Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation, jcm@btobioinnovation.com

Business

Grünenthal (Aachen, Germany) in-licenses exclusive global rights (except Japan) of AstraZeneca’s Zomig, or zolmitriptan, for the treatment of migraines and cluster headaches. Under the terms of the agreement, Grünenthal will make a $200 million upfront payment and up to $120 million in various milestones. AstraZeneca will continue to manufacture and supply Zomig during a transition period.

Innate Pharma (Marseille, France) in-licenses Novo Nordisk’s anti-C5aR an­ti­body aimed at the “ac­cu­mu­la­tion and ac­ti­va­tion of myeloid-de­rived sup­pres­sor cells (MDSC) and neu­trophils in the tumor mi­croen­vi­ron­ment.” Under the terms of the deal, In­nate will make an upfront pay­ment of €40 mil­lion, of which €37.2 mil­lion is com­ing in new In­nate Pharma shares, with only €2.8 mil­lion in cash and up to €370 mil­lion in de­vel­op­ment, reg­u­la­tory and sales mile­stone pay­ments as well as dou­ble-digit roy­al­ties on net sales.

Midatech Pharma (Abingdon, UK) secures  rights to Novartis’ Farydak, or panobinostat, a histone deacetylase (HDAC) inhibitor, for the for the treatment of a rare type of pediatric brain cancer called Diffuse Intrinsic Pontine Glioma (DIPG), an aggressive type of tumor that starts in the brain stem that has a poor prognosis. Financial terms of the deal were not disclosed.

Novartis and Bristol-Myers Squibb team up to investigate the efficacy and the safety of the combinations of Novartis’s Mekinist, or trametinib with BMS’ Opdivo or nivolumab and Oprivo + Yervoy or ipilimumab in patients with microsatellite stable tumors where the tumors are proficient in mismatch repair (MSS cCRC pMMR). Under the terms of the agreement, BMS will conduct the study to establish recommended dosing regimens and evaluate preliminary anti-tumor activity.

Novartis and IBM Watson enter a collaboration aimed at improving breast cancer care. Novartis will bring its breast cancer expertise, while IBM Watson will contribute its data analytics and machine learning expertise. The collaboration seeks to use real-world data to better understand the expected outcomes of various breast cancer treatments.

Merck KGaA enters a collaboration with F-Star (Cambridge, UK) to develop and commercialise five new bispecific immune-oncology antibodies. The deal covers F-star's preclinical FS118, designed to block LAG-3 (Lymphocyte-Activation Gene 3) and PD-L1 (Programmed Death-Ligand 1), two pathways commonly used by cancer cells to evade the immune system. The other bispecific antibodies included in the deal all target specific pathways to augment the anti-tumour immune response. Under the terms of the deal Merck will make a 115 million upfront payment as well as R&D funding and milestone payments and  further payments upon exercising its option and based on milestones, with the potential deal value reaching over 1 billion euros.

AstraZeneca makes a 2.5 million milestone payment to Orexo (Uppsala Sweden) related to the initiation of a phase 1 study with Orexo’s OX-CL1, a leukotriene C4 synthase inhibitor, as a treatment of respiratory disorders including asthma and chronic obstructive pulmonary disease (COPD).

Roche Genentech stops its collaboration with NewLink Genetics (Ames, IO, USA) a few days after reporting disappointing results with navoximod or CDG-0919, an indolamine 2,3-dioxygenase 1 (IDO1) enzyme inhibitor, in combination with Tecentriq, in sharp contrasts with recent results of the combination of Merck’s Keytruda and Incyte’s endocadostat. Genentech returned all the rights to NewLink. Novoximod also failed a phase 2 study for breast cancer. The initial deal was valued at $1 billion with an upfront of $150 million.

Approval of drugs and vaccines

The European Commission approves:

Novo Nordisk’ Refixia as a treatment for prophylaxis, on-demand treatment of bleeding and surgical procedures in adults and adolescents with the condition. Refixia, or nonacog beta pegol; N9-GP, is a glycopegylated recombinant factor molecule that has a significantly improved pharmacokinetic profile and a five-times longer half-life than standard forms of the blood-clotting drug.

….and Bristol-Myers Squibb’s Opdivo, an eighth indication, for the treatment of adults with locally advanced unresectable or mUC after failure of prior platinum-containing therapy, making it the only immuno-oncology agent available for this type of bladder cancer.

In a first, the US Food and Drug Administration is requesting that Endo Pharmaceuticals (Malver, PA, USA), removes an opioid drug, Opana ER, from the market because of its potential for causing abuse. “We are facing an opioid epidemic–a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse,” said FDA Commissioner Scott Gottlieb in a prepared statement. “We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse.”

Drugs at clinical stage

A US FDA advisory committee will review Novartis’s Biologic License Application (BLA) for its Breakthrough Therapy CTL019, or tisagenlecleucel-T, a CAR-T cell therapy for the treatment of pediatric and young adults with relapsed/refractory B-cell acute lymphoblastic leukemia, on July 12.

Medical Devices and Diagnosis News.

Medtronic’s first US FDA approved “artificial pancreas,” is reaching the US market. The system consists in an insulin pump that automatically delivers basal insulin to control blood glucose levels in people with Type 1 diabetes. The system includes a glucose sensor which measures glucose levels in the fluid just under the skin, the MiniMed 670G insulin pump and an infusion patch, which delivers insulin through a catheter. It uses an algorithm to self-adjust the delivery of basal, or background, insulin every five minutes based on real-time data gathered from the sensor.

The MiniMed 670G hybrid closed-loop system adjusts a patient's background insulin dose based on real-time glucose data measured in the fluid just under the skin. (Medtronic)

The US FDA approves the use of Claret Medical’s (Santa Rosa, CA, USA) Sentinel transcatheter aortic valve replacement (TAVR) stroke protection device, making the device the first and only of its kind on the market that reduces the risk of stroke by capturing and removing debris that can break free during TAVR and cause a stroke,

Somnarus (Mountain View, CA, USA), a sleep diagnostics company, presented data showing that SomnaPatch, its disposable adhesive patch effectively detected obstructive sleep apnea of all severity levels. The patch could be an alternative to portable sleep monitors currently used to diagnose the disorder. The SomnaPatch device is placed on the forehead and has a piece that fits over the nose. It weighs less than 1 ounce and records nasal pressure, blood oxygen saturation, pulse rate, respiratory effort, body position and how long a patient is asleep.

Zebra Medical Vision (Shefaayim, Israël) receives a CE mark for its medical image analysis technology. The system uses algorithms to uncover evidence of fatty liver, coronary artery calcium, emphysema and other indicators of disease in CT scans.

Science & Technology

Scientists from A*STAR’s Institute of Medical Biology (IMB) in Singapore, have discovered that gastric cancer is driven by Lgr5-expressing chief cells, a discovery that represents a significant breakthrough in the study of cancer biology, and delivers  crucial insight into gastric cancer development that should prove invaluable for developing more effective treatments in the clinic. According to the World Health Organization, gastric cancer is the fourth leading cause of cancer globally. The most common cause is infection by the bacterium Helicobacter pylori (H. pylori), which accounts for more than 60% of cases. Certain types of H. pylori have greater risks than others.

Scientists at the Institute of Neurology, University College of London, have identified the first blood test able to predict the onset and progression of Huntington’s disease (HD). The test measures levels of a particular neurofilament protein released from damaged brain cells, which has previously been linked to other neurodegenerative diseases but until now hadn’t been assessed in Huntington’s disease.

Cost, Pricing and Market Access

The UK National Institute for Health & Care Excellence (NICE) has now published a Final Appraisal Determination (FAD) recommending the use of AbbVie's Humira, or adalimumab, and Allergan's Ozurdex, or dexamethasone intravitreal implant, as treatments for patients with sight-threatening posterior noninfectious posterior uveitis.

…and rejects Grünenthal’s Zurampic, or lesinurad, as a treatment for hyperuricaemia in gout patients. In spite of reaching adequate uric acid level with the drugs “however, the evidence did not show that lesinurad plus allopurinol reduces flares, improves healing of tophi, or lengthens life compared with allopurinol alone, which are more important for patients,” the Institute noted.

Miscellaneous

US President Donald Trump has asked Francis Collins to stay as the director of the National Institutes of Health (NIH). Collins will need to o fight off an at­tempt by the Trump ad­min­is­tra­tion to reduce the NIH budget by $5.8 bil­lion next year.

People on the move

Johnson & Johnson recruits Merck’s Mathai Mammen as pharma R&D chief to replace Bill Hait, which takes on the role of global head of external innovation.

Maya Said (former Sanofi and former Novartis, now CEO at Outcomes4Me) has been appointed as an independent board member at Transgene’ (Strasbourg, France).

Bioevents

BIO International Convention on June 19-22 in San Diego (USA)

5^thAntibody Industrial Symposium, on June 27-28, in Tours (France)

MedFIT on June 28-29 in Grenoble (France)

Nordic Life Science Days (NLS) 2017 on September 12-14 in Malmö-Copenhagen (Sweden and Denmark)

BIOPharm America on September 26-27 in Boston (USA)

BIO Latin America on October 26-28 in Sao Paulo (Brazil)

BIO Europe on November 6-8 in Berlin (Germany)

World Congress on Biomedical Engineering 2017 on November 9-11 in Xian (China)

BIOFIT on November 28-29 in Strasbourg (France)

http://btobioinnovation.com/events/pharma-biotech-events/

http://btobioinnovation.com/events/in-vitro-diagnostic-events/

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