On November 30, 2017 Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) reported that the European Medicines Agency (EMA) has accepted for review Mylan’s Marketing Authorization Applications (MAA) for proposed biosimilar trastuzumab and proposed biosimilar pegfilgrastim (Press release, Mylan, NOV 30, 2017, View Source [SID1234522323]). Trastuzumab is used to treat certain HER2-positive breast and gastric cancers. Pegfilgrastim is used to reduce the duration of neutropenia (low count of neutrophils, a type of white blood cells) and the incidence of fever associated with neutropenia in adult patients treated with chemotherapy in certain types of cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

EMA acceptance of the submissions follows an earlier withdrawal of both applications in response to an audit conducted by the European inspecting authority of Biocon’s drug product facility. Biocon has completed the Corrective and Preventive Actions (CAPAs) outlined as a result of the audit observations. The CAPAs will be confirmed during reinspection, which will be completed as part of the regulatory review process.

Good Manufacturing Practice (GMP) compliance certificates for Biocon’s two drug substance manufacturing facilities in Bangalore have been issued previously. Approval of these sites is key in the development and approval process as drug substance manufacture is core to the production of the actual biologic product in GMP compliance.

Mylan President Rajiv Malik commented: "We are extremely pleased with the acceptance of our MAAs. Having gone through initial reviews of the applications and after completing the CAPAs from the EMA audit, we are even more confident with the strength of our MAAs. Additionally, the Voluntary Action Indicated (VAI) designation we received from FDA gives us further confidence in the readiness of the manufacturing site. We now look forward to moving ahead with the rest of the regulatory review process in Europe and to bringing these important treatment options to cancer patients.

"These developments also demonstrate Mylan’s commitment to our partnership with Biocon, the strength of the collaboration’s scientific and manufacturing capabilities, and our relentless approach to increasing access to and affordability of important treatment options in Europe and around the world through the introduction of biosimilars."

Dr Arun Chandavarkar, CEO & Joint Managing Director, Biocon said: "EMA’s acceptance for review of the Marketing Authorization Applications (MAAs) for our proposed biosimilars of trastuzumab and pegfilgrastim is indeed a welcome development. These applications were resubmitted upon completion of the Corrective and Preventive Actions (CAPAs), including the modifications of our aseptic drug product facility. We expect these CAPAs to be verified during inspection as part of the review process. We continue to work closely with our partner Mylan in engaging with EMA to provide these high quality, affordable therapy options for cancer patients in Europe."

On November 30, 2017 Pfizer Inc. (NYSE:PFE) and Basilea Pharmaceutica Ltd. (SIX:BSLN), an international biopharmaceutical company specializing in the research and development of anti-infective and oncological medicines, reported they have entered into an agreement whereby Pfizer will be granted the exclusive development and commercialization rights in China and several countries in the Asia Pacific region to CRESEMBA (isavuconazole) (Press release, Pfizer, NOV 30, 2017, View Source [SID1234522326]). CRESEMBA is a novel antifungal medicine for the treatment of adult patients with diagnosed invasive aspergillosis and mucormycosis1, two serious infections associated with significant morbidity and mortality among immunocompromised patients, such as those with advanced HIV and those with cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of the agreement, Pfizer will have exclusive rights to develop, distribute and commercialize CRESEMBA in sixteen Asian Pacific countries and China (including Hong Kong and Macao). These rights do not include Japan. In addition, Pfizer will become the marketing authorization holder for the Asia Pacific Region and China. The specific financial terms of the agreement remain confidential. The agreement is subject to customary regulatory approval.

In July 2017, Pfizer completed an agreement with Basilea to obtain the exclusive commercialization rights to CRESEMBA in Europe (with the exception of the Nordic countries). Since that time, Pfizer has assumed responsibility for the commercialization of CRESEMBA in Austria, France, Germany, Italy, and the United Kingdom and successfully launched CRESEMBA in Spain with additional launches expected in 2018 and beyond.

CRESEMBA was developed in response to the urgent medical need for antifungal medicines for the treatment of invasive fungal infections, which are naturally resistant to many antifungal therapies and have become increasingly resistant to other available therapies. Today, invasive aspergillosis is the most frequently reported fungal infection in immunocompromised individuals within the Asian Pacific region.

"We are excited to extend our partnership with Basilea, a company that shares our passion and commitment to confronting the global challenges of infectious disease management," said Suneet Varma, global president of Pfizer APAC, Greater China and Global Brands. "We believe our extensive geographic footprint in APAC and China, together with our expertise in successfully commercializing innovative medicines, will help enable us to continue to address the unmet medical needs of patients, especially in the area of anti-infectives."

"CRESEMBA is a well differentiated drug that addresses a critical medical need in patients with invasive mold infections," said Ronald Scott, chief executive officer of Basilea. "We are very pleased to be expanding our partnership with Pfizer to China and Asia Pacific where it has a strong commercial presence and a proven track record of successfully developing and commercializing hospital antifungals. We have now established partnerships for isavuconazole with leading pharmaceutical companies in all major markets around the world."

About Pfizer Anti-Infectives

Today, Pfizer is a leading global provider of anti-infective medicines, offering patients access to a diverse portfolio of more than 80 products. Since its pioneering work on penicillin in the 1940s, Pfizer has been actively engaged in the research and development of innovative medicines and creation of policies and educational programs to address the evolving needs of patients and physicians in the area of infectious diseases. In December 2016, Pfizer completed the acquisition of AstraZeneca PLC’s small molecule anti-infective business, which includes both marketed agents and clinical development assets primarily outside the United States.

About invasive aspergillosis and mucormycosis

Invasive fungal diseases (IFDs) are an increasingly common complication associated with high morbidity and mortality among immunocompromised patients such as those with advanced HIV infection and those with cancer. Rates of mortality associated with invasive fungal infections depend upon the pathogen, geographic location and underlying patient characteristics and can be as high as 80-90%. Today, there are limited treatment options available for patients diagnosed with invasive aspergillosis and mucormycosis.

About CRESEMBA (isavuconazole)

CRESEMBA is an intravenous (IV) and oral azole antifungal and the active agent of the prodrug isavuconazonium sulfate. It was approved in March 2015 by the United States Food and Drug Administration (FDA) for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis. The European centralized marketing authorization was granted in October 2015 to isavuconazole for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate. Isavuconazole has orphan drug designation for the approved indications in Europe and the US. The drug is commercialized in the US by Astellas Pharma US. Outside the US and the EU, isavuconazole is not approved for commercial use. Pfizer does not have commercialization rights to CRESEMBA in the United States.

On November 30, 2017 Foundation Medicine, Inc. (NASDAQ:FMI) reported that the U.S. Food and Drug Administration (FDA) approved FoundationOne CDx, the company’s comprehensive companion diagnostic test for solid tumors (Press release, Foundation Medicine, NOV 30, 2017, View Source [SID1234522325]). FoundationOne CDx is intended for use by health care professionals to help inform cancer treatment management in accordance with professional guidelines for patients with solid tumors. The first and only FDA-approved test of its kind for all solid tumors, FoundationOne CDx is a diagnostic test that acts as:

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

a comprehensive companion diagnostic to identify patients who may benefit from treatment with specific FDA-approved targeted therapies;
a comprehensive genomic profiling (CGP) test that includes genomic biomarkers to help inform the use of other targeted oncology therapies, including immunotherapies;
a tool for physicians that identifies patient opportunities for clinical trial participation; and,
an FDA-approved platform for companion diagnostic development for biopharma companies developing precision therapeutics.
FoundationOne CDx assesses all classes of genomic alterations in 324 genes known to drive cancer growth, providing potentially actionable information to help guide treatment decisions. It is also indicated as a companion diagnostic for patients with certain types of non-small cell lung cancer (NSCLC), melanoma, colorectal cancer, ovarian cancer or breast cancer to identify those patients who may benefit from treatment with one of 17 on-label targeted therapies, including 12 therapies currently approved as first-line therapy for their respective indications. FoundationOne CDx also reports genomic biomarkers, such as microsatellite instability (MSI) and tumor mutational burden (TMB), that can help inform the use of immunotherapies; genomic alterations in other genes relevant to patient management; and, relevant clinical trial information.

Based on previous CGP testing conducted by Foundation Medicine, it is estimated that approximately 1 in 3 patients across five common advanced cancers are expected to match with an FDA approved therapy.1 The number of matched on-label therapies indicated on FoundationOne CDx is expected to increase over time as Foundation Medicine and its biopharma partners pursue FDA approval for additional companion diagnostics on the platform. Today, approximately 50% of new cancer drugs in development are projected to have a companion biomarker.2

Concurrent with FDA approval, the Centers for Medicare and Medicaid Services (CMS) issued a preliminary National Coverage Determination (NCD) for FoundationOne CDx. The draft NCD would provide coverage for FDA-approved companion diagnostic claims, as well as a pathway for additional coverage with evidence development in other solid tumor types. The final policy is expected to issue during the first quarter of 2018 following public comment of the preliminary NCD and an administrative period.

"Today we know that many people with cancer do not receive biomarker testing, let alone the comprehensive genomic testing they need to be efficiently matched to the best therapeutic option," said Andrea Ferris, President and CEO of LUNGevity Foundation. "This FDA approval means that, in one test, patients can access therapies where companion diagnostics have been established for their cancer while getting a broad tumor profile that can identify the therapies and clinical trials they could most benefit from. Along with the preliminary national coverage determination, this has the potential to democratize next-generation sequencing, lowering the barriers for patients treated in the community to access these biomarker-driven treatments."

"Comprehensive genomic profiling is the gateway to precision medicine. This decision from the FDA and CMS, which may lead to coverage for Medicare patients, represents an important step forward in improving patient and clinician access to precision medicine – both in setting a new quality standard for this type of testing and offering potentially improved healthcare coverage," said Ankur R. Parikh, DO, Medical Director of Precision Medicine, Cancer Treatment Centers of America. "Access to important genomic information is a critical step in being able to offer innovative and targeted treatment options."

FoundationOne CDx results are delivered in an integrated report that identifies alterations matched to FDA approved therapies, identifies additional alterations in genes known to drive cancer growth, furnishes information about genomic biomarkers, including MSI and TMB, provides relevant clinical trial information, and includes interpretive content developed in accordance with professional guidelines in oncology for patients with any solid tumor.

"Today’s historic parallel review decision from the FDA and CMS represents a major advancement in personalized cancer care," said Troy Cox, chief executive officer at Foundation Medicine. "Physicians will have an FDA-approved test for all solid tumors in their toolkit that can inform targeted and immunotherapy selection, as well as identify patient opportunities for clinical trial participation. Beyond its implications for patient care, we expect that FoundationOne CDx will provide biopharma companies with an FDA-approved platform that can help accelerate drug development and enable personalized oncology care. On behalf of the Foundation Medicine team, I’d like to thank FDA and CMS for their leadership and collaboration as we continue to work through the parallel review process with a shared mission of transforming cancer care."

FoundationOne CDx is the first solid tumor comprehensive genomic profiling test reviewed by the FDA and CMS in their Parallel Review program. FDA approval was based on analytic validation and concordance studies with FDA-approved assays. FoundationOne CDx is expected to be commercially available following finalization of the NCD from CMS.

Conference Call and Webcast Details
Foundation Medicine will conduct a conference call to discuss FDA approval and the draft national coverage determination from CMS for FoundationOne CDx on Friday, December 1 at 8:30 a.m. ET. To access the conference call via phone, dial 1-877-270-2148 from the United States and Canada, or dial 1-412-902-6510 internationally, and for either number reference Foundation Medicine. Dial in approximately ten minutes prior to the start of the call. The live, listen-only webcast of the conference call may be accessed by visiting the investors section of the company’s website at investors.foundationmedicine.com. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the company’s website for two weeks following the call.

About FoundationOne CDx
FoundationOne CDx is a next generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens. The test is intended as a companion diagnostic to identify patients who may benefit from treatment with the targeted therapies listed below in accordance with the approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. The FoundationOne CDx assay is a single-site assay performed at Foundation Medicine, Inc.

EGFR exon 19 deletions and EGFR exon 21 L858R alterations, which may indicate efficacy of erlotinib, afatinib or gefitinib in patients with NSCLC.
EGFR exon 20 T790M alterations which may indicate efficacy of osimertinib in NSCLC patients
ALK rearrangements which may indicate efficacy of crizotinib, alectinib or certinib in NSCLC patients
BRAF V600E which may indicate efficacy of dabrafenib in combination with trametinib in NSCLC patients
BRAF V600E which may indicate efficacy of vemurafenib or dabrafenib in melanoma patients
BRAF V600E and V600K which may indicate efficacy of trametinib or cobimetinib in combination with vemurafenib in melanoma patients
ERBB2 (HER2) amplification which may indicate efficacy of trastuzumab, pertuzumab orado-trastuzumab-emtansine in patients with breast cancer
KRAS wild-type (absence of mutations in codons 12 and 13) which may indicate efficacy of cetuximab in patients with colorectal cancer
KRAS wild-type (absence of mutations in exons 2, 3 and 4) and NRAS wild-type (absence of mutations in exons 2, 3 and 4) which may indicate efficacy of panitumumab in patients with colorectal cancer
BRCA1/2 alterations which may indicate efficacy of rucaparib in patients with ovarian cancer
For more information about FoundationOne CDx, visit View Source

ABX196, a first-in-class iNKT agonist boosting the immune response in cancer

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

ABIVAX is currently developing ABX196, a state of the art immune enhancer candidate based on iNKT activation. This product is largely derived from the technology and exclusive patent rights transferred to ABIVAX by the Scripps Research Institute (La Jolla, CA), the University of Chicago (Chicago, IL) and the Brigham Young University (Salt Lake City, UT)

A phase I clinical trial in healthy volunteers has been completed and showed activation of iNKT cells. Based on these data, new immuno-oncology pre-clinical studies were conducted that demonstrated the potential of the product in oncology, in particular in turning tumors not responsive to anti-PD-1 (cold) to tumors responsive to anti-PD-1 (hot). As ABIVAX is focusing on the antiviral and anti-inflammatory therapeutic spaces and does not intend to play a role in the immune-oncology field, ABIVAX is seeking to out-license this interesting product candidate.

The characteristics of ABX196 are as follows:

ABX196 has been developed from a platform technology proprietary to ABIVAX that identifies "iNKT Agonists" that demonstrate immune enhancing effects in cancer models
ABX196 is a synthetic agonist (glycolipid) of iNKT (invariant Natural Killer T) cells, in a liposomal formulation
ABX196 is well characterized, with stability studies and full toxicity package (including non-human primate studies) conducted prior to the phase I clinical trial in healthy volunteers
Phase I showed ABX196 is well tolerated and triggered both humoral as well as iNKT immune responses in human volunteers
Pre-clinical data show that ABX196 enhances anti-tumoral activity when used alone and in combination with anti-PD-1 antibody, doxorubicin or sorafenib
ABX196 turns a cold (i.e. non-responding to anti-PD-1 antibody) tumor into a hot, responsive tumor in the mouse melanoma model, corresponding to an increase in survival time
ABX196 potentiates the anti-tumoral response to chemotherapy (doxorubicin) in the mouse melanoma model, corresponding to an increase in survival time
ABX196 controls tumor progression in an orthotopic hepatocellular cancer model in mice, again showing a prolongation of survival
In total, POC of anti-tumoral activities has been established in four preclinical cancer models
Easy-to-use liposome formulation, with scaled-up and controlled manufacturing
Strong IP protection and FTO: 5 patent families

On November 29, 2017 Daiichi Sankyo Company, Limited (Headquarters: Chuo-ku, Tokyo; hereafter, Daiichi Sankyo) reported that at a Board of Directors Meeting held today a resolution was passed for an absorption-type merger (hereafter, the merger) with its research subsidiary Asubio Pharma Co., Ltd. (Office location: Kobe-shi, Hyogo Prefecture; hereafter, Asubio), effective April 1, 2018, and an absorption-type merger agreement dated today was concluded (Press release, Daiichi Sankyo, NOV 29, 2017, View Source [SID1234522308]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As the merger is a simplified absorption-type merger with a wholly owned subsidiary company, some items and details are omitted in its disclosure.

1. Purpose of merger
Asubio mainly focuses on psychiatric and neurological diseases, immune and inflammatory diseases and regenerative medicine, conducting research based on its position as a drug discovery venture within the Daiichi Sankyo Group.
Daiichi Sankyo expects the integration of the venture spirit of Asubio into other research activities of Daiichi Sankyo to contribute to improving R&D productivity.

2. Summary of merger
(1) Merger schedule
Date of Board of Directors resolution (Asubio) November 29, 2017
Date of Board of Directors resolution (Daiichi Sankyo) November 30, 2017
Date of conclusion of merger agreement November 30, 2017
Date of merger (effective date) April 1, 2018
Note: For Daiichi Sankyo the merger is a simplified merger as stipulated in Article 796, Paragraph 2 of the Companies Act and for Asubio it is a short form merger as stipulated in Article 784, Paragraph 1 of the Companies Act. Therefore, neither company will hold a general shareholders meeting to approve the merger agreement.

(2) Form of merger
The form of the merger is an absorption-type merger with Daiichi Sankyo as the surviving company; Asubio will be dissolved.

(3) Allocations with merger
Since Asubio is a wholly owned consolidated subsidiary of Daiichi Sankyo, there will be no issuance of new shares or cash allocation with the merger.

(4) Handling of subscription rights to shares and bonds with subscription rights to shares of extinct company
Asubio has not issued any subscription rights to shares or bonds with subscription rights to shares.

3. Outline of merging companies
[Surviving company]
(1) Company name
Daiichi Sankyo Company, Limited
(2) Headquarters location
3-5-1, Nihonbashi Honcho, Chuo-ku, Tokyo, Japan
(3) Representative
Sunao Manabe, Representative Director, President and COO
(4) Type of business
Research & development, manufacture, sales, and marketing of pharmaceutical products, etc.
(5) Paid-in capital
50 billion yen
(6) Foundation date
September 28, 2005
(7) Number of ordinary shares issued
709,011,343
(8) Settlement of accounts
March 31
(9) Primary shareholders and percent of shares held (As of September, 2017)
・ The Master Trust Bank of Japan, Ltd. (trust account): 7.95%
・ Japan Trustee Services Bank, Ltd. (trust account): 6.80%
・ Nippon Life Insurance Company: 5.05%
・ JP MORGAN CHASE BANK 380055: 2.26%
・ Trust & Custody Services Bank, Ltd. as trustee for Mizuho Bank, Ltd. Retirement Benefit Trust Account re-entrusted by Mizuho Trust & Banking Co., Ltd.: 2.03%
(10) Financial position and operating results for immediately preceding business year (ending March, 2017) Japanese accounting standards
Net assets
888,519
million yen
Total assets
1,463,461
million yen
Net assets per share
1,336.57
yen
Revenue
629,151
million yen
Operating income
18,483
million yen
Ordinary income
40,976
million yen
Net income
10,479
million yen
Net income per share
15.61
yen

[Extinct company]
(1) Company name
Asubio Pharma Co., Ltd.
(2) Office location
6-4-3 Minatojima-minamimachi, Chuo-ku, Kobe-shi, Hyogo Prefecture, Japan
(3) Representative
Yoshiharu Minamitake, President & CEO
(4) Type of business
Entrusted research & development of pharmaceuticals, etc.
(5) Paid-in capital
50 million yen
(6) Foundation date
October 16, 2009
(7) Number of ordinary shares issued
1,000
(8) Settlement of accounts
March 31
(9) Principal shareholders, percent of shares held
Daiichi Sankyo Company, Ltd.; 100%
(10)Financial position and operating results for immediately preceding business year (ending March 2017) Japanese accounting standards
Net assets
417
million yen
Total assets
5,753
million yen
Net assets per share
417,792.94
yen
Revenue
8,153
million yen
Operating income
2,870
million yen
Ordinary income
2,870
million yen
Net loss
32
million yen
Net loss per share
32,248.23
yen

4. Situation after merger
Asubio’s office and base of operations in Kobe will be closed and Daiichi Sankyo will take over its business and functions. There will be no change to Daiichi Sankyo’s company name, headquarters location, name and title of representative, type of business, paid-in capital or accounts settlement date with the merger.

5. Expected effect of merger on results
As the merger is with a wholly owned subsidiary, it will have a marginal effect on Daiichi Sankyo’s consolidated results.