Takeda’s MAA Filing Triggers a $10-Million Milestone

Furiex Pharmaceuticals, Inc. recently confirmed that Takeda Global Research & Development Centre (Europe) Ltd. received confirmation on the acceptance of the submission of a Marketing Authorization Application, or MAA, from the European Medicines Agency for alogliptin, a selective dipeptidyl peptidase IV, or DPP-4, inhibitor for the treatment of type 2 diabetes.

Under Furiex’s agreement with Takeda, this acceptance triggers a $10-million milestone payment to Furiex. Furiex receives royalty payments from Takeda for the sale of alogliptin products, trade names NESINA and LIOVEL in Japan, and it will receive royalties on sales in Europe, if approved.

“The acceptance of the MAA submission for alogliptin is an important step in expanding this treatment option to a wider patient population,” said June Almenoff, MD, PhD, President and Chief Medical Officer of Furiex.

“From the onset, we have believed in the value of alogliptin to patients, and we are pleased with this achievement,” added Fred Eshelman, PharmD, Chairman of Furiex,

Alogliptin is a DPP-4 inhibitor being investigated in the US, as an adjunct to diet and exercise, for the treatment of type 2 diabetes. DPP-4 inhibitors address insulin deficiency by slowing the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide). As a result, an increased amount of active incretins enables the pancreas to secrete insulin in a glucose-dependent manner, thereby assisting in the management of blood glucose levels. A New Drug Application for alogliptin was approved in April 2010 by the Japanese Ministry of Health, Labour and Welfare for the treatment of type 2 diabetes, and the therapy is currently available under the brand name NESINA in this market.

Furiex Pharmaceuticals is a drug development collaboration company that uses innovative clinical development design to accelerate and increase value of drug development programs by advancing them through the drug discovery and development process in a cost-efficient manner. Its drug development programs are designed and driven by a core team with extensive drug development experience. The company collaborates with pharmaceutical and biotechnology companies and has a strong, diversified product portfolio and pipeline with multiple therapeutic candidates, including two Phase III-ready assets, one compound in Phase III development with a partner, and two products on the market. The company’s mission is to develop innovative medicines faster and at a lower cost, thereby improving profitability and accelerating time to market while providing life-improving therapies for patients. For more information, visit www.furiex.com.

Zurex Pharma Inc. Secures $6.2-Million Financing

Zurex Pharma, Inc. recently announced it has raised $6.2 million in Series A financing, led by Baird Venture Partners and the State of Wisconsin Investment Board (SWIB), with participation from Wisconsin Investment Partners, Peak Ridge Capital, and individual investors. Zurex will use the capital to develop and commercialize a portfolio of innovative antimicrobial products designed to prevent healthcare acquired infections with a focus on surgical site wounds and catheter-related infections.

The Centers for Disease Control (CDC) estimates that 1.7 million hospital acquired infections occur in the US each year, which cause or result in almost 100,000 deaths. Other reports estimate that 10%, or 2 million patients per year become infected, with annual healthcare costs ranging from $4.5 billion to $11 billion. Zurex is focused on the development and commercialization of three novel, proprietary products designed to prevent and minimize healthcare acquired infections in a variety of inpatient, ambulatory, and home care settings.

“The increasing concern on hospital and home care safety, particularly in relation to healthcare acquired infections, leads to a very compelling market opportunity for Zurex,” said Michael Liang, PhD, Partner at Baird Venture Partners, which is part of a group that has made more than 20 investments in Wisconsin since the 1980s. “The Zurex team has a strong track record of developing innovative medical products and bringing them to market. We look forward to complementing their deep expertise with our operating resources and working together to take the company to the next level.”

“The Zurex executive team is very excited about partnering with Baird Venture Partners and SWIB in addition to securing this vital financing for the company. Our initial product targets have demonstrated impressive results throughout the spectrum of preclinical and clinical development, and we look forward to the opportunity to provide our innovative portfolio of infection control products to healthcare providers and patients,” added Carmine Durham, President and CEO of Zurex.

“We have been meeting with Carmine for over 2 years and have watched him develop a compelling vision and strategy for Zurex. Carmine has also built a top notch management team of Andrew Morgan and Mike Pawlak that has been executing on the Zurex plan while taking advantage of new opportunities along the way. We are pleased to have the opportunity to invest alongside Baird Venture Partners, Wisconsin Investment Partners, and Peak Ridge Capital,” said Chris Prestigiacomo, SWIB Portfolio Manager. “By participating in the Zurex financing, we continue our long-standing support of Wisconsin‘s early stage companies.”

As part of the transaction, Liang and Baird Venture Partners Operating Partner Fred Robertson, MD, will join Zurex’s Board of Directors. For more information, visit www.zurexpharma.com.

Royalty Pharma Raises $600 Million of Debt

Royalty Pharma recently announced it has successfully issued $600 million of incremental Term Loan B debt through RPI Finance Trust (RPIFT), bringing total debt outstanding at RPIFT to approximately $3.4 billion. Proceeds will be used to fund future acquisitions.

The new $600-million tranche was priced at 98.5 with a borrowing spread of Libor + 3% and matures on November 9, 2018, but otherwise has the same terms and conditions as RPIFT’s existing Term Loan B facilities, which consist of a $850-million tranche maturing on November 9, 2016, with a borrowing spread of Libor + 2.75%; and a $1.9-billion tranche maturing on May 9, 2018, with a borrowing spread of Libor + 3%. The new tranche was very well received, with strong demand resulting in the issue size being increased from $500 million to $600 million. Upon issuance of the new debt, RPIFT continues to have a conservative leverage ratio (measured as total debt to EBITDA) of 3.5x, compared to 2.9x prior to issuance. All three rating agencies, Moody’s Investor Service, Standard & Poor’s, and Fitch have affirmed RPIFT’s investment grade ratings.

“Overall, we are very pleased with the positive outcome of this transaction, especially in light of the current market conditions,” said Pablo Legorreta, Founder & Chief Executive Officer. “We believe the robust execution and our ability to maintain the same borrowing spread underscores the strength of Royalty Pharma’s reputation in the debt markets and the underlying high quality of our well diversified royalty portfolio. Despite the weak current market, from a long-term perspective, the overall cost of this debt financing is extremely attractive.”

Susannah Gray, Executive Vice President and Chief Financial Officer, commented, “We appreciate the continued support of our existing lenders and welcome the new lenders to our borrowing group. We believe our ability to place this additional debt demonstrates our lenders confidence in Royalty Pharma’s credit profile.”

Bank of America Merrill Lynch acted as lead book runner. Goldman Sachs and Citigroup acted as joint-book runners. Davis Polk & Wardwell acted as legal advisor to Royalty Pharma.

Royalty Pharma is the industry leader in acquiring royalty interests in marketed and late-stage biopharmaceutical products. With over $7.5 billion in assets, including royalty assets of $7 billion, the company owns royalty interests in over 30 marketed and late-stage biopharmaceutical products. Leading products in Royalty Pharma’s portfolio include: Abbott’s Humira, Johnson and Johnson’s Remicade and Prezista, Gilead’s Atripla, Truvada, Complera, and Emtriva, Pfizer’s Lyrica, Amgen’s Neupogen and Neulasta, Genentech’s Rituxan, Forest‘s Savella, Astella’s Lexiscan, Merck’s Januvia/Janumet, and Roche and UCB’s Cimzia and Mircera. The company has a 15-year history of providing value to holders of royalty interests, including its $700-million acquisition of AstraZeneca’s Humira royalty, its $700-million purchase of a portion of Northwestern University’s Lyrica royalty, its $650-million purchase of New York University’s Remicade royalty, its joint $525-million acquisition with Gilead Sciences of Emory University’s emtricitabine royalty interests, its $609-million acquisition of Astellas’ DPP-IV patent estate and associated royalty interests, and its $761-million acquisition of an interest in the amounts payable to the former shareholders of Fumapharm on Biogen Idec’s BG-12.

Bend Research Increases Hot-Melt Extrusion Capacity

Bend Research Inc. recently announced the expansion of its existing hot-melt extrusion (HME) capacity with the addition of an 18-mm Leistritz twin-screw mixer/extruder.

The 18-mm Leistritz twin-screw mixer/extruder complements Bend Research’s existing 27-mm Leistritz and 19-mm Baker Perkins extruder units, enhancing the company’s melt-extrusion and continuous high-shear wet-granulation capabilities. Many projects have been successfully advanced through the use of extrusion, including one product brought to market with Bend Research’s HME technology.

The 18-mm extruder will blend seamlessly into Bend Research’s science and engineering-based work flows for amorphous dispersions. Additionally, it will complement the company’s core offerings in oral solubilization, including spray-dried dispersions (SDDs) and crystal size reduction.

“As a leader in solubility enhancement and an expert in hot-melt extrusion, we work hard to continually improve and expand in ways that minimize the time, money, and active pharmaceutical ingredient required to advance these projects,” explained Rod Ray, Chairman and Chief Executive Officer at Bend Research. “The addition of this equipment enables us to use less API during formulation and process development, as well as allows for more facile transfer and scale-up from development through clinical trial manufacturing in our cGMP manufacturing facility.”

For a complete listing of Bend Research’s development and manufacturing equipment, please visit www.bendresearch.com/content/cgmp-manufacturing.

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.

Bend Research provides several capabilities, including formulation and dosage form support, assists in process development and optimization, manufactures clinical trial quantities of drug candidates in its cGMP facilities, and advances promising drug candidates from conception through commercialization. Bend Research is a leader in novel formulations, including SDDs and hot-melt extrusions, and controlled-release, inhalation, and biotherapeutics technologies.

CLINiLABS Opens Phase I Unit

Clinilabs, an early phase and specialty CRO that provides clinical drug development services to the pharmaceutical industry, recently announced it has opened a second Phase I unit in Southern New Jersey (Eatontown). The 50-bed capacity, 15,000-square-foot Specialty Pharma Phase I Unit features semi private rooms, a large PK sampling facility, a bioanalytic laboratory, pharmacy, and exam rooms.

Since 2001, Clinilabs has successfully completed clinical trials involving healthy, adult human volunteers and specialty patient populations. The staff has accrued experience in over 800 clinical studies, offering clients the service capacity of a big CRO – delivered by an organization that is right-sized and priced for early phase projects. The opening of the New Jersey Specialty Pharma Phase I Unit expands services currently offered at the company’s 50-bed, state-of-the-art, Phase I unit in Manhattan, raising total bed capacity to 100.

“I am pleased to announce the opening of our new unit in Eatontown, New Jersey,” said Dr. Gary Zammit. “This unit allows us to expand our Phase I capacity in two locations, providing first-in-human through end-of-phase II CRO services to our clients. We are now able to enroll larger samples of normal healthy volunteers and patient populations at our two units and at investigator sites worldwide.”

Clinilabs is a contract research organization that provides early phase and specialty clinical drug development services to industry. The company offer teams, processes, and technology solutions that are designed to serve single center and multicenter early phase studies – services that can be scaled as needed to meet the requirements of any clinical development program. For more information, visit www.clinilabs.com.

Tranzyme Pharma & Norgine Announce Top-Line Data

Tranzyme Pharma and Norgine B.V. recently announced top-line results of the primary analysis of ULISES 008, the second of two Phase III pivotal trials evaluating ulimorelin in postoperative ileus. Consistent with the ULISES 007 data released in March 2012, ULISES 008 did not meet the primary and secondary endpoints as there was no statistical difference between the ulimorelin and placebo groups. The two trials were identical in design and population.

ULISES 008 was a double-blind, multinational, placebo-controlled study to evaluate ulimorelin in accelerating GI recovery in subjects who had undergone partial bowel resection. The study was designed to randomize approximately 330 patients to once-daily IV administration of either 160 or 480 micrograms/kg of study drug, or placebo. The primary endpoint was the time to recovery of GI function as defined by the time from the end of surgery to GI2. GI2 is defined as the later of first bowel movement and tolerance of solid food.

“These results confirm the findings of the earlier ULISES 007 study and support our earlier decision to stop all NDA activities for ulimorelin,” said Franck S. Rousseau, MD, Chief Medical Officer, Tranzyme Pharma. “Tranzyme is now focusing its development efforts on TZP-102, an oral ghrelin agonist in Phase IIb for the treatment of diabetic gastroparesis. Diabetic gastroparesis is a chronic upper GI motility disorder and because the preponderance of ghrelin receptors are located in the upper GI tract, we believe TZP-102 is well suited for this indication. Top-line results from the Phase IIb trial are expected by the end of the year.”

Tranzyme Pharma is a late-stage biopharmaceutical company focused on discovering, developing, and commercializing novel, mechanism-based therapeutics for the treatment of upper gastrointestinal (GI) motility disorders. While approximately 40% of people in the US are affected by these persistent and recurring conditions that disrupt the normal movement of food throughout the GI tract, currently there are a limited number of safe and effective treatment options.

Tranzyme is developing TZP-102, an oral ghrelin agonist for treating the symptoms associated with chronic upper GI motility disorders. This product candidate targets a significant underserved market. Enrollment in a multinational, Phase IIb trial is ongoing; top-line data are expected by year-end 2012. By leveraging its proprietary drug discovery technology, Tranzyme is committed to pursuing first-in-class medicines to address areas of significant unmet medical needs. For more information, visit www.tranzyme.com.

Norgine is an independent, successful European specialty pharmaceutical company that has been established for over 100 years and has a presence in all major European markets. In 2011, Norgine’s net product sales were EURO250 million. The company employs over 1,000 people. Norgine’s focus is the development and marketing of pharmaceutical products that address significant unmet clinical needs in therapeutic areas, such as gastroenterology, hepatology, and supportive care. For more information, visit www.norgine.com.