5/16/2012
Mucosis Announces Positive Data for Mimopath Platform
Mucosis B.V. recently announced Phase I clinical data providing proof-of-concept that Mimopath-based mucosal vaccines are safe and well tolerated as well as able to produce balanced immune responses in both circulating blood and the respiratory tract.
Mucosis, in conjunction with the Centre for Human Drug Research (CHDR; Leiden, the Netherlands), conducted the clinical trial to assess the safety, tolerability, and immunogenicity of nasally administered FluGEM, a Mimopath-based mucosal influenza vaccine containing bacterium-like particles (BLPs) in addition to a standard amount of trivalent split influenza antigen. This Phase I study, which began in March of 2011, was a randomized, blinded, placebo-controlled study and enrolled 60 human subjects 18 to 49 years of age who received either standard amounts of trivalent split influenza antigen or FluGEM vaccine containing increasing doses of BLPs.
Nasal FluGEM was well tolerated with no vaccine-related serious adverse events, and the rate of overall events was comparable to that in the control group. Moreover, FluGEM induced strong hemagglutination inhibition (HAI) antibody responses against the influenza H1N1, H3N2, and B strains. The systemic HAI responses met the seroconversion criteria for licensure as outlined in the EMA guidance document for influenza vaccine licensure, a difficult-to-reach endpoint for mucosal vaccination. Seroconversion rates (ie, percentage of subjects with a 4-fold or higher rise in HAI titer from baseline) ranged from 54% for H3N2, 46% for H1N1, and 50% for B strains. In addition, a potent mucosal immune response was observed in 77% of the subjects, as evidenced by secretion of influenza specific immunoglobulin A molecules in the nasal cavity.
“We are extremely pleased with the recent results of our Mimopath proof-of-concept study in humans,” said Dr. Govert Schouten, CEO of Mucosis. “We now look forward to advancing our platform through the SynGEM respiratory syncytial virus and PneuGEM pneumococcal vaccine programs. In these innovative programs, we apply our core Mimopath technology to deliver vaccine antigens via the most relevant route of administration – the mucosa. We will further develop the FluGEM vaccine candidate in cooperation with corporate, governmental, and non-governmental partners. We also continue to roll out our licensing program that allows partners to leverage our Mimopath technology for use in fields outside our focus of respiratory tract infections.”
Mucosis’s lead vaccine candidate, SynGEM, is designed to prevent infections with Respiratory Syncytial Virus (RSV), which affect over 60 million people worldwide ranging from the very young to the elderly with more than 1 million hospitalizations annually. An RSV vaccine does not yet exist.
Mucosis B.V. is a clinical-stage Dutch biotechnology company with a proprietary platform technology, Mimopath, on which it develops mucosal vaccines with improved efficacy. Mucosis’s lead product is SynGEM, a vaccine to prevent RSV viral infection. In addition, the company develops PneuGEM, a vaccine to prevent diseases caused by pneumococcal bacteria and FluGEM, a vaccine to prevent influenza. Mimopath-based vaccines can be administered needle-free in the nose and mouth, evoking a more natural immune response with a broader base of protection.
The Mimopath technology is based on Lactococcus lactis, a safe bacterium commonly used in the food industry. Mucosis has developed a robust technique to formulate the L. lactis bacteria into non-living bacterium-like particles (BLPs) that can be loaded with antigens from viral, bacterial, parasitic, or tumor origin. The antigen-covered BLPs form a vaccine that can be delivered into the nose or mouth, without the need for a needle. These vaccines raise protective immunity by activation of both the innate and the adaptive immune system. For more information, visit www.mucosis.com.
Novozymes Now Supplying Hyasis, a Novel Pharmaceutical-Grade HA
Novozymes Biopharma, part of Novozymes A/S, recently announced the first shipment of the company’s Bacillus-derived hyaluronic acid, Hyasis, from its newly inaugurated manufacturing facility in
“Shipment of the first commercial hyaluronic acid material from our new Q7 GMP facility marks an important milestone on our journey to becoming a leading producer of high quality hyaluronic acid. With our new patented process, based on the safe bacteria Bacillus subtilis, the market will have access to a new improved source of HA, which is fully compliant with the highest pharmaceutical standards and developed with customers’ specific needs in mind”, said Thomas Videbæk, Executive Vice President of Novozymes A/S.
Hyasis has been specifically designed to fill a gap in the market for biomedical and pharmaceutical manufacturers looking for Q7 regulatory-compliant ingredients with superior performance benefits.
“Improving how our customers can process and formulate HA for medical applications has been the key driver in the development of Novozymes’ new patented HA production process and facility”, added Hans Ole Klingenberg, Global Marketing Director at Novozymes. “Our unique technology will expand opportunities in the pharmaceutical and biomedical industries across multiple applications for HA, creating improved therapeutic treatments with real benefits for both manufacturers and patients.”
Novozymes’ focus on improving processes for its customers has resulted in a hyaluronic acid that offers a wealth of innovative advantages over competitive sources. Superior heat stability permits autoclaving without significant loss of product viscosity, and tight control of molecular weight during production allows for excellent control in formulations. Novozymes’ Hyasis also offers its customers unmatched batch-to-batch consistency in production at large-scale, and the capability of the product to dissolve five times faster than other sources can reduce processing times by up to 50%.
“We believe we have a very strong offering for the medical device and pharmaceutical markets. Not only is Hyasis manufactured in accordance with requirements for an active pharmaceutical ingredient, it also offers unrivalled safety, consistency, and performance to the benefit of our customers and partners. In addition, customers will have access to our dedicated team of researchers who can help them solve their formulation problems, resulting in time and cost-savings, manufacturing processes improvement, and safer and more efficient treatments for patients. In this way, we are setting a whole new standard in the market and redefining the use of hyaluronic acid”, said Thomas Videbæk.
A critical component in the development of an improved biomedical grade HA has been the construction of the new manufacturing facility designed exclusively for Hyasis. Located in
First customers have been testing the product for some time with good results, and Hyasis is now being sold to medical device and pharmaceutical customers. Thomas Videbæk says, “The market for pharmaceutical use of hyaluronic acid is estimated to have a size of DKK 1 billion. With regulations in the medical industry getting tougher and tougher, we believe we are well positioned in Novozymes to offer customers an improved source of hyaluronic acid that will comply with their long term needs – and with our long-term investment in this new facility, we aim to play a leading role in the market for hyaluronic acid for many years to come.”
For more information on Novozymes’ Hyasis, Bacillus-derived hyaluronic acid, visit www.hyasis.com.
Nuevolution Receives Milestone Payment From Boehringer Ingelheim
Nuevolution A/S recently announced that it has received a milestone payment derived from its collaboration with Boehringer Ingelheim. The payment was triggered following identification of potent small molecule compounds that have been shown to disrupt the protein-protein interaction of an undisclosed therapeutic target.
In its collaboration with Boehringer Ingelheim, Nuevolution is applying its proprietary Chemetics technology to identify novel small molecule leads against drug targets of interest to Boehringer Ingelheim. Nuevolution has so far screened about 300 million small molecules against the first of the targets selected under the collaboration.
The Chemetics platform uses innovative DNA labeling to allow fragment-based drug screening at an unprecedented scale forming small molecules and synthetic biologics. In existing collaborations, Nuevolution has successfully identified drug-like small molecules for several challenging target classes, including enzymes and protein-protein interactions.
“We are very pleased about the results that have been obtained thus far in the collaboration with Boehringer Ingelheim. The use of ultra large libraries under the optimized work flow implemented by Nuevolution during the last couple of years, has allowed the rapid identification of interesting compounds for this target,” said Alex Gouliaev, CEO of Nuevolution A/S. “The current results provides a promising basis for the further compound optimization.”
Boehringer Ingelheim and Nuevolution entered into the collaboration in September 2011.
Nuevolution is a leading small molecule lead discovery company founded in 2001 and based in
Nuevolution partners its technology with pharmaceutical and biotechnology companies. The company has entered into agreements with Merck & Co., Lexicon Pharmaceuticals, GlaxoSmithKline, Novartis Pharma, and Boehringer Ingelheim. It has also entered into a joint venture consortium between Nuevolution, EpiTherapeutics, ExpreS2ion Biotechnologies, and Professor Kristian Helin (Biotech Research & Innovation Centre, University of Copenhagen) aiming at discovery and development of novel small molecule drugs against epigenetic factors. Nuevolution has demonstrated the power of Chemetics by identifying highly potent and drug-like novel ligands with the potential to address major unmet medical needs across a range of therapeutic areas and target classes. For more information, visit www.nuevolution.com.
INTAC Technology Combats Misuse of Extended-Release Drugs
During this year’s Annual Scientific Meeting of the American Pain Society (May 16-19, 2012,
Prescription opioids are at the center of a major public health crisis of misuse and abuse in the
Dr. Hans-Jurgen Stahlberg, Director and International Clinical Lead at Grunenthal presented data from a clinical development program aimed at demonstrating bioequivalence between a non-tamper resistant originator product and the product utilizing INTAC formulation technology (Bridging from Conventional Marketed Extended Release Formulations to New Tamper Resistant Alternatives, poster No. 391). The structure and regulatory frame for the study program as well as the results and outcome for physicians and patients were discussed.
INTAC, Grunenthal’s tamper-resistant formulation technology, is designed to deter various relevant routes of abuse/inadvertent misuse from tablet tampering by imposing a specific mechanical stability to the tablet. This mechanical stability is created by the combination of specific excipients together with a unique manufacturing process. Grunenthal’s proprietary INTAC approach is established at commercial manufacturing scale and is featured in FDA-approved products that are marketed by US partners. Grunenthal considers its patent-protected INTAC to be the leading technology for abuse-deterrent and tamper-resistant opioid products. The INTAC technology is available for licensing to interested companies for various product opportunities.
The Grunenthal Group is an independent, family owned international research-based pharmaceutical company headquartered in
OncoMed Pharmaceuticals Files for $115-Million IPO
OncoMed Pharmaceuticals Inc. recently announced it is seeking $115 million in an initial public stock offering. The Redwood City-based cancer drug developer, one of the most successful Bay Area biotech companies at raising venture capital over the past 5 years, said it will use proceeds of the IPO to advance its lead drug (demcizumab, or OMP-21M18) and two other drugs into Phase II clinical trials and for programs with partners GlaxoSmithKline and Bayer AG.
OncoMed, led by CEO Paul Hastings, also will use the money to fund research and drug discovery, the company said in a Securities and Exchange Commission filing. The company’s largest shareholders are US Venture Partners, Latterell Venture Parnters and GlaxoSmithKline.
OncoMed is developing monoclonal antibody drugs that target cancer stem cells, a relatively small subpopulation of stem cells in a tumor that drive tumors to grow and spread. The company believes that by stopping these stem cells from renewing themselves, its drugs can stop cancer from recurring. The company, which has alliances with GlaxoSmith Kline and Bayer AG, has three drugs in clinical development, including one for which it filed an investigational new drug application in April with the Food and Drug Administration. Two other drugs are in preclinical development. For more information, visit www.oncomed.com.
Cornerstone to Acquire EKR Therapeutics for $150 Million
Cornerstone Therapeutics Inc. and EKR Therapeutics, Inc. recently announced they have entered into a definitive merger agreement whereby Cornerstone Therapeutics will acquire EKR Therapeutics. The acquisition expands Cornerstone’s product offerings and commercial infrastructure in the hospital market. The transaction is subject to customary closing conditions, including adoption of the merger agreement by EKR’s stockholders and expiration or termination of any waiting period under US anti-trust laws. The transaction is currently expected to close in late June 2012.
As part of the transaction, Cornerstone will acquire product rights to CARDENE I.V. and RETAVASE. CARDENE I.V. is indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable. RETAVASE is indicated for use in the management of acute myocardial infarction (AMI) in adults, for the improvement of ventricular function following AMI, the reduction of the incidence of congestive heart failure and the reduction of mortality associated with AMI. In 2011, EKR generated $58 million in net revenue, primarily from sales of CARDENE I.V. In 2013, Cornerstone is targeting FDA approval of a new active ingredient supplier and relaunch of RETAVASE, which could increase revenues significantly versus 2012. These products complement Cornerstone’s existing hospital products: CUROSURF, which is indicated for the treatment of neonatal respiratory distress syndrome (RDS) in preterm infants, as well as CRTX 080, a product candidate for treatment of hyponatremia.
“This transaction brings Cornerstone critical mass in the hospital-based therapeutics area and represents a major step forward in our strategy to focus on the hospital channel,” said Craig A. Collard, Cornerstone’s Chief Executive Officer. “With a significantly expanded product portfolio and larger sales and additional account management infrastructure, we believe we have enhanced our platform to drive future growth.”
Mr. Collard continued, “We plan to pursue additional hospital product licensing opportunities and company acquisitions that complement our enhanced hospital presence. We believe this strategy will position Cornerstone for growth and bring the company to the next level of value creation.”
“The successful launch of CARDENE I.V., and development successes of RETAVASE have been great achievements for EKR,” said John E. Bailye, CEO of EKR Therapeutics. “We are very proud of the work our employees have done, particularly our sales organization who has established CARDENE I.V. as an important hospital franchise. We are pleased that Cornerstone recognizes the value of our business and look forward to their success in progressing these products, which will benefit clinicians and the patients they serve.”
Under the terms of the agreement, Cornerstone will make an initial cash payment of approximately $125 million, subject to adjustment in accordance with the terms of the merger agreement, and make certain additional payments contingent upon the achievement of certain milestones related to regulatory approval of a new active ingredient supplier for RETAVASE and sales of RETAVASE during approximately the first 3 years following commercial relaunch. Pursuant to the merger agreement, a newly formed, wholly owned subsidiary of Cornerstone will merge with and into EKR, with EKR continuing after the merger as the surviving corporation and a wholly owned subsidiary of Cornerstone. The EKR Board of Directors has approved the merger agreement and recommended its adoption by EKR’s stockholders.
In connection with the EKR transaction, Cornerstone and its majority shareholder, Chiesi Farmaceutici, SpA, have entered into a debt financing commitment, including customary covenants, whereby Chiesi will provide to Cornerstone a senior secured term loan facility comprised of (i) a 5-year Term Loan A of up to $60 million at 7.5% interest per annum and (ii) a 5-year Term Loan B of up to $30 million at 6.5% per annum. Term Loan B may be converted into common stock of the company at $7.098 per share at Chiesi’s option at any time during the 24 months following the closing of the debt financing.
Cornerstone Therapeutics Inc., headquartered in
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