On August 29, 2017 /PRNewswire/ — Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported that it has completed its acquisition of Patheon N.V. (NYSE: PTHN), a leading contract development and manufacturing organization (CDMO) serving the pharmaceutical and biotechnology sectors, for approximately $7.2 billion (Press release, Thermo Fisher Scientific, AUG 29, 2017, View Source [SID1234520333]). Today’s close follows the expiration of Thermo Fisher’s initial tender offer for Patheon at $35.00 per share in cash.

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"We’re pleased to complete our acquisition of Patheon and look forward to the significant value this transaction will create for our customers and our shareholders," said Marc N. Casper, president and chief executive officer of Thermo Fisher Scientific. "By adding Patheon’s highly complementary CDMO capabilities to our leading clinical trials services and bioproduction technologies, we will be an even stronger partner for our pharmaceutical and biotech customers. We’re delighted to welcome our Patheon colleagues to the Thermo Fisher team and excited about the new opportunities we have to help our customers accelerate innovation and enhance productivity by leveraging our combined strengths."

Patheon generated fiscal 2016 revenue of approximately $1.9 billion and will become part of Thermo Fisher’s Laboratory Products and Services Segment. For the remainder of 2017, the transaction is expected to be approximately $0.09 accretive to adjusted earnings per share1, which includes $0.02 in the third quarter. Details of the 2017 impact will be provided during Thermo Fisher’s third quarter earnings call in late October.

Thermo Fisher continues to expect to realize total synergies of approximately $120 million by year three following the close, consisting of approximately $90 million of cost synergies and approximately $30 million of adjusted operating income benefit from revenue-related synergies.

Further Transaction Details and Timing

Today, Thermo Fisher is acquiring approximately 95.3% of Patheon’s outstanding ordinary shares.

The initial offering period for the tender offer and withdrawal rights expired at 5:00 p.m., New York City time, on August 28, 2017 (the "Expiration Time"). Based on information provided by American Stock Transfer & Trust Company, LLC, the depositary for the tender offer, a total of 138,406,058 Patheon ordinary shares, representing approximately 95.3% of the outstanding Patheon ordinary shares, had been validly tendered and had not been properly withdrawn as of the Expiration Time (excluding 176,509 ordinary shares, representing approximately 0.12% of the aggregate number of ordinary shares outstanding, tendered pursuant to guaranteed delivery procedures that have not yet been delivered in settlement or satisfaction of such guarantee). Thermo Fisher’s wholly owned subsidiary, Thermo Fisher (CN) Luxembourg S.à r.l., has accepted for payment all shares that were validly tendered and were not properly withdrawn as of the Expiration Time, and payment for such shares will be made promptly in accordance with the terms of the offer.

Thermo Fisher also announced the commencement of a subsequent offering period scheduled to expire at 12:01 a.m., New York City time, on September 13, 2017, as more fully described in the tender offer statement on Schedule TO filed by Thermo Fisher with the U.S. Securities and Exchange Commission (the "SEC") on May 31, 2017 (as amended and supplemented, the "Schedule TO"). All ordinary shares validly tendered during the subsequent offering period will be immediately accepted for payment, and tendering holders will thereafter promptly be paid the same form and amount of offer consideration as in the initial offering period. The procedures for tendering shares during the subsequent offering period are described in the Schedule TO and are generally the same as those applicable to the initial offering period, except that the guaranteed delivery procedures may not be used during the subsequent offering period and no withdrawal rights will apply to shares tendered during the subsequent offering period.

Patheon has requested that the New York Stock Exchange (the "NYSE") suspend trading of Patheon ordinary shares after the close of business on September 1, 2017, and Patheon intends to file a Form 25, Notification of Removal from Listing and/or Registration under Section 12(b) of the U.S. Securities Exchange Act of 1934, as amended (the "Exchange Act") with the SEC on such date. Patheon also intends to terminate its reporting obligations under the Exchange Act by filing a Form 15 with the SEC on or about September 11, 2017. Following delisting from the NYSE, Patheon ordinary shares will not be listed or registered on another national securities exchange. Delisting is likely to reduce significantly the liquidity and marketability of any Patheon ordinary shares that have not been tendered pursuant to the tender offer.

Advisors

Goldman Sachs & Co. acted as financial advisor to Thermo Fisher, and Wachtell, Lipton, Rosen & Katz served as legal counsel.

Morgan Stanley & Co. acted as financial advisor to Patheon, and Skadden, Arps, Slate, Meagher & Flom LLP served as legal counsel.

Use of Non-GAAP Financial Measures

In addition to the financial measures prepared in accordance with generally accepted accounting principles (GAAP), we use certain non-GAAP financial measures, including adjusted earnings per share (EPS) and adjusted operating income, which exclude certain acquisition-related costs, including charges for the sale of inventories revalued at the date of acquisition and significant transaction costs; restructuring and other costs/income; and amortization of acquisition-related intangible assets. Adjusted EPS also excludes certain other gains and losses that are either isolated or cannot be expected to occur again with any regularity or predictability, tax provisions/benefits related to the previous items, benefits from tax credit carryforwards, the impact of significant tax audits or events and the results of discontinued operations. We exclude the above items because they are outside of our normal operations and/or, in certain cases, are difficult to forecast accurately for future periods. Thermo Fisher does not provide GAAP financial measures on a forward-looking basis because we are unable to predict with reasonable certainty and without unreasonable effort items such as the timing and amount of future restructuring actions and acquisition-related charges as well as gains or losses from sales of real estate and businesses, the early retirement of debt and the outcome of legal proceedings. The timing and amount of these items are uncertain and could be material to Thermo Fisher’s results computed in accordance with GAAP. These non-GAAP projections should not be considered a substitute for GAAP measures.

On August 29, 2017 Augustus BioTarget reported that An early-stage drug development company in South Carolina has launched an online fundraising campaign to study the ancient spice curcumin in combination with an FDA-approved Immune Checkpoint Inhibitor to fight colon cancer (Press release, Augustus BioTarget, AUG 29, 2017, http://augustusbiotarget.com/wp-content/uploads/2017/08/Press-Release-ABT-August-29-2017.pdf [SID1234556207]).

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Within five days of launch, the company has met 78% of its funding goal on Experiment.com, an online science crowdfunding platform dedicated to scientific research. https://experiment.com/curcumincancerproject

A group of scientists working in the US at Augustus BioTarget, Inc., and in Germany at Rodos Biotarget, GmbH, developed a unique nanocarrier drug delivery system, the CLR-TargoSphere, into which curcumin was encapsulated. This will be studied in mice with colon cancer at the Charles River Labs in North Carolina.

"Our aim is to resurrect the immune response against cancer with targeted curcumin," said Michael Scolaro, founder of Augustus BioTarget and Chief Investigator. "Curcumin is known to possess significant anti-inflammatory and anti-neoplastic properties. But because it is very poorly absorbed and distributed in the body, it has been impractical for clinical use. Delivering curcumin directly to immune cells that are immobilized by cancers promises to help restore anticancer activity.

"Using curcumin in medicine may not secure huge capital investments the way a new iPad does," he added. ‘But with the latest advancements in immune system targeting, its use to fight cancer is now within reach."

On August 28, 2018 the U.S. Food and Drug Administration reported that it took decisive action to prevent the use of a potentially dangerous and unproven treatment belonging to StemImmune Inc. in San Diego, California, and administered to patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, California (Press release, US FDA, AUG 28, 2017, View Source [SID1234526938]). On behalf of the FDA, on Friday, Aug. 25, 2017 the U.S. Marshals Service seized five vials of Vaccinia Virus Vaccine (Live) – a vaccine that is reserved only for people at high risk for smallpox, such as some members of the military. Each of the vials originally contained 100 doses of the vaccine, and although one vial was partially used, four of the vials were intact.

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As the vaccine is not commercially available, the FDA has serious concerns about how StemImmune obtained the product for use as part of an unapproved and potentially dangerous treatment. The FDA is actively investigating the circumstances by which StemImmune came to possess the vaccine.

"Speaking as a cancer survivor, I know all too well the fear and anxiety the diagnosis of cancer can have on a patient and their loved ones and how tempting it can be to believe the audacious but ultimately hollow claims made by these kinds of unscrupulous clinics or others selling so-called cures," said FDA Commissioner Scott Gottlieb, M.D. "The FDA will not allow deceitful actors to take advantage of vulnerable patients by purporting to have treatments or cures for serious diseases without any proof that they actually work. I especially won’t allow cases such as this one to go unchallenged, where we have good medical reasons to believe these purported treatments can actually harm patients and make their conditions worse."

The seizure comes after recent FDA inspections at StemImmune Inc. and the California Stem Cell Treatment Centers confirmed that the vaccine was used to create an unapproved stem cell product (a combination of excess amounts of vaccine and stromal vascular fraction – stem cells derived from body fat), which was then administered to cancer patients with potentially compromised immune systems and for whom the vaccine posed a potential for harm, including myocarditis and pericarditis (inflammation and swelling of the heart and surrounding tissues). The unproven and potentially dangerous treatment was being injected intravenously and directly into patients’ tumors.

Serious health problems, including those that are life-threatening, can also occur in unvaccinated people who are accidentally infected with the vaccinia virus by being in close contact with someone who has recently received the vaccine. In particular, unvaccinated people who are pregnant, or have problems with their heart or immune system, or have skin problems like eczema, dermatitis, psoriasis and have close contact with a vaccine recipient are at an increased risk for inflammation and swelling of the heart and surrounding tissues if they become infected with the vaccine virus, either by being vaccinated or by being in close contact with a person who was vaccinated.

"I’ve directed the agency to vigorously investigate these kinds of unscrupulous clinics using the full range of our tools, be it regulatory enforcement or criminal investigations. Our actions today should also be a warning to others who may be doing similar harm, we will take action to ensure Americans are not put at unnecessary risk," Gottlieb added. "I also urge health care providers, patients and consumers to report these kinds of activities or any adverse events associated with these unproven treatments to the agency through MedWatch."

Health care professionals and consumers should report any adverse events related to treatments received at California Stem Cell Treatment Center to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed form can be submitted online or via fax to 1-800-FDA-0178.

The U.S. Department of Justice filed the seizure complaint, on behalf of the FDA, in the U.S. District Court for the Central District of California.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

On August 23, 2017 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) and Nippon Shinyaku Co., Ltd. (TOKYO: 4516) reported that Chugai filed a new drug application to the Ministry of Health, Labour and Welfare (MHLW), for glycoengineered type II anti-CD20 monoclonal antibody, obinutuzumab (genetical recombination) which was co-developed by the two companies for the treatment of "CD20-positive B-cell follicular lymphoma (FL)" in Japan (Press release, Chugai, AUG 23, 2017, View Source [SID1234520310]).

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"Combination therapy of rituximab and chemotherapy has been used as the standard treatment for CD20-positive B-cell FL for a long time. As a new treatment option, Obinutuzumab was confirmed to be more beneficial than the conventional treatment with rituximab for the treatment of FL," said Dr. Yasushi Ito, Chugai’s Senior Vice President, Head of Project & Lifecycle Management Unit. "We are committed to deliver obinutuzumab to patients as early as possible to contribute to the access to better treatments in Japan."

Dr. Kazuya Mori, Nippon Shinyaku’s Corporate Officer, Head of R&D Administration Div. said "I am very glad that a new drug application for our co-developed product, obinutuzumab, was filed. By adding this new product to our lineup in the area of hematologic malignancies, on which we are focusing, we will make utmost efforts to meet the demands of the clinical setting and contribute to the treatment of patients."

This filing was based on the results of the GALLIUM study, a global phase III clinical study conducted by Roche and participating from Japan and other several clinical studies.
The GALLIUM study is a global Phase III open-label, multi-center, randomized two-arm study that evaluated the efficacy and safety of obinutuzumab plus chemotherapy followed by obinutuzumab alone (obinutuzumab arm) compared with rituximab plus chemotherapy followed by rituximab alone (rituximab arm) in 1,401 patients with previously untreated CD20-positive advanced non-Hodgkin’s lymphoma. The primary endpoint of the study was investigator-assessed progression free survival (PFS) in 1,202 patients with FL. The secondary endpoints were PFS assessed by an independent review committee (IRC), overall survival (OS), safety, and other endpoints.

With respect to the primary endpoint, as the median PFS was not reached, the results showed that obinutuzumab arm reduced the risk of disease progression, recurrence or death in patients with FL by 34 percent (HR=0.66, 95% CI: 0.51-0.85, p=0.0012, stratified log-rank test, Data cut-off: January 31, 2016) compared to rituximab arm. Concerning secondary endpoints, the median PFS assessed by the IRC was not reached as well, the risk of disease progression, recurrence or deaths decreased by 29% (HR=0.71, 95% CI: 0.54-0.93], p=0.0138, stratified log-rank test, Data cut-off: January 31, 2016). The median OS did not reach in both arms due to small numbers of events. As for safety, the adverse events (AEs) expressed in both arms in the GALLIUM study were consistent with previous reports. The Grade 3 or higher AEs which was observed in 5% or more frequently for obinutuzumab arm than rituximab arm was neutropenia (43.9% for obinutuzumab arm vs. 37.9% for rituximab arm).

Obinutuzumab is a glycoengineered type II anti-CD20 monoclonal antibody designed to attach to CD20, a protein expressed on certain B cells, but not on stem cells or plasma cells, same as rituximab which is recommended as a treatment of non-Hodgkin’s lymphoma in treatment guidelines in Japan and overseas. Obinutuzumab is designed to attack and destroy targeted B-cells both directly and together with the body’s immune system.

In Japan, the prevalence of malignant lymphoma was reported to be approximately 27,000 and the number of deaths due to the disease was reported to be approximately 11,000 in 20121, 2). Since the cases of Hodgkin’s lymphoma is reported to account for approximately 8 to 10% of the cases of malignant lymphoma in Japan3), the prevalence of non-Hodgkin’s lymphoma is estimated to be approximately 24,000 and the number of deaths from this condition is estimated to be approximately 10,000. The prevalence of and deaths from malignant lymphoma tend to increase in recent years1, 2), and a same tendency is seen in patients with non-Hodgkin’s lymphoma.

Chugai and Nippon Shinyaku will work for the early approval to provide obinutuzumab as a new treatment option for patients with CD20-positive B-cell follicular lymphoma and medical professionals.

On August 21, 2017 Syros Pharmaceuticals (NASDAQ: SYRS), a biopharmaceutical company pioneering the discovery and development of medicines to control the expression of disease-driving genes, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to SY-1425 for the treatment of acute myeloid leukemia (AML) (Press release, Syros Pharmaceuticals, AUG 21, 2017, View Source [SID1234520301]). SY-1425, an oral first-in-class selective retinoic acid receptor alpha (RARα) agonist, is currently in a Phase 2 clinical trial in genomically defined subsets of patients with AML and myelodysplastic syndrome (MDS).

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"Treatment of AML remains a significant unmet medical need, with many patients lacking adequate therapeutic options," said David A. Roth, M.D., Syros’ Chief Medical Officer. "We believe that SY-1425 may provide a meaningful benefit for subsets of AML patients whose disease is driven by abnormally high expression of the RARA or IRF8 genes. Receiving orphan drug designation is an important regulatory milestone in the development of SY-1425. We’re pleased with the continued progress of the ongoing Phase 2 clinical trial, and we look forward to presenting initial clinical data in the fourth quarter of this year."

The FDA’s Office of Orphan Drug Products grants orphan status to support development of medicines for the treatment of rare diseases that affect fewer than 200,000 people in the United States. Orphan drug designation may provide certain benefits, including a seven-year period of market exclusivity if the drug is approved, tax credits for qualified clinical trials and an exemption from FDA application fees.

Using its gene control platform, Syros discovered subsets of AML and MDS patients with super-enhancers associated with RARA or IRF8. Syros identified proprietary biomarkers related to these super-enhancers. These super-enhancers are believed to drive overexpression of the RARA or IRF8 genes, locking cells in an immature, undifferentiated and proliferative state, leading to disease. In preclinical studies, SY-1425 promoted differentiation of AML cells with high RARA or IRF8 expression and inhibited tumor growth and prolonged survival in patient-derived xenograft models of AML with high RARA expression. Syros estimates that about one-third of AML and MDS patients have either the RARA or IRF8 biomarker, or both.

The ongoing Phase 2 clinical trial of SY-1425 is assessing the safety and efficacy of SY-1425 as a single agent in four AML and MDS patient populations, as well as in combination with azacitidine, a standard-of-care therapy, in newly diagnosed AML patients who are not suitable candidates for standard chemotherapy. All patients in the trial are prospectively selected using biomarkers for high expression of RARA or IRF8. Additional details about the trial can be found using the identifier NCT02807558 at www.clinicaltrials.gov.