Boehringer Ingelheim Started safety of OFEV Study

Boehringer Ingelheim announces the initiation of clinical trial, a new 12 week study to assess the safety, tolerability and pharmacokinetics of add-on treatment with pirfenidone to background therapy with OFEV in patients with idiopathic pulmonary fibrosis (IPF). The trial’s primary endpoint is the percentage of patients with on-treatment gastrointestinal (GI) adverse events from baseline to week 12.

IPF is a rare condition that causes thickening and scarring of the lung tissue over time, a process known as fibrosis. This fibrosis limits the amount of oxygen that can be delivered to the major organs and also causes difficulty breathing. The median survival of IPF patients following diagnosis is just 2-3 years, underlining the importance of early and accurate diagnosis and the vital role of treatments that can help to slow disease progression.

SANOFI AND BOEHRINGER INGELHEIM ON BUSINESS SWAP

Sanofi and Boehringer Ingelheim announced that the companies have entered into exclusive negotiations to swap businesses. The proposed transaction would consist of an exchange of Sanofi animal health business ("Merial") with an enterprise value of €11.4 bn and Boehringer Ingelheim consumer healthcare (CHC) business with an enterprise value of €6.7 bn. Boehringer Ingelheim CHC business in China would be excluded from the transaction. The transaction would also include a gross cash payment from Boehringer Ingelheim to Sanofi of €4.7 bn.

The transaction would allow Sanofi to become the number one ranked player in CHC with expected pro formasales of approximately €5.1 bn in 2015(e) and a global market share close to 4.6%1. Sales of Boehringer Ingelheim CHC business (excluding China) are estimated at about €1.6 bn for 2015 and are highly complementary with those of Sanofi CHC, both in terms of products and geographies. Boehringer Ingelheim CHC would improve the position of Sanofi in Germany and Japan where Sanofi CHC presence is limited, and expand Sanofi presence in its Priority Categories. Sanofi would gain access to iconic brands in Antispasmodics, Gastrointestinal, VMS and Analgesics, and attain critical mass in Cough & Cold. Sanofi CHC business in the US, Europe, Latin America and Eurasia would also expand significantly, giving it multiple leadership postions in key countries and/or on key product categories. 

The animal health industry is a very attractive industry in terms of innovation, growth potential and profitability. Combining Merial's and Boehringer Ingelheim's complementary strengths would create the second largest player in the global animal health market with pro forma sales of approximately € 3.8 bn in 2015(e) with the ability to compete for global market leadership. The combined portfolios and technology platforms in anti-parasitics, vaccines and pharmaceutical specialities would place the combined company in the key growth segments of the industry. The species portfolios are highly complementary building on Merial's expertise in companion animals and poultry and BI's expertise in swine.

Boehringer Ingelheim and MD Anderson Cancer Center in Collaboration

Boehringer Ingelheim and The University of Texas MD Anderson Cancer Center announced a collaboration focused on developing innovative medicines for pancreatic ductal adenocarcinoma (PDAC). The new collaboration combines MD Anderson’s unique understanding of potential drivers of PDAC with Boehringer Ingelheim’s experience in drug discovery and development. 

Pancreatic cancer accounts for four percent of cancer deaths worldwide (330,000 people) and is the seventh most common cause of death from cancer. Pancreatic cancer is anticipated to become the second leading cause of cancer-related death in the United States before 2030. Newly diagnosed patients have a median survival of less than one year, and a 5-year survival rate of only 3 to 5 percent. PDAC is one of the most lethal of cancers due to its late detection and resistance to available standard-of-care therapy. Effective medicines directed against PDAC are therefore urgently needed. 

The collaboration will focus on identifying and developing therapeutic concepts in novel target areas as well as identification of biomarkers that can accurately identify patients who would respond to potential new therapies. 

Boehringer Ingelheim initiates efficacy and safety of BI 1482694

Boehringer Ingelheim announced at the BIO-Europe® conference in Munich, Germany, the initiation of a global Phase II trial evaluating the efficacy and safety of BI 1482694 (HM61713) in patients with T790M mutation-positive non-small cell lung cancer (NSCLC), whose tumours stopped responding to currently available epidermal growth factor receptor (EGFR) directed therapies. The primary endpoint of this trial, which is the first in a broad clinical development programme for BI 1482694, is objective response rate (ORR). 

BI 1482694 is a novel, third-generation, oral, irreversible EGFR mutant-specific tyrosine kinase inhibitor (TKI) developed to specifically target tumours with T790M mutations. At this year’s American Society of Clinical Oncology (ASCO) Annual Meeting, interim results of the Phase I/II clinical trial indicated strong efficacy signals in patients with such tumours, combined with a favourable safety profile.¹ The T790M mutation is known as the most common resistance mechanism to develop in response to treatment with EGFR TKIs. It is found in approximately 50-60% of patients who previously received EGFR TKI therapy. There are currently no EGFR-directed therapies approved specifically for the treatment of this mutation, representing an area of great unmet need for these patients. 

Boehringer Ingelheim licenses Vectron Biosolutions’ expression technology platform

Boehringer Ingelheim, a research-based, global pharmaceutical company, announced today the licensing of Vectron Biosolutions’ expression technology platform.

This non-exclusive license agreement comes as a result of a successful joint feasibility study between the two companies in which Vectron’s proprietary genetic elements were tested for high-yield, soluble production of a protein of interest to Boehringer Ingelheim in Escherichia coli. This agreement gives Boehringer Ingelheim the right to use Vectron’s technology for both production of biopharmaceutical products from their own in-house pipeline, and as part of the Boehringer Ingelheim BioXcellence™ offerings in contract manufacturing.

Vectron Biosolutions was founded in 2008 based on the expression vector technology developed in Professor Svein Valla’s research group at the Norwegian University of Science and Technology, in Trondheim, Norway. The company offers research and development services using its proprietary expression technology platform that has been developed for production of proteins in E. coli and other bacteria. This modular technology is comprised of vector backbones and genetic libraries of Pm promoters, xylS transcription regulators, 5’-UTRs, and signal peptides. Using combinations of these elements it is possible to design expression vectors that are optimized for high-yield, soluble expression of numerous proteins in E. coli and in other bacteria. Vectron Biosolutions is a privately owned company.