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David Michel Tarik Rihani Simon Mayer 14 mars 2013 Alkermes Inc Pennsylvania corporation formed on July 13, 1987 Headquartered in Waltham, Massachusetts. WHY WORK WITH ALKERMES ? 11/03/2013 Product challenge solved 11/03/2013 Principal Parteners The Merger Elan Drug Technologie 1969 in Irland 667 people CRO Develop technologies to unsolved drug formulation challenges NanoCrystal technology; SODAS® Technology… MERGER TRANSACTION Cost of transaction : 950 M$ • 500 $ million in cash • 25% of Newco • 460 $ million in stock worth Alkermes, Inc. Elan Drug Technologies Reasons for the Merger Alkermes.Inc be less reliant on its Risperdal Consta risperidone diversifing portfolio of products valuable late-stage pipeline Robust cashflows to invest in its proprietary drug candidates create a larger, faster-growing biopharmaceutical company 11/03/2013 Elan Drug Technologie No commercial products No commercial organisation Not profitable : Indebtedness Reasons for the Merger be less reliant on its Risperdal Consta risperidone Reasons for the Merger Five Key Products Drive Revenue Growth Reasons for the Merger Financial engine to grow revenue and expand margins Reasons for the Merger Lates stage pipeline drives a long terme growth. Risks Related to New Alkermes 1. Plan of integration may encounter unexpected difficulties or incur unexpected costs. 2. New Alkermes shares will be highly volatile and may decline if the merging is unsuccessful 3. keeping existing customers and obtaining new customers 4. With the approval of Invega, many people on Wall Street were having a problem rationalizing if Invega was going to compete with Risperdal Alkermes' localisation Ireland Facility Ohio Facility Massachusetts Facility Georgia Facility Headquarters (Dublin) Financial analysis Alkermes' revenues Research and development revenue Développement of BYDUREON Pay for sales in Europe Manufacturing and royalty revenues New drugs on the market Product sales , net rising price of VIVITROL authorized sales VIVITROL in Russia Alkermes' expenses Cost of goods manufactured and sold The merger adding the EDT portfolio valued at approximately 70 millions Research and development ALKS 37 et ALKS 9070 Clinical studies remaining old Alkermes Collaboration with Acceleron Alkermes R&D expenses MERGER IMPACT Emergence of long-term debt following the merger with Elan ($441,360 millions) Alkermes‘ technologies Nanotechnology in drug delivery, is being embraced particularly as a means of improving or enhancing the delivery of drugs, It’s considered by many as key to optimising drug delivery. • long-acting injectable technologies enables the gradual release into the body of small molecules at a controlled rate over a specific period of time. • By enabling patients to take medications less frequently, it can be especially beneficial in treating CNS diseases such as psychiatric disorders, in which medication compliance is closely correlated with improved outcomes. • Ex : Medisorb®, LinkeRx® and NanoCrystal®. NanoCrystal technology : (ELAN) allowed for a stable, low viscosity, high drug-loaded formulation in a small injection volume, to be developed. enabling the formulation of poorly water soluble compounds. maintain a drug in its original crystalline form until biologically activated It is Elan’s most successful delivery technology which generated US $1.9 billion in 2010. • customize drug-release profiles and dosage forms – oral delayed release -extended release – pulsatile release -immediate release – and chrono-timed delivery • The OCR technology platform can bring one or more of the following benefits for new and existing drug products: – Highly flexible release profiles – Reduced gastrointestinal irritancy – Tableting technology within a capsule – Hydrophilic matrix-controlled diffusion and erosion – Bilayer technology. • SODAS® Technology (ELAN) (Spheroidal Oral Drug Absorption System ) • is a multiparticulate system for controlling the release of drugs taken orally . • coating of uniform spherical sugar beads of 1-2 mm in diameter with drug and excipients. • then coated with controlled release polymers to form a release rate controlling membrane • Depending on the coating polymers chosen, different release profiles • PRODAS® Technology (Programmable Oral Drug Absorption System) • Multiparticulate minitablet technology system, which combines the benefits of tableting technology within a capsule. • it is possible to combine mini-tablets with different release profiles or sizes within the one capsule in order to achieve high drug loading and constant release profile throughout the GI tract. MXDAS® Technology (MatriXDrug Absorption System) -drug in a hydrophilic polymer matrix, which controls the drug’s rate of release through a process of diffusion and erosion in the gastrointestinal tractDrug. -The tablets can be produced by direct compression or granulation and be enteric coated if required -It was used to develop a sustained release formulation of dalfampridine Ampyra®. http://www.imda.ie/Sectors/IMDA/IMDA.nsf/e3124752f3e585e0802574420058f1ae/da6702efe06341c580257893003ea64c/$FILE/Richie%20Paul_May%202011_F inal.pdf • DUREDAS™ Technology (DUal RElease Drug Absorption System) • -Bilayer tablet which can provide immediate or sustained release of two drugs or different release rates of the same drug in one dosage form. • -initially developed for OTC controlled release analgesics. In this case one layer of the tablets was formulated as an immediate release granulate to achieve rapid onset of action, while the second released the drug slowly to provide sus-tained pain relief. NanoCrystal® • The NanoCrystal technology : reducing the size of drug particles to increase their exposed surface area, stabilizing the nanoparticles to maintain size. improved dissolution rate improved bioavailability, reduced dosage volume, increased maximum tolerated dose. • → it is applicable to all routes of administration of any dosage form. Nanoparticle Technology offer over competing technologies in the poorly water-soluble drug delivery space include: • Rate and extent of drug release independent of pH • Improved bioavailability, rate of absorption and dose • delivery of drug to GI tract • Linearity Rapid dissolution • Excellent stability • High drug loading • present opportunities for disease intervention in addiction, behavior and mood modification, immunology, and pain • understanding of opioid biology and how drug compounds can target disease processes in the brain to treat CNS diseases to develop new drug candidates that target opioid receptors. • supported by a proprietary library of molecules designed to target different types of opioid receptors. • Medifusion. With traditionnal administration , the drug active must remain between a maximum blood level value wich may represent a toxic level and a minimum value below which the drug is no longer effective. -With controlled administration the blood level are constant between the desired maximum and minimum for an extented period of time TECHNOLOGY IMPACT Intangible assets: Phenomen explained by four factors: -collaboration -NanoCrystal -OCR technology -IPR & D Alkermes' products Risperdal consta® -Exclusively manufactured by Alkermes -Marketed and sold by Janssen in more than 90 countries. Indication Risperdal consta® is the first and only long-acting, atypical antipsychotic approved by the FDA (2003) for the treatment of schizophrenia. For bipolar I disorder: the FDA approved Risperdal consta® as both monotherapy and adjunctive therapy to lithium or valproate in the maintenance treatment of bipolar I disorder in May 2009. What is schizophrenia? Schizophrenia is a chronic, severe and disabling brain disorder The disease is marked by: → positive symptoms: -hallucinations -delusions → negative symptoms:-depression -blunted emotions -social withdrawal Worldwide, it is estimated that one person in every 100 develops schizophrenia. Studies have demonstrated that as many as 75% of patients with schizophrenia have difficulty taking their oral medication. What is bipolar I disorder? Bipolar disorder is a brain disorder that causes unusual shifts in a person's mood, energy and ability to function →extreme highs: mania →extreme lows: depression Bipolar disorder affect approximately 5.7 million American adults. The median age of onset for bipolar disorder is 25 years. Mechanism of action Platform technology uses polymer-based microsphere injectable extended-release technology to deliver and maintain therapeutic medication levels in the body through just one injection every two weeks. manufactured and commercialized by Janssen Indication INVEGA SUSTENNA/XEPLION is a once-monthly, long-acting injectable atypical antipsychotic approved by the FDA (2009) for the treatment of schizophrenia in adults. Platform technology Uses nanoparticle injectable extended-release technology to increase the rate of dissolution and enable the formulation of an aqueous suspension for once-monthly intramuscular administration. Risperdal consta and Invega sustenna's net sales Patents : Main competitor • ZYPREXA®RELPREVV® • Marketed and sold by Lilly Vivitrol •Alkermes develop, market and sell, VIVITROL in the U.S. •Royalties revenues by Cilag Indication VIVITROL is the first and only once-monthly injectable medication for the treatment of : →alcohol dependence →opioid detoxification approved by the FDA : -for the treatment of alcohol dependence in April 2006 -for opioid detoxification in October 2010. Mechanism of action Incidence of opioid and alcohol dependence According to the 2010 U.S. National Survey on Drug Use and Health, an estimated 1.5 million people aged 18 or older were dependent on pain relievers or heroin Approximately 18 million people in the U.S. are dependent on or abuse alcohol Platform technology •uses polymer-based microsphere injectable extended-release technology to deliver and maintain therapeutic medication levels in the body through just one injection every four weeks. Vivitrol's net sales Patents : Competitors • In the treatment of alcohol dependence: -CAMPRAL ® (acamprosate calcium) sold by Forest Laboratories -ANTABUSE® (disulfirame) sold by Odyssey -SELINCRO®(nalméfène) sold by Biotie therapies • In the treatment of opioid dependence: -methadone, -oral naltrexone -SUBOXONE® -SUBUTEX ® Each of which is marketed and sold by Reckitt Benckiser Pharmaceuticals, Inc. in the U.S. Ampyra®/Fampyra® •marketed and sold in the U.S. under the trade name AMPYRA by Acorda •marketed and sold outside the U.S. under the trade name FAMPYRA by Biogen Idec •Incorporates our Oral Controlled Release ("OCR") technology. Indication -AMPYRA was approved by the FDA in January 2010 as a treatment to improve walking in patients with Multiple Sclerosis (MS). -FAMPYRA received conditional marketing approval in the EU in July 2011 and is currently being sold by Biogen Idec in select European countries, as well as Australia. What is multiple sclerosis? MS is a chronic, progressive disease in which the immune system attacks and degrades the myelin sheath. People with MS may suffer impairments in any number of neurological functions (often include difficulty walking). Mechanism of action Ampyra's net sales Bydureon® uses our polymer-based microsphere injectable extended-release technology Exenatide is a GLP-1 agonist Indication -In June 2011, the European Commission granted marketing authorization for the treatment of type 2 diabetes in adult patients in combination with: -metformin -sulfonylurea -thiazolidinedione -metformin+ a sulfonylurea -metformin+ a thiazolidinedione -A once-weekly formulation of exenatide. -In January 2012, the FDA approved BYDUREON® as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Pipeline ALKS 3831 ALKS 3831 •Combinaison of ALKS 33 and olanzapine (ZYPREXA) designed to have efficacy of olanzapine with attenued weight gain •Olanzapine show to have highest efficacy, but also highest incidence of weight gain among atypical antipsychotics What is ALKS 33? ALKS 33 is an oral opioid modulator characterized by limited hepatic metabolism and durable pharmacologic activity in modulating brain opioid receptors. 57% of olanzapine patients experience >7% weight gain at one year • Randomized, double-blind placebo-controlled trial to evaluate safety and efficacy of ALKS 3831 in attenuationinduced weight gain in 106 healthy volunteers • Daily oral ALKS 3831 significantly attenued olanzapine-induced weight gain over three weeks • Safety and tolerability of ALKS 3831 similar to olanzapine • Phase 2 study begin mid CY’13. ALKS 5461 A novel therapie for major depressive disorder What is a major depression? • • • • • Fatigue or loss of energy almost every day. Feelings of worthlessness or guilt almost every day. Impaired concentration, indecisiveness. Insomnia or hypersomnia (excessive sleeping) almost every day. diminished interest or pleasure in almost all activities nearly every day • Restlessness or feeling slowed down. • Recurring thoughts of death or suicide. • Significant weight loss or gain ALKS 5461 novel therapie for major depressive disorder (MDD) •Co-formulation of ALKS 33 and buprenorphine to form novel opioid receptor modulator •For patient who have inadequate response to standard antidepressant therapies •Positive phase 1: -multi-center, placebo-controlled, multi-dose study in 32 patients -Well tolerated and significantly improved depression scores on 7 days •Phase 2: 130 patients enrolled in december 2012 (data expected H1 CY’13) Aripiprazole lauroxil (ALKS 9070) A once-Monthly Prodrug of Aripiprazole Platform technology •ALKS 9070 is the first Alkermes’ product candidate to leverage our proprietary LinkeRx TM product platform • A once-monthly injectable atypical antipsychotic in development for the treatment of schizophrenia. • Once in the body, aripiprazole lauroxil converts to aripiprazole. •In December 2011, initiation of a phase 3 clinical trial of aripiprazole lauroxil for the treatment of schizophrenia: -12-weeks, multicenter, double-blind, placebo-controlled study -to assess the efficacy, safety and tolerability of aripiprazole lauroxil -690 patients experiencing acute exacerbation of schizophrenia •Data anticipated late 2013 •New agent to expand long acting treatment options •Patent protection into late 2030 •interest to move from oral to an injectable form: -> increase compliance Manufacturing and royalty revenues Financial year* Conclusion Strategy • Capitalize on growth from our five key commercial products • Continue to advance our pipeline • Grow revenues and manage our expenses to expand our margins Thanks for your attention Any question ?