Saying its proposal is “not actionable,”, NewLink Genetics (NLNK -0.6%) has rejected an unsolicited bid from holding company Evercel.
The board continues to believe its previously announced merger with Lumos Pharma is best for shareholders.
Monday, December 16, 2019
Regeneron cuts share of program with Intellia
Regeneron Pharmaceuticals (REGN -0.4%) has exercised an option under its April 2016 agreement with Intellia Therapeutics (NTLA +0.8%) to reduce its share of global development costs and profits related to transthyretin amyloidosis (ATTR) to 25% from 50%.
Intellia will continue to lead development and commercialization of ATTR products while Regeneron maintains options to in-license exclusive rights to as many as 10 targets, including ATTR, as well as opt-in rights to co-develop and co-commercialize up to five liver targets selected by Intellia.
Alexion nabs rights to two new programs from Dicerna
Dicerna Pharmaceuticals (DRNA +1.6%) and collaboration partner Alexion Pharmaceuticals (ALXN +0.8%) announce that the latter has exercised its option for exclusive rights to two additional GalXC RNAi targets within the complement pathway, increasing the number of programs to four.
Alexion will pay Dicerna $20M for the two licenses.
BioMarin’s vosoritide successful in late-stage achondroplasia study
BioMarin Pharmaceutical (BMRN +3.3%) announces positive results from a Phase 3 clinical trial evaluating vosoritide (BMN 111) in children with achondroplasia, a bone growth disorder characterized by dwarfism.
The study met the primary endpoint of a statistically significant change from baseline in mean annualized growth velocity at week 52 compared to placebo.
The company plans to meet with regulatory authorities in H1 2020 to clarify plans for marketing applications.
Vosoritide is a stabilized version of C-type natriuretic peptide, a natural human peptide that is a positive regulator of bone growth.
FDA OKs Tandem closed-loop artificial pancreas to automatically control insulin
The FDA approved its first automatic insulin dosing system designed to deliver correction boluses as well as adjust background insulin levels to help prevent bouts of high and low blood sugar in people with Type 1 diabetes.
Tandem Diabetes Care’s Control-IQ artificial pancreas system also includes the agency’s first interoperable automated dosing controller, making it capable of connecting with different continuous glucose monitors (CGMs) and alternate controller-enabled insulin pumps, or ACE pumps.
The company plans to make the new software features available free of charge as a update in January 2020 for current users of its t:slim X2 insulin pumps, which received de novo clearance this past February. New pumps equipped with the Control-IQ algorithm are expected to begin shipping at the same time.
“With this clearance, we will be launching the most advanced automated insulin dosing system commercially available in the world today,” Tandem’s president and CEO, John Sheridan, said in a statement.
The pump and controller aim to predict a person’s glucose levels a half-hour ahead and adjust its doses automatically using blood sugar data from Dexcom’s G6 monitoring system. This includes reducing or halting basal insulin delivery if glucose levels drop too low, or calculating an hourly correction bolus if they’re too high—without the need for fingerstick draws or mealtime calibration. The device also includes tailored settings for periods of sleep or exercise.
In a clinical study published earlier this year, the system outperformed current treatments and helped users keep their blood glucose levels within a healthy range an average of 2.6 hours longer. It also had fewer sharp spikes or drops over a 24-hour period.
“Regulatory authorization of the Tandem Control-IQ algorithm for use as part of a hybrid closed-loop system is a huge win for the Type 1 diabetes community and a critical step forward in making day-to-day life better for people living with the disease,” said Aaron Kowalski, president and CEO of the Juvenile Diabetes Research Foundation.
The initial approval of Tandem’s t:slim X2 pump established the new regulatory category of plug-and-play devices known as ACE pumps, allowing users to link their preferred diabetes devices such as CGMs and connected meters.
The latest approval, through the de novo premarket review pathway, does the same. Control-IQ’s interoperable software status now completes the modular trio—alongside swappable ACE pumps and integrated CGMs—paving the way for what the FDA describes as the creation of a complete automated insulin dosing, or AID system, and the faster clearance of similar devices.
“The marketing authorization of this first stand-alone interoperable automated glycemic controller also allows substantially equivalent controller technologies that are developed for diabetes in the future to go through the 510(k) review process, helping to promote timely patient access to innovative technologies that can improve their care and quality of life,” said Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health in the agency’s device center.
Intercept’s NASH decision delayed by FDA, but don’t panic: analysts
Intercept Pharmaceuticals has been gearing up for the potential launch of its nonalcoholic steatohepatitis (NASH) med, but now its wait looks a little longer.
While the FDA was originally due to decide on the company’s application for obeticholic acid by March 26, 2020, Intercept said Friday that date wouldn’t work. That’s because the agency has set an advisory committee hearing to review the application April 22.
The company didn’t announce a new decision date for the candidate—already on the market as Ocaliva to treat primary biliary cholangitis—but it’ll logically have to come after the April hearing.
Analysts aren’t very worried about the delay. Cantor Fitzgerald’s Alethia Young wrote that her team expects a two- or three-month delay, but that the extra wait doesn’t hurt the med’s chances of approval. Instead, the delay is “broadly logistical,” and her team believes the agency’s move to set an AdComm hearing for next year is a “positive update,” she said.
RBC Capital Markets analyst Brian Abrahams made similar points in a note to clients. After speaking with the company, he believes the delay is about “scheduling logistics … rather than any specific concerns or issues with the filing or drug.” The delay will push out potential revenue generation but provides “clarity” about the application, he added.
In the meantime, Intercept has been open about its launch preparations. On a recent conference call, Intercept Chief Operating Officer Jerry Durso said the company has initiated payer talks and hired an internal sales force to support the rollout. The NASH approval would be for patients who’ve developed fibrosis in their livers, and Intercept has already launched its unbranded disease education push.
Roche $4.3B Spark deal wins U.K. antitrust OK, foreshadows like FTC move
After months of delays, Roche has won the first major antitrust clearance for its proposed $4.3 billion buyout of Spark Therapeutics.
Monday, the U.K.’s Competition and Markets Authority (CMA) said it had sanctioned the deal—no strings attached—after a phase 1 investigation found no evidence of anticompetition effect.
Though the U.S. Federal Trade Commission (FTC) has yet to deliver its verdict, the CMA stated that the two authorities have “cooperated closely” in their separate reviews, suggesting a similar move might come from its U.S. counterpart.
As industry watchers have suspected, the U.K. antitrust watchdog was looking at whether adding Spark’s investigational gene therapy to Roche’s rising star performer Hemlibra would hurt competition in the hemophilia A market. In the U.K., Hemlibra is already covered by NHS England for both patients with or without factor VIII inhibitors.
“While gene therapy treatments are likely to compete with Roche’s Hemlibra in the future, the CMA found that Spark is not the only supplier developing a gene therapy treatment and that its products are not currently considered to hold any particular clinical or commercial advantages over those being developed by other suppliers,” the CMA said in a statement.
Notably, BioMarin Pharmaceutical has already filed an EU application for valoctocogene roxaparvovec, a rival gene therapy that analysts suggested could be a better option than Spark’s SPK-8011 based on readouts from clinical studies. In fact, the Spark drug’s lackluster phase 1/2 data on boosting factor VIII levels helped Roche snatch up the biotech at a relatively cheaper price while the latter’s stock was suffering.
Other players developing gene therapies for hemophilia include uniQure and a partnership between Pfizer and Sangamo Therapeutics.
What’s more, the CMA said it also found other non-gene therapies under development that are “likely to become viable alternatives to Roche and Spark’s treatments.”
The CMA first said it was looking more closely at the deal in June, just as the FTC sent the companies a “second request” for additional information—effectively dashing the Swiss drugmaker’s earlier hopes of wrapping up the deal in the third quarter. A recent report by The Capitol Forum stated that FTC staffers had also recommended approval of the deal unconditionally, teeing up a vote by the agency’s five commissioners.
Now, Roche is asking Spark investors to tender their shares by 5 p.m. U.S. ET Monday. However, that deadline—already delayed multiple times due to extensive antitrust reviews—might be pushed back further, given that the FTC has yet to announce its ruling and that Roche might not be able to collect the minimum 50% of Spark shares. As of Dec. 6, only 14.9% of Spark’s outstanding shares had been tendered, Roche previously said.
Despite the extra antitrust scrutiny, Roche has repeatedly said it expects to complete the deal by year-end.
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