Monday, January 7, 2019
Novocure reports Q4 revenue $69.6M, consensus $70.47M
Reports Q4 active patients up 30% from last year at 2.4K and prescriptions received up 21% at 1.3K. Novocure plans to discuss these results with investors at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco.
https://thefly.com/landingPageNews.php?id=2844977
Quidel reports preliminary Q4 revenue $132M-$133M, consensus $132.06M
“We had another great quarter, and a remarkable year, a year in which our efforts and excellent performance were driven significantly by the integration of the acquired Triage assets. We unlocked synergies, brought most international businesses within our control, and aggressively paid down debt,” said Douglas Bryant, president and chief executive officer of Quidel Corporation. “And we did all that without taking our eye off the ball. Notably, Sofia placements, which for the year were nearly 10,000, were higher than in any prior year since launch by far, further demonstrating the competitiveness and resilience of the Sofia instrument system, as well as the global commercial organization’s proficiency in ‘selling the entire bag’,” added Bryant. These preliminary results are based on management’s initial analysis of operations for the quarter ended December 31, 2018.
https://thefly.com/landingPageNews.php?id=2844987
Arvinas Wins Go-Ahead for PROTAC Therapy
Arvinas Inc (NASDAQ: ARVN) disclosed that it has received authorization to proceed for its IND application for PROTAC therapy to treat patients with metastatic castration-resistant prostate cancer.
The announcement came down Monday that the U.S. Food and Drug Administration(FDA) has cleared the company’s investigational new drug application (IND) for ARV-110, an oral androgen receptor (AR) PROTAC™ protein degrader, for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).
Arvinas expects to begin enrollment of a Phase 1 clinical trial for ARV-110 in the first quarter of this year.
According to CEO John Houston, “This IND clearance is a key step forward for Arvinasand for the field of protein degradation
“Our PROTAC platform has demonstrated exciting promise in preclinical studies and represents an entirely new approach to treating patients with mCRPC and many other diseases. We hope ARV-110 will deliver a much-needed new therapeutic option for patients, and we expect to dose our first patient in the first quarter of 2019.”
ARV-110 was developed using Arvinas’ proprietary technology platform – PROTAC (proteolysis-targeting chimera) protein degraders – that uses small molecules to harness the body’s own natural protein recycling system (the ubiquitin proteasome system) to selectively and efficiently remove disease-causing proteins.
Stemline Applies for Euro Marketing Authorization for ELZONRIS
Stemline Therapeutics, Inc. (NASDAQ:STML), a biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, announced today that it has submitted the marketing authorization application (MAA) for ELZONRIS (tagraxofusp) to the European Medicines Agency (EMA). The MAA seeks approval for treating patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). In November 2018, the EMA granted the ELZONRIS MAA accelerated assessment.
On December 21, 2018, ELZONRIS was approved by the U.S. Food and Drug Administration (FDA) for the treatment of BPDCN in adult and pediatric patients, two years and older, in both treatment-naïve and previously-treated populations. ELZONRIS is the first treatment approved for BPDCN and the first approved CD123-targeted therapy.
“The submission of the ELZONRIS MAA is another major step forward for providing this important targeted treatment to patients, globally,” said Ivan Bergstein, M.D., CEO of Stemline Therapeutics. “We look forward to working closely with the EMA to ensure this treatment is available to patients as quickly as possible. In parallel, our commercial team is continuing its ongoing effort to raise awareness of both CD123 testing and BPDCN worldwide. Potential European approval offers us an opportunity to significantly increase the number of patients who may benefit from ELZONRIS.”
Merck loses bid to revive $200 million Gilead verdict at U.S. high court
The U.S. Supreme Court on Monday handed a defeat to Merck & Co by refusing to hear its appeal of a ruling that it had dishonestly obtained patent rights and could not collect a $200 million (£156.5 million) verdict against rival drugmaker Gilead Sciences Inc in a dispute involving blockbuster hepatitis C drugs.
WASHINGTON (Reuters) – The U.S. Supreme Court on Monday handed a defeat to Merck & Co by refusing to hear its appeal of a ruling that it had dishonestly obtained patent rights and could not collect a $200 million (£156.5 million) verdict against rival drugmaker Gilead Sciences Inc in a dispute involving blockbuster hepatitis C drugs.
A jury awarded Merck $200 million in 2016 after finding Gilead’s Hepatitis C drugs Sovaldi and Harvoni infringed two of its patents, but a judge later ruled the patents unenforceable because of a pattern of misconduct by Merck including lying under oath by one of its in-house lawyers.
Merck had urged the Supreme Court to place limits on the doctrine of “unclean hands” that can prevent plaintiffs from winning lawsuits if they acted in bad faith.
Hepatitis C, estimated to infect about 3.2 million Americans, is a viral disease that causes inflammation of the liver that can lead to liver failure. Injection drug use is among the causes of the infection.
Direct-acting anti-viral medications like Gilead’s Sovaldi and Harvoni have revolutionized treatment of hepatitis C, with cure rates of more than 90 percent. Merck holds patents that it has said cover a compound that is the foundation for all major antiviral treatments for chronic hepatitis C.
A federal court jury in San Jose, California awarded Merck $200 million in 2016 after finding Sovaldi and Harvoni infringed two of its patents.
A judge threw out the verdict later that year, ruling that in the process of applying for one of the patents, Merck used confidential information it obtained in 2004 while discussing a possible partnership with Pharmasset Inc, a company Gilead bought in 2011.
The judge also said a Merck in-house lawyer testified untruthfully in a deposition and at trial about his participation in a confidential call with Pharmasset personnel.
Merck’s litigation against Gilead has included several reversals of fortune.
In 2016, a jury in Delaware said Gilead infringed a related patent and ordered it to pay Merck $2.54 billion in royalties, the largest verdict ever in a patent case. But a judge threw out the verdict in February 2018, ruling that Merck’s patent was invalid because it was not sufficiently detailed in its wording.
Durect Says Novartis Ends Non-Opioid Painkiller Deal, Disputes Termination Fee
Durect Monday said Novartis AG Sandoz unit had ended a deal to develop and commercialize Durect’s Posimir non-opioid postoperative painkiller and is disputing its obligation to pay a termination fee.
The Cupertino, Calif., biopharmaceutical company agreed in May 2017 to license Posimir to Sandoz for a $20 million upfront fee, up to $43 million in development and regulatory milestone payments, and up to $230 million in sales-based milestones.
The companies amended the deal a year later, reducing the potential development and regulatory milestone payments to $30 million, after a phase 3 study of Posimir missed its primary endpoint.
Durect on Monday said Sandoz is returning its U.S. development and commercialization rights to Posimir as part of a refocusing of its resources but is disputing its obligation to pay a termination fee. Durect said it has initiated a formal dispute resolution process related to the fee, the amount of which hasn’t been publicly disclosed.
The company said it will evaluate and consider potential next steps for Posimir.
Medtronic early view for below trend reported EPS growth in FY20: JPMorgan
JPMorgan analyst Robbie Marcus noted that Medtronic CFO Karen Parkhill discussed expectations for the back half of FY19 and high level views on FY20 at the firm’s healthcare conference. For FY19, the company is now expecting organic growth closer to the middle of its 5.0-5.5% range, driven by softness in CVG, said Marcus. The CFO said headwinds from higher tax rates and foreign exchange could push reported EPS growth below the company’s long-range target of 8%, but expressed confidence in its ability to still hit its 4% guidance floor, adding that softer reported EPS growth in FY20 should set up FY21 for above trend reported EPS growth, according to Marcus. He maintains an Overweight rating on Medtronic shares, which are down nearly 5% to $83.92 in afternoon trading.
https://thefly.com/landingPageNews.php?id=2844911
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