Argus analyst Jasper Hellweg lowered his price target on Illumina to $340 to reflect its recent Q4 earnings miss along with the company’s view of the product transition not having reached the halfway mark for the upgrade cycle. The analyst also kept his Buy rating on Illumina and raised his FY19 EPS view to $6.56 from $6.34, noting that any unevenness from pre-tariff stocking by customers which has recently impacted results “should dissipate over time.” Hellweg further justifies his positive view on the company based on “strong sales of consumables, continued progress on the company’s product transition, and gradual normalization in the timing of orders.”
https://thefly.com/landingPageNews.php?id=2860027
Wednesday, February 6, 2019
Corvus Pharmaceuticals announces presentation of CPI-444, CPI-006 data
Corvus Pharmaceuticals announced the presentation of updated biomarker and clinical results from its two lead programs that target the adenosine pathway, CPI-444, an adenosine A2A receptor antagonist, and CPI-006, an anti-CD73 antibody. The data were presented at the Immuno-Oncology 360 degrees Conference. The presentation reviewed gene expression data of an adenosine gene signature recently announced by Corvus, in patients with renal cell carcinoma, or RCC, who are participating in Corvus’ ongoing Phase 1/1b study of CPI-444, a selective and potent inhibitor of the adenosine A2A receptor. In particular, the data from the study showed a relationship of this novel biomarker to angiogenesis gene expression data. Such findings indicate that expression of AdenoSig was inversely related to the angiogenesis signature, which has been well studied by others and correlates with response to vascular endothelial growth factor receptor, or VEGFR, inhibitors such as Sutent and other tyrosine kinase inhibitors. Low expression of angiogenesis genes predicts a lack of response to VEGFR inhibition. These data suggest that patients with a high AdenoSig are potentially more likely to respond to treatment with CPI-444 and less likely to respond to VEGFR inhibitors. The company also presented updated clinical results from the ongoing Phase 1/1b dose-escalation study of CPI-006 in patients with a variety of advanced cancers, including non-small cell lung cancer, or NSCLC, RCC and other cancers who have failed standard therapies. The first arm of the study is evaluating CPI-006 as a monotherapy, a second arm is evaluating CPI-006 in combination with CPI-444, and a third arm is planned to evaluate CPI-006 in combination with pembrolizumab, an anti-PD-1 antibody. CPI-006 given as a monotherapy activated B cells and led to a redistribution of these cells along with changes in other immune cells. These data are consistent with immune stimulation induced by CPI-006. CPI-006 reacted with an epitope on CD73 that led to blockade of adenosine production and expression of lymphocyte activation antigens that are independent of adenosine.
https://thefly.com/landingPageNews.php?id=2860041
https://thefly.com/landingPageNews.php?id=2860041
Perrigo Gets FDA OK for Generic Version of Zovirax
Perrigo Company plc (NYSE; TASE: PRGO) today announced it has received final approval from the U.S. Food and Drug Administration for its AB rated Abbreviated New Drug Application referencing Zovirax® Cream, 5% (acyclovir cream, 5%) developed in collaboration with Sol-Gel Technologies Ltd. (NASDAQ: SLGL). The Company anticipates launching the product this month.
Annual market sales for the twelve months ending December 2018 were approximately $92 million as measured by IQVIA™.
Perrigo Executive Vice President and President Rx Pharmaceuticals Sharon Kochan stated, “This final approval and first to market launch is another example of our long-term investment in new products, the team’s impressive execution skills and our solid collaboration with SolGel. We stay committed to providing affordable treatment options for patients in important extended topical categories.”
GSK sees 2019 earnings hit from rival asthma treatments
Britain’s biggest drugmaker GlaxoSmithKline Plc on Wednesday said it expects full-year adjusted profit to be hurt by new competition for its blockbuster asthma drug Advair.
GSK reported adjusted earnings per share of 31.2 pence on sales of about 8.20 billion pounds ($10.62 billion) in the fourth quarter.
Analysts had expected earnings of 27.7 pence and sales of 7.95 billion pounds, according to a company-provided consensus here of 11 analysts.
The company said it expects adjusted earnings per share to decline 5 percent to 9 percent, reflecting recent approval of a generic competitor to Advair in the United States.
Alphabet’s Verily is building a high-tech rehab campus to combat opioid addiction
Verily, Alphabet’s life science division, is building a tech-focused rehab campus in Dayton, Ohio to combat the opioid crisis.
Verily will join two health networks, Kettering Health Network and Premier Health, to create a nonprofit named OneFifteen. The organization will deploy a tech-enabled system of care to treat substance abuse, including a behavioral health treatment center, rehabilitation housing and wrap-around services.
Verily’s technology will integrate the facility and use analytics to measure the effectiveness of various interventions.
Clinical care will be provided d by an operating partner of OneFifteen, Samaritan Behavioral Health, Inc., a subsidiary of Premier Health.
OneFifteen will begin seeing individuals for inpatient and outpatient care in the Spring of 2019. The full campus is expected to be completed in 2020.
“In Montgomery County, Ohio, healthcare providers and public services are at the front lines of what many have termed ‘ground zero’ for the opioid epidemic and are meeting success by taking action through thoughtful public alliances to stem the tide of overdoses in their communities,” Verily said in a press release announcing the new initiative.
Tuesday, February 5, 2019
Facing crackdown in Canada, drugmakers offered billions in price cuts
Canadian pharmaceutical industry lobby groups, in an effort to head off a planned crackdown on prescription drug prices, offered to give up C$8.6 billion (£5.1 billion) in revenue over 10 years, freeze prices or reduce the cost of treating rare diseases, according to interviews and documents seen by Reuters.
Those industry offers did not impress federal officials, coming last year as Canada prepared to expand the powers of a little-known federal watchdog called the Patented Medicine Prices Review Board (PMPRB) to reduce the cost of prescription drugs.
The government proposals would change the countries Canada compares its prices to, dropping the United States where they are highest, and set a formula to assess cost-effectiveness of medicines.
Announced in 2017, the new rules were scheduled to come into effect last month but have been delayed as the government reviews feedback, which has some wondering if they will ever be implemented.
The delay is a setback for supporters of the changes. But documents detailing counter offers from lobby groups Innovative Medicines Canada and BIOTECanada show an industry struggling to win over federal officials.
Unlike other countries with universal healthcare, Canada’s government-funded healthcare system does not cover prescription drugs. Most Canadians rely on an expensive patchwork of public and private insurance plans for that. Among industrialized nations, only the United States and Switzerland spend more on prescriptions per capita.
Declan Hamill, a vice president at Innovative Medicines Canada, said the proposed regulations go too far and could hurt patient access to new drugs in Canada. But his group recognises that the Canadian government wants to make drugs more affordable, he said.
“We’d like to help the government out with that, and we’ve been trying to have discussions with them,” Hamill said.
Lower prices in Canada could eventually hit drugmakers in the most lucrative U.S. market, as Washington evaluates a proposal to base drug prices paid under the government’s Medicare program on the cost of medicines in other developed nations, including Canada.
Global drugmakers, including Johnson & Johnson, Merck & Co, Amgen Inc and others, have argued against the Canadian proposal. They referred questions back to Innovative Medicines Canada.
‘WOULD NOT ACHIEVE THE GOAL’
With major drugmakers united in their condemnation of proposed regulations to rein in prices, Health Canada hired former Bank of Canada governor David Dodge and health economist Åke Blomqvist to assess the government proposal. Their review, completed in August 2018, broadly endorsed the government’s plan, documents seen by Reuters showed.
Prime Minister Justin Trudeau’s senior ministers will eventually decide how to proceed. PMPRB Executive Director Douglas Clark told Reuters the new regime could be running by early 2020.
“People have a tendency to presume that the sky is falling,” Clark said. “I think it’s a little early for people to panic and lament the demise of this policy initiative.”
Health Canada said the industry’s offers do not address drug price problems created by outdated rules.
“The non-regulatory counter-proposals that Innovative Medicines Canada and BIOTECanada jointly submitted to the government would not achieve the goal of ensuring appropriate consumer protection in these circumstances,” the ministry said in an emailed statement.
One offer was to “secure a price reduction target of C$8.6 billion” in net present value terms, according to a letter from officials seen by Reuters.
Hamill said the C$8.6 billion figure was borrowed from a government estimate of how much the PMPRB reforms would reduce revenue and would have been spread over 10 years. He did not say exactly how it would have worked. Total patented medicine sales were C$16.8 billion ($12.8 billion) in 2017, according to the PMPRB.
Health Canada also rejected an offer to freeze prescription drug prices, saying it would not meet its objective of lowering prices.
Health Canada said the industry had also committed to improving access for patients with rare diseases, but that proposal would not help those who have drug plans.
Meanwhile, ahead of a fall election, Trudeau’s government is preparing to announce a limited expansion of the nation’s universal healthcare system to cover part of the cost of prescription medicines, as drug plans grapple with the extremely high cost of newer speciality drugs.
‘WE DON’T WANT TO SHUT THAT DOOR’
The PMPRB caps prices of drugs still under patent protection. If new regulations are adopted, it would change the list of countries whose drug pricing it uses to decide whether costs are excessive, dropping the United States and adding countries with lower prices.
The regulator would also consider for the first time a type of value-based pricing, measuring how cost-effective drugs are in terms of quality-adjusted life years, and force drug companies to privately disclose some confidential discounts.
It is not entirely clear how the PMPRB would use its new powers. In documents posted online, the agency said it could apply new rules to drugs already on the market. But Health Canada said the regime would not apply to those.
Andrew Casey, president of BIOTECanada, would like “a more rigorous sit-down” with the government.
“I fear the consequences when you do something without really working with industry,” he said. “We don’t want to shut that door.”
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