12/19/2012

Biogen Idec & Eisai Inc. Form Strategic Alliance

Biogen Idec and Eisai Inc. recently announced a strategic alliance that will bolster the manufacturing capabilities of both companies’ Research Triangle Park (RTP)-based facilities. Under the terms of the agreement, Biogen Idec will lease a portion of the Eisai facility to manufacture oral solid dose products for both companies. Eisai will provide Biogen Idec with vial-filling services for biologic therapies and packaging services for oral solid dose products. The 10-year lease agreement gives Biogen Idec the option to purchase the Eisai oral solid dose facility.

“We view our supply chain as a lifeline to patients, designed to deliver quality therapies wherever and whenever they are needed,” said John G. Cox, Executive Vice President of Pharmaceutical Operations and Technology, for Biogen Idec. “This innovative capacity-sharing relationship with Eisai fits strategically in our global drug supply network, particularly as we advance our oral therapeutics.”

Approximately 50 Eisai personnel are expected to become Biogen Idec employees in early 2013, building on the company’s RTP workforce, which exceeded 1,000 in 2012. Eisai currently employs approximately 225 full-time employees at its RTP site.

“We look forward to collaborating with Biogen Idec to continue the proud history of drug manufacturing excellence here at our RTP site,” added Lou Arp, General Manager of the Eisai RTP site and President of Global Oncology Manufacturing, for Eisai Inc. “Our alliance will enable both companies to focus on respective areas of expertise while continuing to deliver high-quality and innovative products to patients. Moreover, employees will benefit by working in a highly collaborative environment that offers opportunities to further cultivate their careers.”

Biogen Idec and Eisai have both operated manufacturing facilities in RTP since the mid-1990s. “This alliance underscores the Triangle region’s reputation as a globally competitive location for life sciences,” said Bob Geolas, President and CEO of the Research Triangle Foundation. “In addition, it’s an illustration of the type of collaboration we encourage and foresee becoming more commonplace as the Park moves forward with its new Master Plan.”

Through cutting-edge science and medicine, Biogen Idec discovers, develops, and delivers to patients worldwide innovative therapies for the treatment of neurodegenerative diseases, hemophilia and autoimmune disorders. For more information, visit www.biogenidec.com.

Eisai Inc. was established in 1995 and began marketing its first product in the United States in 1997. Since that time, Eisai Inc. has rapidly grown to become a fully integrated pharmaceutical business. Eisai’s key areas of commercial focus are neurology and oncology. For more information, visit www.eisai.com/US.

The Medicines Company Licenses BMS’ Device for $105 Million

The Medicines Company and Bristol-Myers Squibb Company recently announced that the companies have signed a global license and 2-year collaboration for Recothrom, a recombinant thrombin approved by the US FDA for use as a topical hemostat to control non-arterial bleeding during surgical procedures.

Clive Meanwell, MD, PhD, Chairman and CEO of The Medicines Company, said, “As a marketed, growing product to control blood loss in the hospital, we believe Recothrom is a strategic fit that enables operating leverage with The Medicines Company’s emerging perioperative care portfolio. The financial structures and net revenues fit well with our strategy for aggressive and sustainable growth in acute and intensive care medicine. Of course, thrombin is also a hemodynamic target we know well based on our experience with Angiomax (bivalirudin), a thrombin inhibitor.”

“The Medicines Company’s expertise in advancing the treatment of critical care patients in hospital settings worldwide makes it the natural partner to bring Recothrom to patients and physicians,” said Giovanni Caforio, President, US Pharmaceuticals of Bristol-Myers Squibb. “This agreement is part of Bristol-Myers Squibb’s ongoing efforts to simplify operations, improve our efficiency, and better position ourselves to focus on our important work in areas of significant unmet medical need that are critical to our long-term success.”

Recothrom net revenues in 2011 were $65 million. The product is currently commercially available in the US and Canada. The intellectual property license agreement is global and The Medicines Company anticipates pursuing approvals in additional countries. The transaction is expected to be accretive to earnings per share (EPS) for The Medicines Company in 2013.

Under terms of the agreement, The Medicines Company will pay Bristol-Myers Squibb an up-front collaboration payment of $105 million and an up-front option fee of $10 million. The Medicines Company has also agreed to pay Bristol-Myers Squibb a tiered royalty on annual net revenues of Recothrom during the 2-year collaboration term. Bristol-Myers Squibb will retain responsibility for the manufacturing of Recothrom and will be The Medicine Company’s exclusive supplier of Recothrom during the term of the agreement. The option enables The Medicines Company to acquire the Recothrom assets for a purchase price based on average net sales during the 2-year collaboration term. The transaction is expected to be minimally accretive to EPS for Bristol-Myers Squibb in 2013 and 2014.

The transaction is subject to the satisfaction or waiver of closing conditions, including the expiration or termination of applicable waiting periods under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and the delivery by Bristol-Myers Squibb of certain audited financial information relating to the business. Leerink Swann LLC acted as exclusive financial advisor to The Medicines Company and WilmerHale acted as legal advisor to The Medicines Company. Covington & Burling LLP was legal advisor to Bristol-Myers Squibb.

Recothrom is a surgical hemostat that is applied topically to stop bleeding during surgery. Its active ingredient is recombinant human thrombin (rThrombin), and the product is indicated as an aid to hemostasis whenever control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical. Recothrom is part of a class of surgical hemostats commonly referred to as active hemostats. Other classes of surgical hemostats include mechanical hemostats, flowable hemostats, and fibrin sealants. Recothrom was approved in the US in January 2008 and in Canada in December 2010.

The Medicines Company provides medical solutions to improve health outcomes for patients in acute and intensive care hospitals worldwide. These solutions comprise medicines and knowledge that directly impact the survival and well-being of critically ill patients. For more information, visit www.themedicinescompany.com.

Catalent & UMN Pharma Announce Biosimilar Development Collaboration

Catalent Pharma Solutions and UMN Pharma Inc. recently announced the signing of an agreement to provide UMN Pharma a broad range of biosimilar cell lines using Catalent’s proprietary GPEx technology. The development and manufacturing programs will benefit from the GPEx technology producing very stable and high yielding cell lines.

Under the agreement, UMN Pharma and its subsidiary UNIGEN, which is a contract manufacturer, will produce a number of biosimilars using Catalent’s GPEx cell lines. UMN Pharma, separately, will build an alliance of pharmaceutical companies for product development, including clinical trials, marketing, and sales. UMN Pharma plans to begin multiple biosimilar projects with their alliance companies for the Asian market on an ongoing basis.

“There are great synergies between UMN Pharma and Catalent in terms of technologies, business structure, speed, and culture,” said Masahiro Michishita, Executive Chairman of UMN Pharma. “Harnessing Catalent’s broad biologics development and cell construction expertise gives UMN Pharma a unique platform to grow our biosimilars business globally.”

Barry Littlejohns, Catalent’s Business Unit President, added, “This agreement will allow Catalent to continue to grow its biologics development and manufacturing interests of multiple biosimilars and NBEs, particularly in the Asian market. UMN Pharma’s ambitious expansion plans reflect Catalent’s strategy for growth in what we consider to be a key market.”

Hans-Joachim Rohe, President of Catalent Japan, added, “We are very excited to offer a continuously expanding range of Catalent services to our customers in Japan. With the growing demand for Catalent’s GPEx technology we enforce our position as leading supplier of drug delivery solutions and expert services.”

Founded in 2004, UMN Pharma now has three manufacturing facilities in Japan focused on the development of influenza vaccines based on insect cells. Supported by the Japanese government, UMN Pharma currently has three 600-L bioreactors for influenza vaccine production. In response to the emerging demand for influenza vaccines, also for new biological entities (NBEs) and biosimilars, it has commissioned two additional 21,000-L units in Gifu, to be operational by 2013. UMN Pharma will then add another two 21,000-L facilities by 2016.

Catalent’s biologics group has expressed over 360 cell lines for clients, with dozens of on-going clinical trials throughout the world and two products utilizing the GPEx technology currently on the market. A new state-of-the-art facility with 500-L and 1000-L single-use bioreactors for cGMP manufacturing will be opening in Madison, Wisconsin, in spring 2013.

UMN Pharma has been developing new-generation people-friendly vaccines for the people, including babies, pregnant women, and elderly using a state-of-the-art biotechnology. For more information, visit www.umnpharma.com/en/.

Catalent Pharma Solutions is the global leader in development solutions and advanced drug delivery technologies, providing world-wide clinical and commercial supply capabilities for drugs, biologics, and consumer health products. For more information, visit www.catalent.com.

Aptalis Pharmaceutical Technologies Announces Approval

Aptalis Pharmaceutical Technologies recently announced that the European Commission granted marketing authorization for a new pediatric indication of a new oral granule formulation of Gilead Sciences, Inc.’s Viread (tenofovir disoproxil fumarate) for HIV-1 infected children aged 2 to less than 6 years, and for HIV-1 infected children above 6 years of age for whom a solid dosage form is not appropriate.

This authorization, which covers all 27 countries of the European Union (EU), follows the January 2012 US FDA New Drug Application (NDA) approval of Viread oral powder in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients ages 2 to 5. The oral powder, which utilizes Microcaps taste-masking formulation technology, will be manufactured and supplied to Gilead by Aptalis Pharmatech, Inc. Gilead will be responsible for product commercialization.

“The FDA and European Commission approvals of the oral granule formulation of Gilead’s Viread for use in the US and Europe respectively, are examples of how our company’s turnkey business model differentiates our services in the drug development process. We leverage our breadth of capabilities, experience and expertise to provide a comprehensive resource for our partners to establish effective pathways to commercialization. To this end, we are pleased to have had the opportunity to co-develop the pediatric oral powder formulation of Viread with Gilead using our Microcaps proprietary technology,” said John Fraher, President of Aptalis Pharma.

The microencapsulation technology known as Microcaps employs versatile and precise coating techniques to encapsulate individual drug particles using solvent- and aqueous-based coacervation. This includes taste- and odor-masking, customized release profiles, conversion of liquids to solids and the separation of incompatible materials. Microcaps can also be combined with the company’s AdvaTab technology to provide an orally disintegrating tablet with superior mouth-feel attributes.

Aptalis Pharmaceutical Technologies, formerly known as Eurand Pharmaceutical Technologies, offers a broad portfolio of oral drug delivery technology platforms: Customized Drug Release, Bioavailability Enhancement, and Taste Masking for ODTs (orally disintegrating tablets) and other dosage forms. For more information, visit www.AptalisPharmaTech.com.

FDA Panel Rejects Painkiller Drug

Zogenix, Inc. recently announced that the US FDA Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) voted 2 to 11 (with one abstention) against the approval of Zohydro ER (hydrocodone bitartrate extended-release capsules), an extended-release formulation of hydrocodone without acetaminophen, for the management of moderate-to-severe chronic pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

“Zogenix recognizes and appreciates that prescription opioid misuse and abuse is a critical issue,” said Stephen Farr, PhD, President and Chief Operating Officer of Zogenix. “However, it is also important to remember that there is a documented patient need for an extended-release hydrocodone medicine without acetaminophen. We remain confident in the measures we have proposed to support safe use of Zohydro ER and are committed to continuing to work with the FDA through the review process to bring this treatment option to this specific patient population.”

The Prescription Drug User Fee Act (PDUFA) date for completion of FDA review of the Zohydro ER New Drug Application (NDA) for approval is March 1, 2013. The AADPAC provides the FDA with independent expert advice and recommendations, but the final decision regarding approval of a medication is made by the FDA.

The NDA submission is based on data from over 1,100 patients with chronic pain participating in the pivotal Phase III efficacy study and an open-label Phase III safety study of Zohydro ER. The primary efficacy endpoint and two key secondary endpoints of the efficacy study in chronic low back pain patients were met, and the most frequent treatment emergent adverse events were constipation, nausea, somnolence, and headache. The safety study, in which patients received Zohydro ER for up to 12 months, demonstrated that the incidence of adverse events was consistent with that seen in the efficacy study with the most commonly reported adverse events being consistent with those typically seen with chronic opioid therapy.

If approved, Zohydro ER will be classified as a Drug Enforcement Agency (DEA) Schedule II drug, subject to stricter prescribing and dispensing rules compared to the currently prescribed hydrocodone products. In addition, the Risk Evaluation and Mitigation Strategy (REMS) for Zohydro ER will be consistent with the recently introduced FDA-approved REMS for Extended Release and Long Acting Opioids.

Zogenix, Inc., with offices in San Diego and Emeryville, CA, is a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain. For more information, visit www.zogenix.com.

Ligand Pharmaceuticals & Pfizer Get PDUFA Date

Pfizer Inc. and Ligand Pharmaceuticals Incorporated recently announced that the US FDA accepted for review an NDA for bazedoxifene/conjugated estrogens (BZA/CE), a potential new medicine for non-hysterectomized women for the treatment of moderate-to-severe vasomotor symptoms (VMS) and vulvar and vaginal atrophy (VVA) associated with menopause, as well as the prevention of postmenopausal osteoporosis. The FDA Prescription Drug User Fee Act (PDUFA) date is October 3, 2013.

BZA/CE pairs the selective estrogen receptor modulator (SERM) bazedoxifene with conjugated estrogens. BZA/CE has been studied in a Phase III clinical development program (Selective estrogens, Menopause And Response to Therapy [SMART] trials), which included approximately 7,500 postmenopausal women and assessed the safety and efficacy of BZA/CE for the treatment of moderate-to-severe VMS and VVA associated with menopause, as well as the prevention of postmenopausal osteoporosis. The most common adverse drug reactions observed in the SMART trials were abdominal pain, vaginal yeast infection and muscle spasms.

“Pfizer is dedicated to advancing treatments that may help improve health and well-being at each stage of life,” said Gail Cawkwell, MD, PhD, Vice President, Pfizer’s Medical Affairs. “BZA/CE was developed for non-hysterectomized women with moderate-to-severe menopausal symptoms. This milestone moves us one step closer toward potentially providing the first new treatment option in the US in years for the treatment of these women’s menopausal symptoms.”

BZA/CE was developed by Wyeth Pharmaceuticals and was part of a broader research collaboration with Ligand on SERMs. Pfizer acquired the rights to BZA/CE when it acquired Wyeth.

“Pfizer continues to make good progress with this program, with this NDA submission shortly following the European Marketing Authorization Application submission earlier this year,” said John Higgins, President and Chief Executive Officer, Ligand. “This is an important therapeutic need, and we commend Pfizer for its continued strong commitment to the program.”

Ligand is a biopharmaceutical company that develops and acquires assets it believes will generate royalty revenues and, under its lean corporate cost structure, produce sustainable profitability. Ligand has a diverse asset portfolio addressing the unmet medical needs of patients for a broad spectrum of diseases, including thrombocytopenia, multiple myeloma, diabetes, hepatitis, muscle wasting, dyslipidemia, anemia, and osteoporosis. For more information, visit www.ligand.com.