On July 23, 2015 Bristol-Myers Squibb Company (NYSE:BMY) reported results for the second quarter of 2015, which were highlighted by strong global sales, key regulatory and clinical advances for Opdivo and significant clinical data on the company’s Immuno-Oncology portfolio presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (Press release, Bristol-Myers Squibb, JUL 23, 2015, View Source [SID:1234506597]).

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"We had a very good quarter, with strong sales across our portfolio, encouraging results from clinical trials and important regulatory milestones," said Giovanni Caforio, M.D., chief executive officer, Bristol-Myers Squibb. "I am excited by our progress in Immuno-Oncology as we continue to advance our leadership position and transform cancer treatment. As our Immuno-Oncology data continues to emerge, it is clear we have a tremendous opportunity, and we are making the right strategic investments to capitalize on the full potential of our portfolio."

SECOND QUARTER FINANCIAL RESULTS

Bristol-Myers Squibb posted second quarter 2015 revenues of $4.2 billion, an increase of 7% compared to the same period a year ago. Global revenues increased 16% adjusted for foreign exchange impact.

U.S. revenues decreased 3% to $1.8 billion in the quarter compared to the same period a year ago. International revenues increased 17%.

Gross margin as a percentage of revenues was 75.7% in the quarter compared to 74.5% in the same period a year ago.
Marketing, selling and administrative expenses increased 2% to $968 million in the quarter.
Advertising and product promotion spending decreased 11% to $167 million in the quarter.
Research and development expenses increased 31% to $1.9 billion in the quarter, primarily due to the acquisition of Flexus Biosciences, Inc.

The effective tax rate was 311.5% in the quarter, compared to 25.4% in the second quarter last year.
The company reported net loss attributable to Bristol-Myers Squibb of $130 million, or $0.08 per share, in the quarter compared to net earnings of $333 million, or $0.20 per share, a year ago. The results in the current quarter include an $800 million R&D charge ($0.48 per share) resulting from the Flexus acquisition, which was not deductible for tax purposes.

The company reported non-GAAP net earnings attributable to Bristol-Myers Squibb of $890 million, or $0.53 per share, in the second quarter, compared to $798 million, or $0.48 per share, for the same period in 2014. An overview of specified items is discussed under the "Use of Non-GAAP Financial Information" section.

Cash, cash equivalents and marketable securities were $10.1 billion, with a net cash position of $2.7 billion, as of June 30, 2015.

SECOND QUARTER PRODUCT AND PIPELINE UPDATE

Bristol-Myers Squibb’s global sales in the second quarter included Eliquis, which grew by $266 million, Orencia, which grew 15%, Sprycel, which grew 10%, and Opdivo, which had sales of $122 million. Daklinza and Sunvepra had combined sales of $479 million, which includes $170 million of previously deferred revenue in France as part of an early access program before final pricing was obtained.

Opdivo

In July, the European Medicines Agency (EMA) validated two of the company’s type II variation applications, which seek to extend the current indication for Opdivo. Validation of the applications confirms that the submissions are complete and starts the EMA’s centralized review process. In lung cancer, the proposed new indication addresses the non-squamous, NSCLC population and is based on data from the Phase 3 CheckMate -057 study: Opdivo as monotherapy for the treatment of locally advanced or metastatic non-squamous NSCLC after prior chemotherapy in adults. In melanoma, the proposed new indication aims at extending the use of Opdivo monotherapy in combination with Yervoy for the treatment of advanced (unresectable or metastatic) melanoma in adults and is based on data from the Phase 3 CheckMate -067 study, Phase 2 CheckMate -069 study and the Phase 1b CA209-004 study.

In July, the European Commission (EC) approved Nivolumab BMS for the treatment of locally advanced or metastatic squamous NSCLC after prior chemotherapy. This approval marks the first major treatment advance in squamous NSCLC in more than a decade in the European Union (EU). Nivolumab is the first and only PD-1 immune checkpoint inhibitor to demonstrate overall survival in previously treated metastatic squamous NSCLC. This approval allows for the marketing of nivolumab in all 28 Member States of the EU.

In July, the company announced that an open-label, randomized Phase 3 study evaluating Opdivo versus everolimus in previously treated patients with advanced or metastatic renal cell carcinoma (CheckMate -025) was stopped early because an assessment conducted by the independent Data Monitoring Committee concluded that the study met its endpoint, demonstrating superior overall survival in patients receiving Opdivo compared to the control arm. The company looks forward to sharing these data with health authorities soon.

In June, the EC approved Opdivo for the treatment of advanced (unresectable or metastatic) melanoma in adults, regardless of BRAF status. Opdivo is the first PD-1 immune checkpoint inhibitor to have received EC approval, which allows Opdivo to be marketed in all 28 Member States of the EU.

In June, the U.S. Food and Drug Administration (FDA) accepted for filing and review the supplemental Biologics License Application (sBLA) for the Opdivo+Yervoy regimen in patients with previously untreated advanced melanoma, the first regulatory milestone for an immuno-oncology combination regimen in cancer. The FDA also granted Priority Review for this application, which includes data from CheckMate -069. The projected FDA action date is September 30, 2015.

In May, during ASCO (Free ASCO Whitepaper) in Chicago, the company announced results from three Phase 3 trials for

Opdivo:
CheckMate -057 – In this study evaluating previously treated patients with advanced non-squamous NSCLC, Opdivo became the first PD-1 immune checkpoint inhibitor to demonstrate superior overall survival versus standard of care (docetaxel). A 27% reduction in the risk of progression or death – the primary study endpoint – was reported for Opdivo versus docetaxel. Opdivo was associated with a doubling of overall median survival across the continuum of PD-L1 expression, starting at 1% level of expression. The safety profile of Opdivo in CheckMate -057 was favorable versus docetaxel with grade 3-5 treatment-related adverse events reported in 10% of patients who were treated with Opdivo versus 54% in the docetaxel arm.

CheckMate -017 – In this open-label, randomized study evaluating Opdivo versus docetaxel in previously treated patients with advanced squamous NSCLC, Opdivo demonstrated an overall survival rate of 42% at one year versus 24% for docetaxel, with a median overall survival of 9.2 months versus 6 months, respectively. Opdivo reduced the risk of death by 41%. The safety profile of Opdivo in CheckMate -017 was consistent with prior studies and favorable versus docetaxel. The results were published in The New England Journal of Medicine (NEJM).

CheckMate -067 – In this study evaluating the Opdivo+Yervoy regimen and Opdivo monotherapy versus Yervoy monotherapy in patients with previously untreated advanced melanoma, both the Opdivo+Yervoy regimen and Opdivo monotherapy demonstrated superiority to Yervoy, the current standard of care, for the co-primary endpoint of progression-free survival (PFS). Median PFS was 11.5 months for the Opdivo+Yervoy regimen and 6.9 months for Opdivo monotherapy, versus 2.9 months for Yervoy monotherapy. The Opdivo+Yervoy regimen demonstrated a 58% reduction in the risk of disease progression versus Yervoy, while Opdivo monotherapy demonstrated a 43% risk reduction versus Yervoy monotherapy. The trial is ongoing and patients continue to be followed for overall survival, a co-primary endpoint.

Also at ASCO (Free ASCO Whitepaper), the company announced results from an interim analysis of CA209-040, a Phase 1-2 dose-ranging trial evaluating the safety and anti-tumor activity of Opdivo in previously treated patients with hepatocellular carcinoma or advanced liver cancer. The estimated survival rate in evaluable patients receiving Opdivo was 62% at 12 months. Results also show the safety profile of Opdivo is generally consistent with that previously reported for Opdivo in other tumor types.

In April, the FDA accepted for filing and review an sBLA for Opdivo for the treatment of previously untreated patients with unresectable or metastatic melanoma. The FDA also granted Priority Review for this application. The projected FDA action date is August 27, 2015.

Yervoy

The company announced today that two Yervoy Phase 3 trials, Study -095 in metastatic castration-resistant prostate cancer and Study -156 in newly diagnosed extensive-stage disease small cell lung cancer, did not meet their primary endpoints of overall survival versus standard of care and have been discontinued. No new safety concerns with Yervoy were identified in either study. The company will complete a full evaluation of the data and work with investigators on the future publication of the results.
In July, the Japanese Ministry of Health, Labour and Welfare approved Yervoy for first- and second-line treatment of unresectable malignant melanoma.

Elotuzumab

In June, during ASCO (Free ASCO Whitepaper) and the European Hematology Association (EHA) (Free EHA Whitepaper) meeting in Vienna, the company announced results from an interim analysis of ELOQUENT-2, a Phase 3, randomized, open-label trial that evaluated elotuzumab, an investigational immunostimulatory antibody, in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone for the treatment of relapsed or refractory multiple myeloma. The study showed a 30% reduction in the risk of disease progression or death and a two-year PFS rate of 41% in the elotuzumab arm versus 27% in the control arm, respectively. Results also showed minimal incremental adverse events with the addition of elotuzumab to lenalidomide and dexamethasone. These results validate elotuzumab’s novel mechanism of action of directly activating the immune system in patients with relapsed or refractory multiple myeloma and were published in NEJM.

In June, at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper), the company also announced results from a randomized Phase 2 study that evaluated elotuzumab in combination with bortezomib and dexamethasone versus bortezomib and dexamethasone alone in patients with relapsed or refractory multiple myeloma which, consistent with ELOQUENT-2, demonstrated a 28% reduction in the risk of disease progression or death.

Eliquis

In June, at the International Society on Thrombosis and Haemostasis Congress in Toronto, the company, its partner Pfizer, and Portola Pharmaceuticals announced full results from the second part of ANNEXA-A, a Phase 3, registration-enabling study evaluating the safety and efficacy of andexanet alfa, an investigational antidote and FDA-designated breakthrough therapy, administered as an intravenous bolus followed by a continuous two-hour infusion to sustain the reversal of anticoagulation activity of Eliquis in healthy volunteers ages 50-75 years. Andexanet alfa produced rapid reversal of the anticoagulant effect of Eliquis – as measured by anti-Factor Xa activity, which was sustained for the duration of the infusion – and significantly reduced the level of free unbound Eliquis in the plasma and restored thrombin generation to normal.

HIV

In July, the FDA granted Breakthrough Therapy Designation to the investigational compound BMS-663068, a first-in-class HIV-1 attachment inhibitor, when used in combination with other antiretroviral agents for the treatment of HIV-1 infection in heavily treatment-experienced adult patients.

In July, at the 8th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention in Vancouver, the company announced additional Phase 2a proof-of-concept data for BMS-955176, a novel investigational agent designed to prevent the maturation of HIV-1. The study findings confirmed the antiretroviral activity of BMS-955176 when administered with atazanavir (± ritonavir) and support further development of the second-generation HIV-1 maturation inhibitor.

Reyataz

In June, the FDA granted pediatric exclusivity for Reyataz, providing an additional six-month period of exclusivity in the U.S.
Daklinza

In May, the FDA amended a previously granted Breakthrough Therapy Designation for the investigational combination of daclatasvir and sofosbuvir for use in hepatitis C (HCV) patients. The updated Designation reflects data from ALLY-1, a Phase 3 study of HCV genotype 1 patients with advanced cirrhosis (Child-Pugh Class B or C) and those who develop genotype 1 HCV recurrence post-liver transplant. The data were presented at The International Liver Congress in Vienna, Austria. Daclatasvir is marketed as Daklinza in Japan and the EU.

Evotaz

In July, the EC approved Evotaz tablets in combination with other antiretroviral agents for the treatment of HIV-1 infected adults without known mutations associated with resistance to atazanavir. The approval allows for the marketing of Evotaz in all 28 Member States of the EU.

Nulojix

In May, during the American Transplant Congress in Philadelphia, the company presented results from a seven-year, long-term follow-up of BENEFIT, a prospective, randomized Phase 3 trial in kidney transplant patients. The study demonstrated a statistically significant 43% relative risk reduction of death or graft loss (transplant failure) in patients receiving the Nulojix FDA-approved dosing regimen over those receiving a cyclosporine regimen. There also was a statistically significant survival benefit of 52% relative risk reduction of death or graft loss at five years post-transplant among patients receiving the Nulojix regimen. In the long-term follow-up (years 3-7) on BENEFIT participants, the safety profile of the Nulojix regimen was similar to the cyclosporine regimen.
ANNEXA is a trademark of Portola Pharmaceuticals, Inc.

SECOND QUARTER BUSINESS DEVELOPMENT UPDATE

In July, the company and The Medical University of South Carolina announced a translational research collaboration focused on fibrotic diseases, including scleroderma, renal fibrosis and idiopathic pulmonary fibrosis. The collaboration will include studies designed to improve the mechanistic understanding of fibrosis, explore patient segmentation based on disease characteristics and/or biomarker approaches and predictors of disease progression.

2015 FINANCIAL GUIDANCE

Bristol-Myers Squibb is increasing its 2015 GAAP EPS guidance range from $0.96 – $1.06 to $1.02 – $1.12. The company is also increasing its non-GAAP EPS guidance range from $1.60 – $1.70 to $1.70 – $1.80. Both GAAP and non-GAAP guidance assume current exchange rates and that the R&D tax credit will be extended by Congress in 2015. Key revised 2015 non-GAAP line-item guidance assumptions include:

Worldwide revenues between $15.5 and $15.9 billion.
Full-year gross margin as a percentage of revenues of approximately 76%.
Advertising and promotion expense increasing in the high-single-digit range.
Marketing, sales and administrative expenses decreasing in the low- to mid-single-digit range.
Research and development expenses increasing in the mid-single-digit range.
An effective tax rate of approximately 19%.
The financial guidance for 2015 excludes the impact of any potential future strategic acquisitions and divestitures, and any specified items that have not yet been identified and quantified. The non-GAAP 2015 guidance also excludes other specified items as discussed under "Use of Non-GAAP Financial Information." Details reconciling adjusted non-GAAP amounts with the amounts reflecting specified items are provided in supplemental materials available on the company’s website.

Use of Non-GAAP Financial Information

This press release contains non-GAAP financial measures, including non-GAAP earnings and related earnings per share information. These measures are adjusted to exclude certain costs, expenses, significant gains and losses and other specified items. Among the items in GAAP measures but excluded for purposes of determining adjusted earnings and other adjusted measures are: restructuring and other exit costs; accelerated depreciation charges; IPRD and asset impairments; charges and recoveries relating to significant legal proceedings; upfront, milestone and other payments for in-licensing or acquisition of products that have not achieved regulatory approval which are immediately expensed; pension settlement charges; significant tax events and additional charges related to the Branded Prescription Drug Fee. This information is intended to enhance an investor’s overall understanding of the company’s past financial performance and prospects for the future. Non-GAAP financial measures provide the company and its investors with an indication of the company’s baseline performance before items that are considered by the company not to be reflective of the company’s ongoing results. The company uses non-GAAP gross profit, non-GAAP marketing, selling and administrative expense, non-GAAP research and development expense, and non-GAAP other income and expense measures to set internal budgets, manage costs, allocate resources, and plan and forecast future periods. Non-GAAP effective tax rate measures are primarily used to plan and forecast future periods. Non-GAAP earnings and earnings per share measures are primary indicators the company uses as a basis for evaluating company performance, setting incentive compensation targets, and planning and forecasting of future periods. This information is not intended to be considered in isolation or as a substitute for financial measures prepared in accordance with GAAP.

On July 22, 2015 BioInvent reported its Interim Report 1 January – 30 June 2015 (Press release, BioInvent, JUL 22, 2015, View Source [SID:1234506579]).

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BioInvent’s transformation into a clinical company continues at a fast pace.

Second quarter 2015,
April – June
Net sales for April – June 2015 amounted to SEK 3.7 (32) million.
Earnings after tax for April – June 2015: SEK -25 (3.7) million.
Earnings after tax per share for April – June 2015 before and after dilution:-0.19 (0.04) SEK.
Cash flow from current operations and investment activities for April – June 2015: SEK -31 (-25) million.

Half year results 2015,
January – June
Net sales for January – June 2015 amounted to SEK 4.3 (34) million.
Earnings after tax for January – June 2015: SEK -47 (-15) million.
Earnings after tax for January – June 2015 before and after dilution: SEK -0.39 (-0.17).
Liquid funds as of 30 June 2015: SEK 63 (74) million. Cash flow from current operations and investment activities for January – June 2015: SEK -51 (-48) million.

Important events in the second quarter and after the reporting period

Research results published in April in the respected science journal Cancer Cell showed that BioInvent’s drug candidate BI-1206 has the potential to inhibit resistance to antibody drugs for the treatment of cancer. The article also described groundbreaking findings that resistance to many types of antibody drugs can be overcome by preventing cancer cells from ‘hiding’ from immune cells.
In the second quarter BioInvent raised SEK 77.7 million through an oversubscribed rights issue. Management and key personnel subscribed for new shares corresponding to a total of 2.8 per cent of the shares offered in the rights issue.

In June BioInvent and University of Southampton entered into a research collaboration to develop new immune therapy treatments for cancer by targeting regulatory T cells (T regs).

In June BioInvent announced that its partnership with a leading U.S. biotechnology company had advanced to next phase. The collaboration aims to discover novel therapeutic antibodies to be incorporated into the company’s CAR-T programs. The first of up to three targets covered by the agreement has now been identified and the work to develop appropriate antibodies will be initiated.

BioInvent announced in July that the upcoming phase I/IIa study of TB-403 will be expanded to include children with Ewing’s sarcoma and neuroblastoma in a dose escalation phase of the trial, in addition to the already announced indication medulloblastoma. Further it was announced that late stage negotiations are on-going with a leading clinical network in the US to conduct the trial. The study is planned to commence in Q4 2015.

Comments from the CEO
"The transformation of BioInvent into a company with an internationally competitive clinical portfolio is continuing at a fast pace. In the second quarter of the year we strengthened our financial position through an oversubscribed new issue.

Important progress was made with the publication of BI-1206 research in Cancer Cell, one of the highest ranked science journals in the world, the announcement of a new research partnership with world-leading researchers at the University of Southampton and the high level of activity in our new partnership with a leading US biotech company in the CAR-T area.

The foundations have been laid to create significant financial value. Within the next 12 months three of our projects will be in active clinical trials. This will place BioInvent at the leading edge of immuno-oncology, the most exciting area in drug development. We have a broad portfolio of development projects, we have the expertise to prioritise the most interesting development pathways from a commercial perspective and we have the resources to generate the data necessary to secure lucrative agreements.

Transforming BioInvent has involved a lot of work and there are undoubtedly some big challenges ahead, but I note that we are now in exactly the right place at exactly the right time," says Michael Oredsson, CEO of BioInvent.

Project overview

BioInvent is developing a clinical oncology portfolio with a focus on strategic value creation, retained
market rights and a balanced risk.

Transforming BioInvent has involved a lot of work and there are undoubtedly some big challenges ahead, but I note that we are now in exactly the right place at exactly the right time," says Michael Oredsson, CEO of BioInvent.

Multiple myeloma (BI-505)
Background

In the western world, an average of 5.6 new cases of multiple myeloma per 100,000 people are registered every year, which is equivalent to around 60,000 new cases a year. Multiple myeloma is an incurable cancer for which there are no good drugs to prevent the relapses that affect all patients after treatment with cytotoxic drugs or after a stem cell transplant. Expression of an adhesion protein, ICAM-1 (also called CD54), is elevated in myeloma cells, which makes it a suitable target for a drug candidate. The BI-505 drug candidate is a human antibody that specifically binds to the ICAM-1. BI- 505 affects tumours in two ways – by inducing cell death of myeloma cells and by engaging the Project Primary Indication Discovery Preclinic Phase I Phase II Collaboration BI-505 Multiple Myeloma University of Pennsylvania BI-1206 CLL, NHL Cancer Research UK, Univ. of Southampton TB-403 Medulloblastoma ThromboGenics Preclinical pipeline (based on F.I.R.S.T.TM and n-CoDeR)1) T-reg Oncology University of Southampton Tumor Macrophage Oncology Cancer Research Technology AML Hematologic cancer Internal development 1) The preclinical CLL project has been removed from the list of preclinical projects as this part is included in the development project BI-1206. Development pipeline 3 patient’s immune cells, known as macrophages, to attack myeloma cells. Macrophages are abundant in the bone marrow of myeloma patients, where they are thought to contribute to disease progression and development of resistance to currently available drugs. BI-505 has the ability to get macrophages to attack myeloma cells and has, in several relevant animal models, proved to be more effective at killing tumours than existing drugs. The good safety profile and the effectiveness of the substance against cancer cells that do not bind to tumours, even where these are expressed in low quantities, makes BI-505 especially suitable in preventing multiple myeloma relapses.

Project status
The initial results from the phase I study of BI-505 on patients in advanced stages of multiple myeloma showed that the substance has a good safety profile. In the dosage groups to which extended therapy was offered, 24 percent of these severely ill patients demonstrated stable disease for at least two months, which indicates a positive effect of BI-505, and is in parity with Phase I data for Elotuzumab, currently in phase III clinical development for multiple myeloma. Results from the phase I study were presented in an international conference on multiple myeloma in Kyoto, Japan, and were published in the scientific journal, Clinical Cancer Research, in February 2015. New preclinical data was also presented on the same occasion showing significantly enhanced anti-tumour activity compared with monotherapy when combining the registered drugs Velcade or Revlimid with BI- 505.

The scientific journal, Cancer Cell, presented data showing preclinical proof-of-concept for both BI-505 and for BioInvent’s function-based F.I.R.S.T. platform. The article presents data showing the potent effect of BI-505 in several preclinical multiple myeloma models.

In April 2013 a phase II study in patients with asymptomatic smoldering myeloma was initiated. The study has now been prematurely terminated due to a strategic review of the commercial potential of BI-505 in light of the preclinical and clinical data package. BI-505 will be repositioned to target residual disease in combination with treatments designed to lower tumour burden in conjunction with and after stem-cell transplantation in patients with myeloma. Asymptomatic multiple myeloma is currently not treated with drugs because the side effects are not acceptable in symptom free patients. This indication therefore has very limited commercial potential and the development path is expected to be relatively complicated.

Instead, a clinical study in collaboration with Penn Medicine will be initiated to investigate the potential of BI-505 to deepen the response after autologous stem cell transplantation in combination with low dose Revlimid . BioInvent has also identified an opportunity to develop BI-505 in other orphan indications, and is evaluating parallel clinical development of these at a significantly lower cost and in a shorter timeframe compared with the multiple myeloma indication.

BI-505 has received Orphan Drug Designation for the multiple myeloma indication by both the U.S. Federal Drug Administration (FDA) and European Medicines Agency (EMA).

Non-Hodgkin lymphoma and cronic lymphatic leukemia (BI-1206)
Background

Non-Hodgkin lymphoma (NHL) is an umbrella term for a group of cancers that develop in the body’s lymphatic system. Since lymphatic tissue is present throughout the body, lymphoma can start anywhere. High-grade lymphoma is treated with radiation and/or cytostatic drugs and in many cases with rituximab (Rituxan , Mabthera , Roche). Low-grade lymphoma has a better prognosis and treatment is often only initiated once a patient has disease symptoms.

Chronic lymphatic leukaemia (CLL) is an incurable lymphoma that most commonly affects older men. The disease progression is often slow and patients are normally treated with cytostatic drugs, often in combination with monoclonal antibodies.
In Europe and North America, around 157,000 people every year are diagnosed with NHL and around 35,000 with CLL.

BioInvent’s drug candidate BI-1206 is a fully human antibody aimed at CD32b, an immunosuppressive protein that is overexpressed in patients with lymphoma, especially in patients who respond poorly to currently available drugs like the anti CD20 treatment rituximab. It is well known that CD32b is involved in the development of resistance to current state-of-the-art treatments for NHL and CLL – rituximab. In models for different cancers, CD32b has also been shown to be involved in the development of resistance to treatment with other antibodies. BI-1206 therefore has a very interesting mechanism with the potential for use in both NHL and CLL, as well as other cancer indications. As BI- 1206 blocks the immunosuppressant effect of CD32b, the immune system can be stimulated, which can strengthen the therapeutic effect of both rituximab as well as other antibody-based drugs. Combination therapy with BI-1206 and rituximab in clinically relevant animal models with tumour cells 4 from patients with NHL has demonstrated significantly improved antitumour effects compared to monotherapy with rituximab. A series of studies have shown that as many as half of the cancer patients who responded to an initial rituximab treatment proved to be resistant to the drug at relapse, which indicates a significant medical need for improved therapies for these patients. Combination therapy therefore has the potential to significantly improve the treatment of patients with this disease.

BI-1206 has also shown a strong ability to kill lymphoma cells in preclinical models using tumour cells taken directly from patients. The results indicate that BI-1206 may have the potential to be used as a monotherapy.

Project status

In January 2015 BioInvent entered into an agreement with Cancer Research UK (CRUK),
Cancer Research Technology (CRT) and Leukaemia & Lymphoma Research (LLR) on implementation of a phase I/II study with BI-1206 in patients with CLL and NHL. The first study in patients will be financed and executed by CRUK, CRT and LLR. BioInvent has the opportunity to utilise an exclusive licence for the study data in return for low milestone payments and royalties paid to Cancer Research Technology.

The plan is for this open phase I study to include 50–60 patients who will be treated either only with BI-1206 or BI-1206 in combination with rituximab. Patients with CLL with be recruited first, but smaller groups of patients with other types of NHL, such as mantle cell lymphoma, follicular lymphoma and diffuse large B cell lymphoma, may also be included in the study. The study is expected to start in the second half of 2015.

In April 2015 the prestigious scientific journal Cancer Cell published data showing that BI-1206 has anti-tumour activity and can overcome resistance to antibody treatment in clinically relevant animal models. It is these data that forms the basis for the planned clinical study of BI-1206 in combination with rituximab.

Alongside this clinical study, preclinical studies will continue, principally focused on proving the combination effects of BI-1206 and CD38 antibodies within multiple myeloma. CD38 antibodies constitute a new, very promising class of drug where market approval is pending in the multiple myeloma indication. Despite proven good effects in clinical studies, the data indicates that patients develop resistance to these new drugs as well, which shows that there is a medical need to complement this class of drugs to optimise the treatment of patients. In addition, research regarding CD32b expression in subpopulations within NHL will be done, with the potential to identify the optimal population for treatment with BI-1206.

Medulloblastoma (TB-403)
Background

Medulloblastoma, neuroblastoma and Ewing’s sarcoma are life-threatening, debilitating cancer diseases that exclusively affect children and adolescents. Both diseases are rare and are diagnosed in just over ten individuals per million and year. Preclinical data from medulloblastoma animal models using the monoclonal antibody TB-403 indicates the potential for better clinical results for these patients than with available therapies. The antibody will therefore be evaluated in a clinical study for this indication.

The TB-403 drug project is conducted in cooperation with Oncurious, a subsidiary of the Belgian biopharma company ThromboGenics. BioInvent is paying half of the development costs and has the right to 40 percent of all future revenue from the project.

Project status

A new clinical study with TB-403 in children with medulloblastoma will start in the fourth quarter of 2015. In the dose escalation part of the study, children suffering from neuroblastoma and Ewing’s sarcoma will also be recruited. Preclinical studies evaluating the effect of the antibody in models for neuroblastoma are ongoing. The antibody TB-403 has demonstrated an excellent safety profile in previous clinical trials in patients with liver cancer and glioblastoma. The decision to launch a new clinical trial and further preclinical evaluations is based on new knowledge about the antibody’s mechanism of action, which is described in an article published by Jain et al in the respected journal Cell.

The relatively high development risk of the project is being weighed against the favourable safety profile that TB-403 has demonstrated in earlier trials, the project’s low development costs, and the possibility of using a faster development process than is normally the case.

Preclinical projects

BioInvent’s preclinical research is aimed at expanding the Company’s portfolio of drug candidates. Since 2012 the Company has focused its own research resources entirely on cancer. Over the past decade the Company has accumulated a significant body of experience of relevant disease models within cancer biology and tumour immunology. The basis of the preclinical research are the models used to identify the most effective and potent antibody candidates. These models make it possible to simultaneously conduct an extensive study of the safety and tolerability of the antibody, based on the biology of the disease and the mechanism of action of the antibody.

BioInvent’s research is aimed at developing antibodies with the ability to kill tumour cells through apoptosis (programmed cell death) or by activating the body’s own immune system. With the help of the F.I.R.S.T. platform, the Company is actively seeking new drug candidates for the treatment of different cancers. BioInvent collaborates with leading Swedish and international academic groups to gain access to new therapeutic concepts for the treatment of both serious haematological and solid cancers, which can serve as a basis for the development of new projects. One example is a partnership with Professor Martin Glennie and Professor Mark Cragg and their team at the University of Southampton with whom BioInvent is conducting several parallel collaborative immuno-oncology projects.

Licensing agreements and research collaborations with external partners
The Company has entered into several licensing agreements and, in some cases, research collaborations with a number of external partners including Bayer Pharma, Daiichi Sankyo, Mitsubishi Tanabe Pharma, Servier and Xoma. The structure and terms of these agreements and partnerships vary, but they all have in common that BioInvent receives licence fees, research financing, milestone payments and royalties on the sale of commercial products. Of these external drug development programmes, four projects are currently in phase I and five are in the preclinical phase. It should be noted that one preclinical project is added during the quarter.

Revenues and result
April-June
Net sales for the April-June period amounted to SEK 3.7 million (32). Revenues for the period are derived from partners developing therapeutic antibodies from the n-CoDeR antibody library. BioInvent received in the second quarter of 2014 revenue from sales of the Company’s rights to the drug development candidate ADC-1013 to Alligator Bioscience AB.

The Company’s total costs for the April-June period amounted to SEK 29 million (29). Operating costs are divided between external costs of SEK 19 million (18), personnel costs of SEK 10 million (10) and depreciation of SEK 0.4 million (0.5). Research and development costs for April-June amounted to SEK 21 million (20).

Earnings after tax for April-June amounted to SEK -25 million (3.7). The net financial items, April-June, amounted to SEK 0.0 million (0.3). Earnings per share before and after dilution, April-June, amounted to SEK -0.19 (0.04).

January-June
Net sales for the January-June period amounted to SEK 4.3 million (34). Revenues for the period are derived from partners developing therapeutic antibodies from the n-CoDeR antibody library. BioInvent received in the second quarter of 2014 revenue from sales of the Company’s rights to the drug development candidate ADC-1013 to Alligator Bioscience AB.

The Company’s total costs for the January-June period amounted to SEK 52 million (51). Operating costs are divided between external costs of SEK 32 million (31), personnel costs of SEK 19 million (19) and depreciation of SEK 0.8 million (1.0). Research and development costs for the January-June period amounted to SEK 36 million (34).

Earnings after tax for the January-June period amounted to SEK -47 million (-15). The net financial items amounted to SEK 0.1 million (0.4). Earnings per share before and after dilution amounted to SEK -0.39 (-0.17).

Financial position and cash flow
As of 30 June 2015, the Group’s liquid funds amounted to SEK 63 million (74). The cash flow from current operations and investment activities for the January-June period amounted to SEK -51 million (-48).

The annual general meeting in April 2015 approved the Board of Directors’ resolutions in March 2015 to carry out a new share issue with pre-emptive rights for shareholders of SEK 77.7 before issue costs. The new share issue was completed in May 2015. The subscription price for the new share issues was set to SEK 1.55 per share. The rights issue was oversubscribed. After the share issue the share capital consists of 162,918,961 shares.
The shareholders’ equity amounted to SEK 73 million (91) at the end of the period. The Company’s share capital at the end of the period was SEK 13 million. The equity/assets ratio at the end of the period was 80 (76) per cent. Shareholders’ equity per share amounted to SEK 0.45 (0.81). The Group had no interest-bearing liabilities.

Investments Investments in tangible fixed assets amounted to SEK 0.2 million (-). No investments were made in intangible assets during the period (-).

Parent company
All operations of the Group are conducted by the Parent Company. The Group’s and the Parent Company’s financial statements coincide in every material way.

Organisation
As of 30 June 2015, BioInvent had 39 (36) employees. 33 (30) of these work in research and development.

Employee Incentive Programme
Employee Incentive Programme 2011/2015
The 2011 Annual General Meeting voted in favour of complementing the already established Employee Incentive Programme 2008/2012 aimed at newly employed senior executives and key individuals not participating in Employee Incentive Programme 2008/2012. The number of employee options was within the framework of the number of options still not exercised in Employee Incentive Programme 2008/2012, including previous supplementary programmes.

Each employee option entitles the holder to acquire 1.163 new shares in BioInvent for a subscription price of SEK 26.13 up to 1 December 2015. Subscription price and number of shares that each employee option entitles to are converted pursuant to rights issues carried out. Under the programme 48,105 employee options have been allotted.

Employee Incentive Programme 2013/2017
The 2013 Annual General Meeting voted in favour of establishing a new, long-term employee incentive programme involving the allotment of a maximum of 900,000 employee options free of charge to all Group employees.

The employees will receive options based on their performance in the 2013, 2014 or 2015 financial years and allotment will take place in connection with the publication of the year-end financial statement for the subsequent year. Each employee option will entitle the holder to acquire 1.157 new share in BioInvent for a subscription price of SEK 3.04 during the period from the date of publication of the Company’s year-end financial statement for the 2016 financial year up to and including 1 December 2017. Subscription price and number of shares that each employee option entitles to are converted pursuant to rights issues carried out. Allotment of 100,747 employee options took place in February 2014 and 74,516 employee options took place in February 2015.

To guarantee BioInvent’s commitment and cover the costs associated with Employee Incentive programme 2013/2017, the 2013 Annual General Meeting resolved to issue a maximum of 1,182,780 warrants to BioInvent Finans AB.
If fully exercised, Employee Incentive Programme 2011/2015 and Employee Incentive Programme 2013/2017 will represent a dilution equivalent to around 1.1 percent of the shares in the Company.

Risk factors
The Company’s operations are associated with risks related to factors such as pharmaceutical development, clinical trials and product responsibility, commercialisation and partners, competition and fast technological development, biotechnology and patent risk, compensation for pharmaceutical sales, qualified personnel and key individuals, additional financing requirements, currency risk and interest risk. The aforementioned risks summarize the factors of significance for BioInvent and thus an investment in the BioInvent share.
No significant changes to the risks and uncertainty factors occurred during the period. For a more detailed description of risk factors, see section "Risks and Risk Management", page 29, in the company’s annual report 2014.

Accounting principles
This interim report was prepared in accordance with IAS 34, Interim Financial Reporting, and applicable sections of the Swedish Annual Accounts Act. The accounting principles applied here are the same as those applied in the preparation of the most recent annual report. Changes in IFRS standards entered into force in 2015 has had no material impact on the financial statements. The financial statements of the Parent company coincide in every material way with the consolidated financial statements.

On July 22, 2017 Innokeys Pte. Ltd reported the acquisition of Oncoscience AG, a privately held Germany biotechnology company focused on oncology (Press release, Oncoscience, JUL 22, 2015, View Source [SID1234519930]). The successful acquisition of all outstanding capital stock of Oncoscience, effective on the 16th of July 2015, gives Innokeys the full rights to accelerate the development of nimotuzumab; a EGFR-targeting Monoclonal Antibody licensed from Cuban-based Center of Molecular Immunology, in Europe."Innokeys is committed to leading advances in biopharmaceuticals and the consummation of this acquisition unifies our efforts to advance the development of nimotuzumab and increase patient access in Europe. This commitment reflects our recognition of the work and legacy of Oncoscience founder, the late Ferdinand Bach," said Dr. Rikrik Ilyas, Chief Executive Officer of Innokeys.

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This strategic consolidation falls in line with the nimotuzumab global development plan that includes two pivotal Phase III clinical studies for indications Paediatric Glioma and Pancreatic Cancer. "We are extremely pleased with the acquisition of Oncoscience by Innokeys and are encouraged to continue the clinical development of nimotuzumab towards approval in Europe in indications like Pancreatic Cancer and Pontine Glioma under the Innokeys umbrella", stated Prof. Dr. Dr. Juergen Engel, Chairman of the Supervisory Board of Oncoscience AG.

About nimotuzumab
Nimotuzumab is a humanized monoclonal antibody targeting the Epidermal Growth Factor Receptor (EGFR), invented and developed in Cuba by the Center of Molecular Immunology (CIM). Nimotuzumab has been shown to improve response when used with conventional treatments such as radiation therapy and chemotherapy but with the absence of severe side effects commonly associated with other anti EGFR targeting agents. Nimotuzumab is approved in several jurisdictions and is on late stage development in several major markets such as Japan and Europe.

About Innokeys Pte. Ltd.
Innokeys Pte. Ltd is a Singapore based limited liability company that was set up to leverage the value of innovation in the field of healthcare, especially in biopharmaceuticals. Innokeys activities span from identification, acquisition, development and commercialization of suitable innovations.

About Oncoscience AG
Oncoscience AG is a drug development company founded in 2001 by the late Ferdinand Bach to develop oncology drugs based in Wedel, Germany. Oncoscience holds the rights to develop and commercialize Nimotuzumab in Europe.

About InnoCIMAb Pte. Ltd
InnoCIMAb Pte. Ltd is a Singapore based joint venture between Innokeys Pte. Ltd (80%) and CIMAB SA (20%). CIMAB SA is the commercial representative for products and services developed by The Center of Molecular Immunology (CIM). InnoCIMAb is the licensee of CIMAb, the inventor, manufacturer and IP owner of Nimotuzumab and has the territories of Australia, Canada, Europe, Israel, Japan, South Korea, New Zealand, South East Asia, Taiwan, South Africa, Nigeria and Congo. InnoCIMAb has sublicensed certain territorial Nimotuzumab rights to Innokeys, Oncoscience, Medison, Daiichi Sankyo, Kuhnil Pharmaceuticals, Innogene Kalbiotech, Kalbe Farma and Gen İlaç.

On July 22, 2015 Dynavax Technologies Corporation (NASDAQ: DVAX) reported the pricing of a previously announced underwritten public offering of 4,545,455 shares of its common stock, offered at a price to the public of $27.50 per share (Press release, Dynavax Technologies, JUL 22, 2015, View Source [SID:1234506591]). The gross proceeds to Dynavax from this offering are expected to be approximately $125 million, before deducting the underwriting discount and other estimated offering expenses payable by Dynavax. Dynavax has granted the underwriters a 30-day option to purchase at the public offering price up to an aggregate of 681,818 additional shares of its common stock to cover over-allotments, if any. The offering is expected to close on or about July 27, 2015, subject to customary closing conditions. Dynavax anticipates using the net proceeds from the proposed offering to fund activities associated with completing the ongoing Phase 3 HBV-23 study of HEPLISAV-B, seeking regulatory approval of HEPLISAV-B in the United States, and preparing for the anticipated U.S. commercial launch of HEPLISAV-B, should HEPLISAV-B gain approval by the Food and Drug Administration. In addition, net proceeds from the offering will support continuing the clinical development of our investigational cancer immunotherapeutic product candidate, SD-101, and for other general corporate purposes, including working capital.

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Cowen and Company, RBC Capital Markets and William Blair are acting as joint book-running managers for the offering.

The securities described above are being offered by Dynavax pursuant to a shelf registration statement previously filed with the Securities and Exchange Commission (the "SEC"), which the SEC declared effective on December 3, 2014. A preliminary prospectus supplement related to the offering has been filed with the SEC and a final prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to this offering, when available, may be obtained from Cowen and Company, LLC c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by calling (631) 274-2806 or by faxing (631) 254-7140, or RBC Capital Markets, LLC, Attention: Equity Syndicate, 200 Vesey Street, 8th Floor, New York, NY 10281-8098, or by telephone at (877) 822-4098 or William Blair & Company, L.L.C., Attention: Prospectus Department, 222 West Adams Street, Chicago, IL 60606, by telephone at (800) 621-0687, or by e-mail at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On July 23, 2015 Roche reported strong performance in the first half of 2015 (Press release, Hoffmann-La Roche , JUL 22, 2015, View Source [SID:1234506599]).

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Group sales up 6% at constant exchange rates1, 3% in Swiss francs
Pharmaceuticals Division sales up 5%, driven by oncology (HER2-positive breast cancer medicines +21%, Avastin +9%, MabThera/Rituxan +6%) and immunology (Actemra/RoActemra +25%, Xolair +28%)
Diagnostics Division sales up 7%, driven by Professional Diagnostics (+7%) and Molecular Diagnostics (+12%)
Strong demand for idiopathic pulmonary fibrosis medicine Esbriet
Positive phase III results for ocrelizumab in multiple sclerosis
Immunotherapy candidate atezolizumab delivers positive study results in lung, breast and bladder cancers
Core earnings per share2 increased by 7% at constant exchange rates, 1% in Swiss francs
IFRS3 net income stable at constant exchange rates, -7% in Swiss francs

Outlook for 2015 confirmed

Commenting on the Group’s results, Roche CEO Severin Schwan said: "We had continued strong sales growth in both Pharmaceuticals and Diagnostics in the first half. I am very encouraged by the strong uptake of our new medicine Esbriet, for idiopathic pulmonary fibrosis, following our acquisition of InterMune last year. We have made significant progress in cancer immunotherapy and now have over forty programmes in clinical development. I am also pleased with the very positive results of the phase III studies for ocrelizumab in multiple sclerosis. Based on the strong first half, I am confident we will reach our full-year targets for 2015."

Group results
Strong performance across both divisions

Sales increased 6% in the first half, with significant growth of sales of oncology and immunology medicines. There was also strong growth in the Diagnostics Division, driven particularly by immunodiagnostic and molecular diagnostics products.

In the Pharmaceuticals Division, 5% sales growth was driven by medicines to treat HER2-positive breast cancer (Herceptin, Perjeta, Kadcyla, combined +21%) and Avastin (+9%), which saw very strong growth in use for cervical and ovarian cancers. Avastin is now used to treat seven different types of cancer. MabThera/Rituxan (+6%) for blood cancers and rheumatoid arthritis continued to grow solidly. Actemra/RoActemra (+25%), which is used mainly to treat rheumatoid arthritis, also remained a significant growth contributor in the first six months. Xolair (+28%), which is now used in the treatment of chronic hives as well as asthma, continued to grow strongly. Uptake of Esbriet was very strong in the first six months (229 million Swiss francs). Sales of oral chemotherapy drug Xeloda and anti-viral medicine Valcyte declined as these medicines are no longer patent protected. Sales of hepatitis medicine Pegasys and eye medicine Lucentis were lower as a result of increased competition.

In the Diagnostics Division, sales increased 7%, driven primarily by immunodiagnostic products from the Professional Diagnostics business area (+7%). The Molecular and Tissue Diagnostics business areas also performed well, each up 12%, and sales in Diabetes Care increased 1%, despite ongoing challenging market conditions.

The Swiss franc strengthened considerably against the euro during the first half of 2015, after the Swiss National Bank lifted its exchange rate peg in January, whilst weakening against the US dollar. The Japanese yen continued to further weaken against the Swiss franc, as did most European and Latin American currencies. Overall, there was a significant negative currency impact of 3 percentage points on sales.

Core earnings per share growth ahead of sales2
Core4 operating profit increased 7% in the first half, excluding a one-time income from the sale of filgrastim rights in 2014. On the same basis, core earnings per share (7.22 Swiss francs) were 7% higher.
IFRS net income was 7% lower in Swiss francs at 5.2 billion Swiss francs as a result of the significant negative currency impact, the base effect from the one-time income from the sale of filgrastim rights and the impact from the recent acquisitions, in particular InterMune. In constant exchange rates net income was stable.

Positive data in oncology and neuroscience
In May, Roche presented highly encouraging data for cancer immunotherapy candidate atezolizumab (anti-PDL1) in non-small cell lung cancer, both in monotherapy and in combination with chemotherapy, and in recurrent advanced bladder cancer. There were also positive results for atezolizumab plus chemotherapy in triple negative breast cancer reported earlier in the year. In July, further phase II data showed that atezolizumab shrank tumours in people with locally advanced or metastatic urothelial bladder cancer.
Another oncology highlight was updated data on the MEK inhibitor cobimetinib in combination with Zelboraf, which helped people with BRAF-mutated advanced melanoma live for a year without their disease worsening. In addition, updated data from the phase II NeoSphere study provided additional evidence on the role of Perjeta in combination with Herceptin and chemotherapy, in the neoadjuvant (pre-surgical) treatment of HER2-positive early breast cancer. The results suggest that people who received the Perjeta regimen prior to surgery were 31 percent less likely to experience disease worsening, recurrence or death, compared with those who received Herceptin and chemotherapy. There was also very encouraging data presented for trials of alectinib in ALK-mutated lung cancer that will form the basis of regulatory filing in this type of lung cancer; as well as data from an independent phase III study of Avastin in mesothelioma.

In neuroscience, there was an important milestone in the first half with the readout of two phase III studies of ocrelizumab in relapsing multiple sclerosis, the most common form of the disease. The results showed a significant reduction in both relapses and disability progression compared with an interferon-based standard-of-care treatment.5

Investigational medicine crenezumab will move into phase III clinical development in prodromal-to-mild Alzheimer’s disease. A strategy for higher dosing is being explored for gantenerumab, another candidate for the treatment of Alzheimer’s disease.
Data for investigational biologic ACE910 for hemophilia A was presented in June and showed a reduction in bleeding rates for people on the trial. Roche is moving the ACE910 development programme forward and aims to initiate phase III trials in a subset of patients later in the year.

The FDA granted Roche three Breakthrough Therapy Designations in the first six months: for atezolizumab in PDL1 positive non-small cell lung cancer; venetoclax in a type of relapsed-refractory chronic lymphocytic leukemia; and Actemra/RoActemra in systemic sclerosis. In total, Roche investigational medicines have been granted eight Breakthrough Therapy Designations.

The Group achieved a number of marketing approvals in different markets in the first half: Avastin with chemotherapy in the EU for advanced cervical cancer; Lucentis in the US for diabetic retinopathy; and Zelboraf for advanced melanoma in Japan. In addition, the EU’s Committee for Medicinal Products for Human Use recommended approval of Perjeta for use before surgery in HER2-positive early breast cancer.

Diagnostic product launches to further strengthen key growth areas
There were a number of key product launches in the first half in the Diagnostics division. In Molecular Diagnostics, the cobas DPX test and the cobas HBV quantitative nucleic acid test for use on the cobas 6800/8800 systems were introduced. The US authorities also cleared the cobas HSV1 and HSV2 test, the MRSA/SA test, the cobas Cdiff test, as well as approvals for the cobas KRAS test. In Professional Diagnostics, the improved CARDIAC point-of-care Troponin T test for the cobas h 232 system was launched. Additionally, the Elecsys HTLV-I/II immunoassay has been made available in countries that accept the CE mark (a European Economic Area standard which is used in a number of other countries worldwide). This is a diagnostic test to help detect antibodies against Human T-lymphotropic virus I or II infection in donated blood and routine diagnostic samples.

In the US, the use of the cobas Strep A test and the cobas Liat System were expanded after the CLIA (Clinical Laboratory Improvement Amendments) regulation was waived.

Outlook for 2015
Roche continues to expect sales to grow low- to mid-single digit at constant exchange rates in 2015. Core earnings per share are targeted to grow ahead of sales at constant exchange rates.6 Roche expects to further increase its dividend in Swiss francs.