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May 22, 2018: Genentech issued new U.S. patent [9,975,957]

NEWS BITES - PRIVATE COMPANIES

Genentech has been issued a new U.S. patent titled "Anti-OX40 antibodies and methods of use" by the US Patent and Trademark Office.

ABSTRACT

The invention provides anti-OX40 antibodies and methods of using the same.

Appl. No.14/673,792

INDEX

SECTION 1 GENENTECH PROFILE

SECTION 2 PRESS RELEASES: 2018

SECTION 3 OTHER NEWS: 2018

SECTION 4 GENENTECH PATENTS

SECTION 5 GENENTECH TOP MANAGEMENT

SECTION 1 GENENTECH PROFILE

1.1 ACTIVITIES

Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. We are among the world's leading biotech companies, with multiple products on the market and a promising development pipeline.

1.2 SUMMARY

PermID: 4295912132

Website: http://www.gene.com/

Industry: Biotechnology

Address:

1 DNA Way Mailstop 258A South San Francisco, CA 94080-4990 United States

SECTION 2 PRESS RELEASES: 2018

May 07: Genentech to Present New Data From Its Industry-Leading Oncology Portfolio at The 2018 American Society of Clinical Oncology (ASCO) Annual Meeting

New and updated pivotal combination data from the Tecentriq lung program, including overall survival results from IMpower150 and progression-free survival results from IMpower131

New, longer follow-up data from the Phase III ALEX study of Alecensa in ALK-positive lung cancer

Pivotal data from the hematology clinical development program, including new data for Venclexta and polatuzumab

South San Francisco, CA -- May 7, 2018 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that new data from early and late-stage clinical studies on more than 19 approved and investigational cancer medicines, will be presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from June 1-5 in Chicago. More than 90 abstracts have been accepted across 13 cancer types, including two 'late breakers' and 15 oral presentations.

'New data to be presented from our industry-leading oncology portfolio, including lung and hematology programs, will demonstrate how our science-driven approach aims to improve outcomes for people living with cancer,' said Sandra Horning, M.D., chief medical officer and head of Global Product Development. 'At ASCO, we look forward to sharing our progress and commitment to build the future of personalized healthcare in oncology.'

Key presentations in lung cancer

Key data to be presented at ASCO cover advances from Genentech's lung cancer program, including a combination approach using the cancer immunotherapy Tecentriq (atezolizumab) with targeted therapies and a range of different chemotherapies.

Updated overall survival (OS) data and new patient-reported outcomes (PROs) data from the Phase III IMpower150 study of Tecentriq plus Avastin (bevacizumab) and chemotherapy (carboplatin and paclitaxel) in people with previously-untreated, metastatic non-squamous non-small cell lung cancer (NSCLC), will be presented.

SECTION 3 OTHER NEWS: 2018

May 20: Genentech's HEMLIBRA (emicizumab-kxwh) Reduced Treated Bleeds by 96 Percent Compared to No Prophylaxis in Phase III Haven 3 Study in Hemophilia A Without Factor VIII Inhibitors

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today full results from the Phase III HAVEN 3 study evaluating HEMLIBRA(Registered) (emicizumab-kxwh) prophylaxis administered every week or every two weeks in people with hemophilia A without factor VIII inhibitors and the Phase III HAVEN 4 study evaluating HEMLIBRA prophylaxis administered every four weeks in people with hemophilia A with or without factor VIII inhibitors. Data from both pivotal studies were presented today as late-breaking abstracts at the World Federation of Hemophilia (WFH) 2018 World Congress in Glasgow, Scotland.

"HEMLIBRA is the first medicine to show superior efficacy to prior factor VIII prophylaxis, the current standard of care therapy, as demonstrated by a statistically significant reduction in treated bleeds in the HAVEN 3 study intra-patient comparison," said Johnny Mahlangu, Faculty of Health Sciences, University of the Witwatersrand and NHLS, Johannesburg, South Africa. "Even with current prophylactic treatments, many people with hemophilia A continue to have bleeds that can lead to long-term joint damage, and there is a need for more treatment options."

"These new pivotal data show that HEMLIBRA controlled bleeds in people with hemophilia A, while offering the flexibility of less frequent subcutaneous dosing options," said Sandra Horning, M.D., chief medical officer and head of Global Product Development.

May 14: Genentech: FDA Approves Subcutaneous Formulation of Actemra for use in Active Polyarticular Juvenile Idiopathic Arthritis (PJIA), a Rare Form of Juvenile Arthritis

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved the subcutaneous (SC) formulation of Actemra(Registered) (tocilizumab) for the treatment of active polyarticular juvenile idiopathic arthritis (PJIA) in patients two years of age and older. Actemra can be given alone or in combination with methotrexate (MTX) in patients with PJIA. In 2013, FDA approved the intravenous (IV) formulation of Actemra for patients two years of age and older with active PJIA.

PJIA is a form of juvenile idiopathic arthritis (JIA), a chronic disease of childhood.1 JIA affects approximately 100 in every 100,000 children,2 of which PJIA accounts for around 30 percent.3 PJIA is characterized by inflammation in five or more joints within the first six months of the disease and most commonly affects the small joints in the body such as the hands and feet.3

"Polyarticular juvenile idiopathic arthritis is a rare, often painful disease in children," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "With this approval, we are pleased Actemra offers an alternative delivery option to physicians and parents of children aged two or older to treat this debilitating disease."

In general, the safety observed for Actemra administered subcutaneously was consistent with the known safety profile of Actemra IV, with the exception of injection site reactions (ISRs) and neutropenia (low white blood cell count).

May 13: Genentech to Present New Phase III Data for HEMLIBRA (emicizumab-kxwh) in People With Hemophilia A at the World Federation of Hemophilia 2018 World Congress

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that Phase III results for HEMLIBRA(Registered) (emicizumab-kxwh) will be presented for the first time during the World Federation of Hemophilia (WFH) 2018 World Congress from May 20-24 in Glasgow, Scotland. The late-breaking presentations include positive results from the pivotal HAVEN 3 study of HEMLIBRA dosed every week or every two weeks in people with hemophilia A without factor VIII inhibitors and the pivotal HAVEN 4 study of HEMLIBRA dosed every four weeks in people with hemophilia A with or without factor VIII inhibitors. These data support the promising potential of HEMLIBRA for all people with hemophilia A.

"We look forward to sharing these new results from the HAVEN 3 and HAVEN 4 studies, which demonstrate the potential of HEMLIBRA to redefine treatment expectations for people with hemophilia A with and without inhibitors to factor VIII," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "We will also be sharing real-world data that provides new insight into the impact of hemophilia A treatment on daily life, as part of our ongoing commitment to advancing management and care for the global hemophilia community."

Data from the HAVEN 3 and HAVEN 4 studies will be presented for the first time in late-breaking oral presentations on Monday, May 21.

May 09: Genentech Provides Update on Phase III Study Of TECENTRIQ (Atezolizumab) and COTELLIC (Cobimetinib) in People With Heavily Pre-Treated Locally Advanced or Metastatic Colorectal Cancer

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMblaze370 study evaluating the combination of TECENTRIQ(Registered) (atezolizumab) and COTELLIC (Registered) (cobimetinib) did not meet its primary endpoint of overall survival (OS) compared to regorafenib. The study evaluated the combination in people with difficult-to-treat, locally advanced or metastatic colorectal cancer (CRC) whose disease progressed or who were intolerant to at least two systemic chemotherapy regimens.

More than 95 percent of patients in IMblaze370 have microsatellite stable (MSS) tumors and based on the available data, checkpoint inhibitors as monotherapy have not demonstrated clinically meaningful efficacy in MSS mCRC. The results from IMblaze370 were consistent with this prior monotherapy experience, showing that treatment with TECENTRIQ alone did not provide a meaningful clinical benefit compared to regorafenib in this patient population.

Safety for the combination of TECENTRIQ and COTELLIC appeared to be consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination. The results from IMblaze370 will be further examined and presented at an upcoming medical meeting.

"While these results are not what we hoped for, we remain committed to applying our deep experience to develop medicines that will improve outcomes for people living with gastrointestinal cancers," said Sandra Horning, M.D., chief medical officer and head of Global Product Development.

SECTION 4 GENENTECH PATENTS

4.1 Number of Patents Issued to Genentech (Past 12 Months)

There were a total of 105 patents issued to Genentech in the past 12 months. The highest number (18) were issued in January, 2018.

MonthsNo. of Patents Issued
May8
April10
March9
February7
January18
December7
November7
October7
September7
August8
July6
June11
Total (Past 12 Months)105

4.2 Patents issued by the US PTO and the EPO on same inventions

In the past 24 months the following 2 patents were issued by the USPTO and the European Patent Office (EPO) to Genentech.

TitleUS PTOEPO
Aminopyrimidine Compounds As Inhibitors Of T790m Containing Egfr Mutants9,890,152; 13 Feb, 2018EP3181564 (A1); 21 Jun, 2017
Anti-Vegf Antibodies9,777,059; 03 Oct, 2017EP3173425 (A1); 31 May, 2017

4.3 Previous 10 GENENTECH Patent titles:

Issue DateIssuing OfficePatent TitlePatent Number
May 22, 2018US PTOProcess for the preparation of (E)-3-(4-((E)-2-(2-chloro-4-fluorophenyl)-1-(1H-indazol-5-yl)but-1-en-1-y- l)phenyl)acrylic acid9,975,856
May 22, 2018US PTONSP4 inhibitors and methods of use9,975,963
May 22, 2018US PTOAnti-CD79b antibodies and methods of use9,975,949
May 15, 2018US PTOSubcutaneous anti-HER2 antibody formulations and uses thereof9,968,676
May 15, 2018US PTOProcess for making tricyclic lactam compounds9,969,735
May 15, 2018US PTOTetrahydroisoquinoline estrogen receptor modulators and uses thereof9,969,732
May 15, 2018US PTOProcess for producing optically active 2-alkyl-1,1,3-trialkoxycarbonylpropane9,970,043
May 15, 2018US PTOPertuzumab variants and evaluation thereof9,969,811
May 8, 2018US PTOOxepan-2-yl-pyrazol-4-yl-heterocyclyl-carboxamide compounds and methods of use9,963,446
May 8, 2018US PTOIsoform specific anti-HER4 antibodies9,963,517

4.4 Previous 5 GENENTECH Patent abstracts:

May 22, 2018 Genentech issued new U.S. patent [9,975,856]

ABSTRACT

Processes are described for the preparation of estrogen receptor modulating compound, (E)-3-(4-((E)-2-(2-chloro-4-fluorophenyl)-1-(1H-indazol-5-yl)but-1-en-1-y- l)phenyl)acrylic acid I: ##STR00001## and salts thereof, and intermediates useful for the preparation of I.

May 22, 2018 Genentech issued new U.S. patent [9,975,963]

ABSTRACT

The invention provides NSP4 inhibitors (such as anti-NSP4 antibodies) and methods of using the same.

May 22, 2018 Genentech issued new U.S. patent [9,975,949]

ABSTRACT

The invention provides anti-CD79b antibodies and methods of using the same.

May 15, 2018 Genentech issued new U.S. patent [9,968,676]

ABSTRACT

The present invention relates to a highly concentrated, stable pharmaceutical formulation of a pharmaceutically active anti-HER2 antibody, such as e.g. Trastuzumab (HERCEPTIN.TM.), Pertuzumab or T-DM1, or a mixture of such antibody molecules for subcutaneous injection. In particular, the present invention relates to formulations comprising, in addition to a suitable amount of the anti-HER2 antibody, an effective amount of at least one hyaluronidase enzyme as a combined formulation or for use in form of a co-formulation. The formulations comprise additionally at least one buffering agent, such as e.g. a histidine buffer, a stabilizer or a mixture of two or more stabilizers (e.g. a saccharide, such as e.g. .alpha.,.alpha.-trehalose dihydrate or sucrose, and optionally methionine as a second stabilizer), a nonionic surfactant and an effective amount of at least one hyaluronidase enzyme. Methods for preparing such formulations and their uses thereof are also provided.

May 15, 2018 Genentech issued new U.S. patent [9,969,735]

ABSTRACT

Processes are described for the preparation of tricyclic lactam compound of Formula (I), having the structure and intermediates useful for the preparation of (I). ##STR00001##

SECTION 5 GENENTECH TOP MANAGEMENT

Ian T. Clark, CEO & Director

Severin Schwan, Chairman

Ed Harrington, CFO

Andre Hoffmann, Director

Richard P. Lifton, Director

Alan Hippe, Director

Daniel O''Day, Director

John Irving Bell, Director

Frederick C. Kentz, III, Company Secretary & Senior Vice President

PermID: 4295912132

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