Endo acquires Par Pharmaceuticals for $8.05 Billion

Endo International (Dublin, Ireland) acquires privately-owned Par Pharmaceuticals (Woodcliff Lake, NJ, USA) for $8.05 billion and extends its generics footprint. The deal is structured through a $6.50 billion payment in cash and around $1.55 billion in equity. The deal comes a few month after Endo withdrew its offer to acquire Salix Pharmaceuticals now part of Valeant.

Ipsen acquires OctreoPharm to enlarge its oncology presence

Ipsen (Boulogne-Billancourt, France) acquires privately-owned OctreoPharm Sciences (Berlin Germany) for $50 million to expand its oncology portfolio. OctreoPharm focuses on the development of innovative radioactive labelled compounds for molecular imaging, diagnostics and therapeutic applications. The German firm is developing a theranostic approach for the management of neuroendocrine tumours based on a somatostatin receptor antagonist peptide.

Business

Boehringer buys NASH candidate PX4728A from Pharmaxis

Boehringer Ingelheim (Ingelheim, Germany) has exercised the option to acquire PX4728A from Pharmaxis (Frenchs Forest, Australia) for the treatment of liver disease non-alcoholic steatohepatitis (NASH). PX4728A is a Semicarbazide-Sensitive Amine Oxidase/Vascular Adhesion Protein-1 (SSAO/VAP-1) inhibitor that works by blocking leucocyte adhesion and tissue infiltration in inflammatory processes. The deal is structured around a €27.5 million upfront fee, €55 million in development milestones, €140 million upon drug approval and tiered-sales milestones.

….. and enters into an R&D agreement with Eureka on intra-cellular antibodies

Boehringer Ingelheim and Eureka Therapeutics (Emeryville, CA, USA) have entered into an agreement to discover novel antibodies in oncology. Eurekas’ technology consists in identifying antibodies recognizing intracellular proteins representing the vast majority of cancer-specific targets and which were considered undruggable through large molecules, which only target extracellular or cell surface proteins. Specific terms of the deal were not disclosed.

Sanofi-Genzyme and Ablynx collaborate in multiple sclerosis

Genzyme, a division of Sanofi and Ablynx (Gand, Belgium) have entered into a collaboration to study a series of nanobodies targeting multiple sclerosis. After completion of the study Genzyme has an option to a licensing agreement. Terms of the deal were not disclosed.

NantPharma buys Cynvilog from Sorrrento for $1.3 Billion

Sorrento Therapeutics (San Diego, CA, USA) announced the selling of Cynvilog (paclitaxel nanoparticle polymeric micelle) for $1.3 billion to NatPharma (Lincolnshire, IL, USA). Cynvilog is a new nanoparticle formulation of paclitaxel free of human serum albumin. The deal is structured around a $90 million upfront in cash, $600 million in regulatory milestones and another $600 million in sales milestones.

BioNtech partners with GenMab on cancer immunotherapies

A week after the announcement of its collaboration with Eli Lilly in immunotherapies, BioNTech (Mainz, Germany) announces an agreement with Genmab (Copenhagen, Denmark) in the same immunotherapy domain. In this alliance BioNTech will combine its antibodies and onco-immunotherapy expertise with Genmab's DuoBody® technology platform, which uses a three-step process to produce, purify, and recombine a pair of human IgG1 antibodies. BioNTech will receive $10 million upfront and up to $5 million in potential additional payments.

Janssen acquires autoimmune programme from Novo Nordisk

As a continuation of the spinning off of its non-diabetes programmes Novo Nordisk (Copenhagen, Denmark) has agreed to provide an exclusive license to Janssen Biotech to a programme targeting immune cells via NKG2D, a cell surface receptor. Terms of the deal were not disclosed.  

….and partners with Achillion

Janssen has entered an exclusive license and collaboration agreement with Achillion Pharmaceuticals (New Haven, CT, USA) to develop and commercialise its hepatitis C (HVC) assets. Specific terms of the deal were not disclosed.

Celayd, a Belgian gene therapy company launches its Nasdaq IPO

Celyad (Mont Saint Guibert, Belgium), a company developing gene therapy products for cardiovascular diseases and cancer, filed with the SEC to raise up to $115 million in an initial public offering.  Celyad's stock is currently traded on the Euronext Brussels and Euronext Paris with a market cap of around €450 million.

Abivax, a French biotechnology company prepares its Euronext IPO

Abivax (Paris, France) has announced its intention to file an Initial Public Offering (IPO) in Euronext Paris. The company is seeking cash to move ahead an HIV drug as a well as a therapeutic vaccine against hepatitis B.

Bayer’s diabetes devices business still for sale

Last November Bayer has reported its intention to sell its diabetes devices business valued at around $2.5 billion. For several months, discussions were ongoing with Japanese Panasonic Healthcare without success. Now Bloomberg reports that China’s Sinocare has teamed with Citic Securities and made a $1 billion bid for Germany-based business. Such an acquisition would fit the Chinese government goals of becoming a major producer of medical devices (see below).

Baxter and Baxalta present their business strategies

Baxter (Deerfield, IL, USA) outlined its future strategy at a recent investor conference. Ahead of Baxalta’s spin-off on July 1^st, executives from the companies shared their vision on business strategies. As separate, independent companies, both Baxter and Baxalta will remain leaders in their respective markets, each with an established global presence. "Baxalta's vision is to be a global biopharmaceutical leader striving for excellence in advancing innovative therapies that improve patients' lives," said Ludwig Hantson, who will become Chief Executive Officer for Baxalta upon the spin-off.

Approval of drugs, vaccines, diagnostics and devices

US FDA approves Janssen’s quarterly schizophrenia drug

Janssen Pharmaceuticals, a division of Johnson & Johnson, has received US FDA approval for the Invega Trinza, the first schizophrenia drug dosed once every quarter and which should help patients to better comply their treatment, improve symptom control and medical outcome. Invega Trinza is an atypical antipsychotic three month formulation of paliperidone palmitate which has a clinical efficacy and safety profile consistent with Invega Sustenna, its once a monthly predecessor, approved by the FDA in 2009.

Drugs at clinical stage

Amgen gets European recommendation for Evolocumab

Amgen leads the race, in Europe, against Sanofi/Regeneron to get approval for Repatha (evolocumab). Repotha which belongs to a new class of cholesterol-lowering drug known as PCSK9 inhibitors, has been recommended for approval in Europe.

…and terminates the co-development of brodalumab with AstraZeneca

Amgen has announced that is has terminated its collaboration with AstraZeneca, which started back in 2012, for the co-development and commercialisation of brodalumab, aimed at treating plaque psoriasis, psoriatic arthritis and axial spondyloarthritis. Brodalumab is an antibody which binds to interleukin-17 (IL17) receptor and prevents IL17 from activating the receptor. The decision was “based on events of suicidal ideation and behavior” in the brodalumab programme. AstraZeneca will have sole decisions on the future of the development of the drug.

Vertex’s Orkambi shows significant clinical benefit in cystic fibrosis (“mucoviscidose”)

Vertex (Boston, MA, USA) has published the results of two trials, in patients 12 years of age or older who had cystic fibrosis and were homozygous for the Phe508del CFTR mutation, confirming Orkambi’s benefit in multiple sclerosis. Orkambi is a combination of lumacaflor (VX-809) a CFTR corrector and ivacaflor (VX-770) a CFTR potentiator and is the first therapy that targets the underlying cause of multiple sclerosis. Cystic fibrosis (“mucoviscidose”) is a life-limiting disease that is caused by defective or deficient cystic fibrosis transmembrane conductance regulator (CFTR) protein activity.

Cortendo develops ATL 1103, an antisense product for the treatment of acromegaly

Cortendo (Göteborg, Sweden and Trevose PA, USA), a biopharmaceutical company focused on rare endocrine disorders, has entered in an exclusive license agreement with Antisense Therapeutics (Victoria, Australia) to develop, ATL1103, an antisense designed to block growth hormone receptor (GHr) as a potential treatment of acromegaly. Acromegaly is a hormonal disorder that develops when the pituitary gland produces too much growth hormone during adulthood. When this happens, bones increase in size, including those of hands, feet and face. Under the deal, Cortendo will have development and commercialization rights to Antisense's ATL1103 for endocrinology applications and will make upfront payment of $5m ($3m in cash and $2m in investments) to Antisense Therapeutics.  Cortendo will also make additional payments, contingent upon achieving specific development and commercialization milestones of about $105m.

US FDA grants fast track to Immunomedics’ sacituzumab govitecan for lung cancer 

Immunomedics (Morris Plain, NJ, USA) received fast track designation from US FDA for sacituzumab govitecan for the treatment of patients with metastatic non-small cell lung cancer. Sacituzumab govitecan is an antibody drug conjugate of the active metabolite of irinotecan. The US FDA had already granted fast track status to sacituzumab govitecan for the treatment of patients with triple-negative breast cancer and small-cell lung cancer and orphan drug designation for the treatment of small-cell lung cancer and pancreatic cancer.

…. to Agios’ AG-120 leukemia drug

Agios Pharmaceuticals (Cambridge, MA, USA) got US FDA fast track designation for AG-120, a first in class inhibitor of isocitrate dehydrogenase-1 protein (IDH1) for the treatment of acute myelogenous leukemia patients with IDH1 genetic mutation.

…to Celgene’s and Acceleron’s luspatercep for the treatment of beta-thalassemia

Celegne (Summitt, NJ, USA) and Acceleron Pharma (Cambridge, MA, USA) have received US FDA fast track designation for luspatercept, a modified activing receptor type IIB fusion protein for patients with transfusion dependent or non-transfusion-dependent beta-thalassemia. Unlike erythropoietin, which stimulates the proliferation of early-stage erythrocyte precursor cells, luspatercept regulates late-stage red blood cell precursor cell differentiation and maturation.

US FDA grants orphan status to Alnylam’s revusiran for the treatment of amyloidosis

 Alnylam (Cambridge, MA, USA) and partner Genzyme were granted US FDA orphan status for RNAi therapeutic revusiran for the treatment of amyloidosis. Transthyrein (TTR) mediated amyloidosis (ATTR amyloidosis) is an inherited progressively debilitating often fatal disease caused by mutations in the TTR gene. Revisuran was already granted orphan status in Europe last year.

Sanofi and Regeneron announce positive results for Sarilumab (Ph3), Dupilumab (Ph2)

……. from Phase 3 studies with Sarilumab in Patients with Rheumatoid Arthritis. Sarilumab is an investigational fully-human Interleukin 6 (IL6) receptor antibody.

……and from Pivotal Phase 2 studies with Dupilumab in adult patients with moderate-to-severe asthma. Dupilumab is an investigational drugs that inhibits signaling of Interleukin 4 (IL4) and Interleukin 13 (IL13) two cytokines required for type 2 (Th2) immune response.

Genocea’s genital herpes vaccine with positive phase 2 results

Genocea Biosciences (Cambridge, MA, USA) announced that its GEN-003 genital herpes vaccine met its goal in a phase 2 study. The candidate consists of a protein and adjuvant, and works by targeting a T cell response against the HSV-2 virus. There is currently no cure for genital herpes.

Ebola

In your previous news week edition we have mentioned that Liberia was declared Ebola free and that the disease is now spreading at a slow pace in other West Africa countries. We will therefore no longer entertain this topic under a specific item and replace it with a Medical Devices and Diagnostic dedicated topic.

Medical Devices and Diagnosis News

EndoStim receives CE mark for Lower Esophageal Spincter (LES) stimulation

EndoStim (Nijmegen, The Netherlands), a Dutch medical device company has received CE mark approval for its Lower Esophageal Spincter (LES) stimulation to treat gastroesophageal reflux disease (GERD).

Meridian Biosciences receives CE mark for its new HSV molecular test

Meridian Biosciences (Cincinnati, OH, USA) has received CE mark approval for its new molecular assays to develop Herpes Simplex Virus Type 1 (HSV-1) and Type 2 (HSV-2)

Heart attack and stroke may be predicted by grip strength

An international study, under Canadian leadership, indicates that grip strength test could be used as low-cost screening to identify patients at high risk of death from cardiovascular and non-cardiovascular diseases. Past studies had linked reduced muscular strength to greater risk oh health conditions and premature death. The Canadian study found that for every 5kg reduction in grip strength, participants were at 16% greater risk of all-cause death, 17% high risk of cardiovascular death and 17% increased risk of non-cardiovascular death.

A simple blood test for early detection of breast cancer

A recent study by Swedish researchers provides hope for a new way of early detection of breast cancer. The discovery is based on knowledge on blood cell-free circulating DNA. In cancer diseases, amounts of circulating DNA in blood are increased and contain the tumor specific genetic mutations. A specific study of 20 women with breast cancer gave striking results.

Simple blood test to diagnose Irritable Bowel Syndrome

Commonwealth Laboratories (Salem, MA, USA) has announced the availability of IBSchek™, a simple blood test to diagnose Irritable Bowel Syndrome (IBS). The test is based on the identification of two antibodies – anti CdtB and anti-vinculin which have been

shown to be indicative of diarrhea-prominent IBS.

Philips partners with MIT in $25 million deal to develop innovative med tech products

Royal Philips (Amsterdam, The Netherlands) which has announced several weeks ago its intention to spinning out or selling much of its lighting businesses has also indicated that HealthTech is now becoming one of its major focus. In line with this effort to refocus on healthcare topics Philips has established a 5-year, $25 million partnership with Massachusetts Institute of Technology (MIT) to develop novel product solutions in cardiovascular and cancer diseases. As part of the deal Philips will relocate its research center to Cambridge (MA, USA). Philips is also in the process of making a series of deals, including the $1.2 billion acquisition of catheter-based imaging company Volcano as well as recent partnerships to create a series of innovations including a wearable COPD diagnostic device, a handheld to test for neuropsychiatric disorders and a brain wave application to help immobilized patients communicate.

Miscellaneous

The focus on personalized medicine not matched by companion diagnostic development

According to a report by the Tufts Center for the Study of Drug Development, the focus on personalized medicine has not boosted the development of companion diagnostics as expected. The report indicates that the FDA has only approved seven pairs of drugs and companion diagnostics over the past five years although 73% of the late-stage cancer drugs recently presented to the FDA rely on biomarkers. A report issued earlier this month by the IMS Institute for Healthcare Informatics noted only one of the 10 cancer drugs approved last year included a companion diagnostic.

US FDA issues a warning that SGLT2 inhibitors could be linked with ketoacidosis

The US regulator is warning that antidiabetic drugs of the sodium/glucose cotransporter 2 (SGLT2) inhibitor class could cause serious side effects because of increase in blood ketone levels. Major drugs of this class are Johnson & Johnson’s Invokana (canagliflozin), AstraZeneca's Farxiga (dapagliflozin), and Lilly and Boehringer’s Jardiance (empagliflozin).

AstraZeneca builds a $285 million biologics facility in Sweden

AstraZeneca is building a $285 million facility in Sodertalje (Sweden) to manufacture biologicals for clinical and commercial products with a focus on protein therapies. The facility is expected to be operational in 2019. The addition of this new biotech capability reflects the changing nature of AZ’s portfolio as it focuses more on injectable biotech medicines, which now make up around half of the new drug pipeline.

Medicago builds a Canadian $245 million vaccine plant

Medicago (Quebec, Canada) is building a $245 million manufacturing facility in Quebec City where it will use tobacco plant viruses to produce large quantities of vaccines. It can made flu vaccines in less than 3 weeks much more quickly than using traditional egg-base methods. Medicago already opened a similar facility in Research Triangle Park (NC, USA) which can manufacture 10 million doses per month.

China 2025 plan

The China State Council issued a “Made in China 2025”, the country first ten-year action plan proposing a “three step” strategy of transforming China into a leading manufacturing power by the year 2049, which will mark the 100^th anniversary of the founding of the People’s Republic of China. Amongst the 10 manufacturing sectors bio-medicine and high-end medical equipment have been selected. Over the next 10 years, the council plan said, "a greater emphasis will be placed on quality management in the sector and the nurturing of world-class brands, with environmental considerations and energy efficiency to the forefront."

Bio and Business Events

• MedTech Partnering Forum on May 28-29 in Tokyo (Japan)
• IIR’s IN3 EuroMedtech 2015 on June 10-11 in Vienna (Austria)
• BIO International Convention on June 15-18 in Philadelphia (USA)
• Bio Taiwan 2015 on July 22-26 in Tapei (Taiwan)
• 3^rd Annual Nordic Life Science Days Partnering Conference on September 9-10 in Stockholm (Sweden)
• BioPharm America 2015 on September 15-17 in Boston (USA)

Author: Jean-Claude Muller, Special Advisor at I&IR, jcm@btobioinnovation.com

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