AbbVie’s Imbruvica flunks late-stage pancreatic cancer study

A Phase 3 clinical trial, RESOLVE, evaluating AbbVie’s (NYSE:ABBV) IMBRUVICA (ibrutinib) plus chemo in patients with metastatic pancreatic cancer failed to achieve the primary endpoint. Specifically, the combination did not sufficiency separate from chemo + placebo as determined by progression-free survival (PFS) or overall survival (OS) in a first-line setting.

Complete results will be submitted for presentation at a future medical conference and/or for publication.

Related ticker: (NYSE:JNJ)

https://seekingalpha.com/news/3424405-abbvies-imbruvica-flunks-late-stage-pancreatic-cancer-study

Ipsen data on 1st in-human study of a recombinant fast-acting neurotoxin

Results of the first in-human study of a recombinant neurotoxin are being presented at the TOXINS International Conference in Copenhagen.

Ipsen’s recombinant BoNT serotype E (rBoNT-E) was investigated in a phase I study that demonstrated its safety and tolerability profile in healthy volunteers1. The study also reported that it has a faster onset of action and a shorter duration of effect, as well as a quick time to peak activity, in comparison with established BoNT-A products. Further studies will be initiated to establish potential aesthetic and therapeutic uses of this investigational therapy.

‘The application of recombinant techniques to create novel botulinum toxin-based medicines with different onsets and durations of action, will potentially offer clinicians the flexibility to choose the most appropriate neurotoxin for each patient, which is not an option today,’ said Philippe Picaut, Pharm. D., PhD, Senior Vice President Research & Development for the Neuroscience Therapeutic Area, Ipsen.

Botulinum neurotoxins (BoNTs) are naturally occurring proteins (produced by Clostridium bacteria) that were first discovered in the 19th century. They are classified into seven serotypes (A-G) with the majority of commercialized BoNT products being serotype A. BoNTs are used in multiple different conditions after injection in skeletal muscles (eg cervical dystonia, hemifascial spasm, blepharospasm, spasticity in adult and children; aesthetic); smooth muscles (neurogenic detrusor overactivity, idiopathic bladder overactivity) or exocrine gland hyperfunction (eg sialorrhea, axillary hyperhidrosis).

Alexandre Lebeaut, M.D., Executive Vice President, Research & Development and Chief Scientific Officer, Ipsen stated: ‘Neurotoxin research is advancing at an unprecedented rate and we, at Ipsen, are at the forefront of this transformation, developing innovative therapeutic and aesthetic solutions that help patients take back control of their lives’.

https://www.marketscreener.com/IPSEN-5137/news/Ipsen-presents-the-results-of-the-first-in-human-study-of-a-recombinant-fast-acting-neurotoxin-at-27886370/

MacroGenics Updates Combo Data at ASCO GI Cancers Symposium

MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced presentation of updated data from its Phase 2 clinical trial of margetuximab plus pembrolizumab for patients with advanced HER2+ gastric carcinoma in a poster session at the 2019 ASCO Gastrointestinal Cancers Symposium in San Francisco, California.

The poster was titled ‘Antitumor Activity of Margetuximab plus Pembrolizumab in Patients with Advanced HER2+ (IHC3+) Gastric Carcinoma.’

This Phase 2 open-label, dose escalation study evaluates the combination of margetuximab, an investigational Fc-optimized anti-HER2 monoclonal antibody, with pembrolizumab, an anti-PD-1 antibody, a regimen that is designed to coordinately engage innate and adaptive immunity for the treatment of patients with gastroesophageal cancer. The trial seeks to characterize the safety, tolerability, maximum tolerated dose, and antitumor activity of this combination. Enrolled patients had relapsed or refractory advanced HER2+ gastric or gastroesophageal junction cancer with disease progression after or resistance to treatment with trastuzumab plus chemotherapy. The 25 patients in the most recently enrolled expansion cohort had HER2+ gastric carcinoma that was 3+ by immunohistochemistry (IHC). Patients in the study were enrolled irrespective of PD-L1 expression status.

Acceptable tolerability was observed in the safety population of 95 patients, 92 of whom were treated at the recommended Phase 2 dose of 15 mg/kg for margetuximab and 200mg for pembrolizumab, both on an every three week schedule of administration. Grade 3 or higher treatment-related adverse events (TRAE) occurred in 17.9% of patients, the most common of which was infusion-related reaction (3.2%).

https://www.marketscreener.com/MACROGENICS-INC-14484280/news/MacroGenics-Updated-Clinical-Data-from-Combination-of-Margetuximab-and-Pembrolizumab-in-Gastric-Ca-27886374/

Aerie Announces Acceptance of Its Investigational New Drug Application

Aerie Pharmaceuticals, Inc. (NASDAQ: AERI), an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma, retina diseases and other diseases of the eye today announced that the U.S. Food and Drug Administration (FDA) has reviewed the Investigational New Drug Application (IND) for AR-1105 (dexamethasone intravitreal implant) and it is now in effect, allowing Aerie to initiate human studies in the treatment of macular edema due to retinal vein occlusion (RVO).

The IND was submitted in December 2018. Aerie expects to initiate a Phase 2 clinical study later in the first quarter of 2019.

AR-1105 is a bio-erodible implant that is designed to release the steroid dexamethasone over a six-month sustained period. The method of administration is through commonly used intravitreal injection. The potential benefits of AR-1105 compared to other steroid products include six-month duration of efficacy, improved administration due to a smaller needle size, and possibly a better safety profile due to lower peak drug levels.

‘AR-1105 is the first IND-stage treatment in Aerie’s retina pipeline, which is an important milestone for the company,’ said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie. ‘This quarter we also plan to file an IND for our second retina product, a bio-erodible implant containing the Rho kinase/Protein kinase C inhibitor AR-13503 that is being developed for wet age-related macular degeneration and diabetic macular edema. These products demonstrate the potential of our two enabling platforms for delivering drugs to the back of the eye, the bio-erodible polymer technology we licensed from DSM and the PRINT manufacturing technology licensed from Envisia. As we advance these new treatments in our second significant therapeutic area in eye care, we continue to pursue our goal of building the next major ophthalmic pharmaceutical company.’

https://www.marketscreener.com/AERIE-PHARMACEUTICALS-INC-14688906/news/Aerie-Pharmaceuticals-Announces-Acceptance-of-Its-Investigational-New-Drug-Application-for-AR-1105-27886375/

Fresenius launches dialysis machine for emerging markets

Fresenius Medical Care, the world’s largest provider of dialysis products and services, today announced the launch of its 4008A dialysis machine, which was especially designed to meet the needs of emerging markets. With the launch of the 4008A, the company is aiming to improve accessibility to life-sustaining dialysis treatment for patients in these countries who are living with end-stage renal disease (ESRD).

The 4008A dialysis machine incorporates Fresenius Medical Care’s high therapy standards while minimizing costs for health care systems. It has primarily been deployed in India, with other countries across the Asia-Pacific region to follow. Worldwide, there is an urgent and growing need for patients with ESRD to receive access to dialysis. A systematic review of worldwide access to treatment estimated that almost two million people in Asia with ESRD who needed dialysis were not receiving it – a treatment gap that is double the number of patients actively being treated. Worldwide use of dialysis is projected to more than double by 2030, with the most growth in Asia, but the number of people without access to dialysis is expected to remain substantial.¹

In response to this need, Fresenius Medical Care has developed the 4008A, which provides life-sustaining medical benefits and safety standards at a cost-effective price. Dr. Olaf Schermeier, Chief Executive Officer for Global Research and Development at Fresenius Medical Care, emphasized the importance of the 4008A launch: ‘Our global Research and Development team is in constant dialogue with physicians, nursing staff and patients. We put the benefit for our patients at the center of any new development. That is why we have developed this new high-quality dialysis platform that may allow for better cost effectiveness, and brought it to the market in record time.’

Harry de Wit, CEO of Fresenius Medical Care Asia-Pacific, said: ‘At Fresenius Medical Care, we are proud of the work we do every day to improve the lives of people living with chronic kidney disease. The launch of the 4008A is a demonstration of our continuing commitment to help ensure that life-changing dialysis is brought within reach of the increasing number of patients who need urgent access to this treatment.’

Importantly, the 4008A offers a high level of safety and handling standards, including essential cleaning functions and battery back-up. The machine is designed to be robust and easily handled, making it ideal for demanding infrastructure and remote locations.

The use of ultrapure dialysis fluid is standard in all treatments with the 4008A machine. Evidence suggests that using ultrapure dialysis fluid provides significant medical benefits to patients – for example, through better preservation of residual renal function, which is the ability of the patient’s own kidneys to eliminate water and uremic toxins.²This has been shown to lower mortality and potentially improve quality of life in people with ESRD.^3,4,5 In addition, the use of ultrapure dialysis fluid could also contribute to reduced inflammation for dialysis patients, potentially helping to reduce their cardiovascular risk and morbidity.^6,7

The dialysis machine and the dialyzer are the two most important products in hemodialysis. While the dialyzer filters the patient’s blood, the dialysis machine pumps it and monitors its circulation outside the body. The machine is also used to maintain the composition of the dialysis solution and introduce anticoagulants into the blood. Dialysis treatments generally last three to six hours, and are commonly carried out three times a week.

More than half of all dialysis machines used worldwide are made by Fresenius Medical Care.

https://www.marketscreener.com/FRESENIUS-MEDICAL-CARE-436087/news/Fresenius-Medical-Care-launches-4008A-dialysis-machine-tailored-to-needs-in-emerging-markets-27886396/

Samsung Bioepis-Merck biosimilar to Roche’s Herceptin wins FDA nod

The U.S. Food and Drug Administration said on Friday it had approved a biosimilar to Roche Holding AG’s blockbuster breast cancer treatment, Herceptin.

The biosimilar, Ontruzant, is co-developed by Merck Sharp & Dohme Corp, a unit of Merck & Co Inc, and Samsung Bioepis Co Ltd, which is a joint venture between Samsung BioLogics and Biogen Inc.

The approval https://twitter.com/FDA_Drug_Info/status/1086327386059157504comes just a few weeks after the health regulator gave Celltrion Inc’s Herzuma – another biosimilar to Herceptin – its nod to market it commercially.

Herceptin, which generated sales of 7.01 billion Swiss francs (£5.48 billion) in 2017, is one of the world’s most successful antibody drugs and has been a mainstay of Roche profits for many years.

Herceptin and other complex medicines called biologics are made from living cells, making them difficult to copy with precision. Their similar versions are called biosimilars, instead of generics.

The FDA had declined to approve Pfizer’s biosimilar of Herceptin in April.

https://www.marketscreener.com/CELLTRION-INC-40742914/news/Samsung-Bioepis-Merck-biosimilar-to-Roche-s-Herceptin-wins-FDA-nod-27887300/

Cronos, Canopy seen dominating nascent cannabis market

Cronos and Canopy were started with Outperformer ratings at CIBC, while Aphria was initiated at Neutral

In an analyst note from CIBC this morning titled “Cannabis: The Beginning Of A Global Seismic Shift,” analysts John Zamparo and Krishna Ruthnum wrote that investors are watching the birth of a new industry. They said they expect the cannabis industry to follow the course of other newborn industries, where investors rush to pour capital into the sector and then very few companies live up to their lofty expectations while the industries develop. However, the analysts believe two particular companies — Cronos Group (CRON) and Canopy Growth Corp (CGC) — are likely to be winners that come to dominate the global market. They also believe another cannabis stock — Aphria (APHA) — has concerns that could deter investors.

CRONOS GROUP: There are two recent key achievements that have set Cronos apart from most of its competitors, according to CIBC. The first, the company signing an agreement with Ginkgo Bioworks to produce rare cannabinoids at scale, happened last September. This agreement really accelerates the company’s goal of being a cannabinoid company, rather than simply a cannabis company, the analysts contend. The second was Cronos receiving the backing of tobacco maker Altria Group (MO), with Altria buying a 45% stake in Cronos for ~$2.5B, with warrants that could give Altria majority control. The analysts believe the actions and visions of Cronos’ management team stands above the rest of the field, and they initiated Cronos Group with an Outperformer rating and C$22 price target.

CANOPY GROWTH CORP: Canopy, for years, has emphasized that it aims to be a global medical cannabis company, with co-CEO Bruce Linton stating during a recent earnings call that the Canadian recreational market consumes only about 25% of his time. The company considers cannabis a “disruptive ingredient” that can have “significant consequences for industries such as alcohol, tobacco, sleep aids, pain treatment and mood therapy.” Canopy has a partnership with Constellation Brands (STZ), and $4B in the bank, making it the best-capitalized in the space, the analysts tell investors. CIBC initiated Canopy Growth with an Outperformer rating and C$65 price target.

APHRIA: The debate over the value of Aphria’s international assets and corporate governance concerns have obscured the value of the company’s quality domestic assets, but concerns about corporate governance and capital allocation are not without some validity, the analysts wrote. They initiated Aphria (APHA) with a Neutral rating and C$10 price target.

https://thefly.com/permalinks/entry.php/id2851136/MO;STZ;CRON;CGC;APHA-Cronos-Canopy-seen-dominating-nascent-cannabis-market