-linked, abnormally regenerating disorders such as neoplastic disease, by selectively targeting and enabling tissue apoptosis, allowing extended progression-free survival, with pain relief, palliation, improved quality and dignity of life. It is indicated for the treatment of solid tumors of the breast, liver, and pancreas."

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Dr. Rajah Vijay Kumar D.Sc., Inventor of the Cytotron and Shreis’ technology partner, at Scalene Cybernetics Ltd (SCL), and the Scalene Center for Advanced Research & Development (S-CARD), located in Bengaluru, India, said, "The clinical trial with this non-invasive, tissue engineering platform technology called Quantum Magnetic Resonance Therapy (QMRT) could eventually help to establish the Cytotron as an integral adjunct to existing standards of care in the cancer armamentarium."(Cytotron Publication, 2016)

"We are very encouraged by the breakthrough designation that will expedite review of an Investigational Device Exemption and future marketing application by the FDA, " said Rayol John Augustus Ph.D., Founder-President and COO of SSS-LLC. The diligent support of Dr. R.V. Kumar D.Sc., the dedicated efforts of Emergo by UL based in Austin, Texas, the Shreis’ regulatory team, the staff of SCL and S-CARD, helped ensure a favorable decision by the FDA.

Shreis, while actively pursuing collaborations for clinical trials in the current proposed indications for use, intend to also submit a request for Breakthrough designation in other solid tumors such as adult and pediatric brain tumors, lung cancer, and other life-limiting diseases.

On October 31, 2019 Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) reported that it will release its third quarter 2019 financial results and provide a corporate update on Thursday, November 7, 2019, after the close of the U.S. financial markets (Press release, Arena Pharmaceuticals, OCT 31, 2019, View Source [SID1234550158]). The Company will host a conference call and live webcast to discuss the results with the investment community the same day at 4:30 PM EST.

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Conference Call & Webcast Information
When: Thursday, November 7, 2019, at 4:30 PM EST
Dial-in: (877) 643-7155 (United States) or (914) 495-8552 (International)
Conference ID: 2598434

Please join the conference call at least 10 minutes early to register. You can access the live webcast under the investor relations section of Arena’s website. A replay of the conference call will be archived under the investor relations section of Arena’s website for 30 days after the call.

On October 31, 2019 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics, reported a regulatory and clinical update on IDE196 following receipt of meeting minutes from an End‑of‑Phase 1 (EOP1) meeting with the FDA (Press release, Ideaya Biosciences, OCT 31, 2019, View Source [SID1234550157]). IDE196 is being evaluated for the treatment of MUM and other solid tumors harboring activating GNAQ or GNA11 (GNAQ/11) mutations in its ongoing Phase 1/2 clinical trial entitled "Patients with Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions" (ClinicalTrials.gov Identifier: NCT03947385).

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"Following FDA feedback from the EOP1 meeting, we plan to initiate the Phase 2 single-arm, potentially registration-enabling clinical trial of IDE196 monotherapy. This arm of our clinical trial will target enrollment of 60 evaluable MUM patients with blinded independent central review (BICR)‑determined overall response rate (ORR) as the primary endpoint," said Bao Truong, Vice President, Head of Regulatory Affairs at IDEAYA Biosciences. "We look forward to the continued clinical advancement of IDE196 in MUM and in our broader tissue-type agnostic basket trial to treat other solid tumors that harbor activating GNAQ/11 mutations, including in cutaneous melanoma and colorectal cancer," said Julie Hambleton, M.D., Chief Medical Officer and Senior Vice President at IDEAYA Biosciences.

Regulatory and Clinical Program Highlights for IDE196:

FDA EOP1 meeting minutes indicate that the proposed single-arm Phase 2 IDE196 clinical trial may be adequate to support a new drug application (NDA) seeking Accelerated Approval of IDE196 monotherapy for the treatment of MUM
Phase 2 dose selection, and the single-arm, potentially registration‑enabling Phase 2 part of the Phase 1/2 clinical trial is anticipated to be initiated in Q4 2019
This Phase 2 clinical trial will target enrollment of 60 evaluable MUM patients with the primary endpoint of overall response rate (ORR) as determined by blinded independent central review (BICR), supported by BICR‑determined duration of response (DOR) as a secondary endpoint
The 13-week GLP-compliant toxicology studies in 2 species is scheduled to initiate in November 2019, in support of FDA requirement that results of these studies be submitted prior to enrollment of more than approximately 50 patients in the investigational arm of the clinical trial that will support a marketing application
An immediate release tablet formulation for IDE196 is on-track for introduction in the clinic in Q1 2020, as a potential registration and commercial formulation
Interim data for GNAQ/11 Phase 1/2 basket trial expected in Q2/Q3 2020
Confirmed Complete Response observed at month 31 in one patient previously reported with confirmed Partial Response in the ongoing IDE196 monotherapy clinical trial conducted by Novartis (ClinicalTrials.gov Identifier: NCT02601378)
"We are grateful for the regulatory feedback from the FDA on our single-arm trial design, providing an opportunity for a potential Accelerated Approval path for IDE196 monotherapy in MUM, a high unmet medical need and a solid tumor indication where there are no FDA approved therapies. We are also encouraged to see continued progress in our tissue-type agnostic GNAQ/11 Phase 1/2 basket trial to treat solid tumor patients beyond MUM," said Yujiro S. Hata, Chief Executive Officer and President at IDEAYA Biosciences.

On October 31, 2019 Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, reported that UVADEX (methoxsalen) has received regulatory approval in Australia by the Therapeutic Goods Administration (TGA) for extracorporeal administration with the THERAKOS CELLEX Photopheresis System (Press release, Mallinckrodt, OCT 31, 2019, View Source [SID1234550156]). The treatment is indicated for steroid-refractory and steroid-intolerant chronic graft versus host disease (cGvHD) in adults following allogeneic hematopoietic stem cell (HSC) transplantation. The TGA also approved Uvadex in conjunction with the THERAKOS CELLEX Photopheresis System for the palliative treatment of skin manifestations of cutaneous T-cell lymphoma (CTCL) that is unresponsive to other forms of treatment.

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The TGA approval marks the first combined indication label and the first regulatory approval in the world for UVADEX in conjunction with the THERAKOS Photopheresis System for the treatment of chronic graft versus host disease in adults.

"The TGA approval of UVADEX with the Therakos ECP platform opens up new treatment options for patients with these challenging conditions," said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer, Mallinckrodt. "The cGvHD indication is also an important milestone for Mallinckrodt, confirming the potential benefit of this therapeutic option for patients who are refractory to or intolerant of steroid treatments."

About Chronic Graft Versus Host Disease (cGvHD)
Graft-versus-host-disease is a common complication of hematopoietic stem cell (HSC) transplantation resulting in significant morbidity and mortality.1 It can be classified as acute or chronic based on the clinical presentation and the time of occurrence after the transplantation. Signs and symptoms of cGvHD nearly always occur within the first year post transplantation but can occasionally happen several years later.2 In cGvHD, the skin is the most frequently affected organ with manifestations of itchy rash, hyper or hypopigmentation and changes in texture. However, the disease can affect multiple sites, which may have a major impact upon a patient’s quality of life.2,3 Chronic GvHD can lead to debilitating consequences, such as joint contractures, loss of sight, end-stage lung disease, or mortality resulting from profound chronic immune suppression leading to recurrent or life-threatening infections.1

About Cutaneous T-Cell Lymphoma (CTCL)
Cutaneous T-cell lymphoma (CTCL) is an umbrella term for a group of non-Hodgkin lymphomas involving T lymphocytes that localize in the skin. It is a relatively rare cancer, with 2,500 to 3,000 new cases per year in the United States.4 The age of onset of the condition is typically greater than 50 years, with the incidence rising significantly in the later decades of life.5 CTCL causes visible skin symptoms ranging from a small rash to extensive redness, peeling, burning, soreness, and itchiness all over the body.6,7 CTCL falls into different categories based on the severity of the disease and symptoms.8

Minimum Product Information: UVADEX (methoxsalen) Concentrated Injection for extracorporeal circulation via photopheresis (ECP)

This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems.

Indications in Australia: UVADEX (methoxsalen) is indicated for extracorporeal administration with the THERAKOS CELLEX Photopheresis System for the:

treatment of steroid‑refractory and steroid‑intolerant chronic graft versus host disease (cGVHD) in adults following allogeneic HSC transplantation.
palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL) that is unresponsive to other forms of treatment.
Contraindications: History of idiosyncratic or hypersensitivity reaction to methoxsalen, psoralen compounds or any excipients of UVADEX; co‑existing melanoma, basal cell or squamous cell skin carcinoma; lactation; aphakia. ECP procedure contra-indications: Photosensitive disease; inability to tolerate extracorporeal volume loss; WBC count > 25,000 mm3; previous splenectomy; coagulation disorders. Special warnings and precautions: Only physicians who have special competence in the diagnosis and treatment of cGVHD and CTCL who have special training and experience with the THERAKOS CELLEX Photopheresis System should use UVADEX. Men and women being treated with UVADEX should take adequate contraceptive precautions both during and after completion of photopheresis treatment. Exposure to large doses of UVA causes cataracts in animals, an effect enhanced by the administration of oral methoxsalen. The patient’s eyes should be protected from UVA light by wearing wrap‑around, UVA‑opaque sunglasses during the treatment cycle and during the following 24 hours. Exposure to sunlight or ultraviolet radiation (even through window glass) may result in serious burns and, in the long‑term, "premature aging" of the skin therefore patients should avoid exposure to sunlight during the 24 hours following photopheresis treatment. Thromboembolic events, such as pulmonary embolism and deep vein thrombosis, have been reported with UVADEX administration through photopheresis systems for treatment of patients with graft versus host disease. This product contains 4.1% w/v ethanol and each 1 mL of UVADEX contains 40.55 mg of ethanol. Caution is advised in patients with liver disease, alcoholism, epilepsy, brain injury or disease. No specific information is available for use in renal or hepatic impairment and there is no evidence for dose adjustment in the elderly. The safety and efficacy of UVADEX have not been established in children. Use in pregnancy: Category D. Use in Lactation: UVADEX is contra-indicated. Interactions with other medicines: Effects on P450 system metabolism may affect clearance / activation of other drugs (caffeine, paracetamol) or may extend the methoxsalen half-life leading to prolonged photosensitivity in patients. Methoxsalen binding to albumin may be displaced by dicoumarol, warfarin, promethazine and tolbutamide with potential for enhanced photosensitivity. Caution when treating with concomitant photosensitising agents. Adverse effects: In the clinical trials, published information and postmarketing surveillance of UVADEX/ECP, adverse events were usually mild and transient and in most cases, related to the underlying pathology. Very common: diarrhoea, anaemia, nausea, headache, hypertension, sinusitis, upper respiratory tract infection, fatigue, pain in extremity, pyrexia, cough, dyspnoea, cushingoid, dry eye, photophobia, toothache, anorexia. Common: depression, lacrimation increased, abdominal pain, hypokalaemia, paraesthesia oral, pharyngolaryngeal pain, tachycardia, conjunctivitis, eye pain, visual acuity reduced, dysphagia, chills, mucosal inflammation, nasopharyngitis, contusion, blood pressure diastolic decreased, haemoglobin decreased, hyperglycaemia, hypocalcaemia, neuropathy peripheral, tremor, rash, hypotension. Additional adverse effects seen in clinical trials include vomiting, infections. Adverse events related to the ECP/CELLEX procedure – thromboembolism and severe allergic reactions, vascular access complication, vasovagal spasm, hickman catheter infection/thrombosis, headache, hypercoagulability, haemolysis. Additional adverse events identified post-marketing: anaphylactic reaction, allergic reaction, dysgeusia, exacerbation of congestive heart failure, sepsis, endocarditis, and vomiting. Dosage and Administration: Chronic Graft versus Host Disease: Three ECP treatments in the first week then two ECP treatments per week for at least 12 weeks, or as clinically indicated. Cutaneous T-cell Lymphoma: ECP treatment on two successive days each month for six months. Patients who show an increase in skin scores after eight treatment sessions may have their treatment schedule increased to two successive days every two weeks for the next three months. Refer to full Product Information and THERAKOS CELLEX Operator’s Manual for information regarding administration.

Store below 25°C. Date of first approval: 16 September 2019. Date of revision: 11 October 2019.

Indications and Prescribing Information for Uvadex vary globally. Please refer to the individual country product label for complete information.

Before prescribing Uvadex, please refer to the full Product Information also available by calling + 1 800.778.7898.

ABOUT THERAKOS
Mallinckrodt is the world’s only provider of approved, fully-integrated systems for administering immunomodulatory therapy through ECP. Its Therakos ECP platforms, including the latest generation THERAKOS CELLEX Photopheresis System, are used by academic medical centres, hospitals, and treatment centres in nearly 40 countries and have delivered more than 1 million treatments globally. For more information, please visit www.therakos.co.uk.

Terumo BCT is the exclusive distributor of the Therakos ECP platform in Australia, as well as Latin America and select countries in Europe. To learn more about Terumo BCT, visit www.terumobct.com.

UVADEX (methoxsalen) and THERAKOS CELLEX Photopheresis Systems are separately approved in a number of global markets. Please refer to your local approved labelling for Uvadex and the Operator’s Manual for CELLEX for more information on approved uses for specific indications.

On October 31, 2019 Sumitomo Dainippon Pharma Co., Ltd. (TSE: 4506), a leading Japanese pharmaceutical company, and Roivant Sciences Ltd., a technology-enabled healthcare company, reported that they have signed a definitive agreement for the creation of a novel and broad Strategic Alliance and to form a new company (the "New Company") owned and supported by Sumitomo Dainippon Pharma (Press release, Sumitomo Dainippon Pharma, OCT 31, 2019, View Source [SID1234550155]).

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As previously announced, this will include the transfer to Sumitomo Dainippon Pharma of Roivant’s ownership interests in five of their biopharmaceutical companies ("Vants") and access to Roivant’s proprietary technology platforms, DrugOme and Digital Innovation. In addition, Sumitomo Dainippon Pharma will take an equity stake of over 10% of shares outstanding in Roivant and will have options (the "Options") to acquire Roivant’s ownership interests in up to 6 additional Vants by 2024. These 11 Vants collectively have more than 25 innovative clinical programs, with multiple potential product launches expected from 2020 to 2022.

The transaction will be subject to customary closing conditions and any required governmental approvals. Roivant will receive USD $3 billion from Sumitomo Dainippon Pharma as a payment to enter the Alliance. Exercise of the Options by Sumitomo Dainippon Pharma will trigger additional payments to Roivant. In addition, Sumitomo Dainippon Pharma will enter separate strategic client relationships with Datavant and Alyvant to augment development and commercialization activities.

In addition to Myovant Sciences, Urovant Sciences, Enzyvant Therapeutics, and Altavant Sciences, the fifth Vant in the Alliance will be Spirovant Sciences, a newly unveiled Vant focused on developing innovative gene therapies for cystic fibrosis.

Sumitomo Dainippon Pharma plans to provide financial support to the five Vants in the New Company and intends to leverage potential benefits associated with Sumitomo Dainippon Pharma’s global commercial infrastructure. The New Company will be led by CEO Myrtle Potter, Vant Operating Chair at Roivant Pharma. Additional management team members will include Adele Gulfo, Chief of Commercial Development at Roivant Pharma, Dr. Sam Azoulay, Chief Medical Officer at Roivant Pharma, and Dan Rothman, Chief Information Officer.

Prior to joining Roivant, Ms. Potter served as President and Chief Operating Officer of Genentech. Under her leadership, Genentech achieved record sales and earnings growth each year. Prior to Genentech she was President of Bristol-Myers Squibb’s U.S. Cardiovascular and Metabolic business. Potter is a graduate of the University of Chicago, and she serves on the university’s board of trustees and also on the board of Liberty Mutual Insurance Group. She has also served on the boards of Amazon, Express Scripts, Medco Health Solutions, and Rite Aid.

"I am happy to announce that we have reached an agreement on the Strategic Alliance with Roivant, one of the strategic investments that we are making to address our challenges laid out in the Mid-Term Business Plan 2022," said Hiroshi Nomura, Representative Director, President and CEO of Sumitomo Dainippon Pharma. "This Strategic Alliance allows us to not only acquire potential blockbusters and innovative health technology platforms developed by Roivant, but it will also enable us to deepen our relationship with Roivant, a company that possesses an innovative business model and underlying culture. We expect this relationship will contribute significantly to the establishment of a position as a ‘Global Specialized Player’ which we aspire to be in by 2033."

"We are proud to enter this unique Alliance with Sumitomo Dainippon Pharma," said Vivek Ramaswamy, Founder and CEO of Roivant Sciences. "We hope that our contributions to this Alliance will enable Sumitomo Dainippon Pharma to realize its vision to be a global leader in the biopharmaceutical industry. In addition, we believe that this Alliance will increase the long-term value of each Vant in the Alliance through a combination of strong financial backing and other capabilities."