On June 15, 2022 Orion Corporation ("Orion") reported that it has entered into an agreement with Belgian private company Inovet BV ("Inovet") to acquire its wholly owned subsidiary V.M.D. NV and all companies belonging to V.M.D. NV’s group of companies (V.M.D. NV and its subsidiary companies collectively, "VMD") (Press release, Orion , JUN 15, 2022, View Source [SID1234616008]). VMD is a veterinary pharmaceuticals company specialised in medicines and health products for livestock. It also has a product portfolio for companion animals and minor species. VMD is headquartered in Arendonk, Belgium. VMD has production sites in Arques, France (manufacturing) and in Arendonk (packaging) as well as its own sales operations in Belgium, France, Hungary and Vietnam. VMD’s revenues in 2021 were EUR 61 million, and the group was profitable. Following this acquisition, the 181 employees of VMD will join the Orion Group.

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Through this acquisition, Orion’s Animal Health unit will expand its product portfolio and get a foothold in the livestock market, expand its own geographical presence to Western Europe and expand export markets, and gain a production unit that is specialised in manufacturing of veterinary medicines. The acquisition also supports Orion Group’s growth strategy.

The transaction price is approximately EUR 130 million debt free. The transaction will be funded from Orion’s cash reserves. The immediate cash flow impact of the transaction is approximately EUR 90 million. The transaction will have a positive impact on Orion Animal Health unit’s net sales and EBITDA starting from 2022. The impact on Orion Group’s net sales and operating profit is not material and the transaction does not impact Orion’s outlook for 2022, given on 10 February 2022. Orion will report VMD’s net sales as part of Orion Animal Health’s net sales as of June 2022.

The agreement was signed and the transaction was completed simultaneously today on 15 June 2022.

"We are pleased to welcome our new colleagues to the Orion team. With this acquisition, Orion Animal Health becomes a comprehensive animal health company with wider geographical presence and broad product portfolio covering both companion animals and livestock. In addition, we are strengthening our manufacturing capabilities," said Timo Lappalainen, CEO of Orion Corporation.

"I believe that becoming part of the Orion family ensures the further growth of our business. I have a very good feeling about the new collaboration with the Orion Animal Health unit – mindsets and spirits are very similar to ours. We are looking forward to joining forces and strengthening our presence in the consolidating animal health industry," said Jan Moons, CEO of Inovet.

V.M.D. NV, established in 1973, is a veterinary pharmaceuticals company headquartered in Arendonk, Belgium. Until the transaction it was a wholly owned subsidiary of the Belgian family-owned private holding company Inovet BV. VMD’s product portfolio consists of over 200 generic products which are sold in more than 120 countries. VMD has a production site in Arques, France, logistics and packaging operations in Arendonk as well as its own sales operations in Belgium, France, Hungary and Vietnam. VMD is currently expanding its manufacturing capacity at the Arques site. The companies Biové Laboratoires SAS, Biard SAS, V.M.D. Állatgyógyászati Kft and Inovet Indochine Co., Ltd. are part of VMD.

Webcast and conference call

A webcast and a conference call for analysts, investors and media will be held today on Wednesday, 15 June 2022 at 11.00 EEST. Please register and join the live webcast at View Source

Questions can be asked through the webcast chat function. A recording of the webcast and the presentation material will be available on Orion’s website View Source later today.

On June 15, 2022 Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing targeted protein degradation to deliver novel small molecule protein degrader medicines, reported thyat it has recently dosed the first patients in separate Phase 1 clinical trials evaluating the STAT3 degrader KT-333 and the IRAKIMiD degrader KT-413 (Press release, Kymera Therapeutics, JUN 15, 2022, View Source [SID1234616024]). The KT-333 trial includes patients with relapsed/refractory liquid and solid tumors, including T cell lymphomas and leukemia, and the KT-413 study is enrolling patients with relapsed/refractory B cell lymphomas, including MYD88-mutant diffuse large B cell lymphoma (DLBCL).

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"These programs demonstrate the potential for targeted protein degradation to target critical nodes that traditional modalities can’t effectively address, offering a precision medicine approach to challenging cancers," said Nello Mainolfi, PhD, Co-Founder, President and CEO of Kymera Therapeutics. "The initiation of dosing in these studies represents important progress for Kymera toward understanding the pharmacology and safety of these first-in-class investigational medicines, and we look forward to sharing initial dose escalation clinical data later this year."

About the KT-333 Clinical Program

A target long considered "undruggable," STAT3 is a transcriptional regulator that has been linked to numerous cancers and other inflammatory and autoimmune diseases. KT-333 is a potent and selective heterobifunctional small molecule protein degrader of the STAT3 protein in development for oncology indications.

The Phase 1 trial will evaluate the safety, tolerability, PK/PD and clinical activity of KT-333 in adult patients with relapsed and/or refractory lymphomas and solid tumors. The first stage of the study will explore escalating doses of KT-333. The second stage will consist of four expansion cohorts to further characterize the safety, tolerability, PK/PD and antitumor activity of KT-333 in relapsed and/or refractory peripheral T-cell lymphoma (PTCL), cutaneous T-cell lymphoma (CTCL), large granular lymphocytic leukemia (LGL-L), and solid tumors.

KT-333 was recently granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of PTCL. This designation provides incentives to encourage the development of medicines for rare diseases.

About the KT-413 Clinical Program

KT-413 is a potent and selective heterobifunctional small molecule protein degrader being developed for MYD88-mutant B cell lymphomas that has the potential to be the first precision medicine for these cancers. KT-413 degrades interleukin-1 receptor associated kinase 4 (IRAK4) and the immunomodulatory imide drug (IMiD) substrates Ikaros and Aiolos. It is being developed initially for the treatment of relapsed/refractory MYD88-mutant DLBCL, with the potential to expand into other MYD88-mutant indications.

The Phase 1 trial will evaluate the safety, tolerability, and PK/PD of KT-413 in patients with relapsed and/or refractory B-cell non-Hodgkin’s lymphomas. The first stage will explore escalating doses of single-agent KT-413. The second stage will consist of two expansion cohorts to further characterize the safety, tolerability, PK/PD and antitumor activity of KT-413 in relapsed/refractory MYD88-mutant and MYD88 wild-type DLBCL.

On June 14, 2022 Isofol Medical AB (publ) (Nasdaq Stockholm: ISOFOL), reported that the company invites investors, analysts, and media to a live-streamed R&D Event with a subsequent question and answer session on June 20 at 12:30 CEST (Press release, Isofol Medical, JUN 14, 2022, View Source [SID1234615958]).

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Isofol will shortly present top-line results from the multi-center, global Phase III AGENT study investigating arfolitixorin in combination with 5-FU, oxaliplatin and bevacizumab in advanced, metastatic colorectal cancer (mCRC). The purpose of the event is to provide investors, analysts, and media with a better understanding of the current treatment landscape; medical need for colorectal cancer patients; clinical, regulatory and market access demands; and an update on the AGENT study. Speaking at the R&D Event will be Isofol´s CEO Ulf Jungnelius MD, CMO/CSO Roger Tell MD, and Professor Sebastian Stintzing MD, Charité Universitätsmedizin, Division of Hematology, Oncology and Tumor Immunology. The event will be held in English.

Agenda for the R&D Event

The AGENT study – its design, patient population, endpoints, and an update including the current status of the study and upcoming topline results
The medical need for colorectal cancer patients
The current colorectal cancer treatment landscape and the clinical use of current treatments
Clinical, regulatory, and market access demands for introducing new treatments for colorectal cancer
Q&A-session
The event will be livestreamed and can be followed via a link that will be published on Isofol’s webpage shortly

Questions can be asked prior to the event by sending an email to [email protected] or during the webcast via a chat function. The webcast will also be available on demand on Isofol’s corporate website after the event.

Date and time
June 20, 2022, from 12:30-14:00 p.m. CEST

Webcast link
A link to the webcast will be published on Isofol’s webpage shortly.

On June 14, 2022 AVM Biotechnology, a clinical stage company advancing AVM0703 in the treatment of Non-Hodgkin’s Lymphoma (NHL)/Leukemia, reported that it has been awarded a Phase II Small Business Innovative Research (SBIR) grant (Press release, AVM Biotechnology, JUN 14, 2022, View Source [SID1234615975]). This $2 million National Cancer Institute (NCI) grant will assist in the continuation of the company’s existing clinical trial (AVM0703 for Treatment of Leukemia or Lymphoma, NCT04329728).

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This Phase II grant has been awarded for continued support of the adaptive-design, expansion cohort clinical trial of AVM0703 for "no-option," Relapsed/Refractory (R/R) NHL/Leukemia patients. The study is currently enrolling at City of Hope, UCLA, Norton Cancer Institute, and the University of Texas Southwestern. Additional sites are being brought on-line.

AVM0703:

is a small molecule which triggers the production and release of endogenous bispecific gamma delta TCR+ invariant TCR+ Natural Killer T-like cells (AVM-NKT).
induces AVM-NKT cells rapidly in the blood following a single dose.
is currently the subject of an adaptive design expansion cohort clinical trial with the dose escalation phase nearing completion and the efficacy phase projected to commence soon.
In the ongoing dose escalation phase, which included 11 highly refractory patients who had been heavily pretreated averaging 5.3 prior lines of therapy with 6 of 11 having failed hematopoietic stem cell transplantation (HSCT) or CAR-T, results included:

100% clinical response at 18 mg/kg target Ph II dose, with durable partial response/stable disease ongoing out to greater than 9 months in 1 patient.
Of 10 evaluable patients from the dose-escalation; 4 experienced partial response and 2 other patients subsequently reached complete remission.
An additional 20% achieved stable disease or significant clinical response including durable vision restoration in 1 patient.
One heavily pretreated patient with T-cell lymphoma who did not meet inclusion/exclusion criteria received AVM0703 under an FDA-approved Compassionate Use Program. That patient has experienced a very good partial response.

The drug has been well-tolerated with no reported Dose Limiting Toxicities (DLTs) or grades 4 or 5 adverse events. AVM0703 also potentiates chemotherapy and CAR-T response in pre-clinical models.

NHL is the 7th most common cancer in the US with over half of the 77,240 diagnosed annually over the age of 65. Even with treatment, disease recurs or relapses in approximately 50% of these patients and many become refractory to additional treatment. Patients can undergo many lines of various therapies including chemotherapy, radiation, CAR-T and HSCT which can be associated with significant toxicities and poor outcomes with many relapsing and requiring additional treatment. Based on its strong safety profile and clinical response, AVM0703 presents an appealing alternative to these therapies.

"AVM0703 represents an exciting new treatment option for NHL patients who have failed other therapies or who do not qualify for further chemotherapy, radiation, or cell therapies, including CAR-T. In addition to improvement in disease status, several patients treated with AVM0703 in the dose-escalation phase of the study have qualified for other treatments they had formerly been excluded from accessing," said Joe Luminiello, CEO.

AVM Biotechnology previously received a Phase I NCI grant from the National Institutes of Health (NIH) to study the use of AVM0703 as a preconditioning agent to allow safe and efficient delivery of therapeutic immune cells for cancer treatment. The company has requested breakthrough therapy designation and plans for accelerated approval for commercial launch in mid 2024.

On June 14, 2022 Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, reported preliminary unaudited net product sales for EXPAREL (bupivacaine liposome injectable suspension) and iovera° for the month of May 2022 (Press release, Pacira Pharmaceuticals, JUN 14, 2022, View Source [SID1234615959]). EXPAREL net product sales were $44.9 million, compared with $41.2 million for May 2021. The company also reports average daily growth rates for EXPAREL to account for differences in the number of selling days per reporting period. EXPAREL average daily sales for the month of May 2022 were 104 percent of May 2021. The number of EXPAREL selling days were 22 in May 2022 and 21 in May 2021. Net product sales of iovera° were $1.1 million for the month of May 2022, compared with $1.0 million for May 2021.

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"EXPAREL utilization continues to expand and support the market’s transition to outpatient sites of care. Importantly, EXPAREL is consistently and significantly outperforming the elective surgery market’s recovery, which is facing pockets of persistent pandemic-related disruptions and labor shortages," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "In addition, ZILRETTA is performing well, with a steady increase in new users and more than 220 accounts added year-to-date. For iovera°, the broad rollout of our Generation-2 device is now underway, and we expect the product to return to more robust year-over-year growth later this year."

"Our state-of-the-art training facility in Tampa continues to broaden interest in all three products and accommodates the market’s growing demand for best-practice education around regional blocks.
With the established growth and long-term potential of our product portfolio, we remain highly confident in our outlook for strong revenue and earnings growth as we further cement our leadership position in non-opioid pain management," continued Mr. Stack.

Since early 2020, the company’s revenues have been impacted by COVID-19 and pandemic-related challenges that included the significant postponement or suspension in the scheduling of elective surgical procedures due to public health guidance and government directives. While the degree of impact has diminished during the course of the pandemic due to the introduction of vaccines and the lessening of elective surgery restrictions, certain pandemic-related operational challenges persist. It remains unclear how long it will take the elective surgery market to normalize or if restrictions on elective procedures will recur due to future COVID-19 variants or otherwise.

The company is not providing 2022 revenue or gross margin guidance at this time given the continued uncertainty around COVID-19 and the pace of recovery for the elective surgery market. To provide

greater transparency, the company is reporting monthly intra-quarter unaudited net product sales for EXPAREL and iovera° until it has gained enough visibility around the impacts of COVID-19. The company is also providing weekly EXPAREL utilization and elective surgery data within its investor presentation, which is accessible at investor.pacira.com. Pacira is currently not reporting preliminary monthly ZILRETTA net product sales as the required adjustments for certain product rebate programs are calculated after the end of the quarter. Pacira completed its acquisition of Flexion Therapeutics on November 19, 2021, which added ZILRETTA (triamcinolone acetonide extended-release injectable suspension) to its commercial offering.

The financial information included in this press release is preliminary, unaudited, and subject to adjustment. It does not present all information necessary for an understanding of the company’s financial results for the second quarter or full year 2022.