Biopharmaceutical News Week # 2016.42

Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation, jcm9144@gmail.com

Mergers, Acquisitions and Joint Ventures

Teva Pharmaceuticals is now considering acquiring biosimilar Celltrion (Seoul, South Korea). “We will continue to investigate such opportunities as we balance risk and seek complementary skills in our partners," said Mr Yonatan Beker, director of corporate reputation. Recently Teva inked a pact with the Celltrion seeking exclusive rights to commercialize the South Korean firm's CT-P10, a potential biosimilar for Roche and Biogen's Rituxan, and CT-P6, a biosimilar of Roche's Herceptin, in Canada and the US. Teva was one of the potential bidders to acquire Celltrion back in 2014 when the Korean firm was put on sale.

The acquisition of St Jude Medical by Abbott has triggered the selling off of part of their vascular and electrophysiology units, worth around 1.12 billion to Terumo Corporation (Tokyo, Japan) in an all cash divesture. According to a statement the offloading will consist of St Jude’s Angio-Seal and Femoseal as well as Abbott’ Vado Steerable Sheah. The deal comes as St. Jude sets up a new cybersecurity medical advisory board after a battery failure issue with some of its cardiac rhythm management devices which we reported last week.

Business

Sun Pharma (New Dehli, India) enters and agreement with International Centre for Genetic Engineering and Biotechnology to develop DSV4, a vaccine against all four known strains of dengue fever in using yeast instead of live attenuated virus.

Novartis partners with Cerulean Pharma (Waltham, MA, USA) to develop nanoparticle-drug conjugates combining Novartis' compounds with Cerulean's Dynamic Tumor Targeting technology against as many as five cancer targets. Under the terms of the deal Novartis will make a $5 million upfront payment, milestone fees of up to $1.2 billion, plus sales royalties. Cerulean had a major setback in August, after its lead candidate CRLX101 failed in a combination trial with Roche’s Avastin (bevacizumab) to beat standard of care in the treatment of renal cell carcinoma.

Accurexa (Newark, DE, USA) and StemImmune (Richmond, CA, USA) enter a collaboration on the development of a stem cell-mediated cancer immunotherapy using StemImmune's immunotherapy, which targets cancer using the patient's stem cells, and Accurexa's targeted therapy delivery methods. Accurexa indicated that its delivery methods are an improvement over the current oral standard of care for delivering temozolomide to tumor sites, which is limited by the blood–brain barrier. Financial terms were not disclosed.

Urogen Pharma (Ra’anama, Israel) a drug delivery specialist enters a development deal with Allergan to improve the delivery of drugs to the urinary bladder. UroGen’s platform is based on the RTGel, a polymer that’s liquid at lower temperatures but forms a gel when heated. This characteristic eases delivery into the bladder, and helps it remain there without being excreted. Allergan shall pay a $17.5 million upfront and contingent milestones.

Vertex Pharmaceutical (Boston, MA, USA) updates its R&D collaboration with Cystic Fibrosis Foundation Therapeutics (CFTT). Under the updated agreement, CFFT will pay a $75 million upfront, as well as up to $6 million annually toward development funding. Vertex will pay CFFT royalties, ranging from low single digits to mid-single digits, on compounds first synthesized and/or tested between March 1, 2014, and August 31, 2016.

Merck KGaA and Pfizer have entered a collaboration with Debiopharm International (Lausanne, Switzerland) to assess the potential of combining Debio 1143, an oral small molecule inhibitor of Inhibitor of Apoptosis Proteins (IAPs) with avelumab an investigational fully human anti PD-L1 IgG1 monoclonal antibody, in patients with advanced or metastatic non-small cell lung cancer. Financial terms of the deal were not disclosed.

Pfizer will launch Inflectra (infliximab, dyyb) a biosimilar of Johnson & Johnson’s Remicade, in November, in the US, the first biosimilar monoclonal antibody approved by the FDA. Johnson & Johnson is contesting Pfizer’s right to do so in a lawsuit contending that the biosimilar sponsor infringes patents on cell culture media and considers that the launch will be at risk for Pfizer.

GlaxoSmithKline has decided to pull out of the US market with the HPV vaccine Cervarix leaving Merck’s Gardasil with a stranglehold position on this market at a time where public health officials push to boost vaccination rate. Last year, in the US, GSK’s vaccine “facing very low market demand”, earned just £3 million of an £88 million ($107 million) worldwide total, in sharp contrast with Merck’s global total of $1.9 billion for the Gardasil franchise. According to CDC figures of last year HPV vaccination rates were at 40% for girls and 21% for boys, far short of a US Department of Health and Human Services goal of 80% for both boys and girls by 2020. This week, a CDC committee recommended a two-dose schedule, at least six months apart, for children 15 and under. Recipients aged 15 to 26 will still need to get three doses.

Approval of drugs and vaccines

The European Medicines Agency has approved Shire’s Onivyde, a pegylated liposomal irinotecan hydrochloride trihydrate, as a treatment metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil (5-FU) and leucovorin (LV) in adult patients who have progressed following gemcitabine-based therapy. The drug had been approved by the US FDA in July. The drug was originally developed by Baxalta, which was acquired by Shire earlier this year.

US FDA approves Roche/Genentech’s Tecentriq, or atezolizumab, the first anti-PDL1 cancer immunotherapy approved for the treatment of advanced non-small cell lung cancer (NSCLC) in patients in whom platinum-containing chemotherapy has failed or is failing, regardless of their PD-L1 status. Tecentriq was already approved in the US to treat locally advanced or metastatic urothelial carcinoma (mUC) back in May. The drug will be competing head-to-head with Merck’s Keytruda and Bristol-Myers Squibb’s Opdivo with a list price of $12,500, on par with its rivals.

Drugs at clinical stage

The European Medicines Agency's Committee for Medicinal Products for Human Use is recommending:

Teva Pharmaceutical’s Trisenox or arsenic trioxide as a treatment for newly diagnosed low to intermediate risk acute promyelocytic leukemia (APL), a rare type of acute myeloid leukemia that can rapidly be life-threatening due to uncontrollable bleeding. The drug was already approved in Europe for relapsed or refractory APL.

Intercept Pharmaceutical’s (New York City, NY, USA) orphan drug Ocaliva or obeticholic acid, for the treatment of the rare, chronic and life-threatening liver disease primary biliary cholangitis, in combination with ursodeoxycholic acid (UDCA) for adults whose treatment with UDCA is inadequate or as a monotherapy for adults who can't tolerate UDCA.

AbbVie's orphan drug Venclyxto or venetoclax, for the treatment of adults with chronic lymphocytic leukaemia (CLL).

Advanced Accelerator Applications' (Rosières-près-Troyes, France) orphan therapy SomaKit-TOC (edotreotide) for the diagnosis of gastro-entero-pancreatic neuroendrocrine tumours

Cystadrops orphan drug or mercaptamine for the treatment of corneal cystine crystal deposits in patients with cystinosis, a rare genetic metabolic disease that causes build up of the amino acid cystine in various organs of the body.

Ferring Pharmaceuticals'(Saint Prex, Switzerland) Rekovelle or follitropin delta for approval for controlled ovarian stimulation in women undergoing assisted reproductive technologies.

As well as three generics to treat HIV infection in adults:

Mylan’s Emtricitabine/Tenofovir disoproxil (emtricitabine/tenofovir disoproxil)

KrKa Emtricitabine/Tenofovir disoproxil (emtricitabine/tenofovir disoproxil)

and Mylan Tenofovir disoproxil (tenofovir disoproxil).

The European Medicines Agency grants orphan status:

to Abeona Therapeutics’ (Dallas, Texas, USA) ABO-102, a gene therapy, as a treatment for patients with the rare autosomal recessive disease Sanfilippo syndrome type A, a rare autosomal recessive disease that causes neurocognitive decline, speech loss, loss of mobility, and premature death in children. The drug also received orphan and rare pediatric disease designations from the US FDA

…and to Eiger Biopharmaceuticals (Palo Alto, CA, USA)’ extendin 9-39 for the treatment of non-insulinoma pancreatogenous hypoglycemia syndrome (NIPHS)

US FDA grants accelerated approval to Eli Lilly’s Lartruvo, or olaratumab, combined with doxorubicin as a treatment for advanced soft tissue sarcoma in patients who cannot be treated with surgery or radiotherapy.

US FDA grants orphan status to True North’s (South San Francisco, CA, USA) TNT009, as a treatment for autoimmune hemolytic anemia, including cold agglutinin disease.

US FDA has placed on hold a Phase IIb study assessing Teva and Regeneron's fasinumab, an investigational nerve growth factor inhibitor, for chronic low back pain, after the emergence of a case of adjudicated arthropathy (joint disease) in a patient receiving a high dose of fasinumab and who had advanced osteoarthritis at study entry.

Alkermes (Dublin, Ireland) reports positive topline results in a third pivotal phase 3 program for ALKS 5461, an oral investigational combination drug formulation of buprenorphine and samidorphan, acting as a κ-opioid receptor (KOR) antagonist, for the adjunctive treatment of major depressive disorder

Medical Devices and Diagnosis News

US FDA clears Philips’ cardiac transducer for use with Lumify, a smart device diagnostic ultrasound. The Lumify package consists of an app and two transducers for use with an Android smartphone. The app connects to the cloud, where clinicians may access data and images through Philips’ HealthSuite Digital Platform. In addition to cardiac and abdominal scanning, Lumify also provides focused assessment with sonography for trauma (FAST) examinations.

Johnson & Johnson Innovation (JJI) is creating a new Center for Device Innovation at the Texas Medical Center (TMC) in Houston, which is intended to enable the entire process of creating “breakthrough” medical devices. The new center will include a space for internal projects, as well as for J&J partner companies. It’s intended to enable rapid prototyping for early and midstage product development. The center will also have access to the preclinical facilities at Baylor College of Medicine, Houston Methodist Research Institute, and the Texas Heart Institute (THI).

Cost, Pricing and Market Access

The UK National Institute for Health and Care Excellence recommends the use of Amicus Therapeutics’s (Cranbury, NJ, USA) Galafold or migalastat, for the treatment of the rare genetic disorder Fabry disease, at a price tag of £210,000 per patient per year. Fabry disease is caused by the enzyme alpha-galactosidase A (α-GalA) responsible for breaking down fatty substances in the body's cells, which leads to accumulation of fats in blood vessel walls throughout the body, particularly those in the skin, kidneys, heart, brain and nervous system.

Miscellaneous

The Boston Globe reports the first case of a Mixed Martial Arts cage fighter, 25 years of age, to be publicly identified as having been diagnosed with the degenerative brain disease known as chronic traumatic encephalopathy (CTE). The diagnosis was disclosed by Dr. Bennet Omalu, a forensic pathologist who first discovered CTE in a professional football player (in 2003) and in a professional wrestler (in 2007).

The US is loosening restrictions to Cuba and is clearing the way for US and Cuban researchers to collaborate in a series of disease areas inclunding lung cancer, Zika, chikungunya and dengue. A Cuban- made lung cancer vaccine, CimaVax will be evaluated in a clinical trial at Roswell Park Cancer Institute in Buffalo (NY).

Polyphor (Allschwil, Switzerland) has announced the appointment of Giacomo Di Nepi as its new CEO. He will assume responsibilities on November 1^st. Michael Altorfer, the current CEO, who was appointed just one year ago, will support Giacomo over the coming months to facilitate the transition and then leave the company to pursue other opportunities.

The US FDA has released a draft document focused on the requirements for clinical evaluation of software-as-a-medical devices (SaMD). It aims to “harmonize” US policy with the guidance prepared by the International Medical Device Regulators Forum (IMDRF). Manufacturers will be required to develop evidence to demonstrate the safety, effectiveness and performance of the SaMD, though it will not replace or conflict with premarket or postmarket regulatory requirements. FDA asks for comment on eight aspects of the guidance. Those aspects include whether it adequately addresses the relevant clinical evaluation methods and processes needed for SaMDs, whether other types of SaMDs than those outlined in the document should be addressed and whether the policy would produce unintended consequences for existing regulated devices. “This is really huge, much bigger than many people might appreciate. It would apply to a huge number of mobile apps, as well as stand-alone programs for PCs used in healthcare”, Bradley Merrill Thompson, an attorney with Epstein Becker & Green said.

Bioevents

BIO Europe on November 7-9 in Cologne (Germany)

BIO Latam on November 29-30 in San Juan (Puerto Rico)

Biofit 2016 on November 30-December 1 in Lille (France)

9^th Biotech Showcase Investor Conference on January 9-11, 2017 in San Francisco (USA)

IMPORTANT NOTICE

This document has been prepared by btobioinnovation and is provided to you for information purposes only. The information contained in this document has been obtained from sources that btobioinnovation believes are reliable but btobioinnovation does not warrant that it is accurate or complete. The views presented in this document are those of btobioinnovation’s editor at the time of writing and are subject to change. btobioinnovation has no obligation to update its opinions or the information in this document.

Follow us on social media :