Alcon Acquires PowerVision for $285 Million

Alcon, the eye care division of Novartis, acquired fluid-based intraocular lens maker PowerVision Inc. for $285 million. Alcon made the acquisition ahead of its being spun out by Novartis into its own standalone company. The company said it will bring the PowerVision lens to cataract patients across the globe.

PowerVision, based in Tennessee, was formed to develop fluid-based accommodating intraocular lenses for cataract surgery patients. Alcon said the acquisition of PowerVision demonstrates its commitment to “driving growth and innovation in advanced technology intraocular lenses (AT-IOLS) to meet the needs of cataract surgery patients who desire spectacle independence.” The fluid-based intraocular lens uses the eye’s natural accommodative response to provide near and intermediate vision, Alcon said in its announcement. Additionally, the IOLs boost distance vision in patients.

Alcon said that commercial availability of PowerVision’s IOL technology will be determined following significant additional development and clinical trials of the intraocular lens. Alcon is the global leader in IOL and said it estimates double-digit growth in AT-IOLs, largely driven by new innovations.

Barry Checkin, president, chief executive officer and co-founder of PowerVision, said the company is thrilled to join Alcon and looks forward to that company being able to bring its AT-IOL treatment to the market.

Under terms of the agreement, Alcon paid $285 million for PowerVision. Additional undisclosed payments will be made to the company based on specified regulatory and commercial milestones starting in 2023, Alcon said. Alcon is maintaining its 2023 financial outlook provided at the Capital Markets Days in the fourth quarter of 2018. In the announcement, there was no information regarding the future of the current employees of PowerVision.

Michael Onuscheck, Alcon’s president of global business and innovation, said the company is eager to accelerate development of the “potentially breakthrough accommodating lens technology.”

“By treating cataracts and restoring natural, continuous range of vision, this intraocular lens may be the preferred IOL for cataract surgery patients who desire spectacle independence,” Onuscheck said in a statement.

A cataract is a clouding of the natural lens of the eye that affects vision. It is estimated that cataracts affect about 20 million people in the United States alone. Surgery is the typical treatment for cataract patients. The eye’s cloudy natural lens is removed and replaced with an intraocular lens.

PowerVision’s lens is also being developed for patients with presbyopia, which involves the gradual loss of the eye’s ability to actively focus on close objects, such as smartphones, computers, books and menus. The IOL developed by PowerVision used the eye’s natural accommodating response to transport fluid in the intraocular lens which is implanted in the eye’s capsular bag. Alcon said the PowerVision IOL uses a multifocal design that distributes light between different focal points to benefit presbyopia patients. This technology allows the patient to actively focus on objects, just as the natural crystalline lens does in a youthful eye, providing patients with a natural, continuous range of vision, Alcon said.

Alcon was founded in 1947 in Fort Worth as a small ophthalmic pharmaceutical business. Novartis acquired Alcon for $52 billion in 2011. Alcon has annual sales of about $7 billion. In September, Novartis moved Alcon’s headquarters from Texas to Switzerland.

https://www.biospace.com/article/alcon-acquires-powervision-for-285-million/

Is It Alzheimer’s or Some Other Type of Dementia? Diagnosis Matters

All cases of Alzheimer’s are dementia. However, not all cases of dementia are Alzheimer’s. Within the non-medical community, there is a tendency to just refer to dementia and Alzheimer’s interchangeably, but a summit held by the National Institute Of Neurological Disorders And Stroke, the Alzheimer’s Disease-Related Dementias Summit 2019, emphasizedthat physicians need to make the distinction for best patient care.

Aside from Alzheimer’s disease, other common forms of dementia include vascular disease such as stroke, Lewy body disease, which is a type of Parkinson’s disease, and frontotemporal lobe dementia, which typically affects a different section of the brain than Alzheimer’s, but has similar, but different symptoms. Frontotemporal dementia also tends to occur at younger ages than Alzheimer’s, often between the ages of 40 and 45.

Julie Schneider, a professor at the Rush Alzheimer’s Disease Center in Chicago was the scientific chair of the NIH summit. Schneider told NPR, “There’s a host of things that can cause loss of cognitive function.” But when Schneider was training in medicine in the 1980s and 1990s, “We were taught that almost all dementia is Alzheimer’s disease.”

Alzheimer’s is responsible for somewhere between 60 and 80 percent of dementia cases. But vascular diseases, such as stroke or damage to the blood vessels account for up to 10 percent of dementia cases, Lewy body disease makes up another 10 percent, and frontotemporal lobar degeneration is responsible for less than 10 percent.

Schneider added, “We still believe that Alzheimer’s is important. But these other pathologies are also important.”

Frontotemporal degeneration, according to Walter Koroshetz, director of the NINDS, has a distinct appearance. “Those folks can oftentimes be seen as peculiar but not demented,” he told NPR. “But they can be severely impaired.” Another name for frontotemporal dementia (FTD) is Pick’s disease.

According to the Mayo Clinic, patients with frontotemporal dementia have dramatic changes in their personality and often become “socially inappropriate, impulsive or emotionally indifferent, while others lose the ability to use language.” It is also often misdiagnosed as a psychiatric issue or as Alzheimer’s disease. Most common symptoms, which vary depending on the specific area of the brain affected, including increasingly inappropriate behavior, loss of empathy and other interpersonal skills, lack of judgement and inhibition, apathy, a decline in personal hygiene, changes in eating habits, usually marked by overeating, eating inedible objects, and a lack of awareness of the behavior.

As the name suggests, frontotemporal lobe dementia is caused by shrinkage of the frontotemporal lobes.

Lewy body disease is likely more similar in mechanism to Alzheimer’s disease. For the most part, Alzheimer’s is marked by an accumulation of a specific type of protein called beta-amyloid plaques and tangles that are involved in neuroinflammation. In Lewy body dementia, the plaques and tangles are caused by a different protein, Lewy bodies. Schneider told NPR, “It’s these little aggregates called Lewy bodies, which were first identified in the brains of people with Parkinson’s disease.”

She notes, “You’re going to be more rapidly declining. You might have more motor problems, more falls, gate changes, sleep problems, hallucinations.”

Not only is the distinction useful for knowing what to expect, but the few medications approved to treat Alzheimer’s aren’t effective for treating these other types of dementia. Of course, they’re also not that great at treating Alzheimer’s, and since not all dementias are caused by a single disease, a physician might prescribe one of the available drugs, such as Aricept, regardless.

And then there are strokes or similar damage to the blood vessels in the brain.

Roderick Corriveau, program director at the NINDS, told NPR, “One-third of the people who have strokes go on to have dementia. Preventing strokes is about preventing damage to the brain.”

And while other types of dementias aren’t exactly preventable by lifestyle changes, he notes that patients who have had one stroke can typically avoid another by taking blood thinners and controlling their blood pressure.

https://www.biospace.com/article/differentiating-between-different-types-of-dementias/

Apple Watch Atrial Fibrillation Study Has High Rate of False Positives

Stanford University researchers kicked off the annual meeting of the American College of Cardiology with a very large study of more than 400,000 patients in a trial sponsored byApple. They presented the results of whether the Apple Watch can accurately detect heart rhythm problems. Dubbed the Apple Heart Study, the trial had 419,297 participants, described as “a research study conducted to evaluate whether the Apple Heart Study App can use data collected on the Apple Watch to identify irregular heart rhythms, including those from potentially serious heart conditions such as atrial fibrillation.”

The patients participating wore the Apple Watch and were sent a notification if the smartwatch detected an irregular heartbeat. They were then followed up with an ECG for verification.

Perhaps unsurprising—at least for anyone who has used one of the various smartwatch devices to monitor heart rate, steps, and other metrics, such as the Apple Watch, Garmin, Fitbit or others—there were some concerns about the rate of false positives in the study.

The study used an older version of the Apple Watch, not the latest one launched in September, which had added a built-in electrocardiogram to its pulse sensor. In the study, about 2,160 people, or 0.5 percent, received notifications of irregular heart rhythms. In older people, 65 years and older, the rate was higher, about 3.2 percent, compared to 0.16 percent in people ages 22 to 39.

Of those 2,160 receiving notification, only about 450 didn’t receive and return the wearable ECG patches to the research team. That was because some people didn’t bother calling their physicians or they had already been diagnosed with atrial fibrillation, which disqualified them from the study.

The bottom line was the ECG patches confirmed atrial fibrillation in only 34 percent of the 450 patients who returned the patches. The remaining, about 66 percent, had no confirmed atrial fibrillation. This places some doubt on just how accurate the Apple Watch is at identifying atrial fibrillation, although it also appears that the patient population presented some compliance issues with the trial.

During a panel discussion of the trial, Jeanne Poole, professor at the University of Washington in Seattle, said, “This also has the possibility to lead a lot of patients potentially to be treated unnecessarily or prematurely, or flooding doctors’ offices and cardiologists’ offices with a lot of young people.”

Marco Perez, an associate professor of cardiovascular medicine at Stanford and one of the study’s lead researchers, told the Wall Street Journal, that another way of looking at it was that the Apple Watch detected atrial fibrillation as confirmed by the ECG patch at 84 percent. However, that analysis was performed in a smaller group, in the 86 participants who had positive watch notifications.

Perez, reported Reuters, said, “The physician can use the information from the study, combine it with their assessment … and then guide clinical decisions around what to do with an alert.”

The study results certainly give Apple ammunition to continue this type of study, particularly since the study did not use its new Series 4 Watch, whose built-in electrocardiogram required clearance from the U.S. Food and Drug Administration (FDA).

Is the Apple Watch ready to be used as a default atrial defibrillation monitor in the general population and by physicians with patients with or at high risk of atrial fibrillation? Probably not. But it does seem like a start.

Deepak Bhatt, a cardiologist from Brigham and Women’s Hospital in Boston who was not involved in the trial, told Reuters, “The study is an important first step in figuring out how can we use these technologies in a way that’s evidence based.

Other physicians agreed, and the researchers themselves indicated that physicians should be cautious when using data from consumer devices when treating patients. But they do see the potential of the devices.

https://www.biospace.com/article/apple-watch-atrial-fibrillation-study-has-positive-but-mixed-results/

Puma Biotechnology presents interim results from Phase 2 SUMMIT trial

Puma Biotechnology announced that updated results from the cervical cancer cohort of SUMMIT, an ongoing Phase 2 basket trial examining the efficacy of neratinib in HER2-mutated cancers, were reported at the Society of Gynecologic Oncology 2019 Annual Meeting. The cervical cancer cohort was comprised of 11 patients with advanced and/or metastatic disease treated with neratinib monotherapy. Patients received a median of 2 prior regimens in the recurrent or metastatic setting before entering this trial. Six patients, or 54.5%, had been previously treated with bevacizumab prior to entering the study; 7 patients, or 63.6%, had received prior surgery; and 9 patients, or 81.8%, received prior radiation therapy. The objective response rate was 27.3%. The clinical benefit rate was 54.5% and included 3 patients with confirmed partial responses and 3 patients with stable disease that lasted greater than 16 weeks. The median progression free survival was 7.0 months. The safety profile observed in neratinib-treated cervical cancer patients in SUMMIT was consistent with that reported for HER2-amplified metastatic breast cancer. The most frequently observed adverse event was diarrhea, any grade including 1 grade 3 diarrhea event. The duration of grade 3 diarrhea was 1 day. None of the diarrhea events resulted in dose reduction, dose discontinuation or hospitalization, the company said. Alan Auerbach, CEO and President of Puma Biotechnology, said, “We are very pleased with the activity seen with neratinib in this cohort of patients with HER2-mutated cervical cancer. We look forward to the further development of neratinib in this patient population.”

https://thefly.com/landingPageNews.php?id=2880719

Aimmune news derisking, but no expedited review, says Piper Jaffray

The FDA’s acceptance of Aimmune Therapeutics’ Biologics License Application for AR101 is “clearly derisking,” but the standard 12-month review period is “clearly at odds” with the drug’s Breakthrough Therapy and Fast Track Designation, Piper Jaffray analyst Christopher Raymond tells investors in a research note. The analyst, however, says he never modeled commercialization before Q1 of 2020, and as such views timing as in-line with his model. Further, the analyst points out that the indicated advisory committee to review the filing has long been expected and “should surprise no one.” Raymond keeps an Overweight rating on Aimmune shares with a $60 price target.

https://thefly.com/landingPageNews.php?id=2880499

Thermo Fisher to invest $150M to expand Pharma Services capabilities

Thermo Fisher Scientific announced that it is investing $150M in its Pharma Services business to provide additional capacity for sterile liquid and lyophilized product development and commercial manufacturing. Included in the site expansion projects are Monza and Ferentino, Italy, and Greenville, North Carolina. In response to customer requests, each of the sites will be equipped with aseptic filling lines and isolator technology. Construction is expected to be completed within the next 24 months.

https://thefly.com/landingPageNews.php?id=2880505

Puma Biotechnology partner STA receives marketing authorization in Australia

Puma Biotechnology announced that its licensing partner Specialised Therapeutics Asia, or STA, has received marketing authorization from Australia’s Therapeutic Goods Administration, or TGA, to commercialize NERLYNX in Australia for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer following adjuvant trastuzumab based therapy. STA has submitted regulatory applications to gain approval to introduce NERLYNX in Singapore. Further applications are planned by STA in other countries in South East Asia, including Malaysia, Brunei, Vietnam and Thailand.

https://thefly.com/landingPageNews.php?id=2880515