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Sunday, September 30, 2018

Biotech week ahead, Oct. 1


Biotech shares saw further momentum last week, following up on the gains of the previous two weeks.
Will the momentum continue in the upcoming week? Here are the catalytic events that could drive the sector.

Conferences

  • American Society for Bone and Mineral Research, or ASBMR, 2018 Annual Meeting – Sept. 28 – Oct. 1 in Montréal, Québec, Canada
  • 12th International Conference on Endocrinology,Diabetes and Metabolism – Oct. 1-2, in Osaka, Japan
  • 12th International Conference on Allergy, Asthma & Clinical Immunology – Oct. 1-2, in Moscow, Russia
  • 3rd World Congress on Pediatric Neurology and Pediatric Surgery – Oct. 1-2, in Osaka
  • 13th World Conference on Neurology and Neuromuscular Disorders – Oct. 1-2, in London
  • Cantor Global Healthcare Conference – Oct. 1-3, in New York City
  • Ladenburg Thalmann 2018 Healthcare Conference – Oct. 2, in New York City
  • 3rd International conference on Neuroscience, Neuroradiology & Imaging – Oct. 3-4, in Osaka
  • 2nd International Conference on Cancer Biology, Therapeutics and Drug Discovery & Delivery – Oct. 3-4, in Los Angeles
  • 10th Annual Congress on Biomarkers, Clinical Research & Therapeutics – Oct. 3-4, in Los Angeles
  • American Heart Congress – CVD – Oct. 5-6, in Los Angeles
  • 4th International Conference on Wound Care, Wound Nursing, Tissue Repair & Regenerative Medicine – Oct. 5-6, in Los Angeles
  • World Congress on Fetal and Maternal Medicine – Oct. 5-6, in Osaka

PDUFA Dates

Roche Holdings AG Basel ADR RHHBY 0.49%‘s Genentech unit awaits FDA nod for an expanded indication for its Hemlibra. Hemlibra has already been approved for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with haemophilia A with factor VIII inhibitor. This time around the company is seeking clearance for treating adults and children with haemophilia A without factor VIII inhibitors. The PDUFA date is set for Thursday, Oct. 4.
The FDA is set to rule on Bausch Health Companies Inc BHC 2.31%‘s NDA for its plaque psoriasis treatment IDP-122 lotion Friday, Oct. 5.
Ionis Pharmaceuticals Inc IONS 0.29%, and its affiliate Akcea Therapeutics Inc AKCA 0.77% look ahead to FDA approval of their Inotersen, a RNA-targeted therapeutic for hATTR amyloidosis. PTC Therapeutics, Inc. PTCT 0.13% has a collaboration agreement to market Inotersen in Latin America. The PDUFA date for Inotersen, which has already been approved in the EU, is set for Saturday, Oct. 6.
Paratek Pharmaceuticals Inc PRTK 3.19%‘s broad spectrum antibiotic Omadacycline is being evaluated by the FDA for two indications, namely Community-acquired pneumonia, or CAB, and acute bacterial skin and skin structure infections, or ABSSSI. The company indicated the PDUFA date is likely to be in early October.

Clinical Trial Results

Unum Therapeutics Inc UMRX 2.42% is set to present Sept. 30 initial Phase 1 data for its ACTR707 in combination with Roche’s Rituxan for treating non-Hodgkin lymphoma.
Viking Therapeutics Inc VKTX 2.35% is due to present already-released Phase 2 data for its acute hip fracture treatment VK5211 at the ASBMR 2018 annual meeting on Sept. 30. Recently, the company reported positive results for its non-alcoholic fatty liver disease candidate.
Protalix Biotherapeutics Inc PLX 1.66% will present preliminary Phase 3 open label data for its Fabry disease treatment Pegunigalsidase alfa on Oct. 5.
Audentes Therapeutics Inc BOLD 3.29% is due to release updated Phase 1/2 data for AT132, its treatment candidate for X-linked myotubular myopathy on Oct. 5.

IPO

Guardant Health, which develops non-invasive blood-based cancer diagnostics tests, is set to offer 12.5 million shares in an IPO, with an estimated price range of $15 to $17. The shares are to be listed on the Nasdaq under the ticker symbol GH.
Kodiak Sciences will offer 9 million shares priced between $13 and $15 in an IPO. The company, which develops anti-VEGF inhibitors for wet AMD, plans to list the shares on the Nasdaq under the ticker symbol KOD.
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Sanofi: Hanmi’s new diabetes drug to take on Lilly’s in tests


Sanofi said it would begin global phase-3 clinical trials to compare Hanmi Pharmaceuticals new obesity and diabetes treatment Efpeglenatide with a rival drug by Lilly.
Sanofi, the partner firm for Hanmi, announced on Wednesday that it officially registered the comparison study on online registry disclosure site clinicaltrials.gov. The trials will assess Efpeglenatides noninferiority to Trulicity (dulaglutide) in 900 patients with type-2 diabetes inadequately controlled with metformin, a widely used oral medicine for diabetes.
By administering Efpeglenatide and Trulicity once a week for 56 weeks, the study will compare the drug safety, blood glucose control and weight control effect, changes in blood sugar in empty stomach, and hypoglycemia symptoms.
The French pharmaceutical company is conducting two other types of phase-3 trials globally. The studies aim to compare Efpeglenatide with placebo and to verify the drugs cardiovascular risk.
Efpeglenatide is a long-acting glucagon-like peptide-1 (GLP-1) biological treatment for diabetes. In 2015, Sanofi obtained its license from Hanmi and had since been conducting multiple phase-3 trials simultaneously around the world.
Various trials are swiftly undergoing to prove Efpeglenatides global competitiveness. We will closely work with our partner company to accelerate commercialization of the drug, Hanmi Pharmaceutical CEO Kwon Se-chang said.
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Pfizer: UK regulator certifies use of some out-of-date EpiPens over shortages


Children with severe allergies who need to carry life-saving medication are being forced to rely on out-of-date EpiPens due to a global shortage of the adrenaline shots.
EpiPen and EpiPen Junior devices, which are supplied by Mylan and produced by Pfizer, have faced shortages in the UK and other countries for months. But the crisis has deepened with the Junior version now unavailable.
The latest stock shortages have led the medicines regulator to certify some batches of expired EpiPens as safe amid fears those with severe allergies who go into anaphylactic shock would be left with no alternative.
It was forced to extend the use-by-date of some EpiPens by four months after concerns were raised from users that their current shots were due to expire and they had been unable to get replacements. However, the extension does not apply to the Junior version.
A statement issued to healthcare providers on behalf of the Department of Health noted: “EpiPen and EpiPen Junior will be subject to limited availability for the remainder of 2018. Mylan are now out of stock of EpiPen Junior and interruptions in the supply are anticipated to continue for the coming months.”
More of the Junior devices are expected in stock in October, but it is not clear whether these will meet demand.
Manufacturing problems in the US have meant disruption for suppliers of EpiPens – the most common adrenaline auto-injectors (AAIs) are prescribed to those who suffer severe allergies such as to nuts, milk, fish, shellfish, eggs or some fruits.
Those affected are usually recommended to keep two AAIs with them at all times in case of a reaction. EpiPens can only be used once and have an expiry date of at least 12 months.
The standard device contains 300mcg of adrenaline. Smaller 150mcg Junior AAIs are issued to children who weigh 30kg (4st 10lb) or less.
Adults and older children are being advised they can use their devices up to four months beyond the listed expiry date in an attempt to maintain supply levels but the extension does not apply to the 150mcg devices for younger children.
A statement from the Department of Health and Social Care to healthcare providers said: “Mylan have obtained acceptance from the medicines and healthcare products regulatory agency (MHRA) to extend the use of specific batch numbers of EpiPen 300mcg auto-injectors beyond the labelled expiry date for four months.”
Last week an inquest heard that 15-year-old Natasha Ednan-Laperouse died on a flight after suffering a serious allergic reaction to a Pret A Manger baguette containing sesame seeds. This was despite her father injecting her with two EpiPen devices.
EpiPens make up three-quarters of the 340,000 adrenaline auto-injectors prescribed annually.
There are two other adrenaline auto-injector devices available in the UK: Emerade and Jext. Suppliers of both medicines are working to increase their supplies to the UK over the coming months.
The health department guidance said that if people were left with nothing but expired AAIs they should keep them – until they get replacements – and be prepared to use them.
While AAIs become less effective after their expiry date, they are not harmful, and it is better to use an expired AAI than none at all, it said.
It added that “careful management” of existing supplies would prevent the need for using expired pens.
The health minister, James  O’Shaughnessy, said: “We are doing everything we can to ensure patients continue to access the medications they need and we have issued detailed guidance to healthcare professionals.
“Other brands of adrenaline auto-injectors are available in the UK and we are working closely with Mylan and Pfizer to find a solution to the problem as soon as possible. Any patient unable to obtain supplies of EpiPen should speak to their clinician about using an alternative brand.”
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Akari Data Back Trial Expansion in Orphan Autoinflammatory Diseases


  • Coversin, a first-in-class combined complement C5 and leukotriene B4 (LTB4) inhibitor, is currently being developed to treat four orphan diseases:
    • Thrombotic microangiopathies (TMAs)
    • Bullous pemphigoid (BP)
    • Atypical keratoconjunctivits (AKC)
    • Paroxysmal nocturnal hemoglobinuriua (PNH)
  • All four clinical programs are currently in Phase I/II, Phase II or Phase III, with initial data in BP and AKC expected in the first quarter of 2019
  • New data in two post-transplant TMA pediatric patients treated with Coversin on a named patient basis, presented at the Inborn Errors Working Party (IEWP) meeting, Leiden, The Netherlands, on September 30, 2018, showed in both patients that signs of TMA (red blood cell fragments, thrombocytopaenia, elevated LDH, and hypertension) resolved following treatment with Coversin
Akari Therapeutics, Plc (NASDAQ:AKTX), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics to treat orphan autoimmune and inflammatory diseases where complement and or leukotriene systems are implicated, today announced new clinical data in post-transplant thrombotic microangiopathies.
“This new data represents an exciting development and helps underpin our strategy of using Coversin to target a range of orphan inflammatory diseases with unmet need. These early results from patients with TMA reinforce our belief that Coversin may prove to be effective in diseases where terminal complement activation is critical and dysfunction of LTB4 may also play a role,” said Clive Richardson interim CEO of Akari Therapeutics. “TMAs are challenging conditions in which localized microvascular injury plays a crucial role. We believe that in several diseases, both complement and LTB4 may be involved in the localized pathology. If so, Coversin could provide a novel treatment opportunity for such indications.”
At the annual meeting of the IEWP of the European Society for Blood and Marrow Transplantation (EBMT) in Leiden, The Netherlands, the results from two pediatric patients with hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) treated with Coversin were reported by Dr. Robert Chiesa, the treating clinician at Great Ormond Street Hospital (GOSH), London, UK. These patients were treated on a named patient basis at GOSH and Birmingham Children’s Hospital.
HSCT-TMA is a complication in up to 30% of patients following bone marrow transplantation. In severe cases, pediatric TMA carries a mortality of more than 80%1. Currently, HSCT-TMA has no approved treatment. In both of the pediatric patients treated with Coversin, there was rapid reduction of the markers of complement activation and normalization of markers that are elevated in TMA: platelet count, red blood cell fragments, thrombocytopaenia, elevated LDH, and hypertension. The child treated at GOSH made a complete recovery and Coversin was discontinued after seven weeks. In the second patient, despite resolution of the TMA markers, the patient subsequently died of lung damage which was considered unrelated to treatment with Coversin.
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Roche Diabetes Care partners with digital therapeutics firm Ieso


Roche’s diabetes arm is working with Ieso Digital Health to test the Cambridge, UK-based digital therapeutics firm’s mental health programme in type 2 diabetes patients in the UK and Ireland.
The Swiss pharma company hopes a version of Ieso’s online cognitive behavioural therapy can identify, and help treat, those diabetes patients that also have mental health issues, such as depression and anxiety.
Brett Lewis, general manager of Roche Diabetes Care UK and Ireland, said: “I’m delighted to be embarking on this important research programme with Ieso, whose pioneering cognitive and behavioural interventions are already demonstrating very positive results in treating depression and anxiety. We look forward to getting started and in bringing forward much-needed help for people with diabetes.”
Ieso said its therapists would help change patients’ attitudes and behaviours and improve their quality of life. In an initial pilot phase of the programme, the partners will study how overcoming psychological or mental health issues can improve physical outcomes and reduce health care costs.
Dr Andy Blackwell Ieso Digital HealthDr Andy Blackwell (pictured), group chief science and strategy officer of Ieso Digital Health, said: “We’re very excited to announce this research collaboration with Roche Diabetes Care, which we believe will deliver an integrated behavioural change solution that can really help improve the lives of people with diabetes.”
Nearly one in five people with diabetes also has clinical depression and for those with anxiety and/or depression health care costs increase by around 50%, according to NHS England.
Ieso, which says it is the UK’s largest provider of digitally-enabled, evidence-based mental health care, has treated over 30,000 NHS patients suffering from common mental health disorders to date using its text-based technology platform.
For Roche it’s the next step of its exploration of digital therapeutics. Earlier this year it extended its French cancer pact with Voluntis and launched a multi-centre clinical study of the company’s Zemy solution ahead of seeking regulatory clearance for it.
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Pentagon Building Tech Allowing Troops To Control Machines With Their Minds


Transhumanism is well on its way to becoming a reality in the United States military, as the Pentagon has announced that it’s working on a new “neural interface” technology that would connect human brains directly to machines as a way to control them.
The Defense Advanced Research Projects Agency, also known as DARPA, says the technology, known as Next-Generation Non-Surgical Neurotechnology, or N3, will allow troops to connect to special military control systems using just their brainwaves. The technology will allow for humans to not only control military machines with their minds, but also the inverse – military machines would be able to transmit information to users’ brains as well.
The goal is to combine “the speed and processing power of computers with humans’ ability to adapt to complex situations,” according to DARPA. It will allow people to “control, feel and interact with a remote machine as though it were a part of their own body.”
“From the first time a human carved a rock into a blade or formed a spear, humans have been creating tools to help them interact with the world around them,” says Al Emondi, the program manager at DARPA’s Biological Technologies Office.
“The tools we use have grown more sophisticated over time … but these still require some form of physical control interface – touch, motion or voice. What neural interfaces promise is a richer, more powerful and more natural experience in which our brains effectively become the tool.”

Mark of the beast: melding humans with machines

DARPA claims that the technology is completely innocent, as similar iterations of it for disabled veterans are already in use. “Revolutionizing Prosthetics,” as it’s called, is a program by DARPA that implants electrodes into disabled veterans’ brains, allowing them to control prosthetic limbs simply by thinking about it.
But isn’t that always how egregious new forms of transhumanism typically start? Positive anecdotes about how invasive technologies are “helping people” almost always functions as the gateway to more government control over humans – in this case, military servicemen who are being told that implantable technologies stand to benefit humanity.
DARPA’s rhetoric would have us all believe that combining man with machine is somehow beneficial and even “natural,” even though its true implications are more “mark of the beast” than they are revolutionary breakthrough.
Consider that with N3, able-bodied members of the military would need to ingest “different chemical compounds,” according to reports, in order to activate external sensors that both read and write information to the brain. This technology has to be “bidirectional,” claims DARPA, though the agency has not fully revealed precisely why this is the case.
It’s the type of thing one might expect to see in a sci-fi movie, except it’s now happening in real life. In the future, as openly admitted by DARPA, members of the military will be able to control attack drones with their brains, or deploy robot warriors using just brain motor signals and thoughts.
The technology is even being designed to provide real-time feedback about events happening in the world, such as cyber attacks. Users will purportedly be able to “feel” these events inside their bodies through “sensations.”
“We don’t think about N3 technology as simply a new way to fly a plane or to talk to a computer, but as a  tool for actual human-machine teaming,” Emondi admits.
“As we approach a future in which increasingly autonomous systems will play a greater role in military operations, neural interface technology can help warfighters build a more intuitive interaction with these systems.”
For more information about the agenda of the military-industrial complex to combine man with machine, be sure to see Transhumanism.news.
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Women: Don’t Ignore These 3 Subtle Heart Attack Symptoms


We always associate chest pain with heart attacks, and for good reason, but it’s not the whole story — especially for women. While chest pain is the most common symptom of a heart attack, women can have symptoms that aren’t related to chest pain at all. They need to be on the lookout for other, subtler symptoms.
Also, we need to dig deeper into the symptom of chest pain for both men and women as it relates to heart attacks. It is seldom as dramatic as you might think, and it can feel like pressure or heart burn that  comes on over time.
Below, find three symptoms you should watch for, including information about how to tell if they are benign or cause for concern.

1. Unusual fatigue

Like many women, you’re probably busy most of the time. You may take care of a family, run a household, work outside the home and care for aging parents. You are probably also tired a lot of the time. Most likely this is normal.
But you should pay attention to fatigue if it is new or dramatic. Here’s what to watch out for:
  • You are suddenly worn out after your typical exercise routine.
  • You aren’t exerting yourself, but have fatigue or a “heavy” chest.
  • Simple activity like making the bed, walking to the bathroom or shopping makes you excessively tired.
  • Although you feel exceptionally tired, you also experience sleep disturbance.

2. Sweating and/or shortness of breath

As women age, a lack of exercise and gradual weight gain cause issues like shortness of breath. Hot flashes are a common complaint for many women during menopause.
But these symptoms can signal a heart problem when they happen in certain situations:
  • Sudden sweating or shortness of breath without exertion
  • Breathlessness that continues to worsen over time after exertion
  • Shortness of breath that worsens when lying down and improves when propping up
  • “Stress” sweat (cold, clammy feeling) when there is no real cause for stress
  • Sweating or shortness of breath accompanied by other symptoms such as chest pain or fatigue

3. Neck, jaw, back pain

As intricate as our body’s systems are, they are very adept at giving signals when there is something wrong. When there is a problem with the heart, it triggers nerves in that area, but you sometimes feel pain elsewhere.
Pain in the jaw, back or arms may signal a heart condition, especially if the origin is hard to pinpoint (for example there is no specific muscle or joint that aches). Also, if the discomfort begins or worsens when you are exerting yourself, and then stops when you quit exercising, you should get it checked out.
Here are some other signs to look out for:
  • Women, in particular, can have pain in either arm — not just the left one like many men.
  • Pain in the lower or upper back often starts in the chest and spreads to these areas.
  • The pain is sometimes sudden, not due to physical exertion, and can wake you up at night.
  • You may feel pain that is specific to the left, lower side of the jaw.

What to do if you notice symptoms

Women often say they noticed some of these three warning signs weeks or a month before a heart attack.
The sooner you report a problem, the better the chances are of catching an issue before it becomes a full-blown heart attack. If you experience any of these symptoms, take note and visit your doctor as quickly as possible.
When you see your doctor:
  • Bring a list of your symptoms and when they are occurring.
  • Let him or her know about any related family history.
  • Talk about stress or anything going on in your life that might contribute to a problem.
Your doctor likely will listen to your symptoms and check your pulse and blood pressure. He or she may order blood work, which will show whether your heart is damaged.
Your doctor also may use an electrocardiogram (EKG) to tell whether the electrical activity of your heart is normal, or an echocardiogram to view images of the heart to see if damage has occurred. 
All this is important in identifying any problems and taking steps to intervene before a possible heart attack.

When to call 9-1-1

Get help right away if you have chest pain or discomfort along with any of these symptoms, especially if they last longer than five minutes:
  • Pain or discomfort in other areas of the upper body, including the arms, left shoulder, back, neck, jaw, or stomach
  • Difficulty breathing or shortness of breath
  • Sweating or “cold sweat”
  • Fullness, indigestion, or choking feeling (may feel like heartburn)
  • Nausea or vomiting
  • Light-headedness, dizziness, extreme weakness or anxiety
  • Rapid or irregular heart beats
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