PHARMACY

Shining stars: Luminaries in the generics industry

BY DSN STAFF

Generics continue to save the U.S. healthcare system money. The latest report from IQVIA and the Association for Accessible Medicines found that in 2018, generics drove $293 billion in savings, bringing the 10-year savings total from the drugs to $2 trillion. What’s more, generic medicines account for 90% of the prescriptions filled in the United States.

This month, Drug Store News is shedding some light on the luminaries of the generics industry who are committed to making cost savings possible, while simultaneously helping to keep patients healthy. What follows is a sampling of some of the standouts in the generics industry, what they are accomplishing, and what measures they are implementing to be positioned in the forefront of the generics industry.

Alembic Pharmaceuticals
Founded in 1907, Alembic Pharmaceuticals is based in Vadodara, Gujarat, India. Alembic USA began operation in May 2015.

Craig Salmon, president of U.S. operations, said that Alembic is known as a high-quality manufacturer of both API and finished goods for the United States and other markets. He also said the company has big plans that build on recent achievements.

“Alembic had a very busy year and recently launched our first products for dermatology, as well as our first ophthalmic products,” he said. “Also, we recently acquired an R&D facility in the U.S. In the future, we plan to launch a full suite of oncology and sterile injectable products. Our focus continues to be on being a reliable and quality supplier for our customers,” he said.

Salmon also said that the company’s customer base increasingly has become consolidated with more purchasing volume concentrated with fewer customers.

“The consolidation has led to an increased need for reliable supply partners. A manufacturer’s supply challenge may pose significant risk to the market and particularly patients,” he said. “ Alembic has invested heavily in quality and product development for the U.S. market both in terms of capital expenditures and R&D. Our investment includes a wide range of products, including dermatology, ophthalmics and injectables.”

Amneal
Bridgewater, N.J.-based Amneal was founded in 2002 by Chirag and Chintu Patel, who continue to serve as co-chairmen of the company’s board of directors.

Since then, Amneal has grown organically and through mergers and acquisitions to become one of the leading U.S. generic pharmaceutical companies. Today, Amneal markets a portfolio of roughly 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 focused primarily on central nervous system disorders, hypothyroidism and parasitic infections.

“Amneal is renowned for our quality culture, which is one of the core pillars of our success. We work to consistently meet or exceed quality, industry and global regulatory standards” an Amneal spokesperson said. “For each member of our team, quality is a mindset that helps us achieve our goal to make healthy possible. Every day, across all roles and functions, we embrace the idea that ‘quality begins with me.’”

Amneal recently received approval for and launched its generic version of the Exelon Patch, or rivastigmine transdermal system. “The product is Amneal’s first transdermal product, and demonstrates the company’s commitment to develop and bring to market complex generic products,” the spokesperson said.

Also, Amneal just completed the renovation and expansion of its Brookhaven, N.Y., production facility, allowing for additional capacity. The company also recently completed construction of an 80,000-sq.-ft. distribution facility in Glasgow, Ky.

“Amneal has distinguished itself within the generic industry through its diversified pipeline of complex, high value generic products,” said the company spokesperson, who noted that in 2018, Amneal led the U.S. generics industry in both approvals and launches, including 62 ANDA 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 its portfolio of more than 200 generic products.

Ascend Labs
Ascend Labs, based in Parsippany, N.J., introduced its label into the market in 2008 with three molecules. Today, Ascend markets more than 40 molecules, which when considering all strengths and sizes, accounts for about 150 SKUs.

“With many older molecules that have been rationalized out by other suppliers, Ascend has developed a strong reputation for supply,” executive vice president John Dillaway said. “By holding significant inventory at its distribution center and having completed extended dating studies on many of its products, Ascend has been able to take on new business right away, in many cases, for customers who have a sudden need.”

Ascend has 50 molecules currently awaiting approval and another 100 at various stages of development. “Ascend has focused on adding to its infrastructure rather than discontinuing items,” Dillaway said.
Ascend recently completed a major expansion of its Damon, India facility and has broken ground on what will be its newest manufacturing campus in Indore in central India. This new campus, which is expected to come on line in 2020, will double existing capacity.

“Customer service and its supply ability are Ascend’s distinguishing qualities, and it is working hard to stand out in these areas. With all of the consolidation resulting in larger buying entities, the ability to supply has become one of the most sought after qualities customers seek, and Ascend is putting great resources to work to be seen as a go-to company in this area,” Dillaway said.

Aurobindo Pharma
More than 30 years ago, Ramprasad Reddy, Nityananda Reddy, and a small group of scientists, engineers and professionals founded Windsor, N.J.-based Aurobindo Pharma with a single manufacturing unit specializing in semisynthetic penicillin.

Paul McMahon, vice president of commercial operations, said that Aurobindo has grown its business rapidly, both organically and through acquisitions, to be one of the leading companies in the generics industry. It continues to focus on its core strengths of vertical integration, large scale manufacturing, and a robust research and development portfolio.

Aurobindo 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. The company currently has more than 550 ANDAs filed with the FDA with more than 380 final approvals, McMahon said.

The company also is building for the future, recently opening its large-scale manufacturing facility, Unit 10, which is solely focused on growth in the U.S. market.

Aurobindo focuses on strategic portfolio management across a broad product line with no single product contributing more than 5% of total revenue. In recent years, the company has expanded into new therapeutic categories and delivery methods, such as injectables, oncology, hormones, oral contraceptives, ophthalmics, inhalations, metered dose and dry powder inhalers, biosimilars, and OTCs. “Aurobindo is well positioned in terms of scale, efficiency and cost-effectiveness through it expansive, yet lean operating model, and now ranks among the largest generics suppliers around the globe,” Aurobindo managing director Govind Narayanan, said. “Although this has been fueled largely by organic growth, the recently announced definitive agreement to acquire Sandoz’s U.S. oral solids and dermatology business units further advances Aurobindo’s aggressive growth strategy. This greatly strengthens the company’s vast market presence, as well as the scope and breadth of the partnerships it holds with key customers here in the United States.”

As a result of the Sandoz oral solids and dermatology acquisition, Aurobindo will be adding nearly 300 unique product families to its portfolio to ensure that the company remains one of the leading generic pharmaceutical manufacturers in the world.

Camber Pharmaceuticals
Kon Ostaficiuk, president of Piscataway, N.J.-based Camber Pharmaceuticals, said that for over 10 years, Camber has been one of the fastest-growing generics companies in the United States. He also said that Camber’s goal is balancing supply and demand from pipeline to patient.

“We have numerous new product launches scheduled for the next 12 months, which allows us to bring more value to our partners and the patients they serve,” Ostaficiuk said. “We are deeply focused on maintaining excellence in our supply chain, and continue to put people and procedures in place to accomplish this goal as we add to our portfolio.”

He also said that Camber is known for its Quocustomer service, which includes a dedicated team of seasoned sales professionals who have deep experience in the industry. The company has the goal of using these assets to build partnerships.

“In addition to providing a sustainable, long-term competitive advantage to our customers, 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,” Ostaficiuk said.

With its facilities and the addition of a new manufacturing and warehouse space in India, Camber has more than 2.5 million square feet dedicated solely to the U.S. market. The company also is constructing a new corporate headquarters and expanded warehouse space. “This more than triples our current warehouse space, which allows us to maintain a robust inventory of the products our customers need most,” Ostaficiuk said.

Camber’s current portfolio includes 54 products that encompass 152 SKUs. Forty-six of its products are manufactured by parent company Hetero Drugs, and eight are manufactured by Ascent Pharmaceuticals. Camber’s future pipeline includes 55 ANDAs filed/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,” Ostaficiuk said. “Saving lives is their passion, and they continue to help shape a healthier world through affordable medications as they have for over 25 years.”

Dr. Reddy’s Labs
Founded in 1984, Dr. Reddy’s Labs is based in Princeton, N.J., and Hyderabad, India.

In 1995, Dr. Reddy’s became the first pharmaceutical company in India to file a product patent in the United States. The company also was the first Indian pharma company to be listed on the New York Stock Exchange, as well as the first in the world to create a biosimilar monoclonal antibody — Reditux.

“More recently, as result of our strategy realignment exercise, we are working towards divesting some of our commercial operations, which do not have critical mass or scale,” Marc Kikuchi, CEO of North America generics, said. “The focus will be on developing high value, meaningfully differentiated products, and achieving self-sustainability on our R&D model.”

Dr. Reddy’s has been investing significantly in specialty business, which includes proprietary products and biosimilars. Almost one-third of the company’s total R&D spend was about $226 million for the last fiscal year, Kikuchi said.

“Going forward, we expect to be more selective on the assets we bet on and focus on developing high value, meaningfully differentiated products, while achieving self-sustainability on our R&D model,” he said. “As guided in our fiscal earnings call last month, the overall scale of investment is likely to remain at similar levels,” he said. “We still think that market conditions are favorable for us to grow. We want to create value by enhancing our product portfolio with a plan to launch over 30 new products in FY20.”

Recently, the company announced the launch of some complex products, including daptomycin for injection and isotretinoin capsules.

“There also are some launches which may participate in the competitive market space, however, most of these products are complementary to our existing portfolio offering and are backed by strong vertical integration to compete effectively in the market,” Kikuchi said.

Lupin Pharmacauticals
Lupin Pharmaceuticals, based in Baltimore, is dedicated to delivering high quality, branded and generic pharmaceutical products trusted by healthcare professionals and patients across the country, company officials said.

“Lupin is currently the third largest pharmaceutical company in unbranded and branded generics prescriptions dispensed in the United States, with a 6.2% generic market share,” Bob Hoffman, executive vice president of U.S. generics, said.

Lupin’s history began in 2003 with three Baltimore-based employees and one U.S. generic product approval. The company markets a total of 168 generic products.

“Lupin has established a leading position in the cephalosporin, ACE-inhibitor and cholesterol-reducing product categories,” Hoffman said. “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. As of the end of March 2019, Lupin is the market share leader in 65 out of 175 generic products and is among the top three in 129 out of 175 products in the United States.

Hoffman also said Lupin constantly is engaging with its trade partners and customers, and it has worked hard to strengthen its supply chain to ensure industry-leading service levels.

“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,” he said.

Lupin’s recent product launches include fluoxetine tablets 60 mg; testosterone gel 1.62%, which is the generic of AndroGel; cefixime capsules 400 mg, the generic of Suprax; clobazam tablets, the generic of Onfi; and its second inhalation product, budesonide inhalation suspension 0.5 mg/2mL, the generic of Pulmicort Respules.

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

Novitium Pharma
Founded in January 2016 and based in East Windsor N.J., Novitium Pharma specializes in the development, manufacturing and distribution of niche generic pharmaceutical products.

The company has established a growing commercial product portfolio and developed a pipeline of over 27 ANDAs, spanning a diverse range of dosage forms and therapeutic categories.

“We have built our company around a highly productive and efficient ‘R&D engine,’ permitting us to rapidly bring new products to market, all which are produced within our New Jersey-based manufacturing facility,” Novitium CEO Chad Gassert said.

Novitium has launched six new products since October 2018, including three products the FDA has designated as competitive generic therapies due to a lack of generic options.
The company just launched sildenafil for oral suspension 10 mg/mL, the generic of Pfizer’s Revatio for oral suspension, for the treatment of pulmonary arterial hypertension. “The FDA granted Novitium a competitive generic therapy designation for this product, as we were the first therapeutically equivalent generic approved,” Gassert said.

Finally, Gassert also said the generic pharmaceutical market rapidly is changing and that increased competition, a consolidating customer base, expanding patient demand and supply shortages have all created a rapidly fluctuating environment. “Our integrated, U.S.-based R&D and manufacturing operations allows the flexibility to rapidly address changing customer and market demands,” he said.

Upsher-Smith Labs
Maple Grove, Minn.-based Upsher-Smith was founded a century ago.

Upsher-Smith president and CEO Rusty Field said that from its inception, Upsher-Smith has been known for delivering high-quality, life-enhancing medications to the patients who need them, beginning with its first breakout product, a form of digitalis refined to a singularly high level of consistency.

“This first product established Upsher-Smith’s reputation for quality, consistency and reliability, a reputation that endures to this day,” he said.

Since being acquired by the Japanese generics company Sawai Pharmaceutical in 2017, Upsher-Smith has focused on expanding its generic portfolio. In 2018, Upsher-Smith launched generic versions of Cardura (doxazosin mesylate) tablets, Lomotil (diphenoxylate hydrochloride and atropine sulfate) tablets, Targretin (bexarotene) capsules and Onfi (clobazam) tablets and oral suspension. It also added Vigadrone (vigabatrin) for oral solution 500 mg to its branded neurology portfolio, which includes Qudexy XR (topiramate) extended-release capsules.

In that same year, the company entered into an exclusive agreement with a pharmaceutical partner to market and distribute a group of six ophthalmic and oticANDA products, with combined annual sales of more than $1.6 billion for the 12 months ended March 2018, according to IQVIA.

“In short, during a time period when only 36% of FDA-approved ANDA products launched, Upsher-Smith brought 75% of its approved ANDAs to market,” Field said, adding, “Like all generics companies, Upsher-Smith has faced significant pricing pressure in recent years, but it is well positioned for future growth. The company continues to increase efficiencies and align expenses with expected revenues, with the goal of investing in future endeavors.”

Upsher-Smith aggressively plans to pursue acquisitions of generic and targeted brand opportunities that leverage its commercial team’s capabilities. The company recently announced that it has entered into an agreement to acquire U.S. and other territory rights for migraine medications, Tosymra (sumatriptan) nasal spray 10 mg and Zembrace SymTouch (sumatriptan) injection 3 mg from Dr. Reddy’s.
In June, Upsher-Smith was honored with two Distribution Industry Awards for Notable Achievement in Healthcare, or DIANAs, for “Overall Manufacturer of the Year with sales less than $500 Million” and “Branded Pharmaceutical Product Manufacturer of the Year with sales less than $300 Million” by the Healthcare Distribution Alliance at its 2019 Business and Leadership Conference.

“Looking ahead, the company is investing in infrastructure to expand capabilities, strengthen overall competitiveness and enhance sustainable practices. Through one initiative, Upsher-Smith plans to consolidate all manufacturing into a single, optimized, built-for-purpose site, with the end goal of enhancing efficiency, expanding capabilities and ensuring overall product quality for decades to come,” Field said.

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