|May 2013, Volume XXIII, No. 3|
Industry News In Brief
by Lauren Melton, GE Healthcare
Industry News In Brief, a regular feature of the Boston Area Chapter Newsletter, presents news items concerning companies in the pharma, biotech, medical device and related fields, with an emphasis on companies with a local presence and topics of special interest to our readers.
Alexion Pharmaceuticals and Enobia Pharma have announced that the companies have signed a definitive agreement under which Alexion will acquire 100% of the capital stock of Enobia. Enobia is a private biopharmaceutical company based in Montreal, Canada and Cambridge, Massachusetts, which is focused on the development of therapies to treat patients with ultra-rare and life-threatening genetic metabolic disorders.
Enobia's lead product candidate ENB-0040 (asfotase alfa), is a human recombinant targeted alkaline phosphatase enzyme-replacement therapy for patients suffering with hypophosphatasia (HPP), an ultra-rare, life-threatening, genetic metabolic disease for which there are no approved treatment options. Alexion will acquire full worldwide development and commercial rights to asfotase alfa. Asfotase alfa was awarded orphan drug designation in the US and EU in 2008 and Fast Track status in the US in 2009, and is currently in Phase II clinical development.
Alexion will acquire Enobia in an all-cash transaction. Under the terms of the agreement, Alexion has agreed to pay $610 million in cash upon consummation of the transaction, and up to $470 million in cash to be paid upon achievement of various regulatory and sales milestones. Alexion is not issuing equity in connection with the acquisition. The transaction is subject to customary conditions, including the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. The Boards of both companies have approved the transaction and the companies currently anticipate that the transaction will be completed in the first quarter of 2012. (Source: www.alexionpharma.com, 12 February 2012)
Genzyme, a Sanofi company, has announced that it has begun shipping Fabrazyme® (agalsidase beta) produced at its newly approved plant in Framingham, Massachusetts. As previously communicated, patients in the U.S. are now able to return to full dosing in March. In addition, all new patients in the US are eligible to begin Fabrazyme treatment, at full dosing levels.
In Europe, the process of moving the most severely affected patients to full dose of Fabrazyme will begin in March 2012. Globally, the complete return to normal supply levels of Fabrazyme will begin in the second quarter and continue throughout the year as planned, as Genzyme works to obtain all global regulatory approvals throughout the year and to build inventory.
The FDA and the European Medicines Agency (EMA) approved the manufacturing plant in Framingham for the production of Fabrazyme in January 2012. (Source: Genzyme Website, 01 March, 2012)
A group of business, academic and labor organizations have announced the formation of a coalition that will advocate for the biopharmaceutical industry in Massachusetts. The group will be called the We Work For Massachusetts Coalition. It will be part of a national group, We Work For Health, which is active in 11 other states. Three Central Massachusetts organizations have joined the Massachusetts group: the Blackstone Valley Chamber of Commerce, the Worcester Regional Chamber of Commerce and Worcester-based Massachusetts Biomedical Initiatives.
Kevin O'Sullivan, president and CEO of Massachusetts Biomedical, said the formation of the coalition "is an important effort that will showcase the vital work the bioscience and technology sector does here. We are home to a thriving bioscience industry, first-class research institutions and a strong workforce." (Source: Rick Saia, Worcester Business Journal, 06 March, 2012)
GE Healthcare, a unit of GE, has announced that it has reached an agreement to acquire Xcellerex, Inc. a supplier of innovative manufacturing technologies for the fast-growing biopharmaceutical industry. The acquisition of Xcellerex will allow GE Healthcare to expand its offering of products and services for the manufacture of biopharmaceuticals such as recombinant proteins, antibodies and vaccines. The strong strategic fit between the two companies, combined with expanded capabilities in product development and marketing, will offer significant customer benefits. Financial terms were not disclosed.
Xcellerex develops and produces turn-key biomanufacturing systems and production-scale bioreactors based around single-use components. The proprietary products offer significant advantages such as faster installation, lower capital investment, reduced risk of cross-contamination, and significantly increased flexibility compared with traditional manufacturing technologies.
Xcellerex's production-scale single-use bioreactor systems are complementary to GE Healthcare's products and range of media for cell culture. Xcellerex's FlexFactory® is a complete custom-designed modular production platform based around single-use technologies that helps customers deploy manufacturing capacity more quickly. Combining the expertise and capabilities of the two companies will enable GE Healthcare to offer a substantially wider range of added-value, integrated products and services to the biopharmaceutical industry. The acquisition, which is subject to customary closing conditions, is expected to close in Q2 2012. (Source: GE Healthcare Website, 07 March, 2012)
Asahi Kasei Corporation, and ZOLL Medical Corporation have jointly announced that Asahi Kasei, Japan's leading diversified chemical manufacturer with businesses in the health care, chemicals & fibers, homes & construction materials, and electronics sectors, has entered into a definitive merger agreement with ZOLL, a manufacturer of resuscitation and critical care devices and related software solutions, pursuant to which Asahi Kasei will acquire ZOLL for approximately $2.21 billion. ZOLL develops and manufactures its products in multiple locations in the US, including those in Massachusetts and Rhode Island. The transaction has been approved by the Boards of Directors of both companies.
Moving forward, Asahi Kasei plans strategic investments to accelerate the realization of ZOLL's mission of leading the world in resuscitation technologies, and to build on the ZOLL platform to achieve Asahi Kasei's long term strategic objective of creating a globally competitive health care business with a clear and unique focus on the field of critical care. Asahi Kasei has identified health care as a key strategic sector that will power a new phase of growth for the group, and believes that the acquisition represents a significant milestone in fulfilling its core vision for the health care sector: improving patient quality of life through the creation of innovative technologies and devices for critical care.
The acquisition extends the development of Asahi Kasei's "Health Care for Tomorrow" project, under which the company seeks to advance the development of new businesses through organic growth, targeted acquisitions, and strategic alliances. A key focus area of this effort is the resuscitation sector, an area where ZOLL is already a market leader in the US and has a strong international market presence.
This transaction builds on the alliance between the two companies that was announced in July 2011, under which Asahi Kasei has exclusive rights to market and distribute ZOLL's AED PLUSTM automated external defibrillator (AED) in Japan-the first AED in Japan with a function supporting cardiopulmonary resuscitation (CPR) that incorporates voice guidance and message displays. (Source: ZOLL Website, 12 March, 2012)
Shire has announced that it has withdrawn its Biologics License Application (BLA) for REPLAGAL® (agalsidase alfa) with the FDA. Shire has been in ongoing dialogue with the FDA since the supply shortage of the only US approved treatment for Fabry disease.
In 2009 and again in 2011, the FDA encouraged Shire to submit an application for the approval of REPLAGAL. The information in the application included relevant updates such as manufacturing and open long-term clinical trial data. These discussions led the Company to file a BLA last November in anticipation of a quick review process and eventual approval, allowing Shire to supply more US patients with a therapy they desperately needed at the time.
Recent interactions with the FDA have led Shire to believe that the agency will require additional controlled trials for approval. No concerns over the product's safety profile were raised by the FDA. Shire has concluded that the likely additional studies would cause a significant delay, and an approval of REPLAGAL for US patients would only be possible in the distant future. Shire has therefore decided to withdraw its BLA.
REPLAGAL has been approved in the European Union for over 10 years and is marketed in 46 countries around the world, treating over 70 percent of the Fabry patient population worldwide. Over 1000 patients have switched to REPLAGAL since the beginning of the supply shortage in mid-2009. Shire has been providing REPLAGAL free of charge to around 140 US patients - about 20 percent of the treated US patients - through treatment access programs. Today's decision by Shire does not have any impact on the treatment of REPLAGAL patients outside the US. (Source: Shire Website, 14 March, 2012)
Massachusetts-based MAKScientific, LLC, a privately held company focused on the discovery of novel therapeutics modulating cannabinoid pathways, today announced that it has entered into an exclusive, worldwide option and collaboration agreement with Biogen Idec to develop and commercialize drug candidates for the treatment of multiple sclerosis (MS) and other neurodegenerative diseases.
Under the agreement, Biogen Idec will receive an option for an exclusive license to select discovery-stage MAKScientific drug candidates for all indications worldwide. Upon Biogen Idec's exercise of the option, MAKScientific will be eligible to receive an exercise fee of up to $3 million and up to an additional $31 million in milestone payments associated with the clinical development of the drug candidates. In addition, MAKScientific will be eligible to receive royalties on net sales worldwide. (Source: MAKScientific Website, 14 March, 2012)
Sanofi and Woburn-based Pluromed, a medical device company, have announced that they have entered into a definitive agreement under which Sanofi is to acquire Pluromed. Massachusetts. The acquisition is subject to customary closing conditions.
Pluromed has developed a proprietary polymer technology, called Rapid Transition Polymers, pioneering the use of injectable plugs to improve the safety, efficacy and economics of medical interventions. Sanofi will commercialize Pluromed's LeGoo®, a highly innovative FDA approved and CE marked gel for temporary endovascular occlusion of blood vessels during surgical procedures.
"LeGoo represents a major advancement in surgical technology because of its ability to control bleeding without clamps or snares that can injure delicate blood vessels" said Dr. William E. Cohn, Director, Minimally Invasive Surgical Technology at the Texas Heart Institute in Houston and a member of Pluromed's Board of Directors. "This breakthrough gives surgeons a way to temporarily stop blood flow into the surgical field which is imperative for clear visualization and accurate placement of sutures. I believe this technology will be widely adopted in cardiovascular surgery and perhaps in other fields in the future." (Source: Sanofi Website, 16 March, 2012)
Biogen Idec has donated $500,000 to a University of Massachusetts Medical School fund that finances research of Lou Gehrig's disease, also known as ALS. The fund was created with the help of former Gov. Paul Cellucci, who announced early last year that he had been diagnosed with ALS. He is receiving treatment at UMass, where Dr. Robert H. Brown leads the institution's research efforts on ALS and other neuromuscular diseases.
Sanofi lost an appeals court ruling on its patent-infringement claims against Roche Holding AG's Genentech and Biogen Idec for the cancer drugs Rituxan and Avastin. The US Court of Appeals for the Federal Circuit upheld a lower court ruling that the drugs don't infringe two Sanofi patents. The opinion was posted on the court's website.
Sanofi sued Genentech and Biogen Idec in 2008 after Genentech said it was canceling a licensing agreement that had dated back to 1991. Paris-based Sanofi said the cancer drugs were made using inventions it owned to enhance the expression of a gene and make production more efficient.
US District Judge Susan Illston in San Francisco ruled that Genentech and Biogen Idec didn't use the same steps as those covered by the Sanofi patents. Sanofi said Illston had misconstrued certain terms of the patents. The Federal Circuit rejected the arguments. Sanofi, which said it was disappointed in the decision, can ask the court to reconsider the opinion. (Source: Sanofi Website, 22 March, 2012)
The construction of a long-stalled laboratory building in Boston's Longwood Medical Area has resumed. The $300 million project is part of several development activities in the region's health care sector. The complex, to be called Longwood Center, will be a multi-tiered glass building containing street level shops and laboratory space at what is now a large vacant lot at Brookline and Longwood Avenues.
Construction was previously halted in 2008 due to the economic downturn and limited potential tenants and difficulty with securing financing. The economy appears to be rebounding and medical and health care companies are investing and expanding again with several area hospitals or universities interested in occupying the complex or building their own new complexes in the area. Much of the development is being driven by pharmaceutical companies expanding in Boston and Cambridge as well.
Several area pharma companies are building in Boston or Cambridge, including Novartis AG, Biogen Idec, and Vertex. Several others are looking to move into larger spaces in the area. These include Ironwood Pharmaceuticals, Momenta, Ariad and Merrimack. (Source: Casey Ross, Boston Globe, 23 March, 2012)
AstraZeneca announced that on March 23, 2012 the US District Court for the District of Columbia issued an opinion and order in AstraZeneca's lawsuit against the FDA regarding final marketing approval of generic quetiapine. The Court denied the Company's request for a preliminary injunction and dismissed the lawsuit without prejudice. Notwithstanding the Court's decision, the Company continues to believe strongly in the merits of its position and is evaluating its options. Quetiapine is marketed by AstraZeneca under the tradename Seroquel. (Source: AstraZeneca Website, 26 March, 2012)
Amgen and AstraZeneca have announced an agreement to jointly develop and commercialize five monoclonal antibodies from Amgen's clinical inflammation portfolio (AMG 139, AMG 157, AMG 181, AMG 557 and brodalumab (AMG 827)).
The companies believe all the molecules have novel profiles and offer the potential to deliver important treatments across multiple indications in inflammatory diseases. The collaboration will provide Amgen with additional resources to optimally progress its portfolio, and Amgen will benefit from the strong respiratory, inflammation and asthma development expertise of MedImmune, AstraZeneca's biologics arm. The collaboration will also capitalize on AstraZeneca's global commercial reach in respiratory and gastrointestinal diseases. The agreement does not include certain territories previously partnered by Amgen for brodalumab with Kyowa Hakko Kirin and AMG 557 with Takeda.
Under the terms of the agreement, AstraZeneca will make a one-time $50 million upfront payment and the companies will share both costs and profits. Based on current plans, approximately 65 percent of costs for the 2012-2014 period will be funded by AstraZeneca. Thereafter, the companies will split costs equally. Amgen will book sales globally and will retain a low single-digit royalty for brodalumab and a mid single-digit royalty for the rest of the portfolio, after which the companies will share profits equally. (Source: Amgen Website, 02 April, 2012)
Massachusetts-based Synageva Biopharm, a clinical stage biopharmaceutical company developing therapeutic products for rare disorders, announced today an expansion of its previous collaboration with Mitsubishi Tanabe Pharma Corporation of Osaka, Japan to develop a second protein therapeutic for an undisclosed orphan disease using Synageva's product development capabilities and proprietary protein expression platform.
Under the terms of the agreement, Mitsubishi Tanabe Pharma will make an upfront payment of $9 million. Synageva will receive reimbursement for development costs, potential future development and commercial milestone payments, as well as royalties from potential product revenue. Today's announced agreement does not impact Synageva's previously stated net operating loss guidance of between $40 and $45 million for 2012. (Source: Synageva BioPharma Website, 02 April, 2012)
Chapter Manager: Amy Poole, CAMI - Tel: 1.781.647.4773 and E-mail: firstname.lastname@example.org