Citi analyst Yigal Nochomovitz lowered his price target for Portola Pharmaceuticals to $50 saying early Bevyxxa launch challenges in building physician consensus are “substantially higher” than he expected. Portola guided for no meaningful changes in Bevyxxa revenue through mid-2019 with inflection only likely the second half of 2019, Nochomovitz tells investors in a research note. On a positive note, AndexXa is off to a very good start, the analyst adds. The analyst keeps a Buy rating on Portola.
Friday, August 10, 2018
Citing appeals court ‘anarchy,’ Amgen asks SCOTUS to weigh Sanofi patent spat
Amgen made an aggressive legal bid to push Sanofi and Regeneron’s rival PCSK9 drug off the market when the two were first duking it out in 2015. It didn’t work—but Amgen hasn’t given up. It’s aiming to take the battle to the U.S. Supreme Court instead.
After falling short with its arguments in federal appeals court, Amgen is asking the Supreme Court to strike up a review of the case. Amgen claimed Sanofi and Regeneron stepped on its PCSK9 patents and initially won an injunction against their drug Praluent.
In a petition for a writ of certiorari, Amgen now argues that the U.S. Court of Appeals for the Federal Circuit incorrectly interpreted and ruled on patent law. The company says the court has created its own standard that has resulted in “jurisprudential anarchy.” Amgen markets the PSCK9 cholesterol drug Repatha in a head-to-head battle with Praluent; both products have fallen short of expectations, mostly because payers limited access to the high-priced drugs.
Amgen’s filing comes after years of legal back-and-forth between the drugmakers. Amgen sued Sanofi and Regeneron in 2014, and in early 2016, a jury upheld the Amgen patents and the judge in the case granted an injunction against Praluent sales. Sanofi and Regeneron won a stay of the injunction, but analysts believed Sanofi and Regeneron might be forced to pay Amgen royalties.
An October 2017 decision changed all that. The Federal Circuit ruled that the jury was given incorrect instructions, threw out the injunction and ordered a new trial.
In its Supreme Court filing, Amgen says the appeals court’s approach to patent disputes “defies the statute and precedent.” The company argues the court has created its own “possession” standard that doesn’t fit with the Patent Act, and that the court has created new “sub-tests” to implement its standard. Under the standard, the written description for a patent must prove the inventor possessed the invention on the filing date, according to Amgen’s filing.
From Amgen’s perspective, the “ever-shifting demands of those sub-formulations have left innovators no way of predicting what disclosures will be sufficient” to protect their patents.
Since the appeals court decision, Sanofi and Regeneron have been aggressive in promoting Praluent. In March, the partners presented data at the American College of Cardiology showing the drug cut death risks by 29% in the most vulnerable patients. At the same time, the companies said they would discount the med to within a price range of $4,460 to $7,975 per year suggested by cost watchdog ICER.
Two months later, the partners struck an exclusive deal with leading pharmacy benefit manager Express Scripts, agreeing to lower Praluent’s price to win a spot on the PBM’s national preferred formulary.
China targets Cosentyx, Shingrix, Luxturna, 45 other meds for priority OK
Hey, Big Pharma stars: China wants you. Aiming to speed new drugs to market, China just came up with a target list of 48 treatments greenlighted abroad, including some of the industry’s biggest names.
The idea? Persuade their makers to apply for Chinese approval based on foreign trial data.
Some key new drugs are on the list, including Roche and Chugai’s ALK cancer drug Alecensa, psoriasis therapies Taltz by Eli Lilly and Cosentyx from Novartis, and Takeda’s anti-inflammatory treatment Entyvio. Even a few drugs just approved in the U.S. last year were ID’d as targets, including GlaxoSmithKline’s shingles vaccine Shingrix, Spark Therapeutics’ eye therapy Luxturna and Ultragenyx’s Mepsevii.
The list of “clinically urgently needed new drugs” was developed by experts convened by China’s State Drug Administration. The group mainly considered medications already approved in the U.S., EU and Japan, but not yet marketed in China. According to the agency’s Center for Drug Evaluation, the country is in urgent need of these drugs to fight rare diseases or life-threatening conditions, because no effective treatment exists in China or becuase they’ve shown clear advantages in clinical studies.
Some of the drugs on the list are already on their way to the Chinese market. Merck’s PD-1 star Keytruda, for example, was just waved through a few days ago to treat advanced melanoma patients. AstraZeneca, for one, has filed its PARP inhibitor Lynparza for approval.
As for the others yet to make a bid for approval, the agency says drug developers can apply using foreign data and evidence that supports no racial or ethnic differences in efficacy or safety. Once accepted, their new drug applications will be put under priority review.
China has taken major steps to speed up its drug review process and reduce its backlog of applications. Lynparza, for example, was the first drug to be filed using data from multicenter trials that included China sites, without the usual application to waive a China-specific clinical trial. Keytruda was approved under an accelerated approval process.
The country’s drug regulator also started offering conditional marketing authorizations. Merck’s HPV vaccine Gardasil 9 was handed a conditional nod in May based on foreign clinical data. It took the agency only nine days to make the decision.
China’s CDE is taking public comments on the 48-drug list and the required documents to gain expedited approval until Aug. 18.
Aptevo Therapeutics price target raised to $11 from $9 at Piper Jaffray
Piper Jaffray analyst Edward Tenthoff raised his price target for Aptevo Therapeutics to $11 after Q2 sales of the company’s prophylactic hemophilia B therapy Ixinity beat his estimate. The analyst increased his Ixinity sales forecast to $25M from $18M for 2018 and reiterates an Overweight rating on Aptevo Therapeutics.
Gemphire Therapeutics terminates Phase 2a trial of gemcabene
Gemphire Therapeutics announces that the Data and Safety Monitoring Board at Emory University School of Medicine overseeing the investigator-led open label Phase 2a proof-of-concept trial evaluating gemcabene in pediatric patients with non-alcoholic fatty liver disease has recommended that the trial be terminated due to unanticipated problems. This pediatric NAFLD trial was initiated in early 2018. Patients were treated with gemcabene at a dose of 300 mg once daily. The primary endpoint is a measure of the change in serum alanine transaminase, an enzyme that serves as a biomarker of liver function, from baseline to 12 weeks, and secondary endpoints include, among others, change in hepatic steatosis (liver fat) as measured by non-invasive magnetic resonance imaging – proton density fat fraction. Data on the first three patients who underwent 12 weeks of treatment showed that all three experienced an increase in liver fat content, as measured by MRI-PDFF, and demonstrated increases in ALT. The increase in liver fat was deemed an unexpected problem by the trial investigator because it was an unexpected consistent pattern of worsening of the disease, rather than improvement, creating risk to the patients, which the investigator believed was likely due to the drug. Other patients currently enrolled in the trial have now been taken off gemcabene and early termination visits are being scheduled. The DSMB has recommended additional follow-up of the study subjects to gather additional safety data. The DSMB will provide Gemphire with a written report of their findings in the future once all the patient results have been collated and analyzed.
Mallinckrodt price target raised to $30 from $17 at Mizuho
Mizuho analyst Irina Koffler raised her price target for Mallinckrodt to $30 but reiterates a Neutral rating on the shares. While the valuation post-earnings benefited from higher Acthar sales and improved gross margin, Koffler says she remains cautious on pipeline readouts.
Innovus signs purchase agreement for Apeaz arthritis drug with Showcase
Innovus Pharmaceuticals has entered into a purchase agreement with nationwide retail store chain Showcase, a Canadian company, for its drug Apeaz, for arthritis pain relief. Apeaz will be available in Showcase’s 110 stores across the U.S. and Canada and on its portal starting mid-August. The company’s Apeaz drug shipped 10,218 units in 2018 through June 30 in the United States and 10,875 units shipped in Canada since its launch in that country in mid-April.
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