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Nymox Announces Updates in Regulatory Submissions For Fexapotide Treatment For Prostate Enlargement

On June 19, 2020 Nymox Pharmaceutical Corporation (NASDAQ: NYMX) reported that key steps in its regulatory submission preparations have been completed and the project is firmly on-track (Press release, Nymox, JUN 19, 2020, View Source [SID1234561244]). The majority of its regulatory documentation has proceeded very well, despite the inherent limitations of the business environment in 2020. Certain tasks have been hampered by the Covid pandemic restrictions, similar to other companies in the sector. These remaining tasks are expected to be completed reasonably soon as the Company regains the ability to retrieve required documentation from external sites and to complete other required tasks and on-site activities that were hindered due to the global restrictions in place.

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Dr. Paul Averback, CEO commented "We are extremely pleased with the progress we have been able to achieve despite these obvious limitations due to the pandemic restrictions as we reported in our 6K filing on April 24. I want to thank the whole team for putting in an extraordinary effort towards meeting our regulatory timeline goals. Extremely complex tasks have been coordinated and executed successfully. Given the ongoing reopening of the economy we now expect to attend to the remaining matters near-term. Taking into account the above factors, we are well within our projected timelines as corrected for by the addition of the previously announced Covid-related delay of several months. We are now expecting to file our applications with the authorities approximately by the end of Q3 or early Q4. We will continue to regularly update our shareholders as we complete the entire packages."

"Nymox management is very proud of the quality of our evidence and we not only look forward to the upcoming near-term submissions, but we are highly enthusiastic about the prospects for our Company and its shareholders. This is a field which has a substantial unmet medical need for safer and more effective treatments. The Company has achieved numerous major successes in the past couple years with its intellectual property applications around the world which have greatly extended the timeline value of the Company’s Fexapotide treatments for prostate enlargement and for prostate cancer", Dr. Averback said.

For further in-depth detailed information about the Nymox treatments for prostate enlargement (BPH) and early stage prostate cancer please see peer review publications at the following links: View Source and View Source and visit www.nymox.com.

For more information please contact [email protected] or 800-936-9669.

Perrigo Furthers Its Consumer-Focused Transformation By Divesting Its U.K. Generic Prescription Pharmaceuticals Business For £156 Million Or Approximately $195 Million

On June 19, 2020 Perrigo Company plc (NYSE; TASE: PRGO) reported that it has reached a definitive agreement to sell its U.K.-based Rosemont Pharmaceuticals business, a generic prescription pharmaceuticals manufacturer focused on liquid medicines, to a U.K.-headquartered private equity firm for £156 million or approximately $195 million in cash (Press release, Perrigo Company, JUN 19, 2020, View Source [SID1234561243]). This transaction, which was signed and closed on the same day, represents another step in Perrigo’s transformation to a consumer-focused self-care company.

Perrigo CEO and President Murray S. Kessler commented, "We are pleased to have reached an agreement to divest Perrigo’s non-core Rosemont business and look forward to ensuring a seamless transition. This divestiture, which was accomplished at an attractive ten times adjusted operating income multiple, is an example of Perrigo’s commitment to our transformation to a consumer-focused self-care company while remaining good stewards of shareholder value. We thank the Rosemont employees for their service to Perrigo and are confident the business will do well under new ownership."

In calendar year 2019, Perrigo realized $53 million in net sales and $0.12 of adjusted diluted EPS from the Rosemont business, which was previously included in the Consumer Self-Care International segment.

Dr. Reddy’s Laboratories announces the launch of Abiraterone Acetate Tablets USP, 250 mg in the U.S. Market

On June 19, 2020 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as "Dr. Reddy’s") reported the launch of Abiraterone Acetate Tablets USP, 250 mg, a therapeutic equivalent generic version of Zytiga (abiraterone acetate) approved by the U.S. Food and Drug Administration (USFDA) (Press release, Dr Reddy’s, JUN 19, 2020, View Source [SID1234561241]).

The Zytiga brand and generic market had U.S. sales of approximately $454 million MAT for the most recent twelve months ending in March 2020 according to IQVIA Health*.

Dr. Reddy’s Abiraterone Acetate is available in 250 mg tablets in bottle count sizes of 120.

Roche’s IPATential150 study evaluating ipatasertib in combination with abiraterone and prednisone/prednisolone met one of its co-primary endpoints

On June 19, 2020 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the phase III IPATential150 study met its co-primary endpoint of radiographic progression-free survival (rPFS) in patients with metastatic castration-resistant prostate cancer (mCRPC) and whose tumours had PTEN loss (Press release, Hoffmann-La Roche, JUN 19, 2020, View Source [SID1234561240]). In this patient group, ipatasertib in combination with abiraterone and prednisone/prednisolone provided a statistically significant reduction in the risk of disease worsening or death, compared to current standard of care (abiraterone and prednisone/prednisolone) plus placebo. The other co-primary endpoint of rPFS in the overall study population (ITT) was not met. The safety profile for the combination of ipatasertib and abiraterone was consistent with previous analyses and known risks. The results of the IPATential150 study will be presented at an upcoming medical meeting.

While initial data are encouraging, overall survival benefit and additional secondary endpoints are not yet mature. The trial will continue until the next planned analysis and data will be shared with health authorities.

"Prostate cancer remains a leading cause of death in men worldwide and patients with metastatic castration-resistant prostate cancer can be difficult to treat," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "The early results of the IPATential150 study are encouraging in our ongoing mission to develop new treatment options for people with advanced prostate cancer."

Ipatasertib is an oral, highly specific, investigational medicine designed to target and bind to all three isoforms of AKT (protein kinase B), which blocks the PI3K/AKT signalling pathway – a key driver of cancer cell growth and proliferation in prostate cancer.1,2 The PI3K/AKT pathway has also been implicated in resistance to anti-androgen therapy as androgen receptor (AR) inhibition is associated with an increase in AKT pathway activation.2,3 Functional loss of the tumour suppressor protein PTEN within the tumour, seen in approximately 40-60% of mCRPC patients, results in hyperactivation of the PI3K/AKT pathway and is associated with adverse outcomes such as increased tumour grade and stage, earlier biochemical recurrence after radical prostatectomy, metastasis, prostate-cancer-specific death, and androgen-independent progression.4,5

Roche’s clinical development programme for ipatasertib focuses on tumours that are frequently found to have activation of the PI3K/AKT pathway. In addition to prostate cancer, ipatasertib is being studied in certain types of breast cancer including triple-negative breast cancer (TNBC) and hormone-receptor positive (HR+), HER2- negative breast cancer. Results are anticipated later in 2020.

About the IPATential150 study6
IPATential150 is a double-blind, placebo-controlled, randomised phase III study assessing ipatasertib in combination with abiraterone and prednisone/prednisolone, compared to placebo plus abiraterone and prednisone/prednisolone, in adult male patients with asymptomatic or mildly symptomatic, previously untreated mCRPC.

The co-primary endpoints of the study are investigator-determined rPFS in the overall study population, as well as a subpopulation whose tumours have PTEN loss, as assessed by immunohistochemistry (Ventana assay). PFS in the study is defined as the time from date of randomisation to the first occurrence of disease progression or death from any cause, whichever occurs earlier. Secondary endpoints include overall survival, safety, time to pain progression, time to initiation of cytotoxic chemotherapy and time to function deterioration.

About ipatasertib
Ipatasertib is an oral, highly specific, investigational medicine designed to target and bind to all three isoforms of AKT, which blocks the PI3K/AKT signalling pathway and may prevent cancer cell growth and survival.1,2

Ipatasertib is being studied in tumours that are frequently found to have activation of the PI3K/AKT pathway, including breast and prostate cancers. Clinical studies are ongoing to evaluate the efficacy and safety of ipatasertib and the opportunity it may provide to address significant unmet needs for patients with these diseases.

Ipatasertib was discovered at Genentech in partnership with Array BioPharma Inc. (acquired by Pfizer Inc. on July 30, 2019).

About metastatic castration-resistant prostate cancer (mCRPC)
Prostate cancer is the second most frequent cancer and the fifth leading cause of death in men.7 Metastatic prostate cancer refers to prostate cancer that has spread beyond the prostate to other parts of the body (metastasised).8 Although most men are cured with treatment of localised disease, recurrent or newly diagnosed metastatic disease is associated with significant morbidity and mortality.9,10,11

Primary treatment of advanced prostate cancer is androgen deprivation therapy (ADT); however, up to one-third of patients will progress despite reduction in serum testosterone levels to castrate levels (<50 ng/dL), either through surgical or medical castration.12,13 Castration-resistant prostate cancer (CRPC) is defined by disease progression, as measured by prostate specific antigen (PSA) or radiographic measures, despite adequate suppression of serum testosterone levels.14,15 Despite the current availability of life-extending therapies for mCRPC, the majority of men will die of their disease: the median life expectancy in this population is less than three years.16,17

Prostate cancer growth and survival is driven by abnormal AR signalling. In CRPC, cell growth and proliferation is also commonly driven by activation of the PI3K/AKT signalling pathway.1,2 In particular, functional loss of the tumour suppressor protein PTEN within the tumour, seen in approximately 40-60% of people with mCRPC, results in hyperactivation of the PI3K/AKT pathway.4 PTEN loss is associated with adverse outcomes such as increased tumour grade and stage, earlier biochemical recurrence after radical prostatectomy, metastasis, prostate-cancer-specific death, and androgen-independent progression.5 The PI3K/AKT pathway has also been implicated in resistance to anti-androgen therapy as AR inhibition is associated with an increase in AKT pathway activation, suggesting that the tumour compensates for the loss of one pathway with another.2,3

About Roche in prostate cancer
For more than 50 years, Roche has been developing medicines with the goal of redefining treatment in oncology. Our research and development aim is to provide effective cancer therapies through the discovery and development of novel therapeutics that target the specific molecular pathways associated with cancer. Roche is expanding into additional areas of unmet need, working to find innovative solutions for diseases such as prostate cancer, the most prevalent cancer in men and fifth leading cause of cancer-related male death worldwide.5 Roche is committed to research into genitourinary cancers, including bladder and renal cancers, and to providing life extending treatment options for these patients.

Genentech’s IPATential150 Study Evaluating Ipatasertib in Combination With Abiraterone and Prednisone/Prednisolone Met One of Its Co-Primary Endpoints

On June 19, 2020 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported that the Phase III IPATential150 study met its co-primary endpoint of radiographic progression-free survival (rPFS) in patients with metastatic castration-resistant prostate cancer (mCRPC) and whose tumors had PTEN loss (Press release, Genentech, JUN 19, 2020, View Source [SID1234561233]). In this patient group, ipatasertib in combination with abiraterone and prednisone/prednisolone provided a statistically significant reduction in the risk of disease worsening or death, compared to current standard of care (abiraterone and prednisone/prednisolone) plus placebo. The other co-primary endpoint of rPFS in the overall study population (intention-to-treat) was not met. The safety profile for the combination of ipatasertib and abiraterone was consistent with previous analyses and known risks. The results of the IPATential150 study will be presented at an upcoming medical meeting.

"Prostate cancer remains a leading cause of death in men worldwide and patients with metastatic castration-resistant prostate cancer can be difficult to treat," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "The early results of the IPATential150 study are encouraging in our ongoing mission to develop new treatment options for people with advanced prostate cancer."

Ipatasertib is an oral, highly specific, investigational medicine designed to target and bind to all three isoforms of AKT (protein kinase B), which blocks the PI3K/AKT signaling pathway – a key driver of cancer cell growth and proliferation in prostate cancer. The PI3K/AKT pathway has also been implicated in resistance to anti-androgen therapy as androgen receptor (AR) inhibition is associated with an increase in AKT pathway activation. Functional loss of the tumor suppressor protein PTEN within the tumor, seen in approximately 40-60% of mCRPC patients, results in hyperactivation of the PI3K/AKT pathway and is associated with adverse outcomes such as increased tumor grade and stage, earlier biochemical recurrence after radical prostatectomy, metastasis, prostate-cancer-specific death, and androgen-independent progression.

Genentech’s clinical development program for ipatasertib focuses on tumors that are frequently found to have activation of the PI3K/AKT pathway. In addition to prostate cancer, ipatasertib is being studied in certain types of breast cancer including triple-negative breast cancer (TNBC) and hormone-receptor positive (HR+), HER2- negative breast cancer. Results are anticipated later in 2020.

About the IPATential150 study

IPATential150 is a double-blind, placebo-controlled, randomized Phase III study assessing ipatasertib in combination with abiraterone and prednisone/prednisolone, compared to placebo plus abiraterone and prednisone/prednisolone, in adult male patients with asymptomatic or mildly symptomatic, previously untreated mCRPC.

The co-primary endpoints of the study are investigator-determined radiographic progression-free survival (rPFS) in the overall study population, as well as a subpopulation whose tumors have PTEN loss, as assessed by immunohistochemistry. PFS in the study is defined as the time from date of randomization to the first occurrence of disease progression or death from any cause, whichever occurs earlier. Secondary endpoints include overall survival, safety, time to pain progression, time to initiation of cytotoxic chemotherapy and time to function deterioration.

About ipatasertib

Ipatasertib is an oral, highly specific, investigational medicine designed to target and bind to all three isoforms of AKT, which blocks the PI3K/AKT signaling pathway and may prevent cancer cell growth and survival.

Ipatasertib is being studied in tumors that are frequently found to have activation of the PI3K/AKT pathway, including breast and prostate cancers. Clinical studies are ongoing to evaluate the efficacy and safety of ipatasertib and the opportunity it may provide to address significant unmet needs for patients with these diseases.

Ipatasertib was discovered at Genentech in partnership with Array BioPharma Inc. (acquired by Pfizer Inc. on July 30, 2019).

About metastatic prostate cancer

Prostate cancer is one of the most common types of cancers among men worldwide. According to the American Cancer Society, more than 190,000 men in the United States will be diagnosed with prostate cancer. Metastatic prostate cancer (mPC) is when the disease has spread beyond the prostate to other parts of the body (metastasized). Although most men are cured with treatment of localized disease, recurrent or newly diagnosed metastatic disease is associated with significant morbidity and mortality.

Prostate cancer cells are fueled by androgens, which are male sex hormones including testosterone. Primary treatment of advanced prostate cancer includes androgen deprivation therapy (ADT) to reduce androgen levels in the body to near castration levels. Although most patients with mPC initially respond to ADT, effective treatments are still needed for when resistance develops and disease progresses to metastatic castration-resistant prostate cancer (mCRPC). The majority of men will die of mCRPC, with a median life expectancy of less than three years.