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Acquisition
DWK Life Sciences acquires Müller + Müller-Joh.

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The world’s leading manufacturer of laboratory glass and life science packaging materials, DWK Life Sciences, announces the signing of a definitive purchase agreement of Müller + Müller at August 21st, 2020. Müller + Müller is one of the leading German manufacturers of primary packaging materials made of tubular glass for the pharmaceutical industry. The company will become part of the DWK Life Sciences group upon closing, which is expected for September. Müller + Müller will continue to serve its customers under the same name and will continue to be managed by CEO Florian Müller-Stauch. Dr. Hubertus Müller-Stauch (owner of the company Müller + Müller) will join the advisory board of DWK Life Sciences to support the further expansion of the pharma packaging division.

Müller + Müller is based in Holzminden in Lower Saxony, Germany, and currently employs 135 staff. The family-run company is a key player in the manufacture of vials and has a long history of over 95 years. Thanks to its state-of-the-art technology and continuous process optimisation, Müller + Müller meets the highest quality requirements for pharmaceutical packaging. Every year approx. 300 million glass type I vials are produced at its Holzminden site in accordance with GMP guidelines. Type I borosilicate glass is an excellent material for storing vaccines as the glass is virtually inert. This means that the container glass does not react with its contents and thus represents the standard in vaccine packaging.

“Acquiring the family business Müller + Müller is a significant strategic step for us in expanding our activities in the market for pharmaceuticals packaging,” explains CEO of DWK Life Sciences, Armin Reiche. “We are not just investing in an important growth market here, but also in a company that boasts first class production technology and highly reliable products.”

“Driven by the high demand of the vaccine industry for vials, expansion of our production capacities is the next logical step,” says Florian Müller-Stauch, CEO of Müller + Müller. “We are delighted to have found a strong and reliable partner in DWK who will allow us to further develop our business.”

DWK Life Sciences is a portfolio company of One Equity Partners, a middle market private equity firm that builds market-leading companies by identifying and executing transformative business combinations and partnering with management teams to provide operational support to accelerate growth.

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Pharmaceuticals

Data in Multiple Cancers at ESMO 2020
Merck Advances Oncology Portfolio and Pipeline

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Merckabstracts today announced more than 30 abstracts will be presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 from September 19-21. The abstracts span the Company’s clinical program in oncology across several innovative modalities and mechanisms that have the potential to advance treatment across a range of tumor types including biliary tract, lung and urothelial (bladder) cancers.

“Our oncology ambition is to discover innovative therapies with transformative results. The data being presented in urothelial cancer demonstrate this approach in action, where we are seeing promising results for a new first-line maintenance therapeutic option with BAVENCIO® in this form of cancer,” said Luciano Rossetti, Global Head of Research & Development for the Biopharma business of Merck. “In addition, long-term follow up data in advanced lung cancer from two of our in-house developed mechanisms—our oral MET inhibitor, tepotinib, and our first-in-class bifunctional fusion protein immunotherapy targeting TGF-β/PD-L1, bintrafusp alfa—continue to show sustained impact in one of the leading causes of cancer mortality.”

(Presentations #699O; 704MO; 745P). Primary results from the JAVELIN Bladder 100 study demonstrated an overall survival (OS) benefit for BAVENCIO vs. best supportive care in the first-line maintenance treatment of advanced urothelial carcinoma, making BAVENCIO the first and only immunotherapy to significantly prolong OS in this setting. Three new abstracts from the JAVELIN Bladder 100 study will be presented at ESMO:

  • An oral presentation during the Proffered Paper 1 – GU, non-prostate session scheduled on September 19, 2020 at 5:28pm–5:40pm CEST/11:28am-11:40am EDT, will highlight associations between clinical outcomes and exploratory biomarkers (Presentation #699O)
  • Two other abstracts provide more information on prespecified subgroup analyses, as well as patient-reported outcomes.

(Presentation #910O). Primary results from this Phase III study will be presented. The study is a demonstration of our commitment to develop options for patients with squamous cell carcinoma of the head and neck, and the results increase understanding in the field of the role of immunotherapy.

(Presentations: #1283P; 1286P; 1347P). Three posters from the largest study in patients with non-small cell lung cancer (NSCLC) harboring METex14 skipping treated with tepotinib—an oral, once-daily, highly selective MET inhibitor. Data presented will highlight:

  • Durable clinical activity that has been consistent across clinically relevant subgroups both in treatment-naïve and in previously treated patients as well as in patients with brain metastases as assessed by liquid biopsy or tissue biopsy (Poster #1283P)
  • Health-related quality of life (HRQoL) has been shown to be maintained, with clinically meaningful delays in the time to deterioration of cough, dyspnea, and chest pain (Poster #1286P)
  • A safety profile consisting of mostly mild to moderate adverse events with few treatment discontinuations.

The INSIGHT 2 study assessing the combination of osimertinib and tepotinib in patients with EGFR-mutant NSCLC that has developed resistance to first-line osimertinib treatment due to MET amplification is ongoing and actively recruiting patients (Poster #1415TiP).

Data from the INTR@PID clinical trial program for first in-class bintrafusp alfa, an investigational bifunctional fusion protein, targeting both TGF-β and PD-L1 pathways, shows promising and durable responses across multiple tumor types including NSCLC and biliary tract cancer (BTC) with a manageable safety profile in Phase I expansion cohorts.

Two long-term follow-up studies assessing efficacy and safety from the INTR@PID clinical trial program will be presented as posters at ESMO 2020:

In addition, preliminary analysis will be presented in a mini-oral presentation (#616MO) from a trial conducted by the National Cancer Institute (NCI), the Quick Efficacy Seeking Trial (QuEST) investigating a triple combination therapy (BN-brachyury [BVax] + bintrafusp alfa + N-803) in castration-resistant prostate cancer. Available on demand from September 18 at www.ESMO.org.

For the Company’s first biology-driven leader ERBITUX, a number of investigator-sponsored studies (ISS), including in combination with BAVENCIO (avelumab), continue to demonstrate its steady role across the continuum of care in metastatic colorectal cancer, and backbone of treatment of squamous cell carcinoma of the head and neck. Data demonstrating the role of ERBITUX as a promising combination partner include an oral presentation investigating avelumab plus cetuximab in pre-treated RAS wild type metastatic colorectal cancer patients as rechallenge strategy: the Phase II CAVE (cetuximab-avelumab) mCRC study. This will be presented during the Proffered Paper GI – colorectal session scheduled on September 19, 2:49pm-3:01pm CEST/8:49am-9:01am EDT (Presentation #397O)

*BAVENCIO is under clinical investigation for the first-line maintenance treatment of advanced UC and not yet approved in any markets outside of the US.

Tepotinib is the International Nonproprietary Name (INN) for the MET kinase inhibitor MSC2156119J. Tepotinib is currently under clinical investigation in NSCLC and not yet approved in any markets outside of Japan.

Bintrafusp alfa is currently under clinical investigation and not approved for any use anywhere in the world.

BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody. BAVENCIO has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, BAVENCIO has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models. In November 2014, Merck and Pfizer announced a strategic alliance to co-develop and co-commercialize BAVENCIO.

The European Commission has authorized the use of BAVENCIO in combination with axitinib for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). In September 2017, the European Commission granted conditional marketing authorization for BAVENCIO as a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC).

In the US, BAVENCIO® (avelumab) is indicated for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. BAVENCIO is also indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

BAVENCIO in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC). Additionally, the US Food and Drug Administration (FDA) granted accelerated approval for avelumab (BAVENCIO®) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

BAVENCIO is currently approved for patients with MCC in 50 countries globally, with the majority of these approvals in a broad indication that is not limited to a specific line of treatment.

The special warnings and precautions for use for BAVENCIO monotherapy include infusion-related reactions, as well as immune-related adverse reactions that include pneumonitis and hepatitis (including fatal cases), colitis, pancreatitis (including fatal cases), myocarditis (including fatal cases), endocrinopathies, nephritis and renal dysfunction, and other immune-related adverse reactions. The special warnings and precautions for use for BAVENCIO in combination with axitinib include hepatotoxicity.

The SmPC list of the most common adverse reactions with BAVENCIO monotherapy in patients with solid tumors includes fatigue, nausea, diarrhea, decreased appetite, constipation, infusion-related reactions, weight decreased and vomiting. The list of most common adverse reactions with BAVENCIO in combination with axitinib includes diarrhea, hypertension, fatigue, nausea, dysphonia, decreased appetite, hypothyroidism, cough, headache, dyspnea, and arthralgia.

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