Sangamo, which was scheduled to present at the healthcare conference at 2:30 pm ET, is down $1.33, or 10.4%, to $11.48 in late afternoon trading.
Wednesday, January 9, 2019
Atossa Genetics gains on completing Phase 1 study
Atossa Genetics (NASDAQ:ATOS) reports final results from its Phase 1 dose-escalation study of topical Endoxifen in 24 male subjects.
All objectives were successfully met. No clinically significant safety signals and adverse events were observed. Topical Endoxifen was well tolerated at each dose level and blood samples showed no measurable Endoxifen.
Phase 2 study using topical Endoxifen in women with mammographic breast density (MBD) is anticipated to be completed in Q2 2019.
Shares are up 41% premarket.
Previously: Atossa Genetics announces preliminary results from male Phase 1 study of topical endoxifen (Sept. 13, 2018)
Amarin CEO hints at stronger 2019 outlook for Vascepa sales
Amarin CEO John Thero dropped hints at his breakout session at the JPMorgan Healthcare conference that the comapny has a stronger 2019 outlook for Vascepa than its official guidance offered a week ago, STAT News reports. Though Thero can’t say directly that he expects better sales, he not-so-subtly suggested a stronger sales outlook for the heart drug, the report says
https://thefly.com/landingPageNews.php?id=2846463
In pivot to less-rare diseases, Alexion needs a new sticker-price plan, CEO says
In 2019, Alexion is looking to pivot from an ultrarare-disease company to a rare-disease company—and it knows its pricing strategy has to change.
With its top-selling therapy, Soliris, the company is moving into new diseases that aren’t nearly as rare as its previous targets. The drug recently nabbed an approval in generalized myasthenia gravis and is looking to snag a green light in relapsing neuromyelitis optica spectrum disorder, CEO Ludwig Hantson said at a presentation at the J.P. Morgan Healthcare Conference.
And as the company looks forward to potentially taking on diseases such as amytrophic lateral sclerosis and primary progressive multiple sclerosis, “we want to make sure our pricing strategy is aligned,” Hantson said, adding, “we’re talking about multiplying our patient pool by big numbers.”
Soliris—previously approved for paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome—has perennially made pharma’s list of most expensive drugs, but that’s not what Hantson, who took the helm in 2017, wants to be known for.
“This is about a story of innovation and volume. It is not going to be a story about price and price increases and so on,” he said.
To drive that point home, Alexion recently served up a 10% discount on maintenance doses of Ultomiris, the Soliris follow-up drug that last month snagged an FDA nod in PNH. The discount move helped the company “make sure we’re ready from a global reference pricing perspective,” Hantson said, telling investors, “We want to be ready when one of you comes back with, ‘do you see what’s going on in Washington?’”
Meanwhile, Alexion is also hoping its pricing for Ultomiris will help convince current Soliris patients with PNH to make the switch to the newer drug. It’s set a high target, looking to convert 70% of PNH patients taking by the end of 2020.
Hantson said Alexion can hit that ambitious goal “because we have that very strong value proposition across the board” and “we have an awesome team.”
“That will of course address some of the questions we have on the durability of our Soliris franchise,” he said, adding, “I hope put that question to rest.”
Novartis puts AI on the job to help reps say the right things to the right doctors
Artificial intelligence is a big buzzword in R&D right now, but at Novartis, it’s hard at work in the sales department, too.
Amid far more meetings with digital companies at the J.P. Morgan Healthcare Conference this year, Novartis’ pharma CEO Paul Hudson said he expects 2019 to be the “beginning of the tech disruption” for pharma, in everything from marketing to supply chain.
In past years at JPM, Hudson mainly checked out early-stage biotech companies for potential partnerships, he told FiercePharma. This year? It’s about half health-tech companies, he said.
Obviously, Novartis is jumping right in, as part of CEO Vas Narasimhan’s push to transform the entire company using digital tech. In the field, the drugmaker has equipped salespeople with an AI service that listens to their conversations with doctors and not only suggests other doctors to visit, but subjects to talk up during their meetings.
The program’s “virtual assistant” helps salespeople “plan better, move better and make sure when they show up to see a healthcare professional, they are talking about the things that the healthcare professional is absolutely interested in,” Hudson said.
“When you turn up at the right time with the right things to say, they’re more interested and put more value in it, and our people like the fact that AI is running in the background helping them plan their day,” he added.
In the long run, the program will help the company become more efficient, Hudson said, also citing telemedicine and improved distribution systems as potential digital shakeups heading for the pharma industry.
Under Narasimhan, Novartis has placed a big emphasis on digital. The company in 2017 appointed Bertrand Bodson as its first chief digital officer. In March, the drugmaker teamed with Pear Therapeutics to create software applications to treat patients with schizophrenia and multiple sclerosis. The partners just launched an opioid addiction app this week.
Of course, Novartis isn’t alone in its digital quest. Pfizer, Merck and GlaxoSmithKline also appointed their first chief digital officers over the past couple years, signaling how the trend is taking hold at top drug companies.
Merck appointed former Nike executive Jim Scholefield as its digital lead, while GSK tapped former Walmart executive Karenann Terrell as its chief digital and technology officer. For GSK’s consumer unit, the company picked up former Google and L’Oreal executive Marc Speichert. Pfizer, for its part, named former Quest Diagnostics executive Lidia Fonseca to serve as chief digital officer under new CEO Albert Bourla.
At Morgan dinner for pharma executives, major topic was Amazon
J.P. Morgan Chase CEO Jamie Dimon hosted a private dinner for pharmaceutical executives on Sunday night, ahead of the bank’s health-care conference in San Francisco. There was one company not in attendance that received a lot of attention: Amazon.
About 25 industry leaders attended from companies including Eli Lilly, Pfizer and Johnson & Johnson, along with some of the J.P. Morgan’s investment bankers, according to two people with knowledge of the event who asked not to be named because it was private.
Dimon gave some details around what he hopes to accomplish through the bank’s health partnership, announced last year, with Amazon and Berkshire Hathaway.
He told the room, “We are not happy with health-care costs and want to help,” the people said. It’s a theme that’s gained resonance in Washington, D.C., with President Trump and politicians from both sides of the aisle calling for drug makers to lower prices.
Dimon was peppered with additional questions about Amazon and its ambitions in the health-care market, after the e-retailer purchased online pharmacy PillPack last year. Amazon also has plans for delivering medical supplies, and the company has reportedly been experimenting in areas like electronic medical records and telemedicine.
Some view Amazon as a potential collaborator, while others see the technology giant as a threat.
The J.P. Morgan-Amazon-Berkshire venture is focused on improving health-care quality while lowering costs, initially for their combined 1.2 million employees. The group has grown to about a half-dozen people from across the health industry, but has not yet revealed its strategy.
“I know last year a lot of your stocks went down after some of my comments,” Dimon told the attendees, referencing to the partnership with Amazon. He declined to speculate on Amazon CEO Jeff Bezos’ plans outside of the group, the people said.
On Tuesday, Eli Lilly CEO Dave Ricks acknowledged the dinner with Dimon while on a panel at the conference, and called for other CEOs to take a more active role in the health benefits for employees. Typically, senior leaders aren’t involved in the formation of benefits plans.
“I think here corporate America can lead,” Ricks said. “And I’m sure Jamie would welcome that kind of discussion.”
Halozyme 2019 Pipeline Update And Financial Guidance At JP Morgan
Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, today provided a pipeline update and announced its 2019 financial guidance at the 37th annual JP Morgan Healthcare Conference.
“Looking ahead, our ENHANZE business is gaining momentum with key product development milestones expected this year, including potential FDA approval of a subcutaneous formulation of Herceptin® and regulatory submissions for the subcutaneous formulation of Darzalex® each representing important near-term catalysts,” said Dr. Helen Torley, president and chief executive officer. “In our oncology business, HALO-301 has completed enrollment and topline results are projected in the second half of 2019.”
Halozyme provided an update on the 2019 outlook for its ENHANZE franchise. The company expects to make meaningful progress this year toward its projection of the potential for approximately $1 billion in royalty revenue in 2027. During the first quarter, FDA action is expected on the Biologics License Application (BLA) filed by ENHANZE partner Genentech, a member of the Roche Group, for the subcutaneous (SC) formulation of trastuzumab (Herceptin®). In the second half of 2019, ENHANZE partner Janssen Biotech, Inc. anticipates filing for approval of the SC formulation of its multiple myeloma drug daratumumab (Darzalex®). Also in the second half, Halozyme expects a phase 3 study will be initiated by a partner for an undisclosed target.
By the end of 2019, the company expects three ENHANZE programs to be in phase 3 studies and to have nine active phase 1 programs in addition to its three currently marketed products. This accelerating partner activity supports the projection of the potential for approximately $1 billion in royalty revenue in 2027. Additionally, potential lifetime milestone payments associated with existing ENHANZE partnership programs in development are projected to be $1 billion, with $225 million to $300 million in revenues projected between 2019 and 2021.
The company also provided an update on its late stage targeted oncology asset PEGPH20. Enrollment in HALO-301, the company’s phase 3 study evaluating PEGPH20 in metastatic pancreas cancer, was completed at the end of 2018 with approximately 500 subjects enrolled. The company projects the study will achieve its target of 330 OS (overall survival) events between August and November of 2019. Based on this timeline, the company projects topline results will be available in the second half of 2019.
Halozyme and its partners continue to explore the pan-tumor potential of PEGPH20. This includes ongoing phase 1b studies in pancreas cancer, gastric cancer, gall bladder cancer and cholangiocarcinoma.
2019 Financial Guidance
The company also provided financial guidance for 2019:
- Net revenue of $175 million to $185 million, excluding revenue from any new ENHANZE global collaboration and licensing agreements.
- Operating expenses of $265 million to $275 million, or $225 million to $235 million excluding an expected increase in cost of goods sold. Excluding the cost of goods sold the modest increase in expenses is driven by ENHANZE partner support, and support of the potential commercialization of PEGPH20.
- Operating cash burn of $75 million to $85 million.
- Debt repayment of approximately $90 million.
- Year-end cash balance of $180 million to $190 million.
Table 1. 2019 Financial Guidance
Guidance Range
| |
Net Revenue
|
$175 million to $185 million
|
Operating Expenses
|
$265 million to $275 million
|
Operating Expenses (excl. COGS)
|
$225 million to $235 million
|
Operating Cash Burn
|
$75 million to $85 million
|
Debt Repayment
|
~$90 million
|
Year-end Cash Balance
|
$180 million to $190 million
|
The company plans to report fourth quarter and full year 2018 financial results on February 21, 2019.
A replay of Dr. Torley’s presentation at the conference today can be accessed for the next 90 days via the “Investors” section of www.halozyme.com. Also, a copy of the presentation made today was filed with the Securities and Exchange Commission as part of a Form 8-K that can also be accessed via the “Investors” section of www.halozyme.com.
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