January - April 2020
Boehringer Tngelheim, Enleofen Tnk $1B-Per-Product Anti-TL-11 Partnership Focused on NASH, Lung Disorders
Boehringer Ingelheim announced that it has acquired exclusive global rights to Enleofen Bio's preclinical
interleukin-11 (IL-11) platform to develop new therapies for non-alcoholic steatohepatitis (NASH), interstitial lung diseases (ILDs), and multiple other fibrotic human disorders, in a deal that could generate more than $1 billion per product developed. Through their new collaboration, Boehringer Ingelheim agreed to advance Enleofen’s platform in to clinical development by working with AMC researchers, with an initial focus on NASH andILDs—twocorediseasefocusareasforBoehringerIngelheim.Thecompaniessaidtheycouldexpandtheir partnership into additional fibro-inflammatory conditions based on IL-11's central role in disease.
Rise in R&D Efforts to Push Rare Neurological Disease Treatment Market
According to TMR Research, the global market for rare neurological disease treatment will be driven by the rise in the number of initiatives and incentive policies by government organizations in the field of rare neurological disease treatment. Increased interest among new pharmaceutical companies and several well-established market players and a vast rise in R&D activities in the field has been observed in the recent years. The market is expected to expand at a promising pace over the next few years owing to these factors. Governments across the globe are also putting more focus on the provision of suitable treatment options for rare neurological diseases and guidelines to affected families. Increased efforts into the improvement of diagnostic procedures for a number of rare neurological conditions could also drive the market.
AbbVie, Allergan Merger May Face Regulatory Delay Due to COVTD-19 Despite Drug Sell-off: Report
AbbVie and Allergan are looking for a quick close for their $63 billion merger after agreeing to sell off three drugs to help clear antitrust hurdles. AbbVie and Allergan signed a "consent decree" with the FTC to divest late- stage gastrointestinal candidate brazikumab and two pancreatic replacement enzymes. Earlier in March, the pair closed that sale in the EU for the merger's approval. But despite AbbVie's high hopes of closing the merger in two short months, regulators are warning that the continuing novel coronavirus pandemic could knock that plan off the rails. The FTC said it may consider requesting extensions if companies are not able to produce documents and employees in a timely manner for a review.
Amid a Pandemic, Roche Bets $190M on Arrakis and Drugging RNA
Roche will pay privately held Arrakis Therapeutics $190 million in a wide-ranging deal to co-develop small molecule drugs that target RNA molecules. Cambridge, Massachusetts-based Arrakis will handle the early drug development work, after which Roche can license those that show promise and take the lead on clinical testing. The deal includes a variety of conditional payments that could ultimately exceed “several billion dollars,” though that cash is tied to milestones and may never materialize. Arrakis is one of several emerging companies aiming to target shifty RNA molecules with chemical drugs. Their approach offers the potential to reach drug targets inside cells that are difficult to get at through other methods.
Coronavirus Prompts Hospitals to Fast-Track Telemedicine Projects
Hospitalchiefinformationofficersareputtinginplacenewsystemsandworkflowstogetaheadofagrowing coronavirus epidemic that threatens to tax limited resources and staff. Some health systems are fast-tracking planned technology projects such as telemedicine, aimed at screening patients without requiring them to visit a hospital. To support the new telemedicine effort, the health system also is speeding up software upgrades to Microsoft Corp.'s Windows 10 and Office 365 on PCs at about 60 locations. Doctors will use Microsoft Teams as a collaboration tool for videoconferencing with patients and, if necessary, with other specialists.
Digital Molecule Designer Schrodinger Taps Google Cloud for Parallel Computing
Schrödinger aims to upload its digital drug discovery efforts to Google’s cloud network with plans to employ thousands of processors to simulate billions of potential compounds per week. The three-year collaboration with Google Cloud is designed to substantially increase the speed and capacity of its physics-based molecule modeling platform, with supercomputer-level power being distributed among nationwide centers. “This partnership is expected to allow us to expand the use of our physics-based computational platform to continue to rapidly explore very large swaths of chemical space,” Brauner said in a statement. The agreement comes on the heels of Schrodinger's Nasdaq IPO last month—which went on to raise about $232 million—to help boost its own early pipeline of internally developed drugs.
Takeda's Small Celiac Disease Bet Turns into Acquisition
Takeda has exercised its option to buy U.S.-based PvP Biologics after seeing Phase 1 data from its only candidate, a celiac disease drug called KumaMax that was invented by a University of Washington undergraduate team. The deal will be worth up to $330 million for PvP’s owners, based on development and regulatory milestones for KumaMax, which will now be called TAK-062. Takeda signed PvP to an option deal in 2017, which provided
$35 million to cover research costs and allowed the company to bypass traditional venture capital funding. In Takeda's pipeline, TAK-062 will join TAK-101, in-licensed from COUR Pharmaceutical in 2019, in clinical trials for celiac disease.
Be Careful With Biosimilars Marketing, FDA and FTC Say. We're Watching
The FDA and the Federal Trade Commission (FTC) recently reinforced a commitment to address misleading promotions and anti-competitive practices. The two agencies released a joint statement detailing their promise to police promotional messaging as well as review patent agreements to prevent antitrust collations, share best practices and collaborate on public outreach. In the issued statement, the FDA also announced new draft guidance which notes that companies should be careful when using a reference product and a biosimilar product and should avoid suggesting that a biosimilar product is not highly similar to a reference product or that there are clinically meaningful differences.
Bristol-Myers Launches Biotech Targeting Fibrosis, Inflammation
Bristol-Myers Squibb and partner BioMotiv, a biopharma accelerator, launched a new company focused on creating inflammation and fibrosis medicines. The company, Anteros Pharmaceuticals, is investigating a new class of drugs with intellectual property developed at Yale University and in-licensed by Bristol-Myers. In addition to the IP, Bristol-Myers is contributing data and reagents for a series of small molecules that work on an undisclosed mechanism. Anteros' initial targets are liver and lung fibrosis, with one specific disease being IPF, or idiopathic pulmonary fibrosis. Per deal terms, BioMotiv will monitor the early stages of research and development. If or when Anteros nominates a pre-clinical candidate, Bristol-Myers Squibb has the right to acquire the company.
Lilly Announces Agreement to Acquire Dermira for $1.1B
Eli Lilly and Company and Dermira, Inc have announced a definitive agreement for Lilly to acquire Dermira for $18.75 per share, or approximately $1.1 billion, in an all-cash transaction. This acquisition expands Lilly's immunology pipeline with the addition of lebrikizumab, a novel, investigational, monoclonal antibody for the treatment of moderate-to-severe atopic dermatitis in adolescent and adult patients, aged 12 years and older.The acquisition agreement also expands Lilly's portfolio of marketed dermatology medicines with the addition of QBREXZA, a medicated cloth approved by the US Food and Drug Administration for the topical treatment of primary axillary hyperhidrosis (uncontrolled excessive underarm sweating). Under the terms of the agreement, Lilly will commence a tender offer to acquire all outstanding shares of Dermira, Inc.
Biogen Finds $75M Home for Pfizer Alzheimer's Drug
In an unusual deal between large drugmakers, Biogen will pay Pfizer $75 million to acquire an experimental drug designed to address sleep-related symptoms of Alzheimer's and Parkinson's disease. Pfizer has completed early-stage safety studies for the drug, but in 2018 decided to step back from neuroscience research, offloading some of its investigational therapies into a spin-off called Cerevel Therapeutics. For Biogen, the deal adds another Alzheimer's asset to its pipeline of five therapies aimed at the neurodegenerative condition. That line-up includes the controversial aducanumab, which the Cambridge, Massachusetts-based biotech plans to submit for
U.S. approval this year.