PHARMACY

REX Awards 2019: Generics

BY Sandra Levy

Who are the stars of the generics industry?

They are the companies that truly are making a difference in health care, helping consumers save money and giving retailers another option to offer their shoppers. According to the Association for Accessible Medicine’s 2018 Generic Drug Access & Savings Report, in 2017, generics generated a total of $265 billion in savings.

This month, Drug Store News recognizes the cream of the crop of the generics industry with our Retail Excellence, or REX, Awards. The winning companies were selected for their excellence in these highly competitive times. These are companies that go the extra mile for their customers and they also unquestionably are leaders in innovation.

Here are the 2019 REX Awards winners for the generics category:

Alembic Pharmaceuticals
Bridgewater, N.J.–based Alembic Pharmaceuticals is a subsidiary of the oldest pharmaceutical company in India. Established in 1907 and employing more than 8,000 people, Alembic’s parent company supplies products to more than 90 countries.

Armando Kellum, vice president of sales and marketing, described Alembic as “a vertically integrated organization with expertise spanning across the entire pharmaceuticals value chain, including research and development, manufacturing, and marketing of finished dosage formulations, and active pharmaceutical ingredients, or API, and intermediates.”

Alembic recently received its first approvals for drug dosage forms for dermatology and ophthalmic products. “The company invested over 13% of company-wide sales back into R&D, with 90% plus of that dedicated for the U.S. market,” Kellum said.

Since October 2015, Alembic has launched more than 45 product families and 200 SKUs in the United States. This year, it expects to launch more than 10 new domestic products. “Alembic is committed to differentiating itself in one key category: supply. Alembic strives to have 90-plus days of inventory in stock to cover current and potential needs of our customers. We strive to maintain very high service levels for committed customers, even if this means declining new business. Supply consistency and reliability form the basis of strong relationships with our customers, and consistency for healthcare providers and ultimately patients,” Kellum said.

Amneal Pharmaceuticals
In 2002, Bridgewater, N.J.-based Amneal was founded by Chirag and Chintu Patel, who continue to serve as co-chairmen of the company’s board. Since then, Amneal has grown organically and through mergers and acquisitions to become one of the leading U.S. generic pharmaceutical companies.

The company markets a portfolio of approximately 200 generic product families, including complex dosage forms in a broad range of therapeutic areas. The company also markets a portfolio of branded pharmaceutical products. Amneal recently launched generic Exelon Patch.

“The product is Amneal’s first transdermal product, and demonstrates the company’s commitment to develop and bring to market complex generic products. In its specialty business, IPX203 — an investigational drug being studied for the treatment of Parkinson’s disease — has advanced with the dosing of the first patients in a Phase III clinical trial,” said Andy Boyer, executive vice president of commercial operations.

Amneal has completed the renovation and expansion of its Brookhaven, N.Y. production facility, allowing for additional capacity. It also completed construction of a new 80,000-sq.-ft. distribution facility in Glasgow, Ky.

In 2018, Amneal had 62 abbreviated new drug application approvals, 10 tentative approvals and 42 new products launched. “Thirty-seven percent of the company’s new product launches were from injectable, topical or liquid products, further diversifying our portfolio of more than 200 generic products,” Boyer said.

Anda
Weston Fla.-based Anda was established more than 25 years ago as a niche distribution service of generic pharmaceuticals to U.S. retail independent pharmacies. Over the years, the company developed the product portfolio and distribution capabilities to support the needs of customers, ranging from small independent retail pharmacies in rural areas, long-term care pharmacies and regional chains to national chains.

Today, Anda is one of the leading pharmaceutical distributors within the United States, Puerto Rico and the U.S. Virgin Islands, servicing customers that span across all trade classes within health care. They carry items from nearly 400 manufacturers, including brand, generic and specialty pharmaceuticals; as well as vaccines, injectables, diagnostic tests, medical and surgical supplies, OTCs, vitamins and pet medications.

Anda president Chip Phillips pointed out that the company remains committed to being the trustworthy and flexible resource that customers can rely on to “get what they need, when they need it.”

“Our most recent solutions are capable of supporting the primary and secondary needs of our customers in this ever-changing
industry,” Phillips said. “Good examples of this include our new website, which recently launched, Automated Secondary program, and Customer Dedicated Inventory, or CDI, program. All of these solutions can be customized, which is what enables us to meet the unique needs of each customer.”

The company’s CDI program positions Anda as an extension of its customers’ distribution centers. “We systematically guarantee inventory, so that your product is for your use only,” he said. “At Anda, our people are what makes us unique. Our goal is to provide exceptional service to our customer and vendor partners. We hire remarkable people who are committed to exceed our customer’s expectations. We work closely with our customers and our vendors to understand their needs so together, we can develop meaningful, customizable solutions to support them.”

Ascend Labs
Ascend Labs, based in Parsippany, N.J., launched its label into the market in 2008 with three products. In 2010, Ascend sold a minority interest in itself to Alkem in exchange for marketing exclusivity on any U.S. approvals that Alkem obtained.

By 2012, Ascend sold its remaining shares, and today is a wholly-owned subsidiary of Alkem, which is a $1 billion company with seven manufacturing campuses in India and several in the United States, including an API facility in California and a finished dose facility in St. Louis.

While originally targeting easy-to-manufacture molecules, Ascend targets more difficult molecules to distinguish itself from competitors. “Ascend markets over 40 molecules, which, when considering all strengths and sizes, accounts for about 150 SKUs,” Ascend’s executive vice president John Dillaway said.

Ascend has significant capacity with two existing manufacturing campuses in India dedicated to the U.S. market, and two facilities in the United States. The company’s research and development team are comprised of more than 500 scientists, of whom more than 100 have doctoral degrees.

Dillaway said Ascend has built a significant infrastructure between its manufacturing capabilities and its experienced team of account executives, becoming well known for its ability to supply, and the quality of information and partnership it brings to market.

Ascend has just completed a large physical expansion to its two existing Indian manufacturing campuses, doubling its current manufacturing capacity. It also has broken ground on the third manufacturing campus in India dedicated to the U.S. market — seventh overall for Alkem.

“When complete in 2020, this new facility will double again our capacity, leaving us in a good position to not only stay in our existing molecules, but to handle the over 50 more we have submitted to the FDA and [are] awaiting approval,” Dillaway said.

Aurobindo Pharma
Founded more than 30 years ago, East Windsor, N.J.-based Aurobindo Pharma was created by Ramprasad Reddy, Nityananda Reddy, and a small group of scientists and engineers. The company began operations with a single manufacturing unit specializing in semisynthetic penicillin.

“Aurobindo has managed to grow its business rapidly, both organically and by way of strategic acquisitions, to be one of the leading companies in the industry,” said Paul McMahon, vice president of commercial operations.

Aurobindo continues to focus on its core strengths of vertical integration and large-scale manufacturing. The company has been among the generic firms receiving the highest number of product approvals for several years, and currently ranks third in terms of total volume in the U.S. market. Aurobindo currently has more than 500 ANDAs filed with the FDA and more than 300 final approvals, McMahon said.

Aurobindo recently commercialized its newest large-scale manufacturing facility, unit-10, bolstering its portfolio of large-scale manufacturing infrastructure. It has expanded through various acquisitions both in the United States and European Union, and also has expanded into new therapeutic categories and delivery methods.

The company recently reached a definitive agreement to acquire Sandoz’s U.S. oral solids and dermatology business units. “We look forward to delivering the benefits of this transaction to all our stakeholders, including employees, patients, customers and healthcare providers across the United States,” said Aurobindo managing director Govind Narayanan.

Camber Pharmaceuticals
Piscataway, N.J.-based Camber Pharmaceuticals’ goal is balancing supply and demand from pipeline to patient.

“For over 10 years, Camber Pharmaceuticals has been one of the fastest-
growing generics companies in the U.S. Camber’s commitment is to bring the highest quality generic pharmaceuticals to the market, and to improve quality of life through cost-effective medications,” said company president Kon Ostaficiuk.

Ostaficiuk said that Camber has numerous product launches scheduled for the next 12 months, and that the company is known for exceptional customer service and its dedicated team of seasoned sales professionals with deep experience in the generics industry.

Camber’s goals include strengthening strategic partnership alliances; anticipating and responding to customer needs; maintaining transparency in all areas of business; committing to a reliable and high-quality supply of products; and ramping up tech transfers between facilities.

With well over 1 million sq. ft. of new manufacturing and warehouse space added in India and its new U.S. facilities, Camber now has more than 2.5 million sq. ft. solely dedicated to the U.S. market.

“We are more than 90% vertically integrated on all our products. In addition to our new manufacturing facilities, Camber’s new corporate headquarters and expanded warehouse space are currently under construction,” Ostaficiuk said. “This more than doubles our current warehouse space, which allows us to maintain a robust inventory of the products our customers need most.”

Camber’s current portfolio includes 54 products (152 SKUs), 46 of which are manufactured by Hetero Drugs and eight manufactured by Ascent Pharmaceuticals. Camber’s future pipeline includes 55 ANDAs filed or under review, and 15-plus ANDAs projected for release in 2019.

“Today, our parent company, Hetero Drugs, is the largest privately-held pharmaceutical company in India and a world leader in API production, with strong global presence in over 120 countries. Saving lives is their passion, and they continue to help shape a healthier world through affordable medications as they have for over 25 years,” Ostaficiuk said.

Dr. Reddy’s Labs
Established in 1984 by scientist and entrepreneur K. Anji Reddy, Dr. Reddy’s Labs, based in Princeton, N.J., is an integrated pharmaceutical company, focused on affordable and innovative medicines.

With a vision of making medicines accessible to the millions in India, Anji Reddy developed the company’s first API ingredient, methyldopa, an important drug for the treatment of hypertension and cardiovascular disease that was unavailable in India until 1985.

By 1990, Dr. Reddy’s became the first Indian pharma company to export norfloxacin and ciprofloxacin to Europe and Asia.

Marc Kikuchi, CEO and head of North America generics, said that through its three businesses — pharmaceutical services and active ingredients, global generics and proprietary products — Dr. Reddy’s offers a portfolio of products and services, including APIs, custom pharmaceutical services, generics, biosimilars, and differentiated formulations.

The categories of medication the company offers, which include gastrointestinal, cardiovascular, pain management, oncology, anti-infectives, pediatrics and dermatology, are available in a variety of dosage forms, including tablets, capsules, injectables and topical creams.

Dr. Reddy’s in the United States offers more than 80 SKUs in more than 350 dosing presentations.

The company’s pipeline includes 113 pending applications, including 110 ANDAs and three New Drug Applications.

Key products include metoprolol, metoprolol ER, atorvastatin, zoledronic acid, azacitidine, decitabine, valganciclovir, and, most recently, buprenorphine and naloxone sublingual film.

Edenbridge Pharmaceuticals
Parsippany, N.J.-based Edenbridge Pharmaceuticals is a specialty pharmaceutical company focused on identifying, developing and marketing pharmaceuticals.

“Our approach is to work with best-in-class and like-minded industry partners to deliver our products to physicians and patients everywhere,” said Victor Borelli, Edenbridge’s senior vice president of sales and marketing.

Founded in 2008, the company launched its first product in 2010 and currently sells its commercial products through every major channel of the U.S. prescription pharmaceutical supply chain. “Seven of our products have launched with Edenbridge as the first generic or alternative supplier,” Borelli said.

In 2018, Edenbridge moved into a newly-
designed facility to support its growth. “We have more than doubled our headcount over the past two years with experienced talent and expect to grow by an additional 50% over the next year,” Borelli said.

Edenbridge is poised for aggressive growth with a pipeline that includes complex and limited-competition products.

“Our focus is on being the best partner possible to all parties in the supply chain from suppliers to patients,” Borellis said. “It drives everything we do, from ensuring supply, maintaining deep customer relationships, and continuing to develop and market high-quality products.”

Ingenus Pharmaceuticals
Founded in 2010, Orlando, Fla.-based Ingenus Pharmaceuticals’ mantra is, “We’re making a difference, one product at a time.”

Armed with a team of more than 140 developers and scientists, Ingenus is poised to file 25 ANDAs per year. Ingenus focuses on transdermal, parenteral, semi-solids, injectable, topical foams and sprays, and extended-release products.

By developing and manufacturing products across a multitude of dosage forms, Ingenus is focused on delivering innovative products that are manufactured to the highest standards, improving access to consumers and lowering overall costs across the healthcare continuum.

Lupin Pharmaceuticals
Lupin Pharmaceuticals, based in Baltimore, currently is the third-largest pharmaceutical company in unbranded and branded generics prescriptions dispensed in the United States, with 6.1% generic market share.

Lupin’s journey began in 2003 with three Baltimore-based employees and one U.S. generic product approval. The company markets a total of 168 generic products and has established a leading position in the cephalosporin, ACE-inhibitor, and
cholesterol-reducing product categories.

“Lupin has played to its strengths, focusing on increasing its market shares not only for new product launches, but by executing well to grow market shares for its existing products,” said Bob Hoffman, executive vice president of generics.

As of the end of 2018, Lupin is the market share leader in 68 generic products and among the top three in 120 products in the United States, Hoffman said.

“The majority of Lupin’s products are vertically integrated, which ensures quality control throughout each step of product development and manufacturing. This gives Lupin an unparalleled advantage over its competitors, as it is able to control its supply chain while offering competitive pricing,” Hoffman said.

Lupin aims to expand its pipeline to offer medications in new therapeutic areas, such as dermatology, pediatrics, women’s health, inhalation and complex injectables.

Sun Pharma
Founded in 1983 in India, Sun Pharma, which is based in Hawthorne, N.Y., has been in the United States since 1996. Sun Pharma has created a pipeline of branded products in dermatology, ophthalmology and oncology segments.

“Our global presence is supported by over 40 manufacturing facilities spread across six continents, several R&D centers and a multicultural workforce, comprising more than 50 nationalities,” said Anand Shah, senior director of pricing and marketing at Sun Pharma.

“Being a vertically integrated company, we have the capabilities to develop and manufacture products in the United States, as well as at other locations across the world.,” Shah said. “We are the largest generic dermatology company and amongst the top five branded dermatology companies in the United States.”

An example of the company’s research capabilities is evidenced by the Food and Drug Administration permitting the company to make doxorubicin HCl liposome available to patients when there was a product shortage.

Upsher-Smith Labs
Maple Grove, Minn.-based Upsher-Smith was founded in 1919 by an Englishman named Fredrick Alfred Upsher Smith, who sold a form of digitalis.

Upsher-Smith president and CEO Rusty Field emphasized that from its inception, Upsher-Smith placed a premium on serving patients and pharmacists with a strong focus on quality, honesty and ethics. Since being acquired in 2017 by Sawai, a publicly traded Japanese pharmaceutical company, Upsher-Smith has continued to innovate by diversifying and expanding its portfolio of products.

In fiscal year 2018, Upsher-Smith brought 75% of its ANDAs to market — a move that significantly expanded and diversified its product portfolio.

“What sets us apart from our competitors, however, is our commitment to sustainable growth to drive more value to patients, as well as our ability to provide high-level customer service, foster strong industry relationships and deliver a consistent product supply,” Field said. “In 2019, Upsher-Smith will celebrate its centennial. Even as we focus on portfolio expansion and diversification, we know we must hold tight to the core values that define us.”

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