Alkermes aims to take the next biotech step
pharmafile | December 3, 2015 | Feature | Medical Communications, Research and Development | Alkermes
“We think we can be the next Biogen, or a Celgene or a Vertex – we have that much firepower in our pipeline.”
So says Richard Pops, chairman and chief executive of Alkermes, who makes clear during his interview with Pharmafile.com that the company is determined to meet its goals – to be in the same league as the aforementioned global biotechs – on its own terms.
“We have been building this company for many years. In the biotech environment we decided to go for some of the most serious diseases affecting mankind. And this is a really exciting point in the company’s life.”
Alkermes’ strategy has been to focus on prioritising drug development in areas that Pops describes as ‘Cinderella’ therapy areas; including mental health and neurological conditions. Whereas other companies might see these as risky areas for investment, having grown since its inception in its current form in 2011, Pops says Alkermes is now able to take the financial risk.
“The company has been self-sustaining since 2011 and we are now large enough to place these kinds of big bets all on our own.” He adds: “We have no equity financing, and are not reliant on pharma partnerships – all the drugs we are bringing through our pipeline now are all ‘home-grown’; we are bringing them all right through the pipeline from R&D and nearly to market.”
Alkermes has just had an extended-release schizophrenia drug, Aristada (aripiprazole lauroxil), FDA approved. It is also planning on unblinding two Phase III studies of a new depression drug, ALKS 5461, next year, and launching a Phase II trial of a new MS drug, ALKS 8700. It is also planning to start a Phase I trial for a new drug, for agitation in people with Alzheimer’s disease, in the first quarter of 2016.
The long-acting injectable was developed in partnership with Johnson & Johnson. It’s a new molecular entity of Abilify – historically one of the biggest-selling drugs in the US – which Pops says can take advantage of “an increasing trend towards the use of long-acting injectables” as doctors treat patients towards the goal of preventing relapse and worsening outcomes.
In patients with schizophrenia, where patient compliance can be a challenge, long-acting treatments are used to try to make sure patients maintain treatment. However one of Alkermes’ pharma rivals, Otsuka, has adopted a different strategy. It has teamed up with Proteus Health to develop a digital form of Abilify, embedded with a wirelessly connected sensor that monitors compliance, which is the subject of an ongoing review by the FDA.
Smart pills and radio-frequency identification (RFID) is something Pops says the company may explore in the future for some of its drugs – such as its substance abuse treatment Vivitrol (naltrexone). The drug, for opioid and alcohol dependence, contributes around $150 million, and between 30 and 40%, of the company’s annual sales, and is gaining traction in the US criminal justice system.
Vivitrol notched $37.9 million in sales in the third quarter of 2015, compared to $25.8 million for the same period in the prior year, representing an increase of approximately 47%. “This is one of those drugs that has taken 10 years to become an overnight success,” Pops says.
However, the company has no immediate plans to pursue a smart tech component for its version of Abilify and other drugs for mental health conditions. Instead, Pops says the company is focussing on developing drugs with a more favourable side-effect profile, to encourage drug adherence.
“The medicine is only one element of treatment – although if it is not taken, it has no value. We’re exploring other elements of care. At the moment we are not integrating devices into our tablets – there are positives and negatives of doing that.
“In our Phase III schizophrenia study we showed we can eliminate side effects, like the weight gain we see with olanzapine. That same change makes a big difference [to compliance]. If a drug makes you sleepy or nauseous or gain weight, patients just won’t take it. We’re trying to address that in the same simple but effective way.”
In another mental health condition, depression, Alkermes is in a late-stage trial of a new treatment for major depression, ALKS 5461. The drug targets the opiate system, rather than serotonin receptors targeted by SSRIs, like paroxetine. This may help offset concerns that an opiate-based drug could lead to side effects including addiction.
“Opiates like oxycontin and vicodin are used too much for the treatment of physical pain; we don’t use them for psychological pain. However as opiates are very addictive we have engineered out the addictive potential. One of the distinctive features is that it does not cause euphoria, or a high, and it doesn’t cause withdrawal. It’s designed specifically not to have those properties.”
ALKS 5461 is currently being studied in people who have been refractory to SSRIs, and new data is likely to be published early in 2016. Pops says “there’s tremendous excitement for a new mode of action in depression” and the excitement could also stem from the potential sales of a drug with a new mode of action to treat major depressive disorder.
Alkermes’ total revenues for the quarter were $152.7 million compared to $143.2 million for the same period in 2014, while Alkermes had cash and total investments of $815.5 million, compared to $801.6 million at the end of 2014. It’s this steady growth that Pops says will stand the company in good stead in 2016.
“One year from now I would like to be preparing to file for approval of our investigational depression drug, and be well into recruitment for our trials in MS and for our antipsychotic drug. We are already standing on our own two feet and intend to continue to do so – and bring even more treatments to the clinic.”
Lilian Anekwe
Biography – Richard F. Pops, chairman and chief executive, Alkermes
Richard Pops is chairman and chief executive of Alkermes. He joined Alkermes as its chief executive in 1991, and under his leadership Alkermes has grown from a privately held company with 25 employees to an international, publicly traded biopharma with more than 1,200 employees.
Mr Pops currently serves on the value and coverage advisory council of FasterCures, a Washington, D.C.– based think tank that focuses on accelerating medical research. He is also on the board of directors of Neurocrine Biosciences, Acceleron Pharma and Epizyme, and the US trade bodies the Biotechnology Industry Organization (BIO) and the Pharmaceutical Research and Manufacturers of America (PhRMA).
Company Profile: Alkermes
Alkermes is a biopharmaceutical company that focuses on central nervous system (CNS) diseases. The company was formed as a result of a merger in September 2011 between Alkermes and Elan Drug Technologies (EDT), the former drug formulation and manufacturing division of Élan Corporation. It has since grown to include a diversified commercial product portfolio and a substantial clinical pipeline of CNS product candidates such as schizophrenia, depression, addiction and multiple sclerosis.
Key products
Alkermes has more than 20 commercial drug products and candidates that address serious and chronic diseases such as addiction, schizophrenia, diabetes and depression. Among these, five products are primary to the company:
- Risperidone long-acting injection (a generic of Janssen’s Risperdal Consta) for schizophrenia and bipolar disorder
- Paliperidone palmitate (a generic of Janssen’s Invega Sustenna in the US, Xeplion in Europe) for schizophrenia
- Aminopyridine (a generic of Biogen’s Ampyra in the US, Fampyra in Europe) to improve walking in patients with multiple sclerosis
- Vivitrol (naltrexone) extended-release injectable suspension for alcohol and opioid dependence
- Exenatide extended-release injectable suspension (a generic of Lilly’s Bydureon) for the treatment of type 2 diabetes.
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