Avantor Performance Materials Expands Presence in India

Avantor Performance Materials recently announced it has opened a new pharmaceuticals formulation applications laboratory at the RanQ Remedies facility, an established excipient developer and manufacturer based in Sinnar Nashik, India. Following Avantor’s recent acquisition of RFCL Limited in India, the opening of this new laboratory shows a strong commitment to growth and expansion in the region.

The new lab, which strengthens a strategic development and manufacturing agreement between Avantor and RanQ, will be used to characterize excipients; perform functional testing; develop and characterize drug formulations; and support customer applications and product implementation.

In addition to an applications laboratory, Avantor has completed construction of a pilot plant onsite at the RanQ facility. The pilot plant will be used to develop and scale-up additional performance excipients to extend Avantor’s J.T.Baker PanExcea product line. The PanExcea line includes performance excipients that combine filler, binder, and disintigrant to provide increased excipient functionality for immediate-release and orally disintegrating tablet applications.

“Our partnership with Avantor will allow us to advance our goal of becoming an internationally known, high-quality excipient manufacturer,” said Managing Director of RanQ, Sameer Ranadive. “We look forward to developing a broad range of performance excipients to assist customers in the global pharmaceutical industry.”

RanQ has extensive process development and manufacturing capabilities and expertise. The company is known for developing premixed and other application-focused pharmaceutical excipients that result in a homogenous mix and co-processed excipients that eliminate the need for wet granulation production stages.

“With our proven excipient innovation experience, beaker-to-bulk packaging flexibility, and Q7A quality systems, RanQ will serve as a strategic pharmaceutical partner in the region,” added Avantor Executive Vice President of Pharmaceuticals Paul Smaltz.

“RanQ’s capabilities will help us increase the commercialization speed of Avantor’s line of J.T.Baker PanExcea performance excipients,” said Mr. Smaltz. “By working with RanQ on customer applications, we expect that this alliance will facilitate a rapid introduction of additional novel, high-performance excipients to the global pharmaceutical market.”

“This base of applications support complements our other activities in India,” said Avantor Executive Vice President of Southeast Asia Sushil Mehta. “Our expanded presence will enable us to quickly develop more unique and effective solutions that help customers increase their speed to market.”

“Avantor is a global leader continuing to build upon a legacy of innovation by expanding into new global regions,” said Mr. Smaltz. “Our new applications laboratory will allow Avantor to provide additional value to customers who are developing high-volume manufacturing operations in the Southeast Asian region by conveniently testing and developing drug formulations on site.”

Avantor is continuing to expand in the Southeast Asia region. The company recently acquired RFCL Limited, a leader in laboratory reagents and consumables as well as products for medical diagnostics. Avantor purchased RFCL because of its current presence in the laboratory and pharmaceutical markets in fast-growing Indian market.

Evotec Receives Milestone From Boehringer Ingelheim in Strategic Alliance

Evotec AG recently announced that a back-up compound in its strategic alliance with Boehringer Ingelheim has advanced into a Phase I clinical trial. Evotec will receive a milestone payment of EUR 2.0 million. The compound, which was discovered and optimized within the alliance, is being developed as a novel treatment for neuropathic pain. The alliance has involved working on multiple high-priority targets across key therapeutic areas. To date, it has resulted in 13 milestone payments from multiple programs.

“New more effective treatments against pain are urgently needed,” said Dr. Werner Lanthaler, CEO of Evotec. “We continue to enjoy a rewarding partnership at both scientific and commercial levels with Boehringer Ingelheim.”

In 2004, Evotec entered into a multi-year, multi-target drug discovery collaboration with Boehringer Ingelheim to jointly identify and develop preclinical development candidates for the treatment of various disease areas, including CNS, inflammation, cardiometabolic, and respiratory diseases. In 2009, the collaboration was extended for an additional 4-year term and the scope expanded to include oncology targets. Under the terms of the agreement, Boehringer Ingelheim has full ownership and global responsibility for clinical development, manufacturing, and commercialization of the compounds identified. In return, Evotec receives ongoing research payments and preclinical milestones.

Furthermore, the contract provides substantial long-term upside for Evotec through potential payments for successful milestone achievements during clinical development and royalties when new drugs reach the market.

Evotec is a drug discovery alliance and development partnership company focused on rapidly progressing innovative product approaches with leading pharmaceutical and biotechnology companies. The company operates worldwide providing the highest quality stand-alone and integrated drug discovery solutions, covering all activities from target-to-clinic.

Ashland to Acquire International Specialty Products

Ashland Inc. and International Specialty Products Inc. (ISP) recently announced that Ashland has agreed to acquire privately owned ISP, a global specialty chemical manufacturer of innovative functional ingredients and technologies. Under the terms of the stock purchase agreement, Ashland will pay approximately $3.2 billion for the business in an all-cash transaction. At closing, ISP’s advanced product portfolio will expand Ashland‘s position in high-growth markets such as personal care, pharmaceutical and energy.

For the 12 months ended March 31, 2011, ISP generated sales of approximately $1.6 billion and earnings before interest, taxes, depreciation and amortization (EBITDA) of approximately $360 million. The transaction is expected to be immediately accretive to Ashland‘s earnings per share.

ISP is a leading global supplier of specialty chemicals and performance-enhancing products for consumer and industrial markets. Through its unique offerings, ISP will bring high-value water-soluble polymers and other advanced technologies into Ashland’s functional ingredients business, as well as complementary additives for Ashland’s food and beverage, energy, coatings, adhesives, and water-treatment markets. The acquisition is expected to significantly strengthen Ashland‘s functional ingredients active patent portfolio and its team of research and development scientists. The result will be a stronger, global functional ingredients business with proven technological and application capabilities to solve customers’ unique formulation challenges.

“This defining transaction enables us to significantly expand our market positions in higher margin, higher growth, and less cyclical global markets like personal care and pharmaceuticals,” said Ashland Chairman and Chief Executive Officer James J. O’Brien. “It broadens Ashland‘s presence within attractive growth areas like skin, hair, and oral care, which are large and fast-growing segments of the $5-billion-plus personal care specialty ingredients market. In addition, we expect to more than double the size of our highest-margin functional ingredients business.”

“We are very enthusiastic about the opportunity to combine ISP with Ashland,” added ISP President and Chief Executive Officer Sunil Kumar. “Both companies have a strong commitment to serving customers with innovative solutions and technologies. We appreciate Ashland‘s passion for this business, and we believe this combination offers tremendous potential for our customers, key business partners, and employees.”

“We look forward to welcoming ISP’s employees to Ashland,” said Mr. O’Brien. “Our business models are complementary, and we share common capabilities in formulation, application development, and polymerization. We are disciplined in the underlying processes and operations that enable us to manufacture best-in-class products. Given the quality of leadership within both businesses and our success with the integration of prior acquisitions, we are confident we will achieve a smooth transition to a combined company. We are excited about the opportunities for innovation and growth that lie ahead of us.”

On a pro forma basis giving effect to the transaction, Ashland would have had combined revenue for the 12 months ended March 31, 2011, of approximately $7.6 billion, with nearly half of revenues generated outside North America. The newly combined functional ingredients business is expected to contribute roughly half of Ashland‘s $1.1-billion pro forma EBITDA. Ashland expects to realize annualized run-rate cost savings of approximately $50 million by the second year following the transaction’s close through eliminating redundancies and capturing operational efficiencies.

The transaction, which is expected to close prior to the end of the September quarter, is subject to satisfaction of customary closing conditions and receipt of US and European Union regulatory approvals. The purchase price will be subject to post-closing adjustments for changes in net working capital and certain other items. The transaction will be funded through a combination of cash on hand and committed financing from Citi, The Bank of Nova Scotia, BofA Merrill Lynch, and US Bank National Association, subject to customary terms and conditions. Under the terms of the stock purchase agreement, if the financing is not available and the other conditions to closing are satisfied, ISP has the right to terminate the agreement and require Ashland to pay a fee of $413 million.

3M Signs Development Agreement; Updates Phosphagenics Collaboration

3M Drug Delivery Systems and Radius Health, Inc. recently announced an agreement to collaborate on the development of a transdermal delivery option of BA058, Radius’ novel, proprietary PTHrP (parathyroid hormone-related protein) analog, for the treatment of osteoporosis.

The BA058 Microneedle Patch will use 3M’s patented Microstructured Transdermal System microneedle technology to administer BA058 through the skin, as an alternative to subcutaneous injection. The BA058 patch is expected to combine the ease, convenience, and self-administration attributes of a transdermal patch with the speed and efficiency of a traditional injection. Terms of the agreement were not disclosed.

“Poor adherence to prescribed osteoporosis therapy is a common and serious problem. Patients who drop their treatment unknowingly place themselves at high risk of fracture, which exacts an enormous toll in terms of human and economic cost,” said C. Richard Lyttle, PhD, President and Chief Executive Officer of Radius. “By providing a more convenient treatment alternative to injection that can promote improved compliance, the BA058 Microneedle Patch will be well-positioned to drive expansion of the osteoporosis market.”

Radius’ BA058 Microneedle Patch product is currently undergoing Phase I clinical studies. The company’s recently concluded Phase II human testing of an injectable form of BA058 showed that BA058 significantly increased bone mineral density (BMD) at the lumbar spine and femoral neck (a common osteoporotic fracture site located in the hip joint) after 6 months of therapy, with greater BMD gains relative to Forteo, the reference drug used in the study.

“We are pleased to partner with Radius, a company with deep domain expertise in osteoporosis,” said Jim Vaughan, Division Vice President and General Manager of 3M Drug Delivery Systems Division. “This collaboration continues the validation of 3M’s microneedle patch technology and provides an excellent example of how our technology adds value for promising new therapeutic agents. We look forward to merging 3M’s innovative microneedle technology with Radius’ promising bone-building agent to bring this important new therapy to market.”

3M also announced that Melbourne drug delivery technology company Phosphagenics Limited is a step closer to commercializing its first-in-class oxycodone pain patch following successful completion of their initial global formulation development collaboration. 3M has refined Phosphagenics’ original oxycodone transdermal patch prototype and will commence the development of an improved version that will be used for next stage clinical trials. These trials are scheduled to commence later this year.

The development of the new patch has commenced at 3M’s laboratory in Minnesota. The Melbourne-developed technology has the potential to revolutionize the delivery of the powerful painkiller oxycodone using Phosphagenics’ proprietary TPM transdermal delivery technology.

Phosphagenics’ CEO Dr. Esra Ogru said the original patch prototype was very effective in human trials. But the technology has been boosted by an astounding five-fold improvement in delivering the drug through human skin during in vitro studies, resulting from the collaboration with 3M. This should substantially improve the commercial prospects for the patch.

“Working with 3M with its expertise in patch technology and manufacturing has enabled us to refine and significantly improve the delivery of the oxycodone patch,” she said.

Phosphagenics’ successful completion of the stage one 3M collaboration follows its November 2010 3M announcement. 3M is a multi-billion dollar science-based company producing thousands of products in more than 65 countries. It has a focus on healthcare with products sold in nearly 200 countries.

Dr. Ogru indicated the oxycodone patch development program remains a primary focus. “The oxycodone patch development is the core company pharmaceutical product, and its commercialization is the company’s number one imperative. It offers the best medium-term value inflection potential for the company,” she said.

Rhenovia Enters Strategic Alliance With Portmann Instruments

Rhenovia Pharma SAS, a biotechnology company specialized in the development and optimization of treatments for diseases of the central and peripheral nervous systems, recently announced the signing of a strategic alliance agreement with Portmann Instruments AG. PIAG is a Swiss company specialized in the manufacture and supply of high-precision instrumentation for the chemical, pharmaceutical, and biotech industries. This agreement will enable Rhenovia to establish a permanent presence in Switzerland, one of Europe‘s largest pharmaceutical markets, and to market a range of services there that utilize its biosimulation platform for optimizing the drug discovery and development activities of biopharmaceutical companies.

Through this alliance, Rhenovia and PIAG will pool their respective know-how and areas of expertise to exploit and capitalize on the new technologies developed by Rhenovia. By teaming up with a Swiss company, Rhenovia will be able to forge closer relations with the many biopharmaceutical companies, technology suppliers, and financial institutions with which it does business and to extend the range of services it can offer to the Swiss nutrition and food supplement market. This alliance is aimed at establishing a new company or joint venture, whose structure, funding, and modus operandi will be determined before the year end.

As part of its strategic alliance with Rhenovia, PIAG is to set up a special unit and an ultra-modern laboratory for physico-chemical analysis. This laboratory will enable Rhenovia to push ahead more rapidly with the development of its technological solutions, proceed with the validation of its biosimulation platforms, and establish proof-of-concept for its Rhenovia Isoelectric Filtration Technologies (RHIFT) platform, which is designed to identify and track biological markers of the efficacy and side-effects of drugs, but also has numerous other industrial applications.

The agreement provides for PIAG to take charge of the prototyping of the very advanced transdermal patch developed by the two companies within the bipartite framework of the European Eurostars project, for which Rhenovia was the project leader. PIAG will be responsible for designing the apparatus to be used for feasibility studies and for setting up the pre-industrialization phases.

“We are delighted with the signing of this strategic alliance agreement with PIAG,” said President & CEO of Rhenovia Pharma Dr. Serge Bischoff. “It is the result of a long-running rapprochement between the two companies’ executives, which took concrete shape in 2008 with the Eurostars project. Through this alliance, Rhenovia, which has only been in existence for 4 years, has been able to create its first subsidiary in Switzerland and speed up the international development of its activities, especially in Switzerland and, by extension, Germany. This agreement is indicative of the importance of our technology portfolio, which ranges from biosimulation to drug delivery and includes extremely efficient techniques for administering tailor-made drugs transdermally. Rhenovia has considerably broadened the field of application of its technology platforms, extending it to drug toxicity and the prevention of disease through nutritional health, as well as to the identification of diagnostic and drug efficacy markers. Rhenovia will continue to enter into partnerships and alliances like today’s one with PIAG to consolidate its activities in these new areas and strengthen its core drug design optimization business.”

“We are pleased that our strong partnership with Rhenovia has spawned this alliance,” added CEO of PIAG Peter Stark. “This new agreement will enable PIAG to undertake new activities, diversify its industrial applications and enter new markets, such as high-precision instrumentation for the pharmaceutical and chemical industries and transdermal procedures and devices for innovative therapies.”

Protea Announces Completion of Human Clinical Trial for New Biopharmaceutical

Protea Biosciences, a leading developer of new technology for pharmaceutical research, recently announced that the company, in partnership with Mayoly-Spindler, a European pharmaceutical company, has successfully completed a Phase I/IIA human clinical trial for their MS1819 recombinant Lipase.

The clinical trial was a randomized, placebo-controlled, parallel design conducted at Hospital la Timone in Marseille, France. The goal of the clinical trial was primarily to assess the safety profile and secondarily, to get early evidence of the clinical activity of the MS1819 recombinant lipase in patients with malabsorption syndrome due to exocrine pancreatic insufficiency resulting from chronic pancreatitis.

“The study results are fully in accordance with our expectations,” said Steve Turner, Protea’s CEO. “The completion of our first clinical trial is an important milestone for this promising drug, as well as for Protea.”

Lipase is an enzyme that is produced by the pancreas to digest fat. Chronic pancreatitis is defined as long-term inflammation of the pancreas, characterized by irreversible changes in pancreatic cells. Causes of exocrine pancreatitis insufficiency (EPI) include cystic fibrosis, drug/alcohol abuse, pancreatic cancer, and other conditions. Chronic pancreatitis causes chronic abdominal pain, impairment of hormone and digestive enzyme functions of the pancreas, and can produce serious weight loss. A lack of pancreatic enzymes results in the inability to properly digest food leading to malnutrition. Vitamin absorption (A, D, E, and K) is also impaired.

“We are very pleased to have completed this Phase I/IIA human clinical trial. We strongly believe that such a product could have a significant improvement in the reatment of exocrine pancreatic insufficiency,” added Jean-Nicolas Vernin, Laboratoires Mayoly-Spindler’s CEO.

The worldwide market for treatment of exocrine pancreatic insufficiency is estimated to be $1.2 billion. There are over 200,000 patients in the US who suffer from symptoms of exocrine pancreatic insufficiency. Under terms of their partnership agreement, Protea receives from Mayoly-Spindler the exclusive marketing rights for the drug in North America. The two companies plan to commence the Phase II human clinical trial in 2012.

Protea Biosciences, Inc. develops and commercializes new bioanalytical technologies that enable the direct analysis of the proteins, lipids, and metabolites produced by living cells and organisms. Laboratoires Mayoly-Spindler is a privately owned French pharmaceutical company, founded in 1929, focused primarily on gastroenterology.