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C h a i n D r u g s t o r e D a i l y S u n d a y, A p r i l 1 7 , 2 0 1 6 8 NEW PRODUCTS FROM AMNEAL IN THE PIPELINE Amneal Pharmaceuticals anticipates quite a busy 2016 with several new prod- uct launches on the way. "Amneal has always invested heavily, with a dispro- portionate percentage of its revenue, in growing and broadening our product portfolio across all dosage forms and therapeutic categories," says Jim Luce, Executive Vice President, Sales and Marketing. Since 2012, the company has focused on expanding its portfolio to include many complex dosage forms and technologies such as injectables, topicals, transdermals, inhalation, complex mole- cules and devices. One of its most recent approvals was for tobramycin inhalation solution, which is a generic equivalent for Tobi ® inhalation solution, the compa- ny's first of this dosage form. In addition, Amneal launched a new lidocaine prod- uct line, starting with lidocaine five per- cent ointment and approval on a patch expected shortly. In late 2015, Amneal obtained approval on many differentiated products with high market potential, including oxybutynin chloride ER tablets, omega-3 softgel capsules, dutasteride softgel cap- sules and entecavir tablets. Amneal plans to launch its first injectable product in 2016 through Amneal Biosciences, a wholly-owned subsidiary focused on the institutional and specialty markets. "We've been strategically develop- ing products across all dosage forms," said Luce. "Injectables, both small molecules and biologics, are a natural extension. As we've done in both R&D and operations, we've brought industry experts on board to lead the company into those markets. The Amneal Biosciences team will focus on these products, which will be distributed pri- marily to the institutional segments." The company has several more high- volume/large market products in the pipeline as well. Amneal has 116 ANDAs pending with the U.S. Food and Drug Administration; more than 40 of those are targeted to launch in 2016. Roughly 40 percent of these pending ANDAs cover eFTF, FTM, FTF and other high- value products. An addi- tional 58 ANDAs are expected to be filed before the end of the year. Looking beyond 2016, the future looks equally strong, based on the 184 products currently in development. Luce added, "It isn't any one part of Amneal that drives our value. It takes a village – the scientists, engineers, opera- tions, logistics, sales – to create the most value for our customers. We believe by focusing on our customers and patients, and standing by the values of quality and integrity, this path will allow us to con- tinue sustaining our growth for many years to come." Visit Amneal at booth #202 or go to www.amneal.com to learn more. MEET YOUR NEW SQUEEZE: HELLO NATURALLY FRIENDLY ORAL CARE PRODUCTS hello ® naturally friendly™ oral care debuts new toothpaste options, bringing smiles to kids and adults alike. Fluoride-free and SLS-free toothpastes for both kids and adults are now avail- able, as well as hello extra whitening peroxide free fluoride toothpaste in pure mint. In addition to the new prod- ucts, hello has updated its kids and adult toothpaste packaging to FSC-cer- tified, responsibly-sourced craft paper boxes printed with soy inks. The unique designs feature bold colors and the brand's signature tone of voice, a blend of serious science with a wink. hello respects a brusher's right to choose. For those who prefer toothpaste without fluoride and SLS, hello's new fluoride-free SKUs for kids and adults are made with aloe vera, erythritol and xylitol. hello's fluoride-free pastes help clean, whiten and remove plaque. hello kids fluoride-free and SLS-free tooth- paste is available in a natural watermelon flavor. For adults, fluoride-free and SLS- free toothpaste is offered in a natural sweet mint flavor. "We wanted to develop effective oral care that's as friendly as possible," said Craig Dubitsky, Founder and Chief Executive Officer of hello products. "Some folks don't dig fluoride, SLS or peroxide, so we set out to create new, naturally friendly options that folks wouldn't just use, but that they'd love. With ingredi- ents like xylitol, stevia, aloe vera and erythritol, it's not just about what we took out, but what we put in." In addition to its new fluoride-free and SLS-free products, hello has also just launched a new extra whitening paste with no peroxide. This paste uses a gen- tle silica and calcium carbonate to safely and gently remove stains. Like all hello toothpastes, the new fluoride- and SLS- free pastes and extra whitening paste taste simply fab. The team at hello has said goodbye to many ingredients they feel aren't friendly to the environment or the people who use them: the full product line con- tains no dyes, no parabens, no artificial sweeteners, no triclosan and no microbeads. In addition to the new tooth- pastes, hello offers ADA approved fluoride kids toothpastes in bubble gum and blue raspberry flavors, and fluoride toothpastes in supermint and mojito mint flavors. Each hello fluoride toothpaste is proven to prevent cavities and strengthen enamel. Beyond pastes, hello also offers toothbrushes featuring handles made from 50 percent recycled materials, and breath sprays free from alcohol, dyes, artificial sweeteners and propellant. hello sprays feature glycerin and xylitol to keep your mouth fresh, friendly, won- derfully moisturized and ready for any- thing. For more information, contact Kim Sines by emailing kim@hello-products.com or calling 201.310.3354 STRONGBRIDGE BIOPHARMA PLC PROVIDES UPDATE ON CORPORATE PROGRESS Strongbridge Biopharma plc, a global rare disease biopharmaceutical company focused on the development and com- mercialization of novel therapeutic options, has announced an update on cor- porate progress. "We believe that our rare endocrine disease assets, COR-003 and COR-005, have the potential to be innovative new treatment options for Cushing's syn- drome and acromegaly, respectively, where there is considerable unmet need. We look forward to reaching critical near-term development milestones for each asset, including the reporting of top- line data from the COR-003 SONICS trial during the first half of 2017 and finalizing the technology to be utilized for a long-acting formulation of COR- 005 later this year. As part of our portfo- lio prioritization efforts, we have decided to initiate the return of COR-004 to Antisense Therapeutics. We also contin- ue to evaluate opportunities to maximize Strongbridge's growth potential, and believe that the company's current cash resources are sufficient to fund planned operations into the fourth quarter of 2017," said Matthew Pauls, President and Chief Executive Officer of Strongbridge Biopharma. Strongbridge has prioritized its rare endocrine disease portfolio and will con- tinue to advance clinical development of COR-003 (levoketoconazole), the com- pany's lead product candidate, which is a cortisol inhibitor currently being studied in the global Phase 3 SONICS trial for the treatment of endogenous Cushing's syndrome. The company will also contin- ue to advance development of COR-005, a next-generation somatostatin analog (SSA) with a unique receptor binding profile, being investigated for the treat- ment of acromegaly, with potential addi- tional applications in Cushing's disease and neuroendocrine tumors. SONICS clinical trial enrollment continues to progress as planned, and the company expects to report top-line data during the first half of 2017. For addition- al information about the SONICS trial, visit www.cushingssyndromestudy.com. The company expects to select and finalize the technology to be utilized for a proprietary long-acting formulation of COR-005 in 2016. Additional COR-005 development activities will be sequenced to ensure that the company's existing cash resources are sufficient to fund planned operations through the receipt of data from the COR-003 SONICS trial. Both COR-003 and COR-005 have received orphan designation from the U.S. Food and Drug Administration and the European Medicines Agency. As part of Strongbridge's prioritiza- tion of its rare endocrine disease portfo- lio and following receipt of feedback from regulatory authorities on COR-004, the company has initiated the return of COR-004, a second-generation antisense compound for the potential treatment of acromegaly, to Antisense Therapeutics. Following the return of COR-004, all rights to develop and commercialize COR-004 will revert to, and be the responsibility of Antisense Therapeutics. Further, given Strongbridge's core strategic focus on the development and commercialization of novel therapeutic options for the treatment of rare diseases, the company has decided not to invest fur- ther in the development of BP-2002, a gene-modified probiotic in pre-clinical development for the potential treatment of type 1 and 2 diabetes. The Company is cur- rently exploring potential partnership and out-licensing opportunities for BP-2002. As of December 31, 2015, Strongbridge had cash and cash equiva- lents of $51.4 million and no outstanding debt. The company believes it has suffi- cient existing cash and cash equivalents to fund planned operations into the fourth quarter of 2017, which is after the expected receipt of data from the COR- 003 SONICS trial. About Strongbridge Biopharma Strongbridge Biopharma is a global rare disease biopharmaceutical company focused on the development and commer- cialization of novel therapeutic options. Strongbridge's lead product candidate, COR-003 (levoketoconazole), is a cortisol inhibitor currently being studied in the global Phase 3 SONICS trial for the treat- ment of endogenous Cushing's syndrome. Strongbridge's rare endocrine disease fran- chise also includes COR-005, a next-gener- ation somatostatin analog (SSA) being investigated for the treatment of acromegaly, with potential additional appli- cations in Cushing's disease and neuroen- docrine tumors. Both COR-003 and COR- 005 have received orphan designation from the U.S. Food and Drug Administration and the European Medicines Agency. For more information, visit www.strong bridgebio.com.