Ligand Pharmaceuticals Forms Drug Development Alliance With Chiva Pharmaceuticals

Ligand Pharmaceuticals, Inc. recently announced it has entered into a strategic relationship with Chiva Pharmaceuticals, Inc. to develop multiple Ligand assets and technology in China and potentially worldwide. Chiva is being granted licenses to begin immediate development in China of Ligand’s two clinical-stage HepDirect programs, Pradefovir for hepatitis B and MB01733 for hepatocellular carcinoma. Additionally, Ligand is granting Chiva a non-exclusive HepDirect technology license for the discovery, development, and worldwide commercialization of new compounds in hepatitis B (HepB), hepatitis C (HepC), and hepatocellular carcinoma (HCC).

Chiva is developing these programs to address the high unmet medical need in China‘s fast growing pharmaceutical market. The Chinese government is offering financial support to pharmaceutical companies like Chiva who can develop innovative therapies in China for public health needs, such as infectious disease and oncology.

Under the terms of the agreement, Ligand has the potential to earn over $100 million in milestones and royalties on potential sales. In addition, Ligand has the potential to receive a 10% equity position in Chiva and will also receive an undisclosed percentage of any sublicensing revenue generated from sublicensing of collaboration compounds to third parties in a major world market. Ligand is entitled to receive initial 2011 license payments that total $1 million.

The following technology and programs are included in Ligand’s license to Chiva:

(1) Pradefovir is a HepDirect pro-drug of PMEA, which is the same active metabolite, produced by the FDA-approved HepB drug adefovir dipivoxil (Hepsera). The pro-drug enables higher concentrations of the drug in the liver, the primary site of replication for the hepatitis B virus, and lower concentrations in the kidney, where significant dose-limiting toxicities arise. Pradefovir displayed strong anti-HepB activity in Phase II studies conducted in the US, and Ligand has been attempting to find a partner for further development.

(2) MB07133 is a HepDirect pro-drug of the intermediate form of cytarabine (araC) 5′-monophosphate, which is designed to deliver a high concentration of the active form of the drug for the treatment of hepatocellular carcinoma. MB07133 displayed a strong response rate on intra-hepatic tumor regression in a Phase I/II study conducted in the US.

HepDirect is a pro-drug technology that targets delivery of certain drugs to the liver by using a proprietary chemical modification that renders a drug biologically inactive until cleaved by a liver-specific enzyme. HepDirect may improve efficacy and/or safety of certain drugs and can be applied to marketed or new drug products.

With headquarters in Los Altos Hills, CA, Chiva Pharmaceuticals, Inc. is an affiliate of Hainan Kaihua Pharmaceutical Co., Ltd. (Hainan), a global pharmaceutical company specializing in bringing the best standard of care to the Chinese market, and on making drugs developed in China available to the world. Chiva’s and Hainan’s goal is to build a leading pharmaceutical company in China that competes on the world stage.

Ligand discovers and develops novel drugs that address critical unmet medical needs of patients for a broad spectrum of diseases, including hepatitis, muscle wasting, Alzheimer’s disease, dyslipidemia, diabetes, anemia, COPD, asthma, rheumatoid arthritis, and osteoporosis. Ligand’s proprietary drug discovery and development programs are based on advanced cell-based assays, tissue-specific receptor ligand interactions and gene-expression tools.

Catalent Announces Partnership With Nuron Biotech

Catalent Pharma Solutions, a leading provider of drug and biologic development services, delivery technologies, and supply solutions, recently announced it has entered into an agreement with Nuron Biotech for the formulation and supply of NU100 (interferon beta-1b), a proprietary recombinant human interferon beta compound being developed for the treatment of multiple sclerosis (MS).

Under the terms of the agreement, NU100 will be produced at Catalent’s facility in Brussels, Belgium, where this injectable product will be formulated, filled, and packaged in a prefilled syringe. Nuron Biotech is currently planning to take NU100 into Phase III clinical trials in 2011.

“For decades, Catalent’s sterile technology business has a proven track-record of partnering with innovators like Nuron Biotech to efficiently take products to market faster. We are excited to have the opportunity to apply our sterile delivery expertise to support Nuron through this complex and important stage of product development,” said Sheila Dell, PhD, Vice President Business Development, Catalent. “In addition to preparing and supplying NU100 for Phase III clinical trials, we are pleased to be able to support commercial manufacturing during the product’s first 3 years on the market.”

“Our senior managers have come to know and trust the Catalent team during previous business relationships, and we are pleased to re-establish this mutually beneficial partnership,” added Shankar Musunuri, PhD, MBA, Chief Executive Officer, Founder, Nuron Biotech. “We have strong confidence in Catalent’s ability to support Nuron with NU100 and with other future scale-up and launch opportunities.”

More than 2.1 million people worldwide are thought to be affected by MS. Nuron believes that NU100 will be differentiated from other interferon-beta products by virtue of a certain, patent-protected, high-pressure manufacturing technology that Nuron utilizes, that creates a novel interferon beta-1b product that is free of human serum albumin (HSA) and is essentially free of aggregates.

Catalent’s Sterile Technologies business provides development, clinical, and commercial manufacturing services for sterile injectables and sterile Blow-Fill-Seal products. Catalent’s manufacturing capabilities in this complex arena incorporate an extensive range of sterile injectable offerings, including filling drugs or biologics into vials, prefilled syringes, bags, and other stable delivery formats.

Nuron Biotech is focused on innovative and improved specialty biologics and vaccines. Nuron’s vision is to bring biologics to market with enhanced product profiles to provide better health for patients. Nuron’s Founders and Management team members are veteran biotech executives who have made significant contributions at Pfizer and other biotechnology companies prior to their arrival at Nuron. Nuron is currently working on products in three disease areas; Central Nervous Systems (CNS), Wound Healing, and Vaccines. The company is currently in discussions with other biotechnology companies to expand their portfolio in the areas of specialty biotech and vaccines.

From drug and biologic development services to delivery technologies to supply solutions, Catalent Pharma Solutions has the deepest expertise, the broadest offerings, and the most unique technologies in the industry. With over 75 years of experience, Catalent helps customers get more molecules to market faster, enhance product performance, and provide superior, reliable manufacturing and packaging solutions.

Merck Serono & Domain Therapeutics to Develop Drugs for Parkinson’s Disease

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, recently announced an exclusive development and licensing agreement with Domain Therapeutics, Strasbourg, France, to develop metabotropic glutamate receptor 4 (mGluR4) Positive Allosteric Modulator (PAM) drugs targeting Parkinson’s disease and other neurodegenerative diseases. Domain Therapeutics will contribute optimized compounds that have been developed from their proprietary chemical series. Under the terms of the agreement, the company will receive EUR 2 million in up-front payment and research funding and is eligible for up to EUR 132 million in milestones for the first two products, as well as undisclosed royalties.

“We are pleased to have the opportunity to work with Domain Therapeutics, which has developed great expertise in the G-Protein Coupled Receptor area,” said Bernhard Kirschbaum, Executive Vice President for Global Research and Development at Merck Serono. “This partnership with Domain Therapeutics reflects our long-term commitment to develop new treatments for neurodegenerative diseases.”

“This agreement is a validation of Domain Therapeutics’ business model of addressing difficult GPCRs and partnering compounds, with a significant deal, at an early stage of development,” said Pascal Neuville, CEO, Domain Therapeutics. “Merck Serono is known to set very high standards for the compounds they are licensing, and this deal is a demonstration of the quality of our work. We anticipate that this agreement will enable us to sign further deals of this kind.”

mGluR4 is a glutamate receptor, member of the G-Protein Coupled Receptor (GPCR) family, and is believed to be a potential therapeutic target for Parkinson’s disease. Allosteric modulation of mGluR4 receptors is thought to exert regulatory activity on glutamate-mediated neurotransmission.

AndroScience Awarded NIH Grant to Develop Oral Treatment for Kennedy’s Disease

AndroScience Corp. recently announced receiving a $3.8-million, 3-year milestone-driven, cooperative translational research grant from the National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health (NIH). Through a joint research effort with the Neurogenetics Branch of the NINDS, ASC will use the funding to pursue development of an oral drug treatment for spinal and bulbar muscular atrophy (SBMA) or Kennedy’s Disease, a rare hereditary neurodegenerative disease, which currently has no approved drug available to patients.

Key pathological features of SBMA include progressive motor neuropathy and androgen insensitivity syndrome caused by a distinctive mutation within the androgen receptor (AR) gene. ASC has developed a unique platform of therapeutic small molecule drugs, which selectively and potently enhance degradation of the AR protein, termed AR degradation enhancers (ARD enhancers).

“Given encouraging preclinical results and the clear need for a new therapeutic option for SBMA patients, ASC is excited to continue advancing preclinical development of this promising novel drug candidate,” said ASC President Charles Shih, PhD. “The funding provided by the NINDS/NIH will significantly propel our efforts in validating ARD enhancers as a disease-modifying therapeutic intervention against such a rare and devastating neurodegenerative illness.”

This $3.8-million cooperative translational research grant will leverage expertise from the NINDS and draw upon ASC’s innovative approach to targeting the mutant androgen receptor. The goals of the grant will be to first validate an orally administered ARD enhancer drug is efficacious in the SBMA transgenic animal model, and further, to complete preclinical toxicology, safety pharmacology, and ADME studies necessary in supporting of an IND filing to commence human clinical studies. To date, ASC has provided robust proof-of-concept data using an ARD enhancer compound; demonstrating treatment ameliorates cardinal features of SBMA neuromuscular pathology, restores functional activity, and improves survival in a SBMA transgenic mouse model.

AndroScience is a privately held San Diego, CA-based pharmaceutical company applying expertise in natural product chemistry to develop proprietary small molecule drug compounds targeting disease-dependent intracellular signaling events related to the Androgen Receptor and selective Signal Transducer and Activation of Transcription (STAT) pathways. The company is focused on therapeutic indications of significant medical and commercial importance, including androgen-dependent diseases in both topical and systemic treatment settings and novel approaches to the treatment of cancer. Active ARD enhancer therapeutic programs include topical indications: acne (in Phase IIb clinical trail), alopecia (male pattern baldness), and wound healing; and systemic indications: SBMA, prostate cancer, HBV-induced HCC, and bladder cancer. Currently, the newly discovered STAT inhibitor compounds demonstrate potent anti-tumor properties across a wide range of solid and hematological tumors. ASC is actively seeking licensing partners for multiple products at various stages of program development with both domestic and international-based pharmaceutical companies.

Elestrin Estradiol Gel to be Launched in US With LABLABO’s Airless Metering Dispenser

Azur Pharma recently launched a new Hormonal Replacement Treatment (HRT) on the US market, Elestrin 0.06% Estradiol Gel. A close collaboration with this Irish lab allowed LABLABO to develop a high-performance airless pack using its latest technological advancements with the Airless Metering Dispenser, especially with the EasyFoil aluminium pouch that already won two international awards since its commercial launch: Alufoil Trophy 2009 and the Worldstar Award 2009 for Packaging Excellence.

Made of an aluminium and polyethylen multilayer foil, this new pouch ensures a maximum protection of the product inside against oxygen and UV rays. Its cylinder shape guarantees high restitution rates (up to 98% of the product delivered) and easy filling with basic equipment.

The metering pump delivers a constant and precise dose of 0.92 ml in a way that is necessary for this type of active ingredient. The sales package includes two 38-ml Sillage airless metering dispensers for a 2-month treatment.

This reference leads LABLABO to carry on its sales development strategy on the US market. It has dedicated regulatory support with Drug Master Files (DMFs) registered with the FDA for all of its products and a Quality Assurance organization suited to the pharmaceutical requirements of the Good Manufacturing Practices (GMPs) for which the company received the ISO 15378 certification in December 2010.

Depomed Announces US FDA Approval of Once-Daily Tablets for Post-Herpetic Neuralgia

Depomed, Inc. recently announced the US FDA has approved Gralise (gabapentin) Tablets for once-daily treatment of post-herpetic neuralgia (PHN), which is pain following healing of the rash associated with shingles. Gralise was developed by Depomed under the code name DM-1796 and is licensed to Abbott Products, Inc. in the US, Canada, and Mexico. The approval of Gralise triggers a milestone payment of $48 million from Abbott to Depomed.

“The approval of Gralise is a major step toward achieving our key strategic objective of sustainable profitability in 2011 and beyond,” said Carl Pelzel, President and CEO of Depomed. “I’d like to thank everyone on the Depomed and Abbott teams involved in the development and approval of this important therapy for their hard work and dedication.”

“We are delighted with the approval of Gralise, which marks the third FDA approval of a product developed by Depomed,” added Michael Sweeney, MD, Vice President of Research and Development for Depomed. “Furthermore, the FDA has granted Gralise Orphan Drug status, recognizing it as an important treatment option for patients who suffer from the pain of PHN. We are also very pleased with the product label FDA has approved.”

“The Gralise formulation of gabapentin allows for once-a-day dosing and a tolerability profile that will be a positive addition to physicians’ treatment armamentarium,” said Gordon Irving, MD, Medical Director of the Swedish Pain and Headache Center, Clinical Associate Professor, University of Washington Medical School in Seattle, Washington. “Patients with PHN have long struggled to manage pain following herpes zoster infection. Current therapies require dosing multiple times per day and come with a high incidence of troubling side effects.”

Depomed entered into a license agreement for Gralise (DM-1796) with Solvay Pharmaceuticals in November 2008. Abbott Products assumed the license agreement, and Solvay’s obligations under it as a result of the acquisition of Solvay’s pharmaceutical business by Abbott Laboratories, which was completed in February 2010. In addition to the $48 million milestone payment for approval of Gralise, the license agreement calls for royalties of 14% to 20% on product sales, and sales milestone payments of up to $300 million.

Depomed announced this January that the company had initiated mediation with Abbott Laboratories, the parent company of Abbott Products, regarding Abbott’s commercialization obligations under the license agreement.

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