The U.S. Food and Drug Administration has approved Cablivi in combination with plasma exchange and immunosuppression for the treatment of acquired thrombotic thrombocytopenic purpura in adults. Cablivi is the first FDA approved therapy specifically indicated for the treatment of aTTP. “The U.S. approval of Cablivi provides a much-needed treatment option for people facing this challenging disease. There have been limited medicines available to treat aTTP until now,” says Olivier Brandicourt, M.D., CEO, Sanofi. “Cablivi marks the first U.S. approval in our newly formed rare blood disorders franchise, and we look forward to continuing to provide important medicines for people living with these very serious diseases.” Cablivi received FDA Fast Track designation and was evaluated under Priority Review, which is reserved for medicines that represent significant improvements in safety or efficacy in treating serious conditions. The approval of Cablivi in the U.S. is based on the results of the pivotal multicentre, randomized, double-blind, placebo-controlled Phase 3 clinical study known as HERCULES. This trial evaluated the efficacy of Cablivi in combination with plasma exchange and immunosuppressive therapy versus placebo, plasma exchange and immunosuppressive therapy in 145 adults experiencing an episode of aTTP. In the HERCULES study, treatment with Cablivi in combination with plasma exchange and immunosuppression resulted in a significantly shorter time to platelet count response versus plasma exchange and immunosuppression alone, the study’s primary efficacy endpoint; in secondary endpoints, Cablivi showed a significant reduction on a composite endpoint of aTTP-related death, recurrence of aTTP, or a major thromboembolic event during study drug treatment versus plasma exchange and immunosuppression alone; and a significantly lower percentage of aTTP recurrences in the overall study period versus plasma exchange and immunosuppression alone.
Wednesday, February 6, 2019
Lilly cuts a trio of pipeline assets, including BTK inhibitor, diabetes drug
As it digests its Loxo Oncology acquisition, Eli Lilly is pruning its earlier-stage pipeline.
The Big Pharma has culled a pair of phase 2 assets—a dual amylin calcitonin receptor agonist (DACRA) for the treatment of diabetes and a BTK inhibitor being investigated in immunology—as well as a urocortin-2 peptide, a treatment for heart failure that had reached phase 1. The Big Pharma revealed (PDF) the cuts in its fourth-quarter earnings presentation.
Details were thin on the ground, but Lilly looks to have picked up the diabetes program, dubbed DACRA-042, in its acquisition of KeyBioscience in June 2017. At the time, Lilly paid $55 million upfront for the rights to KeyBioscience’s DACRA pipeline, which was in development for Type 2 diabetes and other metabolic conditions.
The deal gave Lilly access to the synthetic peptide DACRA, KBP-042, which was then in phase 2, as well as to a handful of other programs. The 255-patient phase 2 study of KBP-042 completed in July last year.
As for the BTK inhibitor, Lilly returned the rights to the rheumatoid arthritis drug back to South Korea’s Hanmi Pharmaceutical, reported Korean news outlet Yonhap News Agency in January. The Big Pharma had forked over $50 million upfront to license the drug back in 2015, but with milestones and royalties, the deal had the potential to reach $690 million.
“This month, Lilly has decided to hand back rights to the drug back to us, and we are going to receive all trial data and related ones after the licensing-out deal within 90 days,” Hanmi said in a regulatory filing, Yonhap reported.
The latest cuts follow the removal of seven clinical-stage assets during the third quarter, including a BACE inhibitor for Alzheimer’s. The decision came after after the termination of two phase 3 studies evaluating a different BACE inhibitor, lanabecestat.
Indivior faces big sales loss as Suboxone court loss puts generics on tap next week
Indivior has been fighting off generics to its top-selling Suboxone film, but a federal appeals court has unleashed copycats now charging toward launches next week. And that means hundreds of millions in lost sales for a company that’s been hurting for sales from follow-up drugs.
The U.S. Court of Appeals for the Federal Circuit on Monday denied U.K.-based Indivior’s request to reconsider its decision to toss an injunction that would have barred generic sales by Dr. Reddy’s Laboratories. The Indian drugmaker had launched its copies at risk and Indivior won the now-nixed injunction.
With the court’s decision to lift that ban and reject another hearing, Jefferies analyst James Vane-Tempest expects Dr. Reddy’s to launch its generic next week. The analyst expects Alvogen and Mylan to launch generics as well, he wrote in a Tuesday note to investors.
Suboxone could lose 80% of its market share “within a matter of months” after a generic rollout, the company said. The opioid addiction-fighting film makes up the majority of Indivior’s sales, expected to come in at about $1 billion for 2018. Indivior shares were down about 11% Tuesday morning and have dropped 70% over the past year.
No wonder Indivior still isn’t giving up. The company says it’s planning an emergency motion to stay the generic launch pending a petition at the Supreme Court. That’s a bid not likely to bear fruit, though, Vane-Tempest figures. Indivior’s move to seek a further delay and take the issue to the Supreme Court “is unlikely to be successful in our view,” the analyst wrote.
Suboxone film, containing buprenorphine and naloxone, is placed under the tongue and is used to treat patients with opioid addiction. It’s a follow-up to a tablet version that’s already facing generic competition.
“While we ultimately believe in the strength of our patent portfolio, we acknowledge that the company faces major disruption in the immediate future from a potential material and rapid loss of market share by our Suboxone film product to generic buprenorphine/naloxone sublingual film competition,” Indivior CEO Shaun Thaxter said in a statement.
Indivior expects $990 million to $1.02 billion in sales for the year, with Suboxone film generating most of the haul. Its new buprenorphine injection, Sublocade, is only expected to bring in $8 million to $10 million, while Perseris to treat schizophrenia isn’t expected to generate material sales, the company said after its third quarter results.
While generics would represent a major threat to Indivior’s top drug, the company has “contingency plans,” Vane-Tempest wrote. Indivior plans to bolster launches for Sublocade—which it insists can grow to blockbuster status—and Perseris, while keeping a cash balance of at least $250 million to stay complaint with its debt agreements. The company aims to have about $920 million in cash at the end of its fiscal year 2018. Indivior reports full-year 2018 sales next week.
Humana Hit on Q4 Figures
Humana Inc. (NYSE:HUM) slumped in its stock price on Wednesday, following the release of fourth-quarter results. Revenues came in at $14.1 billion, compared to $13.1 billion in the prior-year quarter.
Pre-tax income (GAAP) measured $436 million, compared to $490 prior-year. Earnings per Share (GAAP) were $2.58, compared to $1.29 prior-year. 2019 EPS guidance of approximately $16.60 to $17.10 on a GAAP basis, $17.00 to $17.50 on an adjusted basis, exceeding long-term growth targets.
The company’s year-over-year results in both 4Q18 and FY 2018 were favorably impacted by strong Medicare Advantage membership growth and significant operating efficiencies in FY 2018 driven by productivity initiatives implemented in 2017.
“GAAP and Adjusted EPS results for 4Q18,” according to the news release, “were further positively impacted by the benefit of a lower tax rate year-over-year as a result of the Tax Reform Law enacted in 4Q17, allowing the company to invest pretax dollars in its employees, the communities of its members, technology and its integrated care delivery model to drive more affordable healthcare and better clinical outcomes; and a lower number of shares in 2018, primarily reflecting share repurchases.
According to CEO Bruce Broussard, “We’re pleased with the consistency of and ongoing improvement in our performance, which can be attributed to our focus on optimizing our core operations.
“The investments we made in 2018 to improve consumer experience, clinical programs and external broker relationships all contributed to our ability to exceed average industry growth in Medicare Advantage (MA) for 2019, with full membership growth estimated between 375,000-400,000 members.”
Good Habits Make Good Managers: Tips to Create a Coaching Culture
For the past several years, the SAP SuccessFactors Human Capital Management (HCM) Research team has been conducting research on the topic of continuous performance management.
A key finding from this research is that shifting to a more continuous method of performance management is as much about changing people’s mindsets as it is changing actual processes. The reason many performance management transformations fail is because managers and employees are unable to abandon their old habits and adopt new patterns of behavior.
Changing people’s habits is far easier said than done. Research suggests it can take anywhere between 18 and 254 days for people to form a new habit, with a median time of 66 days. That’s more than three times the common myth that it takes ‘21 days to make a habit.’
Fortunately, research has identified several strategies companies can leverage to help managers and employees abandon old, ineffective habits and adopt new, more impactful ones. Four of these strategies were nicely summarized in a study that explored the process of habit formation in new gym members. The same strategies that work for improving exercise routines can be applied to creating healthy coaching habits.
Consistency
Participants who exercised in a consistent manner, such as at the same time every day, were more likely to form a habit of exercising compared to participants who did not follow a set pattern or schedule.
This finding speaks to the value of scheduling regular coaching and feedback sessions with employees. Having these meetings may feel awkward at first, but the more consistently they occur the less uncomfortable and more natural they will become. It may be useful to provide managers and employees with suggested guidelines around how often they should be engaging in coaching conversations. It is also important to remember that newly adopted behaviors will not become ingrained overnight. Human resources leaders should encourage and monitor the regular occurrence of coaching conversations over time, even after the initial excitement of shifting to more continuous performance management has faded.
Simplicity
Participants who thought it would be difficult to exercise on a regular basis were less likely to make a habit out of exercising.
Note the emphasis on perception. If people think something is easy to do, they are more likely to do it. The key is making sure people do not view it as something that is inherently hard to do. Talking with employees about their performance and development may not seem like a major challenge, but many managers may view it as ‘yet another thing I have to keep track of and cram into my schedule.’ Fortunately, technology can help managers remember to have coaching conversations by providing email notifications and other system reminders. Technology can also help managers keep track of employees’ progress on activities and achievements as well as document relevant questions and previous discussion topics. By reducing some of the administrative burden associated with continuous performance management, managers may feel less overwhelmed by the prospect of holding regular coaching conversations with employees.
Comfort
People who viewed exercising as an enjoyable activity were more likely to make exercising a long-term habit.
It is not surprising that it is easier to build habits around things we feel comfortable doing. One of the challenges associated with continuous performance management is that many managers do not have knowledge or confidence in their coaching skills. Managers may feel intimidated by the prospect of engaging in coaching conversations or interpret providing employees with feedback as being more difficult or complicated than it needs to be. This is why it is so critical to train managers on what effective coaching behaviors look like and how to provide effective feedback to employees. The more information managers have about the right and wrong ways to engage in ongoing coaching conversations, the more comfortable they will be to carry them out. Ensure managers understand the sorts of topics and questions coaching conversations should focus on and how these conversations differ from the other conversations they may already be having with employees, such as check-ins or development-planning conversations. Provide managers with simple best practices or feedback ‘dos and don’ts’ so that they feel comfortable and confident when entering into a coaching conversation with employees.
Reward
Participants who perceived exercising to be associated with rewards-both internal and external-were more likely to maintain an exercise habit than participants who did not associate exercising with reward.
We often heard from customers that the motivation to engage in coaching conversations seemed to plateau over time. Managers showed excitement early on but tended to revert to their old habits. One of the best ways to motivate employees to change their behaviors is to ensure they see a connection between these behaviors and their personal career goals. This is why it is important for companies to tie continuous performance management activities with other organizational talent management decisions, for example, tracking and rewarding managers based on their commitment to actively coaching and developing employees.
We often compare implementing continuous performance management to changing one’s health habits. It is one thing to recognize that a healthy diet and exercise are important or to buy vegetables and join a gym – it is another to live a healthy lifestyle over time. The same can be said for continuous performance management. Having the right knowledge, training, and tools is important, but these things only add value if managers and employees change their old habits and adopt new patterns of behavior. These four tips can serve as a starting point to help companies break the chain of habit and enable effective coaching behaviors in their organization.
Zai Lab up on positive margetuximab data
Zai Lab Limited (ZLAB +21.1%) is up in early trade in response to positive results from a late-stage study evaluating MacroGenics’ margetuximab in certain breast cancer patients.
Shanghai-base Zai Lab owns development and commercialization rights to the monoclonal antibody (plus two other programs) in China, Hong Kong, Macau and Taiwan under a November 2018 agreement with MGNX.
Piper ‘very bullish’ on Sarepta ahead of limb-girdle muscular dystrophy data
Piper Jaffray analyst Danielle Brill says she remains “very bullish” ahead of the company’s limb-girdle muscular dystrophy data. The analyst reiterates an Overweight rating on the shares with a $200 price target. . Unlike Duchenne muscular dystrophy, in LGMD the vector delivers the native hSGCB gene, meaning accelerated approval based on expression levels alone seems plausible, Brill tells investors in a research note, citing Sarepta management and her firm’s DMD expert. A safety finding in the data is the most unlikely outcome, the analyst says. She believes the stock would drop around 50% in this situation. Brill believes a more plausible outcome is hSGCB expression levels less than 20% but clean safety. She thinks Sarepta shares would drop around 10% in this scenario. The analyst, however, is most confident in a scenario where hSGCB expression is greater than 20% and safety is clean. She sees 10%-20% upside for the stock in this case.
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