Foresite Capital Closes $100 Million Fund for Late-Stage Biotechs

Biotech venture capital isn’t what it used to be, but there’s still money to invest in healthcare. Now one biotech investment firm just starting out has found $100 million to plow into “late-stage” companies. Foresite Capital Management, a San Francisco- and New York-based firm founded by Jim Tananbaum in 2011, said recently it has officially pulled together $100 million for its Foresite Capital Fund I. The fund’s strategy, according to a statement, is to invest in “disruptive, late-stage products and services in a broad range of healthcare from biotechnology, genomics, and diagnostics to healthcare services and medical devices.”

Foresite chose to highlight six current investments in today’s statement, four of which are public companies, while the two private companies have both completed Phase II clinical trials. Foresite singled out AcelRx Pharmaceuticals, Intarcia Therapeutics, Keryx Biopharmaceuticals, Puma Biotechnology, Solta Medical, and Tarsa Therapeutics as model examples from its portfolio.

As opposed to seed or early stage investments just starting out with lots of time, expense, and risk ahead of them, Foresite said it plans to focus on providing growth capital to help companies that are more established.

“We are marrying the best practices of growth investing with healthcare specialization,” Mr. Tananbaum said in a statement. “We are proud of our capital base, extremely excited about the prospects for healthcare growth, and believe on a risk-adjusted basis there has never been a better time to have this focus.”

Mr. Tananbaum, an MD and MBA, is a veteran of the biotech scene, and familiar with the time, expense, and risk that goes with starting something new. He was a co-founder and CEO of South San Francisco-based Theravance, and then worked the past decade as a venture capitalist with Prospect Venture Partners.

One of Mr. Tananbaum’s colleagues from Prospect, Managing Director Dorothy Margolskee, has joined him at Foresite. Prospect, a well-known biotech venture firm that invested in everything from early to late-stage companies, told VentureWire in October 2011 that it was unable to reach its $250 million fundraising goal for a new fund. For more information about Foresite Capital, visit www.foresitecapital.com.

Bend Research Receives EU Certificate

Bend Research Inc. recently announced it has received certification of compliance with European Union (EU) Good Manufacturing Practice (GMP) regulations. This broad certification, which was granted by Sweden’s Medical Products Agency (MPA), covers Bend Research’s manufacture of clinical pharmaceutical supplies for human consumption and testing of those supplies at the company’s GMP facilities.

“The strategic addition of this certification – combined with new capabilities such as high-potency spray”‘drying and future commercial spray”‘drying – strengthens Bend Research’s position as a preferred provider for oral solubilized, modified-release, inhalation, and many other dosage forms,” said Rod Ray, Bend Research CEO.

“We knew the EU’s quality standards were stringent, but we were confident that our operations met those high standards and were eager to demonstrate that to our customers,” Mr. Ray added.

In 2012, Bend Research produced clinical supplies for 16 clients, 37 chemical compounds, and 136 clinical manufacturing lots. Many of these involved the use of advanced dosage forms designed to increase the exposure of low-solubility compounds or provide modified-release delivery profiles.

Bend Research requested the voluntary inspection by the MPA, and certification was granted after an audit of operations by the MPA. The MPA GMP Certificate is recognized by all health authorities in the EU under the EU’s centralized marketing authorization procedure, as well as by authorities of other countries that recognize EU certification.

For more than 35 years, Bend Research has worked with clients to create value by advancing new medicines that improve human health and to solve their most difficult scientific and technical problems. This success is based on the company’s ability to develop, advance, and commercialize pharmaceutical technologies, which grow from a solid base of scientific and engineering fundamental understanding. For more information, visit www.bendresearch.com.

CROs Offer Promise of Innovative, Safe & Effective Development

Pharmaceutical and biotech companies are outsourcing research in order to develop innovative products that meet the rising demand for therapeutics across a range of diseases. The willingness of contract research organizations (CROs) to invest in state-of-the-art facilities to conduct clinical trials is further advancing market prospects.

New analysis from Frost & Sullivan (http://www.healthcare.frost.com), Analysis of the European Contract Research Outsourcing Markets, finds that the markets earned revenues of approximately $6.07 billion in 2011 and estimates this to reach $11.54 billion in 2018. Phase III clinical trials account for the largest share of the total CRO market in Europe.

The promise of novel therapeutic options that offer enhanced efficacy and safety is underlining the appeal of CROs for the pharma and biotech industry.

CROs help support greater innovation and improvements in chemical and biological drug development. They address the urgent need for enhanced therapeutics in cardiovascular, oncology, autoimmune, central nervous system (CNS), infectious, endocrine, and metabolic disease areas.

“Besides functionality, drugs are also tested for their efficacy and safety to ensure they meet the needs of patients across different ethnic groups and climatic zones,” states Frost & Sullivan Research Analyst Deepika Pramod Chopda. “The globalized nature of CROs enables them to facilitate the process of drug development for their clients.”

CROs offer complete and cost-effective solutions for pharma and biotech companies that are often challenged by high development costs and lengthy approval periods. CROs could potentially offer services in drug development as well as clinical trials and testing. CROs currently account for nearly two-thirds of the Phase I to III trials conducted globally.

A key limitation to the seemingly inexorable march of CROs has been the ability of large pharmaceutical and biotech companies to perform R&D and clinical drug testing in-house.

“The availability of specialized research technologies, coupled with an exclusive focus on drug development and testing, will boost the chances of success for CROs and offset the benefits of in-house R&D services,” concludes Chopda. “Strengthening outsourcing partnerships and alliances with leading pharmaceutical and biotech companies through strategic long-term contracts will also support the uptake of CRO services.”

If you are interested in more information on this study, please send an email with your contact details to Anna Zanchi, Corporate Communications, at anna.zanchi@frost.com.

Analysis of the European Contract Research Outsourcing Markets is part of the Life Sciences Growth Partnership Service program, which also includes research in the following markets: European Biosimilars Market, European Pharmaceutical and Biotech Contract Manufacturing Markets and Contract Research and Manufacturing Services Market in India. All research included in subscriptions provide detailed market opportunities and industry trends that have been evaluated following extensive interviews with market participants.

Frost & Sullivan, the Growth Partnership Company, works in collaboration with clients to leverage visionary innovation that addresses the global challenges and related growth opportunities that will make or break today’s market participants.

Generic Statins to Slash Global Market Value

The introduction of generic statins has kick-started a decline that will see the global statins market lose more than $7 billion in revenue by 2018, states the latest report by business intelligence providers GBI Research. The firm’s new report forecasts the worldwide statins market to drop from a 2012 valuation of $19.7 billion to $12.2 billion just 5 years later at a negative Compound Annual Growth Rate (CAGR) of 7.7%.

Statins are increasingly under threat from non-statins and combination therapies (a mixture of statins and non-statins), but the primary threat to global revenue lies with the rise of generic variants. The global statins market declined in 2006 and 2007 due to patent expiries for Merck’s Zocor (simvastatin) and Pravachol (pravastatin), but revenue has remained steady until recently. However, the expiry of Pfizer’s blockbuster drug Lipitor (atorvastatin calcium) in 2011, followed by the immediate launch of generics, has intensified the competition in the statins market and will restrain the commercial opportunities for upcoming products.

The US, the largest single contributor to the global statins market, is expected to demonstrate substantial loss of revenue in the near future and is forecast to slip from a valuation of $10 billion last year to $5.8 billion in 2018 – a depreciation of 42% in just 6 years. GBI Research’s new report predicts that due to the effects of numerous patent expiries, the generic share of the global statins market will reach 34% in 2018 from an 11% share in 2011.

GBI Research is a market-leading provider of business intelligence reports, offering actionable data and forecasts based on the insights of key industry leaders to ensure you stay up-to-date with the latest emerging trends in your markets. For more information on Statins Market to 2018 – Weak Product Pipeline & Shift of Focus Towards Combination Therapies Will Lead to Erosion of Brand Share, please contact the Press Office on +44 (0)1204 543 528 or at pr@gbiresearch.com.

Patheon Makes Investment to Expand Early Development Capabilities

Patheon Inc. recently announced plans for additional investment in its Milton Park facility. Located in Oxfordshire, UK, Milton Park is a dedicated pharmaceutical development services facility focused on early development projects.

As part of its early stage offerings, Milton Park currently provides proof-of-concept and first-in-man development programs for oral dose forms. It also offers Quick to Clinic, which provides clinical trial materials as fast as 4 months from receipt of active pharmaceutical ingredients (APIs). This service has been structured to provide support to emerging pharmaceutical companies with promising molecules.

With the first phase of additional investment to Patheon’s Milton Park facility, the company will be able to expand upon the early development capabilities currently being offered, including the introduction of the SoluPath program. SoluPath is the first fixed-price, multi-platform solution to improve bioavailability that allows parallel formulation screening using multiple leading edge technologies to review aqueous, lipid-based, and solid state formulations. The result is a unique formulation development program for low solubility/bioavailability molecules, which should facilitate a faster route to the clinic. The purchase of a new HME screening tool and spray-drier will supplement existing technologies at Milton Park to provide the SoluPath service to emerging pharmaceutical companies with poorly soluble molecules.

“The introduction of Solupath into Milton Park’s existing capabilities is an exciting addition to Patheon’s service offering in Europe,” said Robin Platt, Senior Director, Operations for Milton Park. “Poorly soluble compounds are increasingly common in pharmaceutical development, and we believe Solupath provides a mechanism for identifying the most effective way of improving bioavailability of molecule in these cases.”

Paul Garofolo, Executive Vice President, Global PDS Operations, added, “Solupath has been operating successfully in Patheon’s North American facilities. Establishing this capability in Europe is part of Patheon’s global strategy to expand early pharmaceutical development services for our customers.”

Tapemark Expands Transdermal Patch Capabilities

Tapemark recently announced the addition of several new capabilities for transdermal patches, including the formulation, blending, and coating steps in the patch manufacturing process. Combined with Tapemark’s existing converting and packaging expertise, Tapemark now is a fully integrated transdermal contract development and manufacturing organization (CDMO), from active pharmaceutical ingredients (APIs) to the finished transdermal patch.

Andy Rensink, President and Chief Operating Officer of Tapemark, explained that upon its 60th anniversary, Tapemark recently invested heavily in expanding both its capabilities and its physical facilities in the realm of transdermals.

“Responding to customer demand for full vertical integration, we’re adding formulation, blending, and coating to our existing superior converting and packaging capabilities. Now we’re a full-service provider in the transdermal space,” said Mr. Rensink.

In addition to a significant investment in new equipment and the facilities build-out currently in progress, the company is adding staff to support the new capabilities.

“The industry really has been searching for a full-service provider such as Tapemark,” added Mr. Rensink. We anticipate strong growth for Tapemark and for the pharma industry, especially as generic drugs continue their push for market share in transdermal patches.”

Tapemark is a full-service CDMO providing web-based (flexible roll goods) manufacturing for Drug, Device, and Combination Products. With new capabilities in Formulation, Blending, and Coating, added to its existing superior Converting and Packaging expertise, Tapemark is now a fully-integrated transdermal CDMO of choice, from API to finished transdermal patch. For more information, visit www.tapemark.com.

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