On April 12, 2022 AbbVie (NYSE: ABBV) reported new data from a Phase 2 trial of navitoclax in combination with ruxolitinib in patients with myelofibrosis (Press release, AbbVie, APR 12, 2022, View Source [SID1234612040]). The results were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting (AACR 2022, abstract #LB108). Navitoclax is an investigational, first-in-class, oral BCL-XL/BCL-2 inhibitor that is designed to activate programmed cell death (apoptosis) in cancer cells. Navitoclax and its safety and efficacy are under evaluation as part of ongoing Phase 2 and registrational Phase 3 studies.

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"Myelofibrosis is a cancer that originates in the bone marrow, leading to fibrosis. Currently, available therapies do not address the underlying disease biology and have not shown a consistent effect on both biomarkers of disease modification and overall survival. Disease control with reversal of bone marrow fibrosis is a key objective for improving patient outcomes," said Mohamed Zaki, M.D., Ph.D., vice president and global head of oncology clinical development at AbbVie. "That’s why we are especially pleased about these early results of navitoclax in combination with ruxolitinib that indicate its novel mechanism of action of inducing cell death may cause reversal of bone marrow fibrosis and extend survival for patients who respond to treatment."

Myelofibrosis is a rare, difficult-to-treat blood cancer that results in excessive scar tissue formation (fibrosis) in the bone marrow. Anti-fibrosis activity, measured by reversal of bone marrow fibrosis (BMF) and reduction in driver gene variant allele frequency (VAF) have been suggested as potential biomarkers to measure disease modification in myelofibrosis, but their association with a survival benefit have not been widely described.1 These data build on AbbVie’s history of transforming standards of care in blood cancers with significant unmet needs.

The results presented at AACR (Free AACR Whitepaper) 2022 were from REFINE (NCT03222609) – a Phase 2 trial evaluating navitoclax in combination with ruxolitinib (a JAK1/2 inhibitor), which included patients with myelofibrosis who had progressed on or had a suboptimal response to at least 12 weeks of ruxolitinib monotherapy. Median exposure to prior ruxolitinib was 91 weeks (range: 19 weeks – 391 weeks) in the first 34 patients enrolled earlier in the trial.

In the exploratory analysis of 32 patients who were evaluable for improvements in BMF, 12 (38%) had a ≥1 grade improvement during any time point in the study. For driver gene VAF reduction, 26 patients were evaluable and 6 (23%) achieved a ≥20% reduction at week 24. Five patients achieved both BMF and VAF responses.

Median overall survival (OS) for all patients was not reached as presented previously by Harrison2 et al. For patients who had a ≥1 grade improvement BMF median OS was not reached compared with 28.5 months for patients who did not experience an improvement. Similarly, median OS was also not reached for patients who achieved a ≥20% driver gene VAF reduction versus 28.5 months for patients who did not.

All 34 patients (100%) experienced at least one adverse event (AE), and 15 (44%) experienced a serious adverse event (SAE).2 The most common AEs of any grade were thrombocytopenia (n= 30, 88%), diarrhea (n= 24, 71%), fatigue (n= 21, 62%), and nausea (n= 13, 38%). The most common SAEs were pneumonia (n= 4, 12%) and splenic infarction (n= 2, 6%).2 There were no SAEs of bleeding and thrombocytopenia was manageable and reversible with dose reduction/interruption of navitoclax and/or ruxolitinib.2 REFINE was a dose-finding study and the target dose of navitoclax was reduced subsequent to these findings.

"Data obtained from this exploratory analysis holds promise for potential future clinical research," said Jacqueline S. Garcia, M.D., Dana-Farber Cancer Institute, assistant professor of medicine at Harvard Medical School. "What is most notable in this analysis is the overall survival among patients who demonstrate VAF and BMF responses and all patients were alive at time of analysis. Patients in this Phase 2 trial had suboptimal response to ruxolitinib at time of study entry and then had navitoclax added to ruxolitinib on the trial. VAF and BMF responses occurred despite the presence of high molecular risk mutations, which suggests the potential efficacy of combination navitoclax and ruxolitinib could be independent of underlying risk factors."

About Navitoclax
Navitoclax is an investigational, oral BCL-XL/BCL-2 inhibitor. The BCL-2 family of proteins are known regulators of the apoptosis pathway.3 Navitoclax is not approved by the U.S. Food and Drug Administration (FDA). Its safety and efficacy are under evaluation as part of ongoing Phase 2 and registrational Phase 3 studies.

AbbVie is currently recruiting for two Phase 3 trials of navitoclax (TRANSFORM-1 and TRANSFORM-2) in combination with ruxolitinib for the treatment of myelofibrosis that will enroll more than 500 patients. The company anticipates pivotal trial readouts and regulatory submission for navitoclax in 2023.

About the REFINE Study
REFINE is a Phase 2, open-label, multicenter study evaluating the tolerability and efficacy of navitoclax alone or when added to ruxolitinib in patients with myelofibrosis.1 The primary outcome measure is the percentage of patients who achieve Spleen Volume Reduction of greater than or equal to 35% (SVR35) from baseline to Week 24. Secondary outcomes measures include percentage of participants achieving 50% reduction in Total Symptom Score from baseline to Week 24 and change in grade of bone marrow fibrosis assessed according to the European Consensus Grading System. More information can be found on www.clinicaltrials.gov (NCT03222609).

About Myelofibrosis
Myelofibrosis is a rare, difficult-to-treat blood cancer that results in excessive scar tissue formation (fibrosis) in the bone marrow. Patients living with myelofibrosis experience symptoms such as an enlarged spleen, fatigue, weakness, and severe anemia, that are often debilitating and greatly impact quality of life. Myelofibrosis also carries a risk of transformation to more aggressive disease such as acute myeloid leukemia.3

On April 12, 2022 Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, reported preliminary revenues of $157.4 to $158.4 million for the first quarter of 2022, compared with $119.0 million for the first quarter of 2021 (Press release, Pacira Pharmaceuticals, APR 12, 2022, View Source [SID1234612039]). The company’s revenues include net product sales of EXPAREL (bupivacaine liposome injectable suspension), ZILRETTA (triamcinolone acetonide extended-release injectable suspension), and the iovera° system. Pacira currently reports a range for preliminary quarterly ZILRETTA net product sales as the required adjustments for certain product rebate programs are calculated after the end of the quarter. The company began recognizing sales of ZILRETTA in November 2021 after completing its acquisition of Flexion Therapeutics, Inc.

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"We are excited to report that March marked record EXPAREL monthly sales, underscoring both our near- and long-term expectations for growth of this product. The increase was driven by the continued expansion and institutionalization of EXPAREL-based blocks as the foundation of enhanced recovery protocols across a variety of surgical procedures," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "We are also making strong progress incorporating ZILRETTA into our operations and recently introduced a simplified pricing and discounting program for our customers. Preliminary findings from our collaborative observational studies have continued to highlight the potential benefits of iovera° cold therapy as a novel approach to treating spasticity. We look forward to meeting with the U.S. Food and Drug Administration later this year to discuss our regulatory strategy for broadening the iovera° label to include this indication."

First Quarter and March 2022 Preliminary Revenue Highlights

•EXPAREL net product sales were $129.2 million and $114.7 million for the first quarters of 2022 and 2021 and $51.2 million and $44.3 million for the months March 2022 and 2021, respectively. EXPAREL daily sales were 113 percent of the prior year for the first quarter and 116 percent for the month of March, respectively. The company reports average daily growth rates for EXPAREL to account for differences in the number of selling days per reporting period. For the first quarter, EXPAREL selling days were 63 in both 2022 and 2021. For the month of March, EXPAREL selling days were 23 in 2022 and 2021. Sales of bupivacaine liposome injectable suspension to a third-party licensee for use in veterinary practice were $1.6 million and $0.8 million in the first quarters of 2022 and 2021, respectively.

•ZILRETTA net product sales are expected to be between $23.0 million and $24.0 million for the first quarter of 2022, compared with $24.6 million for the first quarter of 2021. First quarter 2021 ZILRETTA sales occurred prior to the company’s acquisition of Flexion in November 2021. 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.
•iovera° net product sales were $3.0 million and $3.3 million for the first quarters of 2022 and 2021 and $1.1 million and $1.5 million for the months of March 2022 and 2021.
•First quarter 2022 royalty revenue was $0.6 million, compared with $0.3 million in 2021.

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 completed its acquisition of Flexion Therapeutics on November 19, 2021, which added ZILRETTA 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 first quarter or full year 2022.

On April 12, 2022 Incyte (Nasdaq:INCY) reported that it has scheduled its first quarter financial results conference call and webcast for 8:00 a.m. ET on Tuesday, May 3, 2022 (Press release, Incyte, APR 12, 2022, View Source [SID1234612038]).

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The schedule for the press release and conference call/webcast is as follows:

If you are unable to participate, a replay of the conference call will be available for thirty days. The replay dial-in number for the U.S. is 877-660-6853 and the dial-in number for international callers is 201-612-7415. To access the replay you will need the conference ID number 13728884.

The live webcast with slides can be accessed at Investor.Incyte.com and will be available for replay for ninety days.

On April 12, 2022 Minomic International Limited reported that its wholly owned subsidiary, Minomic Inc., has been granted a Clinical Laboratory Improvement Amendments (CLIA) certification, allowing its lab to officially open for business, in Gaithersburg, MD (Press release, Minomic, APR 12, 2022, View Source [SID1234612027]).

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The CLIA program regulates laboratories that perform testing on patient specimens in order to ensure accurate and reliable test results. CLIA enables the release of test results following the laboratory demonstrating certain quality assurance characteristics relating to analytical validity for the use of that test system in the laboratory’s own environment.

Minomic CEO Brad Walsh said: "This is an important step in the commercialisation process in the US for our MiCheck Prostate LDT."

"Our US team will be rolling out the test in the world’s largest healthcare market, serving patients and clinicians."

"It is estimated that about two million American men undergo transrectal biopsies each year to diagnose prostate cancer. About 1-3% of these can lead to sepsis and death, while only 250,000 are diagnosed with prostate cancer."

"Clearly many of these biopsies are unnecessary, which is why urologists see an unmet need for a more specific test to assist them to identify the right patients to biopsy. In the coming weeks, we look forward to sharing the findings from studies currently in progress for MiCheck Prostate."

On April 12, 2022 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported financial results and corporate updates for the fiscal year ended 31 December 2021 (Press release, Evotec, APR 12, 2022, View Source [SID1234612024]).

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FINANCIALS REFLECT GREAT PERFORMANCE
Group revenues significantly exceeded the revenue target, up 23% to € 618.0 m (+27% like for like, excluding portfolio and fx effects (2020: € 500.9 m))
Base business up 18% (20% adjusted for Sanofi payment in Q1 2020)
Adjusted Group EBITDA in line with guidance at € 107.3 m, up 1% (2020: € 106.7 m); like-for-like growth up 18%
Unpartnered R&D expenses of € 58.1 m (2020: € 46.4 m up 25%)
Very strong liquidity position with € 858.2 m in cash

GREAT PROGRESS ACROSS ALL "BUILDING BLOCKS" OF ACTION PLAN 2025
Multiple new and extended integrated drug discovery, development, and manufacturing alliances
Important clinical trial initiations and significant progress in co-owned pipeline
Excellent progress in iPSC and protein degradation collaborations with Bristol Myers Squibb; Opt-in for EVT8683 and start of clinical development
New EVT Innovate partnerships e.g. in heart failure, kidney disease, RNA-based drug discovery, oncology, etc.
Acceleration & initiation of innovative platforms, tools & technologies – EVOcells, EVOpanOmics, EVOpanHunter, E.INVENT.AI, E.SOLVE, E.RNA, etc.
Launch of three new BRIDGEs, the pandemic preparedness initiative PRROTECT as well as E.MPD, the largest and highest quality molecular patient database (after period-end)
Excellent progress within operational venturing strategy, including Exscientia IPO on NASDAQ
CORPORATE HIGHLIGHTS
Secondary listing on NASDAQ with public offering raising gross proceeds of $ 500 m
Opening of J.POD Redmond, WA (US); initiation of J.POD Toulouse, France (EU)
Expansion of footprint with the acquisition of land and buildings of Verona (Italy) site from GlaxoSmithKline SpA, now "Campus Levi-Montalcini"; Sustainable expansion of "Dorothy Crowfoot Hodgkin Campus" in Abingdon (UK); Relocation of Munich site to Campus Neuried (after period-end)
Dr Matthias Evers joins Evotec as Chief Business Officer (effective 1st May 2022)
FINANCIAL GUIDANCE 2022 – CONTINUED STRONG GROWTH
Group revenues expected to be in a range of € 700 – 720 m (€ 690 – 710 m at constant exchange rates) (2021: € 618.0 m)
Unpartnered research and development expenses expected to be in a range of € 70 – 80 m (2021: € 58.1 m)
Adjusted Group EBITDA expected to be in the range of € 105 – 120 m (€ 95 – 110 m at constant exchange rates) (2021: € 107.3 m)
 

FINANCIALS REFLECT STRONG GROWTH
In 2021, Evotec’s group revenues increased by 23% to € 618.0 m (+27% like for like, excluding portfolio and fx effects) (2020: € 500.9 m), in a market that saw disruptions caused by the COVID-19 pandemic. Like-for-like growth is adjusted for the end of the Sanofi payment after Q1 2020 (€ (8.6) m) and negative foreign exchange effects (€ (9.2) m) in 2021. The positive development was mainly due to the continued robust performance of the base business in all areas as well as higher milestone payments. Due to great progress within both existing and new partnerships (e.g. with Bristol Myers Squibb ("BMS") in neuroscience and with Takeda in RNA-targeting small molecules), revenues from upfront, milestone and licence payments were significantly higher than in the previous year (2020: € 30.1 m) at € 61.3 m. Additionally, fiscal year 2021 benefited from an increased revenue contribution by Just – Evotec Biologics of € 53.6 m (2020: € 41.1 m).

In 2021, Evotec substantially increased its unpartnered R&D expenses of € 58.1 m (2020: € 46.4 m) in order to further accelerate the development of its efficiency and precision medicine platforms as well as the development of new first-in-class drug candidates. Its partnered R&D expenses declined to € 14.1 m (2020: € 17.5 m). "Partnered" are funded projects and are mainly run at the ID Lyon site, which was acquired in 2018.

In 2021, the group’s selling, general and administrative ("SG&A") expenses increased by 37% to € 105.4 m (2020: € 77.2 m), mainly as a result of an increase of the headcount in preparation for future growth as well as NASDAQ listing-related expenses for consulting and legal services as well as higher insurance premiums. One-off expenses for the US listing and other strategic activities amounted to approximately € 1.7 m.

Adjusted Group EBITDA increased to € 107.3 m in 2021 (+1% and + 18% like for like) (2020: € 106.6 m), despite significant expenditures into R&D as well as higher COGS and SG&A expenses ahead of the manufacturing start at J.POD Redmond, WA (US). The increase was mainly due to higher base business, increasing revenues from milestone payments, and favourable R&D tax credits in Italy and France.

Evotec recorded an operating result for 2021 of € 41.0 m (2020: € 48.5 m), due to the reasons mentioned above as well as higher depreciations after completion of the J.POD facility in Redmond, WA (US). With € 215.5 m, the Company’s net income was significantly higher than in the previous year (2020: € 6.3 m). This increase was mainly due to an adjustment to the fair value of Evotec’s stake in Exscientia Ltd. following Exscientia’s IPO in the US.

With the liquidity increase following Evotec’s own public offering on NASDAQ, the net debt ratio at 31 December 2021 (excl. IFRS16) improved to a net cash position of (negative) 5.5x adjusted Group EBITDA (2020: (negative) 1.5x adjusted Group EBITDA) with a net cash position of € 494.3 m and a significantly increased equity ratio of 61.6% (2020: 49.4%).

STRONG PERFORMANCE ACROSS ALL BUSINESS SEGMENTS
EVT Innovate was characterised in 2021 by multiple important clinical trial initiations, an acceleration of the milestone income from its strategic partnerships (e.g. iPSC neuroscience and targeted protein degradation collaborations with BMS as well as the signing of multiple new partnerships e.g., with Takeda in RNA-based drug discovery, with Chinook Therapeutics in chronic kidney diseases, and with Medical Center Hamburg-Eppendorf in heart failure.

In the course of 2021, notable achievements were obtained within Evotec’s strategic partnerships with BMS. BMS exercised a licensing option for EVT8683 and moved the compound into a first clinical Phase I trial shortly thereafter. The opt-in decision by BMS led to a payment of $ 20 m to Evotec. Moreover, the inclusion of a new cell type and additional programme designations triggered payments of more than $ 50 m to Evotec.

In 2021 we also saw several other pipeline assets added to the list of drug candidates in clinical trials: In January 2021, the chikungunya virus antibody EVT894 entered Phase I of clinical development. The immuno-oncology project A2a receptor antagonist in cooperation with Exscientia reached Phase I. Also, Evotec’s oncology agent EVT801 developed in cooperation with Kazia Therapeutics entered clinical development.

In autumn 2021 Bayer’s drug candidate eliapixant (BAY1817080) showed positive Phase IIb results in refractory chronic cough. However, at the beginning of February of 2022 (after period-end), Bayer informed Evotec about its decision to discontinue the development of the investigational P2X3 receptor antagonist eliapixant (BAY1817080). As a consequence of Bayer’s decision, Evotec has the possibility to regain the rights to all P2X3 assets. The Company will evaluate the underlying data and all options.

In 2021, Evotec’s academic BRIDGE model was accelerated through the launch of three new BRIDGE partnerships. In April and May of 2021, beLAB2122, beLAB1407 were launched, each backed by Bristol Myers Squibb with a total funding volume of $ 20 m each. June 2021 saw the launch of Danube Labs, a BRIDGE partnership with CEBINA GmbH to identify and develop academic projects from Central and Eastern Europe into mature therapeutic product development opportunities. The Company made a new investment in the promising Biotech company OxVax that is based on research from Oxford University, and participated in several financing rounds and successful spin-offs, such as Topas Therapeutics, Celmatix and CureXsys. In October of 2021, Exscientia Ltd., in which Evotec has a significant stake, successfully completed an IPO on NASDAQ.

Evotec also made significant progress towards building the globally leading precision medicine platform by accelerating and initiating innovative platforms, tools, and technologies such as EVOcells, EVOpanOmics, EVOpanHunter, E.INVENT.AI, E.SOLVE, E.RNA, etc. At the start of 2022, to leverage the power of molecular data, Evotec launched its molecular patient database (E.MPD). E.MPD is one of the largest and highest quality molecular databases globally.

The EVT Execute segment continued to demonstrate strong progress in 2021 with new and extended alliances. In 2021, Evotec was involved in 842 alliances and recorded a repeat business of 91%. Evotec signed new and extended existing partnerships and alliances, e.g. with Abivax, Annexon, Awakn, 1st Biotherapeutics, Bicycle Therapeutics, EQRx, Evommune, Interline, Related Sciences, Takeda. Just – Evotec Biologics continued its strong growth by continuing the collaboration with the US Department of Defense, and introducing the humanoid antibody library J.HAL℠ to the market.

J.POD REDMOND, WA (US) OPEN FOR BUSINESS, J.POD TOULOUSE, FRANCE (EU) INITIATED
In August 2021, Evotec opened its late-stage clinical and commercial biologics current Good Manufacturing Practice ("cGMP") manufacturing facility, J.POD Redmond WA, (US). The innovative 130,000 square foot cGMP biomanufacturing facility was designed with improved environmental sustainability and a significant compressed construction time compared to traditional biologics manufacturing. Additionally, the design and planning of a second J.POD facility in Europe has been initiated. The build-up of J.POD Toulouse, France (EU) will be supported by the French government, the Occitanie Region, Bpifrance, the Haute-Garonne prefecture as well as the Toulouse Métropole. J.POD Toulouse, France (EU) is expected to be fully operational in 2024.

Dr Werner Lanthaler, Chief Executive Officer of Evotec, commented: "2021 was another very successful year for Evotec, making it the tenth consecutive year of double-digit growth. Our profitable base business gives us the opportunity to reinvest returns into our data-driven platforms, to enter a sustainable growth pattern. Based on our core principles of leveraging data, artificial intelligence and human disease models to improve probabilities of success, Evotec is in an ideal position to drive and thrive as the industry paradigm shifts to effective precision medicines of the future."

FINANCIAL GUIDANCE 2022 – ACCELERATING SUSTAINABLE GROWTH
In 2022, Evotec expects Group revenues to grow in a range of € 700 – 720 m. At unchanged exchange rates compared to 2021, this range is € 690 – 710 m. This assumption is based on current orders on hand, foreseeable new contracts and the extension of contracts as well as prospective milestone payments as well as the current status of the main foreign currency exchange rates (especially US$; GBP). Furthermore, the forecast takes into account – as far as possible – the current global uncertainties related to the COVID-19 pandemic.

Evotec expects to achieve a stable adjusted Group EBITDA in the range of € 105 – 120 m. This projection takes account of increasing expenses for promising R&D projects, continued expansion of capacity and adoption of organisation structures to ensure sustainable growth, the ramp-up of the Just – Evotec Biologics business via investments, the further expansion of the J.POD capacities in the US and the construction of a second J.POD in Toulouse, France.

Evotec’s activities are all related to research and development ("R&D"). Aside from the partnered and funded R&D, Evotec will continue to strongly invest in its own unpartnered R&D to further expand its long-term and sustainable pipeline of first-in-class projects and platforms. Evotec expects unpartnered R&D investments in this area between € 70 and 80 m in 2022. Revenues, Unpartnered R&D expenses, and adjusted EBITDA remain the financial key performance indicators of the Evotec Group.

Download
The full annual report 2021 as well as the sustainability report 2021 will be available for download on April 26.

Webcast/Conference Call
The Company is holding a conference call to discuss the results as well as to provide an update on its performance. The conference call will be held in English.

A simultaneous slide presentation for participants dialling in via phone is available at View Source

Webcast details

To join the audio webcast and to access the presentation slides you will find a link on our homepage shortly before the event.

The on-demand version of the webcast will be available on our website: View Source