Abbott Laboratories, Johnson & Johnson, Medtronic PLC and Boston Scientific Corp. were down after-hours Thursday after a new study found an increasingly common cardiovascular procedure using a device made by several medical technology companies was no better than drug therapy at preventing deaths, strokes and certain other complications. The Wall Street Journal reported late Thursday the outcome of the trial, presented by researchers at the annual scientific meeting of the Heart Rhythm Society in Boston, raises questions about the procedure, known as catheter ablation, to treat patients with atrial fibrillation. The procedure, meant to stop abnormal electrical signals from causing irregular heartbeats, involves a doctor inserting a thin tube through a patient’s blood vessels to deliver tiny scars to heart tissue. Shares of Abbott Laboratories, which makes the device used in the procedure, fell 1.5% to $59.67.
Thursday, May 10, 2018
La Jolla Gets $125M Financing from HealthCare Royalty Partners
La Jolla Pharmaceutical Company (Nasdaq: LJPC) (La Jolla), a leader in the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, today announced that it has closed a $125 million royalty financing agreement with HealthCare Royalty Partners (HCR).
Under the terms of the agreement, La Jolla will receive $125 million in exchange for tiered royalty payments on worldwide net sales of GIAPREZA. Payments under the agreement start annually at a maximum royalty rate, with step-downs based on the achievement of annual net sales thresholds. Through December 31, 2021, the royalty rate will be a maximum of 10%. Starting January 1, 2022, the maximum royalty rate may increase by 4% if an agreed-upon, cumulative sales threshold has not been met, and, starting January 1, 2024, the maximum royalty rate may increase by an additional 4% if a different agreed-upon cumulative sales threshold has not been met. The agreement is subject to maximum aggregate royalty payments to HCR of 180% of the $125 million to be received by La Jolla, at which time the payment obligations under the agreement would expire. The agreement was entered into by La Jolla’s wholly owned subsidiary, La Jolla Pharma, LLC, and HCR has no recourse under the agreement against La Jolla or any assets other than GIAPREZA.
On a pro-forma basis, adjusting for the net proceeds from this transaction, La Jolla’s cash and cash equivalents as of March 31, 2018 were $279 million.
“This transaction provides us with a strong financial position to support the commercial launch of GIAPREZA, while at the same time furthering the development of LJPC-401 and our other programs,” said George F. Tidmarsh, M.D., Ph.D., President and Chief Executive Officer of La Jolla.
“We are pleased to partner with La Jolla,” said Clarke Futch, Managing Partner and Chairman of the Investment Committee of HCR. “Our investment reflects our confidence in GIAPREZA’s ability to meaningfully improve outcomes for patients suffering from septic or other distributive shock.”
Puma target cut by Stifel
Stifel lowered its price target on Puma Biotechnology (NASDAQ: PBYI) to $87.00 (from $95.00) while maintaining a Buy rating.
Analyst Alex Schwartz commented, “Yesterday Puma reported 1Q18 numbers that included $66.5 million in revenue and a $24.3 million net loss. Nerlynx revenues of $36.0 million were below our $42.1 million estimates but in-line with $36 million consensus estimates. As part of the release, management indicated they now expect NALA data during 4Q18/2019 (versus prior 2Q18 expectations) due to slower than expected event rate. As a result, we are pushing out our metastatic revenue estimates by a year. Accordingly, our target price decreases from $95 to $87. Despite our reduction in target price, we remain positive on the stock due to a reasonable chance at positive metastatic breast cancer data (NCCN already recommends Nerlynx to BC patients with brain metastases) and Nerlynx extended adjuvant EMA re-examination success.”
Pfizer to buy Allergan? New reports
Shares of Allergan (NYSE: AGN) are up 3% early Thursday amid renewed speculation Pfizer (NYSE: PFE) could again attempt to acquire it.
KemPharm: Positive topline results from ADHD med trial
KemPharm announced topline results from the first of three pivotal human abuse potential trials for KemPharm’s product candidate, KP415, which is based on a prodrug of d-methylphenidate for the treatment of attention deficit/hyperactivity disorder. “The results from our first pivotal human abuse potential trial for the prodrug contained within KP415 and KP484 could not have been better,” said KemPharm CEO Travis Mickle. “The prodrug itself was not readily converted to the active d-methylphenidate when injected and as a result, produced pharmacodynamic effects that were comparable to placebo based on multiple endpoints of the study. Since lower potential abuse is one of the key elements of the potential value that KP415 and KP484 would bring to the market, we believe these data truly differentiate our prodrug from current stimulant-based ADHD products.
Akcea, Ionis win over most FDA experts to rare disease med, upping success odds
Akcea Therapeutics $AKCA faced a tough uphill battle in search of an approval for their rare disease drug volanesorsen today — and they won.
The FDA advisory committee vote on the drug — spun out from Ionis $IONS — was 12 for, 8 against. The FDA, of course, doesn’t have to go along. But for a rare disease, they usually do — particularly under this administration.
FDA regulators didn’t make the task very easy, highlighting their deep concerns with the sudden plunge in platelets that afflicted a number of patients through the clinical trials for the drug. Investigators never found a reliable way to screen for thrombocytopenia in the trial work, and their internal review planted a red flag on the fact that doctors prescribing this drug would also likely be blindsided by unexpected cases.
Ionis reported a little more that a year ago that it had achieved its efficacy endpoint in Phase III. But five patients were forced out of the trial due to a threatening decline in platelet counts. Grade 4 thrombocytopenia occurred in three patients, which ended after they stopped dosing. There were no withdrawals due to platelet counts after the company began monitoring the side effect.
If it does get an OK, those facts on safety are likely to haunt the company’s sales efforts.
In its favor, though, was a solid set of data demonstrating the drug’s effect in regulating plasma triglyceride for patients with rare cases of familial chylomicronemia syndrome — but without the clear clinical impact that would have helped push this drug over the top with bigger numbers in its favor.
“We thank all the members of the Committee for their time in conducting a thorough and thoughtful review of Waylivra, a new potential first and only therapy for people with familial chylomicronemia syndrome, or FCS. FCS is ultra-rare, severe and potentially fatal with no therapeutic options. The data, including results from two phase three clinical trials, demonstrate clear improvement on several important measures of disease in these patients. We believe that these results provide strong support to make Waylivra available to treat people with FCS,” said Paula Soteropoulos, chief executive officer of Akcea Therapeutics. “We look forward to working with the FDA to complete the final stages of regulatory review for Waylivra. We are committed to the FCS community and will continue to focus on bringing Waylivra to people suffering with this devastating disease.”
Trump lawyer offered Novartis door to President, ex-CEO accepted: Insiders
When Novartis issued its first explanation of its “suspicious” payments to Michael Cohen, the company didn’t blame anyone specific for handing over money to President Trump’s personal attorney.
The second time, it explained the payments away as part of a $1.2 million consulting deal on healthcare policy that Novartis never actually used.
Now, sources inside the company are pointing the finger at one person—former CEO Joe Jimenez—and asserting that Novartis wasn’t buying policy wisdom. It was buying access to the president and his inner circle.
The drugmaker’s payments to Cohen went public late Tuesday in a memo from Michael Avenatti, the attorney representing Stormy Daniels, who claims she had an affair with Trump. Avenatti listed “suspicious financial transactions” between Cohen and a list of others, including AT&T and a company tied to Russian oligarch Viktor Vekselberg.
The memo said Novartis had paid Cohen almost $400,000, which turned out to be one-third the amount the company had actually shelled out to the lawyer, who’s worked for Trump for decades and is often called his “fixer.”
Novartis disclosed its $1.2 million contract with Cohen Wednesday, taking pains to clear CEO Vas Narasimhan, who took the helm in February, of any involvement in the payments. The company said it struck its deal with Cohen long before then, and its payments wrapped up in January.
That laid the buck-stops-here responsibility on Jimenez, albeit without actually mentioning his name. But now, according to a Novartis insider who spoke to CBS News, Cohen approached Jimenez himself soon after Trump was elected, offering advice on gaining access to members of the incoming administration.
An unnamed senior Novartis executive put it more bluntly to NBC News: Cohen “was promising access to the new administration.” And Novartis had multiple reasons to want that access—including Trump’s promise to crack down on drug prices. Jimenez then ordered his team to set up a deal, a Novartis source told Stat.
That’s when Novartis inked the $1.2 million contract. The company said it paid $100,000 per month to Cohen’s Essential Consultants for advice on healthcare policy, though Cohen has no particular expertise in healthcare.
“It was almost as if we were hiring him as a lobbyist,” Stat’s source said.
Jimenez has not yet commented on the reports.
Novartis said it continued paying the consulting firm even after determining—during its first meeting with Cohen—that his advice on administration policy wouldn’t serve Novartis’ purposes. The payments continued, Novartis said, because the contract could only be terminated “for cause.”
Cohen’s offer and Novartis’ payments to the lawyer caught Special Counsel Robert Mueller’s eye, and his team contacted Novartis in November 2017 for information, Newsweek reported. In its Wednesday statement, Novartis said it had cooperated with Mueller’s office and “considers this matter closed as to itself.”
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