On January 22, 2018 Genmab A/S (Nasdaq Copenhagen: GEN) reported that Novartis (SIX Swiss Exchange: NOVN) intends to transition Arzerra (ofatumumab) for the treatment of certain chronic lymphocytic leukemia (CLL) indications from commercial availability to limited availability via compassionate use programs in all markets around the world except the United States (Press release, Genmab, JAN 22, 2018, View Source [SID1234523372]). Novartis will work with regulatory authorities to establish compassionate use programs for patients outside the US currently being treated with Arzerra as an ongoing treatment, to ensure continuity of treatment for all patients who benefit from Arzerra. As a consequence, Novartis will pay Genmab a lump sum of USD 50 million as payment for lost potential milestones and royalties. This amount will be included in Genmab’s 2018 guidance which will be issued on February 21, 2018. Royalties will continue to be earned on net sales of Arzerra. Arzerra is marketed under a collaboration agreement between Genmab and Novartis.

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"Novartis’ intention to transition Arzerra to compassionate use programs in the non-US markets reflects the fact that many more drugs have become available for CLL over the last five years and that there is a low number of patients using Arzerra outside of the US market. The compassionate use programs will ensure that patients who benefit from Arzerra can remain on treatment. We welcome the continued commercial availability of Arzerra for US patients," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Patients accessing the compassionate use program will be offered continued treatment with Arzerra for as long as they benefit from it, free of charge.

Novartis intends to start the transition process as soon as a carefully structured plan has been agreed with the various regulatory authorities.

The two Phase III studies of ofatumumab currently ongoing in Relapsing Multiple Sclerosis and the study of Arzerra in indolent non-Hodgkin lymphoma will continue.

About Ofatumumab (Arzerra)
Ofatumumab is a human monoclonal antibody that is designed to target the CD20 molecule found on the surface of chronic lymphocytic leukemia (CLL) cells and normal B lymphocytes.

In the United States, Arzerra is approved for use in combination with chlorambucil for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate, for use in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed CLL, and for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL. In the European Union, Arzerra is currently approved for use in combination with chlorambucil or bendamustine for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy and in combination with fludarabine and cyclophosphamide for adult patients with relapsed CLL. In more than 60 countries worldwide, including the United States and EU member countries, Arzerra is also currently indicated as monotherapy for the treatment of patients with CLL who are refractory after prior treatment with fludarabine and alemtuzumab.

Please consult the full European Summary of Product Characteristics and full US Prescribing information, including Boxed Warning, for all the labeled safety information for Arzerra.

Under the collaboration with Novartis, a subcutaneous formulation of ofatumumab is also being investigated in two Phase III clinical studies in relapsing multiple sclerosis.

Novartis has rights to develop ofatumumab in autoimmune indications, including multiple sclerosis.

On January 22, 2018 Harbour BioMed reported that it has completed a Series A+ round financing to accelerate its growth, especially the development of multiple clinical programs (Press release, Harbour BioMed, JAN 22, 2018, View Source [SID1234523461]). The A+ round is financed by CDH Investments, a top PE firm in China, with A round investor Advantech Capital participating. Financial details were not disclosed.

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"Within the first year of operation, Harbour BioMed has successfully acquired and integrated the antibody platform company Harbour Antibodies BV, and transformed into a biopharmaceutical company with multifaceted core business. We are building a top-notch antibody discovery and technology team specialized in Immuno-Oncology and Immunology, developing a robust internal pipeline targeting global market, in licensing innovative assets to address high unmet needs for the China market, and forging new partnerships based on internal technology platforms. This progress has been highly recognized by investors and the market," said Dr. Jingsong Wang, CEO of Harbour BioMed. "We are very pleased to collaborate with leading investors such as CDH Investments to accelerate the development of our clinical stage biologic assets, and to strengthen our partnering capabilities."

Dr. Wang noted that in September 2017, Harbour BioMed licensed in two innovative clinical stage biologics, and has assembled an experienced clinical development and regulatory science team. In 2018, Harbour BioMed plans to submit at least two IND targeting multiple indications in areas of high unmet medical needs for Chinese patients.

Harbour BioMed was established in 2016 with $50 million A round financing, and acquired Harbour Antibodies BV and its subsidiaries, one of the few companies that owns technologies for generating fully human monoclonal antibodies, of both conventional as well as heavy chain only form. Current investors of Harbour BioMed include Atlas Venture, Advantech Capital, Legend Capital, CDH Investments and founding team. Harbour BioMed is headquartered with R&D Centers in China. It also has a Business Operation and Innovation Center in Boston, and an Antibody Technology Innovation Center located in Rotterdam, The Netherlands.

On January 22, 2018 VistaGen Therapeutics Inc. (NASDAQ: VTGN), a clinical-stage biopharmaceutical company focused on developing new generation medicines for depression and other central nervous system (CNS) disorders, reported that Shawn Singh, Chief Executive Officer of VistaGen, will provide an update on the Company’s Phase 2 study of AV-101 as an oral new generation adjunctive treatment for Major Depressive Disorder (MDD) and outline key 2018 initiatives at the 14th Annual Noble Capital Markets’ Investor Conference – NobleCon14 – to be held at the W Fort Lauderdale hotel in Fort Lauderdale, FL on Monday, January 29th at 4:30 p.m. ET (Press release, VistaGen Therapeutics, JAN 22, 2018, View Sourcenews/detail/80/vistagen-therapeutics-to-provide-update-on-phase-2-study-for-major-depressive-disorder-and-outline-key-2018-initiatives-at-the-14th-annual-noble-capital-markets-investor-conference" target="_blank" title="View Sourcenews/detail/80/vistagen-therapeutics-to-provide-update-on-phase-2-study-for-major-depressive-disorder-and-outline-key-2018-initiatives-at-the-14th-annual-noble-capital-markets-investor-conference" rel="nofollow">View Source [SID1234523421]).

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The event will be available via video webcast on VistaGen’s investor relations website, View Source, the day following the live presentation.

For more information about NobleCon14, or to schedule a one-on-one meeting with VistaGen’s management, please contact your Noble Capital Markets representative directly, or visit the conference website here.

On January 22, 2018 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported that it will webcast its Quarterly Update Conference Call for the fourth quarter 2017 on Tues., Feb. 20 at 4:30 p.m. ET/1:30 p.m. PT (Press release, Halozyme, JAN 22, 2018, View Source [SID1234523415]). Dr. Helen Torley, president and chief executive officer, will lead the call. On the same date, Halozyme will release financial results for the fourth quarter and year-ended December 31, 2017 following the close of trading.

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The call will be webcast live through the "Investors" section of Halozyme’s corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit the Investors page of www.halozyme.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. The live call may be accessed by dialing (877) 410-5657 (domestic callers) or (334) 323-7224 (international callers) using passcode 769890. A telephone replay will be available after the call by dialing (877) 919-4059 (domestic callers) or (334) 323-0140 (international callers) using replay ID number 95494046.

On January 22, 2018 Cellectar Biosciences, Inc. (Nasdaq:CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported that company management will be participating in Noble Capital Markets’ Fourteenth Annual Investor Conference taking place January 29-30, 2018 at the W Hotel, Fort Lauderdale, Florida. James Caruso, president and chief executive officer of Cellectar Biosciences, will present a company overview and update on Monday, January 29, 2018 at 1:00 p.m. Eastern time (Press release, Cellectar Biosciences, JAN 22, 2018, View Source [SID1234523412]).

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Mr. Caruso’s presentation will be webcast live at noble.mediasite.com/mediasite/Play/bd87d408fdd34479a0030edf85b4af221d and will be accessible on the Events and Presentations section of the company’s website where it will be archived for a period of time.

About Phospholipid Drug Conjugates (PDCs)
Cellectar’s product candidates are built upon its patented cancer cell-targeting delivery and retention platform of optimized phospholipid ether-drug conjugates (PDCs). The PDCTM platform provides selective delivery of a diverse range of oncologic payloads to cancerous cells, whether a hematologic cancer or solid tumor, the primary tumor, a metastatic tumor or cancer stem cells. The selective delivery of oncologic payloads allows for the modification of the payloads’ therapeutic window which may maintain or enhance drug potency while reducing the number and severity of adverse events. The PDC platform takes advantage of a metabolic pathway utilized by all tumor cell types in all stages of the tumor "cycle." This allows the PDC molecules to gain access to the intracellular compartment of the tumor cells and for the PDCs to continue to accumulate over time, which enhances drug efficacy. The PDC platform’s mechanism of entry does not rely upon specific cell surface epitopes or antigens as are required by other targeted delivery platforms. In addition to the benefits provided by the mechanism of entry, PDCs offer the potential advantage of having the ability to be conjugated to molecules in numerous ways, thereby increasing the types of molecules selectively delivered via the PDC. The PDC platform possesses the potential for the discovery and development of the next generation of cancer-targeting agents.