On April 7, 2020 Perrigo Company plc (NYSE; TASE: PRGO) reported preliminary unaudited first quarter 2020 net sales and provided GAAP and non-GAAP operating income for the first quarter (Press release, Perrigo Company, APR 7, 2020, View Source [SID1234556170]).

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Perrigo CEO and President, Murray S. Kessler commented, "While our first priority is the health and wellbeing of our employees and their families, all of us at Perrigo recognize the importance of access to our self-care and health-care products during this global health crisis. For perspective, Perrigo’s Consumer Self-Care Americas business supplies more than half of the acetaminophen (Tylenol equivalent) volume in the United States in addition to many other essential products. During the first quarter, Perrigo continued to experience strong growth across all business segments, while also benefiting from a dramatic surge in demand in March related to the COVID-19 pandemic. Through a herculean effort by our employees, especially our production employees around the world, we were able to supply most of the demand. As a result of these efforts and other factors, Perrigo first quarter net sales increased 14% versus prior year, with organic net sales(1)(2) higher by 11%. First quarter non-GAAP operating income is estimated to be $220 million to $225 million versus $203 million in the prior year quarter. This includes new supplemental bonuses to demonstrate our appreciation to front-line production employees for their dedication and hard work in delivering our essential products to consumers and patients during these unprecedented times."

Preliminary Unaudited First Quarter 2020 Net Sales & Operating Income Range
Consolidated first quarter net sales were approximately $1.3 billion, an increase of 14% compared to the prior year quarter. Excluding exited businesses(2) and the impact of currency, net sales increased 18%. Organic net sales were up 11%.

Worldwide Consumer first quarter net sales were approximately $1.1 billion, an increase of 16% compared to the prior year quarter. Excluding exited businesses and the impact of currency, net sales increased 21%. Organic net sales were up 12%. As a reminder, Worldwide Consumer is comprised of the Consumer Self-Care Americas segment, Consumer Self-Care International segment and corporate.

Consumer Self-Care Americas segment first quarter net sales were approximately $700 million, an increase of 20% compared to the prior year quarter. Excluding exited businesses and the impact of currency, net sales increased 25%. Organic net sales were up 15%.

Consumer Self-Care International segment first quarter net sales were approximately $380 million, an increase of 9% compared to the prior year quarter. Excluding exited businesses and the impact of currency, net sales increased 14%. Organic net sales were up 8%.

Rx segment first quarter net sales were approximately $260 million, an increase of 6% compared to the prior year quarter, which benefitted from the U.S. Food and Drug Administration approval and launch of generic albuterol sulfate inhalation aerosol. This more than offset the negative net sales impact of price erosion on testosterone gel 1.62%, which launched in the prior year with 180-day market exclusivity.

The Company estimates first quarter GAAP operating income of $140 million to $145 million, versus $102 million in the prior year quarter. The Company estimates non-GAAP operating income for the quarter of $220 million to $225 million versus $203 million in the prior year quarter. Both the reported and non-GAAP estimates include $4 million in supplemental production employee bonuses.

The Company currently intends to release complete first quarter 2020 financial results during the last week of April 2020. Given the volatility and uncertainty of the current operating environment, the Company does not expect to modify full-year guidance at that time.

See attached Appendix for reconciliation of adjusted (non-GAAP) to reported (GAAP) financial measures.

(1) Organic net sales growth excludes the 2019 acquisition of Ranir, exited businesses and the impact of currency.

(2) Exited businesses refers to the divested animal health business in the prior year period, which was previously included in the Consumer Self-Care Americas segment, and the divested Canoderm prescription product in the Nordic region in the prior year period, which was previously included in the Consumer Self-Care International business. In 2019, net sales of Canoderm were $13 million with adjusted operating income of $8 million.

On April 7, 2020 Kazia Therapeutics Limited (ASX: KZA;NASDAQ: KZIA), an Australian oncology-focused biotechnology company, reported to share positive interim data from its ongoing phase II study of paxalisib (formerly GDC-0084) in glioblastoma, the most common and most aggressive form of primary brain cancer (Press release, Kazia Therapeutics, APR 7, 2020, View Source [SID1234556187]).

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Key Points

Interim analysis of Part A (escalation cohort) (n=9) showed median overall survival (OS) of 17.7 months, representing a clinically meaningful extension of life when compared to the 12.7 months associated with the existing standard of care, temozolomide
Interim analysis of all evaluable patients (Part A = 9; Part B = 21) shows median progression-free survival (PFS) of 8.5 months, broadly in line with previous analysis, and comparing favourably to the 5.3 months associated with temozolomide
The longest-treated patient remains progression-free 19 months after diagnosis
Approximately half the enrolled patients remain on drug and both OS and PFS figures may further improve as the trial progresses toward conclusion
Kazia expects to present further data in 2H CY2020 and final data in 1H CY2021
Summary of Paxalisib Data in Comparison to Temozolomide (existing standard of care)

Temozolomide
(FDA-approved treatment)

Paxalisib

(interim phase II data)

Progression-Free Survival (PFS)

Measures ability of a drug to slow
growth of a tumour

5.3 months

8.5 months

Overall Survival (OS)

Measures ability of a drug to
prolong life

12.7 months

17.7 months

Kazia CEO, Dr James Garner, commented, "This is an excellent result, and we are delighted with the emerging data. The ‘gold standard’ for any new cancer treatment is the ability to extend life – an especially challenging goal in a disease such as glioblastoma – and this data provides our first evidence that paxalisib may achieve this objective in a very challenging patient population."

He continued, "There have not been any new drug treatments for newly-diagnosed glioblastoma patients for over twenty years, and we aspire to change that situation. We believe that paxalisib is rapidly becoming one of the most promising drug candidates in the global pipeline for this very challenging disease and we will be working strenuously to make it available to patients as quickly and efficiently as possible. The study continues to follow a number of patients who remain on treatment, and we currently expect to report a further data read-out in the second half of the year."

Background

The reported overall survival (OS) figure of 17.7 months represents a strong signal of clinical efficacy. The existing, FDA-approved standard of care, temozolomide, is associated with an OS of 12.7 months in this patient population[1]. Comparison between different studies is always imprecise, but the magnitude of the numerical difference provides powerful evidence that treatment with paxalisib may extend life in this patient group.

The reported progression-free survival (PFS) figure of 8.5 months is slightly better than the figure of 8.4 months previously reported in November 2019. Temozolomide is associated with a PFS of 5.3 months in this patient population.

Before losing patent protection, temozolomide achieved peak sales in excess of US$ 1 billion per annum, which provides an indication of the commercial opportunity associated with a new treatment for glioblastoma.

Thirty patients were enrolled to this study, comprising 9 in Part A, and 21 in Part B. Data reported here are provisional figures from Part A (for OS) and from the entire study population (for PFS), but may change as ongoing patients proceed through the study. The study has been conducted at leading centers of excellence in the United States.

The safety of paxalisib remained broadly consistent with prior experience, with hyperglycaemia (raised blood sugar), oral mucositis (mouth ulcers), and low-grade rash among the most common drug-related toxicities.

In addition to this phase II study in glioblastoma, four other studies are underway with paxalisib in different forms of brain cancer, and it is anticipated that several of these will provide initial efficacy data during CY 2020.

This data had been accepted for presentation at the annual meeting of the American Association of Cancer Research (AACR) (Free AACR Whitepaper) in San Diego, CA from 24 -29 April 2020. However, given the cancellation of the AACR (Free AACR Whitepaper) meeting due to the COVID-19 outbreak, Kazia has determined to provide an update to investors via this ASX announcement.

Next Steps

The phase II study remains ongoing, with approximately half of the total enrolled patient population still receiving drug at the time of analysis and a number of additional patients still in follow-up. At this stage, Kazia expects to present further data in 2H CY2020, and final data in 1H CY2021.

On April 7, 2020 ImaginAb Inc., a leading clinical stage immuno-oncology imaging company, and ARTMS Products Inc., the global leader in the development of novel technologies which enable the production of the world’s most-used diagnostic imaging isotopes, reported they have entered a multi-year non-exclusive partnership to explore a novel radiochemistry manufacture of ImaginAb’s lead asset 89Zr CD8 ImmunoPET (Press release, ImaginAb, APR 7, 2020, View Source;utm_medium=rss&utm_campaign=imaginab-and-artms-announce-strategic-partnership-for-innovative-manufacture-of-89zr-cd8-immunopet-agent [SID1234556191]).

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Under the terms of the agreement, ARTMS’ high-power technology will be deployed to enhance the manufacture of ImaginAb’s proprietary antibody 89Zr-Df-IAB22M2C (89Zr CD8 ImmunoPET).

The CD8 ImmunoPET minibody binds to the CD8 receptor on human T cells and is used for non-invasive PET (positron emission tomography) imaging of CD8 T cells in patients as a pharmacodynamic and predictive marker for immunotherapy. Due to the zirconium-89 (89Zr) labeling of the minibody it can be visualized by PET imaging. ARTMS’ flagship product, the QUANTM Irradiation SystemTM (QISTM), provides for cost-effective, decentralized, and local production of important medical isotopes, including 89Zr which is used for the labelling of ImaginAb’s CD8 ImmunoPET agent.

This pioneering methodology of radiochemistry manufacture represents an innovative way to generate 89Zr which will allow for the local manufacture of a significant commercial scale leading to an increase in 89Zr supply as well as potentially expanding ImaginAb’s supply sites. This new process of manufacturing 89Zr has the potential to be applied in the development of other assets in ImaginAb’s pipeline.

As part of the research collaboration, ARTMS will run pilot and optimization studies to assess radiolabelling of ImaginAb’s CD8 ImmunoPET minibody using this new methodology.

Commenting on the news, Ian Wilson, Chief Executive Officer of ImaginAb, said: "We are very excited to expand our manufacturing capabilities with ARTMS. ImaginAb’s CD8 ImmunoPET technology is the most advanced CD8 PET tracer under clinical development, and this new collaboration has the potential to increase access of our technology to patients and partners alike."

Charles S. Conroy, Chief Executive Officer of ARTMS, added: "We are very pleased to join ImaginAb in the search and establishment of a novel and more efficient manufacturing process. This collaboration fits ARTMS’ vision of being a leading manufacturer of the world’s most needed medical radioisotopes. Our state-of-the-art technology platform and robust global quality-supply network make us uniquely qualified to support ImaginAb. ARTMS and ImaginAb share the same patient-focused mindset and dedication to producing products of the highest quality for patients."

On April 7, 2020 panCELLa reported that it will receive advisory services and up to $400,000 from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP) to help further research and development of its technology platforms for cell therapy (Press release, panCELLa, APR 7, 2020, View Source [SID1234556171]).

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Support from NRC IRAP will go toward the research and development of a two-step safety switch known as panKiller. While panCELLa’s safety switch, known as FailSafeTM, is specifically designed to eliminate only "rogue" or deregulated therapeutic cells, the panKiller system further enhances this platform and provides a means to remove a graft entirely once it has fulfilled its therapeutic purpose. When the therapeutic cells are no longer required, and to avoid serious adverse events, for further safety measures they would be eliminated using panKiller. The panKiller strategy is an effective solution that addresses serious limitations of current cell therapies which involve removal of these therapeutic cells through irradiation. panKiller will enable more prolonged, effective treatment in vivo; and will destroy the therapeutic cells at the appropriate time without the use of radiation to prevent the possibility of a malignancy.

On April 7, 2020 Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that it has received approval from the Center for Drug Evaluation of the China National Medical Products Administration for the Phase Ib/II study of APG-2575, the company’s novel Bcl-2‒selective inhibitor, for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (r/r CLL/SLL) (Press release, Ascentage Pharma, APR 7, 2020, View Source;small-lymphocytic-lymphoma-in-china-301036549.html [SID1234556188]).

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This open-label, Phase Ib/II dose-escalation and dose-expansion study is designed to evaluate the safety, tolerability, and preliminary anticancer activity of APG-2575 as a single agent or in combination therapies for the treatment of patients with r/r CLL/SLL in China.

APG-2575 is a novel, orally administered Bcl-2‒selective inhibitor being developed by Ascentage Pharma. APG-2575 is designed to treat several hematologic malignancies by selectively blocking Bcl-2 to restore the normal apoptosis process in cancer cells.

Recent studies have demonstrated that Bcl-2 inhibitors are effective in CLL/SLL, and Bcl-2 inhibitors in combination with Bruton tyrosine kinase inhibitors or CD20 monoclonal antibodies can deepen patient responses and prolong patient survival. These findings provide the rationale for investigating APG-2525 as a single agent or in combination therapies. The Phase I study of APG-2575 monotherapy, previously commenced in the US, Australia, and China, has shown a favorable safety profile and promising anticancer activity, and the preliminary data support the continued clinical investigation of APG-2575.

CLL/SLL is a hematologic malignancy caused by mature B-cell neoplasms, and it mainly affects middle-aged and elderly populations. The condition is characterized by accumulation of cancerous lymphocytes in peripheral blood, bone marrow, spleen, and lymph nodes. CLL/SLL is the most common type of adult leukemia in North America and Europe but is less common in Asian countries such as China and Japan. However, with an aging population, as well as dietary and lifestyle changes in China, CLL/SLL incidences have been increasing, and more patients develop the condition at younger ages and display greater disease progression. Despite significant initial responses to current first-line treatments, many patients with CLL/SLL need continued treatment to maintain these responses, and relapse often portends a poor prognosis. At present, there are even fewer treatment options for patients with CLL/SLL in China than in Europe or North America, hence representing an urgent clinical need for more effective and safe therapies.

"APG-2575 is a key drug candidate in our development pipeline targeting apoptosis, and the first China-made Bcl-2‒selective inhibitor to enter clinical studies, with great potential as a monotherapy and in combination therapies in several hematologic malignancies. Upon receiving recent approvals and clearances for several Phase Ib/II studies of APG-2575 in China, Australia, and the US, we are now advancing its clinical development globally," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "There is an enormous unmet clinical need in the treatment of CLL/SLL globally. We will soon initiate this Phase Ib/II study of APG-2575 in China, which hopefully will provide a new treatment option to patients with CLL/SLL."