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C h a i n D r u g s t o r e D a i l y M o n d a y, A p r i l 2 7 , 2 0 1 5 1 4 A CONNECTION TO EXCELLENCE Behind every Roxane product, you'll find a team that connects you to the peo- ple who work tirelessly to bring safe and affordable generic pharmaceuticals to patients everywhere. With continual advances in cutting-edge administration and dosage for more than 100 medica- tions, and ongoing efforts to keep its product line affordable and available to as many customers as possible — the team at Roxane Laboratories is focused on meeting and exceeding the needs of each and every one of its customers and patients. In 2013, Boehringer Ingelheim Roxane Inc., opened a new $50 million High Containment Operations facility in Columbus, Ohio in order to meet a grow- ing market demand for high potency and oncology products. The building uses state-of-the-art technology to develop and manufacture differentiated high potency oral solid tablets and capsules in support of Roxane Laboratories' Inc. rap- idly growing generic business. This expanded capacity includes product and analytical development areas, quality control laboratories, active pharmaceutical ingredient filling, manu- facturing and packaging areas and a fin- ished goods warehouse. A unidirectional work flow and state-of-the-art contain- ment technology provides a safe and effi- cient work environment for its people and its customers. Since the opening of the High Containment Operations, the new capacity has given birth to novel dosage forms like Cyclophosphamide Capsules. This new Cyclophosphamide capsule dosage form enabled a more sta- ble supply of a critical care product to patients to who benefit from it most. The Roxane Laboratories Inc. HCO facility provides more opportunity to develop more generic potent compound products that will be available over the next sever- al years. These new potent compound products will offer more affordable med- ications to benefit its customers and the patients they strive to serve. Thanks to the new High Containment Operations facility and the technolo- gies employed, Roxane Laboratories Inc. is posi- tioned now and in the future to broaden its prod- uct portfolio even more. "The investments in technology, time and expertise required to bring such a facility on line cannot be easily achieved. This new facility is a symbol to our customers that Roxane Laboratories Inc. will continue to supply a differentiat- ed, high value pharmaceutical portfolio to our patients and customers for decades to come," said Randy Wilson, General Manager, Roxane Laboratories Inc. For more information, visit www .roxane.com. A FOCUS ON QUALITY For LNK International Inc., which spe- cializes in manufacture of private label over-the-counter pharmaceuticals and contract manufacturing, a focus on quali- ty, is in the company's DNA. "Quality will always keep your product on the shelf," said Joseph Mollica, CEO and Founder of LNK. Many firms say they are committed to delivering quality products, of course, but LNK officials say that at their com- pany it is embedded in their corporate fabric. For LNK President, Pankaj "PK" Chudgar, the ability to oversee all areas of the manufacturing process and the packaging process means that quality standards are built into each step. More than 15 percent of LNK's staff is dedicat- ed to quality control and quality assur- ance. "I think that most would agree that a solid quality program costs a fraction of what a recall will cost," said Chudgar. Historically LNK has focused on producing only high quality products. For example, LNK decided to keep the company focused on over-the-counter pharmaceuticals. This approach has allowed the company to concentrate on what it knows best and does very well for over 35 years. LNK specializes in over the counter pharmaceutical products specifically solid-dose analgesics, cough/cold/allergy/sinus and gastroin- testinal products, and offers more than 140 pharmaceutical formulas in these areas. In answer to its customers' repeated requests to enter the liquid market because of a void of quality liquid sup- pliers LNK has entered into liquids and semi-solid dosage forms. Now offering the industry the same quality and reliabil- ity it has come to know from LNK. As a prime manufacturer, LNK con- trols every step of the production process, from the acquisition of raw materials through the manufacturing and distribution of finished products. By control- ling all aspects of pro- duction, LNK is able to control the quality and keep costs low. LNK produces 99 percent of the products in its facilities in Hauppauge, N.Y. Working directly with the manufac- turer is a real advantage for LNK cus- tomers that seek to create a brand because it allows them to be certain that the products will be of uncompromised quality. As a prime manufacturer, LNK can maintain the integrity of its cus- tomers' products. Working with a prime manufacturer also creates significant advantages for the retailer or national brand client, as the flexibility exists at the manufacturing level to adjust to certain market conditions at a moments notice. "At LNK, quality is taken very seri- ously as it is the foundation for every- thing we do. Our client's relationship with their customers' is taken seriously and quality is the key," said Doug Bausch, Vice President of Sales and Marketing. "As a private brand and contract manufacturer, the reputation of our customer is on the line everyday as well as our own reputation." The payoff from this strat- egy of remaining prime and maintaining a commitment to quality is the fact that LNK is one of largest private label man- ufacturer of O-T-C solid dosage products in the United States. The company has grown steadily over the past 35 years due to the trust that it has earned from its national and inter- national customers, as well as from the increased awareness and satisfaction consumers have regarding the quality of private label brands LNK manufactures. LNK continues to invest in FDA fil- ings and state of the art manufacturing equipment resulting in the manufacture of new quality formulas and products. For more information, visit www .lnkintl.com, call 631.435.3500, email dbausch@lnkintl.com or stop by Meeting Space #230. J. BRIAN BRUCE NAMED VP BUSINESS DEVELOPMENT INTEGRATED MEDICAL PARTNERS, LLC Integrated Medical Partners, LLC (IMP) announces the addition of J. Brian Bruce as Vice President of Business Development. Bruce brings significant knowledge and expertise to IMP, with 27 years of experience in the healthcare industry including sales and marketing strategy in the anesthesia revenue cycle management space as well as technology start-ups. Prior to joining IMP, Bruce helped bring to market Vigilant Health, a work- ing clinical model for the Perioperative Surgical Home. Bruce previously served as Senior Vice President of Business Development at Medac, Inc. and Kam Technologies LLC for 10 years, where he led sales initiatives to help grow the com- pany's market share. "IMP provides hospital-based physi- cian practices and related multispecialty groups a new practice model of collabo- ration," said Burce, "built upon business intelligence capabilities enabling the reporting of patient outcomes. I am thrilled to join IMP and help medical practices run their businesses more effec- tively with specific practice benchmark- ing, clinical and financial informatics, and patient outcome reporting." "Brian is professional, knowledge- able and fully aligned with our overarch- ing goals," said William G. Pickart, CEO. "He is an expert in his field, and we could not have asked for a more dynamic leader to head our anesthesia and multi-special- ty group-based business development initiatives." GRADALIS, INC. ANNOUNCES PHASE 2 DATA OF OVARIAN CANCER PATIENTS WITH VIGIL Gradalis Inc., a late-stage biopharmaceu- tical company, today announced that Phase 2 data for its proprietary personal- ized immunotherapy, Vigil™ (previously named FANG), in the treatment of women with Stages III/IV ovarian cancer were presented in Chicago at the 2015 Annual Meeting of the Society of Gynecologic Oncology. Dr. Jonathan Oh presented data from a multicenter, randomized, open-label Phase 2 trial where women with Stages III/IV high-risk ovarian cancer, who had completed primary surgery and chemotherapy in clinical complete response were randomized 2:1 to Vigi immunotherapy or standard-of-care observation. Vigil therapy was prepared from each patient's own tumor cells obtained at initial surgical debulking and was administered as a standard intrader- mal injection once a month for up to 12 doses. Patients were followed for safety and relapse-free survival (RFS). In 31 randomized patients, all of whom had Stage IIIc or IV cancer, the Vigil-treat- ed patients (N=20) achieved a median RFS of 19.3 months versus 12.4 months in the control patients (N=11), p=.084. No adverse events greater than Grade 1/2 local injec- tion-site irritation/induration were observed in the Vigil-treated patients. "These data demonstrate the poten- tial of Gradalis' innovative personalized immunotherapy, Vigil, to improve tumor control in a setting where no other thera- py is currently approved," said Joseph M. Limber, President and Chief Executive Officer of Gradalis. The company announced this February the initiation and first patient tumor procured on a con- firmatory randomized placebo controlled Phase 3 trial in this patient population. The current Phase 3 trial forms the basis for the Gradalis personalized immunotherapy program. The ovarian cancer program is the first of several development directions utilizing this personalized immunotherapy. Another clinical-stage program targets treatment of high-risk patients with relapsed Ewing's sarcoma, and a Phase 1 pro- gram supports development in multiple other solid tumors.