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Roche delivers strong performance in the first half of 2016

On July 21, 2016 Roche reported continued growth in the first half of 2016 (Press release, Hoffmann-La Roche , JUL 21, 2016, View Source [SID:1234513980]).

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Group sales increased by 5%1 at constant exchange rates, 6% in Swiss francs

Pharmaceuticals Division sales up 4%, driven by oncology and immunology medicines

Diagnostics Division sales grew 6%, driven primarily by immunodiagnostic products; challenging market conditions in Diabetes Care

Core earnings per share grew slightly faster than sales at 5% at constant exchange rates, 7% in Swiss francs

OCREVUS filed in US and EU for relapsing and primary progressive forms of multiple sclerosis; FDA granted priority review

Cancer immunotherapy medicine Tecentriq received accelerated FDA approval in bladder cancer in the US

cobas e801 immunodiagnostic module launched for high-volume testing

Outlook for 2016 confirmed

Key figures January – June
In millions of CHF % change
2016
2015
CER1
CHF

Group sales
25,022
23,585
+5
+6

Pharmaceuticals Division
19,460
18,350
+4
+6

Diagnostics Division
5,562
5,235
+6
+6

Core operating profit
9,854
9,236
+5
+7

Core EPS-diluted (CHF)
7.74
7.22
+5
+7

IFRS net income
5,467
5,249
+3
+4

Commenting on the Group’s results, Roche CEO Severin Schwan said: "In the first half of the year, both our Pharmaceuticals and Diagnostics Divisions showed good growth across all regions. The launch of our first cancer immunotherapy medicine Tecentriq is off to a strong start. We also completed the US and EU filings of OCREVUS, which brings us an important step closer toward launching this promising multiple sclerosis medicine. Based on our half year performance, I am confident that we will meet our full-year targets for 2016."

Group
Strong performance in both divisions
In the first half of 2016, Group sales rose 4.8% at constant exchange rates to CHF 25.0 billion. Core EPS grew 5.2% at constant exchange rates, slightly faster than sales. Core EPS growth reflects the good underlying business performance, investments into the launch of new products and the product pipeline, the one-off accounting impact of changes to the Group’s Swiss pension plans, as well as an early bond redemption.

IFRS net income was up 3% at constant exchange rates and 4% in Swiss francs. The positive currency effect was driven by the weakening of the Swiss franc against the US dollar, the yen and the euro, partly offset by a strengthening of Latin American currencies.

Sales in the Pharmaceuticals Division were up 4% to CHF 19.5 billion, driven by demand for oncology and immunology medicines. Sales in the US increased 4%, led by immunology treatments Xolair and Esbriet, as well as Herceptin and Perjeta against HER2-positive breast cancer. There was high demand for Alecensa, which was recently launched in the US for a specific type of lung cancer. Sales of Lucentis and Tarceva declined due to the continued impact of competition. In Europe (+5%), Perjeta, MabThera/Rituxan and Actemra/RoActemra recorded strong sales growth, especially in Germany and France. In the International region (+4%), growth was driven by HER2 medicines, Avastin and MabThera/Rituxan. This growth was partly offset by lower Pegasys sales due to competition from a new generation of hepatitis C treatments. In Japan, sales rose 2% driven by HER2 medicines, Alecensa and Actemra/RoActemra.

Sales in the Diagnostics Division grew 6% to CHF 5.6 billion. All regions contributed to this growth, particularly Asia-Pacific (+17%). Professional and Tissue Diagnostics grew strongly. Diabetes Care sales were impacted by continued challenging market conditions, especially in North America.

Regulatory approvals
In the second quarter, Roche achieved several key regulatory milestones. In April, Venclexta (venetoclax) received accelerated approval in the US for a specific form of leukemia. This medicine was jointly developed with AbbVie. In May, the FDA granted cancer immunotherapy Tecentriq (atezolizumab) accelerated approval in the US for a specific type of bladder cancer. Also in May, the subcutaneous formulation of MabThera/Rituxan received approval in the EU for people with chronic lymphocytic leukaemia. In June, the European Commission approved Gazyva/Gazyvaro plus bendamustine for the second-line treatment of follicular lymphoma. The EU authorities also approved the combination of Avastin and Tarceva for the treatment of people with a specific type of lung cancer.

Strong Pharma pipeline
Roche made significant progress in late-stage development. In June, the European Medicines Agency (EMA) and the FDA confirmed that the data submission for OCREVUS (ocrelizumab) is complete, and the marketing applications for both relapsing and progressive multiple sclerosis are being reviewed. In addition, the FDA granted priority review for the US application with an action date of 28 December 2016.

In the same month, the largest clinical trial ever conducted in giant cell arteritis (GCA), a serious inflammatory disease of blood vessels, showed positive results. Initially combined with a six-month steroid regimen, Actemra/RoActemra more effectively sustained remission through one year compared to a 6- or 12-month steroid-only regimen in people with newly diagnosed and relapsing GCA.

At the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in June, Roche presented an updated clinical analysis for Tecentriq in previously treated lung cancer. Overall survival benefit was seen regardless of Programmed Death-Ligand 1 (PD-L1) expression compared to chemotherapy. In addition, Roche shared encouraging results from clinical trials with Tecentriq in combination with chemotherapy, targeted anti-cancer medicines and other cancer immunotherapy agents in several tumour types.
In May, a phase III study (J-ALEX) by Chugai found that Alecensa significantly reduced the risk of disease worsening or death compared to crizotinib. This trial in a Japanese patient population with advanced or recurrent ALK-positive non-small cell lung cancer was stopped early after a pre-planned interim analysis.

Roche recently provided an update on the phase III study of Gazyva/Gazyvaro in previously untreated diffuse large B-cell lymphoma (GOYA). The study did not meet its primary goal of extending the time patients live without their disease advancing. In May, another phase III study of Gazyva/Gazyvaro (GALLIUM) was stopped early after a pre-planned interim analysis showed positive results in the first-line treatment of follicular lymphoma. In both studies, Gazyva/Gazyvaro plus chemotherapy was tested head-to-head with MabThera/Rituxan combined with chemotherapy. The GALLIUM data will be submitted to health authorities for approval consideration. Gazyva/Gazyvaro is already approved for previously treated follicular lymphoma.

Portfolio progress in Diagnostics
In May, Roche launched the CoaguChek INRange, the first Bluetooth enabled home device, allowing patients and their healthcare providers greater control over their coagulation status. In June, Roche launched the cobas e801 module in countries accepting the CE Mark. As part of the cobas 8000 analyzer, this module provides increased immunochemistry testing capacity and an extensive test menu to laboratories with high testing volumes. Also in June, the cobas liquid biopsy test for the detection of specific mutations of the epidermal growth factor receptor (EGFR) gene became the first FDA approved liquid biopsy test. It can support therapy guidance in non-small cell lung cancer (NSCLC) via the analysis of a simple blood sample; and it complements the existing tissue-based EGFR test.

Lead cancer immunotherapy candidate granted EU orphan drug designations

On July 20, 2016 Cell Medica, a leader in developing, marketing and manufacturing cellular therapeutics for cancer and viral infections, reported it has received European Commission orphan drug designations for CMD-003 (baltaleucel-T) as a treatment for extranodal NK/T-cell lymphoma, nasal type, and post-transplant lymphoproliferative disorder (Press release, Cell Medica, JUL 20, 2016, View Source [SID:1234513977]).

CMD-003 is comprised of the patient’s immune cells which have been activated to kill malignant cells expressing antigens associated with the oncogenic Epstein Barr virus (EBV). The product has the potential to address a range of EBV-associated lymphomas, nasopharyngeal carcinoma and gastric cancer. The EU designation follows the U.S. Food and Drug Administration (FDA) orphan drug designation for CMD-003 as a treatment for all EBV-associated non-Hodgkin lymphomas.

With the EU orphan designation, Cell Medica can obtain regulatory and financial incentives for developing and marketing CMD-003, along with a ten-year period of marketing exclusivity within the EU after product approval. Cell Medica can also receive protocol assistance from the EMA during product development as well as direct access to the centralized authorization procedure.

Gregg Sando, Chief Executive Officer of Cell Medica said:

"CMD-003 is a novel cellular immunotherapy with the potential to transform the way we treat patients with EBV-associated lymphomas. We are now testing this product in our CITADEL Phase II trial for patients with advanced extranodal NK/T cell lymphoma and look forward to completion of the study next year."

Health Canada Approves IMBRUVICA® (ibrutinib) for First-line Treatment of Chronic Lymphocytic Leukemia

On July 20, 2016 Janssen Inc. reported that Health Canada has approved IMBRUVICA (ibrutinib) an oral, once-daily, single-agent targeted therapy for previously untreated patients with active chronic lymphocytic leukemia (CLL) (Press release, Johnson & Johnson, JUL 20, 2016, View Source [SID:1234513975]). 1 This is the 4th approval for IMBRUVICA , which now is approved for use in all lines of CLL therapy for patients needing treatment, considerably expanding the number of Canadian patients who may benefit from this chemotherapy-free treatment. Chronic lymphocytic leukemia is one of the most common types of leukemia in adults.2

The latest approval is based on data from the Phase 3 RESONATE-2 (PCYC-1115-CA) study, a head-to-head clinical trial comparing IMBRUVICA to chlorambucil (a chemotherapy agent). Results showed using IMBRUVICA first-line was associated with statistically significant improvements in progression-free survival (PFS), overall survival (OS) and overall response rate (ORR) compared with chlorambucil treatment. 3

"The clinical data showed that IMBRUVICA (ibrutinib) is much more effective than the comparator traditional chemotherapy," says Dr. Carolyn Owen, Associate Professor, Division of Hematology and Hematological Malignancies, Foothills Medical Centre*. "Hopefully, this approval will provide an increase in treatment options for patients with CLL that will ensure their disease is well controlled, allowing them to enjoy their life to the fullest."

The expanded IMBRUVICA indication is based on data from the randomized, international, multi-center, openlabel Phase 3 RESONATE-2 trial, involving 269 previously untreated patients with CLL aged 65 years or older. It showed IMBRUVICA significantly improved PFS, OS and ORR versus chlorambucil. At a median follow up of 18.4 months, the PFS, as assessed by an Independent Review Committee (IRC), indicated an 84 per cent statistically significant reduction in the risk of death or progression in the IMBRUVICA arm versus the chlorambucil arm (HR=0.16 [95 per cent CI, 0.091-0.28]).4 Median PFS was not reached for IMBRUVICA versus 18.9 months for chlorambucil (95 per cent CI: 14.1, 22.0). 5 Analysis of OS demonstrated an 84 per cent statistically significant reduction in risk of death for patients in the IMBRUVICA arm (HR=0.16 [95 per cent CI, 0.048-0.56]). Results also showed a statistically significant improvement in ORR in the IMBRUVICA arm versus the chlorambucil arm (82 per cent versus 35 per cent, respectively; p<0.0001).6 Data from RESONATE-2 were presented in an oral session at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on December 7, 2015, in addition to being featured in the official ASH (Free ASH Whitepaper) press program and simultaneously published online in The New England Journal of Medicine.

"We are pleased with the recent approval of IMBRUVICA by Health Canada," says Shelagh Tippet-Fagyas, president of the Leukemia and Lymphoma Society of Canada. "This approval means broader drug access and options for CLL patients, such as the benefit of earlier chemotherapy-free treatments."

The adverse reactions (AR) reported in the Phase 3 RESONATE-2 trial reflect exposure to IMBRUVICA with a median duration of 17.4 months. 7 The most common ARs (≥20 per cent) of any Grade were diarrhea (42 per cent), musculoskeletal pain** (36 per cent), cough (22 per cent) and rash** (21 per cent). The most common Grade 3/4 AR (>five per cent) was pneumonia** (eight per cent).8 Approximately five per cent of patients receiving IMBRUVICA in the studies supporting the CLL indications (PCYC-1102, RESONATE [PCYC-1112] and RESONATE-2) discontinued treatment due to ARs.9 These reactions included pneumonia, subdural hematoma and atrial fibrillation. ARs leading to dose reduction occurred in approximately four per cent of patients.10 Serious warnings and precautions include major bleeding events (some fatal), not to use in patients with moderate or severe hepatic impairment, and not to use concomitantly with a strong CYP3A inhibitor. Other warnings and precautions include effects on ability to drive and use machines, second primary malignancies, atrial fibrillation and atrial flutter, hypertension, decrease in QTcF interval, drug interactions, tumor lysis syndrome, diarrhea, cytopenias, lymphocytosis, leukostasis, minor bleeding events, infections, perioperative considerations, embryo-fetal toxicity, other reproductive risks, risk of exposure to infants through breast milk, and occurrence of certain adverse events more frequently in the elderly.11

About Chronic Lymphocytic Leukemia (CLL)

Chronic lymphocytic leukemia is a slow-growing blood cancer of cells that become white blood cells called lymphocytes, most commonly B cells.12 Chronic lymphocytic leukemia is one of the most common types of leukemia in adults.13 In Canada, there were approximately 2,195 adults diagnosed with CLL in 2010.14 Historically, CLL treatment has been challenging since the more effective treatment regimens were usually associated with high toxicity.15 There has been a real need to develop therapies for CLL that can offer better efficacy and tolerability, especially in older patients. 16

About IMBRUVICA (ibrutinib)

IMBRUVICA contains the medicinal ingredient ibrutinib which is a targeted inhibitor of Bruton’s tyrosine kinase (BTK). Ibrutinib blocks BTK activity, inhibiting cancer cell survival and spread.17 The recommended dose of IMBRUVICA for CLL is 420 mg (three 140-mg capsules) orally, once-daily.18

IMBRUVICA is approved in Canada for the treatment of patients with previously untreated active chronic lymphocytic leukemia (CLL), including those with 17p deletion. It is also approved for the treatment of patients with CLL who have received at least one prior therapy, including those with 17p deletion. IMBRUVICA is approved for the treatment of patients with Waldenström’s macroglobulinemia (WM), and approved (with conditions) for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL).

IMBRUVICA is co-developed by Cilag GmbH International (a member of the Janssen Pharmaceutical Companies) and Pharmacyclics LLC, an AbbVie company. Janssen Inc. markets IMBRUVICA in Canada.

Jounce Therapeutics Announces Major Strategic Collaboration with Celgene Corporation to Develop Next-generation Immuno-oncology Therapies for Patients with Cancer

On July 19, 2016 Jounce Therapeutics, Inc., a company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers for patient enrichment, reported a global strategic collaboration with Celgene Corporation (NASDAQ:CELG) focused on developing and commercializing innovative immuno-oncology treatments for patients with cancer (Press release, Jounce Therapeutics, JUL 19, 2016, View Source [SID:SID1234515271]). The collaboration includes options on Jounce’s lead product candidate, JTX-2011, targeting ICOS, and up to four early-stage programs to be selected from a defined pool of B cell, T regulatory cell and tumor-associated macrophage targets emerging from the Jounce Translational Science Platform and an additional option to equally share a checkpoint immuno-oncology program. Post option exercise, Jounce will lead global development and U.S. commercialization for JTX-2011 and one additional collaboration program.

"Jounce has built a unique immuno-oncology platform and pipeline with a focus on the development of novel cancer therapies matched to patient populations most likely to respond," said Robert Hershberg, M.D., Ph.D., chief scientific officer, Celgene. "This collaboration allows both companies to leverage broad capabilities in immuno-oncology to bring forward a new generation of product candidates for cancer patients."

"Celgene is the ideal partner to collaborate with Jounce to bring potentially transformational treatments to patients with cancer," said Richard Murray, Ph.D., chief executive officer, Jounce Therapeutics. "This partnership is of significant strategic value for Jounce. With Celgene as our partner, we can broaden our platform, advance our discovery programs and execute comprehensive clinical strategies, all in the context of our approach to bring the right immunotherapies to the right patient populations."

Under the terms of the collaboration, Jounce will receive an upfront payment of $225 million and a $36 million equity investment from Celgene. Jounce will also receive regulatory, development, and net sales milestone payments and tiered royalties on ex-U.S. sales. Aggregate payments for development, regulatory and commercial milestones could potentially be $2.3 billion in total across all programs reaching commercialization.

Celgene has the option to opt-in at defined stages of development across the programs. Following any opt-in, Celgene and Jounce will share U.S. profits and losses on all programs, as follows:

Jounce will retain a 60 percent U.S. profit share of JTX-2011, with 40 percent allocated to Celgene;
Jounce will retain a 25 percent U.S. profit share on the first additional program, with 75 percent allocated to Celgene;
Jounce and Celgene will equally share U.S. profits on up to three additional programs;
After opt-in, all development costs will be shared in a manner that is commensurate with product rights; and
Celgene will also receive exclusive ex-U.S. commercialization rights for each of the above programs, and Jounce is eligible to receive a royalty on any resulting ex-U.S. sales. Celgene and Jounce will equally share profits globally for the checkpoint program.

About JTX-2011
Jounce’s lead product candidate, JTX-2011, is a monoclonal antibody that binds to and activates ICOS, the Inducible T cell CO-Stimulator, a protein on the surface of certain T cells that is believed to stimulate an immune response against a patient’s cancer. We are developing JTX-2011 to treat solid tumors as a single agent and in combination with other therapies. JTX-2011 is expected to enter the clinic in the second half of 2016.

Valeant and Progenics Announce FDA Approves RELISTOR® Tablets
for the Treatment of Opioid-Induced Constipation in Adults with
Chronic Non-cancer Pain

On July 19, 2016 Valeant Pharmaceuticals International, Inc. (NYSE & TSX: VRX) and Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) reported that the U.S. Food and Drug Administration has approved RELISTOR (methylnaltrexone bromide) Tablets for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain(Press release, Progenics Pharmaceuticals, JUL 19, 2016, View Source [SID:1234513971]). Valeant expects to commence sales of RELISTOR Tablets in the U.S. in the third quarter of 2016.

"Opioid-induced constipation represents a long-lasting and potentially debilitating side effect of opioid therapy for millions of patients suffering from chronic pain," commented Joseph C. Papa, Chief Executive Officer of Valeant. "We believe Oral RELISTOR represents a new alternative treatment for OIC, and we look forward to introducing the more convenient oral formulation as soon as practicable."

"We are delighted that this milestone for RELISTOR has been achieved, and that patients suffering from OIC will have this new treatment option," said Mark Baker, Chief Executive Officer of Progenics. "We expect the market to be receptive to a more convenient oral tablet formulation of RELISTOR’s well-established subcutaneous preparation. We would like to thank, in particular, Dr. Tage Ramakrishna and Dr. Robert Israel of Valeant for their work over many years in the clinical development of RELISTOR."

"RELISTOR has a unique mechanism of action that binds to mu-opioid receptors without impacting the opioid-mediated analgesic effects on the central nervous system," said Richard L. Rauck, MD, Medical Director, Center for Clinical Research, President, Carolinas Pain Institute, President of the Sceptor Pain Foundation of which he is a founding member, and Immediate Past President of the World Institute of Pain. "This represents a true breakthrough in the treatment of OIC, and addresses a large and growing need in the field of pain management."

Today, the FDA approved RELISTOR Tablets (450 mg once daily) for the treatment of OIC in adults with chronic non-cancer pain. Previously, RELISTOR Subcutaneous Injection (12 mg and 8 mg) was approved in 2008 for the treatment of OIC in adults with advanced illness who are receiving palliative care and in 2014 for the treatment of OIC in adults with chronic non-cancer pain.

About the Phase 3 Clinical Trial of Oral RELISTOR for OIC in Chronic Non-Cancer Pain (NCP)

A randomized, double-blind, Phase 3 trial was conducted to evaluate once-daily dosing of 450 mg (n=200) methylnaltrexone (MNTX) tablets compared to placebo (n=201) in adults with chronic NCP. In the 450 mg treatment arm, MNTX tablets demonstrated statistically significant improvements in rescue-free bowel movement (RFBM) within 4 hours of administration over 28 days of dosing when compared to placebo treatment, achieving the primary endpoint. The 450 mg treatment group also achieved statistical significance for the first key secondary efficacy endpoint where a higher percentage of responders (i.e., had ≥3 RFBMs/week, with an increase of ≥1 RFBM/week from baseline for at least 3 of the 4 weeks) was observed with MNTX treatment as compared to placebo. Overall, efficacy of oral methylnaltrexone in this study was comparable to that reported in clinical studies of subcutaneous methylnaltrexone in subjects with chronic, non-cancer pain. The overall observed safety profile seen in patients treated with oral methylnaltrexone was comparable to placebo in this study.

Important Safety Information about RELISTOR

RELISTOR (methylnaltrexone bromide) Tablets is contraindicated in patients with known or suspected gastrointestinal obstruction and patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation.

Cases of gastrointestinal perforation have been reported in adult patients with OIC and advanced illness with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the gastrointestinal tract (e.g., peptic ulcer disease, Ogilvie’s syndrome, diverticular disease, infiltrative gastrointestinal tract malignancies or peritoneal metastases). Take into account the overall risk-benefit profile when using RELISTOR in patients with these conditions or other conditions which might result in impaired integrity of the gastrointestinal tract wall (e.g., Crohn’s disease). Monitor for the development of severe, persistent, or worsening abdominal pain; discontinue RELISTOR in patients who develop this symptom.

If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their healthcare provider.

Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, and yawning have occurred in patients treated with RELISTOR.

Patients having disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal and/or reduced analgesia. Take into account the overall risk-benefit profile when using RELISTOR in such patients. Monitor for adequacy of analgesia and symptoms of opioid withdrawal in such patients.

Avoid concomitant use of RELISTOR with other opioid antagonists because of the potential for additive effects of opioid receptor antagonism and increased risk of opioid withdrawal.

The most common adverse reactions (≥ 12%) in adult patients with opioid-induced constipation and chronic non-cancer pain receiving RELISTOR tablets were abdominal pain, diarrhea, headaches, abdominal distention, hyperhidrosis, anxiety, muscle spasms, rhinorrhea, and chills. Adverse reactions of abdominal pain, diarrhea, hyperhidrosis, anxiety, rhinorrhea, and chills may reflect symptoms of opioid withdrawal.

Please see complete Prescribing Information for RELISTOR at valeant.com. For more information about RELISTOR, please visit www.relistor.com.

About RELISTOR

Progenics has exclusively licensed development and commercialization rights for its first commercial product, RELISTOR, to Valeant. RELISTOR Tablets (450 mg once daily) is approved in the United States for the treatment of OIC in patients with chronic non-cancer pain. RELISTOR Subcutaneous Injection (12 mg and 8 mg) is a treatment for opioid-induced constipation approved in the United States and worldwide for patients with advanced illness and chronic non-cancer pain.