9/25/2012

BD Introduces Shortest, Thinnest Pen Needle

Studies suggest that as many as one-fifth to one-third of people with diabetes are hesitant or unwilling to give themselves insulin injections for reasons that include needle anxiety. Patients who reported injection-related pain or embarrassment also admitted they intentionally skipped insulin injections more often. A study by the American Association of Diabetes Educators (AADE) revealed that 47% of people with diabetes would be more likely to administer their injections regularly if a product were available that would ease the pain and discomfort of injections. With these needs in mind, BD Medical, a segment of BD (Becton, Dickinson and Company) recently announced the launch in the US of the BD Ultra-Fine Nano Pen Needle with PentaPoint Comfort.

BD’s latest advancement in injection comfort, PentaPoint is a patented 5-bevel needle tip design that creates a flatter, thinner surface to help penetrate the skin with significantly greater ease. In a clinical home-use study, patients who inject insulin found BD’s 5-bevel pen needles to be significantly less painful, easier to insert, more comfortable and preferred overall when compared with current 3-bevel pen needles. Bench tests showed the modified PentaPoint needle tip reduces the force to penetrate the skin by 23% compared to 3-bevel pen needles.

In recent years, advances in needle manufacturing technology, along with shorter and thinner needles, have been associated with progressively improving patient self-rating of injection comfort. At 4 mm by 32 gauge, BD Ultra-Fine Nano is the shortest, thinnest pen needle available, is clinically demonstrated to enhance comfort, and provides a less intimidating injection experience. Combined with a one-handed injection technique and its ability to facilitate flexible site rotation, BD Ultra-Fine Nano may help improve adherence to diabetes therapy regimens to support better health outcomes. PentaPoint Comfort is an enhancement to BD Nano, reflecting that a modified needle tip can further advance patient comfort.

“BD Diabetes Care has been a leader in diabetes injection devices for over 85 years, and is committed to helping improve patients’ transition and adherence to injectable therapies by improving the efficacy, convenience, and comfort of medication delivery. We are excited to provide another first-to-market innovation, designed to dramatically improve the injection experience for the millions of people living with diabetes,” said Linda Tharby, President, BD Medical – Diabetes Care. “Building on the introduction of BD’s smallest needle, the BD Nano, we are confident that our new, patented PentaPoint Comfort technology will provide an even more comfortable injection experience. This will help enable patients to adopt and adhere more easily to the therapy regimens recommended to improve their outcomes.”

The AADE issued injection technique strategies that encourage the use of the smallest possible needle for improved patient comfort and insulin efficacy. The BD Nano 4-mm Pen Needle is proven to be as effective as longer needles for patients of various body types, and provides equivalent glucose control by effectively delivering the insulin dose to subcutaneous tissue, the recommended site for insulin injections, and reducing the risk of injecting into muscle. Intramuscular injection can accelerate insulin absorption and increase the risk of unanticipated hypoglycemia (abnormally low blood sugar). Subcutaneous injection allows the insulin to be absorbed at an appropriate rate, resulting in better glycemic control. For more information, visit www.bd.com/nano.

Catalent Completes $350-Million Offering

Catalent Pharma Solutions, Inc. recently announced the successful completion of its $350-million offering of 7.875% Senior Notes due 2018, issued at par. Catalent has used a portion of the net proceeds from this offering to fund a portion of its tender offer for outstanding 9.5%/10.25% Senior PIK-election Notes due 2015, including related fees and expenses, and expects to use the remaining net proceeds to finance any additional purchases pursuant to the tender offer and any excess for general corporate purposes, which may include repayment of indebtedness.

The Notes, which mature October 15, 2018, were offered in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended, and to non-US persons in accordance with Regulation S of the Securities Act. The Notes have not been registered under the Securities Act or the securities laws of any other jurisdiction and may not be offered or sold in the US or to, or for the benefit of, US persons absent registration under, or an applicable exemption from, the registration requirements of the Securities Act and applicable state securities laws.

Catalent Pharma Solutions is the global leader in development solutions and advanced drug delivery technologies, providing world-wide clinical and commercial supply capabilities for drugs, biologics, and consumer health products. For more information, visit www.catalent.com.

Jubilant HollisterStier Launches Analytical Services Division

Jubilant HollisterStier, a subsidiary of Jubilant Life Sciences, recently announced that its Contract Manufacturing & 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. Jubilant HollisterStier will offer a full suite of testing capabilities, including Raw Materials Testing, Release Testing, Microbiology testing, Laboratory Method Development & Validation, Impurities Testing, and Stability Testing & Storage. These capabilities will be available through its facilities in Spokane, WA, and Montreal, Quebec, Canada.

“The launch of our analytical services offerings is a continuation of our strategy to be a leading provider of services to the Life Sciences industry. We are expanding our analytical capabilities to support a wide array of high-quality laboratory tests, aimed at further servicing our clients and partners,” said Marcelo Morales, Chief Executive Officer, Jubilant HollisterStier.

Jubilant HollisterStier Contract Manufacturing & Services Division is a subsidiary of Jubilant Life Sciences, an integrated pharma and life sciences company headquartered in India. Jubilant HollisterStier provides its customers manufacturing services to aseptically fill liquid and lyophilized products, semi-solid and solid dosage forms at its facilities in the US, Canada, and India. Jubilant HollisterStier offers highly-skilled, cross-functional teams to provide custom solutions to customer-specific project goals from development through commercialization. For more information, visit jublHS.com.

JHP Pharmaceuticals to Produce Lyophilized Biologic

JHP Pharmaceuticals recently announced it has entered into an agreement with an undisclosed pharmaceutical company to produce supplies of a lyophilized biologic for international, late-phase clinical trials.

“We know that customers want to seamlessly progress from clinical batch production to product launch and then commercialization,” said Stuart Hinchen President and CEO of JHP. “JHP’s established infrastructure and expertise transitioning products from clinical to commercial supply are recognized by customers looking for long-term reliability and continuity when selecting a contract manufacturing organization. Additionally, our cGMP compliance record and experienced staff allows customers to focus on their pressing business needs with confidence.”

JHP has successfully supported launches of several products in US and international markets and manufactures products for sale in 86 countries. JHP’s Rochester, MI, manufacturing site’s 25-year history in contract manufacturing is a result of a solid cGMP compliance record, a quality-driven experienced staff and a customer-centric approach.

JHP Pharmaceuticals, headquartered in NJ, provides contract manufacturing of sterile products, including biologics, small molecule, controlled substances, vaccines, ophthalmics, otics, and antibiotics for large and small pharmaceutical and biotech organizations. For more information, visit www.jhppharma.com.

SteadyMed Therapeutics Raises $10.4 Million

SteadyMed Therapeutics Inc., a drug delivery therapeutics company, recently announced it has raised $10.4 million in a private placement of preferred stock. Proceeds from the financing will be used to support the development and commercialization of the company’s lead drug product that leverages its PatchPump technology; a novel, prefilled, size efficient, and disposable subcutaneous drug delivery system for which the company aims to complete pivotal clinical trials in 2013 followed by commercial launch in the US in 2014. Proceeds will also be used to complete the outsourced manufacturing infrastructure to support the company’s commercialization strategy.

The investment comes from current investors KB Partners and Samson Ventures as well as new investment from high net worth individuals and private funds.

“We are very pleased to close this $10.4-million round in addition to the $2.4 million we raised earlier this year,” said Jonathan M.N. Rigby, Chief Executive Officer. “SteadyMed has made impressive progress over the past 12 months in executing our strategy to develop and commercialize our own PatchPump-enabled drug product to treat a life threatening orphan disease, as well as with the securing of collaborations around our unique delivery platform with Biopharmaceutical partners. Raising significant investment in the current economic climate is laudable and a testament to our unique technology, credible strategy, and first-class management team. We are delighted to have the support of our current and new investors.”

SteadyMed Therapeutics, Inc., with offices in San Francisco, CA, and Rehovot, Israel, is a private, venture funded drug delivery therapeutics company engaged in the development for commercialization of its PatchPump technology; a novel, prefilled, size efficient, and disposable subcutaneous drug delivery system. The company’s range of PatchPumps can be customized to deliver liquid drugs, including biologics, with a wide range of volumes and viscosities, in a consistent and controllable manner. The company is leveraging the sustainable cost and technological competitive advantages of its PatchPump platform to create a family of products that benefit patients in target markets, which represent the highest value-to-risk ratios.

For more information, contact Marylyn Rigby at mrigby@steadymed.com. For more information, visit www.steadymed.com.

Selexys Completes Equity Financing & Signs Major Agreement

Selexys Pharmaceuticals, Corp. recently announced it has successfully completed a $23-million Series A equity financing, led by MPM Capital. Additionally, Selexys entered into an agreement with Novartis Pharmaceuticals whereby Novartis has been granted an exclusive option to acquire Selexys and its lead asset, the anti-P-selectin antibody SelG1, following the successful completion of a Phase II clinical study in patients with sickle cell disease. Including up-front, acquisition, and milestone payments, the agreement with Novartis could reach up to $665 million.

The Series A financing includes a new major investor, MPM Capital. Concurrent with the investment, Selexys also announced the addition of Todd Foley, Managing Director of MPM Capital, to the Selexys Pharmaceuticals Board of Directors.

“Patients with sickle cell disease endure great suffering and frequent hospitalization due to painful vasoocclusive crises. Chronic blockade of P-selectin function with SelG1 may improve clinical outcomes and lower the associated cost of patient care,” said Dr. Scott Rollins, President and CEO of Selexys. “We are excited to welcome MPM and Novartis and look forward to a productive partnership.”

The combination of the Novartis agreement and the closing of the Series A financing will allow Selexys to advance the SelG1 program through a large Phase II clinical study in sickle cell patients and will also fund a second program at Selexys, an anti-PSGL-1 antibody, through a Phase I clinical study.

“Vasoocculsive crises represent a significant healthcare problem for sickle cell disease patients, and we were impressed by the early data for SelG1 and the quality of the Selexys team,” said Todd Foley, Managing Director of MPM Capital. “We are pleased to be a part of this successful financing structure, and I look forward to working closely with Selexys.”

SelG1 is an investigational humanized monoclonal antibody directed against P-selectin, a key member of the adhesion molecule family known as the selectins. In preclinical studies, inhibition of P-selectin has been shown to effectively prevent vasoocclusion by blocking critical cell-cell interactions that drive this process. Therapeutic blockade of P-selectin may therefore reduce or prevent vasoocclusive crises in patients with sickle cell disease.

“SelG1 is a first-in-class therapeutic approach for the treatment of vasoocclusive crisis in sickle cell disease,” said Dr. Russell Rother, Selexys Executive Vice-president and COO. “Results from the recently completed Phase I safety study indicate that SelG1 is safe and well tolerated in healthy human subjects, and we are now eager to investigate its safety and efficacy in the sickle cell disease patient population.”

The SelG1 program for sickle cell disease is supported by Small Business Innovation Research (SBIR) fast-track award No. 5R44HL093893-02 and No. 2R44HL093893-03 through the National Heart, Lung and Blood Institute.

Selexys Pharmaceuticals, Corp., is a privately held biopharmaceutical company that is focused on development of therapeutics for the treatment of inflammation, thrombosis, and metastasis across a broad range of severe diseases. Selexys is also developing an antibody directed against PSGL-1 for the treatment of Crohn’s disease, multiple myeloma, and other inflammatory disorders. For more information, visit www.selexys.com.