Innovative Drugs to Transform Alzheimer’s Disease Medication Market

The patent expiry of all four existing EMEA-approved drugs for Alzheimer’s disease (AD) by 2015 is likely to cause a steep decline in the growth of the European AD medication market. However, the approval of next-generation therapies that can delay disease progression and restore cognitive functions are expected to revive opportunities in the market from 2015 to 2018.

New analysis from Frost & Sullivan (http://www.healthcare.frost.com), European Alzheimer’s Disease Medication Market, estimates the market to earn $1.8 billion in 2012 and reach $4.78 billion in 2019, growing at a compound annual growth rate (CAGR) of 15.1% from 2012-2019.

“Increasing R&D activity and a strong pipeline of disease-modifying drugs bode well for market expansion,” notes Frost & Sullivan Senior Research Analyst Aiswariya Chidambaram. “Considerable unexplored opportunities and the commercial goldmine that is the AD medication market have motivated several pharmaceutical and biotechnology companies to invest in R&D, particularly targeting the moderate-to-severe patient group.”

Existing drug classes for AD offer poor therapeutic efficacy. The core focus of new R&D approaches has therefore centered on novel disease-modifying drugs.

“These drugs are expected to offer potential benefits over conventional therapeutic options as they are safer, more effective, and aim to prevent or slow down disease progression rather than provide just symptomatic relief,” adds Chidambaram. “Therefore, these new drugs are expected to command premium prices and fuel market growth.”

A key challenge at present is the looming patent expiry of key blockbuster drugs, including Aricept, Exelon Patch, and Ebixa. Their going off-patent is set to unleash a flood of cheaper generic equivalents that will result in lowered market revenues.

The accurate diagnosis of AD, especially in the early stages, and monitoring of disease progression will play a vital role in promoting proper market segmentation and positioning of drugs by market participants.

AD diagnostics and therapeutics go hand-in-hand. Although the development and approval of new, improved diagnostic tools over a period of time has been a boon to the AD market, the levels of unmet need still remain high.

“The commercialization of the extensively researched advanced diagnostic technologies targeting phosphorylated tau protein and A-beta 42 could open new market opportunities,” concludes Chidambaram. “They not only help patients gain treatment access in the initial stages, but also significantly improve the clinical trial experience.”

If you are interested in more information on this study, please send an email with your contact details to Anna Zanchi, Corporate Communications, at anna.zanchi@frost.com.

European Alzheimer’s Disease Medication Market is part of the Life Sciences Growth Partnership Service program, which also includes research in the following markets: US Alzheimer’s Disease Medication Market and Analysis of the European Bipolar Disorder Therapeutics Market, among others. All research included in subscriptions provide detailed market opportunities and industry trends that have been evaluated following extensive interviews with market participants.

Frost & Sullivan, the Growth Partnership Company, works in collaboration with clients to leverage visionary innovation that addresses the global challenges and related growth opportunities that will make or break today’s market participants. For more information, visit www.frost.com.

Jubilant HollisterStier Secures Significant Contracts

Jubilant HollisterStier, a subsidiary of Jubilant Life Sciences, recently announced its Contract Manufacturing & Services division has recently secured over $100 million in contracts with leading pharmaceutical companies for the commercial manufacturing of multiple sterile parenteral products. These awards are the continuation of existing relationships and will be executed across both parenteral manufacturing locations in Spokane WA, and Montreal Canada. The commercial technology transfer efforts are expected to commence in 2013.

“We are excited to expand our existing strategic commercial relationships, and will bring forward our capabilities in manufacturing excellence, rigorous quality oversight, and project management to support a smooth and timely transfer to our manufacturing locations, said Jubilant HollisterStier Chief Executive Officer, Marcelo Morales.

Jubilant HollisterStier Contract Manufacturing & Services Division is a subsidiary of Jubilant Life Sciences, an integrated pharma and life sciences company headquartered in India. Jubilant HollisterStier provides its customers manufacturing services to aseptically fill liquid and lyophilized products, semi-solid, and solid dosage forms at its facilities in the US, Canada, and India. Jubilant HollisterStier offers highly skilled, cross-functional teams to provide custom solutions to customer-specific project goals from development through commercialization. Jubilant HollisterStier is committed to providing exceptional quality, regulatory expertise and operational excellence to ensure streamlined processes and services in all facilities. For more information, visit www.jublHS.com.

Nanoparticle Technology Facilitates Cancer Metastasis Research

NanoSight, leading manufacturers of unique nanoparticle characterization technology, recently reported on the breakthrough cancer metastasis research of Dr. Hector Peinado Selgas and Dr. David Lyden’s research team from Weill Cornell Medical College.

Lead study author Dr. Peinado, Instructor of Molecular Biology in the Department of Pediatrics at Weill Cornell, describes in his recent published research work in Nature Medicine with senior author Dr. Lyden’s research group how they were able to gain better understanding and characterization of exosomes, secreted nanoparticles from tumor cells.

“In our laboratory, we are interested in analyzing the role of tumor-secreted exosomes in metastasis. We have recently published a study describing how exosomes secreted from melanoma tumor cells are educating bone marrow-derived progenitor cells toward a pro-metastatic phenotype. We are also interested in analyzing the use of exosomes as biomarkers of specific tumor types and their use as prognostic factors, on which Cornell University currently has pending patents on this technology.”

“We have found that the protein content per exosome is increased in metastatic melanoma patients. In addition, we have observed that metastatic cell lines also have increased protein content per exosome. Therefore, knowing the number of exosomes was a definitive and necessary step in our reseach. Before this work, we were only following qualitative changes in exosomes. Now we are able to make quantitative analyses using Nanoparticle Tracking Analysis technology. This has faciliated our recent research work.”

“Prior to using NTA, I was measuring exosome size by electron microscopy. There was no other technique available. The new technology allows us to analyze millions of particles, particle by particle, in minutes giving not only numbers but also population distribution. Although the measurement of the size of the particles is not as accurate as the electron microscopy, NTA does allow us to process a large number of samples in a short time period.”

To find out more about NanoSight and to learn about particle characterization using the company’s unique nanoparticle tracking analysis instrument, visit www.nanosight.com.

Intarcia Therapeutics Secures Landmark $210-Million Financing

Intarcia Therapeutics, Inc. recently announced the simultaneous completion of two financings with total proceeds of $210 million, the largest sum to be raised by a private biotechnology company in at least 25 years. The financings consisted of $160 million in proceeds from a preferred stock private placement and $50 million in proceeds from a private debt placement.

Investors in these financings included existing investors New Enterprise Associates, Inc., New Leaf Venture Partners, and Venrock, as well as new investors, The Baupost Group, LLC, Farallon Capital Management, LLC, and three additional top-tier institutional investors based in Boston and New York.

As a result of these transactions, Intarcia has retained full strategic and financial control of its lead product candidate ITCA 650 (continuous subcutaneous delivery of exenatide), which, if approved, would be the first and only once-yearly, injection-free GLP-1 therapy for the treatment of type 2 diabetes. Intarcia intends to initiate the global Phase III program for ITCA 650 in the first quarter of 2013 with its strategic partner Quintiles, Inc., the world’s leading biopharmaceutical service provider, which has helped develop or commercialize 18 of the 20 best-selling diabetes products.

“With this landmark financing in place, we have fully preserved the vision for our company, and our aim to bring potentially revolutionary clinical, economic, and humanistic benefits to millions of diabetes patients around the world,” said Kurt Graves, Chairman, President, and Chief Executive Officer of Intarcia. “After considering multiple options to maximize shareholder value and scaling up for our ITCA 650 Phase III program, we chose to align with this elite group of investors who not only shares our vision for ITCA 650 in the diabetes marketplace, but has also expressed its confidence in our ability to shepherd ITCA 650 successfully through clinical trial development and to strike the collaborations needed to make ITCA 650 a global market success.”

Robert R. Henry, MD, Professor of Medicine at the University of California, San Diego, Chief, Section of Diabetes, Endocrinology and Metabolism at the VA San Diego Healthcare System, and immediate Past President of the American Diabetes Association, added, “I am excited about this progress for ITCA 650, as it facilitates the launch of a global Phase III program and advances this innovative therapy toward the many patients I believe may benefit from improved efficacy, tolerability, and the ensured compliance and long-term control that could come from a once-yearly therapy. The trials could demonstrate a real treatment breakthrough for patients and, given the global scale of unmet needs in type 2 diabetes, I believe the entire community should be enthusiastic about research like this and potential products like ITCA 650.”

The completed financing will also facilitate the previously announced move of Intarcia’s corporate headquarters to the Boston, MA, area, while keeping its early development capabilities and state-of-the-art manufacturing site at its current location in Hayward, CA.

Morgan Stanley acted as sole structuring advisor to Intarcia for the transaction. In addition, Morgan Stanley acted as sole placement agent for the debt and lead placement agent for the equity. Leerink Swann LLC acted as co-placement agent on the equity.

ITCA 650 (continuous subcutaneous delivery of exenatide) is being developed for the treatment of type 2 diabetes. The investigational therapy employs Intarcia’s proprietary technology platform involving a matchstick-size, miniature osmotic pump that is inserted subcutaneously to provide continuous and consistent drug therapy, and the company’s proprietary formulation technology, which maintains stability of therapeutic proteins and peptides at human body temperatures for long extended periods of time.

Data from Intarcia’s ITCA 650 Phase II program have demonstrated significant and sustained reductions in HbA1c and body weight over 48 weeks of treatment with a marked reduction in the GI adverse events typically associated with the self-injection products in this class. ITCA 650 is an investigational new therapy and is not currently approved by any regulatory authority. Exenatide, the active agent in ITCA 650, is a glucagon-like peptide-1 (GLP-1) receptor agonist currently marketed globally as a twice-daily self-injection therapy for type 2 diabetes. Upon approval, ITCA 650 would represent the first injection-free GLP-1 therapy that can deliver a full year of treatment from a single placement. Intarcia’s robust intellectual property portfolio protects ITCA 650 through 2031.

Intarcia Therapeutics, Inc. is a biopharmaceutical company developing therapies to enhance treatment outcomes by optimizing and improving the efficacy, continuous administration, and tolerability of drug therapies. In addition, delivering medicines just once or twice yearly virtually ensures patient adherence and compliance, which is very poor in most chronic diseases. Intarcia’s drug development expertise and competitive edge are demonstrated by its abilities to stabilize proteins and peptides at above-body temperature and to deliver them in a constant and consistent manner via Intarcia’s proprietary technology platform. Intarcia is pursuing a Phase III-stage development program for type 2 diabetes and has additional programs ongoing for weight regulation to control obesity. In addition to those listed above, investors in Intarcia include Alta Partners, Foresite Capital, and Omega Funds. For more information, visit www.intarcia.com.

EFCG Calls for Mandatory Inspections of All Global API Manufacturing Sites

The European Fine Chemicals Group (EFCG) is proposing a global harmonization of the rules and regulations governing the manufacture of active pharmaceutical ingredients (APIs) to level the worldwide playing field to ensure the quality of APIs and medicines containing them meet the high standard recognized by the developed economies (ICH Q7).

This should be achieved via mandatory inspections of all global API manufacturers via a Mutual Recognition Agreement (MRA) approach and managed by the National Regulatory authorities to share scarce inspection resources and to avoid the present duplication.

This message is at the core of the latest EFCG position paper aimed at all stakeholders in the global API supply chain, including the Regulators, previewed during their October press conference at the CPhI exhibition in Madrid and repeated in their recent joint response (with APIC and SOCMA) to the EU-US Public Consultation on the future of EU-US trade and economic relations, which provides proposals for the EU-US High Level Working Group on Jobs and Growth and to the EU-US High Level Regulatory Cooperation Forum.

EFCG believes that the new Falsified Medicines Directive (2011/62/EU) designed to minimize counterfeit medicines entering the EU market does not adequately address the API quality issues and that in reality it does little to improve upon the present Directive (2001/83/EC) with regard to patient safety.

Evidence of illegal API manufacturing activity in Asia since 2003 is given in the paper, including the 2008 Chinese-sourced heparin case in the US that caused >100 deaths due to a deliberately included and undeclared impurity. For more information, visit www.efcg.cefic.org.

Allergan to Acquire SkinMedica for $350 Million

Allergan, Inc. recently announced it has entered into a definitive agreement with SkinMedica, Inc. to acquire the privately held company’s topical aesthetics skin care business. Under the terms of the agreement, Allergan will pay SkinMedica $350 million up-front (subject to certain adjustments) for the business, which includes a variety of physician-dispensed, non-prescription aesthetic skin care products and prescription products. Allergan will also pay SkinMedica an additional $25 million contingent upon the acquired products achieving a specific level of net sales. The acquisition, which is expected to close later this year, does not include the SkinMedica Colorescience aesthetic make-up line. SkinMedica will be spinning out the Colorescience business in connection with the closing of the acquisition.

“Allergan is widely recognized for our leadership in the facial aesthetics area,” said David E.I. Pyott, Chairman of the Board, President and Chief Executive Officer, Allergan. “The acquisition of SkinMedica will nicely complement our existing facial aesthetics business, which includes products such as BOTOX Cosmetic, JUVEDERM, and LATISSE, and will enable us to take a leadership position in the growing physician-dispensed topical aesthetics skin care category. Most importantly, the acquisition will allow us to expand our product portfolio to better meet the needs of our existing base of physician customers and their patients.”

Following the acquisition, Allergan plans to operate SkinMedica as a separate global business and will leverage a number of Allergan’s existing preferred customer programs with the SkinMedica product line to provide additional benefits to physicians and patients. Bob Rhatigan, who currently serves as Senior Vice President, Facial Aesthetics, Allergan, will assume the role of Senior Vice President, General Manager, and Chief Executive, SkinMedica. Mary Fisher, Chief Executive Officer, SkinMedica, will join Allergan and assist Mr. Rhatigan in the acquisition integration to ensure the maximization of revenue-building opportunities. The Allergan topical aesthetics sales force and the SkinMedica sales force will continue to represent their respective product lines over the near-term.

Following the completion of the acquisition, a larger and combined SkinMedica sales force will assume responsibility for the line of products, including the revolutionary SkinMedica TNS product line, Allergan’s VIVITÉ product line, and LATISSE®, the one and only FDA-approved product to treat inadequate or not enough eye lashes.

SkinMedica, Inc. is focused on developing, acquiring, and commercializing products that improve the appearance of skin. SkinMedica markets and sells to physicians, with a focus on aesthetics, both prescription and non-prescription skin care products. The company’s full line of aesthetic skin care products includes the revolutionary TNS Essential Serum and hallmark TNS Recovery Complex.

Allergan is a multi-specialty healthcare company established more than 60 years ago with a commitment to uncover the best of science and develop and deliver innovative and meaningful treatments to help people reach their life’s potential. Today, it has approximately 10,500 highly dedicated and talented employees, global marketing, and sales capabilities with a presence in more than 100 countries, a rich and ever-evolving portfolio of pharmaceuticals, biologics, medical devices, and over-the-counter consumer products, and state-of-the-art resources in R&D, manufacturing, and safety surveillance that help millions of patients see more clearly, move more freely, and express themselves more fully. For more information, visit www.allergan.com.

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