On July 22, 2021 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the National Comprehensive Cancer Network (NCCN) added Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) to the Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Acute Lymphoblastic Leukemia (ALL), for both pediatric and adult patients (Press release, Jazz Pharmaceuticals, JUL 22, 2021, View Source [SID1234585111]).

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The NCCN Guidelines for ALL and the NCCN Guidelines for Pediatric ALL now include asparaginase erwinia chrysanthemi (recombinant)-rywn as a treatment option for patients with hypersensitivity to E. coli asparaginase products as a component of the multi-agent chemotherapeutic regimen to complete the full treatment course.

"Asparaginase is a core component of chemotherapeutic regimens in ALL and lymphoblastic lymphoma; however, treatments derived from E. coli are associated with the potential for hypersensitivity reactions, which can affect a substantial number of these patients," said Rob Iannone, M.D., M.S.C.E., executive vice president, research and development and chief medical officer at Jazz Pharmaceuticals. "Before the FDA approval of Rylaze, there was a significant need for an effective and reliable supply of asparaginase medicine that would allow patients the opportunity to start and complete their prescribed treatment program with confidence. We are pleased by the NCCN’s decision to quickly incorporate Rylaze into the Clinical Practice Guidelines for ALL."

Rylaze was approved by the U.S. Food and Drug Administration (FDA) on June 30, 2021 for use as a component of a multi-agent chemotherapeutic regimen given by intramuscular injection for the treatment of ALL and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase.1 The approval followed review of a Biologics Licensing Application under the FDA’s Real-Time Oncology Review program, and it was based on clinical data from a pivotal Phase 2/3 trial conducted in collaboration with the Children’s Oncology Group.

The NCCN Guidelines play a pivotal role in decision-making processes for individuals involved in cancer care all over the world, including physicians, nurses, pharmacists, payers, and patients and their families. The guidelines present expert recommendations for cancer screening, diagnosis and treatment, as well as cancer care options that may increase the chances of favorable outcomes for patients.

The NCCN is a not-for-profit alliance of 30 leading U.S. cancer centers devoted to patient care, research and education that aims to facilitate quality, effective, efficient and accessible care so that patients can live better lives.

About Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn)
Rylaze, also known as JZP458, is approved in the U.S. for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase. Rylaze has orphan drug designation for the treatment of ALL/LBL in the United States. Rylaze is a recombinant erwinia asparaginase that uses a novel Pseudomonas fluorescens expression platform. JZP458 was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in October 2019 for the treatment of this patient population. Rylaze was approved as part of the Real-Time Oncology Review program, an initiative of the FDA’s Oncology Center of Excellence designed for efficient delivery of safe and effective cancer treatments to patients.

The full U.S. Prescribing Information for Rylaze is available at: <View Source>

Important Safety Information

RYLAZE should not be given to people who have had:

Serious allergic reactions to RYLAZE
Serious swelling of the pancreas (stomach pain), serious blood clots, or serious bleeding during previous asparaginase treatment
RYLAZE may cause serious side effects, including:

Allergic reactions (a feeling of tightness in your throat, unusual swelling/redness in your throat and/or tongue, or trouble breathing), some of which may be life-threatening
Swelling of the pancreas (stomach pain)
Blood clots (may have a headache or pain in leg, arm, or chest)
Bleeding
Liver problems
Contact your doctor immediately if any of these side effects occur.

Some of the most common side effects with RYLAZE include: liver problems, nausea, bone and muscle pain, tiredness, infection, headache, fever, allergic reactions, fever with low white blood cell count, decreased appetite, mouth swelling (sometimes with sores), bleeding, and too much sugar in the blood.

RYLAZE can harm your unborn baby. Inform your doctor if you are pregnant, planning to become pregnant, or nursing. Females of reproductive potential should use effective contraception (other than oral contraceptives) during treatment and for 3 months following the final dose. Do not breastfeed while receiving RYLAZE and for 1 week after the final dose.

Tell your healthcare provider if there are any side effects that are bothersome or that do not go away.

These are not all the possible side effects of RYLAZE. For more information, ask your healthcare provider.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 (1-800-332-1088).

About ALL
ALL is a cancer of the blood and bone marrow that can progress quickly if not treated.2 Leukemia is the most common cancer in children, and about three out of four of these cases are ALL.3 Although it is one of the most common cancers in children, ALL is among the most curable of the pediatric malignancies due to recent advancements in treatment.4,5 Adults can also develop ALL, and about four of every 10 cases of ALL diagnosed are in adults.6 The American Cancer Society estimates that almost 6,000 new cases of ALL will be diagnosed in the United States in 2021.6 Asparaginase is a core component of multi-agent chemotherapeutic regimens in ALL.7 However, asparaginase treatments derived from E. coli are associated with the potential for development of hypersensitivity reactions.8

About Lymphoblastic Lymphoma
LBL is a rare, fast-growing, aggressive subtype of Non-Hodgkin’s lymphoma, most often seen in teenagers and young adults.7 LBL is a very aggressive lymphoma – also called high-grade lymphoma – which means the lymphoma grows quickly with early spread to different parts of the body.9,10

On July 22, 2021 Plexxikon, a member of the Daiichi Sankyo Group and a leader in structure-guided discovery and development of novel small molecule pharmaceuticals, reported that it has won its patent infringement lawsuit against Novartis (Press release, Plexxikon, JUL 22, 2021, View Source [SID1234585110]). In a jury trial at the U.S. District Court for the Northern District of California, Novartis conceded infringement and sought to invalidate Plexxikon’s patents covering Tafinlar on the grounds of anticipation, written description and enablement. The jury rejected Novartis’s arguments, upheld the validity of Plexxikon’s patents, and found Novartis’s infringement was willful. Plexxikon was awarded damages of $178 million for past infringement of its patents and will receive additional royalty payments for future sales of Tafinlar in the United States through the life of the patents.

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"We are delighted with the jury’s verdict which validates Plexxikon’s pioneering role in the field of BRAF inhibitors and enables proper credit for our proprietary discovery efforts," said Chao Zhang, PhD, chief executive officer. "Genus patents — like those in the lawsuit — are routinely used to prevent competitors from knocking off our scientific innovations with slight molecular changes. We are gratified that the jury upheld their validity, protecting our investment so that we can continue discovering and developing innovative new drugs for patients in need."

Tafinlar was developed by GSK and acquired by Novartis for $2.4B. Tafinlar is a BRAF inhibitor that is approved for the treatment of metastatic melanoma, adjuvant melanoma, non-small cell lung cancer and anaplastic thyroid cancer. Tafinlar also competes with Zelboraf, another BRAF inhibitor that was discovered by Plexxikon and licensed to Roche.

In the suit, Plexxikon alleged that Novartis owed the company substantial royalties on its drug Tafinlar, which infringes two Plexxikon patents (U.S. Patent Nos. 9,469,640; and 9,844,539).

On July 22, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a dermatologic diagnostics company providing personalized genomic information to inform treatment decisions, reported data presentations on two of its skin cancer gene expression profile tests at the Society of Dermatology Physician Assistants (SDPA) Annual Summer Dermatology Conference 2021, taking place from July 22-25, 2021 (Press release, Castle Biosciences, JUL 22, 2021, View Source [SID1234585109]).

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DecisionDx-Melanoma:

DecisionDx-Melanoma is Castle’s gene expression profile test that uses an individual patient’s tumor biology to predict risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node (SLN) positivity, independent of traditional staging factors. Castle presented new data assessing the clinical utility of the DecisionDx-Melanoma test through a poster entitled "Clinical Utility of the 31-Gene Expression Profile Test on the Management of Cutaneous Melanoma by Nurse Practitioners and Physician Assistants." The study highlights nurse practitioners’ and physician assistants’ (NP/PAs) attitudes toward the clinical use of DecisionDx-Melanoma in patients diagnosed with cutaneous melanoma. The poster can be accessed here.

Study methods and findings:

In 2020, an institutional review board (IRB)-approved, 20-question study was conducted to understand the perception and clinical use of DecisionDx-Melanoma by clinicians, including NP/PAs.
Of the 711 survey respondents, 266 self-identified as NP/PAs, with 50% of those (n=133) reporting ordering DecisionDx-Melanoma within the previous year.
89% of the NP/PAs responded that comprehensive prognostic testing (including DecisionDx-Melanoma) could improve patient care.
Most NP/PAs who use DecisionDx-Melanoma (97%) would recommend additional prognostic testing to close friends or family members compared to just 58% of those who do not use DecisionDx-Melanoma.
Among the NP/PAs who ordered DecisionDx-Melanoma in the previous year:
99% would recommend the test to a colleague.
Most would consider patient management changes for patients with a T1 tumor (82%) or stage I melanoma (81%) who received a high-risk Class 2B DecisionDx-Melanoma test result.
"We are pleased that the study results reinforce the clinical utility of DecisionDx-Melanoma in patients diagnosed with cutaneous melanoma," said Bob Cook, Ph.D., senior vice president of research and development. "The study data demonstrate that the majority of NP and PA respondents would consider altering patient management for a thin (T1) tumor or Stage 1 melanoma that received a high-risk DecisionDx-Melanoma result."

DecisionDx-SCC:

DecisionDx-SCC is Castle’s prognostic gene expression profile test for patients diagnosed with high-risk cutaneous squamous cell carcinoma (SCC), designed to use a patient’s tumor biology to predict individual risk of metastasis for patients with SCC and one or more risk factors. Castle presented data on DecisionDx-SCC through a poster entitled "Real-world clinical usage data demonstrates appropriate utilization of the prognostic 40-gene expression profile test for cutaneous squamous cell carcinoma with one or more risk factors." The poster can be found here.

Study methods and findings:

The objective of the study was to demonstrate the independent prognostic value of DecisionDx-SCC within existing risk assessment methods and report on the early clinical usage of DecisionDx-SCC.
Summary metrics were generated on the first 1000 samples received for DecisionDx-SCC testing that met clinical testing criteria. Metrics on early clinical usage include:
Technical reliability of DecisionDx-SCC was 96.3%.
69.0% of samples received DecisionDx-SCC Class 1 results, 26.0% received DecisionDx-SCC Class 2A results and 1.3% received DecisionDx-SCC Class 2B results.
52% of tested patients had three or more risk factors.
This study demonstrated that the intended use population (high-risk SCC patients with one or more risk factors) aligns with the cases that were submitted for clinical testing.
The study also found that DecisionDx-SCC results can be applied as an adjunct to enhance SCC risk stratification and contribute to risk-appropriate surveillance and treatment decisions.
About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 5,700 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. To predict likelihood of sentinel lymph node positivity, the Company utilizes its proprietary algorithm, i31-GEP, to produce an integrated test result. i31-GEP is an artificial intelligence-based neural network algorithm (independently validated in a cohort of 1,674 prospective, consecutively tested patients with T1-T4 cutaneous melanoma) that integrates the DecisionDx-Melanoma test result with the patient’s traditional clinicopathologic features. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. Through March 31, 2021, DecisionDx-Melanoma has been ordered more than 73,396 times for use in patients with cutaneous melanoma.

More information about the test and disease can be found at www.CastleTestInfo.com.

About DecisionDx-SCC

DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous squamous cell carcinoma metastasis for patients with one or more risk factors. The test result, in which patients are stratified into a Class 1 (low), 2A (moderate) or 2B (high) risk category, predicts individual metastatic risk to inform risk-appropriate management.

Peer-reviewed publications have demonstrated that DecisionDx-SCC is an independent predictor of metastatic risk and that integrating DecisionDx-SCC with current prognostic methods can add positive predictive value to clinician decisions regarding staging and management.

On July 22, 2021 McKesson Corporation (NYSE: MCK) (the "Company") reported the determination of the Full Tender Offer Consideration, as shown in the table below, for its previously announced cash tender offer to purchase up to $500,000,000 aggregate principal amount (the "Offer") of its outstanding 6.00% Notes due 2041 (the "6.00% Notes"), 4.883% Notes due 2044 (the "4.883% Notes"), 7.65% Debentures due 2027 (the "7.65% Debentures"), 4.750% Notes due 2029 (the "4.750% Notes"), 3.950% Notes due 2028 (the "3.950% Notes"), 2.85% Notes due 2023 (the "2.85% Notes") and 3.796% Notes due 2024 (the "3.796% Notes" and together with the 6.00% Notes, the 4.883% Notes, the 7.65% Debentures, the 4.750% Notes, the 3.950% Notes and the 2.85% Notes, the "Notes", and each, a "series" of Notes) (Press release, McKesson, JUL 22, 2021, View Source [SID1234585108]). The Company also announced that it has increased the aggregate principal amount of the Notes it will purchase pursuant to the Offer from $500,000,000 to $922,154,000 (as increased, the "Tender Cap") in order to accept all of the Notes that were validly tendered and not validly withdrawn at or prior to the Early Tender Time (as defined below). Except as described in this press release, all other terms of the Offer as described in the Offer Documents (as defined below) remain unchanged.

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On July 8, 2021, the Company commenced the Offer in accordance with the terms and conditions set forth in the offer to purchase, dated July 8, 2021 (the "Offer to Purchase"), and the related letter of transmittal (the "Letter of Transmittal" and, together with the Offer to Purchase, the "Offer Documents"). Select terms of the Offer are described in the table below:

All Notes validly tendered and not validly withdrawn at or prior to the Early Tender Time will be accepted for purchase. Pursuant to the terms of the Offer, the amount of Notes that will be accepted for purchase is subject to the Tender Cap. Accordingly, because the Tender Cap has been reached in respect of tenders made at or prior to the Early Tender Time, no Notes of any series tendered after the Early Tender Time (regardless of acceptance priority level) will be accepted for purchase. As set forth in the Offer to Purchase, holders who validly tendered and did not validly withdraw their Notes at or prior to the Early Tender Time are eligible to receive the Full Tender Offer Consideration, which includes the Early Tender Payment. In addition, holders that validly tender Notes that are accepted for purchase by the Company will receive accrued and unpaid interest from, and including, the last interest payment date for their tendered Notes to, but not including, the settlement date for such Notes, in each case rounded to the nearest cent ("Accrued Interest").

The conditions to the Offer specified in the Offer to Purchase have been satisfied. Pursuant to the terms of the Offer, the Company has exercised its Early Settlement Right. Payment of the Full Tender Offer Consideration to holders of Notes that were accepted for purchase on the Early Acceptance Date is expected to be made on July 23, 2021 (the "Early Settlement Date").

The Withdrawal Deadline for the Offer was 5:00 p.m., New York City time, on July 21, 2021, and has not been extended for any series of Notes. The Offer will expire at 11:59 p.m., New York City time, on August 4, 2021, unless extended or earlier terminated by the Company, with respect to any or all series of Notes.

Capitalized terms used in this press release and not defined herein have the meanings given to them in the Offer to Purchase.

Barclays Capital Inc. and Citigroup Global Markets Inc. are acting as lead dealer managers for the Offer and Wells Fargo Securities, LLC is acting as co-dealer manager for the Offer. For additional information regarding the terms of the Offer, please contact: Barclays Capital Inc. toll-free at (212) 528-7581 or collect at (800) 438-3242 or Citigroup Global Markets Inc. toll-free at (800) 558-3745 or collect at (212) 723-6106. Requests for the Offer Documents may be directed to Global Bondholder Services Corporation, which is acting as the Tender Agent and Information Agent for the Offer, at (866)-924-2200 (toll-free) or by email at [email protected].

On July 22, 2021 ANI Pharmaceuticals, Inc. ("ANI" or the "Company") (NASDAQ: ANIP) reported that the Company will release its second quarter 2021 financial results on Friday, August 6, 2021 (Press release, ANI Pharmaceuticals, JUL 22, 2021, View Source [SID1234585107]).

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Nikhil Lalwani, President and Chief Executive Officer, and Stephen P. Carey, Senior Vice President, Finance, and Chief Financial Officer, will host a conference call to discuss the results as follows:

A replay of the conference call will be available within two hours of the call’s completion and will remain accessible for one-week by dialing 800-695-0974 and entering access code 5412658.