QRxPharma Completes Patient Enrolment of Phase III Comparative Safety Study

QRxPharma Limited recently announced it has completed patient enrolment for Study 022, a Phase III trial comparing the tolerability and safety profile of MoxDuo IR to equi-analgesic doses of either morphine or oxycodone alone. Specifically, the study evaluated the incidence of opioid-related adverse events, including changes in respiratory function, moderate-to-severe nausea, vomiting, and dizziness, in patients with moderate-to-severe postoperative pain following bunionectomy surgery. The trial enrolled 375 patients (n = 125 per treatment group) at 5 US clinical research sites. QRxPharma expects to release top-line data in June.

“This Phase III trial represents a major milestone as it is the first comparison of MoxDuo IR (12 mg/8 mg) to equi-analgesic doses of morphine and oxycodone,” said Dr. John Holaday, Managing Director and CEO, QRxPharma. “With patient enrolment complete, we are optimistic that the pending results will confirm the significant tolerability and safety advantages of MoxDuo IR over these two widely prescribed opioids.”

A prior comparator study in patients experiencing acute postoperative bunionectomy pain demonstrated the potential side effect and safety benefits of MoxDuo IR (6 mg/4 mg) when compared to equi-analgesic doses of morphine (12 mg) or oxycodone (8 mg). Specifically, the occurrence rate of moderate-to-severe adverse events, including nausea, vomiting, and dizziness was reduced by 50% to 75% in MoxDuo IR-treated subjects compared to patients receiving morphine or oxycodone alone at the same 12-mg MED (morphine equivalent dose).

This Phase III study was similarly designed, but compared MoxDuo IR (12 mg/8 mg – 24 mg MED) with equi-analgesic doses of morphine (24 mg) and oxycodone (16 mg). By design, approximately 40% of the enrolled subjects were age 60 years or older, thus providing ample evaluation of the tolerability of the three treatments in this age group.

Trial results will form part of QRxPharma’s European Marketing Authorisation Application (MAA) scheduled for submission in the first quarter of 2012. Study results, when published in medical literature, may, in conjunction with other trial data, be a component of the promotional package following the projected commercial launch of MoxDuo IR in the US in 2012 and in Europe in 2013.

Based on QRxPharma’s recent pre-New Drug Application meeting with the US FDA, the company believes it is on track to file an NDA for MoxDuo IR in mid-2011. MoxDuo is a patented 3:2 ratio fixed dose combination of morphine and oxycodone. Immediate-release MoxDuo targets the acute pain market, a $2.5 billion segment of the $7 billion spent annually on prescription opioids in the US.

QRxPharma Limited is a clinical-stage specialty pharmaceutical company focused on the development and commercialization of new treatments for pain management and CNS disorders. Based on a development strategy that focuses on enhancing and expanding the clinical utility of currently marketed compounds, the company’s product portfolio includes both late- and early stage clinical drug candidates with the potential for reduced risk, abbreviated development paths, and improved patient outcomes. The company intends to co-promote its products in the US and seeks strategic partnerships for worldwide markets.

Avantor Performance Materials to Acquire POCH S.A.

Avantor Performance Materials announced a definitive agreement to acquire POCH S.A. from Kulczyk. Completion of the sale is dependent upon obtaining the necessary clearance from the Polish competition authority, and is subject to customary closing conditions. Terms of the deal were not disclosed.

Avantor Performance Materials, formerly Mallinckrodt Baker, manufactures and markets high-performance chemistries and materials around the world under several well- respected brand names, including the J.T.Baker®, MacronTM, Rankem,V and DiagnovaTM brands. Avantor products are used in a wide range of industries, including biotechnology and pharmaceutical production; electronics and photovoltaic manufacturing; and in research, academic and quality control laboratories. The company is owned by an affiliate of private equity firm New Mountain Capital.

Based in Poland, POCH S.A. manufactures products designed for use in classic and instrumental analysis, filtration, and microbiology. POCH S.A. also sells laboratory equipment and laboratory glass. Moreover, POCH S.A. also manufactures solvents for liquid and gas chromatography and spectroscopy as well as anhydrous solvents. Its markets include pharmaceuticals; food and feed; chemical and petrochemical; environmental protection and research; and analytical chemistry.

“The transaction is part of Avantor’s strategy to strengthen its presence in the global market by growing both organically and through acquisition, expanding into new markets and geographies,” said Avantor President and Chief Executive Officer Jean-Marc Gilson. “POCH fits this strategy because of its established and expansive manufacturing presence and distribution channel in Poland and Eastern Europe.”

“This acquisition will allow for synergies in market and production know-how and enrichment of the combined product portfolio, significantly increasing the level of expertise dedicated to various industry sectors,” said POCH S.A. Chief Executive Officer Jaroslaw Bieszczad. “It will also enhance the competitive standing of POCH, enabling us to offer the high-quality Avantor product lines to our customers, while also giving us new markets for our products through the global Avantor organization.”

MicroDose Therapeutx Announces Development Milestone Triggering Payment Under Respiratory Collaboration

MicroDose Therapeutx, Inc. recently announced that a development milestone in its collaboration with Novartis has been achieved, triggering a payment under the multi-product development and licensing agreement for the MicroDose proprietary dry powder inhaler (DPI). This milestone signals the successful incorporation of MicroDose’s DPI technology into a Novartis platform pulmonary device.

As previously announced, under the terms of the agreement, Novartis is funding development and commercialization of products that employ MicroDose’s DPI technology for the administration of Novartis’ proprietary respiratory compounds. In addition to the up-front payment received, MicroDose is eligible for additional milestone payments and royalties on product sales.

“MicroDose is pleased to announce the achievement of this milestone,” said David Byron, Vice President of Research and Development, MicroDose. “The collaboration with Novartis has yielded a platform embodiment of MicroDose’s DPI technology for Novartis to use in advancing development of a number of their proprietary respiratory pipeline products.”

The MicroDose DPI is among a number of key proprietary drug delivery platforms developed by MicroDose. By employing piezo electronics, the MicroDose DPI has the potential to deliver enhanced performance versus other inhalers, for efficient and reproducible delivery independent of patient coordination, inhalation rate, and posture. MicroDose believes that the flexibility of the inhaler makes it a true platform technology, able to support a broad pipeline of products across the spectrum of patient populations and therapeutic categories.

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 products that address large unmet market opportunities, and on pulmonary and oral drug delivery platforms. The company develops its products and technologies independently as well as in partnership with leading pharmaceutical companies. MicroDose’s current pipeline targets respiratory diseases, such as asthma, COPD, and respiratory syncytial virus (RSV), as well as IBS-C and constipation.

Novozymes Biopharma Collaborates With University to Tailor the Half-Lives of Proteins

Novozymes Biopharma, part of Novozymes A/S, a world leader in bioinnovation, recently unveiled its enhanced next-generation albumin technology, which was developed in collaboration with the University of Oslo, Norway, one of the world’s leading institutions in the research of albumin variants and the neonatal Fc receptor (FcRn).

Built on Novozymes’ original Albufuse platform, the proprietary Albufuse Flex technology has been designed to enable users to adapt and control the pharmacokinetics of their target protein or peptide with retained efficacy, ensuring flexibility and optimal use.

“Novozymes Biopharma is thrilled to introduce Albufuse Flex to the industry,” said Dave Mead, Business Development Director at Novozymes Biopharma. “Albumin is a natural and benign carrier molecule, and by having the unique ability to decrease or increase its half-life it will help our customers to develop novel drugs with improved pharmacokinetic properties for a wide range of applications.”

It has been shown that by manipulating the interaction of albumin and IgGs with FcRn it is possible to tailor their half-lives. The Albufuse Flex technology has been developed to facilitate manipulation based on this FcRn-albumin interaction, enabling a tunable half-life that offers control and flexibility and that, potentially, may improve overall treatment efficacy and patient compliance. In addition to protein- or peptide-based drugs, the enhanced technology also provides a delivery vehicle for small molecules, providing a broad scope of usability.

The enhanced half-life technology has been developed by Novozymes in collaboration with scientists at the University of Oslo. The innovative research developed by the university into the interaction between albumin variants and the neonatal Fc receptor (FcRn) was fundamental in the development of Albufuse Flex.

“The efficacy of peptides, small proteins, and engineered antibody fragments is hampered by short serum half-life,” explained Professor Inger Sandlie, Group Leader at the Norwegian Centre of Excellence for Immune Regulation. “Therefore, strategies to tailor their serum persistence and biodistribution are needed. The unique Albufuse Flex technology solves this problem and will result in enhanced treatment efficacy, more favorable dosing regimes, and improved patient compliance.”

“The successful development of the Albufuse Flex technology illustrates the importance of industry and academic collaboration in turning scientific excellence into products that address medical needs. Novozymes has been an outstanding partner throughout the development process, and the company truly understands the potential of our academic science,” adds Dr Jorund Sollid, Inven2 AS, the University Technology Transfer Office.

Novozymes is a world leader in bioinnovation. Together with customers across a broad array of industries, it creates tomorrow’s industrial biosolutions, improving customers’ business and the use of the planet’s resources. With over 700 products used in 130 countries, Novozymes’ bioinnovations improve industrial performance and safeguard the world’s resources by offering superior and sustainable solutions for tomorrow’s ever-changing marketplace.

Nabi Biopharmaceuticals Completes Final Milestone; $5 Million Payment Received

Nabi Biopharmaceuticals recently announced it has completed the Phase I trial for two of the PentaStaph antigens that began in December 2009. Completion of this trial was the final milestone associated with the sale of the PentaStaph vaccine candidate to GlaxoSmithKline Biologicals S.A. (GSK). As a result of completing this milestone, Nabi has received $5 million under the agreement governing Nabi’s sale of PentaStaph (Pentavalent S. aureus Vaccine) and related assets to GSK.

Nabi sold PentaStaph and related technologies to GSK for a total consideration of $46 million, including $26 million associated with accomplishing four milestone tasks. Including this milestone, Nabi has now earned all of the $26 million in PentaStaph milestone payments. In addition to the milestone payments earned, Nabi received a cash payment of $21.5 million when the transaction closed in November 2009 that included $20 million associated with the transaction close, $1 million associated with the sale of a related preclinical program for a vaccine against S. epidermedis and $0.5 million as reimbursement for license fees and clinical materials previously manufactured for use in the Phase I trial.

“I am extremely proud of our accomplishments associated with the sale of the PentaStaph program having achieved all of the PentaStaph milestones in just over a year since closing the sale transaction,” said Dr. Raafat Fahim, President and Chief Executive Officer of Nabi Biopharmaceuticals. “We have successfully completed all the milestone tasks under the sale agreement.”

Nabi Biopharmaceuticals leverages its experience and knowledge in powering the immune system to develop products that target serious medical conditions in the areas of nicotine addiction and gram-positive bacterial infections. Nabi Biopharmaceuticals is currently developing NicVAX (Nicotine Conjugate Vaccine), an innovative and proprietary investigational vaccine for treatment of nicotine addiction and prevention of smoking relapse.

Axcan & Eurand Announce Name Change

Axcan Intermediate Holdings Inc. recently announced it is changing its name to Aptalis Pharma. The rebranding follows the recently completed combination of two specialty pharma companies focused on gastrointestinal diseases: Axcan and Eurand. Aptalis Pharma also has a new corporate logo and website: www.APTALISPharma.com.

“Our new name, Aptalis, is intended to capture the essence of two great companies that have transformed into one combined organization. Aptalis brings together the strengths and capabilities of our employees, our robust portfolio and growing pipeline, our innovative platform technologies, and our exceptional manufacturing capabilities to exceed the expectations of customers and patients,” said Frank Verwiel, MD, President and Chief Executive Officer.

Aptalis currently markets several products around the world, including ZENPEP, CANASA, CARAFATE, PYLERA, LACTEOL, DELURSAN, and SALOFALK and has several compounds in various stages of development targeting unmet medical needs. The pipeline includes another recent acquisition, AEROQUIN from Mpex Pharmaceuticals, currently in Phase III clinical trials for the treatment of pulmonary infections in patients with cystic fibrosis.

Above all, Aptalis will continue to put patients and their caregivers at the center of everything it does, striving to improve their quality of care thanks to a broader range of products in cystic fibrosis and gastrointestinal disorders; robust pipeline, technology platform, and manufacturing capabilities; and skilled team of professionals with deep understanding of customers’ needs.

Moving forward customers will receive the same great level of service and dedication from Aptalis that they have come to expect from Axcan and Eurand.

“This is an exciting time for Aptalis on our journey to becoming the reference specialty pharmaceutical company providing innovative, effective therapies for unmet medical needs, including cystic fibrosis and gastrointestinal disorders,” added Dr. Verwiel.

Aptalis Pharma Inc., is a privately held, leading specialty pharmaceutical company providing innovative, effective therapies for unmet medical needs including cystic fibrosis and gastrointestinal disorders. Aptalis has manufacturing and commercial operations in the US, the European Union, and Canada. Aptalis also formulates and clinically develops enhanced pharmaceutical and biopharmaceutical products for itself and others using its proprietary technology platforms, including bioavailability enhancement of poorly soluble drugs, custom-release profiles, and taste-masking/orally disintegrating tablet (ODT) formulations.