Protect your pets from the Dog Flu this summer

We are finally in the clear this flu season but your pets may still be at risk. One local veterinarian is encouraging you to get your furry friends vaccinated.

There are two known strains of the Canine Flu that can make dogs sick. The first came from horses more than a decade ago, and the second brought into the United States from Asia in 2015. Both strains have been confirmed in Wisconsin.

“It’s not just a seasonal problem for dogs. It’s all year-round,” said Brook-Falls Vet Hospital & Exotic Care Owner, Dr. Denise Follett.

Dr. Denise Follett — a veterinarian with Brook-Falls Vet Hospital & Exotic Care in Menomonee Falls — keeps a fridge stocked full of the vaccine.

“One hundred percent of dogs who come in contact with this virus get sick from it,” said Dr. Follett.

Often, she says dogs only become mildly ill but if not treated properly, the virus can be deadly.

“About 80 percent will show clinical signs, about ten percent of those do die from it,” Dr. Follett said.

Social dogs, Dr. Follett says, are more prone to “fetching” the virus.

“We take them with us on vacation, we take them camping, we take them hiking, we meet at dog parks,” Dr. Follett said.

IN THIS STORY

• MAP: States with reported cases of dog flu
• Information on K9 influenza

At Muttland Meadows in Grafton, Paul Bamberger’s dog ‘Fred’ had the shot last year, but his vet didn’t suggest it this season.

“I specifically asked about it and they said at this point, ‘no,'” said Bamberger.

Follett says, dogs can swap the virus with a simple sip of water, and can “dig up” the virus 2-5 days before you even notice they’re sick.

“You could be at the dog park, and the dogs look perfectly healthy but they can be shedding it to each other,” said Dr. Follett.

Still, Susie Morter, who brings her pup to the park almost everyday, says she isn’t concerned — at least not yet.

“It’s a wonderful park,” Morter said. “It outweighs the worries of them getting sick from a flu virus. Now I think if there was a point where all the sudden a lot of dogs were getting sick… then you’d have to re-evaluate.”

Dr. Follett says, young puppies and older dogs with underlying health issues are more susceptible to coming down with the flu. CLICK HERE to read more about Canine Influenza.

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Gilead wins Chinese OK for hep C med, but emerging market getting crowded

Epclusa was just greenlighted by China’s Drug Administration (CDA). For hepatitis C patients in China, that means the first pangenotypic treatment will soon be available to them. But for Gilead, it might be too little, too late.

The Chinese authority based its decision on five international phase 3 studies that showed Epclusa’s ability to reach 92% to 100% cure rates across all six hepatitis C genotypes. Before China’s recent updates to its drug approval policies that further align them with those used in developed countries, foreign drugs often had to go through China-specific clinical studies.

“With high cure rates across all HCV genotypes, Epclusa could increase HCV treatment in China by potentially eliminating the need for genotype testing, which can be a barrier to treatment in many settings,” said Professor Lai Wei of Peking University in a statement.

However, the question is never about Epclusa’s efficacy profile, but more about the size of market left for Gilead.

With the dwindling patient base in the U.S. and Europe and the arrival of fierce rivals, sales of Gilead’s HCV franchise have dramatically declined from $14.83 billion in 2016 to $9.14 billion in 2017. For the first quarter of 2018, the number plummeted by 59% to a mere $1 billion.

China represents a new opportunity. The country has about 10 million HCV patients, with about 200,000 new diagnoses each year, according to the nation’s health department. But competition from both Gilead’s multinational pharma archrivals, and local biotechs, is building at an unprecedented speed thanks to China’s recent policy changes designed to hasten approvals for innovative therapies.

It was only last April when Bristol-Myers Squibb’s dual-drug regimen Daklinza and Sunvepra became the first direct-acting antiviral agents approved in the country. Gilead then won approval for Sovaldiin September, the same time AbbVie got its ombitasvir and dasabuvir combo through.

Epclusa’s nod comes just a few weeks after Merck’s Zepatier was approved to treat patients with HCV genotypes 1 and 4. Besides, domestic firm Ascletis is also expected to reach the market in the third quarter with Ganovo (danoprevir) and file an application for its pan-genotypic DAA ravidasvir around the same time.

The bigger concern for Gilead is, of course, the 8-week pangenotypic therapy Mavyret vs.12 weeks for Epclusa. Mavyret is one big reason behind Gilead’s HCV freefall. Since its launch last year, the drug has occupied 45% of the market, said CEO Richard Gonzalez on the company’s first-quarter earnings call. AbbVie filed for Chinese approval last month.

Gilead has said it expects its market share to stabilize by mid-2018, with more predictable but slightly declining patient starts. It hasn’t updated its full-year HCV guidance that now rests at around $3.5 billion to $4 billion, on par with AbbVie’s projection of about $3.5 billion for its HCV business.

Getting their HCV treatments on the Chinese market is only the first step for drugmakers. What comes next is a process of carefully negotiating a price with the government to win coverage on the National Reimbursement Drug List, which entails taking a huge discount to reach a much larger patient population. Securing national insurance coverage could mean do-or-die for a pricey drug sold in the price-sensitive China, especially if a competitor has it.

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Aslan started at buy by BTIG

Aslan Pharmaceuticals initiated with a Buy at BTIG. BTIG analyst Robert Hazlett initiated Aslan Pharmaceutical with a Buy rating and a price target of $16. The analyst notes that this “innovative oncology therapeutics” company has “important pivotal readouts” coming for its Varlitinib program as the management drives its clinical development in Asia. Hazlett estimates that global peak revenue for the treatment in biliary tract cancer and gastric cancer could reach $1.3B, as both of those programs have readouts in the second half of this year / 2019 respectively. The analyst also sees “material promise” for Aslan’s oral DHODH inhibitor in mid-stage development in AML, with phase 2 data readout anticipated for the second half of 2018 as well.

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Amicus jumps over 7% after initiating Fabry treatment in Japan

Earlier today, Amicus Therapeutics announced it has initiated the commercial launch of the oral small molecule pharmacological chaperone Galafold capsules 123mg for treatment of patients aged 16 years and older with a confirmed diagnosis of Fabry disease and who have an amenable mutation. Galafold is the first and only oral precision medicine for Fabry disease in Japan. John F. Crowley, Chairman and CEO of Amicus Therapeutics, Inc., stated, “The launch of Galafold in Japan, less than one year after our J-NDA submission, provides a significant opportunity for us to deliver this oral and differentiated precision medicine to amenable Fabry patients living in Japan. This is the result of Amicus employees, Japanese regulators, and the Fabry community working together to advance Galafold, in particular those physicians and patients who participated in the clinical studies of Galafold and their families. An estimated 850 people are currently known to be living with Fabry disease in Japan. We believe a significant portion of these Fabry patients have amenable mutations that could benefit from treatment with Galafold. Introducing Galafold in Japan is very important to our patient-focused vision to provide Galafold to Fabry patients with amenable mutations throughout the world as soon as possible. We also hope to have many future opportunities to deliver new medicines for people living with rare metabolic diseases in Japan.” Shares of Amicus are up 7.17% or $1.12 to $16.85 per share in early afternoon trading.

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Exact Sciences eyes expanding Cologuard indication after new guidelines

Exact Sciences announced that it “strongly supports” the American Cancer Society’s update to its colorectal cancer screening guidelines announced today. The new guidelines recommend colorectal cancer screening begin at age 45 for people at average risk of the disease. With more than 20 million Americans age 45-49, Exact Sciences affirmed its commitment to seek U.S. Food and Drug Administration approval for making Cologuard, its noninvasive colorectal cancer screening test, available to those in this population who are at average risk for colorectal cancer. Cologuard is currently available to individuals age 50 and older who are at average risk for colorectal cancer. Exact Sciences will seek to expand the product’s current indication to people age 45 and older who are at an average risk for colorectal cancer.

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Gilead started at buy by Piper

Gilead assumed with an Overweight at Piper Jaffray. Piper Jaffray analyst Tyler Van Buren assumed coverage of Gilead Sciences (GILD) with an Overweight rating and $85 price target. The analyst, after speaking with management, has a “high level of conviction” that pricing for the hepatitis C virus franchise has finally stabilized. It is inconceivable that AbbVie (ABBV) will continue to be irrational on pricing, Van Buren tells investors in a research note.

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Gilead, Galapagos NV announce Phase 2 study meets primary endpoint

Gilead (GILD) and Galapagos NV (GLPG) announced that the randomized, placebo-controlled Phase 2 EQUATOR study of filgotinib, an investigational, selective JAK1 inhibitor, in 131 adults with moderate to severe psoriatic arthritis, achieved its primary endpoint of improvement in the signs and symptoms of psoriatic arthritis at Week 16, as assessed by the American College of Rheumatology 20% improvement score. There was an ACR20 response of 80% for filgotinib versus 33% for placebo. The ACR50 and ACR70 responses at Week 16 were also significantly higher for filgotinib versus placebo 48% for filgotinib versus 15%; ACR70: 23% versus 6 percent. Filgotinib was generally well-tolerated in the EQUATOR trial, with no new safety signals observed and similar laboratory changes compared to those reported in previous trials with filgotinib in rheumatoid arthritis patients. The adverse event rate was similar in both groups with mostly mild or moderate events reported. There was one serious infection in the filgotinib group, a patient who experienced pneumonia with a fatal outcome. One other patient receiving filgotinib developed herpes zoster. There were no cases of opportunistic infection, tuberculosis, thromboembolism, or malignancy.

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