On October 25, 2021 Novo Nordisk reported that it initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, OCT 25, 2021, View Source [SID1234591927]). This programme is part of the overall share repurchase programme of up to DKK 18 billion to be executed during a 12-month period beginning 3 February 2021.

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Under the programme initiated 4 August 2021, Novo Nordisk will repurchase B shares for an amount up to DKK 3.3 billion in the period from 5 August 2021 to 1 November 2021.

Since the announcement 18 October 2021, the following transactions have been made:

The details for each transaction made under the share repurchase programme are published on novonordisk.com.

With the transactions stated above, Novo Nordisk owns a total of 22,185,947 B shares of DKK 0.20 as treasury shares, corresponding to 1.0% of the share capital. The total amount of A and B shares in the company is 2,310,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 18 billion during a 12- month period beginning 3 February 2021. As of 22 October 2021, Novo Nordisk has since 3 February 2021 repurchased a total of 23,378,781 B shares at an average share price of DKK 508.12 per B share equal to a transaction value of DKK 11,879,212,530.

On October 25, 2021 Geron Corporation (Nasdaq: GERN), a late-stage biopharmaceutical company focused on the development and commercialization of treatments for hematologic malignancies, reported that imetelstat, the Company’s first in class telomerase inhibitor, has been granted an Innovation Passport, which is the first prescribed entry point to the Innovative Licensing and Access Pathway (ILAP) launched in the United Kingdom (UK) by the Medicines and Healthcare products Regulatory Agency (MHRA) in January 2021, post-Brexit (Press release, Geron, OCT 25, 2021, View Source [SID1234591926]). The objective of this new licensing and access pathway is to reduce the time to market for innovative medicines. Key benefits of being within ILAP include a 150-day accelerated assessment and rolling review of a Marketing Authorization Application (MAA), as well as opportunities for frequent interactions with the review staff at the MHRA and its partner agencies, including the National Institute for Health and Care Excellence (NICE), to discuss imetelstat’s development, regulatory plans and reimbursement plans.

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"We are pleased to participate in this new expedited review pathway established by MHRA and look forward to working with them and their partner agencies as we collaborate to bring imetelstat to UK patients," said Sharon McBain, Geron’s Vice President, Global Regulatory Affairs. "We are pleased imetelstat met the three qualifying criteria for the Innovation Passport and believe that because of the durable transfusion independence across different patient subgroups and strong evidence of disease-modifying activity observed in our IMerge Phase 2 study, imetelstat’s novel telomerase inhibitor approach has the potential to be an important drug in this patient population."

Patients from the IMerge Phase 2 clinical trial achieved durable transfusion independence with imetelstat treatment, including transfusion-free periods greater than one year, irrespective of the disease subgroup, such as ringed sideroblast positive or ringed sideroblast negative. Such durability provides significant and meaningful clinical benefit to lower risk MDS patients given their chronic anemia and the debilitating impact of serial blood transfusions. In addition, depletion of cytogenetic abnormalities and reductions in key driver mutations associated with lower risk MDS were observed, and these results were also correlated with transfusion independence. Taken together, the durability, molecular and cytogenetic data from IMerge Phase 2 provide strong evidence for disease-modifying activity of imetelstat which has the potential to differentiate it from other currently approved and investigational treatments in lower risk MDS today.

Imetelstat is currently being studied in two Phase 3 clinical trials, IMerge Phase 3 in lower risk MDS and IMpactMF in refractory myelofibrosis. Based upon current planning assumptions, Geron expects top-line results for the IMerge Phase 3 clinical trial to be available at the beginning of January 2023.

About ILAP and Innovation Passport

The Innovation Passport is awarded by the UK’s Innovation Licensing and Access Pathway Steering Group, which consists of representatives from MHRA, NICE, the Scottish Medicines Consortium (SMC) and the National Health Service (NHS) England. To enter ILAP and receive an Innovation Passport, an experimental drug needs to meet the following public health and/or patient-centric criteria: (1) the condition is life-threatening or seriously debilitating; (2) the program fulfills at least one of the following: innovative medicine, clinically significant new indication or, it is intended for a special population; and (3) the medicine has the potential to offer benefits to patients. The ILAP aims to accelerate the time to market and facilitate patient access to medicines through the development of a target development profile (TDP) that outlines a unique product-specific roadmap for regulatory and development milestones. Other benefits provided by ILAP include the potential for a 150-day accelerated assessment of a Marketing Authorization Application (MAA) and rolling review. The ILAP also provides opportunities for frequent interactions with the review staff at the MHRA and its partner agencies to discuss the drug’s development and regulatory plans, as well as reimbursement.

About IMerge Phase 3

IMerge Phase 3 is a double-blind, randomized, placebo-controlled Phase 3 clinical trial with registrational intent. The trial is designed to enroll approximately 170 transfusion dependent patients with Low or Intermediate-1 risk myelodysplastic syndromes (MDS), also referred to as lower risk MDS, who have relapsed after or are refractory to prior treatment with an erythropoiesis stimulating agent (ESA). The primary endpoint is the rate of red blood cell (RBC) transfusion independence (TI) for any consecutive period of eight weeks or longer, or 8-week RBC-TI rate. Key secondary endpoints include the rate of RBC-TI lasting at least 24 weeks, or 24-week RBC-TI rate, and the rate of hematologic improvement-erythroid (HI-E), defined as a reduction of at least four units of RBC transfusions over eight weeks compared with the prior RBC transfusion burden.

IMerge Phase 3 is fully enrolled and patient enrollment has been closed. For additional information about IMerge Phase 3, visit ClinicalTrials.gov/NCT02598661.

About Myelodysplastic Syndromes

Myelodysplastic syndromes are a group of diverse blood disorders that develop because bone marrow cells do not mature into healthy blood cells. Many patients develop chronic anemia, the predominant clinical problem in lower risk MDS, and become dependent on red blood cell transfusions which leads to iron overload, heart and kidney complications, decreases in quality of life and shorter overall survival. Approximately 70% of MDS patients are categorized in the lower risk groups at diagnosis, according to the International Prognostic Scoring System that assigns relative risk of progression to acute myelogenous leukemia and overall survival by taking into account the presence of a number of disease factors, such as cytopenias and cytogenetics.

About Imetelstat

Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in myeloid hematologic malignancies. Data from Phase 2 clinical trials provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies resulting in malignant cell apoptosis and potential disease-modifying activity. Imetelstat has been granted Fast Track designation by the United States Food and Drug Administration for both the treatment of patients with non-del(5q) lower risk MDS who are refractory or resistant to an erythropoiesis-stimulating agent and for patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to janus associated kinase (JAK) inhibitor treatment.

On October 25, 2021 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809), reported preliminary and unaudited results for the first nine months ended 30 September 2021 (Press release, Evotec, OCT 25, 2021, View Source;announcements/press-releases/p/evotec-provides-preliminary-nine-month-financial-results-6104 [SID1234591925]).

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Evotec expects revenues from contracts with customers for the first nine months of 2021 to be in the range of € 425 – 435 m; significantly above the € 360.4 m posted in the prior year’s period. Like-for-like growth (excluding Sanofi payments of € 8.6 m in Q1 2020 and negative fx-effects) is expected to be in the range of 24 – 27%
Adjusted Group EBITDA for the first nine months of 2021 is expected to reach € 68 – 72 m, compared to € 76.9 m as of 30 September 2020, affected primarily by planned capacity build-up ahead of imminent production start of J.POD 1 US, Redmond. Like-for-like growth (adjusting for Sanofi and negative fx-effects) is expected to be within a range of 12 – 18%
Evotec expects unpartnered R&D expenses in the period to be between € 41 – 44 m, between € 8 – 11 m higher than in 9M 2020
The expected financial results discussed in this press release are based upon information available to Evotec as of the date hereof. This data is not a comprehensive statement of the Company’s financial results for the nine months ended 30 September 2021, and the closing process and related auditor review have not been completed. During the preparation of Evotec’s comprehensive financial statements adjustments to the preliminary estimated financial information presented herein may be identified, and such changes could be material. There can be no assurance that these estimates will be realised, and these estimates are subject to risks and uncertainties, many of which are not within the Company’s control. The timing of this disclosure is unique to this quarter given the timing of the Company’s application to list on the Nasdaq Global Select Market, and it does not intend to report preliminary results in future quarters. Evotec will issue complete financial results in connection with its 9M conference call on 11 November 2021.

On October 25, 2021 Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a biopharmaceutical company developing and commercializing unique therapies for patient populations in endocrinology, neurology, and gastroenterology, reported a collaboration agreement with Merck , with an option to license Xeris’ suspension-based formulation technology, XeriJect, for use with undisclosed monoclonal antibodies (mAbs) for the purpose of engineering ultra-high concentration, ready-to-use formulations (Press release, Merck & Co, OCT 25, 2021, View Source [SID1234591923]). Terms of the agreement were not disclosed.

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"We are quite excited to be working closely with Merck on this opportunity using our novel platform technology, XeriJect," said Paul R. Edick, Chairman and CEO of Xeris Biopharma. "The XeriJect platform has broad applicability in improving the delivery of large molecules, such as monoclonal antibodies. This is another in a series of collaborations Xeris has undertaken with top 10 pharma companies evaluating the XeriJect technology."

Mr. Edick continued, "These collaborations are important to validating our technology. We recognize they take time to complete and thus, they are not immediately critical to our near-term core business. However, should Merck exercise the negotiated license agreement, they could be very valuable to Xeris. It is the continued growth of Gvoke and Keveyis, the potential for the approval and launch of Recorlev, a pipeline supported by our novel technologies, our strong cash balance, and an expected $50 million in synergies from the Strongbridge acquisition that puts Xeris in a solid financial position."

On October 25, 2021 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications, reported the signing of an agreement with Sagard Healthcare Royalty Partners to monetize a portion of AnaptysBio’s future JEMPERLI royalties and milestones (Press release, AnaptysBio, OCT 25, 2021, View Source [SID1234591922]). AnaptysBio intends to utilize the proceeds of the transaction towards funding of its wholly-owned preclinical and clinical-stage antibody programs.

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"We believe this transaction with Sagard validates the future commercial potential of JEMPERLI and brings significant non-dilutive funding to AnaptysBio," said Hamza Suria, president and chief executive officer of AnaptysBio. "Using our capital-efficient business model, AnaptysBio will continue to focus on advancing wholly-owned therapeutic antibodies to clinical data catalysts and the discovery of novel preclinical antibodies to emerging inflammation and immuno-oncology targets."

"We are thrilled to partner with AnaptysBio on this royalty transaction which reflects our confidence in JEMPERLI as a treatment for patients with certain endometrial and solid tumor cancers. Sagard’s investment is aligned with our goal of accelerating biopharmaceutical innovation by providing our partners with flexible sources of financing," said Ali Alagheband, Partner at Sagard Holdings.

Upon closing of this transaction, which is anticipated by the end of 2021, Sagard will pay AnaptysBio $250 million upfront in exchange for royalties payable to AnaptysBio under its GSK collaboration on annual global net sales of JEMPERLI below $1 billion starting October 2021. The royalty rate applicable below the $1 billion annual net sales threshold is 8%. Sagard may also receive up to a total of $105 million in potential cash milestones, of which $15 million are subject to certain future JEMPERLI regulatory filing and approval milestones and up to $90 million are subject to certain commercial sales milestones due prior to JEMPERLI achieving the $1 billion in annual global net sales threshold.

Royalties payable above $1 billion JEMPERLI annual global net sales, which are paid by GSK at 12% to 25%, and certain milestones payable on annual sales at or above $1 billion are retained by AnaptysBio and are not subject to this Agreement. Royalties and milestones due upon development and commercialization of the AnaptysBio-generated anti-TIM-3 antagonist (cobolimab) or anti-LAG-3 antagonist (GSK4074386) antibodies under the GSK collaboration, including in combination with JEMPERLI, are also not subject to this Agreement. In addition, royalties due to AnaptysBio from GSK’s global net sales of ZEJULA (niraparib) are excluded from this Agreement.

The aggregate JEMPERLI royalties and milestones to be received by Sagard under this Agreement is capped at certain fixed multiples of the upfront payment based upon time. Once Sagard receives an aggregate of either $312.5 million (125% of the upfront) by the end of 2026, or $337.5 million (135% of the upfront) during 2027 or $412.5 million (165% of the upfront) at any time after 2027, the Agreement will expire resulting in AnaptysBio regaining all subsequent JEMPERLI royalties and milestones. The closing of the transaction is subject to the satisfaction of customary closing conditions.

About JEMPERLI
Dostarlimab, the anti-PD-1 antagonist antibody commercially known as JEMPERLI, was generated by AnaptysBio using its proprietary somatic hypermutation (SHM) antibody platform and subsequently developed by TESARO, Inc., now a part of GSK, under a collaboration agreement. In April 2021, JEMPERLI was granted accelerated approval by the FDA for the treatment of certain adult patients with mismatch repair deficient (dMMR) endometrial cancer and conditional approval by the EMA for certain adult patients with dMMR or microsatellite instability-high (MSI-H) endometrial cancer. In August 2021, JEMPERLI was granted accelerated approval by the FDA for certain adult patients with dMMR solid tumors. JEMPERLI is also being developed by GSK for the treatment of other tumor types, including a currently ongoing phase III trial in first-line endometrial cancer (RUBY), an ongoing phase III trial with JEMPERLI and niraparib versus standard of care platinum-based therapy as first-line treatment of ovarian cancer (FIRST), and Phase II trials in non-small cell lung cancer, colorectal cancer, cervical cancer, multiple myeloma and melanoma. In June 2021, GSK estimated potential peak annual global JEMPERLI sales on a non-risk adjusted basis of £1-2 billion pounds, which is currently equal to approximately $1.4-$2.8 billion, for currently approved indications and first-line use in endometrial and ovarian cancer only.