On October 11, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported that new expanded clinical validation data reinforce the ability of the company’s noninvasive Percepta Nasal Swab test to help physicians more accurately assess lung cancer risk in patients with lung nodules (Press release, Veracyte, OCT 11, 2021, View Source [SID1234591072]). The findings also show that the test delivers strong clinical performance across different nodule sizes and cancer stages in current or former smokers, and for patients who have already had other cancer(s).

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The new data underscore the Percepta Nasal Swab test’s ability to help physicians more accurately, quickly and confidently determine which patients with lung nodules found on computerized tomography (CT) scans may avoid unnecessary invasive procedures and which should proceed to diagnostic work-ups and obtain treatment if necessary. The findings will be shared in an oral presentation at the 2021 American College of Chest Physicians (CHEST) Annual Meeting, which is being held virtually October 17-20, 2021. Veracyte also announced it has begun making the Percepta Nasal Swab test available to a limited number of clinical sites as it builds the clinical utility data to support reimbursement.

"Approximately 15 million patients are now recommended for annual lung cancer CT screening and about 1.6 million lung nodules are found incidentally," said Carla R. Lamb, M.D., interventional pulmonologist at Lahey Hospital & Medical Center in Burlington, Mass., who will present the new data. "Today, physicians have limited objective tools to help accurately determine which patients with lung nodules found on CT scans have cancer and which don’t. This uncertainty can lead to unnecessary diagnostic procedures or to potentially delayed diagnosis and treatment. Our findings reinforce the Percepta Nasal Swab test’s ability to more accurately identify patients as low, moderate or high risk for lung cancer so that physicians can make more confident decisions about next steps for their patients."

The Percepta Nasal Swab test’s robust performance in classifying lung cancer risk was previously demonstrated in a blinded, independent validation set of 249 patients from multiple cohorts comprising prospectively collected nasal samples. All patients were current or former smokers undergoing evaluation for lung nodules found on CT scans. Patients were followed for up to one year or until physicians made a final, adjudicated diagnosis. The new expanded data being presented at this year’s CHEST meeting include 63 additional patients with prior (non-lung) cancers who were part of a planned secondary endpoint analysis.

In the expanded cohort of 312 patients, when the Percepta Nasal Swab test identified patients as low risk, its sensitivity was 97%, providing a negative predictive value (NPV) of 98% in a population with the 25% cancer prevalence that would be expected in a broad cohort with suspicious lung nodules. This NPV would assist physicians in avoiding unnecessary invasive procedures in these patients with a very small likelihood of missing a cancer. When the test identified patients as high risk, its specificity was 92%, for a positive predictive value (PPV) of 70% at a malignancy rate of 25%. This PPV would assist physicians in directing these patients to further procedures so they could obtain an accurate diagnosis and speed time to treatment if necessary. Patients in the moderate risk group could be managed according to current clinical guidelines.

In a sub-analysis of the expanded validation set, researchers found that the Percepta Nasal Swab test’s performance is strong across different nodule sizes, with the test identifying 67% of cancers in nodules below 8 mm as moderate risk, while labeling 100% of malignant nodules greater than or equal to 8 mm as high or moderate risk. Performance was also consistent across all stages of non-small cell lung cancer (NSCLC), with 100% of NSCLC Stage II or greater cancers labeled as moderate or high risk.

"These findings suggest that the Percepta Nasal Swab test will provide significant clinical utility across a range of lung nodule sizes and lung cancer stages," said Giulia C. Kennedy, Ph.D., Veracyte’s chief scientific officer and chief medical officer. "We are excited to begin offering the test to sites as part of our clinical utility study and to transform lung cancer early assessment so that more unnecessary procedures can be avoided and more lives can be saved."

Also at the CHEST meeting, real-world data will be presented demonstrating that the Percepta Genomic Sequencing Classifier (GSC) can help reduce unnecessary surgeries and guide next steps in lung cancer evaluation for patients with suspicious lung nodules whose bronchoscopy results were inconclusive. In one retrospective clinical utility study, researchers from the Medical College of Wisconsin found that the Percepta GSC reclassified one-third of lung nodules with indeterminate bronchoscopy results as either low risk or high risk. Similarly, researchers from AnMed Health Medical Center in Anderson, South Carolina, found that the Percepta GSC enabled more than half of patients’ indeterminate lung nodules to be reclassified and, among those moved to a low risk category, there was a significant reduction in the rate of invasive follow-up procedures.

The Percepta Nasal Swab test and GSC use advanced genomic technology to detect smoking-related damage associated with lung cancer in the respiratory tract of current or former smokers. Both tests are part of Veracyte’s comprehensive lung cancer portfolio, which aims to transform care at every step of the patient journey. Collectively, the company’s tests are leveraging cutting-edge genomic science and technology to provide answers and insights that enable physicians and patients to make better, faster and more confident care decisions. Veracyte’s lung cancer portfolio also includes the in-development Percepta Genomic Atlas, which is intended to detect gene alterations that may inform lung cancer treatment decisions, using the same small biopsy that was collected for diagnosis.

About Lung Cancer

Lung cancer kills more than 1.8 million people worldwide each year.i Early detection is key, with a five-year survival rate of nearly 60 percent when the cancer is found early, compared to 6 percent when it is found at a later stage.ii Lung nodules are typically the first sign of lung cancer, but most lung nodules are benign.i Each year in the U.S., an estimated 1.6 million lung nodules are found incidentally on CT scans and, with recently expanded recommendations from the U.S. Preventive Services Task Force, an estimated 15 million Americans are eligible for annual lung cancer CT screening. Physicians currently lack objective tools to accurately determine which lung nodules found on CT are benign and which are cancerous.

On October 11, 2021 Outcomes4Me Inc., developer of a leading free mobile app and platform to navigate cancer treatment and care, reported that it has partnered with Invitae Corporation (NYSE: NVTA), a leading medical genetics company, to expand education and access to genetic testing to breast cancer patients and survivors (Press release, Invitae, OCT 11, 2021, View Source [SID1234591089]). The collaboration leverages the strengths of Invitae, which supplies clinical grade genetic testing, and Outcomes4Me’s 360-degree, validated and evidence-based cancer support and treatment options via its free and easy-to-use app. Initially and currently available in the United States, patients can now receive genetic counseling through Invitae’s partnership with Genome Medical, get testing, and upload their results within the Outcomes4Me app.

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There is a misconception that genetic testing is only useful as a preventative tool prior to a cancer diagnosis. According to Outcomes4Me patient data, almost half of users (46 percent) who qualified for testing (based on NCCN Guidelines) did not receive testing or did not know if they had received testing. However, genetic testing can provide insights that can help inform and refine precision therapy use and clinical treatment trial enrollment. In addition, genetic testing results can be used to help prevent recurrence and reduce incidence of other inherited cancers.

A cancer diagnosis is often overwhelming for patients and their families. Outcomes4Me demystifies cancer by providing the most up-to-date and validated research, support, and treatment options, all grounded in science and data and curated according to the patient’s specific diagnosis. Outcomes4Me partners with the researchers, doctors, and academics that set the rigorous standards of cancer care for all treatment providers, including the National Comprehensive Care Network (NCCN), Vanderbilt-Ingram Cancer Center (VICC) and Massachusetts General Hospital (MGH). The collaboration with Invitae expands access to genetic testing, a vitally important tool in the patient’s cancer care arsenal.

"Outcomes4Me is an indispensable platform for patients with breast cancer, giving them the personalized knowledge and access to timely new trials and targeted therapies that could lead to better health outcomes," said Ed Esplin, M.D., Ph.D., FACMG, FACP, Clinical Geneticist at Invitae. "By providing access to our comprehensive genetic testing and counseling services, Outcomes4Me is adding a valuable resource that will empower patients to advance their knowledge, understanding, and therefore, self-advocacy during treatment and survivorship."

Unlike popular direct-to-consumer genetic testing services, which test for a few specific genetic variants for certain genes, Invitae provides state-of-the-art clinical grade next-generation sequencing-based (NGS) genetic testing that comprehensively analyses more than 80 genes, including all known mutations of the important BRCA1/BRCA2 genes. This comprehensive approach, combined with associated genetic counseling, not only provides insights for cancer patients, but also for family members who may be at risk.

"Our collaboration with Invitae reinforces Outcomes4Me’s mission to give patients back control," said Maya R. Said, Sc. D., Founder and CEO of Outcomes4Me. "Because of this work with Invitae, our valued community now has rare direct access to a much-needed testing service. Outcomes4Me will proudly continue to democratize the best in cancer treatment, research, and support by removing barriers and bias in information flow."

On October 11, 2021 Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, and Flexion Therapeutics, Inc. (Nasdaq: FLXN) reported a definitive agreement pursuant to which Pacira will acquire Flexion for $8.50 per share in cash, plus one non-tradeable contingent value right (CVR) worth up to $8.00 per share in cash (Press release, Pacira Pharmaceuticals, OCT 11, 2021, View Source [SID1234591161]). The CVR is payable (subject to certain terms and conditions) in the event certain sales and/or regulatory milestones are achieved, as set forth in more detail below. The transaction was unanimously approved by the board of directors of each of Pacira and Flexion.

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Flexion is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, local non-opioid therapies for the treatment of patients with musculoskeletal conditions, including osteoarthritis (OA), postsurgical pain and low back pain. Approved in 2017, Flexion’s lead product, ZILRETTA (triamcinolone acetonide extended-release injectable suspension) is the first and only FDA-approved treatment for OA knee pain utilizing extended-release microsphere technology.

"This acquisition is a major milestone in our strategy to build a robust offering of novel, non-opioid treatments to improve patient care along the neural pain pathway while simultaneously providing us with a complementary commercial asset in ZILRETTA for the treatment of OA knee pain," said Dave Stack, chairman and chief executive officer of Pacira. "We believe the Flexion portfolio further solidifies Pacira as a leader in opioid-sparing pain management as we continue to redefine the role of opioids as a last resort rescue medication. Importantly, this acquisition creates diversification and growth to our topline while providing what we would expect to be meaningful synergies that should result in substantial near- and long-term accretion to our cash flows and earnings."

"Pacira shares our commitment to advancing non-opioid pain control and we believe it is ideally positioned to drive continued clinical and commercial success of ZILRETTA, FX201, and FX301," said Michael Clayman, M.D., chief executive officer and co-founder of Flexion. "This combination with Pacira offers Flexion stakeholders excellent prospects for value creation, particularly as the contingent value rights provide the opportunity to continue to benefit from the ongoing success of Flexion’s products and programs."

"I’d like to thank all of our employees – past and present – for their extraordinary commitment and superb contributions that have translated into ZILRETTA, a medicine that matters, getting to increasing numbers of patients in need and to a pipeline of potentially transformative medicines," continued Dr. Clayman.

Pacira Transaction Rationale

Innovative non-opioid portfolio directly aligns with the Pacira mission to provide an opioid alternative to as many patients as possible and address medical needs along the neural pain pathway.
Flexion’s ZILRETTA is a non-opioid injection that will allow Pacira to offer a treatment to manage OA pain of the knee at an earlier stage of the patient’s journey along the neural pain pathway.
Complementary sales call points and clinical-stage pipeline offer significant cost synergies across research and development and commercial activities.
Adds multiple clinical milestones, including the initiation of a Phase 3 registration trial of ZILRETTA in shoulder osteoarthritis and the advancement of Phase 1 studies of FX201 for musculoskeletal pain, including OA, and FX301 as a lower extremity nerve block for postsurgical pain.
Immediately revenue generating and expected to be accretive to full-year 2022 earnings and significantly accretive thereafter.
Transaction Details

Under the terms of the definitive agreement, Pacira will commence a tender offer to acquire all outstanding shares of Flexion for a purchase price of $8.50 per share in cash, plus one non-tradeable CVR. The CVR will entitle Flexion stockholders to up to an additional $8.00 per share in cash payable (subject to certain terms and conditions) upon achievement of the following milestones:

$1.00 per share if total calendar year ZILRETTA net sales achieve $250 million;
$2.00 per share if total calendar year ZILRETTA net sales achieve $375 million;
$3.00 per share if total calendar year ZILRETTA net sales achieve $500 million;
$1.00 per share upon U.S. FDA approval of FX201; and
$1.00 per share upon U.S. FDA approval of FX301.
The milestones associated with each contingent cash payment must be achieved, if at all, on or before December 31, 2030. There can be no assurance any payments will be made with respect to the CVR. The transaction is not subject to any financing condition and Pacira will fund the transaction from its existing cash resources.

Flexion’s board of directors unanimously recommends that Flexion’s stockholders tender their shares in the tender offer. Additionally, Flexion’s directors and executive officers, or their affiliates, have (subject to certain terms and conditions) agreed to tender their shares in the tender offer.

Timing to Close

The transaction is anticipated to close during the fourth quarter of 2021, subject to customary closing conditions, including receipt of required regulatory approvals and the tender of a majority of the outstanding shares of Flexion’s common stock. Following the successful closing of the tender offer, Pacira will acquire any shares of Flexion that are not tendered in the tender offer through a second-step merger at the same consideration as paid in the tender offer.

Third Quarter Performance and Guidance Update

Today Pacira and Flexion are providing the following preliminary unaudited results and updates for the third quarter of 2021. 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 either company’s financial results for the third quarter or full year 2021.

EXPAREL net product sales of $121.9 million for the third quarter and $39.7 million for the month of September 2021, compared with $113.7 million and $39.5 million in the prior year, respectively. The number of EXPAREL selling days for the month of September was 21 in both 2021 and 2020. The elective surgery market faced additional pandemic-related challenges in August and September due to regional surges in COVID-19 delta variant cases, staffing shortages, and surgical fatigue from care teams addressing significant procedure backlogs. These variables began to subside in the latter part of September and Pacira expects the fourth quarter to reflect improving market dynamics.
iovera° net product sales of $4.2 million for the third quarter and $2.3 million for the month of September 2021, compared with $2.7 million and $1.1 million in the prior year, respectively.
Flexion expects that ZILRETTA net sales were in the range of $21 million to $23 million for the third quarter of 2021. Third quarter 2021 sales were negatively impacted, particularly in the second half of the quarter, by the following primary factors: (a) temporary disruptions from rebate program modifications, (b) pandemic-related challenges, and (c) several unanticipated manufacturing batch failures that led to short-dated ZILRETTA inventory resulting in smaller order sizes by physician practices and product returns from specialty distributors.
Consistent with Pacira practices, Flexion is withdrawing its ZILRETTA sales guidance for 2021.
Advisors

J.P. Morgan Securities LLC acted as financial advisor to Pacira and Perkins Coie LLP is serving as its legal advisor. Lazard acted as lead financial advisor and Goldman Sachs also acted as financial advisor to Flexion. Cooley LLP is serving as Flexion’s legal advisor.

Conference Call and Webcast

The Pacira management team will host a conference call today at 8:30 AM ET to discuss the proposed transaction. To participate in the conference call, dial 1-877-845-0779 and provide the passcode 9675803. International callers may dial 1-720-545-0035 and use the same passcode. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the "Events" page on the Pacira website at investor.pacira.com.

For those unable to participate in the live call, a replay will be available at 1-855-859-2056 (domestic) or 1-404-537-3406 (international) using the passcode 9675803. The replay of the call will be available for two weeks from the date of the live call. The webcast will be available on the Pacira website for approximately two weeks following the call.

On October 11, 2021 Ipsen (Euronext: IPN; ADR: IPSEY) reported the appointment of Mari Scheiffele as EVP and President, Specialty Care International, effective November 1st 2021 (Press release, Ipsen, OCT 11, 2021, View Source [SID1234591056]). Based in Boulogne, France, she will be reporting directly to David Loew, CEO, Ipsen, and serve on the Executive Leadership Team.

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"Along with the ELT, we are very pleased to welcome Mari to Ipsen. Her diverse experience will be critical in developing our three key therapeutic areas, Oncology, Rare Disease and Neuroscience, by continuing to strengthen Ipsen’s international commercial presence in over 115 countries, excluding North America. Mari also brings valuable capabilities in transformation which she built over the course of her previous roles at Novartis and McKinsey. We are looking forward to working closely with her," said David Loew, CEO, Ipsen.

Mari brings 20 years of healthcare leadership experience, from across the industry, having worked in the US, Europe and in Japan. She joins Ipsen from Novartis where she has been in both global strategic and country operational roles, first in Japan and then in the UK. Most recently, Mari has been General Manager, Novartis Oncology UK & Ireland where with a focus on patient-centricity, evidence-based medicine, and partnership, she has driven a successful business transformation.

In addition to her depth in Oncology, Mari has worked in other specialty care environments such as ophthalmology, neuroscience and immunology. Prior to Novartis, Mari was a partner at McKinsey & Company in New York and in Switzerland in Pharmaceuticals and Medical Products.

"I’m delighted to be joining Ipsen at such an exciting time," said Mari Scheiffele. "Ipsen has an inspiring strategy, strong growth and a fantastic culture of collaboration, and excellence. I look forward to working with my new colleagues on Ipsen’s International team, across its broad reach of markets, to bring Ipsen’s transformative innovations to patients around the World."

Mari speaks English, Finnish and Japanese and holds a doctorate in neuroscience from Harvard Medical School.

Associated Documents
Ipsen-Appointment-of-Mari-Scheiffele-11-October-2021.pdf

On October 11, 2021 Sandoz, a Novartis division, reported that it has successfully completed the acquisition of GSK’s cephalosporin antibiotics business (Press release, Sandoz, OCT 11, 2021, View Source [SID1234591073]).

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Through this transaction, Sandoz has acquired rights to three established brands (Zinnat, Zinacef and Fortum)) in more than 100 markets, further reinforcing its leading global position in antibiotics. In 2020, the three brands had combined sales of approximately USD 140 million in the relevant markets.

"Antibiotics are the backbone of modern healthcare systems and a central pillar of our worldwide Sandoz patient offering", said Sandoz CEO Richard Saynor. "The successful and timely closing of this important transaction is further proof of our commitment at Sandoz to be a leading global supplier of these essential medicines.

"Cephalosporins are the largest antibiotic segment by global sales and this acquisition complements our #1 position in generic penicillins, the other key segment. It also sets us up for additional synergies driven by an increased promotional footprint across markets."

The transaction excludes rights to certain brands previously divested by GSK in the US, Australia and Germany. GSK will also retain full brand rights in China (excluding Taiwan, Hong Kong and Macau), India, Pakistan, and Egypt and to certain brands in Japan.

In line with its integrated manufacturing strategy, Sandoz intends in the longer term to manufacture Zinnat at sites in its own network, which has global antibiotics production centered on its lead production site in Kundl, Austria. In May, Sandoz announced plans to invest more than EUR 150 million in its uniquely vertically-integrated, European-based antibiotics network.