On March 25, 2021 Antengene Corporation Limited ("Antengene" or "the company", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, reported its annual financial results for the full year ended December 31, 2020 (Press release, Antengene, MAR 25, 2021, View Source [SID1234577180]).

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"In the past year, Antengene achieved numerous breakthroughs in discovery and clinical development, business operations, and organizational development, a result of our outstanding teamwork and execution. As we continue to implement our combinatory and complementary R&D strategy, we have developed a highly differentiated pipeline consisting of 12 innovative assets. In addition, we have broadened our collaboration with other industry-leading biotechnology companies, and obtained the rights to develop and commercialize four in-licensed assets across 17 APAC countries and regions in 2020," said Dr. Jay Mei, Founder, Chairman and CEO of Antengene. "As of today, we submitted NDAs for ATG-010 in five APAC markets, while we accelerate the completion of the first phase of our manufacturing facility and the build-out of our commercial teams in mainland China and other APAC markets. Furthermore, we were granted IND approvals for six additional clinical trials, and advanced three assets into clinical development in China and Australia. In 2020, we successfully completed our Series C financing and IPO on the Hong Kong Stock Exchange, and Antengene was selected as a constituent stock of the Heng Seng Composite Index and an eligible stock in the Shenzhen-Hong Kong Stock Connect in just four months after our IPO. Meanwhile, we officially opened Antengene’s Drug Discovery Center as we continue to advance our in-house discovery and development as planned. At the same time, we entered into partnerships with leading CROs to further accelerate our R&D programs. All of this progress has forged Antengene’s end-to-end fully integrated capabilities that will enable us to translate our robust R&D capabilities into commercial potential."

"In 2021, we remain committed to serving patients and plan to submit additional NDAs to offer patients around the world simultaneous access to our innovative therapies. Adopting a combinatory and complementary R&D strategy, we aim to initiate multiple clinical trials to develop therapies that will complement existing treatments and address treatment gaps in some of the most prevalent oncological indications. This year, we will continue to execute on our strategy of further developing our commercial infrastructure in China and the Asia Pacific region, in an effort to expedite the commercialization of our lead asset; and continue to enrich our pipeline and strengthen our core competitiveness by in-licensing additional highly promising assets. In 2021, we will present our research results at major international conferences, to further build a solid foundation for a first-in-class commercial launch of our lead asset in multiple markets, and to advance several pre-clinical novel assets into clinical stage. Honoring our commitment to patients and pursuing our mission as a member of the healthcare community, we will strive to bring hope to patients and deliver greater return to our investors," added Dr. Jay Mei.

Late-stage Assets

ATG-010 (selinexor, first-in-class XPO1 inhibitor)

Antengene made notable clinical development and regulatory progress to advance its lead hematological malignancy asset, and has submitted new drug applications (NDAs) for ATG-010 in multiple Asia Pacific (APAC) markets, including mainland China.

Events during the Reporting Period

On December 3, 2020, the company announced the submission of NDAs to the Australian Therapeutic Goods Administration (TGA) and the Health Sciences Authority (HSA) of Singapore for the treatment of adult patients with relapsed or refractory multiple myeloma (rrMM) and relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL). Additionally, the company submitted an NDA to the Hong Kong Department of Health for ATG-010 in the treatment of adult patients with rrMM, and NDA with Orphan Drug Designation (ODD) to the South Korean Ministry of Food and Drug Safety (MFDS) for ATG-010 for the treatment of adult patients with rrMM and adult patients with rrDLBCL.
Several clinical studies are underway for ATG-010 in mainland China, including:
A Phase II registrational clinical trial in combination with low-dose dexamethasone in rrMM.
A Phase II clinical trial as monotherapy in rrDLBCL, which has dosed its first patient in 2020.
A Phase III clinical trial in combination with bortezomib and low-dose dexamethasone in rrMM, which was granted an Investigational New Drug (IND) approval from the China’s National Medical Products Administration (NMPA) at the end of 2020.
A Phase III clinical trial as a maintenance monotherapy for patients with endometrial cancer. Antengene has submitted an IND application for the trial to the NMPA in December 2020.
To further explore the clinical potential of ATG-010 in oncology treatment, Antengene also initiated early signal detection studies including a Phase Ib clinical trial in combination with ifosfamide, carboplatin and etoposide (ICE) or gemcitabine and oxaliplatin (GemOx) in treatment of T-cell and NK/T-cell lymphoma, and a Phase II trial in the treatment of KRAS-mutant non-small cell lung cancer (NSCLC).
Events after the Reporting Period

In January 2021, the company submitted an NDA to NMPA of ATG-010 for the treatment of patients with rrMM, and the NDA was subsequently granted priority review by the NMPA.
NMPA approved an IND application for a Phase II/III clinical trial of ATG-010 in combination with rituximab, gemcitabine dexamethasone cisplatin (R-GDP) in rrDLBCL in January 2021.
Clinical Progress by Partner Company

On June 22, 2020, XPOVIO (selinexor) received accelerated approval from the U.S. Food and Drug Administration (U.S. FDA) for the treatment of adult patients with rrDLBCL who have received at least two lines of systemic therapy.
On December 18, 2020, the U.S. FDA approved XPOVIO (selinexor) for the treatment of adult patients with MM who have received at least one prior therapy.
ATG-008 (onatasertib, mTORC1/2 inhibitor)

Events during the Reporting Period

A Phase II study of ATG-008 in patients with hepatocellular carcinoma (HCC) dosed its first patient in the third dose level.
The company initiated a Phase I/II study of ATG-008 in combination with anti-PD-1 antibody in HCC and advanced solid tumors; and a Phase II study in NFE2L2-mutant NSCLC, respectively, in mainland China.
NMPA approved the IND application for a biomarker-driven solid tumor basket trial with ATG-008.
Other Clinical Assets

ATG-019 (dual PAK4/NAMPT inhibitor)

Events during the Reporting Period

A Phase I clinical study of ATG-019 in solid tumor and lymphoma dosed its first patient in Taiwan.

Events after the Reporting Period

The company submitted an IND application to the NMPA for a Phase I clinical study of ATG-019 in solid tumor and lymphoma in January 2021.

ATG-017 (ERK1/2 inhibitor)

Events during the Reporting Period

A Phase I clinical study of ATG-017 in advanced solid tumors and hematological malignancies dosed its first patient in Australia.

ATG-016 (eltanexor, second generation XPO1 inhibitor)

Events during the Reporting Period

NMPA approved the IND application for a Phase I/II clinical study of ATG-016 in high-risk myelodysplastic syndrome (MDS).

Events after the Reporting Period

The company has submitted an IND application for the Phase I/II clinical study of ATG-016 in solid tumors in February 2021.

Pre-Clinical Assets

Antengene made steady progress with its pre-clinical pipeline assets, including ATG-101 (PD-L1/4-1BB bispecific antibody), ATG-018 (ATR inhibitor), ATG-022 (Claudin 18.2 antibody-drug conjugate), ATG-012 (KRAS inhibitor) and two other biologics that it has not yet disclosed target.

Events during the Reporting Period

ATG-101 (PD-L1/4-1BB bispecific antibody)
The company is conducting IND enabling studies to support IND/CTA applications for ATG-101 and plans to submit the applications in 2021.

ATG-018 (ATR inhibitor)
The company is conducting preclinical studies to support IND/CTA applications for ATG-018 and plans to submit the applications in the beginning of 2022.

ATG-022 (Claudin 18.2 antibody-drug conjugate)
The company is conducting preclinical studies to support IND/CTA applications for ATG-022 and plans to submit the applications in 2022.

ATG-012 (KRAS inhibitor)
The company is conducting preclinical studies to support IND/CTA applications for ATG-012 and plan to submit the applications in 2022.

Other Developments

Events during the Reporting Period

The company appointed Mr. John F. Chin, MBA, as Chief Business Officer (CBO), responsible for its global business development and Commercialization; Mr. Thomas Karalis as Head of Asia Pacific Regions, responsible for the commercialization of Antengene’s products in Australia, New Zealand, S. Korea, Taiwan, Hong Kong and ASEAN regions; Dr. Zhinuan Yu, Ph.D., as Corporate Vice President (CVP) of Biometrics and Regulatory Enabling Functions, responsible for the biostatistics and regulatory strategies in programs involving the company’s pipeline assets; and Mr. Dirk Hoenemann, M.D., as Vice President, Head of Medical Affairs for APAC region and Early Clinical Development.
In May 2020, Antengene further strengthened and broadened its partnership with Karyopharm Therapeutics Inc. (Karyopharm) through a territory expansion agreement that granted Antengene the rights to develop and commercialize selinexor, eltanexor, verdinexor and ATG-019 in multiple APAC markets.
In August 2020, Antengene entered into an agreement with the Administrative Committee of the Binhai New Area, Shaoxing, Zhejiang Province in the PRC to obtain an approximately 16,300 square meters manufacturing facility for the commercial production of small molecule drugs.
In October 2020, Antengene’s New Drug Discovery Center was officially opened in Zhangjiang Hi-Tech Park, Shanghai the PRC.
On November 20, 2020, Antengene was successfully listed on The Stock Exchange of Hong Kong Limited.
As of December 31, 2020, Antengene had filed 8 patent applications in China.
Events after the Reporting Period

In March 2021, Antengene selected as a constituent stock of nine benchmark and thematic indexes including the Hang Seng Composite Index. Based on these inclusions, the company was also selected as an eligible stock in the Shenzhen-Hong Kong Stock Connect, effective from March 15, 2021.
In March 2021, Antengene appointed Mr. Kevin Lynch as its Chief Medical Officer (CMO), responsible for the strategic planning and management of medical affairs and clinical development; and Dr. Bo Shan as its Chief Scientific Officer (CSO), responsible for the strategic planning, drug discovery, early development and CMC.
Financial Highlights

IFRS Measures:

The company’s adjusted loss and total comprehensive loss were RMB455.0 million for the year ended December 31, 2020, primarily attributable to the increased research and development costs and administrative expenses.

Non-IFRS Measures:

The company’s cash and bank balances increased by RMB2,363.0 million, to RMB3,109.8 million for the year ended December 31, 2020. This increase was primarily attributable to the Series C financing in July and the IPO in November 2020.

The company’s research and development costs increased by RMB231.9 million, to RMB347.7 million for the year ended December 31, 2020. This increase was primarily attributable to the increased payments made to the company’s licensing partners, expansion of R&D personnel and other clinical-related fees.

The company’s administrative expenses increased by RMB114.9 million, to RMB154.2 million for the year ended December 31, 2020. The increase was primarily attributable to the increase in employee costs and share issue expenses in relation to the initial public offering (IPO) of the company.

A non-cash, one time change of RMB2,356.3 million upon the listing in the fair value loss on convertible redeemable preferred shares as required under the IFRS for the year ended December 31, 2020. The increased of RMB2,141.8 million was primarily attribute to significant increase in the per share fair value upon the completion of the IPO of the Company when re-measuring convertible redeemable preferred shares previously issued to the investors before conversion into the Company’s ordinary shares.

The company’s other income and gains decreased by RMB26.1 million, to RMB26.8 million for the year ended December 31, 2020. This decrease was primarily attributable to the absence of the net foreign exchange gains recorded for the prior year.

The company’s loss and total comprehensive loss increased by RMB2,605.1 million, to RMB2,928.9 million for the year ended December 31, 2020. This increase in loss includes (i) a loss of RMB463.3 million primarily due to the increase in research and development costs and administrative expenses. (ii) A non-cash, one time change of RMB2,141.8 million upon the listing in the fair value loss on convertible redeemable preferred shares as required under the IFRS.

Outlook

Leveraging its combinatory and complementary R&D strategy and through its strong R&D capabilities and strategic approach in developing novel therapies, Antengene continues to realize its vision of treating patients beyond borders and transforming their lives by discovering, developing and commercializing global first-in-class, only-in-class and/or best-in-class therapies.

Antengene will advance the clinical development of its six clinical stage products in multiple therapeutic areas, and continue to implement its dual-engine approach of external partnerships and internal discovery to build up a pipeline focusing on the key oncogenic pathways, tumor microenvironment and tumor associated antigens through its business development, clinical and commercial teams in place globally and across the APAC region. The company also intends to continue implementing its complementary approach to develop the in-licensed assets for additional indications to maximize their commercial potential.

Looking into 2021, Antengene expects to receive NDA approvals for selinexor (ATG-010) during the fourth quarter of 2021 and the first quarter of 2022, in five APAC markets including mainland China, Australia, South Korea, Hong Kong and Singapore. The company will also advance two of its in pre-clinical novel assets into the IND stage.

Antengene’s commercial leadership team has experience in successfully launching multiple top hematology products in China, the wider APAC region, and across markets around the world. The company will continue to build out its commercial team in preparation for the first launch of ATG-010 in Greater China and the rest of APAC to address unmet medical needs in its territories. Antengene expects to build a commercial team of approximately 150 members by year end with dedicated in-house marketing, field force, pricing and market access, and medical affairs teams possessing proven track record and in-depth regional expertise in hematologic oncology.

On March 25, 2021 Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported the peer-reviewed publication of preclinical data of the company’s investigational novel MDM2-p53 inhibitor APG-115 in the journal Nature Immunology unveiling the role of mouse double minute 2 homolog (MDM2) in CD8⁺ T-cell- mediated immunity (Press release, Ascentage Pharma, MAR 25, 2021, View Source [SID1234577179]).

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Titled "The ubiquitin ligase MDM2 sustains STAT5 stability to control T-cell mediated antitumor immunity," the report is published in today’s Nature Immunology. Shaomeng Wang, PhD, cofounder of Ascentage Pharma, Chairman of the company’s Scientific Advisory Board, and the Warner-Lambert/Parke-Davis Professor of Internal Medicine, Pharmacology, and Medicinal Chemistry at the University of Michigan School of Medicine is a co-author of this study. Weiping Zou, MD, PhD, Charles B. de Nancrede Professor of Pathology, Surgery, Immunology and Biology, and Director, Center of Excellence for Cancer Immunology and Immunotherapy at the University of Michigan is the senior and corresponding author of the study.

The MDM2-p53 complex has a proven role in the development and progression of cancer, opening a potential avenue for therapeutic approaches seeking to disrupt the interaction and increase p53-mediated tumor cell death (apoptosis). However, a major challenge is that there are as yet no approved therapies targeting MDM2-p53.

"Before our study, it was unclear whether the MDM2-p53 axis affects CD8⁺ (cytotoxic or cancer-killing) T-cell-mediated antitumor immunity," said Dr. Wang. "Through a series of biochemical, genetic, and functional studies, we have demonstrated that MDM2 plays a pivotal biological role in T-cell stability, survival, and antitumor immunity, potentially laying a foundation for synergistic effects between MDM2-targeted agents such as APG-115 and cancer immunotherapy."

Using in vivo and other experimental models, the authors demonstrated that mice lacking MDM2 in T cells exhibit more rapidly growing tumors with diminished numbers of tumor-infiltrating CD8⁺ T-cells. The authors also showed that MDM2 stabilizes signal transducer and activator of transcription 5 (STAT5), a protein essential for T-cell function and survival. This is an important finding, in part because Ascentage’s drug candidate APG-115 disrupts the MDM2-p53 complex, potentially acting as an "MDM2 enhancer" to stabilize STAT5 and hence augment T-cell immunity.

APG-115 is a novel, orally active molecule that activates p53-mediated apoptosis in tumor cells with wild-type p53 and/or MDM2 amplification. APG-115 is the first MDM2-p53 inhibitor entering clinical development in China, and is currently being investigated in multiple Phase Ib/II clinical studies in solid tumors and hematologic malignancies in China and the US.

"This is truly uncharted territory," said Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma. "There is a significant unmet clinical need for targeted therapies that disrupt the MDM2-p53 complex and not only eradicate tumor cells but also enhance T-cell-mediated immunity. This publication will bring about the incentives and support that will enable us to further accelerate global development and commercialization of this drug candidate," he said. "Given the promising safety and efficacy data obtained thus far, we will expedite development and are hopeful that APG-115 will soon benefit patients worldwide."

Now underway is a phase 2 clinical trial of APG-115 together with the immune checkpoint inhibitor pembrolizumab in patients with PD-1-inhibitor-refractory or relapsed cancers. These include solid tumor, liposarcoma, urothelial carcinoma, and malignant peripheral nerve sheath tumor, which affects the connective tissues surrounding nerves.

On March 25, 2021 Ikena Oncology, Inc. ("Ikena"), a targeted oncology company focused on developing cancer therapies targeting key signaling pathways that drive the formation and spread of cancer, reported the pricing of its initial public offering of 7,812,500 shares of common stock at a public offering price of $16.00 per share (Press release, Ikena Oncology, MAR 25, 2021, View Source [SID1234577177]). The shares are expected to begin trading on the Nasdaq Global Market on March 26, 2021 under the ticker symbol "IKNA." The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Ikena, are expected to be $125.0 million. The offering is expected to close on March 30, 2021, subject to the satisfaction of customary closing conditions. In addition, Ikena has granted the underwriters a 30-day option to purchase up to an additional 1,171,875 shares of common stock at the initial public offering price.

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Jefferies, Cowen, Credit Suisse and William Blair are acting as joint book-running managers for the offering.

The registration statement relating to these securities became effective on March 25, 2021. The offering will be made only by means of a prospectus, copies of which may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by telephone at (833) 297-2926, or by email at [email protected]; Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, NC 27560, by telephone at (800) 221-1037, or by email at [email protected]; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by telephone at (800) 621-0687, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On March 25, 2021 Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B cell discovery engine platform to discover and develop first-in-class antibody therapeutics, reported financial results for the fourth quarter and full year ended December 31, 2020 and provided a corporate update (Press release, Immunome, MAR 25, 2021, View Source [SID1234577176]).

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"The fourth quarter of 2020 was a transformational period for Immunome thanks to our successful initial public offering on the NASDAQ exchange, which raised $44.9 million in gross proceeds," said Purnanand Sarma, Ph.D., President and CEO of Immunome. "That positive momentum continued into 2021, with our recent announcements covering the isolation of antibodies capable of neutralizing SARS-CoV-2 variants in pseudovirus testing as part of our IMM-BCP-01 program, and the advancement of IMM-ONC-01, our proprietary antibody against IL-38 for the potential treatment of solid tumors including malignancies of high unmet need such as cancers of the head and neck and the lung, into IND-enabling studies."

Dr. Sarma continued: "Looking ahead, we expect to provide development program updates in the second quarter of 2021 and to file INDs for both IMM-BCP-01 and IMM-ONC-01 in 2021. We remain excited about the prospects for both of our current development programs and reiterate the confidence we have in our discovery engine to move one to two new candidates into IND-enabling studies per year. I very much look forward to updating you on our progress in the months ahead."

Financial Highlights

Cash and cash equivalents: As of December 31, 2020, cash and cash equivalents totaled $39.8 million.
Research and development (R&D) expenses: R&D expenses for the three months ended December 31, 2020 were $1.8 million. R&D expenses for the year ended December 31, 2020 were $7.5 million.
General and administrative (G&A) expenses: G&A expenses for the three months ended December 31, 2020 were $2.2 million. G&A expenses were $4.8 million for the year ended December 31, 2020.
Net loss: Net loss attributable to common stockholders was $4.1 million, or $0.40 per share, for the three months ended December 31, 2020. Net loss attributable to common stockholders was $17.8 million, or $5.26 per share, for the year ended December 31, 2020.
As of December 31, 2020, Immunome had 10,634,245 shares of common stock outstanding.

On March 25, 2021 PharmaEssentia reported that had repeatedly attempted to terminate the agreement with AOP Orphan concerning BESREMi (Ropeginterferon alfa-2b) (Press release, AOP Orphan Pharmaceuticals, MAR 25, 2021, View Source [SID1234577175]). After two and a half years of arbitral proceedings, in October 2020, the ICC Arbitral Tribunal issued its award in the matter. The arbitral award states that PharmaEssentia’s multiple attempts to terminate the agreement were unjustified, and that AOP Orphan is entitled to payment of damages of approximately EUR 142 million for project delays caused by PharmaEssentia.

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In December 2020, PharmaEssentia filed an application to set aside this arbitral award with the Frankfurt Higher Regional Court, arguing that the award violated public order and PharmaEssentia’s right to be heard. The Frankfurt Higher Regional Court, a German court with major experience in handling this kind of proceedings, called a hearing within less than two months of PharmaEssentia’s filing its setting aside application.

Award declared enforceable

Today, the Frankfurt Higher Regional Court announced its decision. As anticipated, the Court dismissed PharmaEssentia’s set aside application, confirming that both parties had sufficient opportunity to be heard, that all evidence brought before the Arbitral Tribunal was duly taken into consideration, and that the public order was fully respected.

Thus, the award as issued by the ICC Arbitral Tribunal in October 2020 has now been declared enforceable by Frankfurt Higher Regional Court, and AOP Orphan can pursue its enforcement in Germany and elsewhere. An appeal to the German Supreme Court is possible but would not hinder the enforcement of the award.

Rudolf Widmann, Chief Therapeutics Development Officer and Member of the Board of AOP Orphan, explains: "AOP Orphan has always complied with its contractual obligations and is entitled to compensation by PharmaEssentia, following their repeated attempts to boycott the joint project and success of BESREMi. We encourage PEC to accept the arbitral award and work towards cooperative efforts to exploit the full value of BESREMi in the interest of patients and stakeholders of both companies. AOP Orphan has tried to find solutions several times – I would have preferred to invest time and money into making this highly promising drug available to patients with blood cancer, instead of investing it into expensive lawsuits."

About BESREMi

BESREMi is a long-acting, mono-pegylated proline interferon (ATC L03AB15). Its unique pharmacokinetic properties offer a new level of tolerability. BESREMi is designed to be conveniently self-administered subcutaneously with a pen once every two weeks, or monthly after stabilization of hematological parameters. This treatment schedule is expected to lead to overall better safety, tolerability and adherence compared to conventional pegylated interferons. Ropeginterferon alfa-2b was discovered by PharmaEssentia, a long-term partner of AOP Orphan. In 2009, AOP Orphan in-licensed the exclusive rights for clinical development and commercialization of Ropeginterferon alfa-2b in PV and other MPNs for European, Commonwealth of Independent States (CIS), and Middle Eastern markets.