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Boehringer Ingelheim bevacizumab biosimilar candidate demonstrates bioequivalence to Avastin®

On November 16, 2016 Boehringer Ingelheim reported new data from the Phase I INVICTAN-1 study, which show that BI 695502, its bevacizumab biosimilar candidate, is bioequivalent to U.S.-licensed and EU-approved Avastin (Press release, Boehringer Ingelheim, NOV 15, 2016, View Source [SID1234516656]).* Avastin is an angiogenesis inhibitor that is used to treat a variety of cancers.

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BI 695502 met all the pre-defined primary and secondary endpoints in the INVICTAN-1 study. These data were presented in a poster at the American Association of Pharmaceutical Scientists Annual Meeting in Denver, CO, November 13 – 17.

"This study is an important milestone for Boehringer Ingelheim, and supports our commitment to improving the lives of patients with cancer by exploring innovative ways for biosimilars to contribute to the long-term sustainability of the U.S. healthcare system," said Martina Flammer, Vice President, Clinical Development & Medical Affairs Specialty Care, Boehringer Ingelheim Pharmaceuticals, Inc. "We look forward to evaluating BI 695502 in our ongoing Phase III study to establish its safety and efficacy as compared to Avastin."

About BI 695502 and INVICTAN
BI 695502, a bevacizumab biosimilar candidate to Avastin, is a monoclonal antibody that may slow or stop the growth of certain tumor types by preventing the growth of blood vessels that supply the tumor.

INVICTAN-1 (NCT01608087) is a randomized, blinded, single-dose, parallel-arm Phase I clinical study, evaluating bioequivalence (how a drug is absorbed, distributed, metabolized and excreted in the body) of BI 695502 to Avastin. The study enrolled 91 healthy male individuals who were randomized evenly across treatment groups. BI 695502 was well-tolerated in this study, with no clinically relevant differences in safety or immunogenicity evaluations between the BI 695502 and bevacizumab treatment groups.

INVICTAN-2 (NCT02272413) is a randomized, double-blind Phase III study, evaluating efficacy and safety of BI 695502 plus chemotherapy versus Avastin plus chemotherapy in patients with advanced non-squamous non-small cell lung cancer.

Cellectis Announces Successful cGMP Manufacturing for Second Product Candidate: UCART123

On November 15, 2016 Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Alternext: ALCLS; Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene edited CAR T-cells (UCART), reported that a series of production runs of UCART123, a Company’s wholly-owned TALEN gene edited product candidate, was successfully performed in large scale, according to cGMP standards, for the purpose of conducting two Phase 1 clinical trials in patients with acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN).

The cGMP manufacturing of UCART123 clinical batches has been operated with CELLforCURE, a LFB group company and the largest industrial facility for clinical and commercial production of innovative cell and gene therapies in Europe. CELLforCURE is in charge of implementing cGMP manufacturing processes that are designed and developed by Cellectis.

The manufacturing process for Cellectis’ allogeneic CAR T-cell product line, Universal CARTs or UCARTs, yields frozen, off-the-shelf, engineered CAR T-cells. UCARTs are meant to be readily available CAR T-cells for a large patient population. Their production can be industrialized and standardized with defined pharmaceutical release criteria.

UCART123 is an engineered T-cell product candidate that targets CD123, an antigen that is located on CD123-expressing leukemic cells in AML as well as leukemic and other tumoral cells in BPDCN. We are planning to file an Investigational New Drug application (IND) with the United States Food and Drug Administration (FDA) in order to initiate clinical studies.

AML is a devastating clonal hematopoietic stem cell neoplasm characterized by uncontrolled proliferation and accumulation of leukemic blasts in the bone marrow, peripheral blood, and occasionally in other tissues. These cells disrupt normal hematopoiesis and rapidly cause bone marrow failure and death. In the U.S. alone, there are an estimated 19,950 new AML cases per year, with 10,430 estimated deaths per year.

Preclinical and translational activities on UCART123 in AML are performed in collaboration with Dr. Monica Guzman, Associate Professor of Pharmacology in Medicine at Weill Cornell Medical College. The clinical research at Weill Cornell will be led by principal investigator Dr. Gail J. Roboz, Director of the Clinical and Translational Leukemia Programs and Professor of Medicine.

BPDCN is a very rare and aggressive hematological malignancy that is derived from plasmacytoid dendritic cell precursors. BPDCN is primarily a disease of the bone marrow and blood cells, but also often affects skin and lymph nodes.

Cellectis collaborates with the MD Anderson Cancer Center on the preclinical development of UCART123 in BPDCN preliminary to the Phase I clinical trial in BPDCN to be activated. The UCART123 clinical program at MD Anderson will be led by Professor Hagop Kantarjian, MD, Department Chair, Department of Leukemia, Division of Cancer Medicine.

"We are proud of achieving this important milestone for UCART123, our first wholly owned product candidate. The successful translation of an R&D concept into a cGMP clinical grade industrial product is one of the key gating factors for us to move into clinical trials," said Arjan Roozen, Vice President, GMP Solutions and Manufacturing.

"With this work and Cellectis’ breakthrough TALEN-based gene editing technology, we continue building upon the Company’s milestones as a pioneer in the field, strengthening our pipeline and bringing us closer and closer to finding efficient and cost-effective products for cancer patients across the globe," added David J.D. Sourdive, Executive Vice President, Corporate Development, Cellectis.

Amgen And Allergan Submit Biosimilar Biologics License Application For ABP 215 To U.S. Food And Drug Administration

On November 15, 2016 Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) reported the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ABP 215, a biosimilar candidate to Avastin (bevacizumab) (Press release, Amgen, NOV 15, 2016, View Source [SID1234516619]). ABP 215 is the most advanced of the four oncology biosimilar medicines that Amgen and Allergan are collaborating on. The companies believe this submission is the first bevacizumab biosimilar application submitted to the FDA.

"ABP 215 is one of four oncology biosimilars in our pipeline, and today’s BLA submission is an important milestone as Amgen seeks to expand our oncology portfolio," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "ABP 215 has the potential to offer an additional high-quality therapeutic option for patients diagnosed with cancer, continuing Amgen’s mission of providing patients with vital medicines."

"Allergan is committed to developing safe and effective therapies in certain critical disease areas," said David Nicholson, Chief R&D Officer at Allergan. "The filing of ABP 215 is an important step forward in advancing a potential treatment option for patients with disorders susceptible to VEGF inhibition."

ABP 215 is a biosimilar candidate to bevacizumab, a recombinant immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that binds to vascular endothelial growth factor (VEGF) and inhibits the interaction of VEGF with its receptors, VEGF receptor-1 and VEGF receptor-2, thus inhibiting establishment of new blood vessels necessary for the maintenance and growth of solid tumors.

The BLA submission includes analytical, pharmacokinetic and clinical data, as well as pharmacology and toxicology data. The Phase 3 comparative efficacy, safety and immunogenicity study was conducted in adult patients with non-squamous non-small cell lung cancer (NSCLC). The Phase 3 study confirmed no clinically meaningful difference to bevacizumab in terms of efficacy, safety and immunogenicity.

Amgen and Allergan are collaborating on the development and commercialization of four oncology biosimilars. Amgen has a total of nine biosimilars in its portfolio, one which has been approved by the FDA (adalimumab-atto) and eight which are in ongoing development. Allergan is also independently developing biosimilars.

About ABP 215
ABP 215 is being developed as a biosimilar to bevacizumab, which is approved in the U.S., EU and other regions for the treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous NSCLC as well as metastatic carcinoma of the colon or rectum; metastatic renal cell carcinoma; and other region-specific indications.

Merck Raises Profit Forecast for 2016 Following Good Third Quarter

On November 15, 2016 Merck, a leading science and technology company, reported sales growth of 19.3% in the third quarter of 2016 (Press release, Merck KGaA, NOV 15, 2016, View Source [SID1234516617]).

EBITDA pre exceptionals rose sharply by 24.3%.

"We had a good third quarter and are lifting our guidance for the full year," said Stefan Oschmann, CEO and Chairman of the Executive Board of Merck. "We have made good progress with the execution of our strategy. We have advanced our pharmaceutical pipeline and are realizing the cost synergies from the acquisition of Sigma-Aldrich faster than planned. In the course of the year, we have lowered our debt from the acquisition by € 1 billion."
Group sales rose in the third quarter of 2016 by 19.3% to € 3.7 billion (Q3 2015: € 3.1 billion). Thanks to the Life Science business sector, Group sales increased organically by 0.9%, while negative exchange rate effects caused sales to decline slightly by -0.6%. Acquisition-related sales growth of 19.0% mainly reflects the Sigma-Aldrich transaction, which closed in November 2015. From a geographic perspective, North America and Latin America fueled organic growth.

EBITDA pre exceptionals, Merck’s key earnings indicator, grew sharply by 24.3% to € 1.2 billion (Q3 2015: € 944 million). This was mainly attributable to the Sigma-Aldrich acquisition and the good operating performance in Life Science. The Healthcare business sector contributed to the increase in earnings with the good development of operating business, higher royalty and license income, and the release of provisions that had been set up for the termination of clinical development projects. At 31.5%, the EBITDA margin pre exceptionals was higher than in the year-earlier quarter (Q3 2015: 30.3%). Group EBIT grew by 19.9% to € 676 million (Q3 2015: € 564 million). Net income climbed by 25.5% to € 457 million (Q3 2015: € 364 million). Earnings per share pre exceptionals rose in the third quarter of 2016 by 28.8% to € 1.70 (Q3 2015: € 1.32).

As of September 30, 2016, Merck had lowered its net financial debt from the acquisition of Sigma-Aldrichto € 11.6 billion (December 31, 2015: € 12.7 billion). Merck had 50,967 employees worldwide on September 30, 2016.

Merck generates profitable growth in the nine-month period
In the first nine months of 2016, Group net sales grew by 19.3% to € 11.2 billion (January-September 2015: € 9.4 billion). This double-digit growth rate is due to both acquisition effects (19.3%) and organic sales increases (3.6%). The impact of negative exchange rate effects on Group net sales was -3.6% in the first nine months of 2016. EBITDA pre exceptionals of the Merck Group came in at € 3.4 billion in the first nine months of 2016 (January-September 2016: € 2.7 billion), which was 26.7% higher than in the year-earlier period. Earnings per share pre exceptionals climbed 28.1% to € 4.79 in the first nine months of 2016 (January-September 2015: € 3.74).

Healthcare posts organic growth and higher profitability
The Healthcare business sector generated organic sales growth of 1.3% in the third quarter of 2016. This was canceled out by negative foreign exchange effects of
-1.4%. The negative portfolio effect of -1.0% was due to the return of the rights to Kuvan to BioMarin Pharmaceutical at the beginning of the year. Consequently, Healthcare net sales decreased by -1.1% to € 1.7 billion in the third quarter of 2016 (Q3 2015: € 1.7 billion).

The multiple sclerosis drug Rebif saw an organic sales decline of -5.5% in the third quarter of 2016. Including negative exchange rate effects of -1.2%, Rebif sales amounted to € 436 million (Q3 2015: € 468 million). For the oncology drug Erbitux Merck reported sales of € 219 million in the third quarter (Q3 2015: € 223 million) owing to organic sales declines of -0.6% and negative exchange rate effects of
-1.3 %. Merck achieved very strong organic sales growth of 10.2% with the fertility treatment Gonal-f. This was primarily due to the favorable competitive situation in North America, which Merck continued to benefit from. Including negative exchange rate effects of -0.9%, sales grew to € 182 million (Q3 2015: € 167 million).

EBITDA pre exceptionals of the Healthcare business sector rose in the third quarter by 5.2% to € 565 million (Q3 2015: € 537 million). Apart from organic developments, this was also due to the release of provisions amounting to around € 40 million, which had originally been set up for the termination of clinical development projects. Consequently, the EBITDA margin pre exceptionals of Healthcare improved in the third quarter to 33.5 % (Q3 2015: 31.5%).

Life Science generates strong organic sales growth
Thanks to demand from the biotech industry for Merck products, the Life Science business sector achieved strong organic sales growth of 5.7% in the third quarter. Furthermore, the acquisition of Sigma-Aldrich led to an additional 77.4% jump in sales. In the third quarter, foreign exchange had no impact. Consequently, Life Science sales rose by 83.1% to € 1.4 billion (Q3 2015: € 759 million).

With Life Science, the Process Solutions business area, which markets products for the entire pharmaceutical production value chain, again delivered strong organic sales growth in the third quarter with an increase of 10.1%. The main driver was growing demand for filtration and single-use products. The Research Solutions business area, which focuses on academia and pharmaceutical research institutions, reported a slight organic sales decline of -0.4%. Sales by Applied Solutions, which serves clinical and diagnostic testing laboratories as well as the food and environmental industries, grew organically by 3.3%.

EBITDA pre exceptionals of the Life Science business sector climbed by 110.7% to € 424 million in the third quarter (Q3 2015: €  201 million). The EBITDA pre exceptionals margin of Life Science improved significantly to 30.5% (Q3 2015: 26.5%).

Performance Materials maintains high profitability
Net sales of the Performance Materials business sector declined organically in the third quarter by -5.8%, which was primarily due to the expected continued destocking by display industry customers. However, the acquisition-related sales increase of 3.5% attributable to the SAFC Hitech business of Sigma-Aldrich, which has been integrated into the Performance Materials business sector, had a positive impact. In addition, slightly positive exchange rate effects of 1.0% were recorded. Net sales by the Performance Materials business sector thus decreased by -1.3% to € 645 million (Q3 2015: € 653 million).

The Display Materials business unit recorded an organic decline in sales versus a strong year-earlier comparative base. This was due to volume declines of older liquid crystal technologies as well as continued customer destocking. The Integrated Circuits Materials business unit achieved strong organic growth. The business with deposition materials for chip production, which was added to the product portfolio as a result of the acquisition of the SAFC Hitech business of Sigma-Aldrich, performed well.

EBITDA pre exceptionals of Performance Materials fell in the third quarter by -5.4% to € 282 million (Q3 2015: € 298 million). With an EBITDA pre exceptionals margin of 43.7%, the profitability of Performance Materials, which has meanwhile achieved good diversification, was the highest among all the business sectors (Q3 2015: 45.5%).

"We are committed to sustainably securing our market and technology leadership in display materials, whether in liquid crystals, for which we are launching our new, energy-saving SA-VA technology for televisions, or in OLED materials," said Stefan Oschmann. "In addition, we want to leverage our liquid crystals expertise in areas beyond displays, for example in liquid crystal windows."
Merck raises earnings forecast owing to Healthcare
For 2016, Merck continues to expect a moderate organic increase in Group sales in comparison with the previous year. In the third quarter, the business developed in line with expectations. In addition, owing to the acquisition of Sigma-Aldrich, Merck continues to expect a portfolio-related net sales increase in the low double-digit percentage range in 2016. This is still expected to be countered by negative foreign exchange effects that are forecast to range between –3% and –5% due to the currency devaluations in Latin America. Merck thus continues to expect net sales of between € 14.9 billion and € 15.1 billion in 2016.

However, Merck is raising its earnings expectations and now assumes EBITDA pre exceptionals to range between € 4,450 million and € 4,600 million (previously € 4,250 million to € 4,400 million). This improved guidance is due primarily to the Healthcare business sector, which recorded the previously mentioned release of around € 40 million in provisions in the third quarter for research projects terminated in previous years. On the other hand, research and development costs rose in the third quarter to a lesser extent than originally planned owing to good cost management of our research projects and conservative cost budgeting at the beginning of the year. Against this background, Merck now assumes that in the remaining months of the year, the cost increase will also be less pronounced than previously planned. Merck now expects business free cash flow to range between € 3,250 million and € 3,360 million (previously: € 3,140 million to € 3,250 million).
Forecast for FY 2016

10-Q – Quarterly report [Sections 13 or 15(d)]

XBiotech has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, XBiotech, 2017, NOV 14, 2016, View Source [SID1234521567]).