6/27/2012
Hovione Reports Significant Sales Growth
Hovione recently announced that the consolidated sales for the fiscal year ended March 2012 amounted to $180 million, the sixth consecutive year of sales growth, representing a growth of 24% in relation to last year.
“Another year of continued strong performance by the Hovione group. During the last 5 years, Hovione has doubled its sales and has made bold strategic steps to both strengthen its ability to serve innovators and to consolidate its leadership in off-patent contrast agents. Looking forward, and despite the difficult economic environment, we remain confident that 2012 will be another year of solid growth,” said Miguel Calado, Chief Financial Officer.
In addition to the financial results, which reflect the quality of the Team’s performance, overall, 2011 represented a year of great achievements, namely Hovione stood behind three NDA approvals (these were all major NMEs) and in two cases, the approvals were full QbD filings in which Hovione was central to the design and data generation.
All Hovione plants underwent several successful GMP inspections by one or more of the major Medicines’ Agencies – a reflection of the large flow of filings and the high standards of compliance.
“Getting multiple NDA approvals every year is becoming a habit at Hovione, which reflects well both on our customers, on our team, and on the CMO model. Our patient investment in capacity, new technologies, and development methodologies is paying off.” said Guy Villax, Chief Executive Officer.
Hovione is a global company with over 50 years’ experience in Active Pharmaceutical Ingredient and Intermediate Drug Product development and compliant manufacture. With four FDA-inspected sites in the
For more information, contact Marketing & Communications, Isabel Pina, at 351 21 982 9362, email ipina@hovione.com, or visit www.hovione.com.
Catalent & Bend Research Form Strategic Partnership
Catalent Pharma Solutions, Inc. and Bend Research Inc. recently announced they have entered into an agreement to provide integrated solutions for pharmaceutical companies seeking to develop and manufacture specialized multiparticulate oral controlled-release products.
Under the agreement, Bend Research and Catalent will provide an integrated approach to bring complex controlled-release products to market faster and more efficiently with optimal therapeutic and release profiles.
The companies’ combined expertise in formulation development and Catalent’s breadth of services in analytical/CMC, solid-state optimization, clinical and commercial supply will provide pharmaceutical companies with optimal dosage forms and a more efficient path to market. Catalent and Bend Research are developing joint operations and technology-transfer protocols to make the customer experience seamless and efficient while leveraging the strengths of both companies to develop better treatments for patients globally.
“Our integrated approach is geared toward complex, multiparticulate controlled-release products, which traditionally have presented a high scale-up risk when they are transferred to commercial manufacturing sites,” said Rod Ray, CEO of Bend Research. “This partnership with Catalent will provide an efficient pathway for these medicines from early development through commercialization. We believe that Catalent’s breadth of services and demonstrated success in bringing controlled-release products to market, as well as supplying them globally, makes them an ideal complement to our development strengths.”
“Catalent and
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. For more information, visit www.catalent.com.
For more than 35 years, Bend Research has worked with clients to create value by advancing new medicines that improve human health and to solve their most difficult scientific and technical problems. This success is based on the company’s ability to develop, advance, and commercialize pharmaceutical technologies, which grow from a solid base of scientific and engineering fundamental understanding. Bend Research provides several capabilities, including formulation and dosage-form support, assists in process development and optimization, manufactures clinical-trial quantities of drug candidates in its cGMP facilities, and advances promising drug candidates from conception through commercialization. For more information, visit www.bendresearch.com.
AmDerma & Oculus Enter Multi-Country Agreement
AmDerma Pharmaceuticals, LLC, a privately owned company (and parent company of Quinnova Pharmaceuticals, Inc.) and Oculus Innovative Sciences recently announced the execution of an agreement to develop and commercialize Oculus’ novel proprietary Microcyn Technology drug compounds for major dermatological conditions, including acne. The exclusive agreement includes licensing of the dermatology compounds in the
Under the terms of the agreement, Oculus received an undisclosed upfront payment, and will receive multiple clinically based payments upon achievement of several development and regulatory milestones for both acne and secondary indications, as well as future escalating double-digit royalties on net sales of products. The agreement also memorializes the intent for future joint development of additional dermatological products and indications.
“This agreement reflects the AmDerma/Quinnova commitment to the future of dermatology. Microcyn compounds have the potential to bring about significant advancement in the treatment of skin diseases, which affect millions of patients, without adding to the growing problem of antibiotic resistance or steroid overuse,” said Jeffrey Day, Quinnova President. “Our dermatology customers have been pleased with improved patient outcomes as a result of adopting the Microcyn-based compounds for treatment of atopic dermatitis and related skin diseases. We look to build upon this success by growing the family of Microcyn-based dermatology compounds for myriad skin afflictions.”
AmDerma will be responsible for the development costs for the acne formulation as well as other dermatological compounds.
“Oculus is thrilled to expand the scope of our existing partnership with Quinnova and its parent company, AmDerma. Quinnova is doing an exceptional job with the commercial launch of the Atrapro product, and we are confident they are the right partner to commercialize this technology in acne and other dermatological indications,” said Hoji Alimi, Founder and President of Oculus.
AmDerma Pharmaceuticals is a privately held company engaged in the development of pharmaceutical products with dermatological indications. Quinnova Pharmaceuticals, Inc., a wholly owned subsidiary of AmDerma Pharmaceuticals, is a specialty pharmaceutical company founded on innovative, patent-protected dermal delivery technologies. For more information, visit www.quinnova.com.
Oculus Innovative Sciences is a commercial healthcare company that designs, produces, and markets innovative, safe, and effective healthcare products. Oculus is pioneering innovative solutions in multiple markets, including dermatology, oral care, surgical, wound care, animal healthcare and others, and has commercialized products in the
Ambrx & Merck to Design & Develop Biologic Drug Conjugates
Ambrx recently announced the company has entered into a collaboration with Merck to design and develop rationally optimized biologic drug conjugates based on Ambrx’s site-specific protein medicinal chemistry technology.
“Ambrx’s technology has the potential to provide the foundation for a new family of biologic drug conjugates that selectively deliver small molecules to their site of action,” said Peter G. Schultz, PhD, a scientific founder and board member. “Merck’s deep disease area expertise made it the partner of choice in expanding the application of this technology beyond oncology to other important disease areas.”
Under the terms of the agreement, Merck gains worldwide rights to develop and commercialize biotherapeutic drug conjugates directed toward a number of pre-specified targets. Ambrx will receive an upfront payment of $15 million and is eligible to receive milestone payments totaling up to $288 million for successful discovery, development, and commercialization of candidates to all pre-specified targets. In addition, Ambrx will receive royalties on any net sales of products resulting from the collaboration.
“Collaborations are an important part of our strategy to develop a portfolio of next-generation protein therapeutics that may offer significant benefits to patients,” said Richard Murray, PhD, Senior Vice President and Head of Biologics and Vaccines Research at Merck. “This agreement will allow us to combine Ambrx’s expertise in site-specific protein conjugation chemistry with Merck’s expanding antibody capabilities and extensive small molecule resources.”
By combining the targeting properties of biologics with the potent therapeutic properties of small molecules, Merck and Ambrx plan to design and optimize new ways to specifically deliver pharmacologically active compounds to their site of action while minimizing the potential for systemic effects.
Ambrx Inc. is a clinical-stage biopharmaceutical company using an expanded genetic code to create best-in-class biotherapeutics, including antibody drug conjugates and proteins with improved pharmacologic properties. The company is developing ARX201, a long-acting growth hormone that has successfully completed Phase IIb clinical trials. For more information, visit www.ambrx.com.
MicroDose Therapeutx & Moerae Matrix Announce Collaboration
MicroDose Therapeutx, Inc. and Moerae Matrix, Inc. recently announced they have signed a collaboration agreement to develop a dry powder inhalation product of Moerae’s novel MK2 inhibitor, MMI-0100, for the treatment of idiopathic pulmonary fibrosis (IPF), a serious and fatal lung disease for which there are no approved treatments in the US. The collaboration will involve the development and supply of a pulmonary drug delivery system for Moerae and/or its partners utilizing MicroDose’s proprietary inhaler technology in support of chronic administration.
“We are pleased to be partnering with a recognized industry leader in pulmonary drug delivery to advance development of MMI-0100 for IPF,” said Cynthia Lander, PhD, Chairman and Chief Executive Officer of Moerae Matrix. “MicroDose’s piezo-driven dry powder inhaler platform is the optimal technology for delivering our first-in-class peptide therapeutic for treatment of IPF.”
“Moerae has assembled an impressive team to advance this promising treatment approach for this debilitating disease, and we are pleased to be able to contribute to its advancement,” added Scott Fleming, Senior Vice President, Sales and Marketing for MicroDose. “This collaboration in IPF expands the utilization of MicroDose’s inhalation technology into yet another extremely important disease area.”
MMI-0100 is a selective inhibitor of MAPKAP kinase 2 (MK2), a key terminal kinase in the transforming growth factor beta (TGF-beta)/p38 signaling pathway. By targeting a terminal kinase, MMI-0100 has the potential for greater specificity of action and lower off-target toxicity than other anti-fibrotic agents that address targets higher in this important pathway.
“IPF represents an enormous unmet medical need and delivering a drug directly to the lung that inhibits a down-stream kinase in the TGF-beta/p38 pathway is extremely appealing. It is very likely that multiple drugs that interfere with different components of fibrosis will be needed to combat IPF and MK2 inhibition is a novel and exciting target for drug development in this devastating disease,” said Paul W. Noble, MD, Professor of Medicine and Chief, Division of Pulmonary, Allergy and Critical Care Medicine,
“Developing therapeutics for local delivery is a very desirable approach for the treatment of lung diseases in general, and IPF in particular. Doing so should minimize the risk of systemic effects while targeting a kinase now known to be involved in fibrogenesis. Accordingly, this is an attractive approach for treating such a lethal disease,” explained David S. Wilkes, MD, Executive Associate Dean for Research Affairs, August M. Watanabe Professor for Medical Research,
Development of MMI-0100 for treatment of IPF is being funded in part with federal support from the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH) in the Department of Health and Human Services (DHHS), under the Science Moving TowArds Research Translation and Therapy (SMARTT) program (NHLBI Contract No. HHSN268201100017C).
Idiopathic pulmonary fibrosis (IPF) is a progressive, fatal lung disease in which fibrous tissue replaces the alveolar sacs through which we breathe. Over time, scarring of lung tissue causes progressive loss of the ability to breathe effectively, with 70% chance of death occurring within 5 years. There are no approved drug treatments for IPF in the
MMI-0100 is in preclinical development for treatment of idiopathic pulmonary fibrosis and other fibrotic conditions. In the bleomycin mouse model, the industry standard for study of pulmonary fibrosis, MMI-0100 has demonstrated a therapeutic benefit by abrogating collagen deposition when dosed after the onset of fibrosis. MMI-0100’s anti-fibrotic activity has consistently been demonstrated in multiple models of fibrotic conditions, including pulmonary fibrosis, vascular intimal hyperplasia, and post-surgical adhesions. Across model systems, MMI-0100 demonstrates excellent in vivo potency.
The company has compiled a full IND-enabling data package on MMI-0100; the compound also demonstrates a favorable toxicology profile and highly scalable manufacturing process.
Moerae Matrix is a privately held biopharmaceutical company focused on the development of first-in-class targeted therapeutics for fibrotic disease. For more information, visit www.moeraematrix.com.
MicroDose Therapeutx is a private pharmaceutical company dedicated to improving the quality of life for people suffering from serious diseases. The company focuses on developing proprietary pulmonary and oral products that address large unmet market opportunities, and on dry powder inhalation, and combination oral dosage delivery platforms. For more information, visit www.mdtx.com.
Idenix Announces Positive Clinical Data
Idenix Pharmaceuticals, Inc. recently announced results from an ongoing Phase IIb study of IDX184 in combination with pegylated interferon and ribavirin (PegIFN/RBV). Of the first cohort of 31 patients enrolled in the study, those who achieved an eRVR (n=18), defined as having undetectable levels of virus at 4 weeks and 12 weeks, were randomized to stop treatment after either an additional 12 weeks (n=9) or 36 weeks (n=9) of PegIFN/RBV. Of the 9 patients who completed their 12-week PegIFN/RBV extended treatment phase, 100% of patients (4/4) in the 100-mg arm and 80% of patients (4/5) in the 50-mg arm achieved a sustained virologic response 4 weeks after the completion of treatment (SVR4).
Patients who did not achieve an eRVR automatically entered the 36-week PegIFN/RBV extended treatment phase, which is ongoing. To date, the side effect profile of IDX184 combined with PegIFN/RBV is consistent with that of PegIFN/RBV alone.
“We are encouraged by the initial SVR results from the Phase IIb program, which have confirmed previous data showing that IDX184 is a potent nucleotide inhibitor with a profile supporting its potential role as a key component of all-oral direct-acting antiviral (DAA) combination regimens for HCV,” said Ron Renaud, President and Chief Executive Officer of Idenix. “We look forward to initiating interferon-free DAA combination studies in the near term.”
In July 2011, the company initiated enrollment of treatment-naive genotype 1 HCV-infected patients into a randomized, double-blind, parallel group Phase IIb clinical trial of IDX184. The study features two treatment arms, either 50 mg or 100 mg of IDX184 administered once-daily for 12 weeks, each arm in combination with PegIFN/RBV. Response-guided therapy was used to complete an additional 12 or 36 weeks of PegIFN/RBV treatment. Study objectives include safety and tolerability, and antiviral activity endpoints.
Idenix also announced positive data from a 3-day proof-of-concept study evaluating IDX719, an NS5A inhibitor, in 64 treatment-naïve, genotype 1, 2, 3, or 4 HCV-infected patients.
Genotype 1 patients were randomized to receive placebo, 25-mg QD (once-daily), 50-mg QD, 50-mg BID (twice-daily), or 100-mg QD for 3 days. Genotype 2, 3, or 4 patients were randomized to receive placebo, 50-mg BID or 100-mg QD for 3 days.
IDX719 was well tolerated with no serious adverse events reported. Treatment with IDX719 exhibited potent pan-genotypic activity across genotypes. More detailed findings are expected to be presented at a scientific meeting in the second half of 2012.
“We are pleased to demonstrate the first clinical validation of IDX719 in patients in a multiple-dose study with robust activity across multiple HCV genotypes,” said Douglas Mayers, MD, Chief Medical Officer of Idenix. “Given these promising findings, we look forward to initiating a Phase II combination study of IDX719 with IDX184 by the end of this year.”
IDX184 is an unpartnered, novel, liver-targeted nucleotide prodrug of 2′-methyl guanosine, which includes Idenix’s proprietary liver-targeting technology. This technology enables the delivery of nucleoside monophosphate to the liver, leading to the formation of high levels of nucleoside triphosphate, potentially maximizing drug efficacy and limiting systemic side effects with low, once-daily dosing. In the ongoing Phase IIb clinical trial, IDX184 has been well tolerated with a side effect profile similar to that of PegIFN/RBV. In the first cohort of 31 patients, at 12 weeks in an intent-to-treat analysis, the complete early virologic response (< 25 IU/mL at 12 weeks) was 93% for the 100-mg IDX184 arm (n=15) and 81% for the 50-mg IDX184 arm (n=16) of the study. The company completed enrollment of a second cohort of 36 additional patients this past May.
IDX719 is an NS5A inhibitor with low picomolar, pan-genotypic antiviral activity in vitro. In 36 healthy volunteers, IDX719 was safe and well tolerated at single doses of 5 to 100 mg as well as multiple doses of 100 mg for 7 days. Single doses of IDX719 demonstrated potent pan-genotypic antiviral activity in 18 genotype 1, 2, or 3 HCV-infected patients, with greater than 3 log10 viral load reductions achieved in the 100-mg dose arm.
Idenix Pharmaceuticals, Inc., headquartered in
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