On April 19, 2022 (the "Effective Date"), BioXcel Therapeutics, Inc. (the "Company") reported that entered into a credit agreement and guaranty (the "Credit Agreement"), with Oaktree Fund Administration, LLC ("Oaktree") as administrative agent, and the lenders party thereto (the "Lenders"), pursuant to which the Lenders have agreed to loan the Company up to $135.0 million in senior secured term loans (Filing, 8-K, BioXcel Therapeutics, APR 19, 2022, View Source [SID1234612464]). Under the terms of the Credit Agreement, the Company will borrow the first $70.0 million tranche of loans within 30 calendar days after the Company’s receipt of approval from the U.S. Food and Drug Administration (the "FDA") of a New Drug Application ("NDA") in respect of the use of the Company’s BXCL501 product for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder ("BXCL501 FDA Approval"). The BXCL501 FDA Approval was received on April 5, 2022 with the FDA’s approval of IGALMITM. The remaining two tranches of term loan commitments under the Credit Agreement may be borrowed at the Company’s option prior to December 31, 2024 as follows:

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

-$35.0 million upon satisfaction of certain conditions, including receipt of certain regulatory and financial milestones; and

-$30.0 million upon satisfaction of certain conditions, including specified minimum net sales of the Company attributable to sales of BXCL501 for a trailing twelve consecutive month period.

The loans under the Credit Agreement mature on the fifth anniversary of the Effective Date, provided that the Company may, at its option, extend the maturity date to the sixth anniversary of the Effective Date if, prior to December 31, 2024, the Company receives approval from the FDA of an NDA in respect of the use of BXCL501 for the acute treatment of agitation associated with Alzheimer’s Disease and satisfies certain other conditions. The loans under the Credit Agreement bear interest at a fixed annual rate of 10.25%, payable quarterly. Of such interest, 2.25% per annum will be payable in kind by capitalizing and adding such interest to the outstanding principal amount of loans on each quarterly interest payment date from the first payment date on which interest is owed through, and including, the third anniversary of such payment date, unless, with respect to any payment date, the Company elects to pay all or a portion of such interest in cash. The Company will be required to pay a ticking fee equal to 0.750% per annum multiplied by the daily undrawn amount of the commitments commencing 120 days after the funding of the first tranche of the loans payable quarterly through the termination of the commitments.

The Company may voluntarily prepay the Credit Agreement at any time subject to a prepayment fee, which on or prior to the second anniversary of the Effective Date is equal to the amount of interest that would have been paid from, and including, the date of such prepayment to, but excluding, the second anniversary of the Effective Date, plus 4.0% of the principal amount of the senior secured loans being prepaid. However, if any prepayment is made in connection with a change of control event, the prepayment fee will be equal to 12.5% of the principal amount of the senior secured loans being prepaid if such prepayment occurs on or prior to the first anniversary of the Effective Date, and 10% of the principal amount of the senior secured loans being prepaid if such prepayment occurs after the first anniversary of the Effective Date but on or prior to the second anniversary of the Effective Date. Thereafter, at any time after the second anniversary of the Effective Date but on or prior to the third anniversary of the Effective Date, the prepayment fee equals 4.0% of the aggregate outstanding principal amount of the senior secured loans being prepaid, and at any time after the third anniversary of the Effective Date but on or prior to the fourth anniversary of the Effective Date, the prepayment fee equals an amount equal to 2.0% of the aggregate outstanding principal amount of the loans being prepaid. No prepayment fee will apply after the fourth anniversary of the Effective Date. The Company is required to make mandatory prepayments of the loans with net cash proceeds from certain asset sales or insurance proceeds or condemnation awards, in each case, subject to certain exceptions and reinvestment rights, and subject to the prepayment fee.

The Company’s obligations under the Credit Agreement will be guaranteed by the Company’s existing and subsequently acquired or organized subsidiaries, subject to certain exceptions. The Company’s obligations under the Credit Agreement and the related guarantees thereunder are secured, subject to customary permitted liens and other agreed upon exceptions, by (i) a pledge of all of the equity interests of all existing and any future direct subsidiaries of the Company, and (ii) a perfected security interest in all of the tangible and intangible assets of the Company and the guarantors (except that the guarantees provided by the BXCL701 Subsidiaries (as defined below) are unsecured).

The Credit Agreement contains customary representations and warranties and customary affirmative and negative covenants, including, among other things, restrictions on indebtedness, liens, investments, mergers, dispositions, prepayment of other indebtedness, and dividends and other distributions, subject to certain exceptions, including specific exceptions with respect to product commercialization and development activities. The Company must also comply with certain financial covenants, including (i) maintenance of cash or permitted cash equivalent investments in accounts controlled by Oaktree, as administrative agent for the Lenders, of at least (a) $15.0 million from the Effective Date until the date on which the second tranche of loans are funded (the "Step-Up Date") and (b) $20.0 million from and after the Step-Up Date, provided, in the case of (a) and (b), that following any Permitted BXCL701 Release Event (as defined below), such amount will increase by $12.5 million, and following such time as unaffiliated third parties hold ownership of at least 30% of the equity interests in the BXCL701 Subsidiaries, such amount will increase by an additional $5.0 million (provided, that such amount will in no event exceed 50% of the aggregate amount of loans outstanding at any time); and (ii) a minimum revenue test, measured quarterly beginning with the Company’s fiscal quarter ending on December 31, 2023, that requires consolidated net revenue of the Company and its subsidiaries for the six consecutive month period ending on the last day of each such fiscal quarter to not be less than a minimum revenue amount specified in the Credit Agreement. Failure of the Company to comply with the financial covenants will result in an event of default, subject to certain cure rights of the Company with respect to the revenue covenant.

Notwithstanding the foregoing, the Credit Agreement permits OnkosXcel Therapeutics LLC ("OnkosXcel"), the Company’s subsidiary formed to develop BXCL701 and related assets (together with OnkosXcel Employee Holdings LLC and their respective subsidiaries, the "BXCL701 Subsidiaries") to receive third-party investment or transfer all or substantially all of their assets to an unaffiliated third party, in each case subject to terms and conditions set forth in the Credit Agreement, including the escrow of certain proceeds received by the Company and its subsidiaries (other than the BXCL701 Subsidiaries) in respect of these disposition events and, under circumstances set forth in the Credit Agreement, the mandatory prepayment of such escrowed amounts. The Company’s equity interests in the BXCL701 Subsidiaries have been pledged by the Company in support of its obligations under the Credit Agreement, and the BXCL701 Subsidiaries have provided direct guarantees the Company’s obligations under the Credit Agreement on an unsecured basis. However, the pledge, guarantee and other obligations of the BXCL701 Subsidiaries under the Credit Agreement will be released upon certain agreed upon events ("Permitted BXCL701 Release Events"), including an initial public offering by the BXCL701 Subsidiaries or the ownership by unaffiliated third parties of at least 20% of the equity interests in the BXCL701 Subsidiaries.

In connection with the closing of the Credit Agreement, OnkosXcel granted warrants to the Lenders to purchase a number of its LLC units initially equal to 0.875% of its fully diluted capitalization as of the closing of the Credit Agreement (the "Initial 701 Warrants"), subject to increase to up to an aggregate of 1.75% of its fully diluted capitalization as of the closing of the Credit Agreement based on the funding of the two delayed draw tranches of loans provided for under the Credit Agreement (the "Additional 701 Warrants", and collectively, the "701 Warrants"). The exercise price per unit of the 701 Warrants will be set upon the earlier of the closing of the next sale (or related series of related sales) by OnkosXcel of equity securities of OnkosXcel with aggregate proceeds of not less than $20.0 million to unrelated third parties (the "Next Equity Financing") at an exercise price per unit equal to a 10% premium over the price per unit of the equity securities sold by OnkosXcel in such Next Equity Financing or, in the event of a sale of OnkosXcel prior to the Next Equity Financing or an initial public offering constituting the Next Equity Financing, the lesser of (x) 75% of the fair market value of the consideration to be paid for a unit upon the consummation of such transaction and (y) 150% of the valuation applicable to the initial profits units issued by OnkosXcel after the closing of the Credit Agreement.

The 701 Warrants will expire on April 19, 2029. The 701 Warrants may be net exercised at the holder’s election.

The Credit Agreement contains events of default that are customary for financings of this type relating to, among other things, payment defaults, breach of covenants, breach of representations and warranties, cross default to material indebtedness, bankruptcy-related defaults, judgment defaults, breach of the financial covenants described above, and the occurrence of certain change of control events. In certain circumstances, events of default are subject to customary cure periods. Following an event of default and any applicable cure period, the Lenders will have the right upon notice to terminate any undrawn commitments and may accelerate all amounts outstanding under the Credit Agreement, in addition to other remedies available to them as secured creditors of the Company.

Company Warrants, Equity Investment and Registration Rights Agreement

In connection with the Credit Agreement, the Company granted warrants to the Lenders to purchase up to 278,520 shares of the Company’s common stock (the "Warrant Shares") at an exercise price of $20.04 per share (the "Warrants"), which represents the arithmetic average of the volume-weighted average price of the Company’s common stock on the Nasdaq Capital Market during the 30 trading days preceding the issuance of the Warrants. The Warrants will expire on April 19, 2029 and may be net exercised at the holder’s election.

In addition, pursuant to the Credit Agreement, the Lenders have the right to purchase shares of common stock (the "Equity Investment Shares" and together with the Warrant Shares, the "Shares") after the Effective Date, for a purchase price of $5.0 million at a price per share equal to a 10% premium to the volume weighted average price of the common stock over the 30 trading days prior to the Lenders’ election to proceed with such equity investment (the "Equity Investment").

The Company has entered into a Registration Rights Agreement with the Lenders, pursuant to which the Company agreed to file a registration statement on Form S-3 to register the Warrant Shares and, if issued, the Equity Investment Shares, for resale.

Revenue Interest Financing Agreement

In addition, on the Effective Date, the Company entered into a Revenue Interest Financing Agreement (the "RIFA") with Oaktree, as administrative agent, and the purchasers party thereto (the "Purchasers"), pursuant to which the Purchasers have agreed to provide the Company with up to $120.0 million in financing for the Company’s near-term commercial activities of IGALMITM, development and commercialization of BXCL501 and other general corporate purposes. The funding of the first $30.0 million payment is conditioned upon the Company’s receipt of BXCL501 FDA Approval, which occurred on April 5, 2022 with the FDA’s approval of IGALMITM. The remaining commitments under the RIFA may be drawn by the Company at its option prior to December 31, 2024 as follows:

-$45 million payment upon satisfaction of certain conditions, including receipt of certain regulatory and patent related milestones and specified minimum net sales of BXCL501 during any consecutive twelve month period; and

-$45 million payment upon satisfaction of certain conditions, including receipt of certain regulatory and patent related milestones and specified minimum net sales of BXCL501 during any consecutive twelve month period (collectively, such payments by the Purchasers, the "Purchaser Payments").

In exchange for the Purchaser Payments, the Company has agreed to make payments to the Purchasers (the "Revenue Share Payments") equal to a royalty ranging from 7.75% to 0.375% on net sales of BXCL501 in the United States, subject to a hard cap (the "Hard Cap") equal to 175% of the total amount funded in respect of the Purchaser Payments as of any date (the "Funded Amount"). The Company is required to make additional payments to the Purchasers from time to time to ensure that the aggregate amount of payments received by the Purchasers under the RIFA divided by the Funded Amount (such equation, as of any date of determination, the "MOIC") is at least equal to agreed upon minimum levels as of certain dates of determination, subject to terms and conditions set forth in the RIFA.

Commencing with the calendar quarter after the Hard Cap is received by the Purchasers, the Company will pay the Purchasers a flat 0.375% royalty on net sales of BXCL501 in the United States (the "Tail Royalty Payments") through, and including, March 31, 2036. However, no Tail Royalty Payments will be owed unless the conditions to the second tranche of Purchaser Payments have been met (irrespective of whether the Company elects to receive such Purchaser Payment).

The Company’s obligations under the RIFA are secured, subject to customary permitted liens and other agreed upon exceptions and subject to an intercreditor agreement between Oaktree in its capacity as administrative agent for the Lenders, on the one hand, and Oaktree, in its capacity as administrative agent for the Purchasers, on the other hand, by a perfected security interest in (i) accounts receivable arising from net sales of BXCL501 in the United States and one or more segregated bank accounts maintained for the purpose of receiving payments in respect of such accounts receivable, (ii) intellectual property that is claiming or covering BXCL501 itself or any method of using, making or manufacturing BXCL501 and (iii) regulatory approvals, clinical data, and all other assets that underlie BXCL501.

At any time after the funding of the first Purchaser Payment, the Company will have the right, but not the obligation (the "Call Option"), to buy out the Purchasers’ interest in the Revenue Share Payments at a repurchase price (the "Put/Call Price") equal to, as of any date of determination, an amount sufficient that, giving effect to the payment of the Put/Call Price and all other payments made by the Company to the Purchasers pursuant to the RIFA, (i) the MOIC equals 1.225x if such date is before the one-year anniversary of the date the first Purchaser Payment was made, (ii) the MOIC equals 1.375x if such date is on or after the one-year anniversary of the date the first Purchaser Payment was made and before the two-year anniversary of the date the first Purchaser Payment was made, (iii) the MOIC equals 1.525x if such date is on or after the two-year anniversary of the date the first Purchaser Payment was made and before the three-year anniversary of the date the first Purchaser Payment was made, and (iv) the MOIC equals 1.750x if such date is on or after the three-year anniversary of the date the first Purchaser Payment was made. If the Company exercises the Call Option prior to the third anniversary of the Effective Date, then the Purchasers will not be entitled to any Tail Royalty Payments. However, if the Company exercises the Call Option on or after the third anniversary of the Effective Date, then the Company will be required to buy out the Purchasers’ interest in the Tail Royalty Payments in addition to the Revenue Share Payments, and the applicable Put/Call Price will be an amount equal to, as of any date of determination, an amount sufficient that, giving effect to the payment of the Put/Call Price and all other payments made by the Company to the Purchasers pursuant to the RIFA, the MOIC equals 2.25x.

The RIFA contains customary representations and warranties and certain restrictions on the Company’s ability to incur indebtedness and grant liens on intellectual property related to BXCL501. In addition, the RIFA provides that if certain events ("Put Option Events") occur, including certain bankruptcy events, failure to make payments, a change of control, an out-license or sale of all of the rights in and to BXCL501 in the United States, in each case except a permitted licensing transaction (as defined in the RIFA) and, subject to applicable cure periods, material breach of the covenants in the RIFA, Oaktree, at the direction of the Purchasers, may require the Company to repurchase the Purchasers’ interests in the Revenue Share Payments and Tail Royalty Payments at the Put/Call Price. In addition, the Company may terminate the RIFA if a change of control occurs before the first Purchaser Payment is made.

Transactions with BioXcel LLC

In connection with the foregoing financing arrangements, on April 19, 2022 the Company and BioXcel LLC, a significant stockholder of the Company, entered into the BioXcel Trademark License Agreement, pursuant to which BioXcel LLC has granted the Company a royalty-free license to use the BIOXCEL trademark in connection with marketing, promoting and selling any products and services in the field of neuroscience, for which the Company has agreed to pay BioXcel LLC a one-time fee of $135,000, and also entered into the Second Amendment to the Second Amended and Restated Separation and Shared Services Agreement pursuant to which the parties agreed to extend the Company’s option to enter into a Collaborative Services Agreement with BioXcel LLC through December 31, 2024, for which the Company has agreed to pay BioXcel LLC $18,000 per month, prorated for any partial month, as applicable, for the period beginning March 13, 2023 and ending December 31, 2024. BioXcel LLC is majority owned and controlled by BioXcel Holdings, Inc., of which Vimal Mehta, Ph.D., the Company’s Chief Executive Officer, President and member of the Board, is co-founder and serves as Chairman of the Board and Chief Executive Officer, and Krishnan Nandabalan, Ph.D., the Company’s Chief Digital Officer and member of the Board, is also co-founder and serves as President, Secretary and Chief Scientific Officer.

On April 19, 2022 AstraZeneca and Daiichi Sankyo reported that they have received notification of acceptance of the supplemental Biologics License Application (sBLA) of Enhertu (trastuzumab deruxtecan) for the treatment of adult patients in the US with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumours have a HER2 (ERBB2) mutation and who have received a prior systemic therapy (Press release, AstraZeneca, APR 19, 2022, View Source [SID1234612463]). The application has also been granted Priority Review.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Enhertu is a HER2-directed antibody drug conjugate (ADC) being jointly developed by AstraZeneca and Daiichi Sankyo.

The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance.1 The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for their regulatory decision, is during the third quarter of 2022. The Priority Review follows Breakthrough Therapy Designation granted by the FDA for Enhertu in this cancer type in May 2020.

Lung cancer is the second most common form of cancer globally, with more than two million new cases diagnosed in 2020.2 For patients with metastatic NSCLC, prognosis is particularly poor, as only approximately 8% will live beyond five years after diagnosis.3 There are currently no HER2-directed therapies approved specifically for the treatment of HER2-mutant NSCLC,4 which occurs in approximately 2-4% of patients with non-squamous NSCLC.4,5

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "The DESTINY-Lung01 trial confirmed the HER2 mutation as an actionable biomarker in non-small cell lung cancer. If approved, Enhertu has the potential to become a new standard treatment in this patient population, offering a much-needed option for patients with HER2-mutant metastatic non-small cell lung cancer who currently have no targeted treatment options."

Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo, said: "The results of DESTINY-Lung01 showed that Enhertu is the first HER2-directed therapy to demonstrate a strong and robust tumour response in more than half of patients with previously treated HER2-mutant metastatic non-small cell lung cancer. Seeking approval in the US for a third tumour type in three years further demonstrates the significant potential of Enhertu in treating multiple HER2-targetable cancers."

The sBLA is based on data from the registrational DESTINY-Lung01 Phase II trial published in The New England Journal of Medicine, and is supported by the Phase I trial (DS8201-A-J101) published in Cancer Discovery.

Primary results from previously-treated patients with HER2-mutations (cohort 2) of DESTINY-Lung01 demonstrated a confirmed objective response rate (ORR) of 54.9% (95% confidence interval [CI]: 44.2-65.4) in patients treated with Enhertu (6.4mg/kg) as assessed by independent central review (ICR). One (1.1%) complete response (CR) and 49 (53.8%) partial responses (PR) were observed.

A confirmed disease control rate (DCR) of 92.3% was seen with a reduction in tumour size observed in most patients. After a median follow-up of 13.1 months, the median duration of response (DoR) for Enhertu was 9.3 months. The median progression-free survival (PFS) was 8.2 months and the median overall survival (OS) was 17.8 months.

The safety profile of the most common adverse events with Enhertu in DESTINY-Lung01 was consistent with previous clinical trials with no new safety concerns identified.

Enhertu is being further assessed in a comprehensive clinical development programme evaluating efficacy and safety across multiple HER2-targetable cancers, including breast, gastric, lung and colorectal cancers.

Notes

HER2-mutant NSCLC
Lung cancer is the second most common form of cancer globally, with more than two million new cases diagnosed in 2020.2 In the US, lung cancer is the second most commonly diagnosed cancer, with more than 236,000 new cases expected in 2022.6 For patients with metastatic NSCLC, prognosis is particularly poor, as only approximately 8% will live beyond five years after diagnosis.3

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours, including lung, breast, gastric and colorectal cancers. Certain HER2 gene alterations (called HER2 mutations) have been identified in NSCLC as distinct molecular targets and have been reported in approximately 2-4% of patients with non-squamous NSCLC.4,5

While HER2 gene mutations can occur in a range of patients, they are more commonly found in patients with NSCLC who are younger, female, and have never smoked.7 HER2 gene mutations have been independently associated with cancer cell growth and poor prognosis, with an increased incidence of brain metastases.8 Although the role of anti-HER2 treatment is well established in breast and gastric cancers, HER2 is an emerging biomarker in NSCLC with no approved HER2-directed therapies.4,9 Next generation sequencing has been utilised in the identification of HER2 (ERBB2) mutations.10

DESTINY-Lung01
DESTINY-Lung01 is a global Phase II, open-label, two-cohort trial evaluating the safety and efficacy of Enhertu in patients with HER2-mutant (6.4mg/kg) or HER2-overexpressing (defined as IHC3+ or IHC2+) [6.4mg/kg and 5.4mg/kg] unresectable and/or metastatic non-squamous NSCLC who had progressed after one or more systemic therapies. The primary endpoint is confirmed ORR by ICR. Key secondary endpoints include DoR, DCR, PFS, OS and safety. DESTINY-Lung01 enrolled approximately 180 patients at multiple sites, including Asia, Europe and North America. For more information about the trial, visit ClinicalTrials.gov.

Enhertu
Enhertu is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a stable tetrapeptide-based cleavable linker.

Enhertu (5.4mg/kg) is approved in more than 40 countries for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens based on the results from the DESTINY-Breast01 trial.

Enhertu (6.4mg/kg) is approved in several countries for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 trial.

Enhertu development programme
A comprehensive development programme is underway globally, evaluating the efficacy and safety of Enhertu monotherapy across multiple HER2-targetable cancers, including breast, gastric, lung and colorectal cancers. Trials in combination with other anticancer treatments, such as immunotherapy, are also underway.

Regulatory applications for Enhertu are currently under review in Europe, Japan, the US and several other countries for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen based on the results from the DESTINY-Breast03 trial.

Enhertu also is currently under review in Europe for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma who have received a prior anti-HER2-based regimen based on the DESTINY-Gastric01 and DESTINY-Gastric02 trials.

Daiichi Sankyo collaboration
Daiichi Sankyo Company, Limited (TSE: 4568) [referred to as Daiichi Sankyo] and AstraZeneca entered into a global collaboration to jointly develop and commercialise Enhertu (a HER2-directed ADC) in March 2019, and datopotamab deruxtecan (DS-1062; a TROP2-directed ADC) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is responsible for the manufacturing and supply of Enhertu and datopotamab deruxtecan.

AstraZeneca in lung cancer
AstraZeneca is working to bring patients with lung cancer closer to cure through the detection and treatment of early-stage disease, while also pushing the boundaries of science to improve outcomes in the resistant and advanced settings. By defining new therapeutic targets and investigating innovative approaches, the Company aims to match medicines to the patients who can benefit most.

The Company’s comprehensive portfolio includes leading lung cancer medicines and the next wave of innovations, including Tagrisso (osimertinib) and Iressa (gefitinib); Imfinzi (durvalumab) and tremelimumab; Enhertu and datopotamab deruxtecan in collaboration with Daiichi Sankyo; Orpathys (savolitinib) in collaboration with HUTCHMED; as well as a pipeline of potential new medicines and combinations across diverse mechanisms of action.

AstraZeneca is a founding member of the Lung Ambition Alliance, a global coalition working to accelerate innovation and deliver meaningful improvements for people with lung cancer, including and beyond treatment.

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

On April 19, 2022 Alkermes plc (Nasdaq: ALKS) reported that it commenced binding arbitration proceedings in respect of two license agreements with Janssen Pharmaceutica N.V. ("Janssen"), a subsidiary of Johnson & Johnson (Press release, Alkermes, APR 19, 2022, View Source [SID1234612462]). Under these agreements, Janssen received access and rights to Alkermes’ small particle pharmaceutical compound technology, known as NanoCrystal Technology, which enabled a number of successful products, such as INVEGA SUSTENNA, INVEGA TRINZA, INVEGA HAFYERA and CABENUVA. Janssen partially terminated the agreements in the United States effective as of February 2022.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The purpose of the arbitration is to settle, among other things, whether, notwithstanding its partial termination of the agreements, Janssen has a continuing obligation to pay royalties on sales in the United States of products developed under the agreements. Janssen has refused to pay any royalties required by the agreements in the United States since the effective date of the partial terminations. Alkermes strongly disagrees with Janssen’s position and contends that it continues to owe royalties. Alkermes remains committed to enforcing its contractual rights and addressing any unauthorized use of its intellectual property.

Following receipt of the notices of partial termination, Alkermes triggered dispute resolution provisions in the license agreements. The company has engaged with Janssen in an effort to come to a mutually agreeable settlement. No resolution has been achieved. Alkermes remains open to a mutually agreeable resolution.

Under the agreements, the arbitration will be conducted pursuant to the Institute for Conflict Prevention and Resolution (CPR) Rules for Non-Administered Arbitration before a panel of three arbitrators. The arbitration will be confidential, subject to the parties’ disclosure obligations under applicable law. Other than pursuant to these obligations, Alkermes does not intend to comment or provide additional information regarding the arbitration until an order on the merits or other material order is issued in the arbitration or the arbitration is otherwise concluded.

On April 19, 2022 Akoya Biosciences, Inc., (Nasdaq: AKYA), The Spatial Biology Company, reported the appointment of Dr. Ehab A. El-Gabry as the company’s Chief Medical Officer (CMO) (Press release, Akoya Biosciences, APR 19, 2022, View Source [SID1234612461]). In this newly created position, Dr. El-Gabry will lead Akoya’s strategy in advancing the use of its spatial phenotyping solutions in the clinical setting.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. El-Gabry brings a wealth of experiences that are critical to the company’s vision of advancing spatial phenotyping in precision medicine and cancer care. He is a board-certified pathologist who served as the Senior Medical Director for Roche Tissue Diagnostics Personalized Health Care Solutions (PHCS). As the head of the Roche Companion Diagnostics Pathology group, Dr. El-Gabry led the development of multiple digital and manual scoring algorithms and guided the clinical development of numerous commercially available predictive assays, including PD-L1 IHC. He served as Roche Pharma Services Medical Director and provided medical oversight for Roche Digital Solutions, Roche’s portfolio of digital pathology platforms.

At Akoya, Dr. El-Gabry will be a key member of the executive leadership team, responsible for the direction and execution of the company’s translational research and clinical strategy. He will be focused on the evaluation and commercial development of the company’s platforms for future clinical use, including regulatory submissions, cross-sector collaborations with academia and industry, and will ensure that the company’s portfolio of cutting-edge products and services meets the needs of patients, providers, payors, and regulatory agencies.

"We are extremely pleased to welcome an innovative physician-executive of Ehab’s caliber to lead Akoya’s translational and clinical strategy, just as spatial phenotyping is accelerating translational cancer research and as emerging evidence supports its potential to improve patient care," said Brian McKelligon, Chief Executive Officer of Akoya. "Ehab’s expertise and leadership will be invaluable to facilitating the platform advancements and partnerships that are central to our success in the translational and clinical markets."

"I am delighted to assume this leadership role at Akoya and build on the company’s pioneering role in transforming tissue analysis for cancer and life-threatening diseases," said Dr. Ehab El-Gabry. "Throughout my career, I have had a strong interest in discovering and developing new diagnostic tests that enhance our understanding and treatment of diseases like cancer. Spatial phenotyping is evolving from a discovery research technology towards a powerful platform for new, more informative diagnostics. Akoya is pioneering and leading this charge. I am excited to support Akoya and our partners in making this aspiration a reality."

Dr. El-Gabry completed his preliminary general surgery and pathology residencies at the Cleveland Clinic, Ohio. Subsequently, he finished his fellowship training in breast pathology and cytopathology at the University of Florida, Jacksonville. He then joined University of Pittsburgh Medical Center (UPMC) as an independent pathologist and research associate, where he focused on digital pathology.

Dr. El-Gabry has authored over 100 publications and speaks frequently at domestic and international scientific workshops. He received his medical degree from Cairo University Hospitals in Egypt.

On April 19, 2022 Voisin Consulting Life Sciences (VCLS), a leading global regulatory, access to market and clinical consultancy, reported a strategic partnership with EC Innovations in China, a global localization service provider with extensive experience in translating highly regulated life sciences & medical content (Press release, VCLS, APR 19, 2022, View Source [SID1234612452]). The alliance between VCLS and EC Innovations is set to build a long-term and robust relationship to further grow and enhance both companies’ capabilities to provide mutual clients with a higher level of services.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As life sciences and medical industries gather pace and expand globally, regulatory and clinical requirements have become increasingly demanding, stringent and specific, with standards varying between countries. To ensure compliance across this complex regulatory landscape is thus a challenge for any company preparing to expand its footprint and strengthen its presence in foreign markets.

As a matter of course, the complex and ever-changing regulatory requirements call for a comprehensive solution to meet all needs with regard to regulatory consulting, clinical research and medical translation. Hence, this highly anticipated partnership shall bring together industry-leading regulatory consulting services from VCLS and high-quality translation & localization services from EC Innovations to unlock the potential of a full range of consulting & translation solutions. The combined resources, technologies and expertise of the two companies shall enable us to make multilingual compliance issues as painless as possible, helping complete transnational submissions, clear regulatory hurdles and shorten time to market.

As part of this partnership, VCLS and EC Innovations will jointly host multiple virtual and in-person events each year, sharing the knowledge and experience of the leading subject matter experts and our partners to guide clients in complying with the strict regulatory requirements in the life sciences and medical industry.

Dr. Linsen DU, General Manager of VCLS China said:"We at VCLS are excited to combine forces with EC Innovation. We believe that this is a perfect fit to facilitate our local and international clients who need to bring their innovative healthtech products faster to the highly regulated market, to the patients. We are looking forward to developing this partnership further towards achieving common goals."

"Our Life Science Business Unit works for hundreds of pharmaceutical/medical device companies in all kinds of application dossier translation. We are so thrilled to partner with VCLS, who has a deep knowledge and expertise of the global regulatory affairs and clinical consultancy," said Jane Du, Managing Director of EC Innovations (Chengdu), Inc. "This partnership enables us to further assist our clients in navigating the regulatory challenges and ensuring compliance with region-specific language requirements."