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June 21, 2017: Genentech issued new European patent [EP3181564 (A1)]

NEWS BITES - PRIVATE COMPANIES

Genentech has been issued a new European patent titled "AMINOPYRIMIDINE COMPOUNDS AS INHIBITORS OF T790M CONTAINING EGFR MUTANTS" by the European Patent Office.

ABSTRACT

This invention relates to novel compounds of formula (I) which are inhibitors of T790M containing EGFR mutants, to pharmaceutical compositions containing them, to processes for their preparation, and to their use in therapy for the prevention or treatment of cancer.

Appl. No.EP20170152475

Source: European Patent Office

INDEX

SECTION 1 GENENTECH ACTIVITIES

SECTION 2 GENENTECH PROFILE

SECTION 3 GENENTECH TOP MANAGEMENT

SECTION 4 GENENTECH PATENTS

SECTION 5 BUSINESS NEWS ROUND UP

SECTION 1 GENENTECH 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.

SECTION 2 GENENTECH PROFILE

PermID: 4295912132

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

Industry: Biotechnology

Address:

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

SECTION 3 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

SECTION 4 GENENTECH PATENTS

PREVIOUS 10 PATENT STORIES:

Issue DateIssuing OfficePatent TitlePatent Number
Jun 20, 2017US PTODiagnosis and treatments relating to TH2 inhibition9,684,000
Jun 20, 2017US PTOMethods for treating progressive multiple sclerosis9,683,047
Jun 20, 2017US PTOCombinations of AKT and MEK inhibitor compounds, and methods of use9,682,082
Jun 13, 2017US PTOHumanized anti-factor D antibodies and uses thereof9,676,868
Jun 13, 2017US PTOAnti-TAT226 antibodies and immunoconjugates9,675,707
Jun 13, 2017US PTOEstrogen receptor modulator for the treatment of locally advanced or metastatic estrogen receptor positive breast cancer9,675,586
Jun 6, 2017US PTOBenzoxazepin PI3K inhibitor compounds and methods of use9,670,228
May 31, 2017EPOANTI-VEGF ANTIBODIESEP3173425 (A1)
May 30, 2017US PTOMethods of treating liver conditions using Notch2 antagonists9,663,573
May 30, 2017US PTOCompositions and methods useful for stabilizing protein-containing formulations9,662,395

SECTION 5 BUSINESS NEWS ROUND UP

October 04, 2016: Genentech;FDA Grants Breakthrough Therapy Designation for Genentech's Actemra (Tocilizumab) in Giant Cell Arteritis, a Form of Vasculitis

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation status to Actemra(Registered) (tocilizumab) for giant cell arteritis (GCA), a chronic, potentially life-threatening autoimmune condition. The disease is caused by inflammation of large and medium-sized arteries, most often in the head, but also in the aorta and its branches.1

"The FDA Breakthrough Therapy Designation for GCA underscores our continued commitment to explore Actemra in autoimmune diseases with significant unmet need," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "We are looking forward to working with the FDA in the hope of making Actemra available to people with GCA, a condition for which there has been no approved treatment in more than 50 years."

Breakthrough designation is intended to expedite the development and review of medicines with early evidence of potential clinical benefit in serious diseases and to help ensure that patients receive access to medicines as soon as possible. This is the fourteenth Breakthrough Therapy Designation granted to Genentech since 2013, and the second for Actemra.

In June of this year, Genentech announced the positive outcome of the Phase III GiACTA study evaluating Actemra in people with GCA. Results showed that Actemra, initially combined with a six-month steroid (glucocorticoid) regimen, more effectively sustained remission through one year compared to a six- or 12-month steroid-only regimen in people with GCA. Full data will be presented at an upcoming medical meeting in 2016.

Source: Company Website

October 03, 2016: Genentech;FDA Grants Breakthrough Therapy Designation for Genentech's Alecensa(Registered) (Alectinib) for First-Line Treatment of People with ALK-Positive NSCLC

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that it has received a second Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for its anaplastic lymphoma kinase (ALK) inhibitor, Alecensa (alectinib). The latest BTD was granted for the treatment of adult patients with advanced ALK-positive non-small cell lung cancer (NSCLC) who have not received prior treatment with an ALK inhibitor.

"The J-ALEX study that supports the second Breakthrough Designation for Alecensa showed superior efficacy versus the standard of care, crizotinib, in Japanese people with advanced ALK-positive disease," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "The decision by the FDA to grant a second Breakthrough Therapy Designation is recognition of the clinically meaningful improvement in efficacy and safety that Alecensa brings to the care of people with advanced ALK-positive lung cancer who have not received prior treatment with an ALK inhibitor."

The FDA's Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious diseases and to help ensure patients have access to them through FDA approval as soon as possible. Alecensa received its first FDA BTD in June 2013 for people with ALK-positive NSCLC whose disease progressed on treatment with crizotinib.

Alecensa was granted accelerated approval by the FDA in December 2015 for the treatment of people with ALK-positive NSCLC who have progressed on or are intolerant to crizotinib. ALEX, a global, randomized Phase III study, is ongoing, comparing Alecensa to crizotinib as an initial (first-line) treatment for people with advanced NSCLC whose tumors were characterized as ALK-positive by a companion VENTANA ALK (D5F3) CDx Assay immunohistochemistry (IHC) test developed by Roche Tissue Diagnostics. This study is part of the company's commitment to convert the current accelerated approval in people with ALK-positive, metastatic NSCLC who have progressed on or are intolerant to crizotinib to a full approval as an initial treatment.

Source: Company Website

July 17, 2016: Genentech Provides Update on Phase III Study of Gazyva(Registered) in People with Previously Untreated Diffuse Large B-Cell Lymphoma

[Company Release]

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III GOYA study evaluating Gazyva(Registered) (obinutuzumab) plus CHOP chemotherapy (G-CHOP) in people with previously untreated diffuse large B-cell lymphoma (DLBCL) did not meet its primary endpoint of significantly reducing the risk of disease worsening or death (progression-free survival; PFS) compared to Rituxan(Registered) (rituximab) plus CHOP chemotherapy (R-CHOP). Adverse events with Gazyva and Rituxan were consistent with those seen in previous clinical trials when each was combined with various chemotherapies. Data from the GOYA study will be presented at an upcoming medical meeting.

"Two previous studies showed Gazyva helped people with previously untreated follicular lymphoma or chronic lymphocytic leukemia live longer without their disease worsening compared to Rituxan, when each was combined with chemotherapy. We were hopeful we could show a similar result for people with diffuse large B-cell lymphoma and once again improve on the standard of care," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "We will continue to analyze the GOYA data to better understand the results, and to study other investigational treatments in this disease with the goal of further helping these patients."

Source: Company Website

July 07, 2016: FDA Approves Genentech's Xolair(Registered) (omalizumab) for Allergic Asthma in Children

[Company Release] Approval makes Xolair the only biologic for children ages six and up with uncontrolled allergic asthma Asthma is one of the most common long-term diseases in children1, affecting about 6.3 million people younger than 18 in the U.S.2 More than 200,000 allergic asthma patients have been treated with Xolair since its approval in 2003 for people 12 years and older3

South San Francisco, CA -- July 7, 2016 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved Xolair(Registered) (omalizumab) to treat moderate to severe persistent asthma in children six to 11 years of age who have had a positive skin test or in vitro reactivity to an airborne allergen and have symptoms that are inadequately controlled with inhaled corticosteroids4. Xolair is already approved to treat people 12 years and older with allergic asthma.

"Despite our best efforts to control symptoms with inhaled corticosteroids and other medicines, allergic asthma remains a serious problem for many children," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "With this approval, we're pleased to see a proven treatment option is now available for appropriate patients six and older."

Asthma is one of the most common long-term diseases in children1. It affects about 6.3 million people under 18 or one in 12 children in the U.S 2. An estimated 24 million people in the U.S. have asthma. Of this patient population, approximately 60 percent have allergic asthma5. The American Academy of Pediatrics estimates that between 70 and 80 percent of school-aged children with asthma also have allergies, which are among the most common triggers for asthma6.

"Uncontrolled allergic asthma can significantly affect the lives of children," said Cary Sennett, M.D., PhD, president and chief executive officer of the Asthma and Allergy Foundation of America (AAFA). "This approval helps to address an important unmet need for children older than six and their parents or caregivers."

Xolair was first approved in 2003 to treat adults and children 12 years of age and older with moderate to severe persistent allergic asthma not controlled by inhaled steroids. Since its U.S. approval, more than 200,000 patients older than 12 with allergic asthma have been treated with the medicine3. Xolair is not indicated for the treatment of other allergic conditions, acute bronchospasm (serious and sudden breathing problems) or status asthmaticus (acute, severe, prolonged asthma attack that can be life-threatening).

The latest approval is supported by multi-center, randomized, double-blind, placebo-controlled Phase III studies that assessed the efficacy and safety of Xolair in children from six to 11 years old with moderate to severe persistent uncontrolled allergic asthma. The primary study was a 52-week trial, with the primary endpoint measured at 24 weeks4. Supportive safety and efficacy data come from a 28-week study4. Additional safety data come from a five-year non-randomized observational post-marketing study to evaluate the long-term safety of Xolair in patients 12 years and older 7.

Efficacy and Safety Findings

The 52-week study evaluated the safety and efficacy of Xolair as an add-on therapy in children from six to 11 years old with moderate to severe allergic asthma who were inadequately controlled despite the use of inhaled corticosteroids with or without the use of other controller asthma medications. During the first 24 weeks of treatment, steroid doses remained constant from baseline. This was followed by a 28-week period during which inhaled corticosteroid adjustment was allowed. The primary efficacy variable in this study was the rate of asthma exacerbations during the 24-week, fixed steroid treatment phase. An asthma exacerbation was defined as a worsening of asthma symptoms as judged clinically by the investigator, requiring doubling of the baseline inhaled corticosteroid dose for at least three days and/or treatment with rescue systemic corticosteroids for at least three days4.

At 24 weeks, the Xolair treatment group had a statistically significantly lower rate of asthma exacerbations compared to the placebo treatment group (0.45 vs. 0.64, respectively), representing a 31 percent relative rate reduction (rate ratio 0.69, 95 percent CI (0.53, 0.90) p=0.007)4. During the entire 52-week treatment period, the difference in asthma exacerbation rates between the Xolair and placebo treatment groups (0.78 vs. 1.36, respectively) represented a 43 percent relative rate reduction (rate ratio 0.57, 95 percent CI (0.45, 0.72) p<0.001)4.

In clinical studies with pediatric patients six to 11 years old, the most common side effects (≥3 percent in Xolair-treated patients and more frequent than placebo) were common cold symptoms (nasopharyngitis), headache, fever (pyrexia), upper abdominal pain, sore throat (pharyngitis streptococcal), ear discomfort (otitis media), intestinal infection causing abdominal pain, nausea and vomiting (viral gastroenteritis), insect bites (arthropod bites) and nose bleeding (epistaxis)4.

In the U.S., Genentech, Inc. and Novartis Pharmaceuticals Corporation work together to develop and co-promote Xolair.

Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets innovative medicines aimed at improving patients' lives.

Source: Company Website

July 01, 2016: Genentech Announces Definitive Agreement to Acquire Seragon Pharmaceuticals

[Company Release]

Biologics License Application (BLA) acceptance follows European Medicines Agency's (EMA's) validation of the Marketing Authorization Application (MAA) for OCREVUS in relapsing and primary progressive multiple sclerosis (MS) OCREVUS is the first investigational medicine seeking marketing authorization for both relapsing and primary progressive forms of MS

South San Francisco, CA -- June 27, 2016 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) accepted for review the company's Biologics License Application (BLA) for OCREVUS(TradeMark) (ocrelizumab) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), and granted the application Priority Review Designation with a targeted action date of December 28, 2016.

The OCREVUS Marketing Authorization Application (MAA) has also been validated by the European Medicines Agency (EMA). If approved by the FDA and EMA for both indications, OCREVUS would be the first and only treatment indicated for both forms of MS, which affect approximately 95 percent of people at diagnosis.

"OCREVUS is the first investigational medicine to significantly reduce disability progression in people with relapsing and primary progressive forms of MS," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "We are pleased by the FDA's decision to classify their review of the BLA as priority because we believe OCREVUS has the potential to help people living with either of these two forms of MS. We will continue to work closely with the FDA and EMA to bring this investigational medicine to people with MS as quickly as possible."

Priority Review Designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the safety and effectiveness of the treatment of a serious disease. In February 2016, the FDA granted Breakthrough Therapy Designation to OCREVUS for the treatment of PPMS. OCREVUS is the first investigational medicine to receive Breakthrough Therapy Designation in MS.

The OCREVUS marketing applications are based on positive results from three Phase III studies, which met primary and key secondary endpoints. Data from two identical studies (OPERA I and OPERA II) in people with RMS showed superior efficacy of OCREVUS in reducing annualized relapse rates and disability progression sustained for at least three and for at least six months compared with Rebif(Registered) (interferon beta-1a). Data from the ORATORIO study in people with PPMS showed significant reductions in disability progression sustained for at least three and for at least six months, as well as in as other measures of progressive disease compared with placebo. Overall safety (proportion of patients with adverse events and serious adverse events) of OCREVUS in the Phase III studies was similar to interferon beta-1a in the RMS studies and to placebo in the PPMS study. The most common adverse events associated with OCREVUS were infusion-related reactions and infections, which were mostly mild to moderate in severity.

OCREVUS(TradeMark) is the proprietary name submitted to U.S. Food and Drug Administration (FDA) for the investigational medicine ocrelizumab.

Source: Company Website

PermID: 4295912132

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