On June 11, 2018 AOP Orphan´s reported that submission for marketing authorization of Ropeginterferon alfa-2b for treatment of Polycythemia Vera (PV) in the European Union (EU) has resumed after clock-stop (Press release, AOP Orphan Pharmaceuticals, JUN 11, 2018, View Source [SID1234527280]). The conclusion of this centralized procedure is expected for Q4/2018.

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Interferons (IFNs) have been successfully applied in various hematological malignancies including PV, Chronic Myeloid Leukemia (CML) and other myeloproliferative neoplasms (MPNs) for about three decades, however no IFN has obtained regulatory approval in these indications yet.

Ropeginterferon alfa-2b is the first monopegylated IFN with an improved application of only once every two weeks (and only once per month in long-term maintenance treatment). The innovative pegylation technology and the molecule have been invented by PharmaEssentia Corporation (Taiwan Stock Exchange: 6446), a long-term partner of AOP Orphan.

In 2009, AOP Orphan has in-licensed from PharmaEssentia Corporation the exclusive rights to develop and commercialize Ropeginterferon alfa-2b in PV, CML and other MPNs for European, Commonwealth of Independent States (CIS), and Middle Eastern markets.

Since 2009, AOP Orphan´s Development Program in PV including the phase I/II trial PEGINVERA and the phase III trials PROUD-PV, PEN-PV and CONTINUATION-PV, have established high efficacy and favorable safety and tolerability of Ropeginterferon alfa-2b in PV. PharmaEssentia Corporation has invested in preparations for commercialization of the drug in its territory and in the capability for commercial manufacturing of the drug. The company´s world-class cGMP biologics facility in Taichung is certified by the Taiwan Food and Drug Administration (TFDA) and since 2018 also by EMA , and it is designed and operated to be compliant with all U.S. FDA requirements.

Commercial availability of Ropeginterferon alfa-2b is expected to fulfill an increasing need of patients and physicians for the long-term management of a yet incurable class of diseases.

On June 11, 2018 Bristol-Myers Squibb Company (NYSE: BMY) reported that it will take part in Goldman Sachs 39th Annual Global Healthcare Conference on Wednesday, June 13, 2018, in Rancho Palos Verdes, CA (Press release, Bristol-Myers Squibb, JUN 11, 2018, View Source [SID1234527263]). Johanna Mercier, Head of U.S. Commercial, and Fouad Namouni, Head of Oncology Development, will answer questions about the company at 6:20 p.m. ET (3:20 p.m. PT).

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Investors and the general public are invited to listen to a live webcast of the session at View Source An archived edition of the session will be available later that day.

On June 11, 2018 Nordic Nanovector ASA (OSE: NANO) reported that a poster reporting the ability of Betalutin (177Lu-lilotomab satetraxetan) to reverse resistance to anti-CD20 treatment in non-Hodgkin’s lymphoma (NHL) cell lines will be presented at the inaugural AACR (Free AACR Whitepaper) International Meeting: Advances in Malignant Lymphoma (22-26 June, Boston, MA, USA) (Press release, Nordic Nanovector, JUN 11, 2018, View Source [SID1234553500]).

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The preclinical data, described in an abstract published online (link here), demonstrate that treatment of rituximab-resistant NHL cells with Betalutin significantly elevated the expression of the CD20 receptor on the surface of cells. The increase in CD20 receptors re-sensitizes the cells to the anti-CD20 NHL immunotherapies rituximab (Rituxan) and obinutuzumab (Gazyva/Gazyvaro), causing increased tumour cell death.

These results support previous preclinical studies that highlight the synergistic anti-tumour effects of combining Betalutin with rituximab immunotherapy. Nordic Nanovector is planning to investigate this novel combination therapy in patients with relapsed/refractory follicular lymphoma in the Archer-1 Phase 1b clinical study. This study is targeting dosing of the first patient in the second half of 2018.

Details for the poster presentation are as follows:

Poster Title: 177Lu-lilotomab satetraxetan has the potential to counteract resistance to rituximab and obinutuzumab in non-Hodgkin’s lymphoma Session

Date and Time: Saturday 23 June, 11:45 AM to 1:45 PM (Eastern Daylight Time)

Poster Session A: Basic and Translational Science 1

Location: Salon F, 4th floor, Boston Marriot Copley Plaza Permanent

Abstract Number: A28

The poster will be available on the company’s website at the time of the presentation: www.nordicnanovector.com.

On June 11, 2018 BridgeBio Pharma reported that it has entered into an agreement with Alexion Pharmaceuticals, Inc. to acquire cyclic pyranopterin monophosphate (cPMP; ALXN1101), a synthetic enzyme co-factor therapy for patients with the ultra-rare disease caused by molybdenum cofactor deficiency (MoCD) Type A (Press release, BridgeBio, JUN 11, 2018, View Source [SID1234576280]). In addition, BridgeBio announced that it was launching a new subsidiary, Origin Biosciences, with sufficient capital to support clinical development of ALXN1101 through potential regulatory approval and commercialization.

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MoCD is an ultra-rare autosomal recessive inborn error of metabolism. The disease is caused by a mutation in the MOCS1 gene and leads to defective production of cPMP. Clinical signs of MoCD present shortly after birth and progress rapidly. Newborns with MoCD experience difficulty feeding and intractable seizures yet have no approved available therapies. Patients have a median survival of three years, and those who survive often have severe and irreversible injury to their central nervous system.

"Historically, replacing missing or defective proteins has proven highly efficacious for treating loss of function monogenic conditions – in the case of MoCD type A, we are replacing the missing or defective cPMP, providing children with much needed MoCD activity," said Michael Henderson, M.D., senior vice president of asset acquisition at BridgeBio. "BridgeBio’s team is committed to continuing the development of ALXN1101 for infants born with MoCD Type A deficiency, their families and caregivers."

ALXN1101 is a synthetic version of cPMP, the missing cofactor causing MoCD Type A. In previous work with a recombinant form of cPMP, 11 patients with MoCD Type A had normalization of biomarkers within two days, eight patients showed some suppression of seizures, and three patients had near-normal development. ALXN1101 has received Breakthrough Therapy designation from the US FDA.

"Patients born with MoCD face a bleak future, and we will do all we can to pursue the development of this exciting compound, which has the potential to replace the missing enzyme," said Neil Kumar, Ph.D., CEO of BridgeBio. "BridgeBio aims to sustainably pursue even the rarest of diseases, such as MoCD, especially where we can support drug programs that target well described genetic diseases at their source."

While specific terms of the deal have not been disclosed, BridgeBio has committed sufficient resources to Origin Biosciences to enable clinical development, regulatory approval and to support commercialization of ALXN1101. Alexion will receive additional payments upon the realization of development and sales milestones.

On June 11, 2018 Clovis Oncology, Inc. (Nasdaq: CLVS) reported that Patrick J. Mahaffy, Chief Executive Officer and President, will present at the Goldman Sachs 39th Annual Global Healthcare Conference onTuesday, June 12, 2018 at 4:00 PM Pacific Time (Press release, Clovis Oncology, JUN 11, 2018, View Source [SID1234527264]). The conference will be held at the Terranea Resort in Rancho Palos Verdes, CA.

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A live webcast of the presentation can be accessed through the investor relations section of the Company’s website at www.clovisoncology.com. Following the live presentation, a replay of the webcast will be available on the Company’s website for 30 days.