The physical form of an API is important in formulation developmentfor resolving issues in bioavailability and solubility. Particle-engineeringtechnologies can be applied in various ways: crystal design for controllingcrystallization and producing cocrystals; particle-size reduction, achievedthrough jet-milling, wet polishing and nanoparticle generation; and amorphoussolid dispersions, produced by several approaches, such as spray-drying(including as inclusion complexes), hot-melt extrusion (HME), andspray-congealing. 

discussed theseissues with Colin Minchom, vice president, of the Particle Design Business Unitat Hovione.  

 Under what type of situations would crystallization be used? How does itfacilitate the delivery of poorly soluble drugs?  

 Interest in cocrystals has increased in recent years, and the recent FDAguidance on a proposed classification of cocrystals has prompted furtherdiscussion and counter proposals from the industry. The proposed US FDAclassification of cocrystals as crystalline materials containing two or moremolecules in the same crystal lattice is limited but can serve as a startingpoint for discussion.  

The addition of a cocrystal former into the crystalline structure ofthe API changes its physical and chemical properties. It is possible, in somecases, to improve bioavailability to adequate levels while preserving thestability of a crystalline form. For APIs with low glass-transition temperatures,a cocrystal may be favoured over the amorphous form. As such, the use of acocrystal may be an attractive platform to overcome the solubility limitations ofBiopharmaceutics Classification System Class II and Class IV drugs.  

Cocrystal formation is a favored approach for increasing apparentaqueous solubility for poorly water-soluble molecules that have no ionizablegroups, and for which salt formation is not possible, or for where the physicalproperties of the salts formed are not desirable. Solvates and hydrates arewell-accepted crystal forms. In many ways, a cocrystal can be thought of as asolvate, but one whose components are solid at room temperature. The cocrystalwill form if the resulting crystal is thermodynamically more stable than thecomponents. Resulting cocrystal properties are dependent upon many factors,including the starting properties of the API, the physical properties of theco-former and the mechanism by which the cocrystal is formed. To increase theprobability of success, we [Hovione] recommend that at early-development stagesto test other proven platforms, such as solid dispersions, micronized andnanosized crystals and inclusion complexes.  

Applying acoustic levitation for elucidation of amorphous material 

 Controlling nucleation during crystallization is an important task. Whatare the mechanisms for controlling crystallization?  

 Where milling techniques can be thought of as top-down sizingtechniques, controlled crystallization is where the desired particle-sizedistribution is achieved from the bottom up. The objectives of a crystallizationprocess are twofold. On the one hand, the aim is to isolate the API in the rightcrystal form, typically a polymorph that provides the required level of exposureand stability. On the other hand, crystallization may also be a purificationstage, whereby the impurities remain mostly dissolved in the mother liquors.

The kinetics of crystallization (nucleation and crystal growth rates)are driven by the imposed supersaturation levels. The degree of supersaturation,temperature ramp, mixing, filtration and final drying process all contribute tothe final particle-size distribution. Moreover, the relative importance of eachfactor can change at each scale.  

What factors determine particle size? What are the differences inparticle size achieved through jet-milling, wet polishing, and nanoparticlegeneration?  

 Particle-size reduction is not a simple phenomenon. The mechanism ofgenerating the material of the prescribed particle size has a profound effectupon a range of physical properties that may have a significant effect on theresulting pharmaceutical behavior. The final particle size of a materialsubjected to a comminution process is dictated by particle attributes, such ascrystal hardness, morphology, and original crystal size, as well as thesize-reduction method and energy applied. Jet-milling and wet polishing maygenerate materials with equivalent median particle sizes; however, the resultingspan from jet-milled material is likely to be wider than the wet-polishedmaterial. Amorphous material and highly reactive surfaces also may result fromjet-milling while a higher level of crystallinity is maintained with wetpolishing. 

Dry methods, such as jet-milling, tend to be more cost-effective(mainly because they do not require sophisticated isolating techniques), but theyare more aggressive, less reproducible, and more limited in terms of theachievable size reduction.  

 What factors determine which method (i.e., spray-drying, HME,spray-congealing, and inclusion-complex generation) to use to produce theamorphous solid dispersion?  

 Amorphous solid dispersions represent a tremendous opportunity forsolubility enhancement of oral drugs. The resulting supersaturation levels (andhence bioavailability) and the physical stability of the final dosage form,however, depend on the manufacturing method applied. Many approaches areavailable to generate amorphous solid dispersions.   

Spray-drying, being a solvent method, is the most versatile techniqueto obtain solid dispersions due to its gentle process conditions and much widerformulation options. Spray-drying is a technology that works well in nearly everycompound. Another advantage of spray-drying is that it can be effectivelyoperated using much smaller quantities of drug substance, thereby making it themost cost-effective option during early-stage development. 

Melt methods, such as HME and spray-congealing, on the other hand,are more cost effective at the larger scale manufacturing and have the additionaladvantage of being solvent-free techniques. To use these methods, however, thecompound needs to be soluble in the polymer/matrix and physically stablecomplexes need to be created. These methods are also limited to drug substancesthat can sustain relatively high heat loads. All these techniques are relativelywell-established within the pharmaceutical industry, although spray-drying is astep ahead in terms of maturity.  

Although challenging at a very small scale, the rationale design ofan HME formulation is viable when the API is available in pilot-scale quantities.Where an API has low solubility in all preferred spray-drying solvents or retainsextensive solvent following drying, HME may represent the best way forward forthe development of a stable amorphous solid dispersion. Spray-congealing can usesa number of lipophilic excipients, which are useful in formulating poorlywater-soluble compounds that will form self emulsifying drug-delivery systems(SEDD) or self micro-emulsifying drug-delivery systems (SMEDDS) onadministration, as well as the polymers commonly used in spray-dried amorphoussolid dispersions. 

 485 Route One South, Bldg F, First Floor, Iselin, NJ 08830tel. 732.346.3072,  

Articles

Formulation, Manufacturing

Particle-engineering technologies, such as crystal design for crystallization and producting cocrystals, particle-size reduction, and amorphous solid dispersions, help to optimize delivery of a drug.

Seeking Solutions in Solid-State Chemistry

How big is the market for contract- manufacturing services? PharmSource gets that question more than any other. Published estimates of market size vary widely and often seem to be exaggerated or inflated. 

Determining the size of the contract-manufacturing market is a methodological challenge. The biggest obstacle is the fact that most CMOs are either privately owned and do not report their financial results or are part of larger corporations that usually do not  break out their CMO revenues in their financial reports. Although good research can overcome some of these problems, determining market size ends up requiring some amount of "guesstimation." 

Another methodological problem is defining what is included as "contract manufacturing." Many published reports are unclear about what they are measuring, which can lead to widely divergent market-size estimates. Understanding a given market size estimate requires that the reader and user fully appreciate what is being measured. Some of the dimensions that must be considered are discussed below:  

Which products are included in the market? 

The definition can include prescription products, over-the-counter (OTC), and nutritional products. Although prescription and OTC products are both governed by drug GMPs, nutritional products often are not, so the market dynamics and participants tend to be different, albeit with some overlap.

Is the product being manufactured proprietary to the client or is it generic?

 Some estimates of the contract-manufacturing market appear to include generic APIs, which are really commodities that can be bought by any company looking to manufacture a generic or OTC drug. There also are generic or OTC drug products that the manufacturer licenses to a customer to be packaged under the customer's name, the so-called "private label" business. By contrast, pure contract manufacturing involves a CMO manufacturing an API or drug product using the client's proprietary process or proprietary formulation.

 Many manufacturers in emerging markets offer contract manufacturing, but they do not operate under North American, Western European, or Japanese regulatory standards. These companies are competing in a different market and under a different set of terms than manufacturers that meet higher regulatory requirements.

Given the potentially broad dimensions of the CMO industry, users of market-size data must be clear about the applicability of the data they are using. PharmSource recently published its own estimate of the size of the dose CMO market, 

. We measured the market for contract manufacturing of a client's formulation under FDA, Western European, or Japanese GMP standards and built our estimate based on extensive research of company revenues and revenue modeling. 

We (PharmSource) arrived at a contract-dose manufacturing market size of $13.7 billion in 2011. That was up 7% from 2010, but that growth rate includes revenue from facilities that became contract-manufacturing sites during the year after they were acquired by CMOs from biopharmaceutical/pharmaceutical companies. The organic growth rate (i.e., the growth of revenues at facilities that were in CMO networks in 2010) was 6%. We estimate that overall, dose CMOs accounted for 22% of the biopharmaceutical/pharmaceutical industry's dose-related cost-of-goods in 2011. 

Of course, size and growth are not the only dimensions that matter for the health of the industry. Contract-dose manufacturing suffers from overcapacity, especially for solid-dose forms, and the intense competition to sell capacity means that only a minority of dose CMOs make reasonable profits. Further, global biopharmaceutical/pharmaceutical companies continue to show a strong preference for building captive manufacturing, shutting CMOs out from some of the most attractive segments of the market. 

We continue to believe that a consolidation of the industry will happen sooner rather than later, driven by developments in the broader economic and financial environment. When that happens, the industry may not be so big or growing at the same rate, but it will be getting healthier.  

A recent analysis of working capital management practices ofbiopharmaceutical/pharmaceutical companies has some mixed implications for the contract-services industry. The report from financial services giant Citi claims that the global biopharmaceutical/pharmaceutical companies could release $33 billion in cash by managing their working capital better. Working capital is the difference between current assets (which include accounts receivable and inventories) and current liabilities (which include accounts payable and short-term debt). Companies use cash when they build up inventories and receivables and pay their bills; they increase their cash when they run down their inventories, slow payments to suppliers, or collect receivables more aggressively. 

Companies could free up that cash by reducing inventories and taking longer to pay their bills, according to the Citi report. The additional cash resources could be used for licensing and acquisition deals or could be returned to shareholders as dividends and stock buybacks. 

Having to wait longer for their money is not something that CMOs and CROs want to hear. Service providers are already getting squeezed on prices and profit margins, and a slowdown in payments will eat further into their profits by forcing them to borrow more against their lines of credit or to forego discounts they might get from paying their own suppliers. In the worst cases, CROs and CMOs could be forced to delay hiring or purchasing materials and equipment, which would hurt the quality and reliability of the services they provide. 

On the other hand, helping their biopharmaceutical/pharmaceutical clients to reduce their inventories could be a big opportunity for CMOs. Managing inventories is about managing production schedules, cycle times, and supply chains. These are skill sets at which CMOs are supposed to excel because  they are at the core of modern manufacturing practice. CMOs that are able to reduce schedule lock-in times from the traditional three months for dose forms and six to twelve months for APIs could increase their share of business from key customers and probably earn somewhat higher margins. 

The working-capital challenge raised by the Citi report is further proof that success for CMOs will go beyond traditional measures of quality and cost of goods.  

 is president of PharmSource Information Services, Inc., and publisher of 

, tel. 703.383.4903, Twitter@JimPharmSource, 

Outsourcing

Measuring the size of the market for contract manufacturing services requires a careful hand.

Sizing the Market for Contract Manufacturing

Contract manufacturers and fine-chemical producers used CPhI Worldwide, held in Madrid, Oct. 9–13, to highlight recent manufacturing capacity and services partnerships and related partnerships. Some highlights from the show and recent news subsequent to the show are outlined below. 

  won the European Outsourcing award for “best acquisition” following its acquisition and integration of three different UCB sites at Monheim and Zwickau in Germany, and Pianezza in Italy in 2011. The acquisition of the UCB sites follows the integration of R5 Pharmaceuticals in 2010. The acquisitions contributed to revenue gains for the company, with sales growing more than 37% in the past two years, and revenues predicted to grow from $180 million in 2011 to $270 million by the end of the yea, according to the company. 

 is expanding its API manufacturing facility at its European Headquarters in Craigavon, United Kingdom. The expansion  is near completion and will be operational by the end of the year.  This upgrade includes installation of two 1000-L reactors and a pressure-filter dryer, which allows production of GMP APIs up to 150-kg batch. 

 in  biocatalysis. The agreement grants both parties access to their enzyme platform technologies, services, and expertise for the manufacturing of APIs.

 entered into an agreement with Knopp Biosciences to provide various discovery-related services that include medicinal chemistry, drug metabolism and pharmacokinetics, and computer-aided drug discovery, as part of AMRI’s Smartsourcing platform. In other news, AMRI has entered into a multiyear supply agreement for an undisclosed product with Shire US Manufacturing. The agreement extends a previously existing agreement between the two companies. 

 has announced the offering of antibacterial studies from a single site, the Aptuit Center for Drug Discovery and Development in Verona, Italy.

 is planning an expansion of its large-scale API manufacturing facility in Germantown, Wisconsin. The expansion comes three years after commissioning the new site. The expansion will include additional reactor capacity as well as isolation equipment. Alongside capacity additions, CML has made additional investments in engineering controls to ensure the sustainability of the business. 

 have agreed to provide customers with development and manufacturing services for antibody drug conjugates. ADC is developing a “lock and release” solid-phase immobilization technology for production of ADCs. The alliance will offer services for the development, scale-up, manufacturing, and formulation of protein-based drug conjugates. ADC Bio will provide access to proprietary solid-phase immobilization technologies for conjugation and long-term storage of ADCs, and Carbogen Amcis will focus on focus on small- to large-scale GMP supply and on the formulation of ADCs. 

 has agreed to supply an API for a customer’s Phase III program. The agreement is expected to contribute more than $20 million in revenues to Cambrex, which will expand its large-scale multipurpose cGMP assets in 2012 and 2013. 

Catalent Applied Drug Delivery Institute 

 to promote innovation, knowledge-sharing, and collaboration between industry leaders, academic experts, customers and regulators to enhance understanding of available, emerging, and future drug-delivery technologies and improve patient care. As part of its mission, the Catalent Applied Drug Delivery Institute will serve as a link between industry and academia by providing guidance, counsel, and resources on major issues pertaining to drug development, delivery, and formulation. The Institute will develop programs that facilitate mutually beneficial collaborations, increase communication, and shed light on regulatory issues affecting drug developers and researchers. It also will pursue a multitiered approach of seed funding, strategic counsel, and educational programs to advance the adoption of emerging technologies. Catalent announced the launch of the institute at the 2012 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition in Chicago earlier this month 

 has expanded the capacity of its Wisconsin-based API manufacturing plant as a result of an increased demand for contract manufacturing of commercial APIs as well as additional upgrades for improving safety and GMP systems. 

 were awarded at CPhI to recognize innovation in formulation development, drug delivery, chemical manufacturing of APIs and intermediates, and biomanufacturing. The Best Pharma Innovation award featured gold, silver, and bronze winners from five shortlisted entries. Earning the gold and top prize was 

 for its needleless injection vial (NIV), a needle-free vial closure system that can be used on any product supplied in a glass or plastic vial, whether in a liquid, gel, or powder form. 

 took the silver for using bimodal silica as a drug-delivery platform. Merck Millipore’s innovation takes advantage of the two-fold pore structure of silica, which offers a large surface area and good transport properties for drug delivery. The bronze went to 

 for its Multi-Oral Remin remineralization gel, applied in the oral cavity to treat and prevent bleeding gums and tooth erosion. The other two finalists included 

 Multiflex collapsible tube technology, designed to improve on traditional laminate tubes, and 

 alprostadil, formulated as a lyophilized emulsion for injection. 

In addition to recognizing technical advances in drug development and manufacturing, the CPhI Pharma Awards also recognized advances in sustainability. This year’s award included an award for Best Sustainable Packaging, a new award this year that was added to recognize a company for a specific material, machine, or process that facilitated sustainable packaging. The finalists for this award included 

 Unicadose plastic vials, which provide an alternative to glass single-dose vials; 

Eco Save Pack, a carton tray with product-adapted inlays for different market demands; and MeadWestvaco Healthcare’s Shellpak Renew. The award went to 

 for its adherence-enhancing drug packaging, which consists of a recyclable tear-resistant outer carton and an easy-slide blister with a calendar integrated to aid patients in tracking their medication. In another award recognizing sustainability, 

 reports expansion in the areas of activated mPEG manufacturing and in the development and manufacture of APIs for use in preclinical through to commercial development at its manufacturing facility in Mirfield, United Kingdom. 

 announced a biologics development and manufacturing agreement with 

 for Paranta’s lead recombinant human protein for DSM’s at its Brisbane, Australia, facility. DSM had earlier signed a biologics contract manufacturing agreement with Recepta Biopharma, based in Brazil. The contract covers the process development and cGMP manufacture by DSM of one of Recepta’s lead antibodies at DSM’s facilities in Groningen, the Netherlands.

 have formed an exclusive collaboration to provide science-based, spray-dried dispersion solutions and select enabling new polymers for poorly soluble oral drugs. 

 has invested $2 million to expand its facilities for equipment for product mixing and capsule-filling. Delivery of the new equipment started in August and will be completed by February 2013. In other news, Encap Drug Delivery and the School of Pharmacy, Queen’s University Belfast have received funding from the Technology Strategy Board and the Scottish Government that will allow both to enter into a collaborative Knowledge Transfer Partnership on hot-melt extrusion. 

high-speed filling line for presterilized syringes was awarded first place for the “Most Improved Manufacturing Project or Process” category. Innovations on the filling line, developed by Vetter and Bosch Packaging Technology, include an automated spray disinfection tunnel, automated end-to-end handling of tubs, and flexible equipment for various production processes in the filling station.  The line is located at Vetter’s Ravensburg, Germany facility. 

 won the “Most Improved Plant or Facility” award for the redesign of its 221,000-ft

 site in Schorndorf, Germany. The redesign included an update of all air-management systems within the entire controlled-release facility, an increase in manufacturing capacity, and optimized material flows. 

for the “Most Effective Process Development/Scale-Up Program,” 

for the “Most Innovative Relationship,” 

 for the “Best New Partnership/Merger/Acquisition,” 

 for the “Best e-Business or IT Strategy”, and 

 for both the “Best New Product” and the “Outsourcing Executive of the Year.”

 agreed to acquire an API manufacturing facility and an associated R&D facility from Orchid Chemicals & Pharmaceuticals, an Indian pharmaceuticals company, for approximately $200 million. The proposed acquisition follows Hospira’s 2010 purchase of Orchid’s generic injectable business and permits Hospira to be vertically integrated into certain beta-lactam antibiotic APIs. 

 has expanded its solutions to solve issues of poor bioavailability, patient acceptability, and delivery for non-oral routes of administration. Hovione’s toolkit of solutions includes crystal design, particle-size reduction to the micro or nano-scale, and amorphous solid dispersions. These services are offered from bench to commercial scale and are complemented with formulation development and clinical manufacture to Phase II. 

 contract manufacturing and services division has launched an analytical services unit that will provide laboratory method development and related analytical testing as part of its integrated service offerings. 

 for an upfront payment of $105 million, plus further payments of up to $15 million based on fiscal year 2013 performance. The deal is subject to regulatory approval and customary closing conditions. 

 is investing EUR 30 million ($39 million) to build a chromatography plant for the production of large volumes of commercial APIs. The plant will be built on Novasep’s existing site in Mourenx, France, and is expected to be operational and validated within 18 months. The new plant will contain Varicol continuous chromatography systems with 1200-mm diameter columns operated at up to 70 bars. Novasep also recently announced an EUR 3-million ($3.69 million) investment to expand its highly potent API manufacturing capabilities at its Le Mans, France, facility. The expansion is expected to be fully operational by the beginning of 2013.

 and Molecular Profiles have formed an agreement to deliver end-to-end services from initial drug discovery to early- and late-phase manufacturing. 

, a specialty pharmaceutical business focused on the research, development, and manufacturing of gelatin-based dosage forms for $255 million. The acquisition will be structured as a purchase of all of the shares of the entities through which Banner conducts its operations subject to working capital and other adjustments. The acquisition is subject to applicable regulatory approvals and other customary terms and conditions, and is expected to close by the end of 2012.

has received regulatory approval from French health authorities to fill biotechnology products at its site in Monts, France. The Monts site, which employs 200 personnel, comprises three filling lines. Two large capacity lines are used for glass vials for injection and a third one is an aseptic line that fills cartridges. 

, part of Sigma-Aldrich, plans to expand its operations in Scotland by investing in the development of a new powder-manufacturing facility on its Irvine site. SAFC’s new facility in Irvine is its second powder manufacturing facility, which will support SAFC’s risk-management program, providing an internal back-up supplier for its customers. The new facility will be used to service customers across Europe and will create 24 new jobs. The project is being supported by a £1.5-million ($2.42 million) Regional Selective Assistance grant from Scottish Enterprise. 

 has announced that its Tainan, Taiwan, facility will provide commercial manufacturing of topiramate, the API for Vivus’s Qsymia, a new drug for treating obesity that was approved by FDA on July 17, 2012. 

 completed an expansion of its Fairfield, New Jersey, facility on Sept. 20, 2012. The expansion enlarges the size of the facility from 15,000 to 30,000 ft

 by adding modernized and new GMP/GLP-compliant laboratories, and increases ICH Zone 1–4 storage capacities. 

has begun construction of its new compression molding facility in Sri City, India. The plant will become part of West’s global supply chain for its pharmaceutical packaging operations. 

 facility in Tampa, Florida, on Sept. 14, 2012. The building will be used for primary and secondary packaging, labeling, distribution, and warehouse services. This is the company’s second facility in the Tampa Bay area, and the company says it will be audited and approved for domestic as well as European clinical trials. 

Global Feature

Fine-chemical manufacturers producers and contract manufacturers announce manufacturing and service expansions at CPhI in Madrid.

Contract Manufacturers and Fine-Chemicals Producers Expand

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), held a conference late last month with more than 200 public- and private-sector leaders to discuss global-health concerns. The conference focused on how biopharmaceutical innovation addresses health challenges around the world, including diseases that disproportionally affect the poorer regions of the world, and how the private and public sectors can work collectively to address these concerns. 

Although recognizing advances in pharmaceutical innovation and related treatments in difficult-to-treat diseases, such as cancer and HIV/AIDs, IFPMA leaders noted the challenges that still exist.  “Yet some of our greatest challenges lie ahead with bugs resistant to antibiotics, neglected tropical diseases, and non-communicable diseases like cancer and Alzheimer’s,” said IFPMA Director General Eduardo Pisani, in an Oct. 31, 2012, press release. “We need to expand the arsenal of preventative vaccines and treatments through innovation. In recent years, major inroads on key health issues were achieved through global cooperation. Today’s challenges demand this same level of cooperation.” 

 Coinciding with this conference, the IFPMA leadership team consisting of John Lechleiter, chairman, president, and CEO, of Eli Lilly, Masafumi Nogimori, chairman of Astellas, and Stefan Oschmann, CEO of Merck Serono called for “a shared commitment to improving global health through innovation” in a Oct. 31, 2012 joint statement. Highlighting innovative advances such as the development of biotherapeutics, personalized medicines, and vaccines to prevent diseases, the three executives also addressed challenges to further innovation. They emphasized that environments that enable innovation , such as intellectual property protection and global standardization of regulatory best practices, are important  to further advance the development of pharmaceuticals to resolve global-health concerns.  

 In the joint statement, Lechleiter, Nogimori, and Oschmann addressed the challenges and opportunities to improve global public health. “We’re seeing the rise of superbugs resistant to current antibiotics. Neglected tropical diseases continue to hobble emerging economies. And cancer, diabetes, respiratory and neurological disorders, cardiovascular disease, and other noncommunicable diseases (NCDs) are a growing burden on rich and poor countries alike. NCDs now account for 60% of all premature deaths around the world, and it’s estimated that by 2030, over 80%  of premature deaths will be in low- and middle-income countries,” they said. “Making inroads against these problems requires an unprecedented degree of global cooperation. It also demands that we expand our arsenal of medical treatments and cures through ongoing innovation.”

 These pharmaceutical-company executives  also addressed the need for cooperation and a multistakeholder approach. “Solving these global health problems starts with a shared commitment to improving lives. The expertise and contributions of the global health community¬—nurses, doctors, governments, foundations, NGOs [nongovernmental organizations], academic institutions, and industry—have dramatically increased access to quality care and medicines, reaching the farthest corners of the world with life-saving treatment and care. Even with these efforts, fighting disease in developing countries continues to pose enormous challenges. Even when effective treatments exist, infrastructure to deliver and administer them is often lacking.”

In recognizing the need to work together, the pharmaceutical-company executives also stressed the need for intellectual property protection and harmonization of global regulatory standards to address global-health concerns. “None of this is possible though without policies such as intellectual property protection, which is the lifeblood of any enterprise generating value from ideas,” they said in the joint statement. “On average, it takes nearly 14 years and one billion euros to bring a new medicine from the drawing board to the pharmacy. Without the ability to protect one’s intellectual property, medical innovation would not be sustainable. And the benefits of intellectual property protection include not only breakthrough medicines, but, over time, a broad range of low-priced generic medicines, which are critical to fighting disease in low- and middle-income countries. Another key step would be to standardize best practices from national regulatory systems so that medicines can get to patients who need them more quickly and less expensively.” 

 The leaders from Eli Lilly, Astellas, and Merck Serono concluded their joint statement by emphasizing the commitment of the pharmaceutical industry to participate in shared solutions to global health concerns. “Addressing global health challenges is among our most urgent human and societal needs. Working together, we’ve begun to make progress. Our industry will continue to innovate and work with the health community to find new and effective approaches that make life better for millions of people. And we’ll continue to work to help the public and policy-makers understand that innovation is not the problem. It is the solution.”

CSR and Sustainability Forum

Pharmaceutical companies and public health officials gather at the IFPMA Assembly to urge for greater innovation and private and public partnerships to address global health concerns.

Eli Lilly, Merck Serono, and Astellas Call for Innovation in Global Health

 is donating $1 million in funding and product donations to support storm-relief efforts. Grants will be awarded to the American Red Cross, AmeriCares, Direct Relief International and World Vets, and product donations have also been made to Direct Relief International and Feeding America. Product donations have also been supplied to food banks and free clinics in states along the east coast of the US, including New Jersey, New York, North Carolina, South Carolina, and Virginia. 

 and its Amgen Foundation are contributing $250,000 to support relief efforts from the recent storm Sandy, including $100,000 to Direct Relief International, a nonprofit support agency that provides medical assistance to people affected by poverty, disaster, and civil unrest. The remainder of the funding will mainly be disbursed to organizations that specifically support dialysis patients, who require timely treatment. 

 has donated $200,000 to the American Red Cross for storm-relief efforts. In addition, the foundation is also contributing one dollar for every dollar donated by Eli Lilly employees to the American Red Cross or Salvation Army .

 recently highlighted its commitment to certain global-health projects, which include its tuberculosis (TB) compound library to be made available to help stimulate research into TB, its investment in GSK’s Tres Cantos Open Lab to be doubled with an additional £5 million ($8 million) funding awarded, and allowing detailed data from GSK clinical trials to be made available to researchers to further scientific understanding and knowledge. In other news, GSK reported that the GAVI Alliance has announced that GSK’s pneumococcal vaccine, Synflorix will be introduced into the national immunization program in Pakistan. 

, Grantmakers In Aging (GIA), a national association of funders, has launched 

Community AGEnda: Improving America for All Ages,

 announcing five grants of $150,000 each to local groups in Arizona, Florida, Georgia, Indiana, and the greater Kansas City area to accelerate their efforts to become “age-friendly or improve the quality of life for the aging population. addition to the $750,000 provided to the participating regions, Community AGEnda will use an additional $550,000 to assess and support the local efforts and inspire similar work across the country. This work includes promotional activities and the development of planning, assessment and strategy tools and other practical resources, including an online searchable database describing the growing number of age-friendly projects in the United States. The project will also gather national and regional funders to spur greater interest in age-friendly community development. On the local level, participating communities will seek to raise an additional amount equal to one-third or more of their grant in matching funds, a minimum of $50,000 each. 

A roundup of developments in corporate social responsibility (CSR) and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.

CSR and Sustainability in the News

Financing in the biotechnology sector is an important determinant of the health of the biopharmaceutical sector, and thus far in October, financing trends show both strengths and weaknesses. Through the first 10 months of 2012, overall public financing in the life-sciences sector declined on a global basis but increased in the United States. Although financing raised from initial public offerings (IPOs) was down both globally and in the US, money from follow-on offerings in the US were up although follow-ons were down on a global basis. Private-venture capital funding, both globally and in the US increased through the first 10 months of 2012, and financing from a partnering and licensing deals increased on a global basis but declined in the US. 

Overall, a total of 15 life-sciences companies have gone public in the US through the first 10 months of the year raising a total of $1.1 billion, a nearly 11% decline compared to the same period year ago, when 14 companies raised a total of $1.2  billion, according to Burrill & Company. For those companies with US IPOs in 2012, several companies had to  cut their share prices. Seven companies that have gone public in 2012 had to cut their share price to get their deals done. On a global basis, the number of IPOs in the life sciences was 32, down from 41 in the year-ago period. The 32 IPOs through October 2012 raised $2.1 billion compared with $3.7 billion raised from the 41 IPOs, a 44% decline year-over-year. 

 Although IPOs were down, money raised from follow-on offerings in the US were up through October 2012 although financing from follow-on offerings on a global basis declined. US follow-ons for the first 10 months of 2012 raised $5.5 billion, a 28.7% gain year-over-year, according to Burrill & Company. October was a particular robust month. In all, 12 of the 15 life-science follow-ons in the US in October raised $640.5 million, up from just $6 million for the same period a year agoOn a global basis, follow-on offerings raised nearly $6.4 billion through October 2012, a 19.6% decline from the $7.9 billion raised in the year-ago period. The global follow-on totals included China’s already public Fosun Pharma’s $511.6 million initial listing on the Hong Kong Exchange. 

Overall, total public life-sciences financing declined 4.2% on a global basis through October 2012 to $56.6 billion, according to Burrill & Company. In the US all public financings increased 30.4% to $43.4 billion through October 2012. In addition to IPOs and follow-on offerings, other forms of public financing include private investment in public equity, other forms of equity, debt offerings, and other forms of debt. 

 On the private side, global and US venture-capital funding both increased during the first 10 months of 2012, according to Burrill & Company. Global venture-capital financing in the life-sciences sector increased 21.7% from nearly $8.2 billion through October 2011 to almost $10.0 billion through October 2012. US venture-capital funding was also robust, increasing 22.0% from $6.2 billion through October 2011 to $7.6 billion through October 2012.

Merger and acquisition (M&A) activity continued to trail 2011 levels as total global deal values reached $6.5 billion in the month of October, 9.1%  less than the $7.1 billion in October 2011, according to Burrill & Company. Overall, the $94.7 billion in life-sciences deals announced during the first 10 months on a global basis is down 32.4%  from the same period in 2011. US-based M&A was also down in the first 10 months of 2012, declining 12.4% to nearly $68.7 billion through October 2012. Large pharmaceutical and biotechnology  companies have used M&A activity in 2012 to largely add new revenue sources and gain access to new markets and instead have relied on partnering transactions as a less risky way to get access to innovative drugs in development, observes Burrill & Company. Financing from partnering and licensing deals increased on a global basis through the first 10 months of 2012, up 12.8% to $33.0 billion. In the US, financing from partnering deals declined 6.3% to $16.8 billion. 

Biologics

Venture-capital funding is up, but initial public offerings still are weak.

PTSM: Pharmaceutical Technology Sourcing and Management-11-07-2012

Seeking Solutions in Solid-State Chemistry

Sizing the Market for Contract Manufacturing

Contract Manufacturers and Fine-Chemicals Producers Expand

Eli Lilly, Merck Serono, and Astellas Call for Innovation in Global Health

CSR and Sustainability in the News

Mixed Reviews for Biotechnology Financing