7/25/2012
Agile Therapeutics Raises $40 Million
Agile Therapeutics recently announced it has closed a $40-million Series C financing. The round was led by new investor Aisling Capital, LLC, who joins existing Agile investors, including Care Capital, Investor Growth Capital, ProQuest Investments, Kaiser Permanente Ventures, and Novitas Capital.
Agile is preparing for commercialization of its lead product, AG200-15, a once-weekly, low-dose contraceptive patch. Agile recently filed an NDA with the US FDA for AG200-15 and anticipates a response in the first quarter of 2013. The company plans to use the proceeds from the financing to support the pre-launch and launch activities for AG200-15 as well as the continued development of its second product, a progestin-only contraceptive patch, AG890.
“We believe that AG200-15 and AG890 have the potential for significant impact in the contraceptive market, and will fill the need for more contraceptive options that offer convenience for patients. This funding gives us the financial strength to launch AG200-15 successfully and to advance the AG890 program,” said Al Altomari, President and Chief Executive Officer of Agile Therapeutics. “We are extremely pleased to have secured this funding in light of today’s challenging economic conditions and welcome Aisling as an investor in Agile.”
In conjunction with the financing, Dr. Andrew Schiff, Managing Partner at Aisling Capital, has joined the Agile Board of Directors. Dr. Schiff brings significant medical and a business expertise to Agile based on 12 years in the healthcare industry. In addition to serving as Clinical Assistant Professor of Medicine at The New York Presbyterian Hospital, he also serves on the board of directors of several well-respected pharmaceutical and medical device companies.
“I am thrilled to join the Agile Board of Directors at this exciting time in the development of the company,” said Dr. Schiff. “I look forward to working with the outstanding leadership team at Agile to bring AG200-15 to market. Aisling sees great promise in the product as a new option for women looking for convenient contraception that they only have to remember once a week. Additionally, Agile has a promising pipeline, including its progestin-only patch, and I welcome the opportunity to help lay the foundation for the company’s ongoing success.”
AG200-15 is a combination hormonal contraceptive patch, which in clinical studies, has been shown to deliver a low dose of ethinyl estradiol, as well as a dose of levonorgestrel that is consistent with that of low-dose oral contraceptives. The Phase III trials for AG200-15 enrolled more than 2,000 women, and formed the basis for the company’s NDA to the US FDA in 2012. The AG200-15 patch is applied once weekly for 3 weeks, followed by a fourth, patch-free week. The patch may be applied to the abdomen, buttocks, or upper torso, is soft and flexible with a cloth-like, silky feel, and designed to provide excellent adhesion, comfort, and appearance.
Agile Therapeutics is a pharmaceutical development company specializing in Women’s Healthcare products, with an initial focus on providing women with more options and more convenient methods of hormonal contraception. For more information, visit www.agilenttherapeutics.com.
BioTime Signs Agreements With Jade Therapeutics
BioTime, Inc. recently announced the signing of an exclusive sublicense agreement and a supply agreement with Jade Therapeutics, LLC, a developer of an ophthalmological therapeutic sustained-release drug delivery platform. Under the agreements, BioTime will provide Jade with clinical-grade HyStem hydrogels and certain patented technology for use by Jade Therapeutics in the development of new pharmaceutical products for ophthalmologic use. Jade plans to utilize the hydrogels to facilitate time-release topical delivery of recombinant human growth hormone to help heal lesions on the ocular surface. Jade Therapeutics will retain rights to market their product upon completion of development and obtaining marketing approval. Financial terms of the transaction were not disclosed.
“The HyStem product line has potential utility in a wide array of human therapeutic products,” said William P. Tew, PhD, BioTime’s Chief Commercialization Officer. “Numerous published scientific reports have established the efficacy of HyStem to facilitate cell transplantation in animal models, and we currently plan on a near-term approval to market one HyStem–related product, Renevia, in the EU for reconstructive and cosmetic surgery. We believe our HyStem technology may also be useful as a device for the slow, timed release of therapeutic agents, such as those being developed by Jade Therapeutics, as well as for the controlled release of proteins secreted from BioTime’s stem cell lines.”
“The HyStem product line has potential utility in a wide array of human therapeutic products,” added Michael West, PhD, BioTime’s CEO. “We intend to seek additional industry partners for applications that are not core to our own therapeutic product development.”
BioTime’s HyStem hydrogels are proprietary biocompatible hydrogels that mimic the human extracellular matrix (ECM), a web of molecules surrounding cells that is essential to cellular function. When cells lacking the ECM (or an ECM substitute) are introduced into the body, they typically die or fail to function correctly after transplantation. BioTime’s HyStem hydrogels are currently being used by researchers at a number of leading medical schools in studies of stem cell therapies for facilitating wound healing and for the treatment of ischemic stroke, brain cancer, vocal fold scarring, and cardiac infarct.
Jade Therapeutics, LLC, a privately held company headquartered in
BioTime, headquartered in
R-Tech Ueno to Collaborative With
R-Tech Ueno recently announced it will conduct a collaborative study with Tohoku University, a national university corporation, to develop a drug delivery system for Isopropyl Unoprostone (hereinafter referred to as Unoprostone), a compound made by R-Tech Ueno, using a sustained drug delivery system device (patent pending: International Publication No. WO2011/021594) invented by the study team of Prof. Toshiaki Abe M.D. et al, Division of Clinical Cell Therapy, United Centers for Advanced Research and Translational Medicine, Tohoku University, Graduate School of Medicine.
Unlike conventional devices that are inserted into the eye, this new device is a minimally invasive transscleral drug delivery system that is attached to the sclera, and does not require vitreous surgery. A Phase II clinical study of frequent instillations (2 drops per instillation, twice a day) of UF-021 (Unoprostone) Eye Drops, which are under development at the company for the treatment of retinitis pigmentosa, has been completed. According to R-Tech, if the Unoprostone drug delivery system is realized, the treatment with Unoprostone will become feasible in patients with retinitis pigmentosa in whom frequent instillation is difficult.
In addition, the company believes the expanded indication of Unoprostone as a treatment drug for atrophic age-related macular degeneration, for which there is currently no effective therapy, may become possible. It hopes to pursue this collaborative study with Prof. Abe’s study team at
Prostone is a group of functional fatty acids discovered in the early 1980s by R-Tech Ueno founder, Ryuji Ueno, MD, PhD. While it has positive local physiological effects as a drug, it is also a chemical compound free from various systemic adverse reactions that were originally exhibited with Prostaglandin. Rescula (Generic name: Isopropyl Unoprostone) Eye drops 0.12%, approved for marketing in Japan in 1994, is the world’s first Prostone medicine for the treatment of glaucoma and ocular hypertension, and has been reported to have ion (K+ ion) channel opening activity and is able to not only lower the intraocular pressure, but also provide sustained optic nerve protection (in vitro) and improve ocular blood flow in patients with normal-tension glaucoma. It has been approved in 45 countries worldwide since it was first marketed in 1994. In 2009, the formulation was changed to reduce the antiseptic level in Rescula Eye Drops. Since 2010, it has become possible to store the drug at room temperature rather than in a cool place.
For the treatment of retinitis pigmentosa, R-Tech Ueno has also pursued the development of eye drops (Product name: Ocuseva) that contains unoprostone as the main component, and a Phase II clinical study has been completed now. The Phase II clinical study revealed that the number of patients with deteriorated retina sensitivity in the central part of the retina decreased significantly. For more information, visit www.rtechueno.com/em/.
Thermo Fisher Scientific Launches New Extruder for Pharmaceutical Research
Thermo Fisher Scientific Inc., recently announced it launched the Thermo Scientific Pharma 11, a new version of its parallel co-rating twin-screw extruder designed specifically for pharmaceutical research. The 11-mm extruder is easy to use and designed to be fully scalable, minimize material costs and optimize laboratory space. To achieve this, the Pharma 11 extruder features a user-friendly touchscreen and simple washing options. The instrument’s screw and barrel designs are geometrically scalable, and the benchtop device uses a minimal amount of sample material (20 g).
“Our customers in pharmaceutical research are facing several challenges that the Pharma 11 extruder addresses head on,” said Karl Gerhard Hoppmann, Vice President and General Manager of Thermo Fisher’s material characterization business. “The instrument uses small quantities of sample material, solving for the limited availability of active ingredients in this research setting. The Pharma 11 extruder also offers a compact, robust design that saves space while at the same time providing full scalability with the entire line of Thermo Scientific compounding systems.”
The new Pharma 11 extruder offers easy cleaning and validation – all material contact parts are easily removable – as well as an intuitive touchscreen with integrated feeder control. The instrument features a throughput of 20 g/h to 2.5 kg/h and is easily convertible from hot melt extrusion (HME) to twin screw granulation (TSG) applications. The Pharma 11 extruder is ideal for a wide range of drug development applications, including drug delivery systems, implants, tablets, and granules. The GMP-compliant device is also suitable for clinical trials, and the compact design makes it ideal for glove box applications. The Pharma 11 extruder is available immediately. For more information, visit www.thermoscientific.com/mc.
Array BioPharma Reaches Multi-Million Dollar Milestone
Array BioPharma Inc. recently announced that an $8.5-million milestone was achieved in its collaboration with Amgen. Array entered into an agreement with Amgen in December 2009 for the worldwide development of the small-molecule glucokinase activator (GKA) program, including AMG 151. The milestone was achieved after Amgen reached a pre-defined patient enrollment level in a Phase IIa clinical trial.
The Phase IIa trial is a randomized, double-blind, placebo-controlled study of AMG 151 in combination with metformin in patients with type 2 diabetes. The primary endpoint is change in fasting plasma glucose levels from baseline to end of treatment. Amgen continues to advance the trial and seeks to enroll approximately 224 patients.
Under the agreement, Amgen paid an up-front fee of $60 million. Array is also entitled to receive up to approximately $658 million in additional aggregate milestone payments if all clinical and commercialization milestones specified in the agreement for AMG 151 and at least one backup compound are achieved. Array will also receive royalties on sales of any approved drugs developed under the agreement.
Glucokinase activators, such as AMG 151, represent a promising new class of drugs for the treatment of type 2 diabetes. Glucokinase is the enzyme that acts as a glucose sensor in the pancreas and liver. The activation of glucokinase lowers glucose levels by enhancing the ability of the pancreas to sense glucose, which leads to increased insulin production. Simultaneously, GKAs increase the net uptake of blood glucose by the liver. In multiple well-established preclinical models of type 2 diabetes, AMG 151 was highly efficacious in controlling both fasting and non-fasting blood glucose, with rapid onset of effect and maximal efficacy within 5 to 8 once-daily doses. In these studies, when combined with existing standard-of-care drugs (metformin, Januvia (sitagliptin) or Actos (pioglitazone), AMG 151 provided additional glucose control, which reached maximal efficacy after 5 to 7 days of once-daily dosing. AMG 151 did not increase body weight, plasma triglycerides, or total cholesterol, whether used as monotherapy or in combination with other diabetes drugs.
Array BioPharma Inc. is a biopharmaceutical company focused on the discovery, development, and commercialization of targeted small-molecule drugs to treat patients afflicted with cancer and inflammatory diseases. Array has four core proprietary clinical programs: ARRY-614 for myelodysplastic syndromes, ARRY-520 for multiple myeloma, ARRY-797 for pain and ARRY-502 for asthma. In addition, Array has 10 partner-funded clinical programs including two MEK inhibitors in Phase II clinical trials: selumetinib with AstraZeneca and MEK162 with Novartis. For more information, visit www.arraybiopharma.com.
Infinity Pharmaceuticals Regains Worldwide Rights to Multiple Programs
Infinity Pharmaceuticals, Inc. recently announced it has restructured its strategic alliance with Mundipharma International Corporation Limited and Purdue Pharmaceutical Products L.P. by mutual agreement. With this restructuring, Infinity regains worldwide rights for its phosphoinositide-3-kinase (PI3K) program, its fatty acid amide hydrolase (FAAH) program and its early discovery programs. IPI-145, the company’s potent, oral inhibitor of PI3K-delta and -gamma, is currently progressing in a Phase I trial in patients with advanced hematologic malignancies.
“Regaining worldwide rights to all of our programs, particularly our PI3K program, is an important, value-creating development for Infinity,” said Adelene Q. Perkins, President and Chief Executive Officer of Infinity. “Our strategic alliance with Mundipharma and Purdue has been key in building the company, and we are pleased that they will now participate in the value of our PI3K program as a more significant Infinity equity holder, together with our other investors.”
Infinity announced the expansion of its Phase I, open-label, dose-escalation trial of IPI-145 in patients with advanced hematologic malignancies. This expansion cohort will evaluate the safety, pharmacokinetics and efficacy of IPI-145 administered at 25 mg twice daily (BID) in patients with chronic lymphocytic leukemia, indolent non-Hodgkin’s lymphoma or mantle cell lymphoma. There have been confirmed investigator assessments of clinical response at the lowest dose levels, including 15 mg BID and less. To date, IPI-145 has been well tolerated and dose-escalation remains ongoing. The maximum tolerated dose (MTD) of IPI-145 has not yet been determined, and additional expansion cohorts are planned once the MTD is reached. Infinity expects to present data from this trial at a medical meeting in the second half of 2012.
In addition, the company plans to initiate a Phase II trial of IPI-145 in patients with asthma as well as a Phase II trial in patients with rheumatoid arthritis in the second half of 2012.
Under the terms of the termination agreements with Purdue and Mundipharma, Infinity has reacquired all worldwide development and commercialization rights for its PI3K, FAAH, and early discovery programs, and Mundipharma will no longer provide research and development funding to Infinity. Mundipharma and Purdue are entitled to receive royalties on product sales for programs previously included in the strategic alliance, at rates ranging from 1% to 4%. Infinity also entered into a stock purchase agreement with Purdue Pharma under which Infinity will issue and sell 1,896,552 shares of its common stock, at a price of $14.50 per share, for aggregate proceeds to Infinity of $27.5 million. Infinity will also issue 3,520,013 shares of Infinity common stock, at the same price per share, to repay the principal and accrued interest outstanding under the $50-million line of credit made available by PPLP.
These equity purchases are subject to the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and the satisfaction of other customary closing conditions. Upon completion of these equity purchases, PPLP, together with certain associated entities, would hold approximately 28 percent on a combined basis of Infinity’s fully diluted common stock outstanding. In addition, PPLP and the associated entities have agreed to vote any shares held by them in accordance with the voting recommendations put forth by Infinity’s Board of Directors, subject to certain exceptions for shares held by the associated entities prior to entry into the stock purchase agreement with respect to votes on major corporate transactions and charter amendments. Further, Mundipharma’s Board observation rights have terminated.
Infinity is an innovative drug discovery and development company seeking to discover, develop, and deliver to patients best-in-class medicines for diseases with significant unmet need. Infinity combines proven scientific expertise with a passion for developing novel small molecule drugs that target emerging disease pathways. For more information, visit www.infi.com.
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