Biogen has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On April 25, 2017 Immune Therapeutics, Inc. (OTCQB: IMUN), a clinical-stage biopharmaceutical company developing therapies for a range of conditions using LodonalTM its proprietary formulation of lower-dose naltrexone, reported it has submitted its New Drug Application (NDA) to the Pharmacy and Poison Board (PPB) in Kenya for Lodonal for the treatment of patients with HIV and cancer, both as a standalone treatment as well as an adjunct treatment, and as an immunomodulator (Press release, TNI BioTech, APR 25, 2017, View Source [SID1234518733]).

"This NDA submission initiates the process we believe will result in broad access to our therapy for those suffering from immune deficiency disease and cancer." said Noreen Griffin, Chief Executive Officer of Immune Therapeutics. "We recognize the difficulty the immune-comprised community has had in obtaining affordable non-toxic therapies and look forward to working closely with the PPB as they review our application."

A full preclinical and clinical study program supports the filing including: four clinical efficacy trials involving more than 500 HIV/AIDS patients, and one clinical trial with 89 patients for cancer and over 1,200 patients with autoimmune disease. The clinical data showed that Lodonal could improve CD4 count, decrease viral load and reduce the number of opportunistic infections in patients suffering from comprised immune systems.

Omaera Pharmaceuticals, Ltd. and GB Pharma Holding supported this filing. "Without their support, the fast track of this process would not have been possible." noted Griffin. The PPB had a 60-day filing review period to determine whether the NDA is complete and acceptable for filing. "The application was accepted and the company has received an application number. From there, we will move through the regulatory approval process including manufacturing (GMP) assessment, National Quality Control laboratory analysis, regulatory committee review and committee recommendations before the board issues its final ruling. The approval process could take as little as 90 days, after which we will be prepared to take orders for shipment through our recently announced distribution agreement." concluded Griffin. The Company plans to reach commercialization for Lodonal in Kenya in 2017.

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"We look forward to a smooth regulatory process for Lodonal in Kenya. We have significant experience with Kenya’s PPB and have meetings planned with the Ministry of Health before the end of the month." notes Dr. Gloria B. Herndon, President and CEO of GB Pharma Holdings of Washington, DC.

On April 25, 2017 Servier and CTI BioPharma Corp. (CTI BioPharma) (NASDAQ and MTA: CTIC) jointly reported that they agreed to expand their existing license and development collaboration agreement for PIXUVRI (pixantrone) (Press release, CTI BioPharma, APR 24, 2017, View Source;p=RssLanding&cat=news&id=2264222 [SID1234518679]). Under this expanded agreement, Servier will have rights to PIXUVRI in all markets except the US, where CTI BioPharma will retain the commercialization rights. Servier will pay CTI BioPharma €12 million with the potential for CTI BioPharma to receive €76 million in additional sales and regulatory milestone payments as well as royalties on net product sales.

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PIXUVRI has been granted conditional marketing authorization from the European Commission for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphoma (NHL).i As a specific post-authorization requirement, PIXUVRI is currently being investigated in a Phase III clinical trial, PIX306. If positive, the results from this trial will confirm the treatment’s current indication and could support broader indications.

In 2014, CTI granted Servier rights to commercialize the drug globally except in Austria, Denmark, Finland, Germany, Israel, Norway, Sweden, Turkey, UK and the US. With this expanded agreement, which provides Servier’s rights to all markets except the US, the companies will continue to work closely together to build the efficacy and safety evidence for PIXUVRI and to ensure that as many eligible patients as possible are benefitting from it.

"Over the past three years, we have worked hand in hand with our partner, CTI BioPharma, to bring new treatment options to patients in Europe," said U. Marion Schrenk, MD, Head of Therapeutic Area Oncology of Servier. "We are looking forward to leveraging our expertise in these additional markets to ensure more eligible patients have access to PIXUVRI. Oncology is an important focus for us, and we are fully committed to working with our partners, researchers and scientists to provide patients with novel therapeutic options in areas with high unmet needs."

"Servier is an important strategic partner for us and has helped bring PIXUVRI to many patients," said Adam R. Craig, President and CEO of CTI BioPharma. "We look forward to our expanded partnership as we aim to complete the PIX306 trial in the near-term."

About PIXUVRI (pixantrone)
PIXUVRI is a cytotoxic medicine that works by interfering with the DNA within cells and preventing them from making more copies of DNA. This means that the cancer cells in B-cell NHL cannot divide and eventually die.ii

PIXUVRI is conditionally approved in the EU as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell NHL. The benefit has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy.

The Summary of Product Characteristics (SmPC) has the full prescribing information, including the safety and efficacy profile of PIXUVRI in the approved indication. The SmPC is available at www.servier.com.

About NHL
NHL is an uncommon type of cancer that affects the lymphatic system, which is defined as a network of vessels and glands that run throughout the body.iii The lymphatic system is a key component of the immune system, as it plays a role in destroying old or abnormal cells and fighting bacteria and other infections.iv

Around 93,500 new cases of NHL were diagnosed in Europe in 2012, making it the eleventh most common cancer on the continent.v

NHL comprises more than 60 subtypes, with each requiring a different diagnostic evaluation and treatment approaches. Lymphoma patient groups around the world, led by the umbrella group Lymphoma Coalition, have been recently calling for accurate subtype reporting to allow patients to clearly understand their subtype and have better communication with their doctors. Given the complexities of the condition, access to information is essential to empower patients.

On April 24, 2017 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) reported that it will publish its first three months’ 2017 results on May 3, 2017 at 7:00 am CEST (Press release, MorphoSys, APR 24, 2017, View Source [SID1234556343]).

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At 3:00 pm CEST (2:00 pm BST, 9:00 am EDT), the Management Board of MorphoSys AG will host a public conference call and webcast to present MorphoSys’s first quarter interim statement 2017 and provide further details on the Company’s latest developments.

Dial-in numbers (listen only):

Germany: +49 89 2444 32975

United Kingdom: +44 20 3003 2666

USA: +1 202 204 1514

We request that you please dial in up to 10 minutes before the call to ensure a prompt start and a secure line.

The presentation slides and webcast link will be available at the Company’s website at www.morphosys.com/conference-calls
A slide-synchronized audio replay of the conference will also be available at the corporate website following the live event.

The Annual General Meeting of MorphoSys AG will take place on May 17, 2017 in Munich. A live webcast of the event and all related information are available on www.morphosys.com/agm.

On April 20, 2017 Polaris Group reported that its lead therapeutic ADI‑PEG 20 (pegylated arginine deiminase) in combination with pemetrexed and cisplatin (ADIPemCis) demonstrated a good safety profile and a strong efficacy signal in argininosuccinate synthetase (ASS1) deficient malignant pleural mesothelioma (MPM) and non-small cell lung carcinoma (NSCLC), as reported in the Journal of Clinical Oncology (Press release, Polaris Pharmaceuticals, APR 20, 2017, View Source [SID1234526286]). In the first nine patients (5 MPM, 4 NSCLC) enrolled in the dose escalation cohorts of this biomarker-directed phase 1 study, partial response was seen in 7 patients (4 MPM, 3 NSCLC). The study was led by Dr. Peter Szlosarek of Barts Cancer Center, Queen Mary University of London, and involved multiple sites in the United Kingdom.

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The main goal of this phase 1 study is to determine the recommended phase 2 dose, safety and tolerability of ADIPemCis in patients with ASS1-deficient MPM and NSCLC. The nine enrolled patients were treated with fixed-dose pemetrexed and cisplatin (PemCis), the standard first-line chemotherapy for MPM and NSCLC, in combination with increasing doses of ADI‑PEG 20. The treatment appeared to be safe and well tolerated. Notably, three out of four MPM patients with a partial response had non-epithelioid tumor histology, which carries an unfavorable prognosis and historically responded poorly to chemotherapy.

"Based on the encouraging efficacy signal from these preliminary results, we have initiated a randomized, double blind, phase 2/3 trial comparing ADIPemCis with PemCis in patients with non-epithelioid MPM," said John Bomalaski, M.D., Executive Vice President, Medical Affairs at Polaris Pharmaceuticals, Inc. "With ADIPemCis, we hope to bring an effective treatment to this subset of MPM patients, who have a dire need for medical intervention."

About ADI‑PEG 20

ADI‑PEG 20 is a biologic being developed by Polaris Group to treat cancers carrying a major metabolic defect that renders them unable to internally synthesize arginine. Because arginine is essential for protein synthesis and survival of cells, these cancer cells become dependent upon the external supply of arginine to survive and grow. ADI‑PEG 20 is designed to deplete the external supply of arginine, causing arginine-dependent cancer cells to die while leaving the patient’s normal cells unharmed. Multiple cancers have been reported to have a high degree of arginine-dependency and can potentially be treated with ADI‑PEG 20.