On May 19, 2016 Merck, a leading science and technology company, reported significant increases in sales and earnings for the first quarter of 2016. While the acquisition of Sigma-Aldrich played a major role, the business also grew organically (Press release, Merck KGaA, MAY 19, 2016, View Source [SID:1234512594]).

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"We started off 2016 well and have grown profitably. The integration of Sigma-Aldrich is progressing quickly and we are also right on target with our debt reduction," said Stefan Oschmann, Chairman of the Executive Board, in his presentation of the quarterly figures for the first time as Merck CEO. "For 2016 we continue to expect slight organic growth for the Merck Group," said Oschmann.
Group net sales increased in the first quarter of 2016 by 20.5% to € 3.7 billion (Q1 2015: € 3.0 billion). Organically, Group sales rose by 4.7% thanks to the strong operating performance of the Healthcare and Life Science business sectors. Sales increased by 19.8% due to acquisitions, which was primarily attributable to the purchase of Sigma-Aldrich. The acquisition closed in November 2015 and the business has now been consolidated for a full quarter for the first time. Merck experienced currency headwinds of -4.0%, which were mainly due to Latin American currencies. In the first quarter, Merck grew organically in all reporting regions, especially in North America and Latin America. Due to the acquisition of Sigma-Aldrich, the share of sales attributable to North America rose considerably to 26% (Q1 2015: 20%). Accounting for 33% of Group sales, Europe was our largest region.

EBITDA pre exceptionals, the key earnings indicator of the Group, rose by 27.0% to € 1.1 billion (Q1 2015: € 853 million) thanks to the good operational performance of Healthcare and Life Science as well as the Sigma-Aldrich acquisition. Group EBIT rose by 76.8% to € 849 million (Q1 2015: € 480 million). This includes the one-time effect of the gain of around € 325 million from the sale of Kuvan, which was announced in October 2015. Merck’s net income more than doubled in the first three months of the year to € 591 million (Q1 2015: € 282 million). Earnings per share pre exceptionals rose in the first quarter of 2016 by 37.5% to € 1.54 (Q1 2015: € 1.12).

Merck has started deleveraging and reduced its net financial debt in the first quarter by € 581 million to € 12.1 billion. This follows the strong increase in debt at the end of 2015 due to the acquisition of Sigma-Aldrich. As with major acquisitions in the past, Merck is aiming to rapidly and extensively reduce its debt. Merck had 50,259employees worldwide on March 31, 2016.

Healthcare posts good organic growth
The Healthcare business sector achieved good organic sales growth of 5.4% in the first quarter of 2016, growing organically in all regions except for Europe. This was canceled out by negative foreign exchange effects of -6.8%. In addition, the return of the rights to Kuvan to BioMarin Pharmaceuticals lowered sales by -1.0%. Consequently, Healthcare net sales decreased by -2.4% in the first quarter of 2016 to € 1.6 billion (Q1 2015: € 1.7 billion).

Rebif, which is used to treat relapsing-remitting multiple sclerosis, sustained a slight organic sales decline of only -1.5% in the first quarter of 2016 despite increasing competitive pressure from oral formulations. Amid slightly negative currency effects of -0.2%, Rebif sales amounted to € 422 billion (Q1 2015: € 430 million). Sales of the oncology drug Erbitux grew organically by 3.8%. Including currency headwinds of -3.2%, Erbitux sales were stable at € 207 million (Q1 2015: € 205 million). With Gonal-f, the leading recombinant hormone used in the treatment of infertility, Merck achieved strong organic sales growth of 17.0% in the first quarter. Including negative exchange rate effects, sales rose to € 187 million (Q1 2015: € 164 million).

EBITDA pre exceptionals of the Healthcare business sector grew by 10.3% to € 508 million (Q1 2015: € 461 million) thanks to solid organic performance and the end of commission expenses stemming from the co-promotion of Rebif with Pfizer, despite increased R&D spending primarily for the avelumab program in immuno-oncology.

As part of the strategic transfer of products in the Healthcare business sector, as of January 1 we shifted vitamin preparations in India from the Biopharma business to Consumer Health, where they complement the existing business. The annual sales volume of the transferred business is around € 45 million.

Life Science increases profitability both organically and through acquisition
Sales increased in the Life Science business sector in the first quarter of 2016 by 89.3% to € 1.4 billion (Q1 2015: € 738 million). Apart from solid organic growth of 8.9% across all regions, the acquisition of Sigma-Aldrich fueled sales by 81.6% or € 602 million. By contrast, foreign exchange effects only had a minor impact of
-1.3% in the reporting period.

The Process Solutions business area, which markets products and services for the entire pharmaceutical production value chain, generated strong organic sales growth of 15.9%. Applied Solutions, which serves clinical and diagnostic testing laboratories as well as the food and environmental industries, posted an organic sales increase of 3.6%. The Research Solutions business area, which focuses on academia and pharmaceutical research institutions, generated organic sales growth of 2.0%

At € 393 million, EBITDA pre exceptionals of Life Science in the first quarter was more than two times higher than in the year-earlier quarter (Q1 2015: € 184 million). The EBITDA margin pre exceptionals rose to 28.1% (Q1 2015: 25.0%).

Merck is making good progress with the integration of Sigma-Aldrich. "Since completing the acquisition in November, we have added around half of the addressable legacy Merck Millipore portfolio to the industry-leading Sigma-Aldrich e-commerce platform in the United States and 30% in Europe," said Merck CEO Oschmann.

OLED business of Performance Materials is growing further
In the first quarter, net sales of the Performance Materials business sector grew by 0.9% to € 622 million (Q1 2015: € 617 million). This reflects acquisition-related sales increases of 2.7%, which were due to the consolidation of the SAFC Hitech business of Sigma-Aldrich. Organically, sales decreased by -2.4%. This decline in sales was primarily due to the expected destocking by display industry customers.

In the Display Materials business unit, the partly strong growth seen with the innovative liquid crystal technologies such as UB-FFS could not fully offset the volume decline of older liquid crystal technologies as well as destocking by customers. However, Display Materials maintained its market leadership position. The Pigments & Functional Materials business unit delivered moderate organic growth. The Integrated Circuit Materials business unit, which includes the business with materials used to manufacture integrated circuits as well as the SAFC Hitech business from Sigma-Aldrich, generated solid organic sales growth. Within the Performance Materials business sector, the highest growth rates were achieved by the Advanced Technologies business unit. This was primarily due to the expanding business with OLED materials. A new OLED materials production unit in Darmstadt involving an investment of around € 30 million is to be commissioned in the summer to manufacture materials for ultra-modern displays and lighting.

At € 273 million, EBITDA pre exceptionals of Performance Materials was at the previous year’s level (Q1 2015: € 277 million).

Merck confirms and specifies outlook for 2016
Merck has confirmed the qualitative forecast given with the publication of the 2015 Annual Report in March 2016 and specified it. Due to the good business performance in the first quarter, Merck assumes that Group net sales will increase to between € 14.8 billion and € 15.0 billion in 2016 and continues to expect slight organic sales growth. Owing to the acquisition of Sigma-Aldrich, Merck expects a portfolio-related increase in net sales in the low double-digit percentage range. This will be countered by negative foreign exchange effects predicted to range between –3% and –5%, due especially to the continued devaluations of Latin American currencies. The forecast for EBITDA pre exceptionals at Group level in 2016 is between € 4.1 billion and € 4.3 billion. Business free cash flow of the Merck Group is expected to be between € 3.1 billion and € 3.3 billion in 2016. Merck expects earnings per share pre exceptionals of € 5.65 to € 6.00.

Forecast for FY 2016

€ million
Net sales
EBITDA pre exceptionals
Earnings per share pre exceptionals

Merck Group
~14,800 – 15,000
~4,100 – 4,300
€ 5.65 – € 6.00

Healthcare
Slight organic growth, slightly negative portfolio effect due to the divestment of Kuvan
~ 1,800 – 1,900

Life Science
Organic growth in the mid-single-digit percentage range, high double-digit percentage portfolio effect due to the acquisition of Sigma-Aldrich
~1,620 – 1,670

Performance Materials
Organic stable
~ 1,100 – 1,150

Corporate and Other
-400 – -370

Merck Group – Key figures
€ million
Q1 2016
Q1 2015
Change

Net sales
3,665
3,041
20.5%

Operating result (EBIT)
849
480
76.8%

Margin (% of net sales)
23.2%
15.8%

EBITDA
1,282
805
59.1%

Margin (% of net sales)
35.0%
26.5%

EBITDA pre exceptionals
1,084
853
27.0%

Margin (% of net sales)
29.6%
28.0%

Earnings per share (€)
1.36
0.65
> 100.0%

Earnings per share pre exceptionals (€)
1.54
1.12
37.5%

Net income
591
282
>100,0 %

March 31,
2016
Dec. 31,
2015

Net financial debt
12,072
12,654
-4.6%

On May 19, 2016 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) reported the initiation of a biomarker-selected, multi-arm Phase 1 clinical study in metastatic colorectal, non-small cell lung, and head and neck cancers (Press release, Merrimack, MAY 19, 2016, View Source [SID:1234512581]).

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Merrimack’s first-of-its-kind basket study will use a combination of genetic and nongenetic biomarkers to match patients to appropriate novel combinations of investigational drug regimens based on their cancer’s molecular signature. This approach is expected to enable more than 95 percent of eligible patients to qualify for enrollment to one of the investigational arms of the study. Merrimack utilized its systems biology approach to identify the biomarkers and selection criteria of the study.

"This innovative trial design is a major step towards applying precision medicine in the earliest phases of clinical testing, while also ensuring that virtually every patient that enrolls in the study receives one of the investigational regimens," said Christopher Lieu, M.D., Investigator at the CU Cancer Center and Assistant Professor of Medical Oncology at the University of Colorado School of Medicine. "The difficulty with most basket studies is that they identify their patient population solely on genetic mutations, which often results in a very small percentage of patients qualifying for the investigational therapy. By targeting a combination of genetic markers and frequently activated resistance pathways, the vast majority of biopsied patients will be matched to a biomarker-selected study arm."

Merrimack’s approach to biomarker profiling and subsequent patient assignment builds on the foundation of previous basket studies. This study design has broadened its scope by also identifying molecular features in the tumor and its surrounding environment that are believed to indicate which signaling mechanisms are responsible for tumor growth and drug resistance. By exploring the dynamics of multiple molecular features, and by including multiple combinations of investigational therapies from its oncology pipeline, Merrimack expects to investigate a personalized drug regimen in almost all of the basket trial’s eligible patient population.

"We are committed to implementing precision medicine at every stage of clinical development," said Gavin MacBeath, Ph.D., Merrimack’s Senior Vice President of Translational Medicine. "At Merrimack, our research has shown that most cancers have multiple mechanisms supporting tumor growth and we are developing a number of investigational agents that are designed to block key drivers of tumor growth and resistance. We know enough about the biology of these pathways to prospectively assign patients to the investigational regimen that we believe most closely matches their specific disease. We believe this is the first trial to rationally combine novel regimens based upon specific multi-dimensional characteristics of the patient’s tumor. This unique approach is expected to provide a path forward in developing improved outcomes in difficult to treat patient populations."

All patients enrolling in the study will provide a core needle biopsy, which will be tested for KRAS and NRAS mutations and for expression of two resistance ligands – heregulin (HRG) and insulin-like growth factor 1 (IGF-1). Patients will receive Merrimack’s oligoclonal EGFR (epidermal growth factor receptor) inhibitor, MM-151, in combination with another agent that is intended to target their cancer’s mechanism of resistance to EGFR inhibition. Assignment to one of the four trial arms will be based on the following criteria:

Patients that test positive for HRG will be assigned to Group A and receive MM-151 in combination with seribantumab (MM-121), a fully human antibody designed to block heregulin-driven ErbB3 pro-survival signaling.
Patients that test negative for HRG and positive for activating mutations in either KRAS or NRAS will be assigned to Group B and receive MM-151 in combination with trametinib, a MEK inhibitor (Novartis). This regimen is designed to block signaling both upstream and downstream of RAS mutations.
Patients that test negative for HRG, wild-type for KRAS and NRAS, and positive for IGF-1 will be assigned to Group C and receive MM-151 in combination with istiratumab (MM-141), a bispecific antibody designed to block IGF-1R and ErbB3 pro-survival signaling.
Patients that test negative for both HRG and IGF-1 and wild-type for KRAS and NRAS will be assigned to Group D and receive MM-151 in combination with trametinib. This regimen is designed to block signaling from alternative receptors and to delay potential acquisition of KRAS and NRAS mutations.
MM-151, MM-121 and MM-141 are all wholly owned by Merrimack. Further information on the study will be available on clinicaltrials.gov in the coming weeks (Identifier: NCT02538627).

About MM-151

MM-151 is an oligoclonal therapeutic mixture consisting of three fully-human monoclonal antibodies designed to bind and inhibit signaling of the epidermal growth factor receptor (EGFR). EGFR-mediated signaling promotes the growth and survival of cancer cells and has long been recognized as an important drug target in several types of cancer, including colon, lung, breast, pancreatic, and head and neck cancers. MM-151 has previously been tested in a Phase 1 dose-escalation clinical trial in patients with advanced solid tumors.

About Istiratumab (MM-141)

Istiratumab is a tetravalent bispecific antibody designed to block tumor survival signals by inhibiting IGF-1R and ErbB3 (HER3) signaling. IGF-1R and ErbB3 complexes activate major signaling pathways that allow tumor cells to grow and develop resistance to chemotherapy. Currently, istiratumab is in Phase 2 testing in patients with metastatic pancreatic cancer that have a pre-defined IGF-1 biomarker profile. The U.S. Food and Drug Administration (FDA) has granted orphan drug designation for istiratumab for the treatment of pancreatic cancer.

About Seribantumab (MM-121)

Seribantumab is Merrimack’s wholly owned, fully human monoclonal antibody that targets ErbB3, a cell surface receptor that is activated by the ligand heregulin. Heregulin-driven ErbB3 signaling has been implicated as a mechanism of tumor growth and resistance to targeted, cytotoxic and anti-endocrine therapies. When used in the combination setting, seribantumab is designed to block ErbB3 signaling in order to enhance the anti-tumor effect of a combination therapy partner. Seribantumab has been investigated in multiple Phase 2 and Phase 1 clinical trials covering a broad spectrum of patient populations and drug combinations.

On May 19, 2016 Laboratory Corporation of America Holdings (LabCorp) (NYSE:LH) reported the nationwide availability of the VENTANA PD-L1 (SP142) Assay as a complementary diagnostic for TECENTRIQ (atezolizumab), a new immunotherapy treatment for patients with urothelial cancer, the most common form of bladder cancer in the U.S (Press release, LabCorp, MAY 19, 2016, View Source [SID:1234512579]). The test was developed by Roche Diagnostics and was approved on May 18, 2016 by the U.S. Food and Drug Administration (FDA) to identify patients who may benefit from treatment with Genentech’s TECENTRIQ (atezolizumab). The availability of this important new test demonstrates LabCorp’s commitment to provide world-class diagnostics to physicians and their patients.

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"LabCorp is dedicated to improving health and improving lives through the introduction of new tests and by bringing innovative medicines to patients faster," said David P. King, LabCorp’s chairman and chief executive officer. "LabCorp is particularly focused on the development of immunotherapies and tests that pair with these medicines to change the way care is provided to cancer patients, and we are pleased to be among the first laboratories to offer the VENTANA PD-L1 (SP142) assay."

Bladder cancer is the most common malignancy of the urinary system and the ninth most common form of cancer worldwide. Despite urothelial (transitional cell) cancer being the most common form of bladder cancer in the U.S., no major new therapies have been introduced for it in the past 30 years. The availability of TECENTRIQ in combination with the PD-L1 (SP142) test has the potential to significantly improve the treatment of patients diagnosed with this form of cancer. In addition to identifying the PD-L1 protein on tumor infiltrating immune cells, the assay also offers a novel immune cell scoring algorithm that can aid physicians to identify patients for whom treatment with TECENTRIQ may be the right option.

"LabCorp already offers companion diagnostic and complementary diagnostic tests to help identify patients who may benefit from new, targeted immunotherapies for the treatment of melanoma and lung cancer," said Dr. Mark Brecher, LabCorp’s chief medical officer. "The PD-L1 (SP142) assay can help change the way care is provided by helping physicians better understand the potential benefits of treatment with TECENTRIQ for their patients with bladder cancer."

On May 19, 2016 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) and Baxalta Incorporated (NYSE: BXLT) today jointly reported the initiation of a Phase 1 clinical study of Merrimack’s oligoclonal EGFR (epidermal growth factor receptor) inhibitor, MM-151, in combination with ONIVYDE (irinotecan liposome injection) plus fluorouracil (5-FU) and leucovorin in patients with RAS wild-type metastatic colorectal cancer (Press release, Merrimack, MAY 19, 2016, View Source [SID:1234512576]). Data from a prior Phase 1 study of MM-151 supports further clinical evaluation of the investigational therapy in patients with metastatic colorectal cancer. The initiation of this study advances the development path for ONIVYDE.

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"Metastatic colorectal cancer remains a deadly disease with only 11% of patients surviving five years or longer," said Dr. Emily Chan, Principal Investigator, Associate Professor of Medicine and GI Medical Oncologist, Vanderbilt-Ingram Cancer Center. "As our understanding of the dynamics of cancer cells increases, we are able to develop and explore novel targeted combination therapies to combat this deadly disease. This study is a significant step forward toward addressing this unmet medical need, and providing a potential new treatment option to patients facing this deadly disease."

This Phase 1 study will assess the safety and tolerability of the combination of MM-151, a novel antibody mixture of three human antibodies designed to target EGFR which promotes tumor growth, and ONIVYDE, also known as MM-398 or "nal-IRI," plus 5-FU and leucovorin as first or second-line treatment in patients with RAS wild-type metastatic colorectal cancer.

"We are excited to initiate this Phase 1 clinical study, which will enable us to evaluate MM-151 in combination with the ONIVYDE regimen," said J. Marc Pipas, M.D., Medical Director at Merrimack. "Preclinically, MM-151 has shown superior inhibition of the EGFR pathway compared to FDA approved EGFR inhibitors. Combining MM-151 with the ONIVYDE regimen represents an exciting opportunity to investigate a potential new treatment regimen for patients with metastatic colorectal cancer."

The trial will determine the side effect profile of MM-151 in combination with ONIVYDE plus 5-FU and leucovorin and recommended dose for subsequent trials with this combination. Eligible patients for the study must have metastatic disease, have had no prior exposure to irinotecan or an EGFR inhibitor, and have received no more than one prior line of treatment for metastatic disease. Merrimack plans to conduct the study at multiple sites in the United States. Merrimack will be solely responsible for the funding and execution of the Phase 1 study. For more information, please visit www.clinicaltrials.gov.

Merrimack and Baxalta have entered into an exclusive licensing agreement to develop and commercialize ONIVYDE outside of the United States. PharmaEngine, Inc. (Taipei, Taiwan) holds the rights to commercialize ONIVYDE in Taiwan and received the Taiwan FDA approval of ONIVYDE on October 22, 2015.

About MM-151

MM-151 is Merrimack’s wholly owned oligoclonal therapeutic mixture consisting of three fully-human monoclonal antibodies designed to bind and inhibit signaling of the epidermal growth factor receptor (EGFR). EGFR-mediated signaling promotes the growth and survival of cancer cells and has long been recognized as an important drug target in several types of cancer, including colon, lung, breast, pancreatic, and head and neck cancers. MM-151 has previously been tested in a Phase 1 dose-escalation clinical trial in patients with advanced solid tumors.

About ONIVYDE [pronounced \ ‘on – ih – vide \]

ONIVYDE (irinotecan liposome injection), also known as MM-398 or "nal-IRI," is a novel encapsulation of irinotecan in a liposomal formulation. The activated form of irinotecan is SN-38, which functions by inhibiting topoisomerase I (an essential enzyme involved in DNA transcription and replication) and promoting cell death. ONIVYDE was approved by the U.S. Food and Drug Administration in combination with fluorouracil and leucovorin for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. For full prescribing information, including Boxed WARNING, please visit www.ONIVYDE.com.

On May 19, 2016 Celator Pharmaceuticals, Inc. (Nasdaq: CPXX) reported that the United States Food and Drug Administration (FDA) granted Breakthrough Therapy designation to VYXEOS (also known as CPX-351) (Press release, Celator Pharmaceuticals, MAY 19, 2016, View Source [SID:1234512570]). VYXEOS is an investigational product in development as a treatment for AML and other blood cancers.

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The Breakthrough Therapy designation is primarily based upon the positive results from the pivotal Phase 3 clinical trial in older patients with previously untreated high-risk (secondary) AML. The designation is for the treatment of adults with therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC). This designation includes the patient populations enrolled in the Phase 3 clinical trial.

The Phase 3 trial met its primary endpoint demonstrating a statistically significant improvement in overall survival. Data will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2016 Annual Meeting on Saturday, June 4th.

The median overall survival for patients treated with VYXEOS in the study was 9.56 months compared to 5.95 months for patients receiving 7+3, representing a 3.61 month improvement in favor of VYXEOS. The hazard ratio (HR) was 0.69 (p=0.005), which represents a 31% reduction in the risk of death versus 7+3. The percentage of patients alive 12 months after randomization was 41.5% on the VYXEOS arm compared to 27.6% on the 7+3 arm. The percentage of patients alive 24 months after randomization was 31.1% on the VYXEOS arm compared to 12.3% on the 7+3 arm.

Sixty-day all-cause mortality was 13.7% versus 21.2%, in favor of patients treated with VYXEOS.

No substantial difference in Grade 3-5 adverse events was observed between VYXEOS and 7+3. In the intent-to-treat population, Grade 3-5, hematologic adverse events were similar for overall infections, febrile neutropenia, and bleeding events. In the intent-to-treat population, Grade 3-5, non-hematologic adverse events were similar across all organ systems, including cardiac, gastrointestinal, general systems, metabolic disorders, musculoskeletal, nervous system, respiratory, skin and renal.

"We are very happy the FDA granted Breakthrough Therapy designation for VYXEOS," said Scott Jackson, Chief Executive Officer of Celator Pharmaceuticals. "The breadth of the designation, which includes all adults with t-AML and AML-MRC, is encouraging as AML patients are in need of advancements in treatment. We look forward to working with the FDA to bring VYXEOS to patients as quickly as possible."

FDA awards Breakthrough Therapy designation in order to expedite the development and review of new medicines that are intended to treat serious or life-threatening diseases when the therapy has demonstrated substantial improvement over available therapies on at least one clinically significant endpoint or when there is significant unmet medical need.

Celator plans to submit a New Drug Application (NDA) to the FDA by the end of the third quarter of 2016.