2/21/2012
Catalent Pharma Solutions & NewMarket Sign Development Agreement
Catalent Pharma Solutions and NewMarket Pharmaceuticals LLC recently announced they have entered into an agreement to jointly formulate and develop a portfolio of products for treating production and companion animals using Catalent’s proprietary, market-leading Zydis fast-dissolve technology and NewMarket’s DSI platform (Direct Systemic Introduction, patent pending).
NewMarket Pharmaceuticals is currently developing five drugs that will combine Catalent’s Zydis fast-dissolve and their own DSI technologies, initially including NSAIDs, beta agonists, proton pump inhibitors, and behavior modifiers across a variety of species, including horses, dogs, and cattle, with plans to expand the range in other classes. These new animal health products are expected to provide significant advantages over existing formulations currently used across a spectrum of indications for companion animals, equine, and production animals.
“These easy-to-use formulations could revolutionize the way we treat animals by providing for a simple, efficient, accurate method of treatment without the use of needles,” said Mark Ridall, CEO of NewMarket Pharmaceuticals.
“This partnership with NewMarket Pharmaceuticals demonstrates not only our commitment to provide more products and better treatments to our customers, but also signifies the versatile benefits that our Zydis fast-dissolve technology continues to deliver,” added Paul Jenkins, Global VP of Catalent’s ODT business.
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.
NewMarket Pharmaceuticals was founded with the purpose of modernizing drug delivery systems for the treatment of animals. The company has identified a means by which established drugs that have proven safety and efficacy profiles, but exist in outdated or inefficient delivery systems, can be reformulated and administered to animals in a faster, safer, easier, and more accurate manner that has the potential to significantly expand the market for these drugs.
IntelGenx Announces License Agreement With Edgemont Pharmaceuticals
IntelGenx Corp. recently announced it has entered into an exclusive agreement with Edgemont Pharmaceuticals, LLC for the commercialization of IntelGenx’s lead product CPI-300 in US. Under the terms of the agreement, Edgemont has obtained certain exclusive rights to market and sell CPI-300 in the
“We are very pleased that Edgemont, a company focused on neurosciences, will be marketing our lead product. A new private company with experienced marketing executives in the psychiatry and neurology space, we strongly believe Edgemont will be able to devote their time and expertise to ensure this product will have a successful launch. We are confident Edgemont is the ideal company to realize the full potential of CPI-300 and establish it as a successful new brand in the
“We are extremely pleased to have been selected as the company to launch CPI-300 in the
CPI-300 is a novel, high-mg strength formulation of bupropion HCl, the active ingredient in Wellbutrin XL. When launched, CPI-300 will provide high-dose bupropion XL patients the opportunity to achieve their mg dose in a single pill versus the multiple pills they currently need to take. Reducing the number of pills per dose is a well-published and important clinical benefit.
IntelGenx is a drug delivery company focused on the development of oral controlled-release products as well as novel rapidly disintegrating delivery systems. IntelGenx uses its unique multiple layer delivery system to provide zero-order release of active drugs in the gastrointestinal tract. IntelGenx has also developed novel delivery technologies for the rapid delivery of pharmaceutically active substances in the oral cavity based on its experience with rapidly disintegrating films. IntelGenx’s research and development pipeline includes products for the treatment of severe depression, hypertension, erectile dysfunction, benign prostatic hyperplasia, migraine, insomnia, bipolar disorder, idiopathic pulmonary fibrosis, allergies, and pain management.
Edgemont Pharmaceuticals, LLC is a privately held pharmaceutical company with a primary focus and expertise in the field of neuroscience. Edgemont is committed to the development of novel drug formulations and new therapies that can improve patient care.
Malvern & Postnova to Deliver Solution for Characterizing Challenging Particulate Systems
Malvern Instruments and Postnova Analytics recently announced they are co-operating to deliver the combined FFF (Field-Flow Fractionation) and DLS (Dynamic Light Scattering) solutions that today provide critical insight when characterizing a number of challenging particulate systems. Such systems include complex, aggregated, surface-coated, and heterogeneous particles, as well as larger polymers, and aggregated, cross-linked, nano-particles and fibrillated proteins.
Used together, Malvern’s Zetasizer Nano and Postnova’s FFF systems provide information not accessible by other means, and are highly complementary to Malvern’s Viscotek gel permeation chromatography/size exclusion chromatography (GPC/SEC) range.
FFF enables the separation of particles that are too large for analysis by GPC/SEC, and the addition of the Zetasizer Nano as a DLS detector allows the subsequent measurement of absolute particle size. In comparison with batch measurements of DLS using the Zetasizer Nano alone, the addition of FFF considerably increases the resolving power of DLS, extending the range of applications for which it can provide highly detailed information.
“I am very pleased this exclusive co-operation with Postnova means that customers of both our companies will be able to access these powerful analytical techniques, secure in the knowledge that they are backed by the excellent technical and applications support provided by both Postnova and Malvern,” said Paul Clarke, Product Group Manager at Malvern Instruments.
Postnova Analytics is the global market leader and inventor of FFF developing instruments since the 1980s. Its solutions are setting the standards in the environmental, nanotech, polymer, and biotech markets and are ideally suited for high resolution separation, fractionation, and characterization of proteins, biopolymers and nanoparticles. Postnova is the sole supplier of completely integrated FFF Light-Scattering solutions, including award winning Instruments, such as Thermal FFF, Centrifugal FFF, and Flow FFF coupled with Dynamic Light Scattering (DLS).
Malvern Instruments is a market leader in measuring performance-controlling material properties. These include particle size, particle shape, zeta potential, molecular weight, size and conformation, rheological properties, and chemical identification. Malvern delivers the systems, support, and expertise that ensure the analytical integrity and productivity needed to drive research, development, and manufacturing.
DARA BioSciences Signs Exclusive Agreement With Uman Pharma
DARA BioSciences, Inc. recently announced it entered into an exclusive US agreement with Uman Pharma Inc. for commercial rights to gemcitabine, DARA’s second newly licensed anticancer agent. In 2010, gemcitabine generated branded (GEMZAR-Eli Lilly) sales of $780 million, according to IMS data. It went off patent in 2011 in the
“The exclusive agreement with Uman Pharma for rights to commercialize this chemotherapeutic drug in the US leverages DARA’s existing cancer drug development program, provides DARA with an additional commercial opportunity, and further establishes a platform for adding other cancer and cancer-support products through ongoing licensing efforts We believe there is considerable upside potential in the generic, sterile injectable cytotoxic therapies market,” said David J. Drutz, MD, DARA’s President and CEO.
Last month, DARA acquired exclusive US rights to market Soltamox (licensed from Rosemont Pharmaceuticals Ltd.), the only oral liquid formulation of tamoxifen for breast cancer patients who have difficulty swallowing tablet formulations or simply prefer a liquid form of the widely prescribed hormone blocking therapy. DARA is targeting strategic oncology therapies and supportive care products as part of its strategic direction in the cancer market.
By partnering with Uman, a fully integrated pharmaceutical company, DARA has aligned itself with a company that has the expertise and capability to provide cGMP-produced products for worldwide markets. DARA and Uman are working to identify future partnership opportunities for additional sterile injectable products in the oncology market. Uman plans to file an ANDA for gemcitabine with the US FDA later this year.
Uman Pharma is a global pharmaceutical company based in Candiac, on the south
DARA is a specialty pharmaceutical company focused on the development and commercialization of oncology treatment and supportive care products. DARA sharpened its focus in oncology through its January 2012 acquisition of Oncogenerix, Inc., which holds the exclusive
Curis & Debiopharm Announce Initiation of Phase Ib Expansion Study
Curis, Inc. and Debiopharm Group recently announced that Debiopharm has begun treating patients in a Phase Ib clinical trial of Heat Shock Protein 90 (HSP90) inhibitor Debio 0932. Debiopharm recently successfully completed a Phase Ia dose escalation study with Debio 0932 and has indicated that it expects to initiate a combination Phase I/II study in non-small cell lung cancer patients in the second quarter of 2012.
“Our team has been very pleased with the development of Debio 0932, which has become an important molecule in Debiopharm’s pipeline,” said Rolland-Yves Mauvernay, President and Founder of Debiopharm Group. “We believe HSP90 represents an important molecular target in cancer therapy, and we are eager to advance this molecule in the Phase Ib clinical trial, as well in our planned Phase I/II studies, which we hope will yield important new data for the further development of Debio 0932.”
“We have been highly impressed with the depth of Debiopharm’s development expertise and commitment to furthering Debio 0932 into additional clinical studies in 2012,” added Dan Passeri, Curis President and CEO. “Importantly, we continue to be very pleased with the clinical results that have been observed to-date, and we look forward to reporting further progress on this molecule in the future.”
Debiopharm initiated a Phase I clinical trial in April 2010 that was designed to evaluate the maximum tolerated dose and safety of Debio 0932. The first part of the study (Phase Ia), an open-label, multi-center dose escalation trial evaluating the safety and tolerability of escalating multiple dose levels of Debio 0932 given daily or every other day as a single agent by oral administration in patients suffering from advanced solid tumors, was recently completed.
Debio 0932 was generally well tolerated, with no evidence of ocular or liver toxicity, and showed promising signs of efficacy in patients with advanced solid tumors. The recommended dose, established at 1000 mg every day, will be tested in additional patients during the expansion phase (Phase Ib) of the ongoing Phase I study.
Debiopharm expects to treat approximately 30 patients as part of the Phase Ib expansion study. The objectives of this study will be to further assess the safety profile, pharmacokinetics, and pharmacodynamics of Debio 0932 at the recommended dose level and regimen, and to further assess anti-tumor activity in patients with advanced solid tumors, including patients with non-small cell lung cancer.
Debio 0932 is a novel heat shock protein 90 (HSP90) inhibitor with strong affinity for HSP90 alpha/beta, high oral bioavailability, and potent anti-proliferative activity against a broad range of cancer cell lines (with a mean IC50 of 220 nmol/L), including many non-small cell lung cancer (NSCLC) cell lines that are resistant to standard-of-care agents. Debio 0932 potently inhibits tumor growth in subcutaneous xenograft models of a number of solid and hematological malignancies, including models of NSCLC, which harbor mutations conferring acquired or primary erlotinib resistance. Furthermore, Debio 0932 is able to extend animal survival in models of brain metastasis due to its ability to cross the blood-brain barrier, and it enhances the activity of several standard-of-care agents in animal models of cancer.
Debiopharm Group is a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs. The group in-licenses, develops, and/or co-develops promising biological and small molecule drug candidates having reached clinical development Phases I, II, or III, as well as earlier stage candidates.
Curis is a drug development company committed to leveraging its innovative signaling pathway drug technologies to seek to create new targeted small molecule drug candidates for cancer. Curis is building upon its previous experiences in targeting signaling pathways, including the Hedgehog pathway, in its effort to develop proprietary targeted cancer programs.
Sandoz Buys Rights to Apricus Biosciences’ Drug for $28 Million
Apricus Biosciences, Inc. recently announced its wholly owned subsidiary NexMed, Inc. has signed with Sandoz, a division of Novartis, an exclusive collaboration for
“We are very excited about this major European collaboration with such an important international pharmaceutical company as Sandoz,” said Bassam Damaj, Chairman, President, and CEO of Apricus Bio commented. “We are happy to work again with Novartis through their division Sandoz, and we look forward to expanding the reach of our Vitaros product for erectile dysfunction in
The ED market in
Second, Vitaros operates by a different biochemical mechanism than oral ED medications and causes erections to occur in a more localized fashion and more quickly when compared to oral treatments. Vitaros contains a previously known compound, with the chemical name alprostadil. When absorbed through the skin, alprostadil, a vasodilator, directly boosts blood flow, thereby causing an erection. Clinical studies have shown that Vitaros works on average in approximately 15 minutes, compared to a reported onset time of 30 minutes or more for oral medications indicated for the treatment of ED. The side effects reported were localized and transient.
Alprostadil is currently marketed as an injectable drug. Apricus Bio incorporated alprostadil with its NexACT delivery technology, resulting in a rapid and efficient topical delivery of the drug into the penis. In clinical studies, Vitaros worked in patients suffering from mild-to-severe ED, including men who did not respond to Viagra.
Apricus Bio is a San Diego-based, revenue-generating, specialty pharmaceutical company, with commercial products and a broad pipeline across numerous therapeutic classes. Revenues and growth are driven from the sales of the company’s commercial products through its Apricus Pharmaceuticals USA, Inc. and NexMed (USA), Inc. subsidiaries and through out-licensing in certain territories of its product pipeline and NexACT technology.
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