Welcome to Alitair Pharmaceuticals, Inc.

Alitair is a specialty pharmaceutical company with a focus on the respiratory space. Currently, we are developing two orphan drugs for bronchiectasis. We expect to begin phase II clinical trials for both compounds within the next 6 months.

We also have products under development for prescription and over-the-counter cough treatment. Our lead cough candidate is a solid oral dosage form of benzonatate which is protected by a composition-of-matter patent.

Currently, Alitair has four issued patents and we expect to expand our patent portfolio in the near future.

Contact us for more information about our orphan drug candidates, our overdose reduction technology, and our cough licensing opportunities.


 

Orphan Drug Strategy

Alitair’s strategy is to acquire late-stage orphan drug products already approved for therapeutic use outside the United States. This in–licensing-based approach is extremely efficient. In our experience, a typical European-approved product can move rapidly to a late-stage Phase II trial and sometimes a Phase III trial in the United States. To this end, we recently in-licensed ALT-07 and ALT-09, two drugs that are widely used to treat various respiratory diseases; we intend to develop these products for several orphan respiratory indications in the United States.

ALT-07 possesses many characteristics that make it an exciting alternative to current therapies in the orphan respiratory disease space. ALT-07 is administered orally, so it has much higher levels of compliance and adherence when compared to the current, predominantly inhaled treatments. Fundamentally, ALT-07 is safer and better tolerated than inhaled long-acting beta agonists (LABAs) and inhaled cortico-steroids (ICS), which are currently the mainstay of orphan respiratory disease treatment. Recent studies regarding the use of long-acting beta agonists have suggested that in rare cases severe asthma attacks and deaths may be associated with their use, resulting in a black box warning for LABA medications. Additionally, there is evidence that inhaled steroids may be associated with growth retardation in children and osteoporosis in adults. ALT-07 delivers both bronchodilation and anti-inflammatory effects in one oral drug without these side effects. We were granted orphan drug designation for ALT-07 for the treatement of bronchiectasis in the United States.

ALT-09 is a mucolytic drug approved for the treatment of chronic bronchitis and chronic obstructive pulmonary disease (COPD) in more than 30 countries. ALT-09 is also an oral agent, so it will likely delivery the benefit of improved compliance versus ICS. Three clinical trials of ALT-09 for the treatment of bronchiectasis in conjunction with chest physiotherapy have been completed. All three studies showed a significant benefit from adding ALT-09 to the treatment regimen. The studies showed a significant treatment effect on foreced expiratory volume in one second (FEV1) and forced expiratory vital capacity (FEVC). We received an orphan drug designation for ALT-09 for the treatment of bronchiectasis in the United States.




Management

Jim Hoyes Ceo

Jim Hoyes is a proven, effective leader with strong commercial results and broad biopharmaceutical experience across multiple therapeutic areas and specialty spaces.

Prior to joining Alitair as our CEO, Jim has had a long and successful career in the pharmaceutical industry. He founded and led the consulting firm RxC to a global presence and consulted with many leading pharmaceutical companies including: J&J and Novartis.

Prior founding RxC Jim was President and Head of US operations at EMD Serono, Inc. from 2011 to 2013. As President of EMD Serono, he developed and executed the Merck KGaA business plans for the US Market. He had full P/L responsibility for the US commercial business and grew the business from $600M in sales to $2 billion in sales. Jim averaged double-digit growth at EMD Serono in his tenure.

His areas of direct responsibility include Medical, Regulatory and BD; indirect responsibility for US activities of Global Research & Development based in Billerica, MA as Managing Director of US. During his tenure as President, Jim built and developed a high performing Executive Leadership Team. He also served as the key member of the Merck Serono Global Operations Committee.

Jim successfully executed General Manager and Managing Director responsibilities. He was also responsible for operations in Rockland MA, Billerica MA and Washington DC.

Jim was also responsible for implementing the US portion of Merck’s “Fit for 2018” program to improve profitability. He also successfully implemented a Corporate Integrity Agreement; Chief Compliance Officer was a direct report. As lead US executive, he served as Merck’s representative on industry trade groups (PhRMA, BIO) and with government officials in MA and Washington, DC.

Jim Hoyes has a long track record of creating strategies and driving exceptional performance in the life sciences sector. In addition to providing advisory services to clients, Jim focuses on corporate development initiatives in the life sciences sector and the implementation of key strategic initiatives designed to scale up the firm’s global operations. Jim has deep expertise in all areas of corporate development and commercialization of pharmaceutical and biotechnology products. He has led a number of financial transactions including licensing and M&A deals.

Jim is on the board of MassBIO and has served on the boards of PhRMA and BIO. Jim is also involved with the boards of several non-profit community service organizations in the greater Boston area. Jim received a B.S. in Biology from Penn State University

William W. HowardPresident & Chairman

Dr. William W. Howard has twenty-five years of pharmaceutical experience ranging from laboratory research, to the roll out of sales forces in Europe, to the development of new FDA approved products. Howard has worked to develop new products in many categories of prescription and OTC drugs including COPD, Cough, Smoking Cessation, Cholesterol Reduction, Anti-Ulcer, Anti-Arthritic and Migraine therapy. He began his pharmaceutical career with research on drugs of abuse. Following a stint of teaching at Dartmouth College and a post-doctoral at Northwestern, he entered the pharmaceutical industry with the Miles Labs division of Bayer and then moved to Parke-Davis as head of Marketing Management Science. He left Parke-Davis to found Ellard Inc., a pharmaceutical marketing software company and later, after selling Ellard, he founded SDM Inc., a highly successful global consulting firm. Dr. Howard became involved with Adams in 2001 when the first approval letter for Mucinex® was received and he was asked to help with the unexpected OTC status of the product. He continued as a consultant for Adams until 2004 when he joined the company and later became Senior Vice President of New Products and Business Development.

As Sr. VP, he managed all new product development initiatives and all corporate M&A, business development and licensing activity for the company. In addition, he was responsible for managing the development of new intellectual property on a global basis. Dr. Howard was a member of the Business Operations Team (BOT) and was the key driver of the development of the strategic plan employed by Adams. He played a critical role in the initial contact with Reckitt-Benckiser.

William Howard received a Bachelor's and Master's degree from Cleveland State University and a Ph.D. in Experimental Psychology and Statistics from the University of New Mexico. He did post-doctoral work in epidemiology at the Center for Health Services at Northwestern University where he did research on infant mortality. He holds an MBA from Frederick Taylor University.

Peter Wolfe Chief Financial Officer

Mr. Wolfe has spent his career in various financial roles in the financial services, specialty finance and the pharmaceutical/healthcare industries. Most recently Mr. Wolfe has spent his time cultivating start-up organizations in various healthcare entities, often dealing with complicated business models to develop a financial framework for success for many of these first of their kind businesses. Mr. Wolfe has spent the last 14 years of his career in the healthcare industry with half of that time spent at Kos Pharmaceuticals, a publicly traded, fully-integrated specialty pharmaceutical company. Mr. Wolfe assisted in guiding Kos to 27 straight quarters of meeting or exceeding Wall Street quarterly earnings estimates. Finding the most cost-effective way to run a business through the design of more efficient systems is the hallmark of his career achievements. Mr. Wolfe has his BBA from the University of Miami and his MBA from the University of Pittsburgh.

Helmut H. Albrecht, MD, MS, FFPM Chief Scientific Officer

Dr. Helmut H. Albrecht is Chief Scientific Officer at Alitair. He is a 25+ year veteran of the pharmaceutical business and brings a wealth of product development experience to Alitair. Most recently, Helmut was head of R&D at Adams Respiratory Therapeutics (Adams) where he managed a wide variety of product innovation as well as clinical and other development projects for various respiratory conditions (esp. in cough, COPD and allergy). He was also a member of the senior management team at Adams. Prior to joining Adams, Helmut was VP of global Preclinical and Clinical Development and Drug Safety for the Novartis Consumer Health (NCH) OTC business unit and before the globalization of the NCH R&D organization, he served as VP for R&D OTC, North America with responsibility for all R&D functions in the NCH OTC business unit in NA. Earlier in his career he held key positions in the area of pharmaceutical medicine, involving Rx and OTC drugs as well as dietary supplements at SmithKline Beecham Consumer Health, Procter & Gamble OTC Health Care and P&G Pharmaceuticals, and Altana Pharmaceuticals. Helmut has a doctor of medicine from the University of Heidelberg as well as a Master of Science degree in Management & Policy and an advanced New York State Certificate in Health Care Management from SUNY at Stony Brook. He has a diploma in pharmaceutical medicine and is a fellow, as well as previous board member, of the Faculty of Pharmaceutical Medicine (FFPM).

Allen LangjahrGeneral Counsel

Allen Langjahr serves as General Counsel for Alitair. Mr. Langjahr brings more than 27 years of experience as a corporate and healthcare lawyer to his role at Alitair. Mr. Langjahr served as in-house General Counsel to two PBMs, pharmacies, and a specialty insurance company providing prescription drug benefit coverage. Representative clients include Fortune 500 companies, Part D PDP applicants and plans, PBMs, pharmaceutical companies, health information technology and chain, mail order, and specialty pharmacies. Mr.Langjahr's corporate and healthcare experience includes advice and counsel on strategic planning, regulatory compliance, healthcare transactions, intellectual property matters, due diligence/acquisitions, start-up financing, and general corporate matters. Mr.Langjahr graduated with a Bachelor's degree in Accounting from Walsh College University and a Juris Doctorate from Vanderbilt University School of Law. Mr.Langjahr is admitted to practice law in California and New Jersey. He is a member of the American Health Lawyers Association, the Academy of Managed Care Pharmacy and the National Council for Prescription Drug Programs.

Russell F. Somma, Ph.D.Research and Development

Russ Somma is an industry veteran with over 30 years of product development experience, primarily at Ciba-Geigy / Novartis. While at Novartis he held a series of positions in early and late stage product development as well as process introduction which culminated in his position as Technical Project Leader responsible for several novel oral solid dosage forms. He is currently President of SommaTech, LLC a consulting firm focused on helping clients meet the manufacturing and quality control requirements for FDA new product approvals. He has assisted several clients in overcoming FDA Consent Decrees that required total cessation of all manufacturing operations. With Dr. Somma’s help, several have resumed full production operations.

Over the span of his career, Dr. Somma has been involved with every phase of product development from bench top formulations and pilot scale manufacturing to the establishment of full commercial scale operations. Multi-particulate systems are a particular expertise for Somma.

He has been involved in the development, approval and PAI of over 25 NDAs so has considerable experience working with the FDA. Indeed, he received a “Special Recognition Award” from Janet Woodcock, MD of FDA for his work in developing the SUPAC-IR Equipment Guidance. Further, he was awarded the “Hammer” by then VP Al Gore for his efforts to reduce red tape and help improve through put at FDA in the area of manufacturing equipment similarities and process technology.

Dr. Somma has more than 30 publications and presentations in the area of development, manufacturing and quality by design. He is Past Chairman of the International Society of Pharmaceutical Engineers (ISPE) Product Quality Lifecycle Implementation (PQLI) Committee.

He received his BS, MS and Ph.D. in Pharmaceutical Science from Rutgers University. He is a registered pharmacist, as well.

Frank L. KoosVice President, Business Development

Frank Koos serves as Vice President of Business Development at Alitair. He is a sales, marketing, and business development leader with over 20 years of experience in the pharmaceutical industry. Koos has a proven track record driving growth at start-up and leading global companies. Koos has held multiple executive leadership roles throughout his career including Senior Vice President of Sales, Marketing, and Business Development for MiddleBrook Pharmaceuticals, which launched the first FDA-approved once-daily amoxicillin.

Koos also served as the Vice President of Professional Sales at Adams Respiratory Therapeutics and continued in that role after global consumer goods powerhouse Reckitt Benckiser acquired Adams. Prior to Adams, Koos held successive leadership roles including Vice President of Sales for PharMetrics and Group Director, Sales and Service at IMS Health. Previously, Koos was a sales representative and a sales trainer for the Ortho Pharmaceutical division of Johnson and Johnson, and he served as a lieutenant in the United States Army. Koos graduated from Lehigh University with a Bachelor of Arts degree.

Faith Pomeroy-Ward Senior Vice President, Corporate Development

Faith Pomeroy-Ward has over a decade of corporate communications, marketing, and business development experience in the pharmaceutical industry, and she is a prize-winning writer. She has worked on many high-profile brands including Mucinex®, Delsym®, Verizon®, Moxatag®, Cepacol®, BiDil®, Eylea® and Twinings®.

Ms. Pomeroy-Ward began her pharmaceutical career in 2004 with a role in the marketing department at Adams Respiratory Therapeutics, the maker of Mucinex®. In 2005, she was promoted to the investor relations/corporate communications function. When Adams was acquired by Reckitt Benckiser in 2008, she joined Verizon Telecom in its public affairs department. Ms. Pomeroy-Ward was then recruited to lead the investor relations and corporate communications function at MiddleBrook Pharmaceuticals. In that role, she managed all aspects of the company's corporate communications and investor relations programs. She also held key responsibilities in business development and marketing. In 2010, Ms. Pomeroy-Ward began providing corporate communications, investor relations, and marketing consulting services. In 2011, she joined Alitair Pharmaceuticals as Vice President, Corporate Development.




Advisory Board

John Q. Adams Sr.

 John Q. Adams, Sr., serves as president of J.Q. Enterprises, a holding company for his interests in real estate and ranching. During Mr. Adams’ long career in the pharmaceutical industry, he owned three companies: Baylor Laboratories, sold to Norwich Eaton Pharmaceuticals; Allerderm, Inc., sold to Virbac Inc., in France; and Adams Laboratories, a private pharmaceutical company focused on respiratory therapy, sold to Medeva Pharmaceuticals, where from 1991 to 1995, he served as President of Medeva Americas. Mr. Adams later repurchased Adams Laboratories from Medeva and served as its Chairman and Chief Executive Officer. Adams Laboratories changed its name to Adams Respiratory Therapeutics, and Mr. Adams served as Chairman of Adams Respiratory Therapeutics Inc. until October 14, 2005. He has been Vice Chairman of CereScan, Inc ., since June 2009 and its Director since March 2009.

Mr. Adams has served as a Director on several other Boards throughout his career, including Respirics, Inc., Adamis Pharmaceuticals Corporation, Medeva Americas, and Cellegy Pharmaceuticals Inc. He also retains memberships and board positions in several professional and philanthropic organizations, including the American College of Allergy and the Vanderbilt University Voice Center. In July 2007, he was elected to the Board of Trustees for Heidelberg College in Tiffin, Ohio, and in April 2009 he was inducted into the Hall of Excellence of the Ohio Foundation of Independent Colleges which each year honors three distinguished graduates from 34 Ohio colleges. He is also an Honorary Fellow of the American Academy of Otolaryngology-Head and Neck Surgery. Mr. Adams holds a degree in Biology from Heidelberg College.

Robert D. Casale

 Robert D. Casale is a pharmaceutical industry veteran and currently serves as a Director on several Boards, including the Board of Directors for First Aid Shot Therapy, Novalere, and Insight Pharmaceuticals. Previously, Bob served as a Director for NextWave Pharmaceuticals, and he was Chairman of the Board of Directors for Topaz Pharmaceuticals, Inc.

Bob also co-founded Scerene Healthcare, Inc., in 2009 and served as its Chief Executive Officer. Prior to that, Bob served as COO of Adams Respiratory Therapeutics Inc., since October 2006. Bob served as Chief Development Officer, Chief Marketing Officer and Executive Vice President of Adams Respiratory Therapeutics from May 2005 to October 2006. Previously, Bob was Vice President, Business Development and Strategic Planning, for Pfizer, Inc., and he led development of a strategic plan for the newly merged Pfizer and Warner-Lambert consumer businesses.

Beginning in 1986, Bob served in many capacities at the former Warner-Lambert Company. Bob began his career at Warner-Lambert in their legal division, and later became lead counsel for Parke-Davis, the company's pharmaceutical business. He also served as lead counsel for the parent company on all acquisitions, merger, and licensing transactions. Subsequently, he was appointed Warner-Lambert's vice president of marketing for upper respiratory and gastrointestinal (GI) consumer products, including Benadryl®, Sudafed®, Zantac 75®, and Rolaids®. Bob also served as a Global Vice President for Warner-Lambert's GI and skin care businesses.

Bob received a bachelor's degree in business administration and English from Rutgers College in 1980 and a juris doctorate, with honors, from the Rutgers Law School in 1983.

Gene Colice

Dr. Gene Colice is a practicing physician, serving as Director, Pulmonary Critical Care and Respiratory Services at Washington Hospital Center in Washington, D.C. In addition to his duties as a physician, Dr. Colice is also a Professor of Medicine at The George Washington University School of Medicine. He is a Fellow of the American College of Chest Physicians (ACCP) and a member of the American Thoracic Society (ATS). He is currently a member of the editorial board for Respiration and Chest. Dr. Colice has more than 300 publications, presentations and book chapters.

In addition to his medical practice and publications, Dr. Colice has worked in the pharmaceutical industry as a consultant to Adams Respiratory Therapeutics and was Director, Clinical Research at 3M Pharmaceuticals where he created clinical development plans, consistent with strategic business focus, to maximize commercial opportunity for respiratory products and to provide medically necessary safety and efficacy information. He was responsible for preparation of all respiratory study protocols, regulatory filings and scientific manuscripts and for interpretation and analysis of all study data. Specific projects included asthma products (inhaled beta-agonist bronchodilator and inhaled steroids) through NDA and worldwide approval and into Phase IV studies.

Dr. Colice received his medical degree from New York University Medical School in New York, NY, and performed his internship in Internal Medicine at New York University Medical Center, New York, NY, and his residency in Internal Medicine at Bellevue Hospital in New York, NY. He then completed a fellowship in Pulmonary and Critical Care Medicine at Yale-New Haven Medical Center in New Haven, Conn. Subsequently, he was a Professor of Medicine at the Dartmouth Medical School. 




Cough

Focus on Rx and OTC Cough/Cold Products

The Rx cough market is about 25 million prescriptions per year. There are significant unmet needs in the Rx market, particularly the non-narcotic segment. Recent concerns about abuse and overdose associated with narcotics have produced some dramatic shifts in the cough market. Ten years ago, the Rx cough market was about evenly divided between codeine and hydrocodone based products. As the chart below shows, prescriptions for hydrocodone have fallen with significant gains by benzonatate, the only non-narcotic Rx cough product.


It is our core belief that the prescription cough market is large and underserved with significant opportunities for new products, particularly non-narcotic products with patent protection. As the figure below shows, there were approximately 26 million patient visits for cough in 2007. Since there are approximately 25 million cough medicine prescriptions are filled annually, the ratio of visits to prescriptions is high.

R&D Strategy

Alitair’s development strategy emphasizes speed, low research & development costs, and efficient regulatory and marketing strategies. Alitair has had 6 pre-IND meetings with the FDA. These meetings can be used to gain valuable insights into FDA’s view of the proposed development path. As a result of these meetings, Alitair can develop its products using the 505(b)(2) route. No clinical efficacy trials and no safety or pre-clinical studies are required. Instead, Alitair will conduct pharmacokinetic studies (PK). The Company has written correspondence from the FDA supporting these points.

We believe the opportunity for our benzonatate product has an estimated sales potential approaching $100 million annually. Alitair also has a very strong patent portfolio around our benzonatate formulation as the chart below shows.




ODR

Overdose Reduction Technology: ODR™

Alitair's patented overdose reduction formulation ODR™ acts as a passive drug formulation system to reduce the risk of prescription drug overdose no matter how many tablets or capsules are ingested. ODR™ technology provides appropriate release of a drug at labeled doses but limits drug release at excessive doses.

The Prescription Drug Overdose Crisis

Prescription drug overdose is a growing crisis in the U.S., resulting in more than one million emergency department visits annually, at an estimated cost of $4 billion per year. Those one million emergency department visits result in as many as 150,000 hospital admissions per year at an estimated cost of $1.4 billion annually. Prescription drug overdoses result in more than 20,000 deaths annually, more than double the number of deaths caused by illegal drug abuse. Clearly, there is an urgent need for a technology that can reduce prescription drug overdose events.


Overdose Reduction Strategy: ODR™

Although the need for over dose reduction is great, there is presently no drug delivery technology adequately addresses this need. Alitair’s ODR™ technology is not a behavioral program and does not involve any training, education, or labeling. ODR™ is a drug delivery technology that functions passively as part of a drug’s dosage form, limiting the amount of drug released in the digestive system based on the total amount of drug ingested. With ODR™, safety is built in to the dosage form using approved excipients and well-established manufacturing technology.

These data demonstrate that ODR™ can regulate extent of drug release using the exact same formulation. Labeled doses have high extent of release, while excessive doses have low extent of release. Our ODR™ technology allows the labeled dose to work effectively but will protect an individual in the event of a higher dose, regardless of whether it is ingested by accident or intentionally.

Abuse Deterrence Properties Inherent to ODR™

ODR™ has the potential to protect patients from prescription drug overdose, and ODR™ also includes abuse deterrence properties. Our ODR™ technology cannot be circumvented by means commonly employed today, such as crushing the capsules or tablets and smoking or snorting the actives. Significant Market Opportunity for ODR™ Initial tests indicate that ODR™ will work across a broad range of prescription drugs including opioids, anti-depressants and tranquilizers. Clinical testing in humans is the next step for ODR™. We estimate the market at 200 million prescriptions. At a price of approximately $100 per prescription for products utilizing ODR™, ODR™ represents a $20 billion market opportunity.




Perks & Opportunities

Current Offerings