7/26/2011
Daiichi Sankyo Launches Direct Oral Factor Xa Inhibitor
Daiichi Sankyo Company, Limited recently announced the launch of LIXIANA (JAN: Edoxaban Tosilate Hydrate, INN: edoxaban) in
Edoxaban is a once-daily, oral anticoagulant that specifically, reversibly, and directly inhibits the enzyme, Factor Xa, a clotting factor in the blood. Results from clinical studies supported the approval of edoxaban for the prevention of venous thromboembolism (VTE) in patients with total knee arthroplasty, total hip arthroplasty, and hip fracture surgery.
“Today’s launch of edoxaban marks the global debut of the medication, which is an exciting breakthrough for patients who require VTE prevention after major orthopedic surgery,” said Joji Nakayama, President and CEO of Daiichi Sankyo. “Edoxaban demonstrates solid efficacy in clinical trials in this population of patients. Its predictable pharmacokinetic and pharmacodynamic profile allows for a convenient, once-daily dosing.”
The global clinical development program for edoxaban is focused on several indications, including stroke prevention in atrial fibrillation (AF) patients, and treatment and prevention of recurrent VTE. Edoxaban is currently being assessed in the Phase III ENGAGE AF-TIMI 48 study, an ongoing, multinational, randomized, double-blind trial evaluating the efficacy and safety of edoxaban in preventing stroke and systemic embolic events in patients with AF. More than 21,000 patients with AF in 46 countries are being examined, making this the largest trial in this indication to date. In addition, Daiichi Sankyo is currently enrolling patients in its HOKUSAI VTE study, the largest single, double-blind, randomized, multinational Phase III study for the treatment and prevention of recurrent VTE, involving approximately 7,500 patients in 450 clinical sites in approximately 40 countries worldwide.
The Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address the diversified, unmet medical needs of patients in both mature and emerging markets. While maintaining its portfolio of marketed pharmaceuticals for hypertension, hyperlipidemia, and bacterial infections, the Group is engaged in the development of treatments for thrombotic disorders and focused on the discovery of novel oncology and cardiovascular-metabolic therapies.
Hemispherx Biopharma Receives New Patent for Intranasal Ampligen
Hemispherx Biopharma, Inc. recently announced the granting of a new United States Patent for the use of Ampligen as a vaccine adjuvant for use with seasonal influenza vaccine to induce an enhanced immune response against H5N1 avian influenza. The patent describes a method using intranasal administration of Ampligen, a toll-like receptor 3 (TLR3) agonist, along with a seasonal influenza vaccine to enhance an immune response against a H5N1 avian influenza infection compared to the administration of seasonal influenza vaccine alone. Intranasal vaccination stimulates mucosal immunity, which is characterized by a broader, and potentially more effective, immune response.
Influenza epidemics continue to represent a significant medical challenge. Even with existing vaccines, annual influenza epidemics typically result in 20 to 50 million cases, resulting in 30,000 to 40,000 deaths in the
FDA authorization of a clinical trial to evaluate the breadth of immunological protection in healthy volunteers, potentially conveyed by Ampligen, an experimental therapeutic, against influenza viruses has been recently announced.
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx’s flagship products include Alferon N Injection (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen and Alferon LDO. Ampligen is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system. The company’s platform technology includes components for potential treatment of various severely debilitating and life-threatening diseases.
Acorda Therapeutics Announces Initiation of Phase I Clinical Trial in Patients With Heart Failure
Acorda Therapeutics, Inc. recently announced the first patient has been enrolled in the first clinical trial of Glial Growth Factor 2 (GGF2). Acorda is collaborating with the Vanderbilt University Heart and Vascular Institute to conduct this Phase I single-dose trial in patients with heart failure.
“In preclinical models, GGF2 restored the integrity of heart muscle and improved function, which represents a novel approach to treat heart failure,” said Anthony Caggiano, MD, PhD, Vice President of Research and Development at Acorda. “This first clinical trial in patients with heart failure is an important step to assess the safety of GGF2 in humans and will inform the design of potential future trials.”
The primary objective of this double-blind, randomized study is to evaluate the safety and tolerability of GGF2 in patients with heart failure. In this trial, participants will receive either placebo or a low dose of GGF2 administered as a single intravenous infusion. If GGF2 is well tolerated, subsequent groups will receive single infusions of higher doses.
GGF2, which is part of a family of proteins known as neuregulins, has been shown to be pharmacologically active in a number of preclinical models of cardiovascular and neurological conditions. GGF2 acts directly on heart muscle cells, or cardiomyocytes. It is believed to improve the heart’s ability to contract by promoting the repair of tissue damage that results from heart disease or injury. GGF2 may offer a unique treatment strategy as preclinical studies demonstrate that GGF2 acts directly to repair cardiac muscle and improve its contractile function.
Acorda Therapeutics is a biotechnology company developing therapies for multiple sclerosis, spinal cord injury, and related nervous system disorders. The company is commercializing and marketing AMPYRA (dalfampridine) Extended Release Tablets, 10 mg, in the Unites States. AMPYRA is a potassium channel blocker approved as a treatment to improve walking in patients with multiple sclerosis (MS); this was demonstrated by an improvement in walking speed. AMPYRA was developed using Elan’s Matrix Drug Absorption System (MXDAS) technology and is manufactured by Elan based on a supply agreement with Acorda. The company also markets ZANAFLEX CAPSULES (tizanidine hydrochloride), a short-acting drug for the management of spasticity. The pipeline includes a number of products in development for the treatment, regeneration, and repair of the spinal cord and brain.
Apricus Biosciences Files Marketing Application for Vitaros
Apricus Biosciences, Inc. recently announced its filing of a marketing application for Vitaros as a treatment for patients with erectile dysfunction (ED) in
“We are excited about making our third major filing for our flagship product, Vitaros, for the treatment of ED,” said Dr. Bassam Damaj, Chairman, Chief Executive Officer and President of Apricus Bio.
According to IMS Health data, the annual ED market in
The company received marketing approval for Vitaros as a first-line treatment for ED from Health
“Swissmedic is considered one of the most well-respected drug regulatory authorities that is relied on by many countries throughout the world,” said Dr. Damaj. “As we have stated previously, we look forward to applying for approval for this product and for the ED indication in other important international markets in the future.”
The current leading drugs for ED are Viagra, Cialis, and Levitra, which are taken in pill form and work by inhibiting an enzyme called PDE5. There is still a need for new, safe, and effective treatments, however, especially for those patients who cannot or do not respond well to oral medication. Vitaros differs from Viagra, Cialis, and Levitra in two ways. Instead of a pill, it is applied directly to the penis as a cream. The topical application helps to reduce side effects and offers men who do not do well with the existing drugs a patient-friendly alternative. Also, Vitaros operates by a different biochemical mechanism than oral ED medications. It contains a previously marketed ED drug known by the chemical name of alprostadil. When absorbed through the skin, alprostadil directly boosts blood flow, thereby causing an erection within minutes, which the company believes is much faster than the results from the oral treatments.
Alprostadil is currently marketed as an injectable drug or as a suppository inserted into the urethra. The key innovation behind Vitaros is combining alprostadil with Apricus Bio’s NexACT delivery technology, which allows the drug to pass through the skin and makes the treatment much easier to apply. In clinical studies, Vitaros worked in patients suffering from mild to severe ED, including men who did not respond to Viagra. The side effects reported were localized and transient.
Apricus Bio, a San Diego-based, revenue-generating, biopharmaceutical company, has leveraged the flexibility of its clinically validated NexACT drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes. Revenues and growth are driven from out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies worldwide. In addition, the company is seeking to monetize its existing product pipeline, including its first product, Vitaros, approved in Canada for the treatment of erectile dysfunction, which is currently expected to be available on the Canadian market in 2011, as well as compounds in development from preclinical through Phase III, currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes, and Cosmeceuticals among others.
Unilife Commences Initial Supply of the Unifill Syringe to Sanofi
Unilife Corporation recently announced it has commenced the initial supply of validated product of the Unifill syringe to Sanofi, as per the terms of the industrialization agreement between both parties.
Since signing the Exclusive Agreement in July 2008, Sanofi has paid Unilife a total of approximately $40 million, comprising a $16 million (euro 10 million) fee in exchange for the exclusive right to negotiate the purchase of the Unifill syringe, and to help fund the Industrialization Program for the device up to a maximum of $24 million (euro 17 million). Sanofi has secured exclusivity for the Unifill syringe within the full therapeutic classes of antithrombotic agents and vaccines, plus an additional four smaller sub-groups, until June 30, 2014.
Unilife is now in a position to also commence initial sales of the Unifill syringe to other pharmaceutical companies. Upon the receipt of the Unifill syringe, these pharmaceutical customers will typically conduct drug compatibility and stability studies that will test the device in combination with their injectable drugs. The resulting data is then filed as the last step in completing the regulatory process for the drug-device combination product.
“The start of initial sales of the Unifill syringe is arguably the most significant achievement in our company’s history,” said Mr. Alan Shortall, CEO of Unilife. “We very much appreciate the support of Sanofi since 2003, when they had the initiative and vision to approach us to develop a new generation of prefilled syringes that can help to improve patient care, while also enhancing and saving the lives of healthcare workers. The Unifill syringe is generating strong interest from an increasing number of pharmaceutical companies for use in therapeutic classes outside of those retained by Sanofi. These pharmaceutical companies recognize the significant potential of the Unifill syringe to help generate powerful brand differentiation for their injectable drugs within competitive therapeutic drug classes.”
“The integration of safety features within the glass barrel of a prefilled syringe was a challenge that many within the device and pharmaceutical industries thought to be impossible,” added Dr. Ramin Mojdeh, COO of Unilife. “Yet, through our operational expertise, core technology platform, and innovative spirit, we have successfully overcome a number of technical obstacles to commercialize a game-changing device that is now poised to revolutionize the $2.7 billion market for prefilled syringes. The Unifill syringe sits at the leading edge of a rich and diverse platform of advanced drug delivery devices that we are now developing in collaboration with a number of pharmaceutical partners. Having recognized our capacity for device innovation with the Unifill syringe, these top tier pharmaceutical companies are selecting Unilife as their partner to develop other innovative, differentiated, and proprietary devices that are customized to address the specific and unmet needs of their biological drugs. These partnerships will enable us to build upon the success of the Unifill syringe and expand our horizons across several additional high-value market sectors for injectable drug delivery devices.”
Unilife Corporation is a US-based developer, manufacturer, and supplier of advanced drug delivery systems with state-of-the-art facilities in
Allergan to Acquire Dermatologic Company in Deal Worth Up to $275 Million
Allergan, Inc. and Vicept Therapeutics recently announced they have entered into a definitive agreement for Allergan to acquire all of the outstanding shares and assets of the privately held dermatology company. The agreement, estimated to close in the third quarter of 2011, includes a $75 million cash up-front payment by Allergan plus up to an aggregate of $200 million in payments payable by Allergan contingent upon achieving certain future development and regulatory milestones plus additional payments contingent upon acquired products achieving certain sales milestones.
Founded in 2009 and backed by Vivo Ventures, Fidelity Biosciences, and Sofinnova Ventures, Vicept Therapeutics’ lead investigational product, V-101, is a topical cream for the treatment of the erythema (redness) associated with rosacea that has achieved positive results in two randomized, placebo-controlled Phase II studies.
“The two Phase II studies demonstrated the clinical potential of our lead product V-101 in Type I rosacea (Erythematous Rosacea), a dermatological problem for which there currently is no approved therapy,” said Dr. Neal Walker, President and CEO of Vicept. “We believe Allergan is the best company to complete the development and make the therapy available to the clinical community and their patients, fulfilling our shared mission.”
“The acquisition of Vicept Therapeutics will further enhance our dermatology research and development pipeline, and matches our corporate strategy and long-standing commitment to patients suffering from skin disorders,” added Scott M. Whitcup, MD, Executive Vice President, Chief Scientific Officer of Allergan. “We look forward to potentially providing a new treatment option to physicians and their patients suffering from this often burdensome condition.”
“The progress Vicept has made was truly a team effort with strong support from an excellent investor syndicate led by Albert Cha, MD, PhD, from Vivo Ventures,” said Steve Tullman, Executive Chairman of Vicept. “We are very pleased to reach this agreement with Allergan, an outstanding global company with a long track-record in dermatology, who can leverage the full value of our rosacea program with its significant global development and commercialization resources. Leerink Swann, LLC advised the Board of Directors of Vicept in their review of strategic alternatives.”
Rosacea is a common, chronic skin disorder that affects over 15 million Americans and over 45 million people worldwide. Erythematotelenagietic rosacea (ETR), Type I, is the most commonly encountered subtype, and is most characterized by frequent episodes of transient facial erythema (flushing) and non-transient, or persistent, erythema. It may also be accompanied by facial edema, burning, or stinging, and sensitivity of the skin and intolerance to topically applied products is common. Rosacea remains a disorder of uncertain etiology and pathogenesis, though the flushing and erythema of ETR are theorized to arise from an abnormal response of the cutaneous blood vessels of the face to neurological, hormonal, thermal, topical, or other stimuli, resulting in an abnormal dilation of facial blood vessels. There is currently no approved topical therapy for the treatment of ETR.
Vicept Therapeutics, Inc. is a privately held specialty pharmaceutical company with a mission to develop the first effective topically applied therapy directed toward the erythema of rosacea and other disorders characterized by redness and or flushing of the skin. The company is also pursuing the development of topical agents for the treatment and prevention of a number of medical and cosmetic indications including bruising of the skin.
Allergan, Inc. is a multi-specialty healthcare company established 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 more than 9,000 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 OTC 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.
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